36322 Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules

DEPARTMENT OF HEALTH AND the addresses provided below, by make threats to individuals or HUMAN SERVICES August 31, 2021. institutions or suggest that the ADDRESSES: In commenting, please refer individual will take actions to harm the Centers for Medicare & Medicaid to file code CMS–1749–P. Because of individual. CMS continues to encourage Services staff and resource limitations, we cannot individuals not to submit duplicative accept comments by facsimile (FAX) comments. We will post acceptable 42 CFR Parts 413 and 512 transmission. Comments, including comments from multiple unique mass comment submissions, must be commenters even if the content is [CMS–1749–P] submitted in one of the following three identical or nearly identical to other ways (please choose only one of the comments. RIN 0938–AU39 ways listed): Current Procedural Terminology (CPT) Copyright Notice: Throughout this Medicare Program; End-Stage Renal 1. Electronically. You may submit proposed rule, we use CPT® codes and Disease Prospective Payment System, electronic comments on this regulation descriptions to refer to a variety of Payment for Renal Dialysis Services to http://www.regulations.gov. Follow services. We note that CPT® codes and Furnished to Individuals With Acute the ‘‘Submit a comment’’ instructions. descriptions are copyright 2020 Kidney Injury, End-Stage Renal 2. By regular mail. You may mail American Medical Association (AMA). Disease Quality Incentive Program, written comments to the following All Rights Reserved. CPT® is a and End-Stage Renal Disease address ONLY: Centers for Medicare & registered trademark of the AMA. Treatment Choices Model Medicaid Services, Department of Health and Human Services, Attention: Applicable Federal Acquisition AGENCY: Centers for Medicare & CMS–1749–P, P.O. Box 8010, Baltimore, Regulations (FAR) and Defense Federal Medicaid Services (CMS), HHS. MD 21244–8010. Acquisition Regulations (DFAR) apply. ACTION: Proposed rule. Please allow sufficient time for mailed Table of Contents comments to be received before the SUMMARY: This proposed rule would close of the comment period. To assist readers in referencing update the End-Stage Renal Disease 3. By express or overnight mail. You sections contained in this preamble, we (ESRD) Prospective Payment System may send written comments to the are providing a Table of Contents. (PPS) for calendar year (CY) 2022. This following address ONLY: Centers for I. Executive Summary rulemaking also proposes to update the Medicare & Medicaid Services, A. Purpose payment rate for renal dialysis services Department of Health and Human B. Summary of the Major Provisions furnished by an ESRD facility to Services, Attention: CMS–1749–P, Mail C. Summary of Cost and Benefits individuals with acute kidney injury Stop C4–26–05, 7500 Security II. Calendar Year (CY) 2022 End-Stage Renal Disease (ESRD) Prospective Payment (AKI). In addition, this rulemaking Boulevard, Baltimore, MD 21244–1850. System (PPS) proposes to update requirements for the For information on viewing public A. Background ESRD Quality Incentive Program (QIP), comments, see the beginning of the B. Provisions of the Proposed Rule including a proposed measure SUPPLEMENTARY INFORMATION section. C. Proposed Transitional Add-On Payment suppression policy for the duration of FOR FURTHER INFORMATION CONTACT: Adjustment for New and Innovative the coronavirus disease 2019 (COVID– [email protected], for Equipment and Supplies (TPNIES) for 19) public health emergency (PHE) and issues related to the ESRD PPS and CY 2022 Payment as well as proposals to suppress III. Calendar Year (CY) 2022 Payment for coverage and payment for renal dialysis Renal Dialysis Services Furnished to individual ESRD QIP measures under services furnished to individuals with Individuals With Acute Kidney Injury that proposed measure suppression AKI. (AKI) policy. This proposed rule also [email protected], for A. Background announces an extension of time for issues related to the Transitional Add- B. Proposed Annual Payment Rate Update facilities to report September through On Payment Adjustment for New and for CY 2022 December 2020 ESRD QIP data under Innovative Equipment and Supplies IV. End-Stage Renal Disease Quality our Extraordinary Circumstances (TPNIES). Incentive Program (ESRD QIP) Exception (ECE) policy due to CMS A. Background Delia Houseal, (410) 786–2724, for B. Extraordinary Circumstances Exception operational issues, and proposes to not issues related to the ESRD QIP. (ECE) Previously Granted for the ESRD score facilities or reduce payment to any ETC–[email protected], for issues QIP and Notification of ECE Due to ESRD facility in PY 2022. In addition, this related to the ESRD Treatment Choices Quality Reporting System Issues proposed rule includes requests for (ETC) Model. C. Proposed Flexibilities for the ESRD QIP information on topics that are relevant SUPPLEMENTARY INFORMATION: in Response to the COVID–19 PHE to the ESRD QIP. Further, this rule also Inspection of Public Comments: All D. Proposed Special Scoring Methodology and Payment Policy for the PY 2022 proposes changes to the ESRD comments received before the close of Treatment Choices (ETC) Model, which ESRD QIP the comment period are available for E. Proposed Updates to Requirements is a mandatory payment model that is viewing by the public, including any Beginning With the PY 2024 ESRD QIP focused on encouraging greater use of personally identifiable or confidential F. Updates for the PY 2025 ESRD QIP home dialysis and kidney transplants, to business information that is included in G. Requests for Information (RFIs) on reduce Medicare expenditures while a comment. We post all comments Topics Relevant to ESRD QIP preserving or enhancing the quality of received before the close of the V. End-Stage Renal Disease Treatment care furnished to Medicare comment period on the following Choices (ETC) Model beneficiaries. Finally, this proposed rule website as soon as possible after they A. Background B. Provisions of the Proposed Rule includes several requests for have been received: http:// information to inform payment reform C. Requests for Information (RFIs) on www.regulations.gov. Follow the search Topics Relevant to ETC Model under the ESRD PPS. instructions on that website to view VI. Requests for Information DATES: To be assured consideration, public comments. CMS will not post on A. Informing Payment Reform Under the comments must be submitted at one of Regulations.gov public comments that ESRD PPS

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B. Technical Expert Panels (TEPs) 2. Coverage and Payment for Renal information on several important topics, C. Calculation of the Low-Volume Payment Dialysis Services Furnished to including strategies that CMS can use to Adjustment (LVPA) Individuals With Acute Kidney Injury address the gap in existing health D. Calculation of the Case-Mix (AKI) inequities, the addition of COVID–19 Adjustments On June 29, 2015, the President vaccination measures in future E. Calculation of the Outlier Payment signed the Trade Preferences Extension rulemaking, and the use of digital Adjustment quality measurement. F. Calculation of the Pediatric Dialysis Act of 2015 (TPEA) (Pub. L. 114–27). Payment Adjustment Section 808(a) of the TPEA amended 4. End-Stage Renal Disease Treatment G. Modifying the ESRD PPS and Hospital section 1861(s)(2)(F) of the Act to Choices (ETC) Model Cost Reports provide coverage for renal dialysis This rulemaking proposes to H. Modifying the Pediatric Cost Report services furnished on or after January 1, implement changes to the End-Stage I. Modifying Site of Services Provided to 2017, by a renal dialysis facility or a Renal Disease (ESRD) Treatment Medicare Beneficiaries with Acute provider of services paid under section Choices Model (ETC) Model, a Kidney Injury (AKI) 1881(b)(14) of the Act to an individual mandatory Medicare payment model VII. Collection of Information Requirements with acute kidney injury (AKI). Section tested under the authority of section A. Legislative Requirement for Solicitation 808(b) of the TPEA amended section 1115A of the Act. The ETC Model is of Comments 1834 of the Act by adding a new operated by the Center for Medicare and B. Requirements in Regulation Text subsection (r) that provides for payment Medicaid Innovation (Innovation C. Additional Information Collection for renal dialysis services furnished by Center), and tests the use of payment Requirements renal dialysis facilities or providers of adjustments to encourage greater VIII. Response to Comments services paid under section 1881(b)(14) utilization of home dialysis and kidney IX. Economic Analyses of the Act to individuals with AKI at the transplants, in order to preserve or A. Regulatory Impact Analysis ESRD PPS base rate beginning January enhance the quality of care furnished to B. Detailed Economic Analysis 1, 2017. This rule proposes to update Medicare beneficiaries while reducing C. Accounting Statement the AKI payment rate for CY 2022. Medicare expenditures. The ETC Model D. Regulatory Flexibility Act Analysis 3. End-Stage Renal Disease Quality includes ESRD facilities and certain (RFA) Incentive Program (ESRD QIP) clinicians caring for beneficiaries with E. Unfunded Mandates Reform Act ESRD—or Managing Clinicians—located Analysis (UMRA) The End-Stage Renal Disease Quality in Selected Geographic Areas as F. Federalism Incentive Program (ESRD QIP) is participants. G. Congressional Review Act authorized by section 1881(h) of the The ETC Model was finalized as part X. Files Available to the Public via the Act. The Program fosters improved of a final rule published in the Federal Internet patient outcomes by establishing Register on September 29, 2020, titled, Regulations Text incentives for dialysis facilities to meet ‘‘Medicare Program; Specialty Care or exceed performance standards I. Executive Summary Models to Improve Quality of Care and established by the Centers for Medicare Reduce Expenditures’’ (85 FR 61114), A. Purpose & Medicaid Services (CMS). This rule referred to herein as the ‘‘Specialty Care proposes to suppress the use of certain Models final rule.’’ The ETC Model is 1. End-Stage Renal Disease (ESRD) ESRD QIP measure data for scoring and designed to test the effectiveness of Prospective Payment System (PPS) payment adjustment purposes in the PY adjusting certain Medicare payments to 2022 ESRD QIP because we have On January 1, 2011, we implemented ETC Participants (ESRD facilities and determined that circumstances caused the End-Stage Renal Disease (ESRD) Managing Clinicians—clinicians who by the Public Health Emergency (PHE) Prospective Payment System (PPS), a furnish and bill the Monthly Capitation for the coronavirus disease 2019 Payment (MCP) for managing ESRD case-mix adjusted, bundled PPS for (COVID–19) pandemic have Beneficiaries—who have been selected renal dialysis services furnished by significantly affected the validity and to participate in the ETC Model) to ESRD facilities as required by section reliability of the measures and resulting encourage greater utilization of home 1881(b)(14) of the Social Security Act performance scores, as well as special dialysis and kidney transplantation, (the Act), as added by section 153(b) of scoring and payment policies for PY support beneficiary modality choice, the Medicare Improvements for Patients 2022. We are also announcing an reduce Medicare expenditures, and and Providers Act of 2008 (MIPPA) extension of time for facilities to report preserve or enhance the quality of care. (Pub. L. 110–275). Section September-December 2020 ESRD QIP In the Specialty Care Models final rule, 1881(b)(14)(F) of the Act, as added by data under our Extraordinary we established that the ETC Model section 153(b) of MIPPA, and amended Circumstances Exception (ECE) policy adjusts payments for home dialysis and by section 3401(h) of the Patient due to CMS operational issues. home dialysis-related claims with claim Protection and Affordable Care Act (the Beginning with the PY 2024 ESRD QIP, service dates from January 1, 2021 Affordable Care Act) (Pub. L. 111–148), we are proposing to update the through December 31, 2023 through the established that beginning calendar year specifications for the SHR clinical Home Dialysis Payment Adjustment (CY) 2012, and each subsequent year, measure. We are also proposing for the (HDPA). We are assessing the rates of the Secretary of the Department of PY 2024 ESRD QIP to adopt CY 2019 as home dialysis and of kidney transplant Health and Human Services (the the baseline period for purposes of waitlisting and living donor Secretary) shall annually increase calculating the achievement thresholds, transplantation, among beneficiaries payment amounts by an ESRD market benchmarks, and performance standard attributed to ETC Participants during basket increase factor, reduced by the values. Although no new requirements the period beginning January 1, 2021, productivity adjustment described in are proposed for the PY 2025 ESRD QIP, and ending June 30, 2026. Based on section 1886(b)(3)(B)(xi)(II) of the Act. this proposed rule includes policies that those rates, we are applying the This rule proposes updates to the ESRD would apply in PY 2025. This proposed Performance Payment Adjustment (PPA) PPS for CY 2022. rule also includes requests for to claims for dialysis and dialysis-

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related services with claim service dates adult beneficiaries, the proposed FDL reduce payment to any facility in PY beginning July 1, 2022, and ending June amount would decrease from $122.49 to 2022. Beginning with the PY 2024 ESRD 30, 2027. We codified these provisions $111.18, and the MAP amount would QIP, we are proposing to update the in a new subpart of the Code of Federal decrease from $50.92 to $47.87. The 1.0 specifications for the SHR clinical Regulations (CFR) 42 CFR part 512, percent target for outlier payments was measure. We are also proposing for the subpart C. not achieved in CY 2020. Outlier PY 2024 ESRD QIP to adopt CY 2019 as This rulemaking proposes payments represented approximately the baseline period for purposes of modifications to the ETC Model, 0.6 percent of total payments rather than calculating the achievement thresholds, including changes to the home dialysis 1.0 percent. benchmarks, and performance standard rate and transplant rate, the PPA • Update to the offset amount for the values. This proposed rule also achievement benchmarking transitional add-on payment adjustment announces the performance standards methodology, and the PPA for new and innovative equipment and and payment reductions that would improvement benchmarking and scoring supplies (TPNIES) for CY 2022: The apply for PY 2024. This proposed rule methodology. We are also proposing to proposed CY 2022 average per treatment describes several policies continuing for add processes and requirements for ETC offset amount for the transitional add-on PY 2025, but does not propose any new Participants to receive certain data from payment adjustment for new and requirements beginning with the PY CMS and to include certain additional innovative equipment and supplies 2025 ESRD QIP. waivers and flexibilities as part of the (TPNIES) for capital-related assets that This proposed rule includes requests ETC Model test. This proposed rule also are home dialysis machines is $9.41. for public comment on several includes requests for information This proposed offset amount reflects the important topics, including closing the regarding the placement of peritoneal application of the productivity-adjusted gap in health equity, adding a COVID– dialysis catheters and the development market basket increase of 1.0 percent 19 vaccination measure for health care ($9.32 × 1.010 = $9.41). personnel (HCP) and a COVID–19 of a home dialysis beneficiary • experience measure. TPNIES applications received for vaccination measure for ESRD patients CY 2022: This proposed rule presents a to the ESRD QIP measure set in future B. Summary of the Major Provisions summary of the two CY 2022 TPNIES rulemaking, and potential actions and 1. ESRD PPS applications that we received by the priority areas that would enable the February 1, 2021 deadline and our • continued transformation of our quality Update to the ESRD PPS base rate analysis of the applicants’ claims related measurement enterprise toward greater for CY 2022: The proposed CY 2022 to substantial clinical improvement digital capture of data and use of the ESRD PPS base rate is $255.55. This (SCI) and other eligibility criteria for the Fast Healthcare Interoperability proposed amount reflects the TPNIES. Resources (FHIR®) standard. application of the wage index budget- neutrality adjustment factor (.999546) 2. Payment for Renal Dialysis Services 4. ETC Model and a productivity-adjusted market Furnished to Individuals With AKI We are proposing to implement the basket increase of 1.0 percent as We are proposing to update the AKI following changes to the ETC Model required by section 1881(b)(14)(F)(i)(I) payment rate for CY 2022 to $255.55, beginning for the third Measurement of the Act, equaling $255.55 (($253.13 × which is the same as the base rate Year (MY3) of the Model, which begins .999546) × 1.010 = $255.55). proposed under the ESRD PPS for CY January 1, 2022. • Annual update to the wage index: 2022. • Beneficiary Attribution for Living We adjust wage indices on an annual Kidney Donor Transplants: To better 3. ESRD QIP basis using the most current hospital reflect the care relationship between wage data and the latest core-based We are announcing an extension of beneficiaries who receive pre-emptive statistical area (CBSA) delineations to time for facilities to report September living donor transplants (LDT) and the account for differing wage levels in through December 2020 ESRD QIP data Managing Clinicians who provide their areas in which ESRD facilities are under our Extraordinary Circumstances care, we propose to modify the located. For CY 2022, we are proposing Exception (ECE) policy due to CMS methodology for attributing Pre-emptive to update the wage index values based operational issues. We are proposing to LDT Beneficiaries to Managing on the latest available data and adopt a measure suppression policy for Clinicians, such that a Pre-emptive LDT continuing the 2-year transition to the the duration of the COVID–19 PHE that Beneficiary would be attributed to the Office of Management and Budget would enable us to suppress the use of Managing Clinician who submitted the (OMB) delineations as described in the one or more measures in the ESRD QIP most claims for services furnished to the September 14, 2018 OMB Bulletin No. for scoring and payment adjustment beneficiary during the 365 days prior to 18–04. purposes if we determine that the transplant date. • Update to the outlier policy: We are circumstances caused by the COVID–19 • Home Dialysis Rate Calculation: To proposing to update the outlier policy PHE have significantly affected the incentivize additional alternative renal using the most current data, as well as measures and resulting performance replacement modalities under the ETC update the outlier services fixed-dollar scores. We are also proposing to Model, we propose adding nocturnal in- loss (FDL) amounts for adult and suppress the Standardized center dialysis to the calculation of the pediatric patients and Medicare Hospitalization Ratio (SHR) clinical home dialysis rate for ESRD facilities allowable payment (MAP) amounts for measure, the Standardized Readmission not owned in whole or in part by a large adult and pediatric patients for CY 2022 Ratio (SRR) clinical measure, the In- dialysis organization (LDO) as well as using CY 2020 claims data. Based on the Center Hemodialysis Consumer Managing Clinicians. use of the latest available data, the Assessment of Healthcare Providers and • Transplant Rate Beneficiary proposed FDL amount for pediatric Systems (ICH CAHPS) clinical measure, Exclusion: To better align with common beneficiaries would decrease from and the Long-Term Catheter Rate reasons transplant centers do not place $44.78 to $30.38, and the MAP amount clinical measure for PY 2022 under the patients on the transplant waitlist, we would decrease from $30.88 to $28.73, proposed measure suppression policy. propose to exclude beneficiaries with a as compared to CY 2021 values. For Finally, we are proposing to not score or diagnosis of, and who are receiving

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treatment with chemotherapy or kidney disease patient education freestanding ESRD facilities with an radiation for, vital solid organ cancers services via telehealth under the ETC estimated 1.0 percent increase. The from the calculation of the transplant Model. overall impact reflects the effects of the rate. • Kidney Disease Patient Education updated wage index and the proposed • Performance Payment Adjustment Services Coinsurance Waivers: We are payment rate update. We estimate that Achievement Benchmarking proposing to permit Managing the aggregate payments made to ESRD Methodology: When we originally Clinicians who are ETC Participants to facilities for renal dialysis services finalized the ETC Model, we stated our reduce or waive the beneficiary furnished to patients with AKI, at the intent to increase achievement coinsurance for kidney disease patient proposed CY 2022 ESRD PPS base rate, benchmarks above rates observed in education services, subject to certain would increase by $1 million in CY Comparison Geographic Areas for future requirements. We anticipate making the 2022 compared to CY 2021. model years. As such, we propose to determination that the anti-kickback increase achievement benchmarks by 10 statute safe harbor for CMS-sponsored 3. Impacts of the Proposed ESRD QIP percent over rates observed in model patient incentives (42 CFR Our proposals to suppress measures Comparison Geographic Areas every 1001.952(ii)), would be available to for the PY 2022 ESRD QIP and to revise two MYs, beginning in MY3 (2022). We protect the reduction or elimination of the scoring and payment methodology also propose to stratify achievement coinsurance performed in accordance such that no facility will receive a benchmarks based on the proportion of with our proposed policy, if finalized. payment reduction necessitates a attributed beneficiaries who are dually- modification to our previous estimated C. Summary of Costs and Benefits eligible for Medicare and Medicaid or overall economic impact of the PY 2022 receive the Low Income Subsidy (LIS) In section IX.B of this proposed rule, ESRD QIP (84 FR 60651). In the CY 2020 during the MY, in recognition that we set forth a detailed analysis of the ESRD PPS final rule, we estimated that beneficiaries with lower socioeconomic impacts that the proposed changes the overall economic impact of the PY status have lower rates of home dialysis would have on affected entities and 2022 ESRD QIP would be approximately and transplant than those with higher beneficiaries. The impacts include the $229 million as a result of the policies socioeconomic status. following: we had finalized at that time. The $229 • Performance Payment Adjustment million figure for PY 2022 included 1. Impacts of the Proposed ESRD PPS Improvement Benchmarking and costs associated with the collection of Scoring: In conjunction with our The impact table in section IX.B.1.a of information requirements, which we proposal to stratify achievement this proposed rule displays the estimated would be approximately $211 benchmarks based on the proportion of estimated change in payments to ESRD million, and $18 million in estimated beneficiaries who are dual-eligible or facilities in CY 2022 compared to payment reductions across all facilities. LIS recipients, we propose to introduce estimated payments in CY 2021. The However, as a result of the proposals the Health Equity Incentive to the overall impact of the proposed CY 2022 impacting the PY 2022 ESRD QIP we are improvement scoring methodology used changes is projected to be a 1.2 percent making in this proposed rule, we are in calculating the PPA. CMS expects increase in payments. Hospital-based modifying our previous estimate. We that the Health Equity Incentive would ESRD facilities have an estimated 1.3 now estimate that the overall economic encourage ETC Participants to decrease percent increase in payments compared impact of the PY 2022 ESRD QIP would disparities in renal replacement with freestanding facilities with an be approximately $215 million. The modality choice among beneficiaries estimated 1.2 percent increase. We $215 million figure for PY 2022 with lower socioeconomic status by estimate that the aggregate ESRD PPS includes costs associated with the rewarding ETC Participants that expenditures would increase by collection of information requirements. demonstrate significant improvement in approximately $140 million in CY 2022 If our proposals are finalized as the home dialysis rate or transplant rate compared to CY 2021. This reflects a proposed, there would be no payment among their attributed beneficiaries who $120 million increase from the payment reductions in PY 2022. We estimate that are dual-eligible or LIS recipients. We rate update and a $20 million increase the overall economic impact of the PY also propose to adjust the improvement due to the updates to the outlier 2024 ESRD QIP would be approximately scoring calculation to avoid the scenario threshold amounts. Because of the $232 million as a result of the policies where an ETC Participant cannot projected 1.2 percent overall payment we have previously finalized and the receive an improvement score because increase, we estimate there would be an proposals in this proposed rule. The its home dialysis rate or transplant rate increase in beneficiary coinsurance $232 million figure for PY 2024 was zero during the Benchmark Year. payments of 1.2 percent in CY 2022, includes costs associated with the • Performance Payment Adjustment which translates to approximately $30 collection of information requirements, Reports and Related Data Sharing: To million. which we estimate would be ensure that ETC Participants have approximately $215 million, and $17 2. Impacts of the Proposed Payment for timely access to ETC Model reports, we million in estimated payment Renal Dialysis Services Furnished to are proposing a process by which CMS reductions across all facilities. We also Individuals With AKI would share certain model data with estimate that the overall economic ETC Participants. The impact table in section IX.B.2.a of impact of the PY 2025 ESRD QIP would • Medicare Waivers: We are this proposed rule displays the be approximately $232 million as a proposing an additional programmatic estimated change in payments to ESRD result of the policies we have previously waiver to provide Managing Clinicians facilities in CY 2022 compared to finalized. who are ETC Participants additional estimated payments in CY 2021. The flexibility in furnishing the kidney overall impact of the proposed CY 2022 4. Impacts of Proposed Changes to the disease patient education services changes is projected to be a 1.0 percent ETC Model described in § 410.48: A waiver of increase in payments for individuals The impact estimate in section IX.B.4 certain telehealth requirements as with AKI. Hospital-based ESRD of this proposed rule describes the necessary solely for purposes of facilities have an estimated 1.1 percent estimated change in anticipated allowing ETC Participants to furnish increase in payments compared with Medicare program savings arising from

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the ETC Model over the duration of the the Secretary, by no later than January patient case-mix variability. The adult ETC Model as a result of the changes 1, 2016, to analyze the case-mix case-mix adjusters include five proposed in this proposed rule. We payment adjustments under section categories of age, body surface area, low estimate that the ETC Model would 1881(b)(14)(D)(i) of the Act and make body mass index, onset of dialysis, and result in $38 million in net savings over appropriate revisions to those four comorbidity categories (that is, the 6.5-year duration of the ETC Model. adjustments. pericarditis, gastrointestinal tract We also estimate that $7 million of the On April 1, 2014, the Protecting bleeding, hereditary hemolytic or sickle estimated $38 million in net savings Access to Medicare Act of 2014 (PAMA) cell anemia, myelodysplastic would be attributable to changes (Pub. L. 113–93) was enacted. Section syndrome). A different set of case-mix proposed in this proposed rule. 217 of PAMA included several adjusters are applied for the pediatric provisions that apply to the ESRD PPS. population. Pediatric patient-level II. Calendar Year (CY) 2022 End-Stage Specifically, sections 217(b)(1) and (2) adjusters include two age categories Renal Disease (ESRD) Prospective of PAMA amended sections (under age 22, or age 22–26) and two Payment System (PPS) 1881(b)(14)(F) and (I) of the Act and dialysis modalities (that is, peritoneal or A. Background replaced the drug utilization adjustment hemodialysis) (§ 413.235(a) and (b)). that was finalized in the CY 2014 ESRD The ESRD PPS provides for three 1. Statutory Background PPS final rule (78 FR 72161 through facility-level adjustments. The first On January 1, 2011, the Centers for 72170) with specific provisions that payment adjustment accounts for ESRD Medicare & Medicaid Services (CMS) dictated the market basket update for facilities furnishing a low volume of implemented the End-Stage Renal CY 2015 (0.0 percent) and how the dialysis treatments (§ 413.232). The Disease (ESRD) Prospective Payment market basket should be reduced in CY second adjustment reflects differences System (PPS), a case-mix adjusted 2016 through CY 2018. in area wage levels developed from bundled PPS for renal dialysis services Section 217(a)(1) of PAMA amended core-based statistical areas (CBSAs) furnished by ESRD facilities, as required section 632(b)(1) of ATRA to provide (§ 413.231). The third payment by section 1881(b)(14) of the Social that the Secretary may not pay for oral- adjustment accounts for ESRD facilities Security Act (the Act), as added by only ESRD-related drugs under the furnishing renal dialysis services in a section 153(b) of the Medicare ESRD PPS prior to January 1, 2024. rural area (§ 413.233). Improvements for Patients and Section 217(a)(2) of PAMA further There are four additional payment Providers Act of 2008 (MIPPA). Section amended section 632(b)(1) of ATRA by adjustments under the ESRD PPS. The 1881(b)(14)(F) of the Act, as added by requiring that in establishing payment ESRD PPS provides adjustments, when section 153(b) of MIPPA and amended for oral-only drugs under the ESRD PPS, applicable, for: (1) A training add-on for by section 3401(h) of the Patient the Secretary must use data from the home and self-dialysis modalities Protection and Affordable Care Act (the most recent year available. Section (§ 413.235(c)); (2) an additional payment Affordable Care Act), established that 217(c) of PAMA provided that as part of for high cost outliers due to unusual beginning with CY 2012, and each the CY 2016 ESRD PPS rulemaking, the variations in the type or amount of subsequent year, the Secretary of the Secretary shall establish a process for (1) medically necessary care (§ 413.237); (3) Department of Health and Human determining when a product is no a transitional drug add-on payment Services (the Secretary) shall annually longer an oral-only drug; and (2) adjustment (TDAPA) for certain new increase payment amounts by an ESRD including new injectable and renal dialysis drugs and biological market basket increase factor reduced by intravenous products into the ESRD PPS products (§ 413.234(c)); and (4) a the productivity adjustment described bundled payment. transitional add-on payment adjustment in section 1886(b)(3)(B)(xi)(II) of the Finally, on December 19, 2014, the for new and innovative equipment and Act. President signed the Stephen Beck, Jr., supplies (TPNIES) for certain qualifying, Section 632 of the American Taxpayer Achieving a Better Life Experience Act new and innovative renal dialysis Relief Act of 2012 (ATRA) (Pub. L. 112– of 2014 (ABLE) (Pub. L. 113–295). equipment and supplies (§ 413.236(d)). 240) included several provisions that Section 204 of ABLE amended section apply to the ESRD PPS. Section 632(a) 632(b)(1) of ATRA, as amended by 3. Updates to the ESRD PPS of ATRA added section 1881(b)(14)(I) to section 217(a)(1) of PAMA, to provide Policy changes to the ESRD PPS are the Act, which required the Secretary, that payment for oral-only renal dialysis proposed and finalized annually in the by comparing per patient utilization services cannot be made under the Federal Register. The CY 2011 ESRD data from 2007 with such data from ESRD PPS bundled payment prior to PPS final rule was published on August 2012, to reduce the single payment for January 1, 2025. 12, 2010 in the Federal Register (75 FR renal dialysis services furnished on or 49030 through 49214). That rule after January 1, 2014 to reflect the 2. System for Payment of Renal Dialysis implemented the ESRD PPS beginning Secretary’s estimate of the change in the Services on January 1, 2011 in accordance with utilization of ESRD-related drugs and Under the ESRD PPS, a single per- section 1881(b)(14) of the Act, as added biologicals (excluding oral-only ESRD- treatment payment is made to an ESRD by section 153(b) of MIPPA, over a 4- related drugs). Consistent with this facility for all of the renal dialysis year transition period. Since the requirement, in the CY 2014 ESRD PPS services defined in section implementation of the ESRD PPS, we final rule we finalized $29.93 as the 1881(b)(14)(B) of the Act and furnished have published annual rules to make total drug utilization reduction and to individuals for the treatment of ESRD routine updates, policy changes, and finalized a policy to implement the in the ESRD facility or in a patient’s clarifications. amount over a 3- to 4-year transition home. We have codified our definitions On November 9, 2020, we published period (78 FR 72161 through 72170). of renal dialysis services at § 413.171, a final rule in the Federal Register Section 632(b) of ATRA prohibited which is in 42 CFR part 413, subpart H, titled, ‘‘Medicare Program; End-Stage the Secretary from paying for oral-only along with other ESRD PPS payment Renal Disease Prospective Payment ESRD-related drugs and biologicals policies. The ESRD PPS base rate is System, Payment for Renal Dialysis under the ESRD PPS prior to January 1, adjusted for characteristics of both adult Services Furnished to Individuals With 2016. Section 632(c) of ATRA required and pediatric patients and accounts for Acute Kidney Injury, and End-Stage

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Renal Disease Quality Incentive also commonly used to denote the input ending CY 2022) is projected to be 0.6 Program,’’ referred to herein as the ‘‘CY price index (that is, cost categories, their percent. 2021 ESRD PPS final rule’’. In that rule, respective weights, and price proxies As a result of these provisions, the we updated the ESRD PPS base rate, combined) derived from a market proposed CY 2022 ESRD market basket wage index, and outlier policy, for CY basket. Accordingly, the term ‘‘ESRDB increase factor reduced by the 2021. We also finalized an update to the market basket,’’ as used in this productivity adjustment is 1.0 percent. ESRD PPS wage index to adopt the 2018 document, refers to the ESRDB input The proposed market basket increase OMB delineations with a transition price index. factor is calculated by starting with the period, changes to the eligibility criteria We propose to use the CY 2016-based proposed CY 2022 ESRDB market basket and determination process for the ESRDB market basket as finalized and percentage increase factor of 1.6 percent TPNIES, an expansion of the TPNIES to described in the CY 2019 ESRD PPS and reducing it by the proposed include certain new and innovative final rule (83 FR 56951 through 56962) productivity adjustment (the 10-year capital-related assets that are home to compute the CY 2022 ESRDB market moving average of MFP for the period dialysis machines, an addition to the basket increase factor based on the best ending CY 2022) of 0.6 percent. ESRD PPS base rate to include available data. Consistent with As is our general practice, we are calcimimetics in the ESRD PPS bundled historical practice, we propose to proposing that if more recent data payment, and a change to the low- estimate the ESRDB market basket become available after the publication of volume payment adjustment eligibility update based on IHS Global Inc.’s (IGI’s) this proposed rule and before the criteria and attestation requirement to forecast using the most recently publication of the final rule (for account for the coronavirus disease available data. IGI is a nationally example, a more recent estimate of the 2019 (COVID–19) Public Health recognized economic and financial CY 2016-based ESRD market basket Emergency (PHE). For further detailed forecasting firm with which we contract increase factor or productivity information regarding these updates, see to forecast the components of the market adjustment), we would use such data, if 85 FR 71398. baskets. Using this methodology and the appropriate, to determine the final CY B. Provisions of the Proposed Rule IGI first quarter 2021 forecast of the CY 2022 market basket update and 2016-based ESRDB market basket (with productivity adjustment. 1. Proposed CY 2022 ESRD PPS Update historical data through the fourth For the CY 2022 ESRD payment a. Proposed CY 2022 ESRD Bundled quarter of 2020), the proposed CY 2022 update, we propose to continue using a (ESRDB) Market Basket Update, ESRDB market basket increase factor is labor-related share of 52.3 percent for Productivity Adjustment, and Labor- 1.6 percent. the ESRD PPS payment, which was Related Share Under section 1881(b)(14)(F)(i) of the finalized in the CY 2019 ESRD PPS final rule (83 FR 56963). In accordance with section Act, for CY 2012 and each subsequent 1881(b)(14)(F)(i) of the Act, as added by year, the ESRD market basket percentage b. The Proposed CY 2022 ESRD PPS section 153(b) of MIPPA and amended increase factor shall be reduced by the Wage Indices by section 3401(h) of the Affordable productivity adjustment described in (1) Background Care Act, beginning in 2012, the ESRD section 1886(b)(3)(B)(xi)(II) of the Act. PPS payment amounts are required to be The productivity adjustment is Section 1881(b)(14)(D)(iv)(II) of the annually increased by an ESRD market calculated using a projection of Act provides that the ESRD PPS may basket increase factor and reduced by multifactor productivity (MFP), which include a geographic wage index the productivity adjustment described is derived by subtracting the payment adjustment, such as the index in section 1886(b)(3)(B)(xi)(II) of the contribution of labor and capital input referred to in section 1881(b)(12)(D) of Act. The application of the productivity growth from output growth. We the Act, as the Secretary determines to adjustment may result in the increase finalized the detailed methodology for be appropriate. In the CY 2011 ESRD factor being less than 0.0 percent for a deriving the projection of MFP in the PPS final rule (75 FR 49200), we year and may result in payment rates for CY 2012 ESRD PPS final rule (76 FR finalized an adjustment for wages at a year being less than the payment rates 40503 through 40504). The most up-to- § 413.231. Specifically, CMS adjusts the for the preceding year. The statute also date MFP projection methodology is labor-related portion of the base rate to provides that the market basket increase available on the CMS website at https:// account for geographic differences in factor should reflect the changes over www.cms.gov/Research-Statistics-Data- the area wage levels using an time in the prices of an appropriate mix and-Systems/Statistics-Trends-and- appropriate wage index, which reflects of goods and services used to furnish Reports/MedicareProgramRatesStats/ the relative level of hospital wages and renal dialysis services. Downloads/MFPMethodology.pdf. We wage-related costs in the geographic As required under section note that for CY 2022 and beyond, CMS area in which the ESRD facility is 1881(b)(14)(F)(i) of the Act, CMS is changing the name of this adjustment located. We use OMB’s CBSA-based developed an all-inclusive ESRD to refer to it as the productivity geographic area designations to define Bundled (ESRDB) input price index (75 adjustment, which is the term used in urban and rural areas and their FR 49151 through 49162). In the CY sections 1881(b)(14)(F)(i) and corresponding wage index values (75 FR 2015 ESRD PPS final rule we rebased 1886(b)(3)(B)(xi)(II) of the Act, rather 49117). OMB publishes bulletins and revised the ESRDB input price than the multifactor productivity or regarding CBSA changes, including index to reflect a 2012 base year (79 FR MFP adjustment. This is not a change in changes to CBSA numbers and titles. 66129 through 66136). Subsequently, in policy, as we will continue to use the The bulletins are available online at the CY 2019 ESRD PPS final rule, we same methodology for deriving the https://www.whitehouse.gov/omb/ finalized a rebased ESRDB input price adjustment and rely on the same information-for-agencies/bulletins/. index to reflect a 2016 base year (83 FR underlying data. Using this For CY 2022, we would update the 56951 through 56962). methodology and the IGI first quarter wage indices to account for updated Although ‘‘market basket’’ technically 2021 forecast, the proposed productivity wage levels in areas in which ESRD describes the mix of goods and services adjustment for CY 2022 (the 10-year facilities are located using our existing used for ESRD treatment, this term is moving average of MFP for the period methodology. We use the most recent

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pre-floor, pre-reclassified hospital wage OMB Bulletin No. 18–04, beginning medical/surgical supplies, including data collected annually under the with the CY 2021 ESRD PPS wage syringes, used to administer renal inpatient PPS. The ESRD PPS wage index. In addition, we finalized the dialysis drugs and biological products index values are calculated without application of a 5 percent cap on any that were or would have been, prior to regard to geographic reclassifications decrease in an ESRD facility’s wage January 1, 2011, separately billable authorized under sections 1886(d)(8) index from the ESRD facility’s wage under Medicare Part B; (4) renal dialysis and (d)(10) of the Act and utilize index from the prior CY. We finalized drugs and biological products that were prefloor hospital data that are that the transition would be phased in or would have been, prior to January 1, unadjusted for occupational mix. For over 2 years, such that the reduction in 2011, covered under Medicare Part D, CY 2022, the updated wage data are for an ESRD facility’s wage index would be including renal dialysis oral-only drugs hospital cost reporting periods capped at 5 percent in CY 2021, and no effective January 1, 2025; and (5) renal beginning on or after October 1, 2017, cap would be applied to the reduction dialysis equipment and supplies, except and before October 1, 2018 (fiscal year in the wage index for the second year, for capital-related assets that are home [FY] 2018 cost report data). CY 2022. Thus, for CY 2022, the labor- dialysis machines(as defined in We have also adopted methodologies related share to which a facility’s wage § 413.236(a)(2)), that receive the for calculating wage index values for index would be applied is 52.3 percent. transitional add-on payment adjustment ESRD facilities that are located in urban For CY 2022, we are proposing to as specified in § 413.236 after the and rural areas where there is no update the ESRD PPS wage index to use payment period has ended. hospital data. For a full discussion, see the most recent hospital wage data. The In the CY 2011 ESRD PPS final rule CY 2011 and CY 2012 ESRD PPS final proposed CY 2022 ESRD PPS wage (75 FR 49142), CMS stated that for rules at 75 FR 49116 through 49117 and index is set forth in Addendum A and purposes of determining whether an 76 FR 70239 through 70241, is available on the CMS website at ESRD facility would be eligible for an respectively. For urban areas with no https://www.cms.gov/Medicare/ outlier payment, it would be necessary hospital data, we compute the average Medicare-Fee-for-Service-Payment/ for the facility to identify the actual wage index value of all urban areas ESRDpayment/End-Stage-Renal- ESRD outlier services furnished to the within the state to serve as a reasonable Disease-ESRD-Payment-Regulations- patient by line item (that is, date of proxy for the wage index of that urban and-Notices. Addendum A provides a service) on the monthly claim. Renal CBSA, that is, we use that value as the crosswalk between the CY 2021 wage dialysis drugs, laboratory tests, and wage index. For rural areas with no index and the proposed CY 2022 wage medical/surgical supplies that are hospital data, we compute the wage index. Addendum B provides an ESRD recognized as outlier services were index using the average wage index facility level impact analysis. specified in Transmittal 2134, dated values from all contiguous CBSAs to Addendum B is available on the CMS January 14, 2011.2 https://www.cms.gov/ represent a reasonable proxy for that website at https://www.cms.gov/ Regulations-and-Guidance/Guidance/ rural area. We apply the statewide urban Medicare/Medicare-Fee-for-Service- Transmittals/downloads/R2134CP.pdf. average based on the average of all Payment/ESRDpayment/End-Stage- Furthermore, CMS uses administrative urban areas within the state to Renal-Disease-ESRD-Payment- issuances to update the renal dialysis Hinesville-Fort Stewart, Georgia (78 FR Regulations-and-Notices. service items available for outlier 72173), and we apply the wage index for c. Proposed CY 2022 Update to the payment via our quarterly update CMS Guam to American Samoa and the Outlier Policy Change Requests, when applicable. For example, we use these updates to Northern Mariana Islands (78 FR Section 1881(b)(14)(D)(ii) of the Act 1 identify renal dialysis service drugs that 72172). requires that the ESRD PPS include a A wage index floor value (0.5000) is were or would have been covered under payment adjustment for high cost Medicare Part D for outlier eligibility applied under the ESRD PPS as a outliers due to unusual variations in the substitute wage index for areas with purposes and items and services that type or amount of medically necessary have been incorrectly identified as very low wage index values. Currently, care, including variability in the amount all areas with wage index values that eligible outlier services. of erythropoiesis-stimulating agents Under § 413.237, an ESRD facility is fall below the floor are located in Puerto (ESAs) necessary for anemia Rico. However, the wage index floor eligible for an outlier payment if its management. Some examples of the actual or imputed Medicare Allowable value is applicable for any area that may patient conditions that may be reflective fall below the floor. A description of the Payment (MAP) amount per treatment of higher facility costs when furnishing for ESRD outlier services exceeds a history of the wage index floor under dialysis care would be frailty, obesity, the ESRD PPS can be found in the CY threshold. The MAP amount represents and comorbidities, such as secondary the average incurred amount per 2019 ESRD PPS final rule (83 FR 56964 hyperparathyroidism. The ESRD PPS through 56967). treatment for services that were or recognizes high cost patients, and we would have been considered separately An ESRD facility’s wage index is have codified the outlier policy and our applied to the labor-related share of the billable services prior to January 1, methodology for calculating outlier 2011. The threshold is equal to the ESRD PPS base rate. In the CY 2019 payments at § 413.237. ESRD PPS final rule (83 FR 56963), we ESRD facility’s predicted ESRD outlier The policy provides that the following services MAP amount per treatment finalized a labor-related share of 52.3 ESRD outlier items and services are percent, which is based on the 2016- (which is case-mix adjusted and included in the ESRD PPS bundle: (1) described in the following paragraphs) based ESRDB market basket. In the CY Renal dialysis drugs and biological 2021 ESRD PPS final rule (85 FR 71436), products that were or would have been, we updated the OMB delineations as 2 Transmittal 2033 issued August 20, 2010, was prior to January 1, 2011, separately rescinded and replaced by Transmittal 2094, dated described in the September 14, 2018 billable under Medicare Part B; (2) renal November 17, 2010. Transmittal 2094 identified dialysis laboratory tests that were or additional drugs and laboratory tests that may also 1 We note that for the CY 2020 ESRD PPS final be eligible for ESRD outlier payment. Transmittal rule, we did not apply the statewide urban average would have been, prior to January 1, 2094 was rescinded and replaced by Transmittal to Carson City, Nevada because hospital data was 2011, separately billable under 2134, dated January 14, 2011, which included one available to compute the wage index. Medicare Part B ; (3) renal dialysis technical correction.

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plus the fixed-dollar loss (FDL) amount. outlier services MAP amounts for a outlier payments represented In accordance with § 413.237(c), patient are determined by multiplying approximately 0.5 percent of total facilities are paid 80 percent of the per the adjusted average outlier services payments. As discussed in section treatment amount by which the imputed MAP amount by the product of the II.B.1.c.(1) of this proposed rule, CY MAP amount for outlier services (that is, patient-specific case-mix adjusters 2020 claims data show outlier payments the actual incurred amount) exceeds applicable using the outlier services represent approximately 0.6 percent of this threshold. ESRD facilities are payment multipliers developed from the total payments. eligible to receive outlier payments for regression analysis used to compute the treating both adult and pediatric payment adjustments. (1) CY 2022 Update to the Outlier dialysis patients. For CY 2022, we propose that the Services MAP Amounts and FDL In the CY 2011 ESRD PPS final rule outlier services MAP amounts and FDL Amounts and codified in § 413.220(b)(4), using amounts would be derived from claims 2007 data, we established the outlier data from CY 2020. Because we believe For CY 2022, we propose to update percentage, which is used to reduce the that any adjustments made to the MAP the outlier services MAP amounts and per treatment base rate to account for amounts under the ESRD PPS should be FDL amounts to reflect the utilization of the proportion of the estimated total based upon the most recent data year outlier services reported on 2020 claims. payments under the ESRD PPS that are available in order to best predict any For this proposed rule, the outlier outlier payments, at 1.0 percent of total future outlier payments, we propose the services MAP amounts and FDL payments (75 FR 49142 through 49143). outlier thresholds for CY 2022 would be amounts were updated using 2020 We also established the FDL amounts based on utilization of renal dialysis claims data. The impact of this update that are added to the predicted outlier items and services furnished under the is shown in Table 1, which compares services MAP amounts. The outlier ESRD PPS in CY 2020. the outlier services MAP amounts and services MAP amounts and FDL We recognize that the utilization of FDL amounts used for the outlier policy amounts are different for adult and ESAs and other outlier services have in CY 2021 with the updated proposed pediatric patients due to differences in continued to decline under the ESRD estimates for this rule. The estimates for the utilization of separately billable PPS, and that we have lowered the MAP the proposed CY 2022 outlier policy, services among adult and pediatric amounts and FDL amounts every year which are included in Column II of patients (75 FR 49140). As we explained under the ESRD PPS. As discussed in Table 1, were inflation adjusted to in the CY 2011 ESRD PPS final rule (75 the CY 2021 ESRD PPS final rule (85 FR reflect projected 2022 prices for outlier FR 49138 through 49139), the predicted 71438), CY 2019 claims data show services.

Column I Column II Final outlier policy for CY 2021 Proposed outlier policy for CY (based on 2019 data, price inflated 2022 (based on 2020 data, price to 2021)* inflated to 2022)

Age< 18 Age>= 18 Age< 18 Age>= 18 Average outlier services MAP amount er treatment

Standardization for outlier services 1.0390 0.9789 1.0815 0.9824 MIPP A reduction 0.98 0.98 0.98 0.98 Adjusted average outlier services MAP amount $30.88 $50.92 $28.73 $47.87 ixed-dollar loss amount that is added o the predicted MAP to determine the outlier threshold $44.78 $122.49 $30.38 $111.18 atient-month-facilities qualifying for outlier payment 8.80% 5.15% 11.37% 5.45% *Note that Column I was obtained from Column II of Table 5 from the CY 2021 ESRD PPS final rule (85 FR 71437).

The estimated FDL amount per (Column II; $111.18) is lower than that threshold is accompanied by a decrease treatment that determines the CY 2022 used for the CY 2021 outlier policy in the adjusted average MAP for outlier outlier threshold amount for adults (Column I; $122.49). The lower services from $50.92 to $47.87. For

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pediatric patients, there is a decrease in to adjust the ESRD PPS base rate for the applicable CY 2022 estimated the FDL amount from $44.78 to $30.38. projected outlier payments and budget payments, aggregate payments to ESRD There is a corresponding decrease in the neutrality in accordance with sections facilities would remain budget neutral adjusted average MAP for outlier 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) when compared to the target amount of services among pediatric patients, from of the Act, respectively. Specifically, the expenditures. That is, the wage index $30.08 to $28.73. ESRD PPS base rate was developed from budget neutrality adjustment factor We estimate that the percentage of CY 2007 claims (that is, the lowest per ensures that wage index adjustments do patient months qualifying for outlier patient utilization year as required by not increase or decrease aggregate payments in CY 2022 would be 5.45 section 1881(b)(14)(A)(ii) of the Act), Medicare payments with respect to percent for adult patients and 11.37 updated to CY 2011, and represented changes in wage index updates. The CY percent for pediatric patients, based on the average per treatment MAP for 2022 proposed wage index budget- the 2020 claims data. The outlier MAP composite rate and separately billable neutrality adjustment factor is .999546. and FDL amounts continue to be lower services. In accordance with section This application would yield a CY 2022 for pediatric patients than adults due to 1881(b)(14)(D) of the Act and our ESRD PPS proposed base rate of $253.02 the continued lower use of outlier regulation at § 413.230, the per- prior to the application of the proposed services (primarily reflecting lower use treatment payment amount is the sum of market basket increase ($253.13 × of ESAs and other injectable drugs). the ESRD PPS base rate, adjusted for the .999546 = $253.02). patient specific case-mix adjustments, Market Basket Increase: Section (2) Outlier Percentage applicable facility adjustments, 1881(b)(14)(F)(i)(I) of the Act provides In the CY 2011 ESRD PPS final rule geographic differences in area wage that, beginning in 2012, the ESRD PPS (75 FR 49081) and under levels using an area wage index, and payment amounts are required to be § 413.220(b)(4), we reduced the per any applicable outlier payment, training annually increased by the ESRD market treatment base rate by 1 percent to adjustment add-on, TDAPA, and basket percentage increase factor. The account for the proportion of the TPNIES. latest CY 2022 projection of the estimated total payments under the proposed ESRDB market basket (2) Annual Payment Rate Update for CY percentage increase factor is 1.6 percent. ESRD PPS that are outlier payments as 2022 described in § 413.237. Based on the In CY 2022, this amount must be 2020 claims, outlier payments We are proposing an ESRD PPS base reduced by the productivity adjustment represented approximately 0.6 percent rate for CY 2022 of $255.55. This update described in section 1886(b)(3)(B)(xi)(II) of total payments, which is below the 1 reflects several factors, described in of the Act, as required by section percent target due to declines in the use more detail as follows: 1881(b)(14)(F)(i)(II) of the Act. As Wage Index Budget-Neutrality of outlier services. As noted in past discussed previously, the proposed Adjustment Factor: We compute a wage rulemaking, recalibration of the productivity adjustment for CY 2021 is index budget-neutrality adjustment thresholds using 2020 data is expected 0.6 percent, thus yielding a proposed factor that is applied to the ESRD PPS to result in aggregate outlier payments update to the base rate of 1.0 percent for base rate. For CY 2022, we are not close to the 1 percent target in CY 2022. CY 2022. Therefore, the CY 2022 ESRD proposing any changes to the We believe the update to the outlier PPS proposed base rate is $255.55 methodology used to calculate this × MAP and FDL amounts for CY 2022 ($253.02 1.010 = $255.55). factor, which is described in detail in would increase payments for ESRD In summary, we are proposing a CY the CY 2014 ESRD PPS final rule (78 FR beneficiaries requiring higher resource 2022 ESRD PPS base rate of $255.55. 72174). We computed the proposed CY utilization. This would move us closer This amount reflects a proposed CY 2022 wage index budget-neutrality 2022 wage index budget-neutrality to meeting our 1 percent outlier policy adjustment factor using treatment adjustment factor of .999546, and the goal, because we are using more current counts from the 2020 claims and CY 2022 ESRD PPS productivity- data for computing the MAP and FDL, facility-specific CY 2021 payment rates adjusted market basket update of 1.0 which is more in line with current to estimate the total dollar amount that percent. outlier services utilization rates. We each ESRD facility would have received note that recalibration of the FDL in CY 2021. The total of these payments e. Update to the Offset Amount for amounts in this proposed rule would became the target amount of TPNIES result in no change in payments to expenditures for all ESRD facilities for In the CY 2021 ESRD PPS final rule ESRD facilities for beneficiaries with CY 2022. Next, we computed the (85 FR 71427), we expanded eligibility renal dialysis items and services that are estimated dollar amount that would for the TPNIES under § 413.236 to not eligible for outlier payments. have been paid for the same ESRD include certain capital-related assets d. Proposed Impacts to the CY 2022 facilities using the ESRD PPS wage that are home dialysis machines when ESRD PPS Base Rate index for CY 2022. As discussed in used in the home for a single patient. section II.B.1.b of this proposed rule, the We finalized the additional steps that (1) ESRD PPS Base Rate proposed ESRD PPS wage index for CY the Medicare Administrative In the CY 2011 ESRD PPS final rule 2022 includes an update to the most Contractors (MACs) must follow to (75 FR 49071 through 49083), CMS recent hospital wage data, use of the establish the basis of payment of the established the methodology for 2018 OMB delineations, and no cap on TPNIES for these capital-related assets calculating the ESRD PPS per-treatment wage index decreases applied for CY that are home dialysis machines when base rate, that is, ESRD PPS base rate, 2022. The total of these payments used in the home, including an offset to and calculating the per treatment becomes the new CY 2022 amount of the pre-adjusted per treatment amount payment amount, which are codified at wage-adjusted expenditures for all to account for the cost of the home §§ 413.220 and 413.230. The CY 2011 ESRD facilities. The wage index budget- dialysis machine that is already in the ESRD PPS final rule also provides a neutrality factor is calculated as the ESRD PPS base rate. We will pay 65 detailed discussion of the methodology target amount divided by the new CY percent of the MAC-determined used to calculate the ESRD PPS base 2022 amount. When we multiplied the preadjusted per treatment amount rate and the computation of factors used wage index budget neutrality factor by reduced by an offset for 2-calendar

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years. Section § 413.236(f)(3)(v) states take effect; (4) has a Healthcare mortality or a clinically significant that effective January 1, 2022, CMS will Common Procedure Coding System complication; a decreased rate of at least annually update the amount determined (HCPCS) application submitted in one subsequent diagnostic or in paragraph (f)(3)(iv) of § 413.236 by accordance with the official Level II therapeutic intervention; a decreased the ESRD bundled market basket HCPCS coding procedures by September number of future hospitalizations or percentage increase factor minus the 1 of the particular calendar year; (5) is physician visits; a more rapid beneficial productivity adjustment factor. innovative, meaning it meets the SCI resolution of the disease process The CY 2021 offset amount for criteria specified in the Inpatient treatment including, but not limited to, TPNIES for capital-related equipment Prospective Payment System (IPPS) a reduced length of stay or recovery that are home dialysis machines used in regulations at 42 CFR 412.87(b)(1) and time; an improvement in one or more the home is $9.32. As discussed related guidance, and (6) is not a capital activities of daily living; an improved previously in section II.B.1.a of this related asset that an ESRD facility has quality of life; or, a demonstrated greater proposed rule, the proposed CY 2022 an economic interest in through medication adherence or compliance; ESRD bundled market basket increase ownership (regardless of the manner in or, factor minus the productivity which it was acquired). • The totality of the circumstances adjustment is 1.0 percent (1.6 percent Regarding the innovation requirement otherwise demonstrates that the new minus 0.6 percent). Applying the in § 413.236(b)(5), in the CY 2020 ESRD renal dialysis equipment or supply proposed update factor of 1.010 to the PPS final rule (84 FR 60690), we stated substantially improves, relative to renal CY 2021 offset amount results in a that we will use the following criteria to dialysis services previously available, proposed CY 2022 offset amount of evaluate SCI for purposes of the TPNIES the diagnosis or treatment of Medicare $9.41($9.32 × 1.010). We will update under the ESRD PPS based on the IPPS beneficiaries. this calculation to use the most recent SCI criteria in § 412.87(b)(1) and related Third, evidence from the following data available in the CY 2022 ESRD PPS guidance: published or unpublished information final rule. A new technology represents an sources from within the U.S. or advance that substantially improves, elsewhere may be sufficient to establish C. Proposed Transitional Add-On relative to renal dialysis services that a new renal dialysis equipment or Payment Adjustment for New and previously available, the diagnosis or supply represents an advance that Innovative Equipment and Supplies treatment of Medicare beneficiaries. substantially improves, relative to renal (TPNIES) for CY 2022 Payment First, CMS considers the totality of the dialysis services previously available, 1. Background circumstances when making a the diagnosis or treatment of Medicare determination that a new renal dialysis beneficiaries: Clinical trials, peer In the CY 2020 ESRD PPS final rule equipment or supply represents an reviewed journal articles; study results; (84 FR 60681 through 60698), CMS advance that substantially improves, meta-analyses; consensus statements; established the transitional add-on relative to renal dialysis services white papers; patient surveys; case payment adjustment for new and previously available, the diagnosis or studies; reports; systematic literature innovative equipment and supplies treatment of Medicare beneficiaries. reviews; letters from major healthcare (TPNIES) under the ESRD PPS, under Second, a determination that a new associations; editorials and letters to the the authority of section renal dialysis equipment or supply editor; and public comments. Other 1881(b)(14)(D)(iv) of the Act, in order to represents an advance that substantially appropriate information sources may be support ESRD facility use and improves, relative to renal dialysis considered. beneficiary access to these new services previously available, the Fourth, the medical condition technologies. We established this add- diagnosis or treatment of Medicare diagnosed or treated by the new renal on payment adjustment to help address beneficiaries means one of the dialysis equipment or supply may have the unique circumstances experienced following: a low prevalence among Medicare by ESRD facilities when incorporating • The new renal dialysis equipment beneficiaries. Fifth, the new renal new and innovative equipment and or supply offers a treatment option for dialysis equipment or supply may supplies into their businesses and to a patient population unresponsive to, or represent an advance that substantially support ESRD facilities transitioning or ineligible for, currently available improves, relative to services or testing these products during the period treatments; or technologies previously available, the when they are new to market. We added • The new renal dialysis equipment diagnosis or treatment of a § 413.236 to establish the eligibility or supply offers the ability to diagnose subpopulation of patients with the criteria and payment policies for the a medical condition in a patient medical condition diagnosed or treated TPNIES. population where that medical by the new renal dialysis equipment or In the CY 2020 ESRD PPS final rule condition is currently undetectable, or supply. (84 FR 60650), we established in offers the ability to diagnose a medical In the CY 2020 ESRD PPS final rule § 413.236(b) that for dates of service condition earlier in a patient population (84 FR 60681 through 60698), we also occurring on or after January 1, 2020, we than allowed by currently available established a process modeled after will provide the TPNIES to an ESRD methods, and there must also be IPPS’s process of determining if a new facility for furnishing a covered evidence that use of the new renal medical service or technology meets the equipment or supply only if the item: dialysis service to make a diagnosis SCI criteria specified in § 412.87(b)(1). (1) Has been designated by CMS as a affects the management of the patient; or Specifically, similar to the IPPS New renal dialysis service under § 413.171; • The use of the new renal dialysis Technology Add-On Payment, we (2) is new, meaning granted marketing equipment or supply significantly wanted to align our goals with the authorization by the Food and Drug improves clinical outcomes relative to agency’s efforts to transform the Administration (FDA) on or after renal dialysis services previously healthcare delivery system for the ESRD January 1, 2020; (3) is commercially available as demonstrated by one or beneficiary through competition and available by January 1 of the particular more of the following: A reduction in at innovation to provide patients with calendar year, meaning the year in least one clinically significant adverse better value and results. As we discuss which the payment adjustment would event, including a reduction in in the CY 2020 ESRD PPS final rule (84

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FR 60682), we believe it is appropriate beginning on the date of the FDA by encouraging home dialysis. After to facilitate access to new and marketing authorization. Second, we closely considering these issues, we innovative equipment and supplies changed the deadline for TPNIES proposed a revision to § 413.236(b)(6) in through add-on payments similar to the applicants’ HCPCS Level II code the CY 2021 ESRD PPS proposed rule to IPPS New Technology Add-On Payment application submission from September provide an exception to the general and to provide stakeholders with 1 of the particular calendar year to the exclusion for capital-related assets from standard criteria for both inpatient and HCPCS Level II code application eligibility for the TPNIES for capital- outpatient settings. In § 413.236(c), we deadline for biannual Coding Cycle 2 for related assets that are home dialysis established a process for our durable medical equipment, orthotics, machines when used in the home for a announcement of TPNIES prosthetics, and supplies (DMEPOS) single patient and that meet the other determinations and a deadline for items and services as specified in the eligibility criteria in § 413.235(b), and consideration of new renal dialysis HCPCS Level II coding guidance on the finalized the exception as proposed. We equipment or supply applications under CMS website prior to the calendar year. finalized the same determination the ESRD PPS. CMS will consider In addition, a copy of the applicable process for TPNIES applications for whether a new renal dialysis equipment FDA marketing authorization must be capital-related assets that are home or supply meets the eligibility criteria submitted to CMS by the HCPCS Level dialysis machines as for all other specified in § 413.236(b) and summarize II code application deadline for TPNIES applications; that we will the applications received in the annual biannual Coding Cycle 2 for DMEPOS provide a description of the new home ESRD PPS proposed rules. Then, after items and services as specified in the dialysis machine and pertinent facts in consideration of public comments, we HCPCS Level II coding guidance on the the ESRD PPS proposed rule so the will announce the results in the Federal CMS website in order for the equipment public may comment and then publish Register as part of our annual updates or supply to be eligible for the TPNIES the results in the ESRD PPS final rule. and changes to the ESRD PPS in the the following year. Third, we revised We will consider whether the new home ESRD PPS final rule. In the CY 2020 § 413.236(b)(5) to remove a reference to dialysis machine meets the eligibility ESRD PPS final rule, we also specified related guidance on the SCI criterion, as criteria specified in the proposed certain deadlines for the application the guidance has already been codified. revisions to § 413.236(b) and announce requirements. We noted that we would the results in the Federal Register as Finally, in the CY 2021 ESRD PPS only consider a complete application part of our annual updates and changes final rule, we expanded the TPNIES received by February 1 prior to the to the ESRD PPS. Per § 413.236(c), we policy to include certain capital-related particular calendar year. In addition, we will only consider, for additional assets that are home dialysis machines required that FDA marketing payment using the TPNIES for a when used in the home for a single authorization for the equipment or particular calendar year, an application patient. We explained that capital- supply must occur by September 1 prior for a capital-related asset that is a home related assets are defined in the to the particular calendar year. We also dialysis machine received by February 1 Provider Reimbursement Manual stated in the CY 2020 ESRD PPS final prior to the particular calendar year. If (chapter 1, section 104.1) as assets that rule (84 FR 60690 through 60691) that the application is not received by we would establish a workgroup of CMS a provider has an economic interest in February 1, the application will be medical and other staff to review the through ownership (regardless of the denied and the applicant will need to materials submitted as part of the manner in which they were acquired). reapply within 3 years beginning on the TPNIES application, public comments, We noted that examples of capital- date of FDA marketing authorization in FDA marketing authorization, and related assets for ESRD facilities are order to be considered for the TPNIES, HCPCS application information and dialysis machines and water in accordance with the proposed assess the extent to which the product purification systems. We explained that revisions to § 413.236(b)(2). provides SCI over current technologies. while in the CY 2020 ESRD PPS In the CY 2021 ESRD PPS final rule, In the CY 2020 ESRD PPS final rule, proposed rule (84 FR 38354), we stated at § 413.236(f), we finalized a pricing we established § 413.236(d) to provide a that we did not believe capital-related methodology for capital-related assets payment adjustment for a new and assets should be eligible for additional that are home dialysis machines when innovative renal dialysis equipment or payment through the TPNIES because used in the home for a single patient by supply. We stated that the TPNIES is the cost of these items is captured in requiring MACs to calculate the annual paid for 2-calendar years. Following cost reports, they depreciate over time, allowance and the preadjusted per payment of the TPNIES, the ESRD PPS and are generally used for multiple treatment amount. The pre-adjusted per base rate will not be modified and the patients, there were a number of other treatment amount is reduced by an new and innovative renal dialysis factors we considered that led us to estimated average per treatment offset equipment or supply will become an consider expanding eligibility for these amount to account for the costs already eligible outlier service as provided in technologies in the CY 2021 ESRD PPS paid through the ESRD PPS base rate. § 413.237. rulemaking. We explained that, The CY 2021 TPNIES offset amount was Regarding the basis of payment for the following publication of the CY 2020 $9.32, and we finalized that this amount TPNIES, in the CY 2020 ESRD PPS final ESRD PPS final rule, we continued to will be updated on an annual basis so rule, we finalized at § 413.236(e) that study the issue of payment for capital- that it is consistent with how the ESRD the TPNIES is based on 65 percent of related assets under the ESRD PPS, PPS base rate is updated. the price established by the MACs, taking into account information from a We revised § 413.236(d) to reflect that using the information from the invoice wide variety of stakeholders and recent we would pay 65 percent of the pre- and other specified sources of developments and initiatives regarding adjusted per treatment amount minus information. In the CY 2021 ESRD PPS kidney care. For example, we the offset for capital-related assets that final rule (85 FR 71410 through 71464), considered various HHS home dialysis are home dialysis machines when used we made several changes to the TPNIES initiatives, Executive Orders to in the home for a single patient. eligibility criteria at § 413.236. First, we transform kidney care, and how the risk We revised § 413.236(d)(2) to reflect revised the definition of new at of COVID–19 for particularly vulnerable that following payment of the TPNIES, § 413.236(b)(2) as within 3 years ESRD beneficiaries could be mitigated the ESRD PPS base rate will not be

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modified and the new and innovative a. Tablo® System capture and automatic wireless renal dialysis equipment or supply will Outset Medical, Inc. submitted an transmission eliminate the need for be an eligible outlier service as provided application for the TPNIES for the manual record keeping by the patient, in § 413.237, except a capital-related ® ® care partner, or nurse. Per the applicant, Tablo System (Tablo ) for CY 2022. ® asset that is a home dialysis machine According to the applicant, the a single-use Tablo Cartridge with user- will not be an eligible outlier service as technology is an HD machine that has friendly pre-strung blood, saline, and provided in § 413.237. In summary, been designed for patient-driven self- infusion tubing and a series of sensor- under the current eligibility care and to minimize system training receptors mounted to a user-friendly requirements in § 413.236(b), CMS time. The applicant also stated that the organizer snaps easily into the system provides for a TPNIES to an ESRD system is intended to substantially minimizing difficult connections that facility for furnishing a covered improve the treatment of people with require additional training. The equipment or supply only if the item: ESRD by removing barriers to home applicant stated that automated features, including an integrated blood pressure (1) Has been designated by CMS as a dialysis. The applicant explained that ® monitor, air removal, priming, and renal dialysis service under § 413.171; the Tablo System is comprised of (1) ® blood return, minimize user errors, save (2) Is new, meaning within 3 years the Tablo Console with integrated water purification, on-demand dialysate time, and streamline the user beginning on the date of the FDA experience. marketing authorization; (3) Is production, and a simple-to-use touchscreen interface; (2) a proprietary, Fourth, the applicant stated that the commercially available by January 1 of ® disposable, single-use pre-strung Tablo System’s two-way wireless the particular calendar year, meaning connectivity and data analytics provide the year in which the payment cartridge that easily clicks into place, minimizing steps, touch points, and the ability to continuously activate new adjustment would take effect; (4) Has a connections; and (3) the Tablo® capabilities and enhancements through complete HCPCS Level II code Connectivity and Data Ecosystem. Per wireless software updates, while also application submitted in accordance the applicant, the system is built to enabling predictive preventative with the HCPCS Level II coding function in a connected setting with maintenance to maximize machine procedures on the CMS website, by the cloud-based system monitoring, patient uptime. HCPCS Level II code application analytics and clinical recordkeeping. The applicant stated that currently 88 deadline for biannual Coding Cycle 2 for The applicant stated that the Tablo® percent of patients receive HD in a DMEPOS items and services as specified System’s unique features combine to clinic 3 times per week, for 3.0 to 4.5 in the HCPCS Level II coding guidance provide a significantly differentiated HD hours a day and fewer than 2 percent on the CMS website prior to the solution with many benefits. First, the perform HD treatment at home.4 The calendar year; (5) Is innovative, meaning applicant stated that the Tablo® applicant stated that 25 to 36 percent of it meets the criteria specified in System’s intuitive touchscreen interface home HD patients return to in-center § 412.87(b)(1) of this chapter; and (6) Is makes it easy to learn and use, guiding care within 1 year of initiating HD at not a capital-related asset, except for users through treatment from start to home.56 Per the applicant, barriers to capital-related assets that are home finish using step-by-step instructions home dialysis adoption and retention dialysis machines. with simple words and animation. The have been well studied and include We received two applications for the applicant also stated that instructions treatment burden for patients and care include non-technical language and partner fatigue; technical challenges TPNIES for CY 2022. A discussion of color-coded parts to enable easier with operating a HD machine; space, these applications is presented below. training, faster set-up, and simpler home modifications, and supplies The applications received are for management including clear alarm management; patients not wanting technologies commonly used for the explanations and resolution medical equipment in the home; and treatment of ESRD: Hemodialysis (HD) instructions. safety concerns.78 and peritoneal dialysis (PD). Detailed Second, the applicant stated that the definitions for HD and PD are found in Tablo® System can accommodate 4 United States Renal Data System. 2020 USRDS Chapter 11, Section 10 of the Medicare treatments at home allowing for Annual Data Report: Epidemiology of kidney Benefits Policy Manual (Pub. L. 100– flexibility in treatment frequencies, disease in the United States, End-Stage Renal 3 Disease Chapter 2. National Institutes of Health, 02). In brief, HD is a process that durations, and flow rates. Per the National Institute of Diabetes and Digestive and involves blood passing through an applicant, the Tablo® System does not Kidney Diseases, Bethesda, MD, 2020. Available at: artificial kidney machine and the waste have a pre-configured dialyzer, which https://adr.usrds.org/2020/end-stage-renaldisease/ introduction-to-volume-2. Accessed on Jan. 21, products diffusing across a manmade allows clinicians to use a broad range of 2021. membrane into a bath solution known dialyzer types and manufactures, 5 Seshasai, R.K., et al. (2019). The home as dialysate after which the cleansed allowing for greater customization of hemodialysis patient experience: A qualitative blood is returned to the patient’s body. treatment for the patient. The applicant assessment of modality use and discontinuation. stated that this is an improvement over Hemodialysis International, 23: 139–150, 2019. HD is accomplished usually in 3 to 5 doi:10.1111/hdi.12713. hour sessions, 3 times a week. PD is a the incumbent home device, which 6 Weinhandl, Eric D., Collins Allan, Incidence of process that involves waste products requires a separate device component Therapy Cessation among Home Hemodialysis passing from the patient’s body through and complex process to switch to Patients in the United States, Abstract presented, American Society of Nephrology Kidney Week the peritoneal membrane into the another dialyzer. Third, the applicant stated that the 2016. peritoneal (abdominal) cavity where the ® 7 Seshasai, R.K., et al. (2019). The home bath solution (dialysate) is introduced Tablo System is an all-in-one system hemodialysis patient experience: A qualitative with integrated water purification and and removed periodically. assessment of modality use and discontinuation. on-demand dialysate production, Hemodialysis International, 23: 139–150, 2019. eliminating the need for industrial water doi:10.1111/hdi.12713. 3 Medicare Benefits Policy Manual (Pub. L. 100– 8 Chan, Christopher T. et al. (2018). Exploring 102), available at: https://www.cms.gov/ treatment rooms that are required to Barriers and Potential Solutions in Home Dialysis: Regulations-and-Guidance/Guidance/Manuals/ operate traditional HD machines. The An NKF–KDOQI Conference Outcomes Report Downloads/bp102c11.pdf. applicant also stated that electronic data Continued

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The applicant stated that innovation starting dialysis.12 The applicant stated (2) Newness Criterion (§ 413.236(b)(2)) in making home dialysis more that patients and clinicians should With respect to the second TPNIES accessible to patients has been lacking weigh the risks and benefits of both eligibility criterion under due to a lack of investment funding, options and select the one that meets § 413.236(b)(2), whether the item is limited incremental reimbursement for the individual patient’s preferences, new, meaning within 3 years beginning new technology, and a consolidated, goals, values and physiology. Per the on the date of the FDA marketing price-sensitive dialysis provider market applicant, because PD relies on the authorization, the applicant stated that where the lack of market competition is patient’s own membrane, physiologic the Tablo® System received FDA costly and has been associated with changes can occur and result in patients marketing authorization for home use increased hospitalizations in dialysis who are unable to continue PD due to on March 31, 2020. Therefore, the patients.9 The applicant stated that the loss of the ability to achieve adequacy. ® ® Tablo System is considered new. We Tablo System was designed to address The applicant stated that these home note that, in reviewing the enclosure to many system-related barriers that result patients could consider home HD rather which the March 31, 2020 FDA in patients resigning themselves to in- than a return to in-center and noted that authorization letter refers, the center care and/or stopping home the practice of transitioning from one applicant’s Section 510(k) submission modalities due to the burden of self- home modality to another is indicates that the Tablo® Cartridge was managed therapy. acknowledged by experts to be reviewed separately from the Tablo® The applicant stated that while PD, underutilized and is particularly System and has its own separate 510(k) like HD, removes excess fluid and waste pronounced in the U.S., where the ratio clearance. As discussed in the CY 2021 13 from the body, it has a different of PD use to home HD is 6:1, as ESRD PPS final rule, CMS determined 14 mechanism of action and relies on the compared to 4:1 in Canada. that the cartridge did not meet the body’s own membrane, the peritoneum, The applicant asserted that that the newness criterion for the TPNIES (85 FR to act as the ‘‘dialyzer’’. Per the Tablo® System presents a significant ® 71464) and as such, the cartridge is not applicant, PD requires surgical clinical improvement over NxStage new. placement of a catheter in the abdomen System One (NxStage®), the current and utilizes a cleansing fluid, dialysate, standard of home HD care, with the goal (3) Commercial Availability Criterion that must be infused and dwell in the of getting patients access to easier to use (§ 413.236(b)(3)) abdomen to remove waste products technology and increasing the number With respect to the third TPNIES from the blood. The applicant stated of patients who can do dialysis at home. eligibility criterion under ® that PD must be conducted daily to Per the applicant, NxStage is the only § 413.236(b)(3), whether the item is achieve adequate dialysis and can be other mobile HD machine that is commercial available by January 1 of the conducted manually or via a cycler; approved for home use. particular calendar year, meaning the while in contrast, HD directly cleanses (1) Renal Dialysis Service Criterion year in which the payment adjustment the blood with the use of a HD machine, (§ 413.236(b)(1)) would take effect, the applicant stated dialysate and a dialyzer, which acts as that the Tablo® System became an artificial kidney in removing excess With respect to the first TPNIES available for home use on April 1, 2020. fluid and toxins. The applicant stated eligibility criterion under Therefore, the Tablo® System is that HD also requires surgical placement § 413.236(b)(1), whether the item has commercially available. of a dialysis access, which is usually in been designated by CMS as a renal dialysis service under § 413.171, (4) HCPCS Level II Application the form of a catheter or a more maintenance dialysis treatments and all Criterion (§ 413.236(b)(4)) permanent arteriovenous fistula.10 The applicant asserted that PD is the associated services, including With respect to the fourth TPNIES dominant home therapy used around historically defined dialysis-related eligibility criterion under the world, but should not be solely drugs, laboratory tests, equipment, § 413.236(b)(4), whether the applicant relied upon to increase growth in home supplies, and staff time, were included submitted a HCPCS Level II code dialysis, as there are physiological in the composite rate for renal dialysis application by the July 6, 2021 deadline, services as of December 31, 2010 (75 FR contraindications.11 The applicant also the applicant stated that it intends to 49036). An in-home HD machine would stated that there is recent evidence that submit a HCPCS Level II code be considered equipment necessary for post 90-day mortality is higher in PD application by the deadline. the provision of maintenance dialysis patients than in HD patients. Per the and, therefore, we would consider this (5) Innovation Criterion applicant, multivariable risk–adjusted a renal dialysis service under § 413.171. (§§ 413.236(b)(5) and 412.87(b)(1)) analyses demonstrate that the mortality hazard ratio of HD versus PD is 0.74 (95 With respect to the fifth TPNIES 12 Mukhopadhyay, P., Woodside, K.J., Schaubel, eligibility criterion under percent confidence interval (CI), 0.68– D.E., Repeck, K., McCullough, K., Shahinian, V.B., § 413.236(b)(5), that the item is 0.80) in the 270 to 360-day period after . . . & Saran, R. (2020). Survival among incident peritoneal dialysis versus hemodialysis patients innovative, meaning it meets the SCI who initiate with an arteriovenous fistula. Kidney criteria specified in § 412.87(b)(1), the American Journal of Kidney Diseases, Volume 73, Medicine, 2(6), 732–741. ® Issue 3, 363–371. applicant claimed that the Tablo 13 United States Renal Data System. 2020 USRDS 9 System significantly improves clinical Erickson, K.F., Zheng, Y., Ho, V., Winkelmayer, Annual Data Report: Epidemiology of kidney W.C., Bhattacharya, J., & Chertow, G.M. (2018). disease in the United States, End-Stage Renal outcomes relative to the current Market Competition and Health Outcomes in Disease Chapter 2. National Institutes of Health, standard of care for home HD services, Hemodialysis. Health services research, 53(5), National Institute of Diabetes and Digestive and 3680–3703. https://doi.org/10.1111/1475- which it identified as the incumbent Kidney Diseases, Bethesda, MD, 2020. Available at: NxStage® home dialysis machine. The 6773.12835. https://adr.usrds.org/2020/end-stage-renaldisease/ 10 Blake, P.G., Quinn, R.R., & Oliver, M.J. (2013). introduction-to-volume-2. Accessed on Jan 21, 2021. applicant presented the following SCI Peritoneal dialysis and the process of modality 14 Canada Institute for Health Information (2020): claims: (1) Decreased treatment selection. Peritoneal dialysis international: journal Annual Statistics. Available at: https:// frequency with adequate dialysis of the International Society for Peritoneal Dialysis, secure.cihi.ca/estore/ clearance; (2) increased adherence to 33(3), 233–241. https://doi.org/10.3747/ productSeries.htm?locale=en&pc=PCC24&_ pdi.2012.00119. ga=2.265337481.729263172.1612199530- dialysis treatment and retention to home 11 Ibid. 510791291.1610562424. Accessed on Jan. 31, 2021. therapy; and (3) improved patient

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quality of life. The applicant supported supplemental content included with the remained in the trial for approximately these claims with the Tablo® application. Specifically, the applicant 21 weeks, during which time they were Investigational Device Exemption (IDE) submitted numerous supplemental prescribed HD with the Tablo® System Study 15 and secondary support from background materials related to the on a 4 times per week schedule. The four papers 16 17 18 19 and two posters.20 21 dialysis industry, reimbursement applicant explained that the trial The applicant also provided comparison patterns, modalities, treatment consisted of 4 treatment periods: (1) A data from three studies directly related frequencies, patient adherence, 1 week, in-center run-in period; (2) an to the incumbent 22 23 24 and an hospitalization rates, and quality of life. in-center period of 32 treatments additional study that, based on the The applicant also submitted several (approximately 8 weeks) during which timeframe of the study, likely involved letters of support for the Tablo® System; ESRD facility staff managed the dialysis participants undergoing treatment with three from dialysis patients, three from treatments; (3) a transition period of up NxStage® although the article does not nephrologists, and one from a dialysis to 4 weeks to train the patient and care directly reference the incumbent.25 clinic nurse. These letters emphasized partner in managing the dialysis; and (4) We provide an overview of these ten benefits of the Tablo® System, including a final in-home period of 32 treatments sources below, followed by the reduced frequency of dialysis treatment, (approximately 8 weeks). applicant’s summary of how the data improved home dialysis retention, With respect to the applicant’s support each claim of SCI. We conclude reduced patient and caregiver burden, secondary sources of support, a poster with a discussion of the way in which reduced patient fatigue, and improved presentation from Alvarez, et al., we have applied the requirements of patient quality of life. presented dialysis adequacy data § 413.236(b)(5) to our review of the collected from a retrospective review of (a) Applicant SCI Sources application and a summary of our 29 patients’ (18 males, 11 females and concerns. We have not included As stated previously, the applicant’s 17 percent Black, 10 percent Hispanic) detailed summaries of the remaining primary support for its three SCI claims dialysis records. The study compared comes from a prospective, multicenter, Kt/V results of patients aged 34–84 ® 15 Clinicaltrials.gov website. https:// open-label, non-randomized crossover receiving dialysis using the Tablo www.clinicaltrials.gov/ct2/show/NCT02460263. study that compared in-center and in- System to patients receiving dialysis Last Updated July 1, 2020. https:// home HD performance using the Tablo® from a conventional HD machine. The www.clinicaltrials.gov/ProvidedDocs/63/ _ System. Per the applicant, this study is majority of patients used a fistula or NCT02460263/Prot 000.pdf. ® 16 Chertow, G.M., Alvarez, L., Plumb, T.J., referred to as the Tablo Investigational graft (59 percent fistula, 28 percent graft, Prichard, S.S., & Aragon, M. (2020). Patient- Device Exemption (IDE) Study and the 10 percent catheter). One hundred reported outcomes from the investigational device original study protocol and amendments ninety two dialysis treatments were exemption study of the Tablo hemodialysis system. were approved by FDA and registered conducted on a thrice-weekly schedule Hemodialysis International, 24(4), 480–486. on http://www.clinicaltrials.gov as ID: ® 17 Leypoldt, J.K., Prichard, S., Chertow, G.M., & using the Tablo System with a Alvarez, L. (2019). Differential molecular modeling NCT02460263. The applicant stated that dialysate flow rate of 300 mL per predictions of mid and conventional dialysate of the 30 participants enrolled (17 White minute. A single pool Kt/V of greater flows. Blood purification, 47(4), 369–376. and 13 Black or African American), 28 than 1.2 was achieved in 94 percent of 18 Safety and efficacy of the Tablo hemodialysis (18 men and 10 women) completed the treatments in patients less than 90 kg system for in-center and home hemodialysis Plumb, study. Thirteen of the participants had T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern, J.G., with an average duration of treatment at Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. previous home HD experience with 224 +/¥29 minutes and in 79 percent ® and Aragon, M.A. (2019), Hemodialysis NxStage , and the remainder had of treatments in patients greater than 90 International. previously received conventional in- kg with an average duration of treatment 19 Plumb, Troy J., Luis Alvarez, Dennis L. Ross, center HD care. The applicant also at 249 +/¥27 minutes. The average Joseph J. Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, ® ¥ Graham E. Abra, Sarah S. Prichard, Glenn M. noted that the Tablo IDE study sample achieved Kt/V was 1.4 +/ 0.2 among ® Chertow, and Michael A. Aragon. ‘‘Self-care was comprised of a representative treatments provided with the Tablo training using the Tablo hemodialysis system.’’ cohort of dialysis patients and reports System. Eighty-eight treatments were Hemodialysis International (2020). that it was similar to the population conducted using a conventional HD 20 Alvarez, Luis et al. Urea Clearance Results in studied for the IDE study for the machine with a dialysate flow rate of Patients Dialyzed Thrice Weekly Using a Dialysate ® Flow of 300 mL/min, clinical abstract, presented incumbent NxStage . As described in 500 mL per minute. A single pool Kt/ March 2019, Annual Dialysis Conference, Dallas, the study protocol, the primary and V of greater than 1.2 was achieved in 93 TX. secondary efficacy endpoints were a percent of treatments in patients less 21 Chahal, Y., Plumb, T., Aragon M. (2020). standardized weekly Kt/V of greater than 90 kg with an average duration of Patient Device Preference for Home Hemodialysis: than or equal to 2.1 and ultrafiltration ¥ A Subset Analysis of the Tablo Home IDE Trial. treatment at 227 +/ 21 minutes and in Poster Presentation at National Kidney Foundation (fluid removal) value as reported by the 83 percent of treatments in patients Spring Clinical Conference, March 2020. device within ten percent of the greater than 90 kg with an average 22 Kraus, M., et al., A comparison of center-based expected fluid removal based on the duration of treatment at 249 +/¥14 vs. home-based daily hemodialysis for patients with ultrafiltration prescription and the minutes. The average achieved Kt/V was end-stage renal disease. Hemodialysis International, Tablo® Console fluid removal algorithm, ¥ 11: 468–477, (2007). 1.6 +/ 0.4 among the conventional HD 26 27 23 Finkelstein, F.O., et al. (2012). At-home short respectively. We clarify that Kt/V is a treatments. daily hemodialysis improves the long-term health- value used to quantify dialysis Next, an article from Chertow, et al., related quality of life. Kidney international, 82(5), treatment adequacy and ‘‘K’’ = dialyzer described additional data from the 561–569. clearance, ‘‘t’’ = time, and ‘‘V’’ = Tablo® IDE study (discussed 24 Weinhandl, E.D., Gilbertson, D.T., & Collins, Volume of distribution of urea. The previously), including health-related A.J. (2016). Mortality, hospitalization, and technique failure in daily home hemodialysis and applicant stated that each participant quality of life, to further assess the ® matched peritoneal dialysis patients: A matched served as his or her own control and safety of home HD with the Tablo cohort study. American Journal of Kidney Diseases, 67(1), 98–110. 26 Clinicaltrials.gov website. https:// 27 Alvarez, Luis et al. Urea Clearance Results in 25 Suri, R.S., Li, L., & Nesrallah, G.E. (2015). The www.clinicaltrials.gov/ct2/show/NCT02460263. Patients Dialyzed Thrice Weekly Using a Dialysate risk of hospitalization and modality failure with Last Updated July 1, 2020. https:// Flow of 300 mL/min, clinical abstract, presented home dialysis. Kidney international, 88(2), 360– www.clinicaltrials.gov/ProvidedDocs/63/ March 2019, Annual Dialysis Conference, Dallas, 368. NCT02460263/Prot_000.pdf. TX.

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System. Demographic information dialysis. Patients with a urea volume of Next, a separate article by Plumb et identified the mean age as 49.8 ± 13 distribution of 40 L would require 255 al., reports additional data from the years, 62 percent male, 62 percent minutes of dialysis. Patients with a urea Tablo® IDE study (previously discussed) White, 38 percent Black or African volume of distribution of 45 L would regarding participants’ assessment of the American, 23 percent Hispanic or require over 270 minutes of dialysis. Tablo® System’s ease-of-use, the degree Latino, 68 percent Not Hispanic or With a blood flow of 400 mL per of dependence on health care workers Latino, and 8 percent not reported, minute, patients with a urea volume of and caregivers after training with the among patients established on home distribution of 40 L could achieve the system was complete, and the training HD. Among the patients new to home target single pool Kt/V of greater than time required for a participant to be HD, the mean age was identified as 54.2 1.2 with 240 minutes of dialysis. competent in self-care. Demographic ± 10.4 years, 65 percent male, 53 Patients with a volume of distribution of information reflected the mean age as percent White, 47 percent Black or 45 L could achieve the target with 270 52.6 years, 18 men, 10 women, 16 African American, 29 percent Hispanic minutes of dialysis. The authors did not White, 7 Hispanic or Latino, 9 Not or Latino, 71 percent Not Hispanic or model urea kinetics for patients with Hispanic or Latino, and 12 Black or Latino, and 0 percent not reported. volumes of distribution greater than 45 African American. Participants were Twenty-eight of 30 patients (93 percent) L.29 stratified according to whether they completed all trial periods. Adherence Next, an article by Plumb, et al., were previously on self-care dialysis at ® to the prescribed 4 treatments per week described the Tablo IDE study home or conventional in-center HD. schedule was 96 percent in-center and (discussed previously). Demographic Thirteen participants had previous 99 percent in-home. The median time to information reflected the mean age as experience performing self-care HD. The ± recovery was 1.5 hours during the in- 52.3 11.6 years, 19 men and the remaining 15 participants had previous center and 2 hours during the at-home following racial and ethnic experience with in-center HD only. All ® phase of the trial. Median index values representation: 17 White, 13 Black or participants rated the Tablo System’s on the 5-level EuroQol-5 Dimension African American, 8 Hispanic or Latino, setup, treatment, and takedown on a (EQ–5D–5L) (a self-assessed, health and 21 Not Hispanic or Latino. scale from 1 (very difficult) to 5 (very related, quality of life questionnaire) Comparisons among the 28 patients in simple) and indicated whether they had were similar during the in-center as this study and subsequent secondary required assistance with treatment over analyses were either made between the the prior 7 days. Set up times were compared to in-home dialysis at 0.832 ® and 0.826, respectively. Patients new to 8 weeks of using the Tablo System for similar regardless of whether the home HD had lower median values in-center HD and the 8 weeks of the participants were previously on self- Tablo® System for in-home HD or care HD or conventional in-center HD. (0.751) for both in-center and in-home ® periods. Patients who had used home between using the Tablo System in- For the participants previously on in- dialysis prior to the trial had higher home HD and the treatment provided center HD, the average set up time for median values during both in-center prior to study enrollment. In both the concentrates was 0.93 minutes and settings, patients dialyzed using the for the cartridge, 9.35 minutes. For (0.903) and in-home (0.906) periods. ® Patients reported feeling alert or well- Tablo System 4 times per week. The participants previously on self-care rested with little difficulty falling or primary efficacy endpoint was home HD, the average set up time for staying asleep or feeling tired and worn achievement of a weekly standard Kt/V the concentrates was 1.22 minutes and out when using the Tablo® System in greater than or equal to 2.1 in both the for the cartridge, 10.28 minutes. The 8-week in-center phase of the study and ® either environment. The authors average rating of the Tablo System’s the 8-week in-home phase of the study. concluded that when using the Tablo® ease of use for setup was 4.5, treatment This endpoint was achieved in 199 of System in-home, patients reported 4.6, and take down 4.6 among the 200 weeks in the in-center dialysis similar time to recovery, general health participants previously on self-care period and in 168 of 171 weeks in the status, and sleep quality compared to home HD. In comparison, based on in-home dialysis period. The primary using the Tablo® System in-center.28 recollection (not based on rating during safety endpoint of adverse event rates Next, an article from Leypoldt, et al., time of use) these participants’ average were similar at 1.9 percent in the in- described the use of uremic solute rating of their previous device’s ease of center dialysis period and 1.8 percent in kinetic models to assess dialysis use for setup was 3.5, treatment 3.3, and the in-home dialysis period. The adequacy via theoretical single pool Kt/ take down 3.8. The average rating of the secondary efficacy endpoint was ® V levels when varying the dialysis blood Tablo System’s ease of use for setup whether the ultrafiltration volume and and treatment was 4.6 and 4.7 for take flow rates and the patient urea volume rate achieved the prescribed levels. In of distribution. A comparison was made down among participants without prior both in-center and in-home dialysis, 94 self-care experience. between dialysate flows of 300 and 500 percent of treatments achieved mL/min at blood flows of both 300 and Among patients surveyed, caregiver successful delivery of ultrafiltration, assistance was required in 62 percent of 400 mL/min. The patient urea volume of defined as a rate within ten percent of distribution range modeled by the patient-weeks during home self-care. the prescribed value. Of 960 in-center Participants previously on self-care authors ranged from 25 to 45 L. Under dialysis services and 896 in-home ideal conditions, the authors home HD required some caregiver dialysis services, 922 and 884 were assistance in 42 percent of the in-home demonstrate that with a blood flow of completed respectively, yielding 300 mL per minute, a single pool Kt/V dialysis treatment weeks. Participants adherence rates of 96 percent and 99 previously on conventional in-center of greater than 1.2 could be achieved in percent.30 patients with a urea volume of dialysis required some caregiver assistance in 35 percent of the in-home distribution of 35 L and 240 minutes of 29 Leypoldt, J.K., Prichard, S., Chertow, G.M., & dialysis treatment weeks. The Alvarez, L. (2019). Differential molecular modeling 28 Chertow, G.M., Alvarez, L., Plumb, T.J., predictions of mid and conventional dialysate requirement for some form of assistance Prichard, S.S., & Aragon, M. (2020). Patient- flows. Blood purification, 47(4), 369–376. reported outcomes from the investigational device 30 Safety and efficacy of the Tablo hemodialysis Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. exemption study of the Tablo hemodialysis system. system for in-center and home hemodialysis Plumb, and Aragon, M.A. (2019), Hemodialysis Hemodialysis International, 24(4), 480–486. T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern, J.G., International.

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among participants with or without 38 percent female, 24 White, 6 Black or and 70 percent White. Of the 291 previous self-care experience was not African American, 1 American Indian or participants, 154 completed the 12- meaningfully different. Finally, the Alaskan native, and 1 Asian. The 8- month follow-up (as-treated cohort). authors noted that a protocol week In-Center Phase (6 days/week) was In the total cohort analysis, both the amendment allowed for the recording of followed by a 2-week transition period physical- and mental-component the number of training sessions and then followed by the 8-week Home summary scores improved over the 12- necessary to deem a patient competent Phase (6 days/week). Data was collected month period, as did all 8 individual to do self-care dialysis. This recording retrospectively on HD treatment domains of the SF–36. The as-treated was limited to the last 15 participants parameters immediately preceding the cohort analysis showed similar enrolled into the study. Five of these study in a subset of patients. Twenty-six improvements with the exception of the participants had previous self-care out of 32 patients (81 percent) role-emotional domain. Significantly, in dialysis at home experience. The successfully completed the study. the as-treated cohort, the percentage of average number of training sessions Treatment compliance (defined as patients achieving a physical required to be deemed competent was completing 43 to 48 treatments in a component summary score at least 3.6 for participants with previous self- given phase) was comparable between equivalent to the general population care dialysis at home experience and 3.9 the 2 treatment environments (88 more than doubled. The authors sessions for participants with only percent In-Center vs. 89 percent Home). concluded by noting that at-home short conventional in-center HD experience.31 Successful delivery of at least 90 daily HD is associated with long-term Next, a poster presentation from percent of prescribed fluid volume improvements in various physical and Chahal et al., reported patient device (primary endpoint) was achieved in 98.5 mental health-related quality of life preference of prior in-home HD patients percent of treatments in-center and 97.3 measures.34 ® based on data from the Tablo IDE percent at home. Total effluent volume Third, in Weinhandl et al., authors study (previously discussed). The as a percentage of prescribed volume described a cohort study in which 4,201 authors noted that 13 of the 30 was between 94 percent and 100 percent new home HD patients in 2007 were ® participants in the Tablo IDE trial were for all study weeks. The composite rate matched with 4,201 new PD patients in performing in-home HD at the time of of intradialytic and interdialytic adverse 2010 from the United States Renal Data enrollment and that prior to the study, events per 100 treatments was System (USRDS) database to assess dialysis prescriptions averaged 4.5 significantly higher for the In-Center relative mortality, hospitalization, and treatments per week with an average Phase (5.30) compared with the Home technique failure. Demographic time of 3.1 hours per session. Trial information reflected the mean age as Phase (2.10; p=0.007). Compared with ± prescriptions were for 4 days per week the period immediately preceding the 53.8 14.9 years, 67 percent male, 33 and an average of 3.4 hours per session. study, there were reductions in blood percent female, 24.4 percent Black, and Adherence to the study regimen was 97 75.6 percent Nonblack. Daily home HD pressure, antihypertensive medications, ® percent and 92 percent of surveys were and interdialytic weight gain. The study patients initiated use of NxStage from completed. The authors concluded that concluded that daily home HD with a 2007 through 2010. Authors reported participants with prior home HD home HD was associated with 20 ® small, easy-to-use HD device is a viable experience preferred the Tablo System dialysis option for ESRD patients percent lower risk for all-cause compared to their prior device and 85.6 capable of self/partner administered mortality, 8 percent lower risk for all- ® cause hospitalization, and 37 percent percent found that the Tablo System dialysis.33 32 was easier to use. Second, an article from Finkelstein et lower risk for technique failure, all As stated previously in this section of al., reports on interim results of the relative to PD. Regarding the proposed rule, the applicant Following Rehabilitation, Economics hospitalization, risk comparisons submitted several sources pertaining to favored home HD for cardiovascular ® and Everyday-Dialysis Outcome the incumbent, NxStage. First, an Measurements (FREEDOM) study, a disease and dialysis access infection article from Kraus et al., describes a multi-center, prospective, cohort study and PD for bloodstream infection. feasibility study to demonstrate the of at-home short daily HD with a Authors noted that matching was safety of center-based versus home- planned 12-month follow-up unlikely to reduce confounding based daily HD with the NxStage® (ClinicalTrials.gov identifier, attributable to unmeasured factors, portable HD device. This retrospective NCT00288613). Eligible patients were including residual kidney function; lack analysis examined the extent to which adults with ESRD requiring dialysis of data regarding dialysis frequency, clinical effects previously associated who were being initiated on short daily duration, and dose in daily home HD with short-daily dialysis were also seen patients and frequency and solution in ® HD (prescribed 6 times per week) at using the NxStage device. The authors ® PD patients; and diagnosis codes used to home using the NxStage cycler and conducted a prospective, two-treatment, classify admissions. The authors who had Medicare as their primary two-period, open-label, crossover study concluded that these data suggest that insurance payer. The authors examined of in-center HD vs. home HD in 32 relative to peritoneal dialysis, daily the long-term effect of short daily HD on patients treated at six U.S. centers. home HD is associated with decreased health-related quality of life, as Demographic information reflected the mortality, hospitalization, and measured by the Short Form-36 (SF–36) mean age as 51 years, 63 percent male, technique failure but that risks for health survey. The survey was mortality and hospitalization were administered at baseline, 4 and 12 31 Plumb, Troy J., Luis Alvarez, Dennis L. Ross, similar with these modalities in new months after initiation of short daily HD Joseph J. Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, dialysis patients.35 Graham E. Abra, Sarah S. Prichard, Glenn M. to 291 (total cohort) participants. Chertow, and Michael A. Aragon. ‘‘Self-care Demographic information reflected the training using the Tablo hemodialysis system.’’ 34 Finkelstein, F.O., et al. (2012). At-home short Hemodialysis International (2020). mean age as 53 years, 66 percent male daily hemodialysis improves the long-term health- 32 Chahal, Y., Plumb, T., Aragon M. (2020). related quality of life. Kidney International, 82(5), Patient Device Preference for Home Hemodialysis: 33 Kraus, M., et al., A comparison of center-based 561–569. A Subset Analysis of the Tablo Home IDE Trial. vs. home-based daily hemodialysis for patients with 35 Weinhandl, E.D., Gilbertson, D.T., & Collins, Poster Presentation at National Kidney Foundation end-stage renal disease. Hemodialysis International, A.J. (2016). Mortality, hospitalization, and Spring Clinical Conference, March 2020. 11: 468–477, (2007). Continued

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Fourth, in Suri et al., 1116, daily applicant stated that adequate dialysis The applicant stated that Dialysis home HD patients were matched by for a standard, thrice weekly treatment Outcomes and Practice Patterns Study propensity scores to 2784, schedule is a single treatment clearance (DOPPS) data demonstrate that the contemporaneous USRDS patients of urea, expressed as a single-pool Kt/ current U.S. practice for thrice weekly receiving home peritoneal dialysis. The V (spKt/V) of greater than 1.2 where ‘‘K’’ dialysis occurs at an average treatment authors compared hospitalization rates = dialyzer clearance, ‘‘t’’ = time, and time of greater than 220 minutes, and from cardiovascular, infectious, access- ‘‘V’’ = Volume of distribution of urea. has increased in the last 25 years.40 Per related or bleeding causes, and modality The applicant also stated that dialyzer the applicant, with the limited ‘‘t’’, a failure risk. Similar analyses were clearance, or ‘‘K’’, is dependent on the single-pooled Kt/V of >1.2 cannot be performed for 1187, daily home HD mass transfer coefficient (KoA) expected to be achieved for the majority patients matched to 3173, USRDS characteristics of the prescribed dialyzer of U.S. patients with ESRD on a thrice patients receiving in-center and prescribed blood and dialysate flow weekly schedule, requiring increased conventional HD. Demographic rates. The applicant further noted that treatment frequency 41 at home for these information identified the mean age as limitations in ‘‘K’’ or ‘‘t’’ affect the patients to meet the desired clearance 50.5 years, 67.3 percent male, 70.9 ability of a patient to achieve adequate level. percent White, 26.6 percent Black, and clearance during a dialysis treatment. In citing Leypoldt et al., the applicant 2.5 percent Other, among the daily Per the applicant, across a broad range stated that data from the Hemodialysis home HD patients. Among the home PD of weights, patients using the Tablo® (HEMO) trial combined with modeling patients, the mean age was identified as System can achieve the target of dialysis results from Leypoldt et al.,42 allow for 50.9 years, 66.9 percent male, 73.1 adequacy, a single pool Kt/V of 1.2, with an estimation of the patients with ESRD, percent White, 25.1 percent Black and 3 treatments per week in less than 4 based on weight, that cannot be 1.2 percent Other. The composite hours.37 The applicant also stated that expected to achieve target clearance hospitalization rate was significantly when used 4 times per week, patients with standard thrice weekly dialysis at lower with daily home HD than with PD using the Tablo® System had a higher this treatment duration. The applicant (0.93 vs. 1.35/patient-year). Daily home mean weekly standard Kt/V with explained that because urea is evenly HD patients spent significantly fewer equivalent or better dialysis-related distributed throughout a body’s water, days in the hospital than PD patients hospitalization rates,38 as compared to the volume of distribution of urea is (5.2 vs. 9.2 days/patient-year), and NxStage® IDE patients prescribed equal to a patient’s total volume of significantly more daily home HD therapy at 6 days per week.39 water. The applicant also stated that patients remained admission-free (52 total body water and volume of The applicant stated that the Tablo® percent daily home dialysis vs. 32 distribution of urea can be expressed as System’s on-demand dialysate percent peritoneal dialysis). In contrast, a volume or as a percentage of total production has no limitation to the there was no significant difference in weight and can vary based on numerous volume of dialysate that can be hospitalizations between daily home HD factors including disease state. The produced and used during a single and conventional HD (0.93 vs. 1.10/ applicant stated that it is possible to treatment. The applicant further stated patient-year). Cardiovascular estimate the percent of water for the that this facilitates the delivery of hospitalizations were lower with daily ESRD population from the HEMO trial adequate dialysis clearance (Kt/V) in a 43 home HD than with conventional HD as summarized in Leypoldt et al. The standard duration and target frequency (0.68) while infectious and access applicant stated that in the trial, the of 3 times per week, as well as alternate hospitalizations were higher (1.15) and mean patient weight was 69.8kg and the frequencies and durations as preferred 1.25 respectively). Significantly more mean patient volume of body water (V) by a patient or recommended by a PD than daily home HD patients was 30.9L. The applicant further health care provider. switched back to in-center HD (44 explained that from this, total body ® percent vs. 15 percent). In this prevalent The applicant asserted that NxStage, water (and volume of distribution of cohort, daily home HD was associated when attached to its Pureflow device, urea) are calculated as 44.3 percent of with fewer admissions and hospital requires users to batch a set amount of the mean weight of patients with ESRD × days than PD, and a substantially lower dialysate (maximum of 60 liters) in (44.3 = 30.9L/69.8kg 100). Per the risk of modality failure.36 advance of a treatment or use sterile applicant, applying this 44.3 percent of dialysate bags (maximum of 30 liters). total body weight to the volumes of (b) Applicant SCI Claims The applicant also stated that at its distribution in Leypoldt et al.44 allows Regarding the applicant’s first claim maximum dialysate flow rate (Qd) of the conversion of the kinetic model that the Tablo® System decreases 300ml/min, NxStage® greatly limits described into anticipated patient treatment frequency with adequate time by restricting treatment to a weights. The applicant further stated dialysis clearance, the applicant stated maximum of 200 minutes before that the Tablo® System is the only exhausting its dialysate capacity (200 40 Tentori F, Zhang J, Li Y, Karaboyas A, Kerr P, min = 60L/300ml/min). Saran R, Bommer J, Port F, Akiba T, Pisoni R, mobile HD device approved for use in Robinson B. Longer dialysis session length is the home that can achieve adequate associated with better intermediate outcomes and dialysis in as little as 3 treatments per 37 Alvarez, Luis et al. Urea Clearance Results in survival among patients on in-center three times per week, while also providing flexibility Patients Dialyzed Thrice Weekly Using a Dialysate week hemodialysis: results from the Dialysis for more frequent dialysis and thus Flow of 300 mL/min, clinical abstract, presented Outcomes and Practice Patterns Study (DOPPS). March 2019, Annual Dialysis Conference, Dallas, Nephrol Dial Transplant. 2012 Nov;27(11):4180–8. greater personalization of care. The TX. doi: 10.1093/ndt/gfs021. Epub 2012 Mar 19. PMID: 38 Plumb, T.J., Alvarez, L., Ross, D.L., Lee, J.J., 22431708; PMCID: PMC3529546. technique failure in daily home hemodialysis and Mulhern, J.G., Bell, J.L., Abra, G., Prichard, S.S., 41 Health Management Associates (HMA) analysis matched peritoneal dialysis patients: A matched Chertow, G.M. and Aragon, M.A. (2019). Safety and of 2018 100% Medicare Outpatient file. cohort study. American Journal of Kidney Diseases, efficacy of the Tablo hemodialysis system for in- 42 Leypoldt, J.K., Prichard, S., Chertow, G.M., & 67(1), 98–110. center and home hemodialysis. Hemodialysis Alvarez, L. (2019). Differential molecular modeling 36 Suri, R.S., Li, L., & Nesrallah, G.E. (2015). The International. predictions of mid and conventional dialysate risk of hospitalization and modality failure with 39 NxStage Clearance Calculator. Available at: flows. Blood Purification, 47(4), 369–376. home dialysis. Kidney International, 88(2), 360– https://dosingcalculator.nxstage.com/ 43 Ibid. 368. DosingCalculator/. Accessed on Jan 21, 2021. 44 Ibid.

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that in calculating with standard blood amounting to an estimated annual cost increasing patients’ symptom burden.53 flow and a higher dialyzer mass transfer to Medicare of $122 to $126 million.49 The applicant stated that by achieving area coefficient for urea (KoA) diayzer, However, based on CMS review of adequacy targets with fewer treatments, a 200 minute treatment at a dialysate dialysis facility claims data, among all Tablo® System patients can be expected flow rate (Qd) of 300ml/min would not beneficiaries who had home dialysis to have fewer vascular access achieve what the applicant refers to as treatments in 2018, 39.1 percent had 5 interventions and health care providers the CMS target spKt/V target 1.2 for or more dialysis sessions at least once will have increased flexibility in patients with a volume of distribution of during any week. The overall percentage personalizing the frequency and urea (V) of 35L or greater. The applicant of beneficiary-weeks that had 5 or more duration of patient treatments.54 55 The stated that these assumptions were home HD sessions in 2018 was 20.9 applicant stated that reducing treatment drawn from NxStage® technical percent. Medicare payment for these frequency while maintaining adequate specifications.45 46 The applicant stated additional sessions totaled $17 million. patient clearance levels may also reduce that at 44.3 percent of total weight, this We note that, as indicated in Local complications that lead to volume of distribution of urea correlates Coverage Determination ID L35014, hospitalizations. The applicant stated to patients with ESRD with a mean ‘‘Frequency of Dialysis’’ (revised that during the Tablo® IDE study, weight above 79 kg (79 = 35L/.443) or effective September 26, 2019),50 CMS patients using the Tablo® System 4 approximately 174 pounds. Per the established payment for HD based on times per week, for an average duration applicant, patients at or above this conventional treatment which is defined of less than 4 hours per treatment, had weight cannot be expected to achieve a as 3 times per week. Sessions in excess an all-cause hospital admission rate of spKt/V urea of 1.2 on a thrice weekly of 3 times per week must be both 426 per 1,000 patient-years whereas in schedule using the NxStage® system at reasonable and necessary in order to the general dialysis population, the all- its maximal dialysate flow rate. receive payment. Covered indications cause admission rate is 1,688 per 1,000 The applicant stated that for the include metabolic conditions (acidosis, patient-years, and for patients who majority of the U.S. prevalent ESRD hyperkalemia, hyperphosphatemia), utilize peritoneal dialysis, the population between the ages of 22–74, fluid positive status not controlled with hospitalization rate is 1,460 per 1,000 whose mean weight is between 84.3– routine dialysis, pregnancy, heart patient years.56 89.1 kg by age group,47 thrice weekly failure, pericarditis, and incomplete The applicant stated that while therapy at home on NxStage® would not dialysis secondary to hypotension or NxStage® has not specifically reported achieve the Medicare coverage standard. access issues. The applicant asserted the hospitalization rates per patient-year Specifically, per the applicant, that the use of the Tablo® System would from its IDE study, published data from Medicare’s national coverage policy is decrease the number of necessary Weinhandl et al.,57 and Suri et al.,58 to reimburse for dialysis care 3 times dialysis treatments, without affecting report hospital admission rates amongst per week, regardless of the modality that patient outcomes such as clearance or patients on daily home HD ranging from is used and health care providers are hospitalizations. 930 to 1,663 per 1,000 patient-years, expected to ensure that patients receive The applicant stated that there is using a national sample of dialysis adequate clearance with the 3 times per clinical evidence and expert consensus patients matched for comparison to week cadence. The applicant also stated that as treatment frequency increases, similar peritoneal and in-center dialysis that Medicare Administrative native residual kidney function drops, patients. We clarify that this would Contractors (MACs) have discretion in patient and care partner burden represent 930 to 1,663 cases observed reimbursing additional treatments with increases, and vascular access medical justification.48 Per the complications increase.51 52 Per the 53 Safety and efficacy of the Tablo hemodialysis applicant, home use of the Tablo® system for in-center and home hemodialysis Plumb, applicant, an analysis of Medicare T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern, J.G., claims data from 2018 finds that despite System can reduce the need for a fifth Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. the limitations of the reimbursement or sixth weekly treatment without and Aragon, M.A. (2019), Hemodialysis policy, Medicare is paying for 5 or more International. treatments per week in 50 percent of 49 Health Management Associates (HMA) analysis 54 FHN Trial Group. (2010). In-center hemodialysis six times per week versus three times home HD patients nationwide, of 2018 100 percent Medicare Outpatient file. 50 Medicare Coverage Database. Retrieved May 24, per week. New England Journal of Medicine, 2021 from: https://www.cms.gov/medicare- 363(24), 2287–2300. 45 Leypoldt, J.K., Prichard, S., Chertow, G.M., & coverage-database/details/lcd-details.aspx? 55 Kuo, T.H., Tseng, C.T., Lin, W.H., Chao, J.Y., Alvarez, L. (2019). Differential molecular modeling LCDId=35014&ver=39&NCDId=79&ncdver=1& Wang, W.M., Li, C.Y., & Wang, M.C. (2015). predictions of mid and conventional dialysate SearchType=Advanced&CoverageSelection=Both& Association Between Vascular Access Dysfunction flows. Blood Purification, 47(4), 369–376. NCSelection=NCA%7CCAL%7CNCD%7 and Subsequent Major Adverse Cardiovascular 46 Daugirdas JT, Greene T, Depner TA, Chumela CMEDCAC%7CTA%7CMCD&ArticleType= Events in Patients on Hemodialysis: A Population- C, Rocco, MJ, Chertow, GM for the Hemodialysis Ed%7CKey%7CSAD%7CFAQ&PolicyType=Final& Based Nested Case–Control Study. Medicine, (HEMO) Study Group. Anthropometrically s=-%7C5%7C6%7C66%7C67%7C 94(26). Estimated Total Body Water Volumes are Larger 9%7C38%7C63%7C41%7C64%7C65%7C44& 56 United States Renal Data System. 2020 USRDS than Modeled Urea Volume in Chronic KeyWord=transplant&KeyWordLookUp= Annual Data Report: Epidemiology of kidney Hemodialysis Patients: Effects of Age, Race and Doc&KeyWordSearchType=Exact&kq=true& disease in the United States, End-Stage Renal Gender. 2003. Kidney Int. 64:1108–1119. bc=IAAAADgAAAAA&. Disease Chapter 2. National Institutes of Health, 47 United States Renal Data System. 2020 USRDS 51 National Kidney Foundation. KDOQI clinical National Institute of Diabetes and Digestive and Annual Data Report: Epidemiology of kidney practice guideline for hemodialysis adequacy: 2015 Kidney Diseases, Bethesda, MD, 2020. Available at: disease in the United States, End-Stage Renal update. Am J Kidney Dis. 2015;66(5):884–930. https://adr.usrds.org/2020/end-stage-renaldisease/ Disease Chapter 2. National Institutes of Health, 52 Shafi T, Wilson RF, Greer R, Zhang A, Sozio introduction-to-volume-2. Reference Table G2. National Institute of Diabetes and Digestive and S, Tan M, Bass EB. End-stage Renal Disease in the 57 Weinhandl, E.D., Gilbertson, D.T., & Collins, Kidney Diseases, Bethesda, MD, 2020. Available at: Medicare Population: Frequency and Duration of A.J. (2016). Mortality, hospitalization, and https://adr.usrds.org/2020/end-stage-renaldisease/ Hemodialysis and Quality of Life Assessment. technique failure in daily home hemodialysis and introduction-to-volume-2. Accessed on Jan 21, 2021. Technology Assessment Program Project ID No. matched peritoneal dialysis patients: A matched 48 Wilk, A.S., Hirth, R.A., Zhang, W., Wheeler, JHE51000. (Prepared by the Johns Hopkins cohort study. American Journal of Kidney Diseases, J.R., Turenne, M.N., Nahra, T.A., . . . & Messana, University Evidence-based Practice Center under 67(1), 98–110. J.M. (2018). Persistent variation in Medicare contract number HHSA 290–2015–00006I) 58 Suri, R.S., Li, L., & Nesrallah, G.E. (2015). The payment authorization for home hemodialysis Rockville, MD: Agency for Healthcare Research and risk of hospitalization and modality failure with treatments. Health services research, 53(2), 649– Quality. July 2020. Available at: http:// home dialysis. Kidney international, 88(2), 360– 670. www.ahrq.gov/research/findings/ta/index.html. 368.

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among 1,000 persons during 1 year. The represent a significant improvement improved adherence and retention rates applicant also noted that all data on over the treatment adherence rate and that the Tablo® System is designed home patients in Weinhandl et al. came reported in the NxStage® IDE, where the to enable patients to become proficient from a matched cohort of NxStage® treatment compliance rate was defined and independent in using the Tablo® patients. Per the applicant, in Suri et al., less stringently as missing 5 or fewer System after an average of 3.9 days.66 data were collected prior to 2015 and treatments of the 48 possible treatments Per the applicant, published NxStage® that during this timeframe, it can be and was only 89 percent among patients IDE data 67 reported an average of 14.5 reasonably assumed that home HD at home and during the study period.62 days ‘‘to complete device training on patients were using NxStage® for Per the applicant, using a comparable NxStage®.’’ The applicant stated that, in treatment. The applicant stated that the metric of missing 5 or fewer of all comparison, device-related training time results from these studies suggest that possible treatments at home, Tablo® IDE is reduced by at least 50 percent on the patients receiving treatment at home patients at home had a 100 percent Tablo® System. Per the applicant, the with NxStage® 5 to 6 times per week do treatment compliance rate. reduced training time and ease of use not have a lower all-cause The applicant stated that technique will likely improve retention and hospitalization rate, relative to matched failure in home HD, defined as reduced potentially reduce the number of in-center HD patients. The applicant retention at home and a return to in- reimbursable training sessions. The concluded by stating that because of the center care, has been high with applicant stated that because of the clinical and demographic diversity of NxStage®. Per the applicant, real world significant role that caregivers play in ® the Tablo System’s patient population, data show that technique failure occurs supporting home dialysis treatments,68 the applicant’s results show incremental in 36 percent of home HD patients using care partner burnout and a patient’s improvement over the hospitalization NxStage® within 1 year of initiating perception of being a burden is rate of the current home HD population. treatment.63 The applicant stated that associated with discontinuation of home Regarding the applicant’s second this is challenging for the patient and 69 70 ® therapy. Per the applicant, the 28 claim that the Tablo System increases taxing on the healthcare system that has patients who entered the home phase of adherence to dialysis treatment and invested in providing patients with the Tablo® IDE study were asked weekly retention to home therapy, the applicant home dialysis training and in paying for if they needed help with their dialysis ® stated that patients using the Tablo more frequent therapy. treatments during the prior 7 days. The System have improved adherence to The applicant stated that by directly applicant stated that a 96 percent ® prescribed treatments and a higher rate comparing the Tablo System’s response rate (216 of 224 possible) was ® of retention to home therapy. The retention to that of NxStage , the achieved at the end of the study and applicant further stated that this applicant assessed rates in the that for both prior-in-center and increased adherence and retention is analogous IDE populations while NxStage® study participants, in 79 likely to improve patient outcomes by excluding those who exited either study percent of the treatment weeks, patients reducing the rate of dialysis-related for reasons unrelated to the device such reported needing no assistance from hospitalizations and other adverse as receipt of a transplant or death. The their care partner in performing dialysis events associated with missing applicant stated that the Tablo® System 59 set-up, treatment, or breakdown. The treatment in this patient population. demonstrated a 97 percent (28 of 29) applicant explained that among the 13 The applicant stated that adherence to patient retention rate for the entire IDE prior in-home patients, all of whom prescribed dialysis treatments is crucial study and a 100 percent retention rate were formerly NxStage® users, for dialysis patients because missed in the in-home phase of the trial among participants reported needing help from treatments increases the risk of dialysis both prior NxStage® users and prior in- 60 a trained individual with dialysis dropout, hospitalization, and death. 64 ® center patients. The applicant stated treatment in 69 percent of treatment Per the applicant, the Tablo IDE study that in comparison, 81 percent of weeks, with 46 percent of instances demonstrated a 99 percent treatment ® participants completed the NxStage involving a need for device-related help. adherence rate to all prescribed home IDE study.65 71 61 We clarify that per Plumb, et al., this treatments among both prior in-center The applicant stated that the Tablo® participants and prior self-care home 66 ® System’s ease of use contributed to the Plumb, Troy J., Luis Alvarez, Dennis L. Ross, HD participants who used NxStage . Joseph J. Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, The applicant also stated that the 62 Kraus, M., et al., A comparison of center-based Graham E. Abra, Sarah S. Prichard, Glenn M. ® Tablo System’s adherence rates were vs. home-based daily hemodialysis for patients with Chertow, and Michael A. Aragon. ‘‘Self-care similar among both the prior in-center end-stage renal disease. Hemodialysis training using the Tablo hemodialysis system.’’ Hemodialysis International (2020). and prior self-care participants. The International,11: 468–477, (2007). The authors performed a feasibility study to demonstrate the 67 Kraus, M., et al., A comparison of center-based applicant stated that these results safety of center-based vs. home-based daily vs. home-based daily hemodialysis for patients with hemodialysis with the NxStage System One end-stage renal disease. Hemodialysis 59 Chan, K.E., Thadhani, R.I., & Maddux, F.W. portable hemodialysis device. International,11: 468–477, (2007). (2014). Adherence barriers to chronic dialysis in the 63 Weinhandl, Eric D., Collins Allan, Incidence of 68 Seshasai, R.K., et al. (2019) The home United States. Journal of the American Society of Therapy Cessation among Home Hemodialysis hemodialysis patient experience: A qualitative Nephrology, 25(11), 2642–2648. Supporting Patients in the United States, Abstract presented, assessment of modality use and discontinuation. evidence of association between decreased dialysis American Society of Nephrology Kidney Week Hemodialysis International, 23: 139–150 (2019). adherence and poor patient health and utilization 2016. 69 Suri, R.S., Larive, B., Hall, Y., Kimmel, P.L., outcomes. 64 Safety and efficacy of the Tablo hemodialysis Kliger, A.S., Levin, N., . . . & Frequent 60 Weinhandl, Eric D., Collins Allan, Incidence of system for in-center and home hemodialysis Plumb, Hemodialysis Network (FHN) Trial Group. (2014). Therapy Cessation among Home Hemodialysis T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern, J.G., Effects of frequent hemodialysis on perceived Patients in the United States, Abstract presented, Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. caregiver burden in the Frequent Hemodialysis American Society of Nephrology Kidney Week and Aragon, M.A. (2019), Hemodialysis Network trials. Clinical Journal of the American 2016. International. Society of Nephrology, 9(5), 936–942. 61 Safety and efficacy of the Tablo hemodialysis 65 Kraus M, Burkart J, Hegeman R, Solomon R, 70 Jacquet, S., & Trinh, E. (2019). The potential system for in-center and home hemodialysis Plumb, Coplon N, Moran J. A comparison of center-based burden of home dialysis on patients and caregivers: T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern, J.G., vs. home-based daily hemodialysis for patients with A narrative review. Canadian journal of kidney Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. end-stage renal disease. Hemodial Int. 2007 health and disease, 6, 2054358119893335. and Aragon, M.A. (2019), Hemodialysis Oct;11(4):468–77. doi: 10.1111/j.1542– 71 Plumb, Troy J., Luis Alvarez, Dennis L. Ross, International. 4758.2007.00229.x. PMID: 17922746. Joseph J. Lee, Jeffrey G. Mulhern, Jeffrey L. Bell,

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is the baseline percentage and reflects 9 and monitoring as compared to adjusted measure that was then of the 13 patients with previous self- NxStage®. translated to the EQ–5D scale, and the care experience. The applicant stated Regarding the applicant’s third claim applicant did not have access to ® that patients reported needing help with that the Tablo System improves patient standard error estimates for the Mental treatment in only 42 percent of quality of life, the applicant stated that Component Score (MCS) and Physical ® treatment weeks while using the Tablo® patients on the Tablo System Component Score (PCS), its System, which is a 39 percent reduction experience reduced disease burden, interpretation of this estimate and its from baseline NxStage® use; and only dialysis related symptoms, and an variance is limited. Per the applicant, 18 percent of these instances related to improved quality of life at home as nonetheless, it provides a sense of the use of the Tablo® System, which is a 61 compared to in-center and existing comparable HR-QoL of this sample of ® percent reduction in rate from baseline home care options. Per the applicant, NxStage patients at follow-up. The NxStage® use.72 patients with ESRD experience applicant further noted that mean EQ– significant dialysis-related symptoms 5D index values for traditional HD and The applicant stated that it collected including difficulty sleeping, dizziness, PD patients reported from a meta- weekly data from patients by asking and pain associated with recovery time analysis of existing studies in the them to rate the extent to which they that affect mental and physical health literature are 0.56 (95 percent CI: 0.49– believed that they were a burden on a and lead to decreased overall quality of 0.62) and 0.58 (95 percent CI: 0.5–0.67), ® scale of 1 to 5, with 1 representing never life.75 Per the applicant, the Tablo IDE respectively.78 and 5 representing always. The study assessed several validated Patient- Per the applicant, patients in the applicant stated that this measure was Reported Outcome Measures (PROMs) Tablo® IDE study reported mean EQ–5D adapted from an instrument used in to better understand overall health- index values of 0.821 (SD: ±0.163) 79 in assessing terminally ill patients.73 The related quality of life (HR-QoL). The the home phase of the study with final applicant stated that the subpopulation applicant explained that the overall measures taken at approximately 5 of study participants who had measure was the EQ–5D–5L, a months from trial start. The applicant ® previously used NxStage reported an validated, preference-based PROM in stated that this is a significant average score of 3.1 for self-perceived which patients self-assess mobility, self- improvement when using traditional HD burden on their care partner when using care, usual activities, pain/discomfort, patients as a comparator, and higher 76 their prior device, which subsequently and anxiety/depression. The applicant overall HR-QoL as compared to reduced to 2.4 when using the Tablo® stated that from these domains, an index NxStage® patients. The applicant System (a 23 percent reduction in score value is calculated to report a summary emphasized that participants in the from baseline NxStage® use).74 Per the score that ranges from 0 (death) to 1 (full Tablo® IDE trial underwent a reduced applicant, these data underscore that a health). treatment frequency as compared to Per the applicant, while the NxStage® significant increase in patients’ participants in the FREEDOM study IDE study did not report results for a confidence, ability to achieve treatment who were prescribed 6 treatments per quality-of-life instrument, HR-QoL was independence at home, and subsequent week on NxStage®. The applicant stated assessed in NxStage® patients in a reduction in the sense of self burden can that among patients in the Tablo® IDE prospective multicenter observational positively contribute to success in the study who had previously been using study referred to as the FREEDOM trial, NxStage®, the mean EQ–5D score during home setting. The applicant further which examined the effects of at-home the in-home phase of the study was noted that the ease of use, reduced dialysis 6 times per week with the 0.906 (SD: ±0.119) and asserted that this training time, and substantial reduction NxStage® System on costs and HR-QoL in care partner assistance required for is significantly greater than index ® using the SF–36 instrument. The the Tablo System correlated to the applicant further stated that the population values for HD and peritoneal improved retention and adherence rates reported results at 4-month follow-up dialysis. ® in the Tablo IDE study. The applicant among these patients 77 translates to a The applicant stated that sleep stated that on a population level, this mean EQ–5D score of 0.70. The problems are present in 60 percent of likely translates to reduced barriers to patients with chronic kidney disease applicant included an appendix 80 continuing home HD once initiated, and describing the Methodology to Derive (CKD) and ESRD and that patients ultimately, a reduced risk of adverse EQ–5D Scores from the FREEDOM rank fatigue and lack of energy as the outcomes due to missed treatments. The Study Results in its application and most important contributor to their 81 applicant also stated that the Tablo® derived a predicted mean EQ–5D score decreased quality of life. Per the System’s electronic data capture and of 0.695–0.70 at follow up for the 78 Liem, Y.S., Bosch, J.L., & Hunink, M.M. (2008). automatic wireless transmission FREEDOM study. The applicant further Preference-based quality of life of patients on renal eliminates the need for manual record noted that because this estimate is based replacement therapy: A systematic review and keeping, which represents an on the average aggregate change for an meta-analysis. Value in Health, 11(4), 733–741. improvement with respect to burden 79 Chertow, G.M., Alvarez, L., Plumb, T.J., 75 Gabbay, E., Meyer, K.B., Griffith, J.L., Prichard, S.S., & Aragon, M. (2020). Patient- Richardson, M.M., & Miskulin, D.C. (2010). reported outcomes from the investigational device Graham E. Abra, Sarah S. Prichard, Glenn M. Temporal trends in healthrelated quality of life exemption study of the Tablo hemodialysis system. Chertow, and Michael A. Aragon. ‘‘Self-care among hemodialysis patients in the United States. Hemodialysis International, 24(4), 480–486. training using the Tablo hemodialysis system.’’ Clinical journal of the American Society of 80 Davison SN, Levin A, Moss AH, Jha V, Brown Hemodialysis International (2020). Nephrology, 5(2), 261–267. EA, Brennan F, Murtagh FE, Naicker S, Germain MJ, 72 Ibid. 76 Yang, F., Wong, C.K., Luo, N., Piercy, J., Moon, O’Donoghue DJ, Morton RL, Obrador GT; Kidney 73 Chochinov, H.M., Kristjanson, L.J., Hack, T.F., R., & Jackson, J. (2019). Mapping the kidney disease Disease: Improving Global Outcomes. Executive Hassard, T., McClement, S., & Harlos, M. (2007). quality of life 36-item short form survey (KDQOL– summary of the KDIGO Controversies Conference Burden to others and the terminally ill. Journal of 36) to the EQ–5D–3L and the EQ–5D–5L in patients on Supportive Care in Chronic Kidney Disease: pain and symptom management, 34(5), 463–471. undergoing dialysis. The European Journal of Developing a roadmap to improving quality care. 74 Chertow, G.M., Alvarez, L., Plumb, T.J., Health Economics, 20(8), 1195–1206. Kidney Int. 2015 Sep;88(3):447–59. Prichard, S.S., & Aragon, M. (2020). Patient- 77 Finkelstein, F.O., et al. (2012). At-home short 81 Urquhart-Secord, Rachel et al. (2016). Patient reported outcomes from the investigational device daily hemodialysis improves the long-term health- and Caregiver Priorities for Outcomes in exemption study of the Tablo hemodialysis system. related quality of life. Kidney international, 82(5), Hemodialysis: An International Nominal Group Hemodialysis International, 24(4), 480–486. 561–569. Continued

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applicant, the frequency of sleep-related symptoms previously experienced remain on the Tablo® System at the end symptoms among the Tablo® System’s during dialysis. The applicant also of the study.89 patients was assessed by a survey that stated that at the end of each study In summary, the applicant claimed was administered weekly during the treatment, participants were surveyed that the Tablo® System improves the Tablo® IDE study. The applicant stated regarding the presence of any symptoms treatment of Medicare beneficiaries that, in the absence of a well-validated during that treatment on the Tablo® relative to the incumbent by focusing on sleep survey specific to the ESRD System. Per the applicant, a total of 8 outcomes set forth in population, study investigators selected (26.7 percent) subjects reported § 412.87(b)(1)(ii)(C), including a survey questions from previously hypotensive symptoms during the decreased number of treatments to validated sleep questionnaires in the Tablo® System treatments during the in- achieve dialysis adequacy, which the non-ESRD population, based on their home treatment period, compared to 27 applicant stated leads to greater relevance to the study population.82 83 (90 percent) subjects reporting adherence to prescribed therapy, and The applicant explained that questions hypotensive symptoms at baseline (prior improved quality of life. ® were designed to focus on quality of to initiating care on the Tablo System). (c) CMS Preliminary Assessment of SCI sleep and restfulness and noted that The applicant reported a 70 percent Claims and Sources these measures are validated for use reduction in the rate of patient-reported After a review of the information among chronically ill populations and hypotensive symptoms while on the measure the frequency of 4 key sleep- ® provided by the applicant, we have Tablo System, though we were unable identified the following concerns related symptoms. The applicant stated to validate the source of this statement. that, while at home, patients on the regarding the SCI eligibility criterion for Tablo® System reported improved The applicant stated that currently, the TPNIES. We note that, consistent quality of sleep, with a measurable ESRD patients on dialysis report with § 413.236(c), CMS will announce meaningfully lower quality of life its final determination regarding reduction in rate of patient-reported ® sleep symptoms ranging from a 10–60 compared to those with other chronic whether Tablo meets the SCI criterion 86 percent reduction, depending on illnesses. The applicant further noted and other eligibility criteria for the symptom.84 The applicant stated that that decreased quality of life is TPNIES in the CY 2022 ESRD PPS final this reduction was observed among associated with a meaningful decline in rule. With respect to the applicant’s claim study participants who were previously continuation of home therapy, dialysis that patients can achieve dialysis receiving dialysis in-center (average frequency, and worse clinical and 87 adequacy in as little as 3 treatments per magnitude of reduction in rate across health care utilization outcomes. week, we note that the Tablo® IDE study symptoms: 42 percent) and among study The applicant concluded by asserting did not test whether patients receive that the totality of evidence submitted participants who were previously adequate dialysis on a thrice-weekly ® in support of the Tablo® System receiving in-home dialysis on NxStage schedule. Instead, data published from demonstrates SCI over the current ® (average magnitude of reduction in rate the Tablo IDE study address a weekly across symptoms: 27 percent). Per the standard of home dialysis care. The measure of dialysis adequacy among applicant, on average, sleep-related applicant also stated that patient patients treated on a 4 times per week difficulties reduced from being reported preference for devices is currently used schedule. The applicant relied on in 33 percent of treatment weeks while by FDA to guide marketing modeling and unpublished data on on NxStage® to 23 percent of treatment authorization decisions and provides ® patients receiving thrice-weekly dialysis weeks while on the Tablo System. important information on the benefit in making the conclusion that dialysis The applicant stated that hypotensive and risks that some patients are willing adequacy can be reached on a thrice- 88 symptoms such as feelings of dizziness to trade when choosing a device. Per weekly schedule. Specifically, the and lightheadedness are associated with the applicant, patients may be more applicant referred to a theoretical the drops in blood pressure that can likely to choose home dialysis to the modeling study based on historical data occur during dialysis and are also extent that the device is both accessible from the USRDS, Medicare claims, and among the top ten symptoms dialysis and easy to use. The applicant also historical outcomes from NxStage® ® patients report that impact their quality stated that 86 percent of prior NxStage observational studies. The applicant of life.85 Per the applicant, participants patients in the Tablo® IDE study found ® ® also stated that findings from a in the Tablo IDE study were asked at the Tablo System easier to use than retrospective review of 29 patients the time of enrollment regarding their incumbent device and preferred to receiving treatment with the Tablo® System on a thrice-weekly schedule Technique Study American Journal of Kidney 86 Liem, Y.S., Bosch, J.L., Arends, L.R., affirm the results from the modeling Diseases, Volume 68, Issue 3, 444–454. Heijenbrok-Kal, M.H., & Hunink, M.M. (2007). study. We also note that the authors in 82 Morin, C.M., Belleville, G., Be´langer, L., & Quality of life assessed with the Medical Outcomes 90 Ivers, H. (2011). The Insomnia Severity Index: Study Short Form 36-Item Health Survey of patients Alvarez et al. stated that conclusions Psychometric indicators to detect insomnia cases on renal replacement therapy: A systematic review about fluid removal could not be made and evaluate treatment response. Sleep, 34(5), 601– and meta-analysis. Value in Health, 10(5), 390–397. from their study. We would be 608. 87 Lowrie, E.G., Curtin, R.B., LePain, N., & interested in whether additional studies 83 Natale, V., Fabbri, M., Tonetti, L., & Martoni, Schatell, D. (2003). Medical outcomes study short M. (2014). Psychometric goodness of the mini sleep form-36: A consistent and powerful predictor of are available that address issues related questionnaire. Psychiatry and clinical morbidity and mortality in dialysis patients. to effective fluid removal using home neurosciences, 68(7), 568–573. American Journal of Kidney Diseases, 41(6), 1286– 84 Chertow, G.M., Alvarez, L., Plumb, T.J., 1292. 89 Chahal, Y., Plumb, T., Aragon M. (2020). Prichard, S.S., & Aragon, M. (2020). Patient- 88 Food and Drug Administration Center for Patient Device Preference for Home Hemodialysis: reported outcomes from the investigational device Devices and Radiological Health (2020). ‘‘Patient A Subset Analysis of the Tablo Home IDE Trial. exemption study of the Tablo hemodialysis system. Preference-Sensitive Areas: Using Patient Poster Presentation at National Kidney Foundation Hemodialysis International, 24(4), 480–486. Preference Information in Medical Device Spring Clinical Conference, March 2020. 85 Urquhart-Secord, Rachel et al. (2016). Patient Evaluation’’ Available at: https://www.fda.gov/ 90 Alvarez, Luis et al. Urea Clearance Results in and Caregiver Priorities for Outcomes in about-fda/cdrh-patient-engagement/patient- Patients Dialyzed Thrice Weekly Using a Dialysate Hemodialysis: An International Nominal Group preference-sensitive-areas-using-patientpreference- Flow of 300 mL/min, clinical abstract, presented Technique Study American Journal of Kidney information-medical-device-evaluation. Accessed March 2019, Annual Dialysis Conference, Dallas, Diseases, Volume 68, Issue 3, 444–454. Jan 21, 2021. Texas.

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self-care dialysis thrice-weekly with the (6) Capital Related Assets Criterion that only about 12 percent of eligible Tablo® System. We invite comments on (§ 413.236(b)(6)) patients are on PD therapy.97 The whether less frequent dialysis sessions With respect to the sixth TPNIES applicant claimed that the risk of PD- would represent SCI over shorter, more eligibility criterion under related peritonitis, and the challenges to frequent sessions that, according to the § 413.236(b)(6), whether the item is a detect it, are the main reasons for these applicant, are common among users of capital-related asset and home dialysis figures. The guidelines for diagnosis of the incumbent technology. machine, § 413.236(a)(2) defines these PD-related peritonitis, as outlined by the The applicant’s second claim was that International Society for Peritoneal ® terms. First, a capital-related asset is an the Tablo System increases adherence asset that an ESRD facility has an Dialysis (ISPD), recommend that to dialysis treatment and retention to economic interest in through ownership peritonitis be diagnosed when at least 2 home therapy, which may reduce (regardless of the manner in which it of the following criteria are present: (1) dialysis-related hospitalizations and was acquired) and is subject to The patient experiences clinical features other adverse events associated with depreciation. Equipment obtained by consistent with peritonitis (abdominal missing treatment. This claim was pain and/or cloudy dialysate effluent); ® the ESRD facility through operating supported by the Tablo IDE study (28 leases are not considered capital-related (2) the patient’s dialysate effluent has a participants completed the study) and assets. Second, home dialysis machines whole blood count (WBC) >100 cells/mL the use of historical comparisons to or >0.1 × 10/L with polymorphonuclear ® are HD machines and PD cyclers in their prior studies involving the NxStage entirety (meaning that one new part of (PMN) cells >50 percent; and (3) System. The applicant noted that a machine does not make the entire positive dialysis effluent culture is ® 98 hospitalization rates from the Tablo capital-related asset new) that receive identified. Additionally, the IDE trial were lower than rates in the FDA marketing authorization for home guidelines recommend that PD patients general dialysis population and rates use and when used in the home for a presenting with cloudy effluent be reported in two observational studies of presumed to have peritonitis and treated ® single patient. The applicant identified patients using the NxStage device. the Tablo® System as an asset that an as such until the diagnosis can be 99 While the applicant cited an all-cause ESRD facility has an economic interest confirmed or excluded. Per the hospitalization rate of 426 per 1000 in through ownership, is subject to guidelines, this means that for patients patient years in the Tablo® IDE study, undergoing PD treatments at home, it is 91 92 depreciation, and is an HD machine that it does not appear that the sources received FDA marketing authorization recommended that they self-monitor for published these hospitalization rates. for home use. Therefore, the Tablo® symptoms of peritonitis, cloudy We further note that the applicant relied System is a capital-related asset that is dialysate and/or abdominal pain, and on historical comparisons in asserting a home dialysis machine. We welcome seek medical attention for additional that that patients treated with the ® testing and treatment upon experiencing ® comments on the Tablo System’s status Tablo System experience reduced as a capital related asset that is a home any or both of these symptoms. disease burden and improved quality of dialysis machine. According to the applicant, despite the life. fact that peritonitis is highly prevalent, We note that in the Tablo® IDE study, b. CloudCath Peritoneal Dialysis Drain symptom monitoring is insensitive and the before-after comparisons in patients Set Monitoring System (CloudCath non-specific, which can contribute to with NxStage® regarding improved System) late presentation for medical attention ® sleep compared to prior to the Tablo CloudCath submitted an application and treatment. The applicant asserted System may be prone to recall bias in for the TPNIES for the CloudCath that under the current standard of care, that participants’ experiences with PD patients face the following ® Peritoneal Dialysis Drain Set Monitoring NxStage were not recorded at the time System (CloudCath System) for CY challenges in detecting peritonitis. First, ® they were receiving NxStage 2022. According to the application, the the applicant stated that patients’ fluid treatments, but rather, were based on observation has low compliance rates as ® CloudCath System is a tabletop passive recall at the time of the Tablo IDE drainage system that detects and it relies on patients’ close examination study. monitors solid particles in dialysate of their own dialysate effluent during We understand that greater flexibility effluent during PD treatments. Solid PD treatments, which often occur while for patients in the way that they receive particles in dialysate effluent, patients are asleep. Second, the their dialysis treatments may represent manifesting itself as cloudy dialysate, applicant noted that it can be difficult a benefit to Medicare beneficiaries who may indicate that the patient has for patients to visually detect peritonitis are candidates to receive this treatment peritonitis, the inflammation of the in dialysate effluent using a ‘‘newspaper in the home setting. We invite peritoneum in the abdominal wall test’’ for cloudiness, and can be even comments on whether this potential usually due to a bacterial or fungal more difficult to see when the fluid is benefit represents SCI, including 93 drained into a toilet, where it is diluted ® infection. PD therapy is a common whether the Tablo System represents cause of peritonitis.94 If left untreated, by water. The applicant stated that, as an advance that substantially improves, the condition can be life threatening.95 a result of these challenges, patients relative to renal dialysis services PD-related peritonitis is a major with ESRD suffer unsatisfactorily high previously available, the treatment of complication and challenge to the long- mortality and morbidity from Medicare beneficiaries. term success and adherence of patients on PD therapy.96 The applicant stated 36(5):481–508, June 9, 2016, available at: http:// 91 Safety and efficacy of the Tablo hemodialysis dx.doi.org/10.3747/pdi.2016.00078. system for in-center and home hemodialysis Plumb, 97 Briggs, et al., ‘‘Early Detection of Peritonitis in 93 T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern, J.G., Mayo Clinic Staff, ‘‘Peritonitis,’’ June 18, 2020, Patients Undergoing Peritoneal Dialysis: A Device Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. available at: https://www.mayoclinic.org/diseases- and Cloud-Based Algorithmic Solution,’’ and Aragon, M.A. (2019), Hemodialysis conditions/peritonitis/symptoms-causes/syc- unpublished report. International. 20376247. 98 Kam-Tao Li, Philip, et al., ‘‘ISPD Peritonitis 92 Chertow, G.M., Alvarez, L., Plumb, T.J., 94 Ibid. recommendations: 2016 Update on Prevention and Prichard, S. S., & Aragon, M. (2020). Patient- 95 Ibid. Treatment,’’ Peritoneal Dialysis International 2016; reported outcomes from the investigational device 96 Kam-Tao Li, Philip, et al., ‘‘ISPD Peritonitis 36(5):481–508, June 9, 2016, available at: http:// exemption study of the Tablo hemodialysis system. recommendations: 2016 Update on Prevention and dx.doi.org/10.3747/pdi.2016.00078. Hemodialysis International, 24(4), 480–486. Treatment,’’ Peritoneal Dialysis International 2016; 99 Ibid.

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peritonitis, as well as high rates of PD eligible for the TPNIES, the applicant tested the ability of the CloudCath modality loss, meaning they must must apply within three years of the System and its dialysate effluent discontinue PD and begin a different FDA marketing authorization date and monitoring algorithm to detect type of dialysis treatment. Per the receive FDA marketing authorization by indicators of peritonitis.100 The proof of applicant, the CloudCath System the HCPCS Level II deadline of July 6, principle observational study consisted addresses these challenges by detecting 2021. The applicant stated that it of 70 PD patients outside of the U.S. changes in dialysate effluent at much anticipates the CloudCath System will who had been on PD for a long interval lower levels of particle concentrations receive FDA marketing authorization by of time (>10 days), and thus were at an than the amount needed to accumulate the HCPCS Level II deadline. increased risk of developing peritonitis. for visual detection by patients. Out of the 64 PD patients whose data (3) Commercial Availability Criterion Per the applicant, the CloudCath were included in the study, over 40 PD (§ 413.236(b)(3)) System consists of three components: patients were receiving intermittent PD, (1) Drain set, (2) sensor, and (3) patient Regarding the third TPNIES eligibility which is not commonly used in the U.S. monitoring software. As explained in criterion in § 413.236(b)(3), that the item The remainder of the participants were the application, the CloudCath System’s is commercially available by January 1 receiving Continuous Ambulatory drain set connects to a compatible PD of the particular calendar year, meaning Peritoneal Dialysis. The report states cycler’s drain line to enable draining the year in which the payment that in the U.S., PD is generally and monitoring of dialysate effluent adjustment would take effect, the performed in a modality called before routing the fluid to the drainage applicant stated that the CloudCath Continuous Cycling Peritoneal Dialysis receptacle. Per the CloudCath System System is not currently commercially (CCPD), in which a cycler automatically User Guide, included in the application, available because it has not received administers multiple dialysis exchange the CloudCath System is compatible FDA marketing authorization. The cycles, typically while patients sleep. with the following PD cyclers: Baxter applicant noted that it expects the Samples were collected from patients’ Healthcare Home Choice PROTM, Baxter CloudCath System will be commercially PD effluent drainage bags and measured Healthcare AMIATM Automated PD available immediately after receiving in the CloudCath System against a System, and Fresenius Liberty® Select FDA marketing authorization. proprietary Turbidity Score threshold Cycler. Per the applicant, once the (4) HCPCS Level II Application value and also tested for reference CloudCath System is attached to a Criterion (§ 413.236(b)(4)) laboratory measurements according to compatible cycler, the dialysate effluent ISPD guidelines for WBC count and Regarding the fourth TPNIES runs through the drain set, through the differential (>100 cells/mL, >50 percent eligibility criterion in § 413.236(b)(4) CloudCath System’s optical sensor. The PMN).101 Regarding the Turbidity Score requiring that the applicant submit a applicant explained that the CloudCath threshold value, the study set a score to complete HCPCS Level II code System’s optical sensor detects and determine if the effluent sample in the application by the HCPCS Level II monitors changing concentrations of CloudCath System was infected or not; application deadline of July 6, 2021, the solid particles in the dialysate effluent samples greater than or equal to the applicant stated that it has not during each dialysis cycle and reports Turbidity Score threshold value would submitted an application yet, but the concentrations in a turbidity score. be classified as infected, and samples intends to apply by the deadline. Per the applicant, the CloudCath System less than the Turbidity Score threshold will indicate whether dialysate effluent (5) Innovation Criteria (§§ 413.236(b)(5) value would be classified as non- has normal turbidity and will notify the and 412.87(b)(1)) infected. The crude sensitivity and patient and/or health care professional (a) SCI Claims and Sources specificity of the CloudCath System was if the dialysate effluent turbidity has 96.2 percent and 91.2 percent, exceeded the notification threshold set With regard to the fifth TPNIES respectively. A majority of false by the patient’s dialysis provider. The eligibility criterion under positives (44 of 77 samples) occurred applicant stated that the optical sensor’s § 413.236(b)(5), that the item is among patients already receiving hardware and software components innovative, meaning it meets the SCI antibiotic treatment for peritonitis, and allow for data trending over time and criteria specified in § 412.87(b)(1), the another 20 false positive reports remote monitoring by a healthcare applicant asserted that the CloudCath occurred because the patient had professional. System offers SCI over technologies elevated turbidity due to a cause other currently available for the Medicare than peritonitis. The investigators (1) Renal Dialysis Service Criterion patient population by offering the subsequently removed samples from (§ 413.236(b)(1)) ability to monitor changes in turbidity patients already receiving treatment for of peritoneal dialysate effluent through Regarding the first TPNIES eligibility peritonitis, setting the sensitivity for continuous remote monitoring in criterion in § 413.236(b)(1), that the item detecting peritonitis using the patients with ESRD receiving PD has been designated by CMS as a renal CloudCath System at 99 percent and the therapy, earlier than the current dialysis service under § 413.171, specificity at 97.6 percent. monitoring for peritonitis is a service standard of care. By allowing the The second study the applicant that is essential for dialysis, and clinical standard of care to be initiated submitted is the Prospective Clinical earlier, per the applicant, the use of the therefore would be considered a renal Study to Evaluate the Ability of the CloudCath System changes the dialysis service under § 413.171. CloudCath System to Detect Peritonitis management of peritonitis patients by (2) Newness Criterion (§ 413.236(b)(2)) enabling clinicians to both diagnose 100 Briggs, et al., ‘‘Early Detection of Peritonitis in With respect to the second TPNIES peritonitis and initiate antibiotic Patients Undergoing Peritoneal Dialysis: A Device eligibility criterion in § 413.236(b)(2), treatment earlier. and Cloud-Based Algorithmic Solution,’’ that the item is new, meaning within 3 The applicant submitted two studies unpublished report. years beginning on the date of the FDA on the technology in support of the SCI 101 Kam-Tao Li, Philip, et al., ‘‘ISPD Peritonitis recommendations: 2016 Update on Prevention and marketing authorization, the applicant claims. The applicant included a Treatment,’’ Peritoneal Dialysis International 2016; stated that it is seeking 510(k) marketing preliminary, unpublished report by 36(5):481–508, June 9, 2016, available at: http:// authorization from the FDA. To be Briggs, et al. on a clinical study that dx.doi.org/10.3747/pdi.2016.00078.

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Compared to Standard of Care during The CloudCath System also detected infections other than In-Home Peritoneal Dialysis peritonitis 27 to 344 hours prior to peritonitis.119 120 121 Per the applicant, (CATCH).102 CloudCath initiated this participants presenting to the hospital these articles on time-to-treatment ongoing single-arm, open-label, multi- or clinic with signs or symptoms of demonstrate that the CloudCath center study to demonstrate that the peritonitis.113 The applicant stated that System’s ability to detect effluent CloudCath System is able to detect these results support the claim that the changes substantially earlier improves changes in turbidity associated with CloudCath System would enable the standard of care, enabling PD-related peritonitis in PD patients prior to diagnosis of peritonitis earlier than the peritonitis diagnosis and antibiotic laboratory diagnosis of peritonitis with current standard of care through treatment earlier while decreasing the a high degree of specificity and turbidity monitoring. likelihood of PD-failure due to PD- sensitivity. The target enrollment is 186 In addition to the studies on the related peritonitis. participants over 18 years of age using technology, the applicant submitted an The applicant also submitted letters of CCPD as their PD modality, with at least article by Muthucumarana, et al. on the support from a nephrologist at an 2 exchanges per night.103 Patients with impact of time-to-treatment on clinical academic institution and the following active infection and/or cancer are outcomes of PD-related peritonitis.114 ESRD patient advocacy groups: The excluded from the trial.104 The primary The article includes data from the American Kidney Fund, the American endpoint is time of peritonitis detection Presentation and the Time of Initial Association of Kidney Patients, and the by the CloudCath System (defined as Administration of Antibiotics With International Society of Nephrology. two consecutive Turbidity Scores >7.0) Outcomes of Peritonitis (PROMPT) The letter of support from Dr. Thomas as compared to laboratory evidence of Study, a prospective multicenter from A. Golper, president-elect of the peritonitis (defined as WBC count >100 2012 to 2014 that observed symptom-to- International Society of Nephrology, cells/mL or >0.1 × 109/L with percentage contact time, contact-to-treatment time, endorsed the CloudCath System’s ability of PMN >50 percent).105 While the defined as the time from health care to detect peritonitis and enable study is ongoing, the applicant included presentation to initial antibiotic, and clinicians to begin to treat the infection the study protocol and preliminary symptom-to-treatment time in earlier, preventing hospitalizations and results with its application.106 The Australian PD patients. 116 patients related complications such as the preliminary results demonstrate that as participated in the survey, 83 of which abandonment of home dialysis. The of December 29, 2020, 132 participants were caucasian and 14 were letter also stated that the CloudCath have been enrolled in the CATCH Study aboriginal.115 Out of the sample size of System helps address the challenge of at 13 sites.107 Of the 132 enrolled 116 survey participants, there were 159 peritonitis as the main reason for participants, 59.1 percent of participants episodes of PD-related peritonitis. Of abandonment of PD for HD, and will were male, 65.9 percent of participants these, 38 patient episodes met the encourage a greater number of patients were White and 29.6 percent of primary outcome of PD failure (defined to select PD as their dialysis modality of participants were Black or African as catheter removal or death) at 30 choice. The letters from the American 108 American. Enrolled participants days.116 The median symptom-to- Association of Kidney Patients and the underwent an average of 4.5 exchanges treatment time was 9.0 hours in all International Society of Nephrology 109 per night. The preliminary results patients, 13.6 hours in the PD-fail group, encouraged CMS to consider the indicate that, as of December 29, 2020, and 8.0 hours in the PD-cure group.117 CloudCath System’s application, there have been 7 peritonitis events that The study found that the risk of PD- explaining that the technology would met the ISPD peritoneal fluid cell 110 failure increased by 5.5 percent for each have several benefits to patients, for counts and differentials standard. All hour of delay of administration of example, by reducing peritonitis-related 7 of the peritonitis events were also 111 antibiotics once patients presented to a hospitalizations, increasing adherence detected by the CloudCath System. In health care provider.118 However, to PD, and encouraging higher 5 out of the 7 peritonitis events, the neither symptom-to-contact nor utilization of PD as a viable alternative CloudCath System detected peritonitis symptom-to-treatment was associated to in-center HD. The American Kidney 44 to 368 hours prior to the time of with PD-failure in non-adjusted Fund’s letter emphasized that detection from a clinical laboratory.112 analyses, and the time from presentation peritonitis is a significant concern for to a health care provider to treatment PD patients 122 and requested CMS 102 CloudCath, ‘‘A Prospective Clinical Study to Evaluate the Ability of the CloudCath System to was only associated with PD-failure support of all efforts that ensure patients Detect Peritonitis Compared to Standard of Care outcomes in multivariable-adjusted during In-Home Peritoneal Dialysis (CATCH),’’ analyses in a subset of patients who 119 Gacouin, A. et al., ‘‘Severe pneumonia due to Preliminary Clinical Study Report (NCT04515498), presented to hospital-based facilities. In Legionella pneumophila: prognostic factors, impact Jan 27, 2020. of delayed appropriate antimicrobial therapy,’’ 103 addition to the Muthucumarana et al. CloudCath, ‘‘A Prospective Clinical Study to Intensive Care Medicine 28, 686–691 (2002), Evaluate the Ability of the CloudCath System to article, the applicant cited to other https://doi.org/10.1007/s00134–002–1304–8. Detect Peritonitis Compared to Standard of Care studies that have found that antibiotic 120 Houck, PM. et al., ‘‘Timing of antibiotic during In-Home Peritoneal Dialysis (CATCH),’’ administration and outcomes for Medicare patients Study Protocol (CC–P–001), June 24, 2020. treatment should begin as soon as hospitalized with community-acquired 104 possible in order to effectively treat Ibid. pneumonia,’’ Arch Intern Med. 2004 Mar 105 Ibid. 22;164(6):637–44. doi: 10.1001/archinte.164.6.637. 113 106 CloudCath, ‘‘A Prospective Clinical Study to Ibid. PMID: 15037492. 114 Evaluate the Ability of the CloudCath System to Muthucumarana, et al., ‘‘The Relationship 121 Lodise TP, et al., ‘‘Outcomes analysis of Detect Peritonitis Compared to Standard of Care Between Presentation and the Time of Initial delayed antibiotic treatment for hospital-acquired during In-Home Peritoneal Dialysis (CATCH),’’ Administration of Antibiotics With Outcomes of Staphylococcus aureus bacteremia,’’Clin Infect Dis. Preliminary Clinical Study Report (NCT04515498), Peritonitis in Peritoneal Dialysis Patients: The 2003 Jun 1;36(11):1418–23. doi: 10.1086/375057. Jan 27, 2020. PROMPT Study.,’’ Kidney Int Rep. 2016 Jun Epub 2003 May 20. PMID: 12766837. 107 Ibid. 11;1(2):65–72. doi: 10.1016/j.ekir.2016.05.003. 122 Mehrotra, Rajnish et al., ‘‘The Current State of 108 PMID: 29142915; PMCID: PMC5678844. Ibid. Peritoneal Dialysis,’’ Journal of the American 109 115 Ibid. Ibid. Society of Nephrology 27: 3238–3252, 2016. doi: 110 Ibid. 116 Ibid. 10.1681/ASN.2016010112, available at: https:// 111 Ibid. 117 Ibid. jasn.asnjournals.org/content/jnephrol/27/11/ 112 Ibid. 118 Ibid. 3238.full.pdf?with-ds=yes.

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with ESRD undergoing PD treatments of the study, so that neither the cases, healthcare providers may decide can quickly detect and treat infections. participants nor the investigators would to wait for confirmation via patient be aware of the device measurements.123 symptoms, cell count, or positive (b) CMS Preliminary Assessment of SCI Therefore, the CATCH study did not culture as stated in the ISPD guidelines Claims and Sources examine patient and clinician behavior, on diagnosis.126 The preliminary results After a review of the information including the medical management of of the CATCH study demonstrate that in provided by the applicant, we note the the patient, after the CloudCath System 5 out of 7 PD-related peritonitis events, following concerns with regard to the detected the solid particles in the the CloudCath System detected PD- SCI criterion under § 413.236(b)(5) and dialysate effluent. The Briggs et al. related peritonitis 33 to 367 hours prior § 412.87(b)(1). We note that, consistent study also did not examine how use of to the time of detection from a clinical with § 413.236(c), CMS will announce the CloudCath System impacted laboratory.127 The CloudCath System its final determination regarding management of the patient. The also detected PD-related peritonitis 27 whether the CloudCath System meets investigators in that study stated, ‘‘none to 344 hours prior to participants the SCI criterion and other eligibility of the data from our device was used for presenting to a healthcare facility with criteria for the TPNIES in the CY 2022 clinical decision making,’’ meaning that symptoms of PD-related peritonitis.128 ESRD PPS final rule. the study did not test how or if the We note that no evidence was submitted Because the applicant claims to offer CloudCath System offered the ability to to show that clinicians would begin to the ability to diagnose a medical diagnose a medical condition and how treat suspected peritonitis if the condition, PD-related peritonitis, earlier use of the CloudCath System to make a CloudCath System alerted the patient in a patient population than allowed by diagnosis affected the management of and clinician of possible PD-related currently available methods, the the patient.124 Because the studies peritonitis that was too early to detect applicant must also include evidence submitted did not observe how patients via any of the ISPD guidelines.129 In that use of the new technology to make and clinicians use the CloudCath other words, we have not received a diagnosis affects the management of System’s monitoring to make decisions evidence to demonstrate that the the patient, as required under the SCI regarding patient management, we are CloudCath System would affect medical criterion at § 412.87(b)(1)(ii)(B). concerned that we will not be able to management of the patient by replacing Specifically, § 412.87(b)(1)(ii)(B) states make a determination on whether early one of the ISPD guidelines for that a determination that a technology detection of PD-related peritonitis by diagnosis.130 represents SCI over existing technology the CloudCath System meets the SCI Additionally, CMS notes that the means: The new medical service or criterion at § 412.87(b)(1)(ii)(B). applicant has not submitted evidence to technology offers the ability to diagnose Similarly, while the applicant submitted show that beginning treatment for a medical condition in a patient evidence to show that time-to-treatment presumed PD-related peritonitis in population where that medical plays a role in preventing PD failure in condition is currently undetectable, or patients with ESRD prior to the patients with ESRD with PD-related occurrence of any of the ISPD guidelines offers the ability to diagnose a medical peritonitis,125 CMS has not received any condition earlier in a patient population would not be harmful to patients. In the information regarding how the Briggs et al. study, the CloudCath than allowed by currently available CloudCath System would affect methods and there must also be System identified 20 false positives that management of the patient by reducing occurred because the patient had evidence that use of the new medical time-to-treatment for patients with service or technology to make a elevated turbidity due to some cause ESRD receiving PD therapy. CMS also other than PD-related peritonitis.131 diagnosis affects the management of the notes that the applicant referenced patient. However, the applicant did not explain studies that support beginning or provide evidence on whether It is not clear to us whether the antibacterial therapy for infections other studies submitted demonstrate or beginning treatment for PD-related than PD-related peritonitis, like peritonitis for a group of patients with examine the impacts of using the pneumonia, and, therefore do not technology on patients with ESRD such ESRD who tested positive, but were in directly demonstrate the importance of fact negative for the condition, was that we can determine whether it time-to-treatment for PD-related clinically advisable. CMS is concerned represents an advance that substantially peritonitis. that the CloudCath System’s potential improves the treatment of Medicare Additionally, it is not clear to us beneficiaries compared to renal dialysis whether the CloudCath System would for false positive results may lead to services previously available. We note affect medical management of the that the studies submitted serve as 126 Kam-Tao Li, Philip, et al., ‘‘ISPD Peritonitis patient because use of the technology recommendations: 2016 Update on Prevention and ‘‘proof of concept,’’ as they provide may potentially detect solid particles in Treatment,’’ Peritoneal Dialysis International 2016; evidence that the CloudCath System dialysate effluent so early, that, in some 36(5):481–508, June 9, 2016, available at: http:// detects solid particles in dialysate dx.doi.org/10.3747/pdi.2016.00078. 127 CloudCath, ‘‘A Prospective Clinical Study to effluent that may indicate PD-related 123 CloudCath, ‘‘A Prospective Clinical Study to Evaluate the Ability of the CloudCath System to Evaluate the Ability of the CloudCath System to peritonitis, and, may do so earlier than Detect Peritonitis Compared to Standard of Care patient observation and a cell count test. Detect Peritonitis Compared to Standard of Care during In-Home Peritoneal Dialysis (CATCH),’’ during In-Home Peritoneal Dialysis (CATCH),’’ However, the studies are limited in that Preliminary Clinical Study Report, NCT04515498, Preliminary Clinical Study Report (NCT04515498), they do not observe how the CloudCath Jan 27, 2020. Jan 27, 2020. 128 System, in detecting the solid particles 124 Briggs, et al., ‘‘Early Detection of Peritonitis in Ibid. 129 in dialysate effluent and doing so earlier Patients Undergoing Peritoneal Dialysis: A Device Kam-Tao Li, Philip, et al., ‘‘ISPD Peritonitis and Cloud-Based Algorithmic Solution,’’ recommendations: 2016 Update on Prevention and than a cell count test, affects the unpublished report. Treatment,’’ Peritoneal Dialysis International 2016; management of the patient, as required 125 Muthucumarana, et al., ‘‘The Relationship 36(5):481–508, June 9, 2016, available at: http:// under the SCI criterion at Between Presentation and the Time of Initial dx.doi.org/10.3747/pdi.2016.00078. § 412.87(b)(1)(ii)(B). For example, as Administration of Antibiotics With Outcomes of 130 Ibid. 131 part of the CATCH Study, investigators Peritonitis in Peritoneal Dialysis Patients: The Briggs, et al., ‘‘Early Detection of Peritonitis in PROMPT Study.,’’ Kidney Int Rep. 2016 Jun Patients Undergoing Peritoneal Dialysis: A Device deactivated the notification capability of 11;1(2):65–72. doi: 10.1016/j.ekir.2016.05.003. and Cloud-Based Algorithmic Solution,’’ the CloudCath System for the duration PMID: 29142915; PMCID: PMC5678844. unpublished report.

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clinicians beginning treatment for PD- subsection (r) of section 1834 of the Act 1881(b)(14)(D)(iv)(II) of the Act.133 related peritonitis when not necessary and the amendments to section Accordingly, we apply the same wage in an already vulnerable group of 1881(s)(2)(F) of the Act, including the index under § 413.231 that is used Medicare beneficiaries. We welcome payment rate for AKI dialysis (81 FR under the ESRD PPS and discussed in public comment on these issues. 77866 through 77872, and 77965). We section II.B.1.b of this proposed rule. interpret section 1834(r)(1) of the Act as (6) Capital Related Assets Criterion The AKI dialysis payment rate is requiring the amount of payment for (§ 413.236(b)(6)) adjusted by the wage index for a AKI dialysis services to be the base rate particular ESRD facility in the same way Regarding the sixth TPNIES eligibility for renal dialysis services determined that the ESRD PPS base rate is adjusted criterion in § 413.236(b)(6), limiting for a year under the ESRD PPS base rate by the wage index for that facility (81 capital-related assets from being eligible as set forth in § 413.220, updated by the for the TPNIES, except those that are FR 77868). Specifically, we apply the ESRD bundled market basket percentage wage index to the labor-related share of home dialysis machines, the applicant increase factor minus a productivity the ESRD PPS base rate that we utilize stated that the CloudCath System is not adjustment as set forth in for AKI dialysis to compute the wage a capital-related asset. The applicant § 413.196(d)(1), adjusted for wages as set explained that the CloudCath System forth in § 413.231, and adjusted by any adjusted per-treatment AKI dialysis does not meet the definition of a capital- other amounts deemed appropriate by payment rate. As stated previously, we related asset, as defined in the Provider the Secretary under § 413.373. We are proposing a CY 2022 AKI dialysis Reimbursement Manual (chapter 1, codified this policy in § 413.372 (81 FR payment rate of $255.55, adjusted by the section 104.1), because the device is not 77965). ESRD facility’s wage index. subject to depreciation, nor is used by IV. End-Stage Renal Disease Quality a provider as part of a regular lease B. Proposed Annual Payment Rate Incentive Program (ESRD QIP) agreement.132 Update for CY 2022 III. Calendar Year (CY) 2022 Payment 1. CY 2022 AKI Dialysis Payment Rate A. Background for Renal Dialysis Services Furnished The payment rate for AKI dialysis is For a detailed discussion of the End- to Individuals With Acute Kidney the ESRD PPS base rate determined for Stage Renal Disease Quality Incentive Injury (AKI) a year under section 1881(b)(14) of the Program’s (ESRD QIP’s) background and Act, which is the finalized ESRD PPS A. Background history, including a description of the base rate, including the applicable Program’s authorizing statute and the The Trade Preferences Extension Act annual productivity-adjusted market policies that we have adopted in of 2015 (TPEA) (Pub. L. 114–27) was basket payment update, geographic previous final rules, we refer readers to enacted on June 29, 2015, and amended wage adjustments, and any other the Act to provide coverage and discretionary adjustments, for such year. the following final rules: payment for dialysis furnished by an We note that ESRD facilities have the • CY 2011 ESRD PPS final rule (75 FR ESRD facility to an individual with ability to bill Medicare for non-renal 49030), acute kidney injury (AKI). Specifically, dialysis items and services and receive • CY 2012 ESRD PPS final rule (76 FR section 808(a) of the TPEA amended separate payment in addition to the 628), section 1861(s)(2)(F) of the Act to payment rate for AKI dialysis. • provide coverage for renal dialysis As discussed in section II.B.1.d of this CY 2012 ESRD PPS final rule (76 FR services furnished on or after January 1, proposed rule, the CY 2022 proposed 70228), 2017, by a renal dialysis facility or a ESRD PPS base rate is $255.55, which • CY 2013 ESRD PPS final rule (77 FR provider of services paid under section reflects the application of the proposed 67450), 1881(b)(14) of the Act to an individual CY 2022 wage index budget-neutrality • with AKI. Section 808(b) of the TPEA CY 2014 ESRD PPS final rule (78 FR adjustment factor of .999546 and the CY 72156), amended section 1834 of the Act by 2022 proposed ESRDB market basket • adding a subsection (r) to provide increase of 1.6 percent reduced by the CY 2015 ESRD PPS final rule (79 FR payment, beginning January 1, 2017, for productivity adjustment of 0.6 66120), renal dialysis services furnished by percentage point, that is, 1.0 percent. • CY 2016 ESRD PPS final rule (80 FR renal dialysis facilities or providers of Accordingly, we are proposing a CY 68968), services paid under section 1881(b)(14) 2022 per treatment payment rate of • CY 2017 ESRD PPS final rule (81 FR of the Act to individuals with AKI at the $255.55 for renal dialysis services 77834), ESRD PPS base rate, as adjusted by any furnished by ESRD facilities to applicable geographic adjustment individuals with AKI. This payment rate • CY 2018 ESRD PPS final rule (82 FR applied under section is further adjusted by the wage index, as 50738), 1881(b)(14)(D)(iv)(II) of the Act and discussed in the next section of this • CY 2019 ESRD PPS final rule (83 FR adjusted (on a budget neutral basis for proposed rule. 56922), payments under section 1834(r) of the • Act) by any other adjustment factor 2. Geographic Adjustment Factor CY 2020 ESRD PPS final rule (84 FR under section 1881(b)(14)(D) of the Act Under section 1834(r)(1) of the Act 60648), and that the Secretary elects. and § 413.372, the amount of payment • CY 2021 ESRD PPS final rule (85 FR In the CY 2017 ESRD PPS final rule, for AKI dialysis services is the base rate 71398). we finalized several coverage and for renal dialysis services determined We have also codified many of our payment policies in order to implement for a year under section 1881(b)(14) of policies for the ESRD QIP at 42 CFR the Act (updated by the ESRD bundled 413.177 and 413.178. 132 CMS Provider Reimbursement Manual, market basket and reduced by the Chapter 1, Section 104.1. Available at: https:// www.cms.gov/Regulations-and-Guidance/ productivity adjustment), as adjusted by Guidance/Manuals/Paper-Based-Manuals-Items/ any applicable geographic adjustment CMS021929. factor applied under section 133 Section 1881(b)(14)(D)(iv)(II) of the Act.

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B. Extraordinary Circumstances policy changes implemented in many CMS applications. It also provides Exception (ECE) Previously Granted for response to COVID–19, and therefore a single location for users to modify the ESRD QIP and Notification of ECE may not provide a nationally their profile, change their password, Due to ESRD Quality Reporting System comparable assessment of performance update their challenge question, and Issues in keeping with the program goal of add or remove two-factor authentication national comparison. devices. Users can register for a HARP 1. Extraordinary Circumstance In the September 2020 IFC, we account by going to the QualityNet Exception (ECE) Previously Granted in welcomed public comments on our HARP Registration page, available at Response to the COVID–19 PHE policy to update our regulations at https://harp.cms.gov/register/profile- On March 22, 2020, in response to the § 413.178(d)(7) to consider a facility as info. COVID–19 PHE, we announced relief for having opted out of the ECE with Since the launch of EQRS, several clinicians, providers, hospitals, and respect to NHSN data reported for Q4 critical data submission issues have facilities participating in Medicare 2019 if the facility actually reported the been identified that impact the overall quality reporting and value-based data by the submission deadline, quality and accuracy of data available to purchasing programs.134 On March 27, without notifying CMS, and on the support the implementation of the ESRD 2020, we published a supplemental exception we finalized to the ECE opt QIP, and we suspended all clinical data guidance memorandum that described out policy for the ESRD QIP to exclude submissions into EQRS to allow time to the scope and duration of the ECEs we any ESRD QIP data that facilities resolve the issue.137 Based on our were granting under each Medicare optionally reported during Q1 and Q2 assessment, the data submission issues quality reporting and VBP program.135 2020 from our calculation of PY 2022 only impact ESRD QIP, Dialysis Star Each of these ECEs relieved these TPSs and from the baseline for PY 2023. Ratings, Dialysis Facility Compare and providers and facilities of their We will respond to the public data submitted for ESRD Network obligation to report data for Q4 CY 2019, comments we received in the CY 2022 quality improvement activities. We have Q1 and Q2 CY 2020, but we stated that ESRD PPS final rule. analyzed the data submission issues and believe that the data systems issues will we would score such data if optionally 2. Notification of ECE Due to ESRD be resolved on or about July 12, 2021. reported. Quality Reporting System (EQRS) Issues The September 2020 IFC updated the We recognize that these operational ECE we granted in response to the On November 9, 2020,136 we systems issues will prevent facilities COVID–19 PHE for the ESRD QIP and launched the ESRD Quality Reporting from submitting ESRD QIP clinical data several other quality reporting programs System (EQRS). The EQRS contains the until the data systems issues are (85 FR 54827 through 54838). functionalities of the following three resolved. Therefore, we are announcing In the IFC, we updated the ECE policy legacy ESRD Systems in one global a blanket extension of remaining CY for the ESRD QIP (85 FR 54828 through application: (1) A quality measure and 2020 clinical reporting deadlines. Under 54830). First, we updated our VBP performance score review system this extension, facilities will have until regulations at § 413.178(d)(7) to state (ESRD QIP System); (2) an ESRD patient September 1, 2021 to submit September that a facility has opted out of the ECE registry and quality measure reporting through December 2020 ESRD QIP for COVID–19 with respect to the system through CROWNWeb; and (3) clinical data. We believe this reporting reporting of Q4 CY 2019 NHSN data if Medicare coverage determination extension aligns with the time estimated the facility actually reported the data by support through the Renal Management for resolution of our operational systems the March 31, 2020 deadline but did not Information System (REMIS). The issues and will give dialysis facilities notify CMS that it would do so. transition to EQRS supports our efforts nearly seven weeks to submit their data Additionally, we finalized that facilities to consolidate the functionalities of the to EQRS. We will provide further details would not have the option to opt-out of CROWNWeb, ESRD QIP System, and to facilities when the EQRS issues are the ECE we granted with respect to Q1 REMIS applications into a single resolved, as well as when facilities can and Q2 2020 ESRD QIP data. We stated system, and aims to provide ongoing begin submitting their data for CY 2020 that measures calculated using excepted support to the ESRD user community to and CY 2021, through routine data could affect the national foster accurate and timely monthly data communication channels to facilities, comparability of these data due to the submission. This migration eliminates vendors, Quality Improvement geographic differences of COVID–19 the need for multiple user accounts, and Organizations (QIOs) and ESRD incidence rates and hospitalizations will in the long-term also improve the Networks. The communications could along with different impacts resulting overall user experience and reduce include memos, emails, and notices on from different state and local law and burden due to enhanced navigation the public QualityNet website (https:// features. www.qualitynet.org/). We discuss the 134 CMS, Press Release, CMS Announces Relief In order to access EQRS, all treatment of impacted CY 2020 data in for Clinicians, Providers, Hospitals and Facilities authorized users must create an account this proposed rule. As this situation is Participating in Quality Reporting Programs in with the Health Care Quality ongoing, we will announce any relevant Response to COVID–19 (Mar. 22, 2020), https:// Information Systems (HCQIS) Access www.cms.gov/newsroom/press-releases/cms- extension deadlines and data announces-relief-clinicians-providers-hospitals- Roles and Profile, known as HARP, submission requirements for impacted and-facilities-participating-quality-reporting. which is a secure identity management CY 2021 data through the routine 135 CMS, Exceptions and Extensions for Quality portal provided by CMS. Previously, communication channels discussed Reporting Requirements for Acute Care Hospitals, users created separate accounts for each above. PPS-Exempt Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing Facilities, Home Health ESRD application through CMS’ Because the current data submissions Agencies, Hospices, Inpatient Rehabilitation Enterprise Identity Data Management issue will not be resolved until on or Facilities, Long-Term Care Hospitals, Ambulatory (EIDM) system. Creating an account via about July 12, 2021 and has impacted all Surgical Centers, Renal Dialysis Facilities, and HARP provides users with a user ID and facilities that participate in ESRD QIP, MIPS Eligible Clinicians Affected by COVID–19 (Mar. 27, 2020), https://www.cms.gov/files/ password that can be used to access we believe that granting a blanket ECE document/guidance-memo-exceptions-and- extensions-quality-reporting-and-value-based- 136 https://mycrownweb.org/2020/11/november- 137 https://mycrownweb.org/2021/02/eqrs-data- purchasing-programs.pdf. 2020-newsletter/. reporting-update-feb-2021/.

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to all facilities without a request under accuracy of the data needed to calculate data after facilities are able to resume 42 CFR 413.178(d)(6)(ii) is the accurate ESRD QIP scores used for PY data submission. Due to the timing of appropriate remedy under these 2022 ESRD QIP calculations because this reporting extension, we believe that circumstances. We also believe that patient admittance dates, discharge there are no feasible alternative data requiring facilities to report the CY 2020 dates, record status in response files, sources for PY 2022. Therefore, we data impacted by this ECE by September clinical data, and the number of active believe that the scoring and payment 1, 2021 is reasonable. In our data patient cases are data points that are modifications for PY 2022 as proposed suspension announcements, we noted included in measure calculations for all in section IV.D in this proposed rule are that facilities are expected to continue of the PY 2022 ESRD QIP measures. If appropriate in this situation. to use EQRS to collect clinical data to these data points are incorrect, then this complete tasks such as admit and would impact our ability to accurately C. Proposed Flexibilities for the ESRD discharge patients, complete CMS forms calculate measures and would distort a QIP in Response to the COVID–19 PHE (such as the CMS–2728: End Stage facility’s measure performance. 1. Proposal To Adopt a Measure Renal Disease Medical Evidence Report Therefore, because of the EQRS Suppression Policy for the Duration of Medicare Entitlement and/or Patient system issues described above, and the COVID–19 PHE Registration, CMS–2744: End Stage additionally, due to the impact of the In previous rules, we have identified Renal Disease Annual Facillity Survey COVID–19 PHE on some of the PY 2022 the need for flexibility in our quality Form, and CMS–2746: ESRD Death ESRD QIP measures, as described more measurement programs to account for Notification), add or update treatment fully in section IV.C. of this proposed changing conditions that are beyond summaries, resolve notifications within rule, we are proposing to not score or participating facilities’ or practitioners’ a timely manner, and should also award a TPS to any facility, or reduce control. We identified this need because continue to keep facilities’ information payment to any facility, in PY 2022, as we would like to ensure that up-to-date. In other words, although discussed more fully in section IV.D. facilities were unable to submit clinical Although we considered if there may participants in our programs are not data through EQRS, facilities were be any alternative data sources for the affected negatively when their quality advised that they must continue to measures impacted by these EQRS performance suffers for reasons not due collect the clinical data. system issues, we concluded that this to the care provided, but instead due to While we are working to resolve all was not feasible for several reasons. external factors. known systems issues by on or about First, all 14 ESRD QIP measures for PY A significant example of the type of July 12, 2021 and reopen submissions so 2022 are impacted by these system external factor that may affect quality that facilities may submit their issues. Although certain measures do measurement is the COVID–19 PHE, September through December 2020 not require that facilities submit clinical which has had, and continues to have, ESRD QIP data no later than September data into EQRS, we use EQRS data to significant and ongoing effects on the 1, 2021, we will only be able to ensure determine whether a facility has treated provision of medical care in the country the validity of the impacted data after a sufficient number of patients in order and around the world. The COVID–19 they are submitted. Given that the to meet the measure’s minimum patient pandemic and associated PHE have system issues experienced during the case threshold necessary to calculate the impeded effective quality measurement initial implementation of the EQRS, if measure for ESRD QIP. For example, the in many ways. Changes to clinical not fully resolved, could potentially National Healthcare Safety Network practices to accommodate safety impact the accuracy and reliability of (NHSN) Bloodstream Infection (BSI) protocols for medical personnel and the data reported, we are concerned that clinical measure requires that facilities patients, as well as unpredicted changes facilities may be unfairly penalized report data to NHSN. However, the in the number of stays and facility-level because the current systems issues may measure also has a requirement to case mixes, have affected the data used impact the quality of the data. The exclude facilities that do not treat at in quality measurement and the EQRS system issues have resulted in least 11 eligible in-center hemodialysis resulting quality scores. Measures used multiple or incorrect dates of patient patients during the 12 month in the ESRD QIP need to be evaluated admissions and/or discharges, as well as performance period. In order to to determine whether their showing duplicate patient records. determine whether a facility has treated specifications need to be updated to Facilities have also expressed concerns at least 11 eligible patients, we use account for new clinical guidelines, about their experience with EQRS EQRS admission data and Medicare diagnosis or procedure codes, and issues, noting that there is no way for a claims data in order to determine medication changes that we have facility to verify accuracy or whether the facility is eligible to receive observed during the PHE. Additionally, completeness. They have reported a score on the measure.138 because COVID–19 prevalence is not issues including missing record status We ultimately decided to propose the consistent across the country, dialysis in response files, which means that special rule for PY 2022, as described facilities located in different areas have facilities do not know if the records further, because not only do these been affected differently at different were accepted or received an error system issues impact all ESRD QIP times throughout the pandemic. Under response, and issues with determining measures, which could lead to distorted those circumstances, we remain whether clinical data are accepted performance scores and unfair penalties, significantly concerned that the ESRD because the information does not show but we also want to provide facilities QIP’s quality measure scores that are in the user interface or the reports that with the business certainty they need calculated using data submitted during facilities are receiving from EQRS. regarding their PY 2022 payments. In the PHE for COVID–19 will be distorted We recognize stakeholders’ concerns order to determine whether all data and will result in skewed payment about the potential impact to the quality quality issues have been resolved when incentives and inequitable payments, of data for CY 2020. We believe the EQRS reopens for data submissions, we particularly for dialysis facilities that observed system issues, and any will need time to validate the impacted have treated more COVID–19 patients unresolved issues that may be identified than others. only after data submissions are 138 https://www.cms.gov/files/document/cy-2021- It is not our intention to penalize resumed, could impact the quality and final-technical-specifications-20201130.pdf. dialysis facilities based on measure

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scores that we believe are distorted by measurement. Similarly, we believe that ++ the generally accepted scientific the COVID–19 pandemic and, thus, not a measure may be focused on a clinical understanding of the nature or reflective of the quality of care that the topic or subject that is proximal to the biological pathway of the disease or measures in the ESRD QIP were disease, pathogen, or other health pathogen, particularly for a novel designed to assess. As discussed above, impacts of the PHE. As has been the disease or pathogen of unknown origin. the COVID–19 pandemic has had, and case during the COVID–19 pandemic, • Factor 4: Significant national continues to have, significant and we believe that rapid or unprecedented shortages or rapid or unprecedented enduring effects on health care systems changes in clinical guidelines and care changes in: around the world, and affects care delivery, potentially including ++ Healthcare personnel; decisions, including those made on appropriate treatments, drugs, or other ++ medical supplies, equipment, or clinical topics covered by the ESRD protocols may affect quality diagnostic tools or materials; or QIP’s measures. As a result of the measurement significantly and should ++ patient case volumes or facility- COVID–19 PHE, dialysis facilities could not be attributed to the participating level case mix. We also considered alternatives to provide care to their patients that meets facility positively or negatively. We also this proposed policy that could fulfill the underlying clinical standard but note that scientific understanding of a our objective to not penalize dialysis results in worse measured performance, particular disease or pathogen may facilities for measure results that are and by extension, payment penalties in evolve quickly during an emergency, distorted due to the COVID–19 PHE. As the ESRD QIP. We are also concerned especially in cases of new disease or noted above, the country continues to that regional differences in COVID–19 conditions. Finally, we believe that, as prevalence during the performance grapple with the effects of the COVID– evidenced during the COVID–19 19 pandemic, and in March 2020, CMS period for PY 2022 have directly pandemic, national or regional shortages affected dialysis facilities’ measure issued a nationwide, blanket or changes in health care personnel, Extraordinary Circumstances Exception scores on the ESRD QIP for PY 2022. medical supplies, equipment, diagnostic Although these regional differences in (ECE) for all hospitals and other tools, and patient case volumes or case facilities participating in our quality COVID–19 prevalence rates do not mix may result in significant distortions reflect differences in the quality of care reporting and VBP programs in response to quality measurement. to the COVID–19 PHE. This blanket ECE furnished by dialysis facilities, they Based on these considerations, we could directly affect the payment excepted all data reporting requirements developed a number of Measure for Q1 and Q2 2020 data, including penalties that these facilities could Suppression Factors that we believe receive and could result in an unfair claims data and data collected through should guide our determination of the CDC’s web-based surveillance and inequitable distribution of those whether to propose to suppress ESRD penalties. These inequities could be system for this data period, and quality QIP measures for one or more payment data collection resumed on July 1, 2020. especially pronounced for dialysis years that overlap with the COVID–19 facilities that have treated a large For claims-based measures, we also PHE. We are proposing to adopt these stated that we would exclude all number of COVID–19 patients. Measure Suppression Factors for use in We are therefore proposing to adopt a qualifying Q1 and Q2 2020 claims from the ESRD QIP and, for consistency, the policy for the duration of the COVID–19 our measure calculations. We following other VBP programs: Hospital PHE that would enable us to suppress considered extending this blanket ECE VBP, Hospital Readmissions Reduction the use of ESRD QIP measure data for that we issued for Q1 and Q2 2020 to Program, Hospital-Acquired Condition all facilities if we determine that also include Q3 and Q4 2020. This (HAC) Reduction Program, and Skilled circumstances caused by the COVID–19 alternative would protect providers and Nursing Facility VBP Program (see, for PHE have affected those measures and suppliers from having their quality data example, 86 FR 25460 through 25462, the resulting total performance scores used for quality scoring purposes while 25470 through 25472, and 25497 (TPSs) significantly. We are also those data are likely to have been through 25499). We believe that these proposing, as described in more detail affected significantly by the COVID–19 in section IV.C.2. of this proposed rule, Measure Suppression Factors will help PHE. However, this option would make to suppress certain measures for the PY us evaluate measures in the ESRD QIP quality data collection and reporting to 2022 program year because we have and that their adoption in the other VBP CMS no longer mandatory and would determined that circumstances caused programs noted above will help ensure leave no comprehensive data available by the COVID–19 PHE have affected consistency in our measure evaluations for us to provide confidential those measures significantly. In across programs. The proposed Measure performance feedback to providers nor Suppression Factors are: for monitoring and to inform decision- addition, due to both the impacts of the • COVID–19 PHE on certain measures and Factor 1: Significant deviation in making for potential future the EQRS system issues described in national performance on the measure programmatic changes, particularly as section IV.B.2. we are proposing to during the COVID–19 PHE, which could the PHE is extended. adopt a special scoring and payment be significantly better or significantly As an alternative to the proposed rule for PY 2022, as described more worse compared to historical quality measure suppression policy, we fully in section IV.D. performance during the immediately also considered not suppressing any In developing this proposed policy, preceding program years. measures under the ESRD QIP. we considered what circumstances • Factor 2: Clinical proximity of the However, this alternative would mean caused by the COVID–19 PHE would measure’s focus to the relevant disease, assessing dialysis facilities using quality affect a quality measure significantly pathogen, or health impacts of the measure data that has been significantly enough to warrant its suppression in a COVID–19 PHE. affected by the COVID–19 pandemic. value-based purchasing (VBP) program. • Factor 3: Rapid or unprecedented Additionally, given the geographic We believe that a significant deviation changes in: disparities in the COVID–19 pandemic’s in measured performance that can be ++ Clinical guidelines, care delivery effects, implementation of the PY 2022 reasonably attributed to the COVID–19 or practice, treatments, drugs, or related ESRD QIP as previously finalized would PHE is a significant indicator of changes protocols, or equipment or diagnostic place dialysis facilities in regions that in clinical conditions that affect quality tools or materials; or were more heavily impacted by the

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pandemic in Q3 and Q4 of 2020 at a significantly better or significantly diagnosed with COVID–19 resulted in disadvantage compared to facilities in worse compared to historical higher mortality rates, higher rates of regions that were more heavily performance during the immediately discharge to hospice or skilled nursing impacted during the first two quarters preceding program years; and proposed facilities, and lower rates of discharge to for CY 2020. Measure Suppression Factor 4, home than hospitalizations involving We view this measure suppression Significant national shortages or rapid patients who are not diagnosed with proposal as a necessity to ensure that or unprecedented changes in: COVID–19. Specifically, the the ESRD QIP does not penalize ++ Healthcare personnel; hospitalization rate for Medicare facilities based on external factors that ++ medical supplies, equipment, or dialysis patients diagnosed with were beyond the control of facilities. We diagnostic tools or materials; or COVID–19 was more than 7 times intend for this proposed policy to ++ patient case volumes or facility- greater than the hospitalization rate level case mix); provide short-term relief to dialysis • during the same period for Medicare facilities when we have determined that In-Center Hemodialysis Consumer dialysis patients who were not one or more of the Measure Suppression Assessment of Healthcare Providers and diagnosed with COVID–19, which is Factors warrants the suppression of an Systems (ICH CAHPS) Survey much greater than the relative risk of ESRD QIP measure. Administration clinical measure (under hospitalization for any other We welcome public comments on this proposed Measure Suppression Factor comorbidity. This indicates that proposal for the adoption of a measure 1, Significant deviation in national COVID–19 has had a significant impact suppression policy for the duration of performance on the measure during the on the hospitalization rate for dialysis the COVID–19 PHE, and also on the COVID–19 PHE, which could be patients. Because COVID–19 Medicare proposed Measure Suppression Factors significantly better or significantly dialysis patients are at significantly that we developed for purposes of this worse compared to historical greater risk of hospitalization, and the proposed policy. performance during the immediately SHR clinical measure was not preceding program years); and developed to account for the impact of 2. Proposals To Suppress Four ESRD • Long-Term Catheter Rate clinical COVID–19 on this patient population, QIP Measures for PY 2022 measure (under proposed Measure we are concerned about the effects of Suppression Factor 1, Significant a. Background the observed COVID–19 hospitalizations deviation in national performance on on the SHR clinical measure. We also In response to the PHE for the the measure during the COVID–19 PHE, note that COVID–19 affected different COVID–19 pandemic, we have which could be significantly better or regions of the country at different rates conducted analyses of the fourteen significantly worse compared to depending on factors like time of year, current ESRD QIP measures to historical performance during the geographic density, state and local determine whether and how COVID–19 immediately preceding program years). may have impacted the validity of these policies, and health care system measures. For the reasons discussed b. Proposal To Suppress the SHR capacity. Because of the increased below, we have concluded that COVID– Clinical Measure for PY 2022 hospitalization risk associated with 19 has so severely impacted the validity We are proposing to suppress the SHR COVID–19 and the Medicare dialysis of four measures that we cannot fairly clinical measure for the PY 2022 patient population, we are concerned and equitably score these measures for program year under proposed Measure that these regional differences in the PY 2022 program year, and we are Suppression Factor 1, Significant COVID–19 rates has led to distorted proposing to suppress these measures deviation in national performance on hospitalization rates such that we for the PY 2022 program year for all the measure during the COVID–19 PHE, cannot reliably measure national ESRD QIP participants. Specifically, the which could be significantly better or performance on the SHR clinical measures we are proposing to suppress significantly worse as compared to measure. for the PY 2022 ESRD QIP are as historical performance during the Our analysis of the available Medicare follows: immediately preceding program years. claims data indicates that the COVID–19 • SHR clinical measure (under The SHR clinical measure is an all- PHE has had significant effects on proposed Measure Suppression Factor cause, risk-standardized rate of hospital admissions of dialysis patients, 1, Significant deviation in national hospitalizations during a 1-year and will result in significant deviation performance on the measure during the observation window. The standardized in national performance on the measure COVID–19 PHE, which could be hospitalization ratio is defined as the during the COVID–19 PHE which could significantly better or significantly ratio of the number of hospital be significantly worse as compared to worse compared to historical admissions that occur for Medicare historical performance during the performance during the immediately ESRD dialysis patients treated at a immediately preceding program years. preceding program years; and proposed particular facility to the number of Not only are there effects on patients Measure Suppression Factor 4, hospitalizations that would be expected diagnosed with COVID–19, but the Significant national shortages or rapid given the characteristics of the dialysis presence of the virus strongly affected or unprecedented changes in: facility’s patients and the national norm hospital admission patterns of dialysis ++ Healthcare personnel; for dialysis facilities. This measure is patients from March 2020 to June 2020, ++ medical supplies, equipment, or calculated as a ratio but can also be and we are concerned that similar diagnostic tools or materials; or (iii) expressed as a rate. The intent of the effects will be seen in the balance of the patient case volumes or facility-level SHR clinical measure is to improve calendar year (CY) as the PHE case mix); health care delivery and care continued. Because the COVID–19 • Standardized Readmission Ratio coordination to help reduce unplanned pandemic swept through geographic (SRR) clinical measure (under proposed hospitalization among ESRD patients. regions of the country unevenly, we are Measure Suppression Factor 1, Based on our analysis of Medicare concerned that dialysis facilities in Significant deviation in national dialysis patient data from January 2020 different regions of the country would performance on the measure during the through August 2020, we found that have been affected differently COVID–19 PHE, which could be hospitalizations involving patients throughout the 2020 year, thereby

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skewing measure performance and believe this approach might help the dialysis facility to which the patient affecting national comparability due to distinguish between ESRD-related is discharged, and the discharging acute significant and unprecedented changes hospitalizations and COVID–19 related care or critical access hospitals in patient case volumes or facility-level hospitalizations that might otherwise involved. Our analysis indicates case mix. Given the limitations of the impact SHR clinical measure potential competing risks of higher data available to us for CY 2020, we calculations. mortality and lower readmissions due to believe the resulting performance We welcome public comment on our patient death or discharge to hospice, measurement on the SHR clinical proposal to suppress the SHR clinical both of which would remove them from measure would not be sufficiently measure for PY 2022. the denominator for the SRR clinical reliable or valid for use in the ESRD c. Proposal To Suppress the SRR measure. If readmissions rates are lower QIP. Clinical Measure for PY 2022 because patient mortality is higher due We are proposing to suppress this to the impact of COVID–19 on dialysis measure for the PY 2022 program year, We are proposing to suppress the SRR patients, then readmission rates are rather than remove it, because we clinical measure for the PY 2022 distorted by appearing significantly believe that the SHR clinical measure is program year under proposed Measure better compared to historical an important part of the ESRD QIP Suppression Factor 1, Significant performance during the immediately measure set. However, we are concerned deviation in national performance on preceding program years. Based on the that the COVID–19 PHE affects measure the measure during the COVID–19 PHE, impact of COVID–19 on SRR results, performance on the current SHR clinical which could be significantly better or including the deviance in measurement, measure such that we would not be able significantly worse compared to we concluded that the SRR clinical to score facilities fairly or equitably on historical performance during the measure meets our criteria for Factor 1 it. Additionally, we would continue to immediately preceding program years. where performance data would collect the measure’s claims data from The SRR assesses the number of significantly deviate from historical data participating facilities so that we can readmission events for the patients at a performance and would be considered monitor the effect of the circumstances facility, relative to the number of unreliable. Therefore, we believe the on quality measurement and determine readmission events that would be resulting performance measurement on the appropriate policies in the future. expected based on overall national rates the SRR clinical measure would not be We would also continue to provide and the characteristics of the patients at sufficiently reliable or valid for use in confidential feedback reports to that facility as well as the number of the ESRD QIP. facilities as part of program activities to discharges. The intent of the SRR We are proposing to suppress this ensure that they are made aware of the clinical measure has always been to measure for the PY 2022 program year, changes in performance rates that we improve care coordination between rather than remove it, because we observe. We also intend to publicly dialysis facilities and hospitals to believe that the SRR clinical measure is report PY 2022 data where feasible and improve communication prior to and an important part of the ESRD QIP appropriately caveated. post discharge. Program measure set. However, we are We are currently exploring ways to Based on our analysis, we found that concerned that the PHE for the COVID– adjust effectively for the systematic index discharge hospitalizations 19 pandemic affects measure effects of the COVID–19 PHE on involving dialysis patients diagnosed performance on the current SRR clinical hospital admissions for the SHR clinical with COVID–19 resulted in lower measure such that we will not be able measure. However, we are still working readmissions and higher mortality rates to score facilities fairly or equitably on to improve these COVID–19 adjustments within the first 7 days. We used index it. Additionally, we would continue to and verify the validity of a potential hospitalizations occurring from January collect the measure’s claims data from modified version of the SHR clinical 1, 2020 through June 30, 2020 to participating facilities so that we can measure as additional data become identify eligible index hospitalizations monitor the effect of the circumstances available. As an alternative, we and unplanned hospital readmissions. on quality measurement and determine considered whether we could exclude In an analysis of unadjusted the appropriate policies in the future. patients with a diagnosis of COVID–19 readmission and death rates by COVID– We would also continue to provide from the SHR clinical measure cohort, 19 hospitalization status and days since confidential feedback reports to but we determined suppression will index discharge, during the first 4 to 7 facilities as part of program activities to provide us with additional time and days after discharge there was a ensure that they are made aware of the additional months of data potentially readmission rate of 81.3 percent of changes in performance rates that we impacted by COVID–19 to more dialysis patients hospitalized with observe. We also intend to publicly thoroughly evaluate a broader range of COVID–19, as compared to 82.6 percent report PY 2022 data where feasible and alternatives. We want to ensure that the of dialysis patients hospitalized without appropriately caveated. measure reflects care provided to COVID–19. During that same 4 to 7 day We are currently exploring ways to Medicare dialysis patients and we are time period, the unadjusted mortality adjust effectively for the systematic concerned that excluding otherwise rate for dialysis patients hospitalized effects of the COVID–19 PHE on eligible patients may not accurately with COVID–19 was 16.9 percent, hospital admissions for the SRR clinical reflect the care provided, particularly compared with 10.9 percent of patients measure. However, we are still working given the unequal distribution of hospitalized without COVID–19. Based to improve these COVID–19 adjustments COVID–19 patients across facilities and on this discrepancy, we are concerned and verify the validity of a potential hospitals over time. As an alternative about the effects of these observations modified version of the SRR clinical approach, we also might consider on the calculations for the SRR clinical measure as additional data becomes updating the specifications for the SHR measure. The denominator of SRR available. As an alternative approach, clinical measure to eliminate any reflects the expected number of index we might also consider eliminating from exposure time and events after infection discharges followed by an unplanned the calculation of the SRR clinical for patients who contract COVID–19, as readmission within 4 to 30 days in each measure any cases of patients who had COVID–19 symptoms may continue to facility, which is derived from a model a COVID–19 event prior to or at the time affect patients after infection. We that accounts for patient characteristics, of index hospitalization. We believe this

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approach might help distinguish the PY 2022 performance period for the believe that the ICH CAHPS measure is between ESRD-related readmissions and ICH CAHPS measure is January 1, 2020 an important part of the ESRD QIP COVID–19 related readmissions that through December 31, 2020, and the ICH measure set. However, we are concerned might otherwise impact SRR clinical CAHPS survey is administered twice a that the COVID–19 PHE affects measure measure calculations. year (once in the spring and once in the performance on the current ICH CAHPS We welcome public comment on our fall), we only have data available from measure such that we will not be able proposal to suppress the SRR clinical the fall CY 2020 survey to calculate to score facilities fairly or equitably on measure for PY 2022. facility performance on this measure. it. Additionally, participating facilities Therefore, facilities would only be would continue to report the measure’s d. Proposal To Suppress the ICH CAHPS scored on data based on one ICH data to CMS so that we can monitor the Clinical Measure for PY 2022 CAHPS survey administration for CY effect of the circumstances on quality We are proposing to suppress the ICH 2020, rather than two. Even if we were measurement and determine the CAHPS clinical measure for the PY 2022 to score facilities based on the one ICH appropriate policies in the future. We program year under proposed Measure CAHPS survey administered in the fall, would also continue to provide Suppression Factor 1, Significant our preliminary data indicates that 95 confidential feedback reports to deviation in national performance on percent of facilities would not be facilities as part of program activities to the measure during the COVID–19 PHE, eligible for scoring on ICH CAHPS for ensure that they are made aware of the which could be significantly better or CY 2020. By contrast, 58.9 percent of changes in performance rates that we significantly worse compared to facilities were not eligible for ICH observe. We also intend to publicly historical performance during the CAHPS during CY 2018. If we were to report PY 2022 data where feasible and immediately preceding program years. score the 5 percent of eligible facilities appropriately caveated. Based on our analysis of CY 2020 ICH on ICH CAHPS, we believe there would We welcome public comment on our CAHPS data, we have found a be a significant deviation in national proposal to suppress the ICH CAHPS significant decrease in response scores performance on this measure compared measure for the PY 2022 program year. as compared to previous years. to the national performance based on e. Proposal To Suppress Long-Term The ICH CAHPS clinical measure is 41.1 percent of facilities eligible for Catheter Rate Clinical Measure for PY scored based on three composite scoring on ICH CAHPS during 2018. 2022 measures and three global ratings.139 This is a significant deviation in Global ratings questions employ a scale national performance on this measure Under the measure suppression of 0 to 10, worst to best; each of the compared to historical performance policy discussion in section IV.C.1 of questions within a composite measure during the immediately preceding this proposed rule, we are proposing to use either ‘‘Yes’’ or ‘‘No’’ responses, or program years. Given this significant suppress the Long-Term Catheter Rate response categories ranging from deviation in national performance clinical measure for the PY 2022 ‘‘Never’’ to ‘‘Always’’ to assess the during the PHE, we believe the ICH program year under proposed Measure patient’s experience of care at a facility. CAHPS clinical measure meets the Suppression Factor 1, Significant Facility performance on each composite criteria for Measure Suppression Factor deviation in national performance on measure is determined by the percent of 1. the measure during the COVID–19 PHE, patients who choose ‘‘top-box’’ We also believe that this significant which could be significantly better or responses (that is, most positive or change in performance may unfairly significantly worse compared to ‘‘Always’’) to the ICH CAHPS survey penalize facilities and that suppressing historical performance during the questions in each domain. The ICH this measure for the PY 2022 program immediately preceding program years. CAHPS survey is administered twice year will address concerns about the Based on our analysis of Long-Term yearly, once in the spring and once in potential unintended consequences of Catheter Rate clinical measure data the fall. penalizing facilities that treat COVID–19 during CY 2020, we have found a Because of the ECE we granted in diagnosed patients in the ESRD QIP. As significant increase in long-term response to the COVID–19 PHE, alternative approaches, we considered catheter use as compared to previous facilities were not required to submit CY changing the performance period or years, which may be the result of 2020 spring ICH CAHPS data for scoring facilities on one survey hesitancy to seek medical treatment purposes of the ESRD QIP. On administration, but otherwise meeting among dialysis patients concerned September 2, 2020, we published an the 30 completed surveys requirement. about being exposed to COVID–19 interim final rule with comment (IFC) in However, we found that neither of these during the PHE. In the CY 2018 ESRD PPS final rule, the Federal Register titled, ‘‘Medicare approaches were feasible; extending the we finalized the inclusion of the and Medicaid Programs, Clinical performance period would not Hemodialysis Vascular Access: Long- Laboratory Improvement Amendments accurately reflect ICH CAHPS Term Catheter Rate clinical measure in (CLIA), and Patient Protection and performance during CY 2020, and as the ESRD QIP measure set beginning Affordable Care Act; Additional Policy discussed above, an estimated 95 with the PY 2021 program (82 FR and Regulatory Revisions in Response to percent of facilities would not be 50778). The Long-Term Catheter Rate the COVID–19 Public Health eligible for ICH CAHPS scoring on one clinical measure is defined as the Emergency’’ (85 FR 54820) referred to survey. Therefore, to avoid unfairly percentage of adult hemodialysis herein as the ‘‘September 2020 IFC’’. In penalizing facilities due to their patient-months using a catheter the September 2020 IFC, we noted that performance on the ICH CAHPS survey continuously for three months or longer we would not use any first or second for the PY 2022 ESRD QIP, we believe for vascular access. The measure is quarter CY 2020 data to calculate TPSs it is appropriate to suppress the ICH based on vascular access data reported for the applicable performance period CAHPS measure for CY 2020, which is in the Consolidated Renal Operations in (85 FR 54829 through 54830). Because the performance period for the PY 2022 ESRD QIP program year (83 FR 57010). a Web-enabled Network (CROWNWeb) 139 Groupings of questions and composite We are proposing to suppress this and excludes patient-months where a measures can be found at https://ichcahps.org/ measure for the PY 2022 program year, patient has a catheter in place and has Portals/0/ICH_Composites_English.pdf. rather than remove it, because we a limited life expectancy.

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Our analysis based on the available report PY 2022 data where feasible and Performance Scores for any facility. We data indicates that long-term catheter appropriately caveated. are also proposing to not apply any use rates have increased significantly We welcome public comment on our payment reductions to ESRD facilities during the COVID–19 PHE. Average proposal to suppress the Long-Term for PY 2022. long-term catheter rates were averaging Catheter Rate clinical measure for the In order to ensure that a facility is around 12 percent in CY 2017 and CY PY 2022 program year. aware of any changes to its measure 2018. In CY 2019, rates increased to D. Proposed Special Scoring rates that we have observed, we are average around 12.25 percent. This Methodology and Payment Policy for the proposing to provide confidential increase continued into CY 2020, with PY 2022 ESRD QIP feedback reports that contain the rates reaching a peak of 14.7 percent in measure rates we calculated for PY June 2020 and declining slightly to 14.3 As described in section IV.B.2 of this 2022. Performance scores for facilities percent in July and August 2020. After proposed rule, we have considered the would be released on Dialysis Facility remaining around 12 percent for 3 impact of operational systems issues Compare and footnoted to indicate consecutive years, we view a sudden 2 preventing facilities from submitting potential accuracy concerns with the percent increase in average long-term September through December 2020 scores. Performance score certificates catheter rates as a significant deviation patient and clinical data into the EQRS would be generated with the TPS compared to historical performance from November 1, 2020 through on or showing as ‘‘Not Applicable.’’ during immediately preceding years. We about July 12, 2021. Even when We propose to codify these policies are concerned that the COVID–PHE facilities are able to submit the for PY 2022 at 42 CFR 413.177(a) and impacted the ability of ESRD patients to September through December 2020 § 413.178(h). seek treatment from medical providers patient and clinical data by September However if the policies in sections regarding their catheter use, either due 1, 2021, we will need time to validate IV.C and IV.D of this proposed rule are to difficulty accessing treatment due to the quality and reliability of the not finalized, the PY 2022 ESRD QIP COVID–19 precautions at healthcare impacted data in order to determine payment would be as implemented in facilities, or due to increased patient whether all data quality issues have accordance with our current policy, as reluctance to seek medical treatment been resolved. In addition, as described well as the payment reduction ranges because of risk of COVID–19 exposure in section IV.C. we believe four of the finalized in the CY 2020 ESRD PPS final and increased health risks resulting ESRD QIP measures have been impacted rule (84 FR 60725 through 60727). therefrom, and that these contributed to by the COVID–19 PHE that could result We invite public comment on this the significant increase in long-term in distorted measure performance for PY proposed special scoring and payment catheter use rates. 2022. policy for the PY 2022 ESRD QIP. We are proposing to suppress this It is not our intention to penalize measure for the PY 2022 program year, dialysis facilities based on the E. Proposed Updates to Requirements rather than remove it, because we performance on data that are not Beginning With the PY 2024 ESRD QIP believe that the Long-Term Catheter reliable, thus, not reflective of the 1. PY 2024 ESRD QIP Measure Set Rate clinical measure is an important quality of care that the measures in the part of the ESRD QIP measure set. program are designed to assess. Under our current policy, we retain However, we are concerned that the Therefore, we are proposing a special all ESRD QIP measures from year to year PHE for COVID–19 affects measure rule for PY 2022 scoring for the ESRD unless we propose through rulemaking performance on the current Long-Term QIP under which we would calculate to remove them or otherwise provide Catheter Rate clinical measure such that measure rates for all measures, but notification of immediate removal if a we will not be able to score facilities would not calculate achievement and measure raises potential safety issues fairly or equitably on it. Additionally, improvement points for any of them (77 FR 67475). Accordingly, the PY participating facilities would continue because they have all been impacted by 2024 ESRD QIP measure set will include to report the measure’s data to CMS so the operational systems issues and, as the same 14 measures as the PY 2023 that we can monitor the effect of the proposed above, we believe that four of ESRD QIP measure set (85 FR 71465 circumstances on quality measurement them have additionally been through 71466). These measures are and determine the appropriate policies significantly impacted by COVID. described in Table 2. For the most in the future. We would also continue Because we would not calculate recent information on each measure’s to provide confidential feedback reports achievement and improvement scores technical specifications for PY 2024, we to facilities as part of program activities for any measures, we are also proposing refer readers to the CMS ESRD Measures to ensure that they are made aware of under this special rule that we would Manual for the 2021 Performance the changes in performance rates that not score any of the measures in the four Period.140 we observe. We also intend to publicly domains or calculate or award Total BILLING CODE 4120–01–P

140 https://www.cms.gov/files/document/esrd- measures-manual-v61.pdf.

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TABLE 2: PY 2024 ESRD QIP Measure Set

National Measure Title and Description Quality Forum (NQF)# 0258 In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CARPS) Survey Administration, a clinical measure Measure assesses patients' self-reported experience of care through percentage of patient responses to multiple testing tools. 2496 Standardized Readmission Ratio (SRR), a clinical measure Ratio of the number of observed unplanned 30-day hospital readmissions to the number of expected unplanned 30-day readmissions. Based on Standardized Transfusion Ratio (STrR), a reporting measure NQF Ratio of the number of observed eligible red blood cell transfusion events occurring in patients dialyzing at #2979 a facility to the number of eligible transfusions that would be expected. NIA (Kt/V) Dialysis Adequacy Comprehensive, a clinical measure A measure of dialysis adequacy where K is dialyzer clearance, t is dialysis time, and V is total body water volume. Percentage of all patient months for patients whose delivered dose of dialysis (either hemodialysis or peritoneal dialysis) met the specified threshold during the reporting period. 2977 Hemodialysis Vascular Access: Standardized Fistula Rate clinical measure Measures the use of an arteriovenous (AV) fistula as the sole means of vascular access as of the last hemodialysis treatment session of the month. 2978 Hemodialysis Vascular Access: Long-Term Catheter Rate clinical measure Measures the use of a catheter continuously for 3 months or longer as of the last hemodialysis treatment session of the month. 1454 Hypercalcemia, a clinical measure Proportion of patient-months with 3-month rolling average of total uncorrected serum or plasma calcium greater than 10.2 mgldL. 1463 Standardized Hospitalization Ratio (SHR), a clinical measure Risk-adjusted SHR of the number of observed hospitalizations to the number of expected hospitalizations. Based on Clinical Depression Screening and Follow-Up, a reporting measure NQF Facility reports in End Stage Renal Disease Quality Reporting System (EQRS) one of six conditions for #0418 each qualifying patient treated during performance period. NIA Ultrafiltration Rate (UFR), a reporting measure Number of patient-months for which a facility reports elements required for ultrafiltration rates for each qualifying patient. Based on National Healthcare Safety Network (NHSN) Bloodstream Infection (BSI) in Hemodialysis Patients, a NQF clinical measure #1460 The Standardized Infection Ratio (SIR) ofBSis will be calculated among patients receiving hemodialysis at outpatient hemodialysis centers. NIA NHSN Dialysis Event reporting measure Number of months for which facility reports NHSN Dialysis Event data to the Centers for Disease Control and Prevention (CDC). NIA Percentage of Prevalent Patients Waitlisted (PPPW), a clinical measure Percentage of patients at each dialysis facility who were on the kidney or kidney-pancreas transplant waitlist averaged across patients prevalent on the last day of each month during the performance period. 2988 Medication Reconciliation for Patients Receiving Care at Dialysis Facilities (MedRec ), a reporting measure Percentage of patient-months for which medication reconciliation was performed and documented by an eligible professional.

BILLING CODE 4120–01–C a. Proposal To Update the Standardized measure is a National Quality Forum We discuss our proposal to update the Hospitalization Ratio (SHR) Clinical (NQF)-endorsed all-cause, risk- SHR clinical measure in the following Measure Beginning With the PY 2024 standardized rate of hospitalizations section. ESRD QIP during a 1-year observation window. The standardized hospitalization ratio is In the CY 2017 ESRD PPS final rule, defined as the ratio of the number of we adopted the SHR clinical measure hospital admissions that occur for under the authority of section Medicare ESRD dialysis patients treated 1881(h)(2)(B)(ii) of the Act (81 FR 77906 at a particular facility to the number of through 77911). The SHR clinical hospitalizations that would be expected

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given the characteristics of the dialysis Information Management System/ When the Measure Applications facility’s patients and the national norm CROWNWeb provides tracking by Partnership Hospital Workgroup for dialysis facilities. This measure is dialysis provider and treatment convened on January 11, 2021, it calculated as a ratio but can also be modality for non-Medicare patients, and reviewed the MUC List, including the expressed as a rate. information on hospitalizations and SHR clinical measure. The Measure Hospitalizations are an important patient comorbidities are obtained from Applications Partnership Hospital indicator of patient morbidity and Medicare Inpatient Claims Standard Workgroup recognized that quality of life. On average, dialysis Analysis Files. In the CY 2019 ESRD hospitalization rates vary across dialysis patients are admitted to the hospital PPS final rule, we increased the weight facilities, even after adjusting for patient nearly twice a year and spend an of the SHR clinical measure from 8.25 characteristics, which suggests that average of 11.2 days in the hospital per percent to 14 percent of the TPS (83 FR hospitalizations might be influenced by year.141 Hospitalizations account for 56992 through 56997). approximately 33 percent of total On November 20, 2020, NQF dialysis facility practices. The Measure Medicare expenditures for ESRD completed its most recent review of the Applications Partnership Hospital patients.142 Studies have shown that SHR clinical measure, a measure Workgroup also noted that the SHR improved health care delivery and care maintenance review, and renewed the clinical measure seeks to improve coordination may help reduce measure’s endorsement. As part of this patient outcomes by measuring unplanned acute care including review, the NQF endorsed updating the hospitalization ratios among dialysis hospitalization.143 Hospitalization rates prevalent comorbidity adjustment, facilities, and that the measure seeks to vary across dialysis facilities even after which would group 210 individual ICD– promote communication between the adjustment for patient characteristics, 9–CM prevalent comorbidities into 90 dialysis facilities and other care settings suggesting that hospitalizations might condition groups, derived from the to improve care transitions.145 In its be influenced by dialysis facility Agency for Healthcare Research and final report, the Measure Applications practices. An adjusted facility-level Quality (AHRQ) Clinical Classifications Partnership supported this measure for standardized hospitalization ratio, Software (CCS) groups. The updated rulemaking.146 accounting for differences in patients’ prevalent comorbidity adjustment In this proposed rule, we are characteristics, plays an important role would also limit the source of prevalent proposing to update the SHR clinical in identifying potential problems, and comorbidities to inpatient claims. The measure specifications to align with the helps facilities provide cost-effective switch to using only Medicare inpatient NQF-endorsed updates. These include quality health care to help limit claims to identify prevalent updates to the risk adjustment method escalating medical costs. comorbidities is due to the lack of of the measure, which include a In the CY 2017 ESRD PPS final rule, Medicare outpatient claims data for the prevalent comorbidity adjustment, the we finalized our proposal to adopt the growing Medicare Advantage (MA) addition of MA patients and a MA SHR clinical measure, which was a patient population. By using the original indicator in the model, updates to modified version of the NQF-endorsed set of Medicare claims datasets SHR clinical measure (NQF #1463), as (inpatient, outpatient, hospice, skilled parameterization of existing adjustment part of the ESRD QIP measure set (81 FR nursing, and home health), the NQF factors and re-evaluation of interactions, 77911). In that final rule, we stated that stated its concern that MA patient and an indicator for a patient’s time our modified SHR clinical measure prevalent comorbidities would be spent in a skilled nursing facility. would incorporate 210 prevalent systematically biased. These MA patient We believe that adopting these comorbidities into our risk adjustment prevalent comorbidities would only be updates would be consistent with our calculation, as our analyses suggested populated by Medicare inpatient claims, stated goal of evaluating opportunities that incorporating prevalent as compared to non-MA patient to more closely align ESRD QIP comorbidities would result in a more prevalent comorbidities that would be measures with NQF measure robust and reliable measure of populated by the aforementioned set of specifications (84 FR 60724). The SHR hospitalization (81 FR 77906 through Medicare claim sources. The updated clinical measure seeks to improve 77907). In that final rule, we explained NQF-endorsed SHR clinical measure patient outcomes by measuring that data used to calculate the SHR would also include all time at risk for hospitalization ratios among dialysis clinical measure are derived from an MA patients, and added a MA indicator facilities, and we believe that these extensive national ESRD patient for adjustment in the model. The NQF- database (81 FR 77908). We noted that updates would result in a more reliable endorsed specifications also included and robust SHR clinical measure. the database is comprehensive for updates to parameterization of existing Medicare Parts A and B patients, and adjustment factors and re-evaluation of We seek comment on this proposal to that non-Medicare patients are included interactions, and also created three update the SHR clinical measure in all sources except for the Medicare distinct groups of patients to use in the specifications for use in the ESRD QIP payment records. In that final rule, we SHR model based on time spent in a beginning with PY 2024. also stated that the Standard skilled nursing facility, noting that nursing home residence is a marker of measures-under-consideration-list-2020-report.pdf 141 United States Renal Data System. 2018 United higher morbidity. on January 29 2021. States Renal Data System annual data report: 145 Measure Applications Partnership. Measure Epidemiology of kidney disease in the United The updated SHR clinical measure Applications Partnership Preliminary States. National Institutes of Health, National was included on the publicly available Recommendations 2020–2021. Accessed on January Institute of Diabetes and Digestive and Kidney ‘‘List of Measures under Consideration 24, 2021 at: http://www.qualityforum.org/Project_ Diseases, Bethesda, MD 2018. for December 21, 2020’’ (MUC List), a Pages/MAP_Hospital_Workgroup.aspx. 142 Ibid. 146 Measure Applications Partnership. Measure 143 list of measures under consideration for Office of the Assistant Secretary for Planning 144 Applications Partnership 2020–2021: and Evaluation, U.S. Department of Health & use in various Medicare programs. Considerations for Implementing Measures in Human Services. Advancing American Kidney Federal Programs: Clinician, Hospital & PAC/LTC. Health. 2019. Available at: https://aspe.hhs.gov/ 144 National Quality Forum. List of Measures Accessed on April 28, 2021 at: https:// system/files/pdf/262046/ Under Consideration for December 21, 2020. www.qualityforum.org/WorkArea/ AdvancingAmericanKidneyHealth.pdf. Accessed at: https://www.cms.gov/files/document/ linkit.aspx?LinkIdentifier=id&ItemID=94893.

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2. Performance Standards for the PY and second quarter data for CY 2020 are set performance standards for certain 2024 ESRD QIP excluded from scoring for purposes of measures, even though they would be Section 1881(h)(4)(A) of the Act the ESRD QIP. We are concerned that it based on partial year data. We are requires the Secretary to establish will be difficult to assess levels of concerned that this may create performance standards with respect to achievement and improvement if the performance standards for certain the measures selected for the ESRD QIP performance standards are based on measures that would be difficult for 147 for a performance period with respect to partial year data. Our preliminary facilities to attain with a full 12 months a year. The performance standards must analysis indicates that the effect of the of data. include levels of achievement and excluded data would create higher Therefore, in this proposed rule, we improvement, as required by section performance standards for certain are proposing to calculate the 1881(h)(4)(B) of the Act, and must be measures and lower performance performance standards for PY 2024 established prior to the beginning of the standards for other measures, which using CY 2019 data, which is the most performance period for the year may skew achievement and recently available full calendar year of involved, as required by section improvement thresholds for facilities data we can use to calculate those 1881(h)(4)(C) of the Act. We refer and therefore may result in performance standards. Due to the impact of CY 2020 readers to the CY 2013 ESRD PPS final standards that do not accurately reflect data that is excluded from the ESRD QIP rule (76 FR 70277) for a discussion of levels of achievement and improvement. for scoring purposes, we believe that Our current policy substitutes the the achievement and improvement using CY 2019 data for performance performance standard, achievement standards that we have established for standard setting purposes is threshold, and/or benchmark for a clinical measures used in the ESRD QIP. appropriate. Consistent with our measure for a performance year if final We define the terms ‘‘achievement established policy, we would continue threshold,’’ ‘‘benchmark,’’ numerical values for the performance standard, achievement threshold, and/or to use the prior year’s numerical values ‘‘improvement threshold,’’ and for performance standard, achievement ‘‘performance standard’’ in our benchmark are worse than the numerical values for that measure in the threshold, and benchmark if the most regulations at § 413.178(a)(1), (3), (7), recent full CY’s final numerical values and (12), respectively. previous year of the ESRD QIP (82 FR 50764). We adopted this policy because are worse. a. Proposal To Update the Performance we believe that the ESRD QIP should We welcome public comments on this Standards Applicable to the PY 2024 not have lower performance standards proposal. Clinical Measures than in previous years. However, our b. Performance Standards for the PY Our current policy is to automatically general policy provides flexibility to 2024 ESRD QIP if Proposal to Use CY adopt a performance and baseline substitute the performance standard, 2019 as the Baseline Period is Finalized period for each year that is 1 year achievement threshold and benchmark advanced from those specified for the in appropriate cases (82 FR 50764). Table 3 displays the achievement previous payment year (84 FR 60728). Although the lower performance thresholds, 50th percentiles of the Under this policy, CY 2022 is currently standards would be substituted with national performance, and benchmarks the performance period and CY 2020 is those from the prior year, the higher for the PY 2024 clinical measures, and the baseline period for the PY 2024 performance standards would be used to we would use these standards if our ESRD QIP. However, under the proposal to use CY 2019 as the baseline 147 We note that for most ESRD QIP measures, period is finalized. nationwide ECE that we granted in this partial year data would be measure data from response to the COVID–19 PHE, first July and August 2020. BILLING CODE 4120–01–P

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TABLE 3: Performance Standards for the PY 2024 ESRD QIP Clinical Measures if P roposa I t 0 U se CY 2019 as th e B aseI' me P er10 . d IS. F'ma I' 1ze d Measure Achievement Median (50th Benchmark (90th Threshold (15th Percentile of Percentile of National Percentile of National Performance) National Performance) Performance) Vascular Access Type (VAT) I Standardized Fistula Rate 53.29% 64.36% 76.77% Catheter Rate - 18.35% -11.04% -4.69% Kt/V Comprehensive 94.33% 97.61% 99.42% Hypercalcemia 1.54% 0.49% 0.00%* Standardized Readmission Ratio 1.268* 0.998* 0.629* NHSNBSI 1.193 0.516 0* Standardized Hospitalization Ratio 1.230 0.971 0.691 PPPW 8.12%* 16.73%* 33.90%* ICH CARPS: Nephrologists' 58.20% 67.90% 79.15% Communication and Caring ICH CARPS: Quality of Dialysis Center 54.64% 63.08% 72.66% Care and Operations ICH CARPS: Providing Information to 74.49% 81.09% 87.80% Patients ICH CARPS: Overall Rating of 49.33%* 62.22%* 76.57%* Nephrologists ICH CARPS: Overall Rating of Dialysis 50.02% 63.37% 78.30% Center Staff ICH CARPS: Overall Rating of the 54.51% 69.04% 83.72% Dialysis Facility Note: Values marked with an asterisk(*) are also the final performance standards for those measures for PY 2023. In accordance with our longstanding policy, we are using those numerical values for those measures for PY 2024 because they are higher standards than the PY 2024 numerical values for those measures. Data sources: VAT measures: 2019 CROWNWeb; SRR, SHR: 2019 Medicare claims; Kt/V: 2019 CROWNWeb; Hypercalcemia: 2019 CROWNWeb; NHSN: 2019 CDC; ICH CARPS: CMS 2019; PPPW: 2019 CROWNWeb and 2019 OPTN.

In addition, we have summarized in measures in the PY 2024 ESRD QIP. We these standards as a result of the Table 4 existing requirements for are not making any proposals to change COVID–19 PHE. successful reporting on reporting

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TABLE 4: Requirements for Successful Reporting on the PY 2024 ESRD QIP Reporting Measures

Measure Reporting Frequency Data Elements Ultra.filtration 4 data elements are reported for • In-Center Hemodialysis (ICHD) Kt/V Date every HD Kt/V session during • Post-Dialysis Weight the week of the monthly Kt/V • Pre-Dialysis Weight draw, and the number of • Delivered Minutes of BUN Hemodialysis sessions of dialysis is reported • Number of sessions of dialysis delivered by the monthly dialysis unit to the patient in the reporting Month Med.Rec Monthly • Date of the medication reconciliation. • Type of eligible professional who completed the medication reconciliation: o physician, o nurse, oARNP, oPA, o pharmacist, or o pharmacy technician personnel • Name of eligible professional Clinical 1 of 6 conditions reported • Screening for clinical depression is documented as Depression annually being positive and a follow-up plan is documented. Screening • Screening for clinical depression documented as and Follow- positive, a follow-up plan Up is not documented, and the facility possesses documentation that the patient is not eligible. • Screening for clinical depression documented as positive, the facility possesses no documentation of a follow-up plan, and no reason is given. • Screening for clinical depression documented as negative and no follow-up plan required. • Screening for clinical depression not documented, but the facility possesses documentation stating the patient is not eligible. • Clinical depression screening not documented, and no reason is given. NHSN Monthly Three types of dialysis events reported: Dialysis • IV antimicrobial start; Event • positive blood culture; and • pus, redness, or increased swelling at the vascular access site. STrR At least 10 patient-years at risk during the performance period.

3. Eligibility Requirements for the PY 2024 ESRD QIP Our current minimum eligibility requirements for scoring the ESRD QIP measures are described in Table 5.

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TABLE 5: Eligibility Requirements for Scoring on ESRD QIP Measures

Measure Minimum data requirements CCN open date Small facility adjuster Kt/V Comprehensive 11 qualifying patients NIA 11-25 qualifying patients (Clinical) VAT: Long-term 11 qualifying patients NIA 11-25 qualifying patients Catheter Rate (Clinical) VAT: Standardized 11 qualifying patients NIA 11-25 qualifying patients Fistula Rate (Clinical) Hypercalcemia 11 qualifying patients NIA 11-25 qualifying patients (Clinical) NHSN BSI (Clinical) 11 qualifying patients Before October 1 prior 11-25 qualifying patients to the performance period that applies to the program year. NHSN Dialysis Event 11 qualifying patients NIA NIA (Reporting) SRR (Clinical) 11 index discharges NIA 11-41 index discharges STrR (Reporting) 10 patient-years at risk NIA NIA SHR (Clinical) 5 patient-years at risk NIA 5-14 patient-years at risk ICH CARPS (Clinical) Facilities with 30 or more survey-eligible Before October 1 prior NIA patients during the calendar year to the performance preceding the performance period must period that applies to submit survey results. Facilities will not the program year. receive a score if they do not obtain a total of at least 30 completed surveys during the performance period Depression Screening 11 qualifying patients Before April 1 of the NIA and Follow-Up performance (Reporting) period that applies to the program year. Ultrafiltration 11 qualifying patients Before April 1 of the NIA (Reporting) performance period that applies to the program year. MedRec (Reporting) 11 qualifying patients Before October 1 prior NIA to the performance period that applies to the program year. PPPW (Clinical) 11 qualifying patients NIA 11-25 qualifying patients

4. Payment Reduction Scale for the PY percentile of national performance on reduction. We note that the mTPS in 2024 ESRD QIP all clinical measures and the median of this proposed rule is based on data from national ESRD facility performance on CY 2019 instead of the PY 2024 baseline Under our current policy, a facility all reporting measures. period (CY 2020) because we have will not receive a payment reduction for Our current policy, which is codified proposed to use CY 2019 as the baseline a payment year in connection with its at § 413.177 of our regulations, also period for that payment year. performance for the ESRD QIP if it implements the payment reductions on achieves a TPS that is at or above the a sliding scale using ranges that reflect We refer readers to Table 3 for the minimum TPS (mTPS) that we establish payment reduction differentials of 0.5 estimated values of the 50th percentile for the payment year. We have defined percent for each 10 points that the of national performance for each clinical the mTPS in our regulations at facility’s TPS falls below the mTPS (76 measure. Under our current policy, a § 413.178(a)(8) as, with respect to a FR 634 through 635). facility that achieves a TPS of 56 or payment year, the TPS that an ESRD For PY 2024, based on available data, below would receive a payment facility would receive if, during the a facility must meet or exceed a mTPS reduction based on the TPS ranges baseline period it performed at the 50th of 57 in order to avoid a payment indicated in Table 6.

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TABLE 6 : E s t°Ima t e d P avmen t R e d UC t°IOU S caI e fior PY 2024 B ase d on CY 2019 Data Total uerformance score Reduction (%) 100-57 0%

56-47 0.5%

46-37 1.0%

36-27 1.5%

26-0 2.0%

BILLING CODE 4120–01–C standards that we have established for 4. Scoring the PY 2025 ESRD QIP If we do not finalize the proposed clinical measures used in the ESRD QIP. a. Scoring Facility Performance on update to our performance standards We define the terms ‘‘achievement policy as described in section IV.E.2.a of Clinical Measures threshold,’’ ‘‘benchmark,’’ this proposed rule, then we would ‘‘improvement threshold,’’ and In the CY 2014 ESRD PPS final rule, update the mTPS for PY 2024, as well we finalized policies for scoring as the payment reduction ranges for that ‘‘performance standard’’ in our regulations at § 413.178(a)(1), (3), (7), performance on clinical measures based payment year, in the CY 2022 ESRD PPS on achievement and improvement (78 and (12), respectively. In section final rule using data from CY 2020. FR 72215 through 72216). In the CY IV.E.2.a of this proposed rule, we note 2019 ESRD PPS final rule, we finalized F. Updates for the PY 2025 ESRD QIP that we are proposing to use CY 2019 a policy to continue use of this 1. Continuing Measures for the PY 2025 data for purposes of calculating the methodology for future payment years ESRD QIP performance standards for PY 2024 (83 FR 57011) and we codified these because, due to the anticipated impact Under our previously adopted policy, scoring policies at § 413.178(e). of CY 2020 data that is excluded from the PY 2024 ESRD QIP measure set will In this proposed rule, we are not also be used for PY 2025. At this time, the ESRD QIP for scoring purposes proposing any changes to this policy for we are not proposing to adopt any new during CY 2020, we believe that using PY 2025. measures beginning with the PY 2025 CY 2019 data for performance standard setting purposes would be appropriate. b. Scoring Facility Performance on ESRD QIP. Reporting Measures 2. Performance Period for the PY 2025 a. Performance Standards for Clinical Our policy for scoring performance on ESRD QIP Measures in the PY 2025 ESRD QIP reporting measures is codified at We continue to believe that 12-month At this time, we do not have the § 413.178(e), and more information on performance and baseline periods necessary data to assign numerical our scoring policy for reporting provide us sufficiently reliable quality values to the achievement thresholds, measures can be found in the CY 2020 measure data for the ESRD QIP. Under benchmarks, and 50th percentiles of ESRD PPS final rule (84 FR 60728). We previously finalized policies for scoring this policy, we would adopt CY 2023 as national performance for the clinical performance on the NHSN Dialysis the performance period and CY 2021 as measures for the PY 2025 ESRD QIP Event reporting measure in the CY 2018 the baseline period for the PY 2025 because we do not have CY 2021 data. ESRD QIP. ESRD PPS final rule (82 FR 50780 We intend to publish these numerical In this proposed rule, we are not through 50781), as well as policies for proposing any changes to this policy. values, using CY 2021 data, in the CY scoring the MedRec reporting measure 2023 ESRD PPS final rule. and Clinical Depression Screening and 3. Performance Standards for the PY Follow-up reporting measure in the CY 2025 ESRD QIP b. Performance Standards for the Reporting Measures in the PY 2025 2019 ESRD PPS final rule (83 FR 57011). Section 1881(h)(4)(A) of the Act ESRD QIP We also previously finalized the scoring requires the Secretary to establish policy for the STrR reporting measure in performance standards with respect to In the CY 2019 ESRD PPS final rule, the CY 2020 ESRD PPS final rule (84 FR the measures selected for the ESRD QIP we finalized the continued use of 60721 through 60723). In the CY 2021 for a performance period with respect to existing performance standards for the ESRD PPS final rule, we finalized our a year. The performance standards must Screening for Clinical Depression and updated scoring methodology for the include levels of achievement and Follow-Up reporting measure, the Ultrafiltration Rate reporting measure improvement, as required by section Ultrafiltration Rate reporting measure, (85 FR 71468 through 71470). 1881(h)(4)(B) of the Act, and must be the NHSN Dialysis Event reporting In this proposed rule, we are not established prior to the beginning of the measure, and the MedRec reporting proposing any changes to this policy for performance period for the year measure (83 FR 57010 through 57011). PY 2025. involved, as required by section We will continue use of these 1881(h)(4)(C) of the Act. We refer 5. Weighting the Measure Domains and readers to the CY 2012 ESRD PPS final performance standards in PY 2025. the TPS for PY 2025 rule (76 FR 70277) for a discussion of Under our current policy, we assign the achievement and improvement the Patient & Family Engagement

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Measure Domain a weight of 15 percent stratification of quality measure results Readmission rates for common of the TPS, the Care Coordination by race and ethnicity; (c) Improving conditions in the Hospital Readmissions Measure Domain a weight of 30 percent Demographic Data Collection; and (d) Reduction Program are higher for Black of the TPS, the Clinical Care Measure Potential Creation of an ESRD Facility Medicare beneficiaries and higher for Domain a weight of 40 percent of the Equity Score to Synthesize Results Hispanic Medicare beneficiaries with TPS, and the Safety Measure domain a Across Multiple Social Risk Factors. Congestive Heart Failure and Acute weight of 15 percent of the TPS. • Solicitation of public comment. Myocardial Infarction.163 164 165 166 167 In the CY 2019 ESRD PPS final rule, This section specifies 11 requests for Although Black Americans represent 7.5 we finalized a policy to assign weights feedback on the topics specified in this percent of all older adult Medicare to individual measures and a policy to RFI. beneficiaries, they represent 28 percent redistribute the weight of unscored 168 a. Background of those with ESRD. Among measures (83 FR 57011 through 57012). individuals with ESRD the odds of 30- In the CY 2020 ESRD PPS final rule, we Significant and persistent inequities day hospital readmission are 19 percent finalized a policy to use the measure in health care outcomes exist in the higher for Black beneficiaries as weights we finalized for PY 2022 for the U.S.148 Belonging to a racial or ethnic compared with white beneficiaries.169 PY 2023 ESRD QIP and subsequent minority group, living with a disability, Studies have also shown that African payment years, and also to use the PY being a member of the lesbian, gay, Americans are significantly more likely 2022 measure weight redistribution bisexual, transgender, and queer than white Americans to die policy for the PY 2023 ESRD QIP and (LGBTQ+) community, living in a rural prematurely from heart disease and subsequent payment years (84 FR 60728 area, or being near or below the poverty stroke.170 The COVID–19 pandemic has through 60729). We are not proposing level, is often associated with worse further illustrated many of these any updates to these policies for PY health outcomes.149 150 151 152 153 154 155 156 longstanding health inequities with 2025. Such disparities in health outcomes are higher rates of infection, hospitalization, the result of number of factors, but and mortality among Black, Latino, and G. Requests for Information (RFIs) on importantly for CMS programs, although Indigenous and Native American Topics Relevant to ESRD QIP not the sole determinant, poor access 1. Closing the Health Equity Gap in and provision of lower quality health 158 Guide to Reducing Disparities in CMS Quality Programs Request for care contribute to health disparities. For Readmissions. CMS Office of Minority Health. Information instance, numerous studies have shown Revised August 2018. Available at: https:// that among Medicare beneficiaries, www.cms.gov/About-CMS/Agency-Information/ Persistent inequities in health care OMH/Downloads/OMH_Readmissions_Guide.pdf. racial and ethnic minority individuals 159 outcomes exist in the United States Singh JA, Lu X., Rosenthal GE, Ibrahim S., often receive lower quality of care, (U.S.), including among Medicare Cram P. Racial disparities in knee and hip total report lower experiences of care, and joint arthroplasty: An 18-year analysis of national patients. In recognition of persistent experience more frequent hospital Medicare data. Ann Rheum Dis. 2014 Dec;73(12): health disparities and the importance of 2107–15. readmissions and operative closing the health equity gap, we 160 Rivera-Hernandez M., Rahman M., Mor V., complications.157 158 159 160 161 162 request information on expanding Trivedi AN. Racial Disparities in Readmission Rates among Patients Discharged to Skilled Nursing several related CMS programs to make 148 United States Department of Health and Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672– reporting of health disparities based on Human Services. ‘‘Healthy People 2020: Disparities. 1679. social risk factors and race and 2014.’’ Available at: https://www.healthy 161 Joynt KE, Orav E., Jha AK. Thirty-Day ethnicity, and disability more people.gov/2020/about/foundation-health- Readmission Rates for Medicare Beneficiaries by comprehensive and actionable for measures/Disparities. Race and Site of Care. JAMA. 2011;305(7):675–681. 149 Joynt KE, Orav E., Jha AK. Thirty-Day 162 Tsai TC, Orav EJ, Joynt KE. Disparities in dialysis facilities, providers, and Readmission Rates for Medicare Beneficiaries by surgical 30-day readmission rates for Medicare patients. The following is part of an Race and Site of Care. JAMA. 2011;305(7):675–681. beneficiaries by race and site of care. Ann Surg. Jun ongoing effort across CMS to evaluate 150 Lindenauer PK, Lagu T., Rothberg MB, et al. 2014;259(6):1086–1090. appropriate initiatives to reduce health Income Inequality and 30 Day Outcomes After 163 Rodriguez F., Joynt KE, Lopez L., Saldana F., Acute Myocardial Infarction, Heart Failure, and Jha AK. Readmission rates for Hispanic Medicare disparities. Feedback will be used to Pneumonia: Retrospective Cohort Study. British beneficiaries with heart failure and acute inform the creation of a future, Medical Journal. 2013;346. myocardial infarction. Am Heart J. Aug 2011;162(2): comprehensive, request for information 151 Trivedi AN, Nsa W., Hausmann LRM, et al. 254–261 e253. (RFI) focused on closing the health Quality and Equity of Care in U.S. Hospitals. New 164 Centers for Medicare and Medicaid Services. equity gap in CMS programs and England Journal of Medicine. 2014;371(24):2298– Medicare Hospital Quality Chartbook: Performance 2308. Report on Outcome Measures; 2014. policies. This RFI contains four parts: • 152 Polyakova, M., et al. Racial Disparities In 165 Guide to Reducing Disparities in Background. This section provides Excess All-Cause Mortality During The Early Readmissions. CMS Office of Minority Health. information on existing statements COVID–19 Pandemic Varied Substantially Across Revised August 2018. Available at: https:// describing our commitment to health States. Health Affairs. 2021; 40(2): 307–316. www.cms.gov/About-CMS/Agency-Information/ 153 Rural Health Research Gateway. Rural OMH/Downloads/OMH_Readmissions_Guide.pdf. equity, and existing initiatives with an 166 emphasis on reducing disparity. Communities: Age, Income, and Health Status. Prieto-Centurion V., Gussin HA, Rolle AJ, • Rural Health Research Recap. November 2018. Krishnan JA. Chronic obstructive pulmonary Current CMS Disparity Methods. 154 Polyakova, M., et al. Racial Disparities In disease readmissions at minority-serving This section describes the methods, Excess All-Cause Mortality During The Early institutions. Ann Am Thorac Soc. Dec measures, and indicators of social risk COVID–19 Pandemic Varied Substantially Across 2013;10(6):680–684. currently used with the CMS Disparity States. Health Affairs. 2021; 40(2): 307–316. 167 Joynt KE, Orav E., Jha AK. Thirty-Day 155 Readmission Rates for Medicare Beneficiaries by Methods. www.cdc.gov/mmwr/volumes/70/wr/ • mm7005a1.htm. Race and Site of Care. JAMA. 2011;305(7):675–681. Future potential stratification of 156 https://www.ncbi.nlm.nih.gov/pmc/articles/ 168 https://www.cms.gov/About-CMS/Agency- quality measure results. This section PMC7386532/. Information/OMH/Downloads/ESRD- describes four potential future 157 Martino, SC, Elliott, MN, Dembosky, JW, Infographic.pdf. expansions of the CMS Disparity Hambarsoomian, K., Burkhart, Q., Klein, DJ, 169 Ibid. Gildner, J., and Haviland, AM. Racial, Ethnic, and 170 HHS. Heart disease and African Americans. Methods, including (a) Future potential Gender Disparities in Health Care in Medicare (March 29, 2021). https:// stratification of quality measure results Advantage. Baltimore, MD: CMS Office of Minority www.minorityhealth.hhs.gov/omh/browse.aspx?lvl= by dual eligibility; (b) Future potential Health. 2020. 4&lvlid=19.

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persons relative to white persons.171 172 a useful, common definition for equity • The Racial, Ethnic, and Gender In the ESRD patient population, one across different areas of government, Disparities in Health Care in Medicare study found that the rate of COVID–19 although numerous other definitions of Advantage Stratified Report, which hospitalizations among dialysis patients equity exist. highlights racial and ethnic differences peaked at 40 times higher than the rate Our ongoing commitment to closing in health care experiences and clinical in the general population during the the equity gap in CMS quality programs care, compares quality of care for pandemic, with Black, Latino, and is demonstrated by a portfolio of women and men, and looks at racial and Asian persons hospitalized at a higher programs aimed at making information ethnic differences in quality of care rate than white persons.173 As noted by on the quality of health care providers among women and men separately for the Centers for Disease Control ‘‘long- and services, including disparities, more Medicare Advantage plans.182 standing systemic health and social transparent to consumers and providers. • The Rural-Urban Disparities in inequities have put many people from The CMS Equity Plan for Improving Health Care in Medicare Report which racial and ethnic minority groups at Quality in Medicare outlines a path to details rural-urban differences in health increased risk of getting sick and dying equity which aims to support Quality care experiences and clinical care.183 • from COVID–19.’’ 174 One important Improvement Networks and Quality The Standardized Patient strategy for addressing these important Improvement Organizations (QIN– Assessment Data Elements for certain inequities is by improving data QIOs); federal, state, local, and tribal post-acute care Quality Reporting collection to allow for better organizations; providers; researchers; Programs, which now includes data measurement and reporting on equity policymakers; beneficiaries and their reporting for race and ethnicity and across our programs and policies. families; and other stakeholders in preferred language, in addition to We are committed to achieving equity activities to achieve health equity.177 screening questions for social needs (84 The CMS Equity Plan for Improving FR 42536 through 42588). in health care outcomes for our • beneficiaries by supporting providers in Quality in Medicare focuses on three The CMS Innovation Center’s quality improvement activities to reduce core priority areas which inform our Accountable Health Communities health inequities, enabling them to policies and programs: (1) Increasing Model which includes standardized make more informed decisions, and understanding and awareness of collection of health-related social needs promoting provider accountability for disparities; (2) developing and data. • The Guide to Reducing Disparities health care disparities.175 For the disseminating solutions to achieve which provides an overview of key purposes of this rule, we are using a health equity; and (3) implementing issues related to disparities in definition of equity established in sustainable actions to achieve health 178 179 readmissions and reviews set of Executive Order 13985, as ‘‘the equity. The CMS Quality Strategy activities that can help hospital leaders consistent and systematic fair, just, and and Meaningful Measures 180 reduce readmissions in diverse impartial treatment of all individuals, Framework include elimination of racial and ethnic disparities as a central populations.184 including individuals who belong to • The Chronic Kidney Disease underserved communities that have principle. Our efforts aimed at closing the health equity gap to date have Disparities: Educational Guide for been denied such treatment, such as Primary Care, which is intended to Black, Latino, and Indigenous and included both providing transparency of health disparities, supporting providers foster the development of primary care Native American persons, Asian practice teams in order to enhance care Americans and Pacific Islanders and with evidence-informed solutions to achieve health equity, and reporting to for vulnerable patients with chronic other persons of color; members of providers on gaps in quality in the kidney disease (CKD) and are at risk of religious minorities; lesbian, gay, following: progression of disease or complications. bisexual, transgender, and queer • The CMS Mapping Medicare The guide provides information about (LGBTQ+) persons; persons with Disparities Tool which is an interactive disparities in the care of patients with disabilities; persons who live in rural map that identifies areas of disparities CKD, presents potential actions that areas; and persons otherwise adversely and is a starting point to understand and may improve care and suggests other affected by persistent poverty or 176 investigate geographic, racial and ethnic available resources that may be used by inequality.’’ We note that this differences in health outcomes for primary care practice teams in caring for definition was recently established by Medicare patients.181 vulnerable patients.185 the Biden administration, and provides • The CMS Disparity Methods which 177 Centers for Medicare and Medicaid Services provide hospital-level confidential 171 https://www.cms.gov/files/document/ Office of Minority Health. The CMS Equity Plan for results stratified by dual eligibility for medicare-covid-19-data-snapshot-fact-sheet.pdf. Improving Quality in Medicare. 2015. https:// 172 Ochieng N., Cubanski J., Neuman T., Artiga S., www.cms.gov/About-CMS/Agency-Information/ condition-specific readmission and Damico A. Racial and Ethnic Health Inequities OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_ and Medicare. Kaiser Family Foundation. February 090615.pdf. 182 https://www.cms.gov/About-CMS/Agency- 2021. Available at: https://www.kff.org/medicare/ 178 Centers for Medicare and Medicaid Services Information/OMH/research-and-data/statistics-and- report/racial-and-ethnic-health-inequities-and- Office of Minority Health. Paving The Way To data/stratified-reporting. medicare/. Equity: A Progress Report. 2015–2021. https:// 183 Centers for Medicare & Medicaid Services. 173 Weinhandl ED, Wetmore, JB, Peng Y., et al. www.cms.gov/files/document/paving-way-equity- Rural-Urban Disparities in Health Care in Medicare. Initial effects of COVID–19 on patients with ESKD. cms-omh-progress-report.pdf. 2019. https://www.cms.gov/About-CMS/Agency- J Am Soc Nephrol. Published online April 8, 179 Centers for Medicare Services. CMS Quality Information/OMH/Downloads/Rural-Urban- 2021.doi:10.1681/ASN.2021010009. Strategy. 2016. https://www.cms.gov/Medicare/ Disparities-in-Health-Care-in-Medicare-Report.pdf. 174 https://www.cdc.gov/coronavirus/2019-ncov/ Quality-Initiatives-Patient-Assessment-Instruments/ 184 Guide to Reducing Disparities in community/health-equity/race-ethnicity.html. QualityInitiativesGenInfo/Downloads/CMS-Quality- Readmissions. CMS Office of Minority Health. 175 https://www.cms.gov/Medicare/Quality- Strategy.pdf. Revised August 2018. Available at: https:// Initiatives-Patient-Assessment-Instruments/Quality 180 https://www.cms.gov/Medicare/Quality- www.cms.gov/About-CMS/Agency-Information/ InitiativesGenInfo/Downloads/CMS-Quality- Initiatives-Patient-Assessment-Instruments/ OMH/Downloads/OMH_Readmissions_Guide.pdf. Strategy.pdf. QualityInitiativesGenInfo/MMF/General-info-Sub- 185 CMS. Chronic Kidney Disease Disparities: 176 https://www.federalregister.gov/documents/ Page. Educational Guide for Primary Care. February 2020. 2021/01/25/2021-01753/advancing-racial-equity- 181 https://www.cms.gov/About-CMS/Agency- Available at: https://www.cms.gov/files/document/ and-support-for-underserved-communities-through- Information/OMH/OMH-Mapping-Medicare- chronic-kidney-disease-disparities-educational- the-federal-government. Disparities. guide-primary-care.pdf.

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measures currently included in the improvement by calculating differences (1) Stratification of Quality Measure Hospital Readmissions Reduction in outcome rates among patient groups Results—Dual Eligibility Program (see 84 FR 42496 through within a hospital while accounting for As described above, landmark reports 42500 for a discussion of using stratified their clinical risk factors. This method by NASEM 190 and ASPE,191 which have data in additional measures). also allows for a comparison of the examined the influence of social risk These programs are informed by magnitude of disparity across hospitals, factors on several of our quality reports by the National Academies of so hospitals could assess how well they programs, have shown that in the Science, Engineering and Medicine are closing disparity gaps compared to context of VBP programs, dual (NASEM) 186 and the Office of the other hospitals. The second eligibility, as an indicator of social risk, Assistant Secretary for Planning and 187 methodological approach (the Across- is a powerful predictor of poor health Evaluation (ASPE) which have outcomes. We are considering examined the influence of social risk Hospital method) is complementary and assesses hospitals’ outcome rates for stratification of quality measure results factors on several of our quality in the ESRD QIP and are considering programs. In this request for public dual-eligible patients only, across hospitals, allowing for a comparison which measures would be most comment, we address only the eighth appropriate for stratification and if dual initiative listed above, the CMS among hospitals on their performance caring for their patients with social risk eligibility would be a meaningful social Disparity Methods, which we have risk factor for stratification. implemented for measures in the factors. In the CY 2018 ESRD PPS For the ESRD QIP, we would consider Hospital Readmissions Reduction proposed rule (82 FR 31202 through disparity reporting using two disparity Program and are considering in other 31203), we also specifically solicited methods the Within-Facility and programs, including the ESRD QIP. We feedback on which social risk factors Across-Facility methods. The first discuss the implementation of these provide the most valuable information method (based on the Within-Hospital methods to date and present to stakeholders. In addition, feedback disparity method, described above) considerations for continuing to was solicited on the methodology for would aim to promote quality improve and expand these methods. illuminating differences in outcomes improvement by calculating differences b. Current CMS Disparity Methods rates among patient groups within a in outcome rates between dual and non- provider’s patient population that dual eligible patient groups within a We first sought public comment on facility while accounting for their potential confidential and public would also allow for a comparison of clinical risk factors. This method would reporting of ESRD QIP measure data those differences, or disparities, across allow for a comparison of those stratified by social risk factors in the CY providers. Overall, comments supported differences, or disparities, across 2018 ESRD PPS proposed rule (82 FR the use of dual eligibility as a proxy for facilities, so facilities could assess how 31202). We initially focused on social risk, although commenters also well they are closing disparity gaps stratification by dual eligibility, which suggested investigation of additional compared to other facilities. The second is consistent with recommendations social risk factors, and we continue to approach (based on the Across-Hospital from ASPE’s First Report to Congress consider commenter suggestions for method) would be complementary and which was required by the Improving which risk factors provide the most assesses facilities’ outcome rates for Medicare Post-Acute Care valuable information to stakeholders. subgroups of patients, such as dual Transformation (IMPACT) Act of 2014 c. Future Potential Expansion of the eligible patients, across facilities, (Pub. L. 113–185).188 This report found allowing for a comparison among that in the context of value-based CMS Disparity Methods to the ESRD facilities on their performance caring for purchasing (VBP) programs, dual QIP their patients with social risk factors. eligibility was among the most powerful We are committed to advancing predictors of poor health outcomes health equity by improving data (2) Stratification of Quality Measure among those social risk factors that collection to better measure and analyze Results—Race and Ethnicity ASPE examined and tested. In the FY disparities across programs and The Administration’s Executive Order 2018 IPPS/LTCH PPS final rule we also policies.189 As we previously noted, we on Advancing Racial Equity and solicited feedback on two potential have been considering, among other Support for Underserved Communities methods for illuminating differences in things, expanding our efforts to provide Through the Federal Government outcomes rates among patient groups directs agencies to assess potential within a provider’s patient population stratified data for additional social risk factors and measures, optimizing the barriers that underserved communities that would also allow for a comparison and individuals may face to enrollment of those differences, or disparities, ease-of-use of the results, enhancing public transparency of equity results, in and access to benefits and services in across providers for the Hospital IQR federal programs. As summarized earlier and building towards provider program (82 FR 38403 through 38409). in the preamble, studies have shown accountability for health equity. We are The first method (the Within-Hospital that among Medicare beneficiaries, disparity method) promotes quality seeking public comment on the racial and ethnic minority persons often potential stratification of quality experience worse health outcomes, 186 National Academies of Sciences, Engineering, measures in the ESRD QIP across two including more frequent hospital and Medicine. 2016. Accounting for Social Risk social risk factors: Dual eligibility and Factors in Medicare Payment: Identifying Social readmissions and procedural Risk Factors. Washington, DC: The National race/ethnicity. Academies Press. https://doi.org/10.17226/21858. 190 National Academies of Sciences, Engineering, 187 https://aspe.hhs.gov/pdf-report/report- and Medicine. 2016. Accounting for Social Risk congress-social-risk-factors-and-performance- Factors in Medicare Payment: Identifying Social under-medicares-value-based-purchasing- Risk Factors. Washington, DC: The National programs. 189 Centers for Medicare Services. CMS Quality Academies Press. https://doi.org/10.17226/21858. 188 https://aspe.hhs.gov/pdf-report/report- Strategy. 2016. https://www.cms.gov/Medicare/ 191 https://aspe.hhs.gov/pdf-report/report- congress-social-risk-factors-and-performance- Quality-Initiatives-Patient-Assessment-Instruments/ congress-social-risk-factors-and-performance- under-medicares-value-based-purchasing- QualityInitiativesGenInfo/Downloads/CMS-Quality- under-medicares-value-based-purchasing- programs. Strategy.pdf. programs.

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complications.192 We also note that the such a granular level can facilitate the may result in overestimation or prevalence of ESRD is higher among accurate identification and analysis of underestimation in the quality of care racial minorities.193 For example, in health disparities based on race and received by certain groups of 2016 ESRD prevalence was ethnicity. Further, the ‘‘Race & beneficiaries. approximately 9.5 times greater in Ethnicity—CDC’’ code system has a We continue to work with public and Native Hawaiians and Pacific Islanders, hierarchy that rolls up to the OMB private partners to better collect and 3.7 times greater in African Americans, minimum categories for race and leverage data on social risk to improve 1.5 times greater in American Indians ethnicity and, thus, supports our understanding of how these factors and Alaska Natives, and 1.3 times aggregation and reporting using the can be better measured in order to close greater in Asians.194 An important part OMB standard. ONC includes both the the health equity gap. Among other of identifying and addressing inequities CDC and OMB standards in its criterion things, we have developed an Inventory in health care is improving data for certified health IT products.198 For of Resources for Standardized collection to allow us to better measure race and ethnicity, a certified health IT Demographic and Language Data and report on equity across our product must be able to express both Collection 203 and supported collection programs and policies. We are detailed races and ethnicities using any of specialized International considering stratification of quality of the 900 plus concepts in the ‘‘Race & Classification of Disease, 10th Edition, measure results in the ESRD QIP by race Ethnicity—CDC’’ code system in PHIN Clinical Modification (ICD–10–CM) and ethnicity, and are identifying which VADS, as well as aggregate each one of codes for describing the socioeconomic, measures would be most appropriate for a patient’s races and ethnicities to the cultural, and environmental stratification. categories in the OMB standard for race determinants of health, and sponsored As outlined in the 1997 Office of and ethnicity. This approach can reduce several initiatives to statistically Management and Budget (OMB) burden on providers recording estimate race and ethnicity information Revisions to the Standards for the demographics using certified products. when it is absent.204 Collection of Federal Data on Race and Self-reported race and ethnicity data The Office of the National Ethnicity, the racial and ethnic remain the gold standard for classifying Coordinator for Health Information categories which may be used for an individual according to race or Technology (ONC) included social, reporting the disparity methods are ethnicity. However, historical psychological, and behavioral standards considered to be social and cultural, not inaccuracies in federal data systems and in the 2015 Edition health information biological or genetic.195 The 1997 OMB limited collection classifications have technology certification criteria (2015 Standard lists five minimum categories contributed to the limited quality of race Edition), providing interoperability of race: (1) American Indian or Alaska and ethnicity information in our standards LOINC (Logical Observation Native; (2) Asian; (3) Black or African administrative data systems.199 In recent Identifiers Names and Codes) and American; (4) Native Hawaiian or Other decades, to address these data quality SNOMED CT (Systematized Pacific Islander; (5) and White. In the issues, CMS has undertaken numerous Nomenclature of Medicine—Clinical OMB standards, Hispanic or Latino is initiatives, including updating data Terms) for financial strain, education, the only ethnicity category included, taxonomies and conducting direct social connection and isolation, and and since race and ethnicity are two mailings to some beneficiaries to enable others. Additional stakeholder efforts separate and distinct concepts, persons more comprehensive race and ethnic underway to expand capabilities to who report themselves as Hispanic or identification.200 201 Despite those capture additional social determinants Latino can be of any race.196 Another efforts, studies reveal varying data of health data elements include the example, the ‘‘Race & Ethnicity—CDC’’ accuracy in identification of racial and Gravity Project to identify and code system in Public Health ethnic groups in Medicare harmonize social risk factor data for Information Network (PHIN) Vocabulary administrative data, with higher interoperable electronic health Access and Distribution Systems sensitivity for correctly identifying information exchange for EHR fields, as (VADS) 197 permits a much more white and Black individuals, and lower well as proposals to expand the ICD–10 granular structured recording of a sensitivity for correctly identifying (International Classification of Diseases, patient’s race and ethnicity with its individuals of Hispanic ethnicity or of Tenth Revision) Z-codes, the inclusion of over 900 concepts for race Asian/Pacific Islander and American alphanumeric codes used worldwide to 202 and ethnicity. The recording and Indian/Alaskan Native race. represent diagnoses.205 exchange of patient race and ethnicity at Incorrectly classified race or ethnicity While development of sustainable and consistent programs to collect data on 198 192 https://www.kff.org/medicare/report/racial- ONC criteria for certified health IT products: social determinants of health can be and-ethnic-health-inequities-and-medicare/. https://www.healthit.gov/isa/representing-patient- considerable undertakings, we recognize race-and-ethnicity. 193 United States Renal Data System. 2018 Annual 199 Eicheldinger, C., & Bonito, A. (2008). More Data Report: ESRD Incidence, Prevalence, Patient 203 accurate racial and ethnic codes for Medicare Centers for Medicare and Medicaid Services. Characteristics, and Treatment Modalities. administrative data. Health Care Financing Review, Building an Organizational Response to Health Available online at https://www.usrds.org/2018/ 29(3), 27–42. Disparities Inventory of Resources for Standardized view/Default.aspx. 200 Demographic and Language Data Collection. 2020. 194 Filice CE, Joynt KE. Examining Race and United States Renal Data System. 2018 Annual Ethnicity Information in Medicare Administrative https://www.cms.gov/About-CMS/Agency- Data Report, Vol 2, Figure 1.12. Available online at Data. Med Care. 2017;55(12):e170-e176. Information/OMH/Downloads/Data-Collection- https://www.usrds.org/2018/view/Default.aspx. doi:10.1097/MLR.0000000000000608. Resources.pdf. 195 Executive Office of the President Office of 201 Eicheldinger, C., & Bonito, A. (2008). More 204 https://pubmed.ncbi.nlm.nih.gov/18567241/, Management and Budget, Office of Information and accurate racial and ethnic codes for Medicare https://pubmed.ncbi.nlm.nih.gov/30506674/, Regulatory Affairs. Revisions to the standards for administrative data. Health Care Financing Review, Eicheldinger C., Bonito A. More accurate racial and the classification of federal data on race and 29(3), 27–42. ethnic codes for Medicare administrative data. ethnicity. Vol 62. Federal Register. 1997:58782– 202 Centers for Medicare and Medicaid Services. Health Care Finance Rev. 2008;29(3):27–42. Haas 58790. Building an Organizational Response to Health A., Elliott MN, Dembosky JW, et al. Imputation of 196 https://www.census.gov/topics/population/ Disparities Inventory of Resources for Standardized race/ethnicity to enable measurement of HEDIS hispanic-origin/about.html. Demographic and Language Data Collection. 2020. performance by race/ethnicity. Health Serv Res. 197 https://phinvads.cdc.gov/vads/ https://www.cms.gov/About-CMS/Agency- 2019;54(1):13–23. doi:10.1111/1475–6773.13099. ViewValueSet.action?id=67D34BBC-617F-DD11- Information/OMH/Downloads/Data-Collection- 205 https://aspe.hhs.gov/pdf-report/second- B38D-00188B398520. Resources.pdf. impact-report-to-congress.

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that another method to identify better beneficiary language preference, state of results for groups of individuals (such race and ethnicity data is needed in the residence, and the source of the race as the facility-level) and is not intended, short term to address the need for and ethnicity code in Medicare nor being considered, as an approach for reporting on health equity. In working administrative data to reclassify some inferring the race and ethnicity of an with our contractors, two algorithms beneficiaries as Hispanic or Asian individual. However, despite the high have been developed to indirectly Pacific Islander (API).208 In recent years, degree of statistical accuracy of the estimate the race and ethnicity of we have also worked with another indirect estimation algorithms under Medicare beneficiaries (as described contractor to develop a new approach, consideration there remains the small further in the next section). We believe the Medicare Bayesian Improved risk of unintentionally introducing bias. that using indirect estimation can help Surname Geocoding (MBISG), which For example, if the indirect estimation to overcome the current limitations of combines Medicare administrative data, is not as accurate in correctly estimating demographic information and enable first and surname matching, geocoded race and ethnicity in certain geographies timelier reporting of equity results until residential address linked to the 2010 or populations it could lead to some longer term collaborations to improve U.S. Census, and uses both Bayesian bias in the method results. Such bias demographic data quality across the updating and multinomial logistic might result in slight overestimation or health care sector materialize. The use regression to estimate the probability of underestimation of the quality of care of indirectly estimated race and belonging to each of six racial/ethnic received by a given group. We feel this ethnicity for conducting stratified groups.209 amount of bias is considerably less than reporting does not place any additional The MBISG model is currently used to would be expected if stratified reporting collection or reporting burdens on conduct the national, contract-level, was conducted using the race and facilities as these data are derived using stratified reporting of Medicare Part C & ethnicity currently contained in our existing administrative and Census- D performance data for Medicare administrative data. Indirect estimation linked data. Advantage Plans by race and of race and ethnicity is envisioned as an Indirect estimation relies on a ethnicity.210 Validation testing reveals intermediate step, filling the pressing statistical imputation method for concordances of 0.88–0.95 between need for more accurate demographic inferring a missing variable or indirectly estimated and self-report information for the purposes of improving an imperfect administrative among individuals who identify as exploring inequities in service delivery, variable using a related set of White, Black, Hispanic, and Asian while allowing newer approaches, as information that is more readily Pacific Islander for the MBISG version described in the next section, for 206 available. Indirectly estimated data 2.0 and concordances with self-reported enhancing demographic data collection. are most commonly used at the race and ethnicity of 0.96–0.99 for these We are interested in learning more population level (such as the facility or same groups for MBISG version about, and soliciting comments, about health plan-level), where aggregated 2.1.211 212 The algorithms under the potential benefits and challenges results form a more accurate description consideration are considerably less associated with measuring facility of the population than existing, accurate for individuals who self- equity using an imputation algorithm to imperfect data sets. These methods identify as American Indian or Alaskan enhance existing administrative data often estimate race and ethnicity using Native as well as for those who self- quality for race and ethnicity until self- a combination of other data sources identify as multiracial.213 reported information is sufficiently which are predictive of self-identified Indirect estimation can be a available. race and ethnicity, such as language statistically reliable approach for (3) Improving Demographic Data preference, information about race and calculating population-level equity Collection ethnicity in our administrative records, Stratified facility-level reporting using first and last names matched to 208 Eicheldinger, C., & Bonito, A. (2008). More validated lists of names correlated to accurate racial and ethnic codes for Medicare indirectly estimated race and ethnicity specific national origin groups, and the administrative data. Health Care Financing Review, and dual eligibility would represent an racial and ethnic composition of the 29(3), 27–42. important advance in our ability to 209 surrounding neighborhood. Indirect Haas, A., Elliott, M. et al., (2018). Imputation provide equity reports to facilities. of race/ethnicity to enable measurement of HEDIS However, self-reported disability status, estimation has been used in other performance by race/ethnicity. Health Services settings to support population-based Research, 54:13–23. race and ethnicity data remain the gold equity measurement when self- 210 https://www.cms.gov/About-CMS/Agency- standard for classifying an individual identified data are not available.207 Information/OMH/research-and-data/statistics-and- according to disability status, race or As discussed earlier in the preamble, data/stratified-reporting. ethnicity. The CMS Quality Strategy 211 Haas, A., Elliott, M. et al., (2018). Imputation outlines our commitment to we have previously supported the of race/ethnicity to enable measurement of HEDIS development of two such methods of performance by race/ethnicity. Health Services strengthening infrastructure and data indirect estimation of race and ethnicity Research, 54:13–23. systems by ensuring that standardized of Medicare beneficiaries. One indirect 212 https://www.cms.gov/files/document/racial- demographic information is collected to estimation approach, developed by our ethnic-gender-disparities-health-care-medicare- identify disparities in health care advantage.pdf. delivery outcomes.214 Collection and contractor, uses Medicare 213 Haas, A., Elliott, M. et al., (2018). Imputation administrative data, first name and of race/ethnicity to enable measurement of HEDIS sharing of a standardized set of social, surname matching, derived from the performance by race/ethnicity. Health Services psychological, and behavioral data by U.S. Census and other sources, with Research, 54:13–23 and Bonito AJ, Bann C., facilities, including disability status and Eicheldinger C., Carpenter L. Creation of New Race- race and ethnicity, using electronic data Ethnicity Codes and Socioeconomic Status (SES) 206 IOM. 2009. Race, Ethnicity, and Language Indicators for Medicare Beneficiaries. Final Report, definitions which permit nationwide, Data: Standardization for Health Care Quality Sub-Task 2. (Prepared by RTI International for the interoperable health information Improvement. Washington, DC: The National Centers for Medicare and Medicaid Services Academies Press. through an interagency agreement with the Agency 214 The Centers for Medicare & Medicaid Services. 207 IOM. 2009. Race, Ethnicity, and Language for Healthcare Research and Policy, under Contract CMS Quality Strategy. 2016. https://www.cms.gov/ Data: Standardization for Health Care Quality No. 500–00–0024, Task No. 21) AHRQ Publication Medicare/Quality-Initiatives-Patient-Assessment- Improvement. Washington, DC: The National No. 08–0029–EF. Rockville, MD, Agency for Instruments/QualityInitiativesGenInfo/Downloads/ Academies Press. Healthcare Research and Quality. January 2008. CMS-Quality-Strategy.pdf.

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exchange, can significantly enhance the facilities. Aggregated results from Prior to any future public reporting of accuracy and robustness of our equity multiple measures and multiple social stratified measure data using indirectly reporting.215 This could potentially risk factors, from the CMS Disparity estimated race and ethnicity include expansion to additional social Methods, in the format of a summary information, if we determine that an risk factors, such as language preference score, can improve the usefulness of the ESRD Facility Equity Score can be and disability status, where accuracy of equity results. In working with our feasibly and accurately calculated, we administrative data is currently limited. contractors, we recently developed an would provide results of the ESRD We are mindful that additional equity summary score for Medicare Facility Equity Score, in confidential resources, including data collection and Advantage contract/plans, the Health facility specific reports which facilities staff training may be necessary to ensure Equity Summary Score (HESS), with and their QIN–QIOs would be able to that conditions are created whereby all application to stratified reporting using download. Any potential future patients are comfortable answering all two social risk factors: Dual eligibility proposal to display the ESRD Facility demographic questions, and that and race and as described in Equity Score on the Care Compare or individual preferences for non-response Incentivizing Excellent Care to At-Risk successor website would be made are maintained. Groups with a Health Equity Summary through future RFI or rulemaking. We are also interested in learning 218 Score. d. Solicitation of Public Comment about and are soliciting comments on The HESS calculates standardized current data collection practices by and combined performance scores We are seeking comment on the facilities to capture demographic data blended across the two social risk possibility of stratifying ESRD QIP elements (such as race, ethnicity, sex, factors. The HESS also combines results measures by dual eligibility and race sexual orientation and gender identity of the within-plan (similar to the and ethnicity. We are soliciting public (SOGI), language preference, and Within-Facility method) and across-plan comments on the application of the disability status). Further, we are method (similar to the Across-Facility within-facility or across-facility interested in potential challenges facing method) across multiple performance disparities methods if we were to facility collection of a minimum set of measures. stratify ESRD QIP measures. We are also demographic data elements in We are considering building an ESRD seeking comment on the possibility of alignment with national data collection Facility Equity Score, not yet developed, facility collection of standardized standards (such as the standards which would be modeled off the HESS demographic information for the finalized by the Affordable Care Act) 216 but adapted to the context of risk- purposes of potential future quality and standards for interoperable adjusted facility outcome measures and reporting and measure stratification. In exchange (such as the U.S. Core Data for potentially other ESRD QIP quality addition, we are seeking comment on Interoperability put forth by the Office measures. We envision that the ESRD the potential design of a facility equity of the National Coordinator for Health Facility Equity Score would synthesize score for calculating results across Information Technology for results for a range of measures and using multiple social risk factors and incorporation in certified health IT multiple social risk factors, using measures, including race and disability. products as part of the 2015 Edition of measures and social risk factors which Any data pertaining to these areas that health IT certification criteria.) 217 would be reported to facilities as part of are recommended for collection for Advancing data interoperability through the CMS Disparity Methods. We believe measure reporting for a CMS program collection of a minimum set of that creation of the ESRD Facility Equity and any potential public disclosure on demographic data collection has the Score has the potential to supplement Care Compare or successor website potential for improving the robustness the overall measure data already would be addressed through a separate of the disparity methods results, reporting on the Care Compare or and future notice- and-comment potentially permitting reporting using successor website, by providing easy to rulemaking. We plan to continue more accurate, self-reported, interpret information regarding working with ASPE, facilities, the information, such as race and ethnicity, disparities measured within individual public, and other key stakeholders on and expanding reporting to additional facilities and across facilities nationally. this important issue to identify policy dimensions of equity, including A summary score would decrease solutions that achieve the goals of stratified reporting by disability status. burden by minimizing the number of attaining health equity for all patients measure results provided and providing and minimizing unintended (4) Potential Creation of an ESRD consequences. We look forward to Facility Equity Score to Synthesize an overall indicator of equity. The ESRD Facility Equity Score under receiving feedback on these topics and Results Across Multiple Social Risk note for readers that responses to the Factors consideration would potentially: • Summarize facility performance RFI will not directly impact payment As we describe above, we are across multiple social risk factors decisions. We also note our intention for considering expanding the disparity (initially dual eligibility and indirectly additional RFI or rulemaking on this methods to include two social risk estimated race and ethnicity, as topic in the future. Specifically, we are inviting public factors (dual eligibility and race/ described above). comment on the following: ethnicity). This approach would • Summarize facility performance improve the comprehensiveness of across the two disparity methods (that Future Potential Stratification of Quality health equity information provided to is, the Within-Facility Disparity Method Measure Results and the Across-Facility Disparity • 215 The Office of the National Coordinator for The possible stratification of Health Information Technology. United State Core Method) and potentially multiple facility-specific reports for ESRD QIP Data for Interoperability Draft Version 2. 2021. measures. measure data by dual-eligibility status, https://www.healthit.gov/isa/sites/isa/files/2021-01/ including which measures would be Draft-USCDI-Version-2-January-2021-Final.pdf. 218 Agniel D., Martino S.C., Burkhart Q., et al. most appropriate for stratification; 216 https://minorityhealth.hhs.gov/assets/pdf/ Incentivizing Excellent Care to At-Risk Groups with • checked/1/Fact_Sheet_Section_4302.pdf. a Health Equity Summary Score. J Gen Intern Med. The potential future application of 217 https://www.healthit.gov/sites/default/files/ Published online November 11, 2019 Nov 11. doi: indirect estimation of race and ethnicity 2020-08/2015EdCures_Update_CCG_USCDI.pdf. 10.1007/s11606–019–05473–x. information to permit stratification of

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measure data for reporting ESRD score and how improved demographic occur through exposure to respiratory facility-level disparity results; data could assist with these efforts. droplets when a person is in close • Appropriate privacy safeguards contact with someone who has COVID– 2. COVID–19 Vaccination Measures with respect to data produced from the 19.227 Although less common, COVID– Request for Information indirect estimation of race and ethnicity 19 can also spread when individuals are to ensure that such data is properly a. Background not in close contact if small droplets or identified if/when it is shared with On January 31, 2020, the Secretary particles containing the virus linger in facilities. declared a PHE for the U.S. in response the air after the person who is infected • 228 Ways to address the challenges of to the global outbreak of SARS–CoV–2, has left the space. Another means of defining and collecting, accurate and a novel (new) coronavirus that causes a less common transmission is contact standardized self-identified disease named ‘‘coronavirus disease with a contaminated surface.229 demographic information, including 2019’’ (COVID–19).219 COVID–19 is a According to the CDC, those at greatest information on race and ethnicity, contagious respiratory infection 220 that risk of infection are persons who have disability, and language preference for can cause serious illness and death. had prolonged, unprotected close the purposes of reporting, measure Older individuals and those with contact (that is, within 6 feet for 15 stratification and other data collection underlying medical conditions are minutes or longer) with an individual efforts relating to quality. considered to be at higher risk for more with confirmed SARS–CoV–2 infection, • Recommendations for other types of serious complications from COVID– regardless of whether the individual has readily available data elements for 19.221 symptoms.230 Although personal measuring disadvantage and As of April 2, 2021, the U.S. reported protective equipment (PPE) and other discrimination for the purposes of over 30 million cases of COVID–19 and infection-control precautions can reduce reporting, measure stratification and over 550,000 COVID–19 deaths.222 the likelihood of transmission in health other data collection efforts relating to Hospitals and health systems saw care settings, COVID–19 can spread quality, in addition, or in combination significant surges of COVID–19 patients between healthcare personnel (HCP) with race and ethnicity. as community infection levels and patients, or from patient to patient • Recommendations for types of increased.223 From December 2, 2020 given the close contact that may occur quality measures or measurement through January 30, 2021, more than during the provision of care.231 The domains to prioritize for stratified 100,000 Americans were in the hospital CDC has emphasized that health care reporting by dual eligibility, race and with COVID–19 at the same time.224 settings can be high-risk places for ethnicity, and disability. Evidence indicates that COVID–19 COVID–19 exposure and • Examples of approaches, methods, primarily spreads when individuals are transmission.232 research, and/or considerations for use in close contact with one another.225 As part of its national strategy to of data-driven technologies that do not The virus is typically transmitted address COVID–19, the Biden facilitate exacerbation of health through respiratory droplets or small Administration stated that it would inequities, recognizing that biases may particles created when someone who is work with states and the private sector occur in methodology or be encoded in infected with the virus coughs, sneezes, to execute an aggressive vaccination datasets. sings, talks or breathes.226 Thus, the strategy and outlined a goal of Improving Demographic Data Collection CDC advises that infections mainly administering 200 million shots in 100 days.233 After achieving this goal,234 the • Experiences of users of certified 219 U.S. Dept of Health and Human Services, Biden Administration announced a new health IT regarding local adoption of Office of the Assistant Secretary for Preparedness goal to administer at least one COVID– practices for collection of social, and Response. (2020). Determination that a Public Health Emergency Exists. Available at: https:// psychological, and behavioral data www.phe.gov/emergency/news/healthactions/phe/ 227 Ibid. elements, the perceived value of using Pages/2019-nCoV.aspx. 228 Ibid. these data for improving decision- 220 Centers for Disease Control and Prevention. 229 Ibid. making and care delivery, and the (2020). Your Health: Symptoms of Coronavirus. 230 Centers for Disease Control and Prevention. potential challenges and benefits of Available at: https://www.cdc.gov/coronavirus/ (2021). When to Quarantine. Accessed on April 2, 2019-ncov/symptoms-testing/symptoms.html. 2021 at: https://www.cdc.gov/coronavirus/2019- collecting more granular, structured 221 Ibid. ncov/if-you-are-sick/quarantine.html. demographic information, such as the 222 Centers for Disease Control and Prevention. 231 Centers for Disease Control and Prevention. ‘‘Race & Ethnicity—CDC’’ code system. (2020). CDC COVID Data Tracker. Available at: (2021). Interim U.S. Guidance for Risk Assessment • The possible collection of a https://covid.cdc.gov/covid-data-tracker/#cases_ and Work Restrictions for Healthcare Personnel minimum set of social, psychological, casesper100klast7days. with Potential Exposure to COVID–19. Accessed on 223 Associated Press. Tired to the Bone. Hospitals April 2 at: https://www.cdc.gov/coronavirus/2019- and behavioral data elements by ESRD Overwhelmed with Virus Cases. November 18, ncov/hcp/faq.html#Transmission. facilities at the time of admission using 2020. Accessed on December 16, 2020, at https:// 232 Dooling, K, McClung, M, et al. ‘‘The Advisory structured, interoperable electronic data apnews.com/article/hospitals-overwhelmed- Committee on Immunization Practices’ Interim standards, for the purposes of reporting, coronavirus-cases- Recommendations for Allocating Initial Supplies of 74a1f0dc3634917a5dc13408455cd895. Also see: COVID–19 Vaccine—United States, 2020.’’ Morb measure stratification and other data New York Times. Just how full are U.S. intensive Mortal Wkly Rep. 2020; 69(49): 1857–1859. collection efforts relating to quality. care units? New data paints an alarming picture. 233 The White House. Remarks by President Biden November 18, 2020. Accessed on December 16, on the COVID–19 Response and the State of Potential Creation of an ESRD Facility 2020, at: https://www.nytimes.com/2020/12/09/ Vaccinations. Accessed on April 3, 2021 at: https:// Equity Score To Synthesize Results world/just-how-full-are-us-intensive-care-units-new- www.whitehouse.gov/briefing-room/speeches- Across Multiple Social Risk Factors data-paints-an-alarming-picture.html. remarks/2021/03/29/remarks-by-president-biden- 224 | • U.S. Currently Hospitalized The COVID on-the-covid-19-response-and-the-state-of- The possible creation and Tracking Project. Accessed January 31, 2021 at: vaccinations/. confidential reporting of an ESRD https://covidtracking.com/data/charts/us-currently- 234 The White House. Remarks by President Biden Facility Equity Score to synthesize hospitalized. on the COVID–19 Response and the State of results across multiple social risk factors 225 Centers for Disease Control and Prevention. Vaccinations. Accessed on June 2, 2021 at: https:// (2021). How COVID–19 Spreads. Accessed on April and disparity measures. www.whitehouse.gov/briefing-room/speeches- • 3, 2021 at: https://www.cdc.gov/coronavirus/2019- remarks/2021/04/21/remarks-by-president-biden- Interventions ESRD facilities could ncov/prevent-getting-sick/how-covid-spreads.html. on-the-covid-19-response-and-the-state-of- institute to improve a low facility equity 226 Ibid. vaccinations-2/.

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19 vaccine shot to 70 percent of the U.S. recommendations indicated that ESRD Facility Quality Reporting Program (86 adult population by July 4th, 2021.235 patients would be offered the COVID–19 FR 19994 through 19998). We note that Although the goal of the U.S. vaccine based on their high-risk status there is not a pay for reporting program government is to ensure that every as part of phase 1c.241 under the ESRD PPS, however, we American who wants to receive a As of June 22, 2021 the CDC reported believe that the public reporting of COVID–19 vaccine can receive one, that over 319 million doses of COVID– vaccination data on Dialysis Facility federal agencies recommended that 19 vaccine had been administered, and Compare is important and would help early vaccination efforts focus on those approximately 150.4 million people had to inform patients of a facility’s COVID– critical to the PHE response, including received a complete vaccination 19 vaccination rates of HCP. Currently, HCP providing direct care to patients course.242 President Biden indicated on there is a measure for HCP 245 and with COVID–19, and individuals at April 6, 2021 that the U.S. has sufficient another for patient COVID–19 highest risk for developing severe vaccine supply to make every adult vaccination 246 rates and such measures illness from COVID–19.236 For example, eligible to receive a vaccine beginning are currently reported to CDC’s National the CDC’s Advisory Committee on April 19, 2021.243 Furthermore, on Healthcare Safety Network via ESRD Immunization Practices (ACIP) March 25, 2021, the Biden Networks. The two measures track the recommended that HCP should be Administration announced a new proportions of a facility’s HCP and among those individuals prioritized to partnership with dialysis facilities to patient population, respectively, that receive the initial, limited supply of the provide COVID–19 vaccinations directly have been fully vaccinated against COVID–19 vaccination, given the to people receiving dialysis and HCP in COVID–19. Facilities were able to begin potential for transmission in health care dialysis facilities.244 weekly COVID–19 vaccination reporting settings and the need to preserve health for HCP in December 2020,247 and were 237 b. COVID–19 Vaccination Coverage care system capacity. Research Among Healthcare Personnel (HCP) able to begin weekly COVID–19 suggests most states followed this Measure vaccination reporting for patients in recommendation,238 and HCP began March 2021.248 Currently, 89 percent of We believe it is important to receiving the vaccine in mid-December ESRD facilities are reporting HCP 239 incentivize and track HCP vaccination of 2020. Although the vaccination vaccination rates and almost 95 percent in dialysis facilities through quality strategy for individuals at highest risk of ESRD facilities are reporting patient measurement in order to protect health for developing severe illness from vaccination rates on these measures. We care workers, patients, and caregivers, COVID–19, including ESRD patients, are evaluating options for publicly 240 and to help sustain the ability of these has varied from state to state, ACIP reporting the data on official CMS facilities to continue serving their datasets that compare the quality of care 235 communities throughout the PHE and The White House. Remarks by President Biden provided in Medicare-certified dialysis on the COVID–19 Response and the State of beyond. We recognize the importance of facilities nationwide. We are also Vaccinations. Accessed on June 4, 2021, at: https:// COVID–19 vaccination, and have www.whitehouse.gov/briefing-room/statements- exploring the potential future inclusion releases/2021/05/04/fact-sheet-president-biden-to- proposed to include a COVID–19 HCP vaccination measure quality measure in of a COVID–19 vaccination measure to announce-goal-to-administer-at-least-one-vaccine- the ESRD QIP. Therefore, we are seeking shot-to-70-of-the-u-s-adult-population-by-july-4th/. various pay for reporting programs, such 236 Health and Human Services, Department of as the Inpatient Psychiatric Facility public comment on adding a new Defense. (2020) From the Factory to the Frontlines: Quality Reporting Program (86 FR 19501 measure, COVID–19 Vaccination The Operation Warp Speed Strategy for Distributing Coverage Among HCP, to the ESRD QIP a COVID–19 Vaccine. Accessed December 18 at: through 19504), the Hospital Inpatient https://www.hhs.gov/sites/default/files/strategy-for- Quality Reporting Program (86 FR 25571 measure set in the next rulemaking distributing-covid-19-vaccine.pdf; Centers for through 25575), and the Skilled Nursing cycle. The measure would assess the Disease Control (2020). COVID–19 Vaccination proportion of a facility’s health care Program Interim Playbook for Jurisdiction workforce that has been vaccinated Operations. Accessed December 18 at: https:// 241 Dooling K, Marin M, Wallace M, et al. ‘‘The www.cdc.gov/vaccines/imz-managers/downloads/ Advisory Committee on Immunization Practices’ against COVID–19. COVID-19-Vaccination-Program-Interim_ Updated Interim Recommendation for Allocation of HCP are at risk of carrying COVID–19 Playbook.pdf. COVID–19 Vaccine—United States, December infection to patients, experiencing 237 Dooling, K, McClung, M, et al. ‘‘The Advisory 2020.’’ MMWR Morb Mortal Wkly Rep 2021; illness or death as a result of COVID– Committee on Immunization Practices’ Interim 69:1657–1660. ACIP recommended that the COVID– ≥ Recommendations for Allocating Initial Supplies of 19 vaccine should be offered to persons aged 75 19 themselves, and transmitting it to COVID–19 Vaccine—United States, 2020.’’ Morb. years and non–health care frontline essential their families, friends, and the general Mortal Wkly Rep. 2020; 69(49): 1857–1859. ACIP workers in Phase 1b, and to persons aged 16–64 public. We believe facilities should also recommended that long-term care residents be years with high-risk medical conditions in Phase track the level of vaccination among prioritized to receive the vaccine, given their age, 1c. high levels of underlying medical conditions, and 242 Centers for Disease Control and Prevention. their HCP as part of their efforts to congregate living situations make them high risk for COVID Data Tracker. COVID–19 Vaccinations in the assess and reduce the risk of severe illness from COVID–19. United States. Accessed June 23, 2021 at: https:// transmission of COVID–19 within their 238 Kates, J, Michaud, J, Tolbert, J. ‘‘How Are covid.cdc.gov/covid-data-tracker/#vaccinations. facilities. HCP vaccination can States Prioritizing Who Will Get the COVID–19 243 The White House. Remarks by President Biden Vaccine First?’’ Kaiser Family Foundation. Marking the 150 Millionth COVID–19 Vaccine Shot. potentially reduce illness that leads to December 14, 2020. Accessed on December 16 at Accessed April 8, 2021 at: https:// work absence and limit disruptions to https://www.kff.org/policy-watch/how-are-states- www.whitehouse.gov/briefing-room/speeches- care.249 Data from influenza vaccination prioritizing-who-will-get-the-covid-19-vaccine-first/. remarks/2021/04/06/remarks-by-president-biden- 239 Associated Press. ‘Healing is Coming:’ U.S. marking-the-150-millionth-covid-19-vaccine-shot/. 245 https://www.cdc.gov/nhsn/hps/weekly-covid- Health Workers Start Getting Vaccine. December 15, 244 The White House. FACT SHEET: Biden vac/index.html. 2020. Accessed on December 16 at: https:// Administration Announces Historic $10 Billion 246 apnews.com/article/us-health-workers-coronavirus- Investment to Expand Access to COVID–19 https://www.cdc.gov/nhsn/dialysis/pt-covid- vaccine-56df745388a9fc12ae93c6f9a0d0e81f. Vaccines and Build Vaccine Confidence in Hardest- vac/index.html. 247 240 Kates, J, Michaud, J, Tolbert, J. ‘‘The COVID– Hit and Highest-Risk Communities. March 25, 2021. https://www.cdc.gov/nhsn/pdfs/hps/covidvax/ 19 Vaccine Priority Line Continues to Change as Available at: https://www.whitehouse.gov/briefing- weekly-covid-guidance-508.pdf. States Make Further Updates.’’ Kaiser Family room/statements-releases/2021/03/25/fact-sheet- 248 https://www.cdc.gov/nhsn/pdfs/dialysis/ Foundation. January 21, 2021. Accessed on January biden-administration-announces-historic-10-billion- covidvax/getting-started-508.pdf. 29 at https://www.kff.org/policy-watch/the-covid- investment-to-expand-access-to-covid-19-vaccines- 249 Centers for Disease Control and Prevention. 19-vaccine-priority-line-continues-to-change-as- and-build-vaccine-confidence-in-hardest-hit-and- Overview of Influenza Vaccination among Health states-make-further-updates/. highest-risk-communities/. Continued

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demonstrates that provider uptake of the and reduce the risk of transmission of Hospital Workgroup did not support vaccine is associated with that provider COVID–19 within their facilities. We these two measures for rulemaking, recommending vaccination to also believe that publishing the subject to potential for mitigation.256 To patients,250 and we believe HCP vaccination rates will be helpful to mitigate its concerns, the Measure COVID–19 vaccination in dialysis many ESRD patients, including those Applications Partnership Hospital facilities could similarly increase uptake who are at high-risk for developing Workgroup believed that both measures among that patient population. We also serious complications from COVID–19, needed well-documented evidence, believe that publishing the HCP as they choose facilities from which to finalized specifications, testing, and vaccination rates will be helpful to seek treatment. Under CMS’ Meaningful NQF endorsement prior to many patients, including those who are Measures Framework, the COVID–19 implementation.257 Subsequently, the at high-risk for developing serious measure addresses the quality priority Measure Applications Partnership complications from COVID–19, as they of ‘‘Promoting Effective Prevention and Coordinating Committee met on January choose facilities from which to seek Treatment of Chronic Disease’’ through 25, 2021, and reviewed the COVID–19 treatment. Under CMS’ Meaningful the Meaningful Measures Area of Vaccination Coverage Among HCP Measures Framework, the COVID–19 ‘‘Preventive Care.’’ measure and the COVID–19 Vaccination measure would address the quality Coverage for Patients in ESRD Facilities d. Review by the Measures Application priority of ‘‘Promoting Effective Measure. In the 2020–2021 Measure Partnership and NQF Prevention and Treatment of Chronic Applications Partnership Final Disease’’ through the Meaningful The COVID–19 HCP vaccination Recommendations, Measure Measures Area of ‘‘Preventive Care.’’ measure and the COVID–19 patient Applications Partnership offered vaccination measure were included on conditional support for rulemaking c. COVID–19 Vaccination Coverage for the publicly available ‘‘List of Measures contingent on CMS bringing the Patients in End-Stage Renal Disease under Consideration for December 21, measures back to Measure Applications (ESRD) Facilities Measure 2020’’ (MUC List), a list of measures Partnership once the specifications are We believe it is important to under consideration for use in various further refined.258 The Measure encourage patient vaccination in Medicare programs.253 When the Applications Partnership specifically dialysis facilities in order to protect Measure Applications Partnership stated, ‘‘the incomplete specifications health care workers, patients, and Hospital Workgroup convened on require immediate mitigation and caregivers, and to help sustain the January 11, 2021, it reviewed measures further development should ability of these facilities to continue on the MUC List including the two continue.’’ 259 The Measure serving their communities throughout COVID–19 vaccination measures. The Applications Partnership further noted the PHE and beyond. COVID–19 can Measure Applications Partnership that the measures would add value to cause outbreaks in ESRD facilities, and Hospital Workgroup recognized that the the ESRD QIP measure set by providing may disproportionately affect ESRD proposed measures represent a visibility into an important intervention patients due to the nature of the promising effort to advance to limit COVID–19 infections in HCP treatment and sharing of common measurement for an evolving national and the ESRD patients for whom they spaces.251 Many patients treated in pandemic and that it would bring value provide care.260 CMS brought both ESRD facilities have other underlying to the ESRD QIP measure set by measures back to the Measure chronic conditions, and therefore are providing transparency about an Applications Partnership on March 15, highly susceptible to illness and important COVID–19 intervention to 2021 to provide additional information disease.252 Sufficient vaccination help prevent infections in HCP and and continue discussing mitigation. patients.254 The Measure Applications coverage among patients in ESRD e. Request for Public Comment facilities may reduce transmission of Partnership Hospital Workgroup also SARS–CoV–2, thereby protecting them stated that collecting information on In this proposed rule, we would like from COVID–19 mortality. Therefore, COVID–19 vaccination coverage among to seek public comment on potentially we are seeking public comment on HCP and ESRD patients, and providing adding the two new COVID–19 adding new measure, COVID–19 feedback to facilities, will allow vaccination measures discussed above, Vaccination Coverage Among Patients, facilities to benchmark coverage rates the COVID–19 vaccination measure for to the ESRD QIP measure set in future and improve coverage in their facility. HCP and the COVID–19 vaccination rulemaking. The measure would assess The Measure Applications Partnership measure for patients, to the ESRD QIP 261 the proportion of a facility’s patient Hospital Workgroup further noted that measure set. population that has been vaccinated reducing rates of COVID–19 in HCP and We are also interested in public against COVID–19. ESRD patients may reduce transmission comment on data collection, We believe facilities should track the among a patient population that is level of vaccination among their highly susceptible to illness and 256 Ibid. 257 patients as part of their efforts to assess disease, and also reduce instances of Ibid. staff shortages due to illness.255 258 Measure Applications Partnership. 2020–2021 MAP Final Recommendations. Accessed on Care Personnel. October 2020. (2020) Accessed In its preliminary recommendations, February 3, 2021 at: http://www.qualityforum.org/ March 16, 2021 at: https://www.cdc.gov/flu/toolkit/ the Measure Applications Partnership Setting_Priorities/Partnership/Measure_ long-term-care/why.htm. Applications_Partnership.aspx. 250 Measure Application Committee Coordinating 253 National Quality Forum. List of Measures 259 Measure Applications Partnership. 2020–2021 Committee Meeting Presentation. March 15, 2021. Under Consideration for December 21, 2020. MAP Final Recommendations. Accessed on (2021) Accessed March 16, 2021 at: http:// Accessed at: https://www.cms.gov/files/document/ February 23, 2021 at: http://www.qualityforum.org/ www.qualityforum.org/Project_Pages/MAP_ measures-under-consideration-list-2020-report.pdf Project_Pages/MAP_Hospital_Workgroup.aspx. Coordinating_Committee.aspx. on January 29 2021. 260 Measure Applications Partnership. 2020–2021 251 Verma, A., Patel, A., Tio, M., Waikar, S., 254 Measure Applications Partnership. MAP MAP Final Recommendations. Accessed on ‘‘Caring for Dialysis Patients in a Time of COVID– Preliminary Recommendations 2020–2021. February 23, 2021 at: http://www.qualityforum.org/ 19’’. Kidney Medicine, Volume 2, Issue 6, 2020, Accessed on January 24, 2021 at: http:// Project_Pages/MAP_Hospital_Workgroup.aspx. Pages 787–792, ISSN 2590–0595. Available at www.qualityforum.org/Project_Pages/MAP_ 261 Specifications for both measures available at: https://doi.org/10.1016/j.xkme.2020.07.006. Hospital_Workgroup.aspx. https://www.qualityforum.org/WorkArea/ 252 Ibid. 255 Ibid. linkit.aspx?LinkIdentifier=id&ItemID=94650.

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submission, and reporting for the part introduces four possible steps that certain payers. At the same time, the COVID–19 vaccination measure for HCP would enable transformation of CMS’ Office of the National Coordinator for and the COVID–19 vaccination measure quality measurement enterprise to be Health Information Technology (ONC) for patients. For example, we are fully digital by 2025. Specific requests finalized policies in the ONC 21st considering requiring reporting for these for input are included in the section. Century Cures Act final rule (85 FR measures on an annual basis for the • Solicitation of Comments. This part 25642) to advance the interoperability of performance period for each calendar lists all requests for input included in health IT as defined in section 4003 of year corresponding to the associated the above sections of this RFI. the Cures Act, including the ‘‘complete payment year, and the reporting period a. Background access, exchange, and use of all would be January 1 through December electronically accessible health 31 annually. Based on the measures As required by law, we implemented information.’’ Closely working with currently being developed by the CDC quality measurement programs and ONC, we collaboratively identified HL7 that were submitted to the Measure value-based purchasing programs across Fast Healthcare Interoperability Applications Partnership, facilities a broad range of inpatient, outpatient, Resources (FHIR®) Release 4.0.1 as the would report the measures through the and post-acute care (PAC) settings, standard to support Application National Healthcare Safety Network consistent with our mission to improve Programming Interface (API) policies in (NHSN) web-based surveillance system. the quality of health care for Americans both rules. ONC, on behalf of HHS, We also seek public comment from through measurement, transparency, adopted the HL7 FHIR Release 4.0.1 for stakeholders on other ways to collect and increasingly, value-based APIs and related implementation data on COVID–19 vaccination rates at purchasing. These quality programs are specifications at 45 CFR 170.215. We dialysis facilities for ESRD QIP purposes foundational for incentivizing value- believe the FHIR standard has the and their associated costs and burdens. based care, contributing to potential to be a more efficient and Given the immediacy of the PHE for improvements in health care, enhancing modular standard to enable APIs. We COVID–19, as well as the importance of patient outcomes, and informing also believe this standard enables continuing to monitor and make consumer choice. We aim to move fully collaboration and information sharing, publicly available COVID–19 to digital quality measurement by 2025. which is essential for delivering high- vaccination rates as the PHE ends, we We acknowledge providers within the quality care and better outcomes at a anticipate rulemaking on this various care and practice settings lower cost. By aligning technology requirement in the CY 2023 rulemaking covered by our quality programs may be requirements for payers, health care cycle. at different stages of readiness, and providers, and health IT developers, 3. Advancing to Digital Quality therefore, the timeline for achieving full HHS can advance-an interoperable Measurement and the Use of Fast digital quality measurement across our health IT infrastructure that ensures Healthcare Interoperability Resources quality reporting programs may vary. providers and patients have access to We also continue to evolve the (FHIR) health data when and where it is Medicare Promoting Interoperability needed. We aim to move fully to digital Program that advances the use of In the ONC 21st Century Cures Act quality measurement in CMS quality certified electronic health record (EHR) final rule ONC adopted a ‘‘Standardized reporting and value-based purchasing technology, from an initial focus on API for Patient and Population programs by 2025. As part of this electronic data capture to enhancing modernization of our quality Services’’ certification criterion for information exchange and expanding health IT that requires the use of the measurement enterprise, we are issuing quality measurement (83 FR 41634). this request for information (RFI). The FHIR Release 4 and several However, reporting quality data via implementation specifications. Health purpose of this RFI is to gather broad EHRs remains burdensome, and our public input solely for planning IT certified to this criterion will offer current approach to quality single patient and multiple patient purposes for our transition to digital measurement does not readily quality measurement. Any updates to services that can be accessed by third incorporate emerging data sources such party applications (85 FR 25742).263 The specific program requirements related to as patient-reported outcomes (PRO) and providing data for quality measurement ONC 21st Century Cures Act final rule patient-generated health data also requires health IT developers and reporting provisions would be (PGHD).262 There is a need to streamline addressed through future rulemaking, as update their certified health IT to our approach to data collection, support the U.S. Core Data for necessary. This RFI contains four parts: calculation, and reporting to fully 264 • Background. This part provides Interoperability (USCDI) standard. leverage clinical and patient-centered The scope of patient data identified in information on our quality measurement information for measurement, programs and our goal to move fully to the USCDI and the data standards that improvement, and learning. support this data set are expected to digital quality measurement by 2025. Additionally, advancements in This part also provides a summary of evolve over time, starting with data technical standards and regulatory specified in Version 1 of the USCDI. In other recent HHS policy developments initiatives to improve interoperability of that are advancing interoperability and November 2020, ONC issued an interim healthcare data are creating an final rule with comment period could support our move towards full opportunity to significantly improve our digital quality measurement. extending the date when health IT • quality measurement systems. In May developers must make technology Definition of Digital Quality 2020, we finalized interoperability Measures (dQMs). This part provides a meeting updated certification criteria requirements in the CMS available under the ONC Health IT potential definition for dQMs. Specific Interoperability and Patient Access final requests for input are included in the rule (85 FR 25510) to support 263 Application Programming Interfaces (API) section. beneficiary access to data held by • Changes Under Consideration to Resource Guide, Version 1.0. Available at: https:// www.healthit.gov/sites/default/files/page/2020-11/ Advance Digital Quality Measurement: 262 What are patient generated health data: API-Resource-Guide_v1_0.pdf. Actions in Four Areas to Transition to https://www.healthit.gov/topic/otherhot-topics/ 264 https://www.healthit.gov/isa/united-states- Digital Quality Measures by 2025. This what-are-patient-generated-health-data. core-data-interoperability-uscdi.

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Certification Program until December systems within a specific care setting.266 electronically transmit interoperable 31, 2022 (85 FR 70064).265 This may be further complicated by data for dQMs could reinforce other The CMS Interoperability and Patient systems which integrate a wide range of activities to support quality Access final rule (85 FR 25510) and data schemas. This process is measurement and improvement (for program policies build on the ONC 21st burdensome and costly, and it is example, the aggregation of data across Century Cures Act final rule (85 FR difficult to reliably obtain high quality multiple data sources, rapid-cycle 25642). The CMS Interoperability and data across systems. As health IT feedback, and alignment of Patient Access final rule and policies developers map their health IT data to programmatic requirements). require certain payers (for example, the FHIR standard and related The transition to dQMs relies on Medicare Advantage organizations, implementation specifications, APIs can advances in data standardization and Medicaid, and CHIP fee for service enable these data to be easily accessible interoperability. As providers and programs, Medicaid managed care for measurement or other use cases, payers work to implement the required plans, CHIP managed care entities, and such as care coordination, clinical advances in interoperability over the Qualified Health Plan [QHP] issuers on decision support, and supporting next several years, we will continue to the Federally-facilitated Exchanges patient access. support reporting of eCQMs through [FFEs]) to implement and maintain a We believe the emerging data CMS quality reporting programs and standards-based Patient Access API standardization and interoperability through the Promoting Interoperability using HL7 FHIR Release 4.0.1 to make enabled by APIs will support the programs.267 These fully digital available certain data to their enrollees transition to full digital quality measures continue to be important and beneficiaries (called ‘‘patients’’ in measurement by 2025, and are drivers of interoperability advancement the CMS interoperability rule). These committed to exploring and seeking and learning. CMS is currently re- certain data include data concerning input on potential solutions for the specifying and testing these measures to claims and encounters, with the intent transition to digital quality use FHIR rather than the currently to ensure access to their own health care measurement as described in this RFI. adopted Quality Data Model (QDM) in anticipation of the wider use of FHIR information through third-party b. Definition of Digital Quality Measures software applications. The rule also standards. CMS intends to apply established new Conditions of In this section we seek to refine the significant components of the output of Participation for Medicare and Medicaid definition of digital quality measures this work, such as the re-specified participating hospitals, psychiatric (dQMs) to further operationalize our measure logic and the learning done hospitals, and critical access hospitals objective of fully transitioning to dQMs through measure testing with FHIR (CAHs), requiring them to send by 2025. We previously noted dQMs use APIs, to define and build future dQMs electronic notifications to another ‘‘sources of health information that are that take advantage of the expansion of healthcare facility or community captured and can be transmitted standardized, interoperable data. electronically and via interoperable provider or practitioner when a patient c. Changes Under Consideration To is admitted, discharged, or transferred systems.’’ (85 FR 84845). In this RFI, we seek input on future elaboration that Advance Digital Quality Measurement: (85 FR 25603). In the CY 2021 Physician Potential Actions in Four Areas To Fee Schedule (PFS) final rule (85 FR would define a dQM as a software that processes digital data to produce a Transition to Digital Quality Measures 84472), we finalized a policy to align by 2025 the certified EHR technology required measure score or measure scores. Data for use in the Promoting Interoperability sources for dQMs may include Building on the advances in programs and the MIPS Promoting administrative systems, electronically interoperability and learning from Interoperability performance category submitted clinical assessment data, case testing of FHIR-converted eCQMs, we with the updates to health IT management systems, EHRs, aim to move fully to dQMs, originating certification criteria finalized in the instruments (for example, medical from sources of health information that ONC 21st Century Cures Act. Under this devices and wearable devices), patient are captured and can be transmitted policy, eligible clinicians, MIPS eligible portals or applications (for example, for electronically via interoperable systems, clinicians, and eligible hospitals and collection of patient-generated health by 2025. To enable this transformation, we are CAHs participating in the Promoting data), health information exchanges considering further modernizing the Interoperability Programs, must use (HIEs) or registries, and other sources. quality measurement enterprise in four technology meeting the updated We also note that dQMs are intended to major ways: (1) Leverage and advance certification criteria for performance improve the patient experience standards for digital data and obtain all and reporting periods beginning in 2023 including quality of care, improve the EHR data required for quality measures (85 FR 84825). health of populations, and/or reduce costs. via provider FHIR-based APIs; (2) The use of APIs can also reduce long- We discuss one potential approach to redesign our quality measures to be self- standing barriers to quality developing dQM software in section contained tools; (3) better support data measurement. Currently, health IT IV.G.3.c of this proposed rule. In this aggregation; and (4) work to align developers are required to implement section, we are seeking comment on the measure requirements across our individual measure specifications potential definition of dQMs in this RFI. reporting programs, other federal within their health IT product. The We also seek feedback on how programs and agencies, and the private health IT developer must also leveraging advances in technology (for sector where appropriate. accommodate how that product example, FHIR APIs) to access and These changes would enable us to connects with the unique variety of collect and utilize more timely, 266 The Office of the National Coordinator for actionable, and standardized data from 265 Information Blocking and the ONC Health IT Health Information Technology, Strategy on diverse sources and care settings to Certification Program: Extension of Compliance Reducing Regulatory and Administrative Burden Dates and Timeframes in Response to the Covid– Relating to the Use of Health IT and EHRs, Final improve the scope and quality of data 19 Public Health Emergency. https:// Report (Feb. 2020). Available at: https:// www.govinfo.gov/content/pkg/FR-2020-11-04/pdf/ www.healthit.gov/sites/default/files/page/2020-02/ 267 eCQI Resource Center, https:// 2020-24376.pdf. BurdenReport_0.pdf. ecqi.healthit.gov/.

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used in quality reporting and payment measures and reduce the burden of and artificial intelligence, can support programs, reduce quality reporting reporting digital quality measure results. this evolution. These techniques can be burden, and make results available to We can fully leverage this advance to applied to validating observed patterns stakeholders in a rapid-cycle fashion. adapt eCQMs and expand to other in data and inferences or conclusions Data collection and reporting efforts dQMs through the adoption of drawn from associations, as data are would become more efficient, supported interoperable standards across other received, to ensure high quality data are by advances in interoperability and data digital data sources. We are considering used for measurement. standardization. Aggregation of data methods and approaches to leverage the We are seeking feedback on the goal from multiple sources would allow interoperability data requirements for of aligning data needed for quality assessments of costs and outcomes to be APIs set by the ONC 21st Century Cures measurement with interoperability measured across multiple care settings Act final rule for certified health requirements and the strengths and for an individual patient or clinical technology to support modernization of limitations of this approach. We are also conditions. We believe that aggregating CMS quality measure reporting. As seeking feedback on the importance of data for measurement can incorporate a discussed previously, these and approaches to supporting inclusion more holistic assessment of an requirements will be included in of PGHD and other currently non- individual’s health and healthcare and certified technology in future years (85 standardized data. We also welcome produce the rich set of data needed to FR 84825), including availability of data comment on approaches for testing data enable patients and caregivers to make included in the USCDI via standards- quality and validity. informed decisions by combining data based APIs, and CMS will require from multiple sources (for example, clinicians and hospitals participating in (2) Redesigning Quality Measures To Be patient reported data, EHR data, and MIPS and the Promoting Self-Contained Tools claims data) for measurement. Interoperability Programs, respectively, We are considering approaches for Perhaps most importantly, these steps to transition to use of certified deploying quality measures to take would help us deliver on the full technology updated consistent with the advantage of standardized data and promise of quality measurement and 2015 Cures Edition Update (85 FR interoperability requirements that have drive us toward a learning health system 84825). expanded flexibility and functionality that transforms healthcare quality, Digital data used for measurement compared to CMS’ current eCQMs. We safety, and coordination and effectively could expand beyond data captured in are considering defining and developing measures and achieves value-based care. traditional clinical settings, dQM software as end-to-end measure The shift from a static to a learning administrative claims data, and EHRs. calculation solutions that retrieve data health system hinges on the Many important data sources are not from primarily FHIR resources interoperability of healthcare data, and currently captured digitally, such as maintained by providers, payers, CMS, the use of standardized data. dQMs survey and PGHD. We intend to work to and others; calculate measure score(s); would leverage this interoperability to innovate and broaden the digital data and produce reports. In general, we deliver on the promise of a learning used across the quality measurement believe to optimize the use of health system wherein standards-based enterprise beyond the clinical EHR and standardized and interoperable data, the data sharing and analysis, rapid-cycle administrative claims. Agreed upon software solution for dQMs should do feedback, and quality measurement and standards for these data, and associated the following: incentives are aligned for continuous implementation guides will be • Have the flexibility to support improvement in patient-centered care. important for interoperability and calculation of single or multiple quality Similarly, standardized, interoperable quality measurement. We will consider measure(s). data used for measurement can also be developing clear guidelines and • Perform three functions: (i) Obtain used for other use cases, such as clinical requirements for these digital data that data via automated queries from a broad decision support and care coordination align with interoperability set of digital data sources (initially from and care decision support, which requirements, for example, expressing EHRs, and in the future from claims, impacts health care and care quality. in standards, exposing via APIs, and PRO, and PGHD); (ii) calculate the We are requesting comments on four incentivizing technologies that innovate measure score according to measure potential future actions that would data capture and interoperability. logic; and (iii) generate measure score enable transformation to a fully digital High quality data are also essential for report(s). quality measurement enterprise by reliable and valid measurement. Hence, • Be compatible with any data source 2025. in implementing the shift to capture all systems that implement standard clinical EHR data via FHIR-based APIs, (1) Leveraging and Advancing Standards interoperability requirements. we would support efforts to strengthen • Exist separately from digital data for Digital Data and Obtaining All EHR and test the quality of the data obtained source(s) and respect the limitations of Data Required for Quality Measures via through FHIR-based APIs for quality the functionality of those data sources. Provider FHIR-Based APIs measurement. We currently conduct • Be tested and updated We are considering targeting the data audits of electronic data with functions independently of the data source required for our quality measures that including checks for data completeness systems. utilize EHR data to be data retrieved via and data accuracy, confirmation of • Operate in accordance with health FHIR-based APIs based on standardized, proper data formatting, alignment with information protection requirements interoperable data. Utilizing standards, and appropriate data under applicable laws and comply with standardized data for EHR-based cleaning. These functions would governance functions for health measurement (based on FHIR and continue and be applied to dQMs and information exchange. associated implementation guides) and further expanded to automate the • Have the flexibility to be deployed aligning where possible with manual validation of the data compared by individual health systems, health IT interoperability requirements can to the original data source (for example, vendors, data aggregators, and health eliminate the data collection burden the medical record) where possible. plans; and/or run by CMS depending on providers currently experience with Analytic advancements such as natural the program and measure needs and required chart-abstracted quality language processing, big data analytics, specifications.

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• Be designed to enable easy process and to encourage market safety, timeliness, efficiency, installation for supplemental uses by innovation. effectiveness, equitability, and patient- medical professionals and other non- We seek feedback on aggregation of centeredness. It would leverage several technical end-users, such as local data from multiple sources being used existing federal and public-private calculation of quality measure scores or to inform measurement. We also seek efforts including our Meaningful quality improvement. feedback on the role data aggregators Measures 2.0 Framework; the Federal • Have the flexibility to employ can and should play in CMS quality Electronic Health Record Modernization current and evolving advanced analytic measure reporting in collaboration with (DoD/VA); the Agency for Healthcare approaches such as natural language providers, and how we can best Research and Quality’s Clinical processing. facilitate and enable aggregation. Decision Support Initiative; the Centers • Be designed to support pro- for Disease Control and Prevention’s (4) Potential Future Alignment of Adapting Clinical Guidelines for the competitive practices for development, Measures Across Reporting Programs, maintenance, and implementation and Digital Age initiative; the Core Quality Federal and State Agencies, and the Measure Collaborative, which convenes diffusion of quality measurement and Private Sector related quality improvement and stakeholders from America’s Health clinical tools through for example the We are committed to using policy Insurance Plans (AHIP), CMS, NQF, use of open-source core architecture. levers and working with stakeholders to provider organizations, private payers, We seek comment on these suggested solve the issue of interoperable data and consumers and develops consensus functionalities and other additional exchange and to transition to full digital on quality measures for provider functionalities that quality measure quality measurement. We are specialties; and the NQF-convened tools should ideally have particularly in considering the future potential Measure Applications Partnership, the context of the pending availability of development and multi-staged which recommends measures for use in standardized and interoperable data (for implementation of a common portfolio public payment and reporting programs. example, standardized EHR data of dQMs across our regulated programs, We would coordinate with HL7’s available via FHIR-based APIs). agencies, and private payers. This ongoing work to advance FHIR resources in critical areas to support We are also interested whether and common portfolio would require patient care and measurement such as how this more open, agile strategy may alignment of: (1) Measure concepts and social determinants of health. Through facilitate broader engagement in quality specifications including narrative this coordination, we would identify measure development, the use of tools statements, measure logic, and value which existing measures could be used developed for measurement for local sets, and (2) the individual data or evolved to be used as dQMs, in quality improvement, and/or the elements used to build these measure recognition of current healthcare application of quality tools for related specifications and calculate the measure logic. Further, the required data practice and priorities. purposes such as public health or This multi-stakeholder, joint federal research. elements would be limited to standardized, interoperable data and industry, made possible and (3) Building a Pathway to Data elements to the fullest extent possible; enabled by the pending advances Aggregation in Support of Quality hence, part of the alignment strategy towards true interoperability, would Measurement will be the consideration and yield a significantly improved quality measurement enterprise. The success of Using multiple sources of collected advancement of data standards and implementation guides for key data the dQM portfolio would be enhanced data to inform measurement would by the degree to which the measures reduce data fragmentation (or, different elements. We would coordinate closely with quality measure developers, achieve our programmatic requirements pieces of data regarding a single patient for measures as well as the requirements stored in many different places). federal and state agencies, and private payers to develop and to maintain a of other agencies and payers. Additionally, we are also considering We seek feedback on initial priority expanding and establishing policies and cohesive dQM portfolio that meets our programmatic requirements and that areas for the dQM portfolio given processes for data aggregation and evolving interoperability requirements measure calculation by third-party fully aligns across federal and state agencies and payers to the extent (for example, measurement areas, aggregators that include, but are not measure requirements, tools, and data limited to, HIEs and clinical registries. possible. We intend for this coordination to be standards). We also seek to identify Qualified Clinical Data Registries and opportunities to collaborate with other Qualified Registries that report quality ongoing and allow for continuous refinement to ensure quality measures federal agencies, states, and the private measures for eligible clinicians in the sector to adopt standards and Merit-based Incentive Payment System remain aligned with evolving healthcare practices and priorities (for example, technology-driven solutions to address (MIPS) program are potential our quality measurement priorities 268 PROs, disparities, care coordination), examples at 42 CFR across sectors. 414.1440(b)(2)(iv) and (v) and and track with the transformation of § 414.1440(c)(2)(iii) and (iv) and can data collection, alignment with health d. Solicitation of Comments IT module updates including also support measure reporting. We are As noted previously, we seek input on capabilities and standards adopted by considering establishing similar policies the future development of the following: ONC (for example, standards to enable for third-party aggregators to maintain • Definition of Digital Quality APIs). This coordination would build on the integrity of our measure reporting Measures: We are seeking feedback on the principles outlined in HHS’ the following as described in section National Health Quality Roadmap.269 It 268 Calendar Year (CY) 2021 Physician Fee IV.G.3.c.(2): Schedule Final Rule: Finalized (New and Updated) would focus on the quality domains of ++ Do you have feedback on the dQM Qualified Clinical Data Registry (QCDR) and definition? Qualified Registry Policies, https://qpp-cm-prod- 269 Department of Health and Human Services, content.s3.amazonaws.com/uploads/1362/ National Health Quality Roadmap (May 2020). ++ Does this approach to defining QCDR%20and%20QR%20Updates Available at: https://www.hhs.gov/sites/default/ and deploying dQMs to interface with %202021%20Final%20Rule%20Fact%20Sheet.pdf. files/national-health-quality-roadmap.pdf. FHIR-based APIs seem promising? We

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also welcome more specific comments We plan to continue working with Model, as well as HRRs with at least 20 on the attributes or functions to support other agencies and stakeholders to percent of component ZIP codes 270 such an approach of deploying dQMs. coordinate and to inform any potential located in Maryland. CMS excludes all • Changes Under Consideration to transition to dQMs by 2025. While we U.S. Territories from the Selected Advance Digital Quality Measurement: will not be responding to specific Geographic Areas. Actions in Four Areas to Transition to comments submitted in response to this Under the ETC Model, ETC Digital Quality Measures by 2025 RFI in the CY 2022 ESRD PPS final rule, Participants are subject to two payment ++ We are seeking feedback on the we will actively consider all input as we adjustments. The first is the Home following as described in section develop future regulatory proposals or Dialysis Payment Adjustment (HDPA), IV.G.3.c.(1) of this proposed rule: future subregulatory policy guidance. which is an upward adjustment on —Do you agree with the goal of Any updates to specific program certain payments made to participating aligning data needed for quality requirements related to quality ESRD facilities under the ESRD PPS on measurement with that required for measurement and reporting provisions home dialysis claims, and an upward interoperability? What are the strengths would be addressed through separate adjustment to the MCP paid to and limitations of this approach? and future notice-and-comment participating Managing Clinicians on —How important is a data rulemaking, as necessary. home dialysis-related claims. The HDPA standardization approach that also applies to claims with claim service V. End-Stage Renal Disease Treatment dates beginning in January 1, 2021, and supports inclusion of PGHD and other Choices (ETC) Model currently non-standardized data? ending on December 31, 2023. —What are possible approaches for A. Background The second payment adjustment testing data quality and validity? under the ETC Model is the 1. Overview of the ETC Model Performance Payment Adjustment ++ We are seeking feedback on the As described in the Specialty Care (PPA). For the PPA, we assess ETC following as described in section Models final rule (85 FR 61114), Participants’ home dialysis rate and IV.G.3.c.(2) of this proposed rule: beneficiaries with ESRD are among the transplant rate during a Measurement —What functionalities, described in most medically fragile and high-cost Year (MY), which includes 12 months of section IV.G.3.c.(2) of this proposed rule populations served by the Medicare performance data. Each MY overlaps or others, should quality measure tools program. ESRD Beneficiaries require with the previous MY, if any, and the ideally have in the context of the dialysis or kidney transplantation to subsequent MY, if any, for a period of pending availability of standardized and survive, and the majority of ESRD 6 months. Each MY has a corresponding interoperable data (for example, Beneficiaries receiving dialysis receive PPA Period—a 6-month period which standardized EHR data available via hemodialysis in an ESRD facility. begins 6 months after the conclusion of FHIR-based APIs)? However, as described in the Specialty the MY. We adjust certain payments for —How would this more open, agile Care Models final rule, alternative renal ETC Participants during the PPA Period strategy for end-to-end measure replacement modalities to in-center based on the ETC Participant’s home calculation facilitate broader hemodialysis, including home dialysis dialysis rate and transplant rate, engagement in quality measure and kidney transplantation, are calculated as the sum of the transplant development, the use of tools developed associated with improved clinical waitlist rate and the living donor for measurement for local quality outcomes, better quality of life, and transplant rate, during the improvement, and/or the application of lower costs than in-center hemodialysis corresponding MY. Based on an ETC quality tools for related purposes such (85 FR 61264). Participant’s achievement in relation to as public health or research? Section 1115A of the Act authorizes benchmarks based on the home dialysis ++ We seek feedback on the the Innovation Center to test innovative rate and transplant rate observed in following as described in section payment and service delivery models Comparison Geographic Areas during IV.G.3.c.(3) of this proposed rule: expected to reduce Medicare, Medicaid, the Benchmark Year, and the ETC —Do you have feedback on policy and CHIP expenditures while preserving Participant’s improvement in relation to considerations for aggregation of data or enhancing the quality of care its own home dialysis rate and from multiple sources being used to furnished to such programs’ transplant rate during the Benchmark inform measurement? beneficiaries. The purpose of the ETC Year, we make an upward or downward —Do you have feedback on the role Model is to test the effectiveness of adjustment to certain payments to the data aggregators can and should play in adjusting certain Medicare payments to ETC Participant. The magnitude of the CMS quality measure reporting in ESRD facilities and Managing Clinicians positive and negative PPAs for ETC collaboration with providers? How can to encourage greater utilization of home Participants increases over the course of CMS best facilitate and enable dialysis and kidney transplantation, the ETC Model. These PPAs apply to aggregation? support beneficiary modality choice, claims with claim service dates ++ We seek feedback on the reduce Medicare expenditures, and beginning July 1, 2022, and ending June following as described in section preserve or enhance the quality of care. 30, 2027. IV.G.3.c.(4) of this proposed rule: The ETC Model is a mandatory —What are initial priority areas for payment model, as we seek to test the 2. Summary of Proposed Changes to the the dQM portfolio (for example, effect of payment incentives on ETC Model measurement areas, measure availability and choice of treatment In this proposed rule, we are requirements, tools)? modality among a diverse group of proposing a number of policy changes to —We also seek to identify providers and suppliers. ESRD facilities the ETC Model beginning for the third opportunities to collaborate with other and Managing Clinicians are selected as Measurement Year (MY3) of the Model, federal agencies, states, and the private ETC Participants based on their location which begins January 1, 2022. We are sector to adopt standards and in Selected Geographic Areas—a set of proposing changes to the methodology technology-driven solutions to address 30 percent of Hospital Referral Regions our quality measurement priorities and (HRRs) that have been randomly 270 ZIP code TM is a trademark of the United across sectors. selected to be included in the ETC States Postal Service.

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for attributing Pre-emptive LDT rulemaking, including updating dialysis rate with 80 percent power and Beneficiaries to Managing Clinicians to benchmarks for ETC Participants and an alpha of 0.05. Given the updated better reflect the care relationship adjusting model parameters based on expectation that the transplant waitlist between beneficiaries who receive pre- our implementation experience. rate is likely to increase by 3-percentage emptive LDT transplants and the points as a result of the ETC Model, the 3. Impact of Proposed Changes on the Managing Clinicians who provide their ETC Model Evaluation power analysis shows the evaluation care. We are also proposing to include would also have sufficient sample size nocturnal in-center dialysis in the As we described in the Specialty Care to detect, as statistically significant, a 3- numerator of the home dialysis rate Models final rule, an evaluation of the percentage point change in the calculation for ESRD facilities not ETC Model will be conducted in transplant waitlist rate with 80 percent owned in whole or in part by an LDO accordance with section 1115A(b)(4) of power and an alpha of 0.05. as well as Managing Clinicians, to the Act, which requires the Secretary to incentivize additional alternative renal evaluate each model tested by the B. Provisions of the Proposed Rule replacement modalities. In addition, we Innovation Center. We noted that we 1. Technical Clarifications are proposing to exclude beneficiaries believe an independent evaluation of For ESRD facilities that are ETC who are diagnosed with and receiving the Model is necessary to understand Participants, the ETC Model makes treatment with chemotherapy or the impacts of the Model on quality of certain upward and downward radiation for vital solid organ cancers care and Medicare program adjustments to the Adjusted ESRD PPS from the transplant rate to align with expenditures (85 FR 61345). per Treatment Base Rate for certain common transplant center requirements. We propose to update the evaluation We are proposing to modify the PPA plan presented in the Specialty Care dialysis claims via the Home Dialysis achievement benchmarking Models final rule to account for all the Payment Adjustment (HDPA) and the methodology to increase achievement policies proposed in this rule, if Performance Payment Adjustment benchmarks by 10 percent above rates finalized. However, changes in the (PPA). The term ‘‘Adjusted ESRD PPS observed in Comparison Geographic construction of the PPA, if finalized, per Treatment Base Rate’’ is defined at Areas every two MYs, beginning for would have no impact on the evaluation 42 CFR 512.310 as the per-treatment MY3 (2022). We are proposing to stratify approach to analyzing the final PPA payment amount as defined in § 413.230 PPA achievement benchmarks based on values. This is because the evaluation of this chapter, including patient-level the proportion of attributed plan already includes a consideration of adjustments and facility-level beneficiaries who are dually-eligible for the final PPA values, rather than an adjustments, and excluding any Medicare and Medicaid or receive the evaluation of each step in the PPA applicable training adjustment, add-on Low-Income Subsidy during the MY, calculation. However, we expect to payment amount, outlier payment and to introduce the Health Equity conduct subgroup analyses in the amount, TDAPA amount, and TPNIES Incentive to the PPA improvement evaluation to determine the effect of the amount. In this proposed rule, we are scoring methodology, both in an effort proposed Health Equity Incentive, if clarifying the claims subject to to encourage ETC Participants to finalized, in reducing health disparities adjustment under the ETC Model. address disparities in renal replacement among beneficiaries with lower Specifically, as § 413.230 is specific to modality choice among beneficiaries socioeconomic status. the calculation of payment amounts with lower socioeconomic status. We As part of the detailed economic under the ESRD PPS, we clarify that the are proposing to modify the PPA analysis included in section IX.B.4 of HDPA and PPA do not apply to claims improvement benchmarking and scoring this proposed rule, the transplant from ESRD facilities that are not paid methodology to ensure an ETC waitlist benchmarks were annually under ESRD PPS and are instead paid Participant can receive an improvement inflated by approximately 3-percentage through other Medicare payment score even if its home dialysis rate or points growth. This was a change from systems. transplant rate was zero during the the Specialty Care Models final rule (85 We are also updating the name of one relevant Benchmark Year. FR 61352), where the waitlist of the sources of data used throughout We are proposing to add processes benchmarks were annually inflated by the ETC Model. In the Specialty Care and requirements for CMS to share approximately 2-percentage points Models final rule, we specify that one certain model data with ETC growth observed during years 2017 source of data for the ETC Model is Participants. We are also proposing through 2019 to project rates of growth. CROWNWeb, a data management additional programmatic waivers as By increasing the expected effect to a system that CMS uses to collect data necessary solely for purposes of 3-percentage point change, we improve from ESRD facilities (85 FR 61317). allowing Managing Clinicians who are our ability to detect such an effect at the Since publication, CMS has replaced ETC participants to furnish kidney ETC Model’s current size. In the CROWNWeb with the End Stage Renal disease patient education services via Specialty Care Models final rule, we Disease Quality Reporting System telehealth under the ETC Model. In stated that to detect a 2-percentage point (EQRS). As such, we will refer to addition, we propose to permit increase in the transplant waitlist rate, CROWNWeb for data that was generated Managing Clinicians who are ETC we would need 30 percent of the 306 before the change to EQRS, which CMS Participants to reduce or waive HRRs in order to detect an effect of this began using in 2020, and EQRS for data beneficiary coinsurance for kidney size with 80 percent power and an alpha that was generated after the change to disease patient education services, of 0.05. Further, we stated that a model EQRS. subject to certain requirements. CMS of this size would be large enough to expects that the proposed changes detect a one and one-half percentage 2. Performance Payment Adjustment would continue to promote the larger point change in the home dialysis rate (PPA) Beneficiary Attribution for Living goals of increased renal replacement (85 FR 61280). We clarify that our Kidney Donor Transplants modality choice and are based on many unadjusted power calculations show In the Specialty Care Models final of the issues we laid out in the Specialty that the model requires 30 percent of the rule, we established that beneficiaries Care Models final rule as issues for 306 HRRs to detect the one and one-half are attributed to Managing Clinicians for which CMS was considering further percentage point change in the home the purposes of calculating the home

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dialysis rate and transplant rate (85 FR that require nephrologist support over attribute Pre-emptive LDT Beneficiaries 61297). For the home dialysis rate and time in order to inform beneficiaries of to the Managing Clinician who assisted the transplant waitlist and living donor their transplant options and to assist the Beneficiary through the living donor kidney transplant portions of the them in finding a living donor. transplant process. We seek comment transplant rate, as described in 42 CFR However, the current Pre-emptive LDT on these proposed changes for Pre- 512.360(c)(2)(i), an ESRD Beneficiary is Beneficiary attribution methodology is emptive LDT Beneficiary attribution to generally attributed to the Managing based on visits from the beginning of a Managing Clinicians beginning for MY3 Clinician with the earliest monthly MY. As a result, if a Pre-emptive LDT in proposed new § 512.360(c)(2)(iii). capitation payment (MCP) claim billed Beneficiary has a transplant early in a 3. PPA Home Dialysis Rate during the month. If more than one MY, the beneficiary may be attributed to Managing Clinician submits a claim for a transplant nephrologist who may have a. Background on Home Dialysis Rate the MCP furnished to a single ESRD had only a single visit with the Calculation Beneficiary with the same earliest claim beneficiary, rather than the Managing A primary goal of the ETC Model is service date at the claim line through Clinician who oversaw the largest share to support beneficiary modality choice date for the month, the ESRD of the care that led to the beneficiary by encouraging ETC Participants to Beneficiary is randomly attributed to receiving the living donor transplant. support beneficiaries in selecting one of these Managing Clinicians. As a result, we propose to update the alternatives to in-center dialysis. Under However, a beneficiary who receives attribution methodology for Pre-emptive 42 CFR 512.365(b), CMS includes in- a pre-emptive living donor transplant LDT Beneficiaries to Managing center self-dialysis treatment beneficiary (Pre-emptive LDT Beneficiary) is not on Clinicians, beginning for MY3, in new years in the numerator of the home dialysis and therefore cannot be provisions at § 512.360(c)(2)(iii). Rather dialysis rate. Specifically, the home attributed to a Managing Clinician using than attributing a Pre-emptive LDT dialysis rate for both Managing an MCP claim. As a result, under Beneficiary to the Managing Clinician Clinicians and ESRD facilities is § 512.360(c)(2)(ii), a Pre-emptive LDT with the plurality of claims from the calculated as the number of dialysis Beneficiary is generally attributed to the start of the MY and the month of the treatment beneficiary years during the Managing Clinician with whom the Pre- transplant, beginning for MY3, we MY in which attributed beneficiaries emptive LDT Beneficiary had the most propose to attribute Pre-emptive LDT received dialysis at home, plus one half claims between the start of the MY and Beneficiaries to the Managing Clinician of the total number of dialysis treatment the month of the transplant. If no with whom the beneficiary has had the beneficiary years during the MY in Managing Clinician has had the which the attributed beneficiaries plurality of claims for a given Pre- most claims during the 365 days prior to the transplant date. Further, we received self-dialysis in center. As emptive LDT Beneficiary such that described in the Specialty Care Models multiple Managing Clinicians each had propose that if no Managing Clinician has had the most claims for the Pre- final rule, we included self-dialysis in the same number of claims for that the home dialysis rate calculation beneficiary during the MY, the Pre- emptive LDT Beneficiary such that multiple Managing Clinicians each had because we believe in-center self- emptive LDT Beneficiary is attributed to dialysis may provide a gradual the Managing Clinician associated with the same number of claims for that beneficiary in the 365 days preceding transition from in-center to home the latest claim service date during the dialysis, and provide beneficiaries with MY up to and including the month of the date of the transplant, the Pre- emptive LDT Beneficiary would be the time needed to get comfortable the transplant, as described in conducting dialysis by themselves, § 512.360(c)(2)(ii)(A). If no Managing attributed to the Managing Clinician associated with the latest claim service under medical supervision (85 FR Clinician had the plurality of claims for 61306). a given Pre-emptive LDT Beneficiary date at the claim line through date during the 365 days preceding the date The denominator for the home such that multiple Managing Clinicians dialysis rate is the total dialysis each had the same number of services of the transplant. We propose that if more than one of those Managing treatment beneficiary years for for that beneficiary during the MY, and attributed ESRD beneficiaries during the more than one of those Managing Clinicians had the latest claim service date at the claim line through date MY, as described in §§ 512.365(b)(1)(i) Clinicians had the latest claim service and 512.365(b)(2)(i). This includes the date during the MY up to and including during the 365 days preceding the date of the transplant, the Pre-emptive LDT months during which attributed the month of the transplant, the Pre- beneficiaries received maintenance emptive LDT Beneficiary is randomly Beneficiary would be randomly dialysis at home or in an ESRD facility. attributed to one of these Managing attributed to one of these Managing Clinicians, as described in Clinicians. We propose that the Pre- b. Nocturnal Dialysis emptive LDT Beneficiary would be § 512.360(c)(2)(ii)(B). Nocturnal in-center dialysis is a form considered eligible for attribution to a Upon further review of the beneficiary of in-center dialysis conducted Managing Clinician under this proposed attribution methodology for living donor overnight for extended hours while the new § 512.360(c)(2)(iii) if the Pre- kidney transplants, we realized that an beneficiary is asleep. This dialysis is emptive LDT Beneficiary has at least 1 unintended consequence of the current longer and slower than traditional in- eligible–month during the 12-month attribution methodology is that Pre- center dialysis, can take more than 5 period that includes the month of the emptive LDT Beneficiaries may be hours per treatment, and can be transplant and the 11 months prior to attributed to the nephrologist who performed 3 to 7 days a week. As this the transplant month. We propose that manages their transplant, not the type of in-center dialysis is conducted an eligible month would refer to a Managing Clinician who has seen them overnight, it allows the beneficiary more through the living donor transplant month during which the Pre-emptive time and flexibility to have a continuous process. To avoid this effect, CMS LDT Beneficiary not does not meet job, as well as a social and family life.271 believes it is necessary to update the exclusion criteria in § 512.360(b). CMS attribution methodology for Pre-emptive is proposing changes for Pre-emptive 271 Wilk, Adam S., Lea, Janice P. (2019). How LDT Beneficiaries. Living donor LDT Beneficiary attribution to Managing Extended Hemodialysis Treatment Time Can Affect transplants are relatively rare events Clinicians in order to identify and Continued

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Dialysis conducted at a slower rate While nocturnal in-center dialysis comments that some ESRD facilities, over a longer period of time is also offers some of the same clinical and particularly independent ESRD facilities associated with positive health impacts quality of life benefits as home dialysis or ESRD facilities owned by small in comparison to traditional dialysis, in comparison to traditional in-center dialysis organizations, may be unable to including improved blood pressure dialysis, use of nocturnal in-center develop and maintain a home dialysis control, better phosphate control, better dialysis is rare. Based on analyses program (85 FR 61322 through 61324). management of anemia and bone and described in section IX.B.4.a.(4) of this Operating a home dialysis program mineral metabolism, improved proposed rule, less than 1 percent of requires specialized staff, as well as cardiovascular disease, increases in urea beneficiaries eligible for attribution to upfront investment in additional reduction ratio, and better beneficiary ETC Participants were receiving self- equipment and certification. quality of life measures.272 273 274 275 276 dialysis or nocturnal in-center dialysis Establishing a nocturnal in-center In addition to the clinical benefits, in 2019. Potential limitations to dialysis program does not require nocturnal in-center dialysis also nocturnal in-center dialysis utilization additional equipment or certification, provides an alternative to traditional in- include supply factors. At present, few and may be more feasible for center dialysis for those beneficiaries for ESRD facilities offer nocturnal dialysis; independent ESRD facilities or ESRD whom home dialysis is not an option in 2019, approximately 1 percent of facilities owned by small dialysis due to limited financial resources, ESRD facilities furnished nocturnal in- organizations, and by extension, the housing insecurity, lack of social center dialysis based on our analysis of Managing Clinicians who serve their support, or personal preference. For claims data. ESRD facilities may face patients. example, a beneficiary experiencing staffing challenges to initiating a We considered including nocturnal housing insecurity may be unable to nocturnal dialysis program. Potential in-center dialysis in the numerator of dialyze at home due to inability to limitations to nocturnal in-center the home dialysis rate for ESRD receive and store home dialysis dialysis also include demand factors: facilities owned in whole or in part by materials. However, that beneficiary beneficiaries may be unaware of could receive nocturnal in-center LDOs as well. However, we do not nocturnal in-center dialysis, or may be believe that ESRD facilities owned in dialysis, thereby receiving the clinical averse to sleeping at an ESRD facility or benefits of a longer, slower dialysis whole or in part by LDOs face the same experience difficulty sleeping while resource constraints in establishing a process and the flexibility associated receiving dialysis.279 with not having to receive traditional in- home dialysis program as independent center dialysis during the day.277 278 c. Proposed Inclusion of Nocturnal In- ESRD facilities or ESRD facilities owned Center Dialysis in Home Dialysis Rate by small dialysis organizations. ESRD Patient Quality of Life. Clinical Journal of the facilities owned in whole or in part by We propose to modify the home LDOs may be more likely to have access American Society of Nephrology, 23, 479–485. dialysis rate calculation, for ETC doi:10.1111/hdi.12782. to a home dialysis program, either in the 272 Burton, J. and Graham-Brown, M., 2018. Participants that are either ESRD ESRD facility itself or within the Nocturnal hemodialysis. Current Opinion in facilities not owned in whole or in part network of facilities owned by the same Nephrology and Hypertension, 27(6), pp.472–477. by an LDO or Managing Clinicians, to 273 parent company in that facility’s Kalim, S., Wald, R., Yan, A. T., Goldstein, M. include nocturnal in-center dialysis in B., Kiaii, M., Xu, D., . . . Perl, J. (2018). Extended aggregation group. ESRD facilities duration nocturnal hemodialysis and changes in the numerator beginning for MY3. As owned in whole or in part by LDOs may plasma metabolite profiles. Clinical Journal of the described previously in this section of also have greater access to the upfront American Society of Nephrology, 13(3), 436–444. the proposed rule, we believe this capital necessary to establish a home doi:10.2215/cjn.08790817. modality allows beneficiaries to 274 dialysis program if they do not already Nesrallah, G. E., Lindsay, R. M., Cuerden, M. continue to receive maintenance S., Garg, A. X., Port, F., Austin, P. C., . . . Suri, R. have, or have access to, a home dialysis S. (2012). Intensive hemodialysis associates with dialysis in an ESRD facility under program. improved survival compared with conventional medical supervision, but at a time of hemodialysis. Journal of the American Society of day that is more convenient for them, At present, there is not a single Nephrology, 23(4), 696–705. doi:10.1681/ and in a manner that is associated with definition of what qualifies a legal entity asn.2011070676. that owns ESRD facilities as an LDO. In 275 Wong, B., Collister, D., Muneer, M., Storie, D., improved health outcomes. In Courtney, M., Lloyd, A., . . . Pauly, R. P. (2017). In- particular, we believe that including general, definitions of LDO focus on the center nocturnal hemodialysis versus conventional nocturnal in-center dialysis in the home number of ESRD facilities owned by the hemodialysis: A systematic review of the evidence. dialysis rate may improve access to legal entity. Other Innovation Center American Journal of Kidney Diseases, 70(2), 218– models have used such definitions: The 234. doi:10.1053/j.ajkd.2017.01.047. alternative renal replacement modalities 276 Wilk, Adam S., Lea, Janice P. (2019). How for beneficiaries who are unable to Comprehensive ESRD Care (CEC) Model Extended Hemodialysis Treatment Time Can Affect dialyze at home. defined an LDO as a legal entity owning Patient Quality of Life. Clinical Journal of the In addition to promoting access to the 200 or more ESRD facilities; the Kidney American Society of Nephrology, 23, 479–485. benefits of additional alternative renal Care Choices (KCC) Model defines an doi:10.1111/hdi.12782. LDO as a legal entity owning 35 or more 276 Lacson E, Diaz-Buxo J. In-center nocturnal replacement modalities for ESRD hemodialysis performed thrice-weekly—a Beneficiaries who may not be able to ESRD facilities. Outside of Innovation provider’s perspective. Semin Dial. 2011 Nov– dialyze at home, we believe that Center models, definitions used by Dec;24(6):668–73. doi: 10.1111/j.1525– including nocturnal in-center dialysis in academic researchers vary significantly. 139X.2011.00998.x. Epub 2011 Nov 22. PMID: For example, in 2015 the United States 22106828. the calculation of the home dialysis rate 277 Bugeja A, Dacouris N, Thomas A, Marticorena offers an additional pathway to success Renal Data System (USRDS), a national R, McFarlane P, Donnelly S, Goldstein M. In-center for ETC Participants with more limited data registry funded by the National nocturnal hemodialysis: another option in the resources. As described in the Specialty Institutes of Health (NIH), defined an management of chronic kidney disease. Clin J Am LDO as a dialysis organization one that Soc Nephrol. 2009 Apr;4(4):778–83. doi: 10.2215/ Care Models final rule, we received CJN.05221008. Epub 2009 Apr 1. PMID: 19339410; owns and operates 200 or more ESRD 280 PMCID: PMC2666425. Dec;24(6):668–73. doi: 10.1111/j.1525– facilities. Other academic research 278 Lacson E, Diaz-Buxo J. In-center nocturnal 139X.2011.00998.x. Epub 2011 Nov 22. PMID: hemodialysis performed thrice-weekly—a 22106828. 280 United States Renal Data System. 2015. ‘‘2015 provider’s perspective. Semin Dial. 2011 Nov– 279 Ibid. Researcher’s Guide to the USRDS Database.’’

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has employed thresholds as low as outcomes and savings to Medicare 7 and the type of care code is 2, and owning 20 or more ESRD facilities and compared to traditional in-center with the modifier UJ, which specifies as high as owning 1,000 or more ESRD dialysis, we acknowledge that its that a claim with Type of Bill 072X is facilities to consider a legal entity an inclusion in the home dialysis rate may for nocturnal in-center dialysis. We seek LDO.281 282 Other definitions do not reduce the incentive for ESRD facilities comment on these proposed changes to focus on the number of ESRD facilities not owned in whole or in part by an § 512.365(b). owned, but on the relative size of LDO to invest in a home dialysis 4. Performance Payment Adjustment dialysis organizations in the market, or infrastructure. We therefore propose to Transplant Rate rather, the individual dialysis include nocturnal in-center dialysis as organizations themselves. For example, one half of the total number of dialysis a. Status of Organ Availability in its March 2021 report to Congress, the treatment beneficiary years during the The ETC Model is designed to Medicare Payment Advisory MY in which the attributed beneficiaries encourage greater rates of Commission (MedPAC) refers to the two received nocturnal in-center dialysis in transplantation. In the proposed rule largest dialysis organizations in the the numerator of the home dialysis rate published on July 18, 2019 in the country as LDOs based on their relative calculation for ESRD facilities not Federal Register titled, ‘‘Medicare share of ESRD facilities and Medicare owned in whole or in part by an ETC 283 Program; Specialty Care Models to treatments. Based on our review of LDO as well as Managing Clinicians. We Improve Quality of Care and Reduce definitions commonly used, for the believe this policy would effectively Expenditures’’ (84 FR 34478), referred to purposes of the ETC Model we propose balance the benefits of nocturnal in- herein as the ‘‘Specialty Care Models to define the term ‘‘ETC Large Dialysis center dialysis and its ability to help proposed rule,’’ CMS proposed to Organization,’’ abbreviated ‘‘ETC LDO,’’ beneficiaries transition to home dialysis include the rate of transplants, both as a legal entity that owns, in whole or with the recognition that in-center living and deceased donor transplants, in part, 500 or more ESRD facilities. nocturnal dialysis is not home dialysis in the numerator for the ETC Model’s Based on the current distribution of and does not have all of the same transplant rate. However, in the numbers of ESRD facilities owned by benefits. As described in the Specialty Specialty Care Models final rule, we dialysis organizations operating in the Care Models final rule, we included one recognized the limitations of supply of market, we believe this threshold is half of the total number of dialysis deceased donor organs and updated the appropriate, as it differentiates the treatment beneficiary years during the transplant rate to be calculated as the largest dialysis organizations, which at MY in which the attributed beneficiaries sum of the transplant waitlist rate and present own over 2,500 ESRD facilities, received self-dialysis in center in the the living donor transplant rate (85 FR from smaller dialysis organizations, the home dialysis rate calculation for a 61310). We stated that though a next largest of which owns similar reason (85 FR 61306). approximately 350 ESRD facilities. We transplant is often the best treatment for As such, we propose to amend believe the difference in size represents a beneficiary with ESRD, in light of the § 512.365(b) such that, beginning for a meaningful difference in access to current shortage of deceased donor MY3, the numerator for the home resources necessary to establish a home organs for transplant, the transplant dialysis program, as well as the dialysis rate for ESRD facilities not waitlist rate and living donor transplant likelihood that an ESRD facility’s owned in whole or in part by an ETC rate are currently more within the aggregation group would have at least LDO and Managing Clinicians would be control of an ETC Participant (85 FR one ESRD facility with a home dialysis the total number of dialysis treatment 61309). program in the aggregation group. We beneficiary years during the MY in However, in the Specialty Care seek comment on our proposal to which attributed ESRD Beneficiaries Models final rule, we indicated our include nocturnal in-center dialysis received maintenance dialysis at home, intent to observe the supply of deceased beneficiary years in the numerator of the plus one half of the total number of donor organs available for home dialysis rate calculation only for dialysis treatment beneficiary years transplantation, with the goal of ESRD facilities not owned in whole or during the MY in which attributed potentially modifying the transplant rate in part by an ETC LDO, as well as our ESRD Beneficiaries received calculation for the future (85 FR 61309). proposal to define an ETC LDO as a maintenance dialysis via self-dialysis, Since the Specialty Care Models final legal entity owning 500 or more ESRD plus one half of the total number of rule was published on September 29, facilities. dialysis treatment beneficiary years 2020, there have been several initiatives While nocturnal in-center dialysis can during the MY in which attributed pursued by the federal government that potentially result in better patient health ESRD Beneficiaries received could potentially have the effect of maintenance dialysis via in-center increasing the supply of both living https://usrds.org/media/2219/2015_usrds_ nocturnal dialysis. We further propose donor organs and deceased donor researchers_guide_15.pdf. to add paragraph (C) to both organs. 281 Mehrotra R, Khawar O, Duong U, Fried L, §§ 512.365(b)(1)(ii) and 512.365(b)(2)(ii) On September 22, 2020, the Health Norris K, Nissenson A, Kalantar-Zadeh K. to specify that nocturnal in-center Resources and Services Administration Ownership patterns of dialysis units and peritoneal (HRSA) published a final rule in the dialysis in the United States: utilization and dialysis beneficiary years included in outcomes. Am J Kidney Dis. 2009 Aug;54(2):289– the numerator of the home dialysis rate Federal Register titled ‘‘Removing 98. doi: 10.1053/j.ajkd.2009.01.262. Epub 2009 Apr calculation would be composed of those Financial Disincentives to Living Organ 8. PMID: 19359081. months during which attributed ESRD Donation’’ (85 FR 59438). This rule 282 Gander JC, Zhang X, Ross K, et al. Association Beneficiaries received nocturnal in- removes financial barriers to organ Between Dialysis Facility Ownership and Access to Kidney Transplantation. JAMA. 2019;322(10):957– center dialysis, such that 1-beneficiary donation by expanding the scope of 973. doi:10.1001/jama.2019.12803. year is comprised of 12-beneficiary reimbursable expenses incurred by 283 Medicare Payment Advisory Commission. months. The months in which an living organ donors to include lost 2021. Report to the Congress: Medicare and the attributed ESRD Beneficiary received wages, and child-care and elder-care health care delivery system. Washington, DC: expenses incurred by a caregiver. The MedPAC. http://www.medpac.gov/docs/default- nocturnal in-center dialysis would be source/reports/mar21_medpac_report_to_the_ identified by claims with Type of Bill rule went into effect on October 22, congress_sec.pdf. 072X, where the type of facility code is 2020.

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Additionally, on December 2, 2020, Accordingly, we did not exclude Pre-emptive LDT Beneficiaries with a CMS published in the Federal Register beneficiaries with cancer from diagnosis of vital solid organ cancer for a final rule titled, ‘‘Medicare and attribution to ETC Participants for which they are receiving chemotherapy Medicaid Programs; Organ Procurement purposes of calculating the home or radiation therapy. Both a diagnosis Organizations Conditions for Coverage: dialysis rate or the transplant rate in the code and a treatment code are necessary Revisions to the Outcome Measure Specialty Care Models final rule. to appropriately identify an ESRD Requirements for Organ Procurement Nevertheless, after we published the Beneficiary or Pre-emptive LDT Organizations’’ (85 FR 77898), revising Specialty Care Models final rule, we Beneficiary with a vital solid organ Conditions for Coverage (CfCs) for conducted further analysis, to determine cancer who is receiving treatment with Organ Procurement Organizations if a difference existed in either the home either radiation or chemotherapy. (OPOs). The final rule revised the CfCs dialysis rate or transplant rate in However, through our analysis we have for OPOs in order to increase donation beneficiaries with cancer and identified beneficiaries who have only a rates and organ transplantation rates beneficiaries without cancer. Using the treatment code available during the MY and replaced the old outcome measures Medicare claims data and input from and do not have a diagnosis code during with new transparent, reliable, and clinical specialists in the field of that period. Hence, we are proposing to objective measures. The final rule went nephrology, we found that the majority include a lookback period of 6-months into effect on March 30, 2021. The new of ESRD Beneficiaries with cancer, prior to the MY, so that the appropriate outcome measures will be implemented specifically ESRD Beneficiaries with diagnosis code can be identified for for the recertification cycle beginning in cancer in vital solid organs (heart, lung, ESRD Beneficiaries and Pre-emptive 2022 and ending in 2026. The goals of liver, and kidney), are not considered to LDT Beneficiaries who have only this rule are complementary to the goals be eligible candidates for transplant. treatment codes available in the current of the ETC Model, as the revised CfCs Many transplant centers do not consider MY. In the alternative, we considered a are intended to increase the supply of these beneficiaries for transplant and 12-month lookback period, but did not organs, and the ETC Model is designed require them to be cancer-free for a find any significant difference in the to incentivize higher rates of specific period of time prior to assessing number of ESRD Beneficiaries and Pre- transplantation. their eligibility for transplant. This is emptive LDT Beneficiaries that had a Finally, as described in the Specialty true for getting on a transplant waitlist diagnosis code for a vital organ solid Care Models final rule, CMS is in the and for receiving living donor cancer during a 12-month lookback process of implementing the ETC transplants, as a beneficiary either needs period as compared to a 6-month Learning Collaborative (85 FR 61346). to be cancer-free or be in an initial stage lookback period. The ETC Learning Collaborative is a of cancer diagnosis to be considered for We propose to identify ESRD voluntary learning system focused on transplant. Beneficiaries and, if applicable, Pre- increasing the availability of deceased In addition, we found that ESRD emptive LDT Beneficiaries with a donor kidneys for transplantation. The Beneficiaries who have a diagnosis of diagnosis of vital solid organ cancer and ETC Learning Collaborative works with solid organ cancer for which they were receiving treatment with radiation or and supports ETC Participants and other receiving treatment, specifically chemotherapy by using Medicare stakeholders required for successful radiation or chemotherapy, are less kidney transplantation, such as likely to be in the numerator of the claims. For purposes of the transplant transplant centers, OPOs, and large transplant rate—so, being placed on the rate calculations, an ESRD Beneficiary donor hospitals. CMS is currently in the transplant waitlist or receive a living or Pre-emptive LDT Beneficiary would process of jointly implementing the ETC donor transplant—than ESRD be considered to have a diagnosis of Learning Collaborative with HRSA. Beneficiaries without a diagnosis of vital solid cancer during the MY, if the We are pleased that these efforts have vital solid organ cancer. By contrast, we ESRD Beneficiary has a claim with one progressed since the publication of the did not find any evidence to suggest that of the following ICD–10 diagnosis Specialty Care Models final rule. ESRD Beneficiaries with cancer had a codes: However, given that these efforts are significant difference in the home • C22.0–C22.9 (malignant neoplasm still in the implementation process, we dialysis rate compared to the ESRD of liver and intrahepatic bile ducts), do not believe that it would be Beneficiaries without cancer. • C34.10–C34.12 (malignant appropriate to update the transplant rate As noted previously, under neoplasm of upper lobe, bronchus or to include accountability for deceased §§ 512.310 and 512.365(c), the lung), donor transplants, rather than transplant transplant rate has two components: • C34.2 (malignant neoplasm of waitlisting, at this time. We still intend The transplant waitlist rate and the middle lobe, bronchus or lung), to update the transplant rate through living donor transplant rate. Upon • C34.30–C34.32 (malignant future rulemaking to include further review and analysis, beginning neoplasm of lower lobe, bronchus or accountability for deceased donor for MY3, we propose to exclude ESRD lung), transplants, but we are not proposing to Beneficiaries and, if applicable, Pre- • C34.80–C34.82 (malignant do so at this time. emptive LDT Beneficiaries who have neoplasm of overlapping sites of been diagnosed with vital solid organ Beneficiary Exclusions From the bronchus and lung), cancers (heart, lung, liver and kidney) • Transplant Rate and who are receiving treatment, in the C34.90–C34.92 (malignant As we discussed in the Specialty Care form of radiation or chemotherapy, for neoplasm of unspecified part of Models final rule (85 FR 61300), CMS bronchus or lung), such cancers from both components of • received comments about excluding the denominator of the transplant rate C38.0 (malignant neoplasm of ESRD Beneficiaries with cancer from for both ESRD facilities and Managing heart), attribution to ETC Participants, as there Clinicians for the duration of the MY. • C38.8 (malignant neoplasm of was concern about treatment Furthermore, we propose to include a overlapping sites of heart, mediastinum appropriateness. However, at that time, lookback period, a period of time prior and pleura), CMS did not have any evidence to to the MY, to appropriately identify the • C46.50–C46.52 (Kaposi’s sarcoma of suggest that this is a concern. ESRD Beneficiaries and, if applicable, lung),

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• C64.1, C64.2, C64.9 (malignant DB12B9Z, DB12BB1, DB12BBZ, DW23HZZ, DW23JZZ, DWY37ZZ, neoplasm of kidney, except renal DB12BCZ, DB12BYZ, DB22DZZ, DWY38ZZ, DWY3FZZ (radiation of pelvis), DB22HZZ, DB22JZZ, DBY27ZZ, abdomen); • C78.00–C78.02 (secondary DBY28ZZ, DBY2FZZ, DBY2KZZ We seek comment on the proposal to malignant neoplasm of lung), (radiation of lung); • • amend § 512.365(c) to exclude ESRD C78.7 (secondary malignant ICD–10–PCS DB070ZZ, DB071ZZ, Beneficiaries and, if applicable, Pre- DB072ZZ, DB073Z0, DB073ZZ, neoplasm of liver and intrahepatic bile emptive LDT Beneficiaries with a DB074ZZ, DB075ZZ, DB076ZZ, duct), diagnosis of vital solid organ cancer and • DB1797Z, DB1798Z, DB1799Z, C79.00–C79.02 (secondary receiving treatment with chemotherapy DB179BZ, DB179CZ, DB179YZ, malignant neoplasm of kidney and renal or radiation from the denominator of the DB17B6Z, DB17B7Z, DB17B8Z, pelvis), transplant rate as a whole, including • C7A.090 (malignant carcinoid DB17B9Z, DB17BB1, DB17BBZ, both the transplant waitlist rate tumor of the bronchus and lung), DB17BCZ, DB17BYZ, DB27DZZ, component and the living donor • C7A.093 (malignant carcinoid DB27HZZ, DB27JZZ, DBY77ZZ, transplant rate component, for the tumor of the kidney), or DBY78ZZ, DBY7FZZ, DBY7KZZ duration of the MY for both ESRD • C7B.02 (secondary carcinoid tumors (radiation of chest wall); facilities and Managing Clinicians. of liver). • ICD–10–PCS DF000ZZ, DF001ZZ, We propose that for the purposes of DF002ZZ, DF003Z0, DF003ZZ, 5. PPA Achievement Benchmarking the transplant rate calculations, an DF004ZZ, DF005ZZ, DF006ZZ, ESRD Beneficiary or Pre-emptive LDT DF1097Z, DF1098Z, DF1099Z, a. Background on Achievement Beneficiary would be considered to be DF109BZ, DF109CZ, DF109YZ, Benchmarking receiving treatment for vital solid organ DF10B6Z, DF10B7Z, DF10B8Z, Under the ETC Model, the PPA is a cancer with either chemotherapy or DF10B9Z, DF10BB1, DF10BBZ, positive or negative adjustment on radiation in the MY if the ESRD DF10BCZ, DF10BYZ, DF0DZZ, dialysis and dialysis-related Medicare Beneficiary or Pre-emptive LDT DF20HZZ, DF20JZZ, DFY07ZZ, payments, for both home dialysis and Beneficiary has a claim with one of the DFY08ZZ, DFY0CZZ, DFY0FZZ, in-center dialysis. To calculate an ETC following codes: DFY0KZZ (radiation of liver); Participant’s PPA, we assess ETC • ® • ICD–10–PCS DT000ZZ, DT001ZZ, CPT 96401–96402, 96405–96406, Participant achievement on the home DT002ZZ, DT003Z0, DT003ZZ, 96409, 96411, 96413, 96415–96417, dialysis rate and transplant rate in DT004ZZ, DT005ZZ, DT006ZZ, 96420, 96422–26423, 96425, 96440, relation to achievement and DT1097Z, DT1098Z, DT1099Z, 96446 (chemotherapy administration); improvement benchmarks, as described • ® DT109BZ, DT109CZ, DT109YZ, CPT 96549 (unlisted in 42 CFR 512.370(b) and § 512.370(c), DT10B6Z, DT10B7Z, DT10B8Z, chemotherapy procedure); respectively. The Model more heavily • ® DT10B9Z, DT10BB1, DT10BBZ, CPT 77373 (stereotactic body weights achievement of results, DT10BCZ, DT10BYZ, DT20DZZ, radiation therapy); allowing participating Managing • CPT® 77401–77402, 77407, 77412 DT20HZZ, DT20JZZ, DTY07ZZ, Clinicians or ESRD facilities to earn up (radiation treatment delivery); DTY08ZZ, DTY0CZZ, DTY0FZZ to 2 points in the scoring methodology, • CPT® 77423 (high energy neutron (radiation of kidney); as opposed to only 1.5 points for radiation treatment delivery); • ICD–10–PCS DW020ZZ, DW021ZZ, maximum level of improvement, as • CPT® 77424–77425 (intraoperative DW022ZZ, DW023Z0, DW023ZZ, described in §§ 512.370(b) and radiation treatment delivery); DW024ZZ, DW025ZZ, DW026ZZ, • CPT® 77520, 77522–77523, 77525 DW1297Z, DW1298Z, DW1299Z, 512.370(c). (proton treatment delivery); DW129BZ, DW129CZ, DW129YZ, The achievement benchmarks are • CPT® 77761–77763 (intracavitary DW12B6Z, DW12B7Z, DW12B8Z, constructed based on the home dialysis radiation source application); DW12B9Z, DW12BB1, DW12BBZ, rate and transplant rate observed in • CPT® 77770–77772, 77778, 77789, DW12BCZ, DW12BYZ, DW22DZZ, Comparison Geographic Areas during 77799 (clinical brachytherapy radiation DW22HZZ, DW22JZZ, DWY27ZZ, corresponding Benchmark Years. treatment); DWY28ZZ, DWY2FZZ (radiation of Achievement benchmarks are percentile • CPT® 79005, 79101, 79200, 79300, chest); or based, and an ETC Participant receives 79403, 79440, 79445, 79999 • ICD–10–PCS DW030ZZ, DW031ZZ, the achievement points that correspond (radiopharmaceutical therapy); DW032ZZ, DW033Z0, DW033ZZ, with its performance, at the aggregation • ICD–10–PCS DB020ZZ, DB021ZZ, DW034ZZ, DW035ZZ, DW036ZZ, group level, on the home dialysis rate DB022ZZ, DB023Z0, DB023ZZ, DW1397Z, DW1398Z, DW1399Z, and transplant rate in relation to the DB024ZZ, DB025ZZ, DB026ZZ, DW139BZ, DW139CZ, DW139YZ, achievement benchmarks, as described DB1297Z, DB1298Z, DB1299Z, DW13B6Z, DW13B7Z, DW13B8Z, in § 512.370(b). Table 7 details the DB129BZ, DB129CZ, DB129YZ, DW13B9Z, DW13BB1, DW13BBZ, achievement score scale described in DB12B6Z, DB12B7Z, DB12B8Z, DW13BCZ, DB13BYZ, DW23DZZ, § 512.370(b).

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TABLE 7: Current Scoring Methodology for Achievement Scores

Achievement Score Scale for MYl and MY2 Points 901:h+ Percentile of benchmark rates for Comparison Geographic Areas during the 2 Benchmark Year 751:h+ Percentile of benchmark rates for Comparison Geographic Areas during the 1.5 Benchmark Year 501:h+ Percentile of benchmark rates for Comparison Geographic Areas during the 1 Benchmark Year 30th+ Percentile of benchmark rates for Comparison Geographic Areas during the 0.5 Benchmark Year <30th Percentile of benchmark rates for Comparison Geographic Areas during the 0 Benchmark Year

In the Specialty Care Models as socioeconomic status, may impact a c. Proposed Achievement Benchmarking proposed rule, we proposed to apply beneficiary’s likelihood to receive home and Scoring this achievement benchmark policy dialysis or transplant. We discussed (1) Achievement Benchmarking and only for MY1 and MY2, and stated our commenters’ suggestions to incorporate Scoring for MY3 Through MY10 intent to increase achievement consideration of socioeconomic status benchmarks for ETC Participants above in two elements of the ETC Model: (1) We propose to modify the percentile- the rates observed in Comparison Beneficiary attribution; and (2) risk based achievement benchmarking methodology based on the home Geographic Areas. We stated our belief adjustment. However, we declined to dialysis rate and transplant rate that increasing the achievement exclude beneficiaries from attribution observed in Comparison Geographic benchmarks for future MYs, which we based on socioeconomic status. Noting would do through subsequent Areas during the Benchmark Year as the the importance of not excluding these basis for achievement benchmarks in rulemaking, was necessary in order to beneficiaries, CMS stated its intent to provide sufficient incentive for ETC MY3 through MY10. Rather than using assess the use of various codes for Participants to increase rates of home rates observed in Comparison purposes of adding any additional dialysis and transplantation at a rate Geographic Areas, we propose to modify beneficiary exclusions from attribution faster than would occur absent the ETC § 512.370(b)(1) to use rates observed in Model (84 FR 34556 through 34557). In to ETC Participants based on Comparison Geographic Areas as the the Specialty Care Models final rule, in socioeconomic status, homelessness, or base for the achievement benchmarks, response to comments, we finalized the other social determinants of health and to increase the achievement applicability of the achievement through future rulemaking (85 FR benchmarks above the Comparison benchmarks for MY1–MY2 and for 61299). We also noted that commenters’ Geographic Area rates during the subsequent MYs (85 FR 61323), but suggestions for ways to risk adjust the Benchmark Year by 10 percent every reiterated our intent to establish a home dialysis rate based on two MYs, beginning for MY3. As such, different method for establishing socioeconomic status were a significant we propose that achievement achievement benchmarks for future departure from the policy originally benchmarks would be calculated by years of the Model through subsequent proposed (85 FR 61315). multiplying the percentile rate observed in Comparison Geographic Areas during rulemaking (85 FR 61320). We stated We continue to acknowledge the the Benchmark Year by 1.1 for MY3 and our belief that future modifications to impact that non-clinical factors, such as MY4, by 1.2 for MY5 and MY6, by 1.3 the achievement benchmark socioeconomic status, have on a methodology finalized in the Specialty for MY7 and MY8, and by 1.4 for MY9 beneficiary’s likelihood to receive home and MY10. Care Models final rule would be dialysis or a transplant. Based on our necessary to provide sufficient incentive Based on CMS analyses detailed in additional analysis of Medicare claims for ETC Participants to raise home section IX.B.4 of this proposed rule, this data show that beneficiaries who are dialysis and transplant rates at a rate proposed methodology for increasing dual-eligible for Medicare and Medicaid faster than would occur absent the ETC benchmarks by 10 percent every two Model (85 FR 61321). However, we or receive the Medicare Low-Income MYs would produce results in keeping clarified that while we had stated a goal Subsidy (LIS) are less likely than with the initial impact estimates for the of 80 percent of an ETC Participant’s beneficiaries who are not dual-eligible ETC Model, as described in the receiving home dialysis or a transplant and are not LIS recipients to dialyze at Specialty Care Models final rule (85 FR in order to receive the maximum home or to receive a kidney transplant. 61353 through 61354). In the Specialty upward payment adjustment by the As such, ETC Participants who have a Care Models final rule, we estimated final MYs, we were not finalizing that higher proportion of attributed impacts based on projected growth rates goal in the Specialty Care Models final beneficiaries who are dual-eligible or for the home dialysis and transplant rule (85 FR 61321). LIS recipients may be less likely to rates based on historical observation, achieve high home dialysis and projected a 1.5 percentage point growth b. Addressing Socioeconomic Factors transplant rates than ETC Participants rate (85 FR 61354). In section IX.B.4 of That Impact ETC Participant this proposed rule, updated projections Achievement who have a lower proportion of attributed beneficiaries who are dual- assume the same projected growth rate, In the Specialty Care Models final eligible or LIS recipients. but note that observed rates of increase rule, we acknowledged commenters’ have accelerated in more recent data. As concerns that non-clinical factors, such such, we believe that this proposed rate

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of increase would be attainable for ETC FR 34556), we are not proposing to upward payment adjustment by the Participants, as initial impact estimates increase achievement benchmarks such final MYs. were based on rates of increase observed that of 80 percent of an ETC Table 8 details the proposed scoring on the home dialysis rate and transplant Participant’s attributed beneficiaries methodology for assessment of MY3 rate before the ETC Model began (85 FR would need to be receiving home through MY10 achievement scores. 61353). We also note that, unlike in the dialysis or a transplant in order for the Specialty Care Models proposed rule (84 ETC Participant to receive the maximum

TABLE 8: Proposed Scoring Methodology for Assessment of Measurement Years 3 th roue h 10 A c h.1evemen t S cores on th e H ome D.1a1vs1s I . R a t e an d T ransp Ian t R ae t Achievement Score Scale Points MY3 andMY4 MY5andMY6 MY7 andMY8 MY9 andMYlO 1.1 * (90lh+ Percentile 1.2 * (90lh+ Percentile 1.3 * (90th+ Percentile 1.4 * (90lh+ Percentile 2 of benchmark rates for of benchmark rates for of benchmark rates for of benchmark rates for Comparison Comparison Comparison Comparison Geographic Areas Geographic Areas Geographic Areas Geographic Areas during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year) Year) Year) Year) 1.1 * (7 5th+ Percentile 1.2 * (75lh+ Percentile 1.3 * (7 5th+ Percentile 1.4 * (75lh+ Percentile 1.5 of benchmark rates for of benchmark rates for of benchmark rates for of benchmark rates for Comparison Comparison Comparison Comparison Geographic Areas Geographic Areas Geographic Areas Geographic Areas during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year) Year) Year) Year) 1.1 * (50lh+ Percentile 1.2 * (50lh+ Percentile 1.3 * (50th+ Percentile 1.4 * (50lh+ Percentile 1 of benchmark rates for of benchmark rates for of benchmark rates for of benchmark rates for Comparison Comparison Comparison Comparison Geographic Areas Geographic Areas Geographic Areas Geographic Areas during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year) Year) Year) Year) 1.1 * (30th+ Percentile 1.2 * (30th+ Percentile 1.3 * (30th+ Percentile 1.4 * (30th+ Percentile 0.5 of benchmark rates for of benchmark rates for of benchmark rates for of benchmark rates for Comparison Comparison Comparison Comparison Geographic Areas Geographic Areas Geographic Areas Geographic Areas during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year) Year) Year) Year) 1.1 * (<30th Percentile 1.2 * (<30th Percentile 1.3 * (<30 th Percentile 1.4 * (<30th Percentile 0 of benchmark rates for of benchmark rates for of benchmark rates for of benchmark rates for Comparison Comparison Comparison Comparison Geographic Areas Geographic Areas Geographic Areas Geographic Areas during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year) Year) Year) Year)

We considered increasing percentage point amounts by which to We believe that the proposed achievement benchmarks by a increase benchmarks as the home approach for increasing achievement percentage point amount, rather than by dialysis rate and transplant rate benchmarks over the course of the ETC a percent amount, every two MYs (for observed in Comparison Geographic Model balances the intent of the model example, increasing achievement Areas are not sufficiently similar to design to increase rates of home dialysis benchmarks by 10-percentage points for expect the same percentage point and transplantation above what would MY3 and MY4, by 20-percentage points growth rate for the two rates. have occurred in the absence of the for MY5 and MY6, etc.). However, we We also considered proposing to Model with what is achievable for ETC believe that this percentage point-based modify the Benchmark Year, such that Participants, based on rates of home approach would be less flexible to and the Benchmark Year would be a fixed dialysis and transplantation observed at accommodating of variation in the duration (for example, July 1, 2018 the high ends of the distributions (for underlying distributions of home through June 30, 2019), rather than a additional discussion, see section dialysis and transplant rates than the period of time defined in relation to the IX.B.4.a.(3) of this proposed rule). We percent-based approach we are relevant MY. However, we determined also believe the proposed approach proposing. We also believe this that this approach would not account would provide clarity to ETC percentage point-based approach would for aggregate changes in the home Participants about the benchmarking add additional complexity, as we would dialysis rate and transplant rate over methodology for the duration of the ETC likely need to develop separate time. Model while maintaining flexibility in

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that methodology to address long term We considered using more than two during the Benchmark Year because the trends in the home dialysis rate and strata, in order to increase the precision denominator of the improvement score transplant rate. of the achievement benchmarks and the calculation is zero, and division by zero We seek public comment on our degree of similarity between ETC is undefined. Thus, an aggregation proposal to modify the achievement Participants within a given stratum. group in this situation will not receive benchmarking methodology under However, increasing the number of an improvement score if the Benchmark § 512.370(b) beginning for MY3 to strata would decrease the number of Year rate is zero, even if the aggregation increase achievement benchmarks, and observations within each stratum, in group has made improvements in the the proposal to increase achievement turn decreasing statistical reliability. home dialysis rate and/or the transplant benchmarks by 10 percent every two Additionally, analysis of the rate between the Benchmark Year and MYs above percentile-based rates of distribution of the home dialysis rate MY. observed in Comparison Geographic and transplant rate demonstrates that b. Incentivizing Improvement for Areas. the underlying distribution does not Socioeconomically Disadvantaged lend itself to more than two strata, as (2) Achievement Benchmark Beneficiaries Stratification by Dual-Eligible and Low the distribution is not multi-modal. For Income Subsidy (LIS) Status this reason, we are proposing only two As described in section V.B.5.b of this strata. proposed rule, beneficiaries who are We also propose to modify We seek public comment on our dual-eligible or receive the LIS are less § 512.370(b) to stratify achievement proposal to amend § 512.370(b) to likely than beneficiaries who are not benchmarks based on the proportion of stratify achievement benchmarks based dual-eligible and do not receive the LIS beneficiary years attributed to the ETC on the proportion of attributed to dialyze at home or receive a kidney Participant’s aggregation group for beneficiary years for which attributed transplant. As described previously in which attributed beneficiaries were beneficiaries were dual-eligible or this section of the proposed rule, we are dually-eligible for Medicare and received the LIS, and on our proposal to proposing to stratify achievement Medicaid or received the LIS, based on create two strata for this purpose. benchmarks by the proportion of rates in Comparison Geographic Areas. attributed beneficiary years for 6. PPA Improvement Benchmarking and Under our proposal, we would create beneficiaries who are dual-eligible or Scoring two strata with the cutpoint set at 50 LIS recipients to avoid disadvantaging percent of attributed beneficiary years a. Background on Improvement ETC Participants who provide care for a being for attributed beneficiaries who Benchmarking and Scoring high proportion of these beneficiaries. were dual-eligible or received the LIS. Another part of the scoring However, this proposed stratification As such, there would be one stratum for would not provide a direct financial ETC Participants whose aggregation methodology for the PPA is incentive for ETC Participants to focus groups had 50 percent or more of their improvement scoring. We calculate an on reducing disparities by improving attributed beneficiary years during the ETC Participant’s improvement score the home dialysis rate and transplant MY for beneficiaries who were dual- under § 512.370(c) by comparing MY rate for beneficiaries who are dual- eligible or received the LIS, based on performance on the home dialysis rate eligible or receive the LIS. We are rates in Comparison Geographic Areas and transplant rate against past ETC interested in creating that incentive as for aggregation groups with 50 percent Participant performance. As described part of the ETC Model, as these or more attributed beneficiary years in the Specialty Care Models final rule, beneficiaries may require additional during the Benchmark Year being for the purpose of the improvement score is support from ETC Participants to pursue dual-eligible or LIS beneficiaries. There to acknowledge efforts made in practice home dialysis and transplant as would be a second stratum for ETC transformation to improve rates of home Participants whose aggregation groups dialysis and transplants (85 FR 61318). alternative renal replacement had less than 50 percent of their The percentage improvement in the ETC modalities. attributed beneficiary years during the Participant’s MY performance on the c. Proposed Changes to Improvement MY for beneficiaries who were dual- home dialysis rate and the transplant Benchmarking and Scoring eligible or received the LIS, based on rate relative to the Benchmark Year rate (1) Revised Improvement Calculation rates in Comparison Geographic Areas is scored as follows: for aggregation groups with less than 50 • Greater than 10 percent improvement As described above, when the percent attributed beneficiary years relative to the Benchmark Year rate: Benchmark Year rate for an aggregation during the Benchmark Year being for 1.5 points group is zero, the aggregation group dual-eligible or LIS beneficiaries. We • Greater than 5 percent improvement cannot receive an improvement score, propose to determine whether an relative to the Benchmark Year rate: 1 even if the aggregation group has made attributed beneficiary was dual-eligible point improvements in the home dialysis rate or received the LIS for a given month • Greater than 0 percent improvement and transplant rate between the using Medicare administrative data. We relative to the Benchmark Year rate: Benchmark Year and MY. To address believe this proposal would address 0.5 points this issue, we propose to amend concerns that socioeconomic factors • Less than or equal to the Benchmark § 512.370(c)(1) to change the may impact a beneficiary’s likelihood to Year rate: 0 points improvement calculation such that the receive alternative renal replacement However, when the Benchmark Year aggregation group’s Benchmark Year modalities, lowering the transplant rate rate is zero, an improvement score for rate cannot be zero. Specifically, for and home dialysis rates for ETC the MY cannot be calculated. This is MY3 through MY10, we propose to add Participants who provide services to because, when calculating percent one beneficiary month to the numerator low income beneficiaries. We expect change, as used in improvement of the home dialysis rate and the that stratifying the achievement scoring, the Benchmark Year rate is the transplant rate for the Benchmark Year benchmarks as proposed would increase denominator. As such, we cannot rate for an ETC Participant’s aggregation home dialysis rate and transplant rates calculate percent improvement for an group Benchmark Year when that rate is for such ETC Participants. aggregation group with a rate of zero zero. CMS does not propose to change

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the denominator of the Benchmark Year Equity Incentive would benefit proposed threshold for earning the rate calculations because doing so attributed beneficiaries who are dual Health Equity Incentive would generally would negate the purpose of eligible or receive the LIS, by require significant effort on the part of mathematically correcting ETC encouraging ETC Participants to address the ETC Participant. Participants’ improvement scoring. CMS disparities in access to alternative renal We propose that an ESRD Beneficiary does not expect that adding a replacement modalities among these or Pre-emptive LDT Beneficiary would beneficiary month to the numerator of beneficiaries. We believe that providing be considered to be dual eligible or an the Benchmark Year rate calculations, as this incentive for ETC Participants to LIS recipient for a given month if at any proposed, would affect the increase their home dialysis and point during the month the beneficiary improvement scoring enough to change transplant rate among their dual eligible was dually eligible for Medicare and the number of points awarded to the or LIS beneficiary population would Medicaid or an LIS recipient. We ETC Participant, and has the advantage ultimately reduce this disparity in propose to determine whether an that it would enable an improvement access for the beneficiaries in question. attributed beneficiary was dual-eligible score to be calculated, even when the Therefore, we believe this incentive to or received the LIS using Medicare Benchmark Year rate is zero. reduce socioeconomic disparities in administrative data. access to alternative renal replacement We propose to modify § 512.370(c) (2) Health Equity Incentive modalities would be an improvement to such that the improvement To incentivize ETC Participants to the PPA scoring methodology. benchmarking and scoring methodology decrease disparities in the home dialysis We propose to amend § 512.370(c) to for MY1 and MY2 would be specified at rate and transplant rate between add the Health Equity Incentive to the § 512.370(c)(1), and the improvement beneficiaries who are dual-eligible or improvement scoring methodology, benchmarking and scoring methodology LIS recipients and those who are not, beginning for MY3. We propose that the for MY3 through MY10, described we propose to add a Health Equity Health Equity Incentive would be equal above, would be specified at Incentive to the improvement scoring to 0.5 points, which would be added to § 512.370(c)(2). We seek comment on methodology. We propose to define the the ETC Participant’s improvement the proposal to modify § 512.370(c) Health Equity Incentive at § 512.310 as score for the home dialysis rate or for accordingly. the amount added to the ETC the transplant rate, calculated as We considered using a rolling Participant’s improvement score described in § 512.370(c)(1), such that approach to setting the threshold for calculated as described in the maximum improvement score earning the Health Equity Incentive, § 512.370(c)(1) if the ETC Participant’s would increase from 1.5 points to 2 such that the threshold would be aggregation group demonstrated points for ETC Participants that earn the recalculated every other MY, to reflect sufficient improvement on the home Health Equity Incentive. Therefore, for changes in underlying disparities. dialysis rate or transplant rate for those ETC Participants that earn the Under this approach, we would attributed beneficiaries who are dual- Home Equity Incentive, we propose that calculate the threshold as one standard eligible or LIS recipients between the the ETC Participant’s improvement deviation above the average difference Benchmark Year and the MY. We score for the home dialysis rate and for between the home dialysis rate and the propose that this improvement on the the transplant rate would be the sum of transplant rate for attributed home dialysis rate or transplant rate the improvement score calculated as beneficiaries who are dual-eligible or would be based on the performance of described in § 512.370(c)(1) and the LIS recipients and those beneficiaries the ETC Participant’s aggregation group. Health Equity Incentive. The Health who are not dual-eligible or LIS As noted previously in this section of Equity Incentive would allow ETC recipients, rounded to the nearest the proposed rule, socioeconomic Participants to increase their integer. We would calculate this factors impact a beneficiary’s receipt of improvement score, and thereby threshold either using data from the alternative renal replacement increase their payment adjustment. Benchmark Year, such that ETC modalities. Beneficiaries with limited We propose to award the Health Participants would know the threshold resources may require more assistance Equity Incentive to an ETC Participant for earning the Health Equity Incentive from ESRD facilities and Managing if the ETC Participant’s aggregation in advance of the MY, or using data Clinicians to use alternative renal group’s home dialysis rate and/or from the MY, such that the threshold for replacement modalities. We believe our transplant rate among attributed earning the Health Equity Incentive proposal to add a Health Equity beneficiaries who are dual-eligible or would accurately reflect the magnitude Incentive would benefit these LIS recipients increases by 5 or more of the disparity observed during the MY. beneficiaries and improve scoring for percentage points from the Benchmark However, we believe that setting a home dialysis rate and transplant rate Year to the MY. We believe that 5- threshold for earning the Health Equity for ETC Participants that serve percentage points is the correct Incentive applicable for all MYs, disproportionately high numbers of threshold for awarding the Health beginning for MY3, is more appropriate. beneficiaries with lower socioeconomic Equity Incentive based on our analysis This approach would be in keeping with status. To earn the Health Equity of Medicare claims. Five percentage the intent of the proposed Health Equity Incentive, ETC Participants would have points is one standard deviation above Incentive, which is to provide ETC to demonstrate sufficiently significant the average difference between the Participants a financial incentive to improvement on the home dialysis rate home dialysis rate and the transplant focus on decreasing the disparity in the or transplant rate among their attributed rate for attributed beneficiaries who are home dialysis and transplant rates beneficiaries who are dual eligible or dual-eligible or LIS recipients and those between beneficiaries who are dual- receive the LIS between the Benchmark beneficiaries who are not dual-eligible eligible or LIS recipients, and those who Year and the MY. ETC Participants who or LIS recipients, rounded to the nearest are not. We believe providing ETC earn the Health Equity Incentive would integer. We anticipate improvement in Participants clear information about receive a 0.5 point increase on their home dialysis and transplant rates what they need to achieve to earn the improvement score, thus increasing the among dual-eligible or LIS recipients Health Equity Incentive in advance maximum improvement score to 2 between the MY and the Benchmark would best enable them to work towards points. We believe the proposed Health Year, but we expect that attaining the the goal.

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We propose that ETC Participants in We seek comment on our proposed into the ETC Participant’s home dialysis aggregation groups that fall below a low- definition for the Health Equity rate, transplant waitlist rate, and living volume threshold would be ineligible to Incentive at § 512.310 and our proposal donor transplant rate, to better identify earn the Health Equity Incentive. to amend § 512.370(c) to add the Health care coordination and care management Specifically, we propose that an ETC Equity Incentive to the improvement opportunities, and to have the Participant in an aggregation group with scoring methodology for the home opportunity to seek targeted review of fewer than 11 attributed beneficiary dialysis rate and the transplant rate. We CMS’s calculation of the MPS. The years comprised of months in which also seek comment on our proposal to purpose of the targeted review process, ESRD Beneficiaries and, if applicable, set the threshold for earning the Health established under current § 512.390(b), Pre-emptive LDT Beneficiaries are dual Equity Incentive at 5-percentage points which we would redesignate as eligible or LIS recipients during either improvement from the Benchmark Year paragraph (c), is to determine whether the Benchmark Year or the MY would to the MY. an incorrect PPA has been applied be ineligible to earn the Health Equity during the PPA Period. CMS 7. PPA Reports and Data Sharing Incentive. We selected this particular additionally believes that timely access low-volume threshold for consistency a. Background on Beneficiary to this data is important and proposes with the low-volume threshold for the Attribution and Performance Reporting to require CMS to make this data applicability of the PPA generally, as Under the ETC Model, as described in available twice a year, prior to each PPA specified at § 512.385. We believe it is 42 CFR 512.360, CMS attributes ESRD Period in an MY. In the following sections of this necessary to apply a low volume Beneficiaries and, if applicable, Pre- proposed rule, we describe our threshold in determining whether an emptive LDT Beneficiaries to an ETC proposed process for CMS to share and ETC Participant has earned the Home Participant for each month during a MY for ETC Participants to retrieve certain Equity Incentive to ensure statistical based on the beneficiary’s receipt of reliability of the home dialysis rate and beneficiary-identifiable attribution data services during that month. CMS and performance data, as well as the transplant rate calculations. This performs this attribution for a MY statistical reliability provides protections that would apply to this retrospectively, after the end of the MY. data under a data sharing agreement consistency in the home dialysis rate As described in § 512.365, each ETC and transplant rate calculations. with CMS. We also describe our Participant’s performance is assessed proposed process for sharing certain Therefore, similar results are produced based on the transplant rate and home under consistent conditions when aggregate, de-identified performance dialysis rate among the population of data with ETC Participants. applying a low volume threshold to ETC beneficiaries attributed to the ETC Participants. We are proposing a low- Participant. As described in 42 CFR b. CMS Sharing of Beneficiary- volume threshold specific to attributed 512.370 and 42 CFR 512.380, these rates Identifiable Data beneficiaries who are dual-eligible or are used to calculate the ETC We propose to establish a process in receive the LIS because whether an ETC Participant’s MPS and, in turn, the ETC new § 512.390(b)(1) under which CMS Participant has earned the Health Equity Participant’s PPA. The PPA is then used would share certain beneficiary- Incentive is being assessed on this to adjust certain Medicare payments of identifiable data with ETC Participants subset of attributed beneficiaries. the ETC Participant during 6-month regarding their attributed beneficiaries We propose to amend the Modality PPA periods, with the first PPA Period and performance under the ETC Model. Performance Score (MPS) methodology taking place from July 1, 2022, through We are proposing that, in accordance to incorporate the Health Equity December 31, 2022. As described in 42 with the timing of the notification Incentive. To that end, we propose to CFR 512.390(a), CMS will notify each requirement described in § 512.390(a), modify § 512.370(d) such that the ETC Participant, in a form and manner CMS would be required to make the calculation of the MPS for MY1 and determined by CMS, of the ETC beneficiary-identifiable data pertaining MY2 is specified at § 512.370(d)(1), and Participant’s attributed beneficiaries, to a given PPA Period available for the calculation of the MPS for MY3 MPS, and PPA for a PPA Period no later retrieval by ETC Participants no later through MY10 is specified at than one month before the start of the than 1 month before the start of that § 512.370(d)(2). We propose that the applicable PPA Period. PPA Period. The ETC Participant would formula for the MPS for MY3 through In order to ensure ETC Participant be able to retrieve this data at any point MY10 would be the following: have timely access to these ETC Model during the relevant PPA Period, but, in Modality Performance Score reports, we are proposing to add a new accordance with current § 512.390(b)(1), = 2 paragraph (b) to § 512.390 to establish a which would be redesignated as process for CMS to share certain paragraph (c)(1), the ETC Participant × (Higher of the home dialysis beneficiary-identifiable and aggregate would have 90 days from the date that achievement or (home dialysis data with ETC Participants pertaining to CMS shares the MPS, including the data improvement score + Health Equity their participation in the ETC Model. CMS used in calculating the MPS, to Bonus †)) CMS believes that ETC Participants request a targeted review. We propose + (Higher of the transplant achievement need this data to successfully coordinate that CMS would notify ETC Participants or (transplant improvement score the care of their ESRD Beneficiaries and, of the availability of the beneficiary- + Health Equity Bonus †)) if applicable, Pre-emptive LDT identifiable data for a relevant PPA † The Health Equity Incentive is Beneficiaries; to succeed under the ETC Period and the process for retrieving applied to the home dialysis Model; and to assess CMS’s calculations that data, through the ETC listserv and improvement score or transplant of the individual ETC Participant’s PPA through the ETC Model website, improvement score only if earned by the for a given PPA Period. Specifically, available at https://innovation.cms.gov/ ETC Participant and provided that the CMS believes that ETC Participants innovation-models/esrd-treatment- ETC Participant is not ineligible to must have a clear understanding of the choices-model. receive the Home Equity Incentive as beneficiaries CMS has attributed to Regarding the specific beneficiary- described in proposed them under the ETC Model and how identifiable data that CMS would be § 512.370(c)(2)(iii). each attributed beneficiary has factored required to share with ETC Participants,

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we are proposing in care clearinghouses) are barred from believe that the proposed data § 512.390(b)(1)(ii)(A) to include, when using or disclosing individually disclosures are consistent with the available, the following data for each identifiable health information (called purposes for which the data discussed PPA Period: The ETC Participant’s ‘‘protected health information’’ or PHI) in this rule was collected, and thus, attributed beneficiaries’ names, in a manner that is not explicitly should not run afoul of the Privacy Act, Medicare Beneficiary Identifiers (MBIs), permitted or required under the HIPAA provided we ensure that an appropriate dates of birth, dual-eligible status, and Privacy Rule, without the individual’s Privacy Act system of records ‘‘routine LIS recipient status. We believe that the authorization. The Medicare FFS use’’ is in place prior to making any patient’s name, MBI, and date of birth program, a ‘‘health plan’’ function of the disclosures. The systems of records from constitute the minimum elements to Department, is subject to the HIPAA which CMS would share data are the enable an ETC Participant to properly Privacy Rule limitations on the Medicare Integrated Data Repository identify an attributed beneficiary, and to disclosure of PHI, without an (‘‘IDR’’), system of records number 09– confirm the identity of an attributed individual’s authorization. ETC 70–0571, and the Health Resources and during any communications with a Participants are also covered entities, Services Administration (‘‘HRSA’’) beneficiary or a beneficiary’s caregiver, provided they are health care providers Organ Procurement and Transplantation as appropriate and allowable. In as defined by 45 CFR 160.103 and they Network (‘‘OPTN’’)/Scientific Registry addition, the ETC Participant needs to or their agents electronically engage in of Transplant Recipients (‘‘SRTR’’) Data be aware of each attributed beneficiary’s one or more HIPAA standard System, system of records number 09– dual-eligible status and LIS recipient transactions, such as for claims, 15–0055. status to understand how each eligibility or enrollment transactions. We believe that establishing a attributed beneficiary contributed to The proposed disclosure of ETC regulatory requirement for CMS to share how CMS calculated the ETC Model beneficiary-identifiable data the beneficiary-identifiable data Participant’s Health Equity Incentive, if would be permitted by the HIPAA described above would be appropriate finalized. We propose in Privacy Rule under the provisions that for the ETC Model for several reasons. § 512.390(b)(1)(ii)(B) that this permit disclosures of PHI as ‘‘required First, we believe that all ETC beneficiary-identifiable data also would by law.’’ Under 45 CFR 164.512(a)(1), a Participants not only desire but need include, when available, data regarding covered entity may use or disclose PHI this data to know which beneficiaries the ETC Participant’s performance to the extent that such use or disclosure CMS has attributed to them (and thus is under the ETC Model, including, for is required by law and the use or holding them financially accountable each attributed beneficiary, as disclosure complies with and is limited for such beneficiaries’ individual applicable, the number of months the to the relevant requirements of such contributions to the ETC Participant’s 284 beneficiary was attributed to the ETC law. We are proposing to establish a performance measures described in 42 Participant, received home dialysis, self- requirement under § 512.390(b)(1) for CFR part 512, subpart C, with the dialysis, or nocturnal in-center dialysis, CMS to share this data with ETC proposed modifications described in or was on a transplant waitlist; and the Participants. this proposed rule, if finalized), and for The Privacy Act of 1974 also places number of months that have passed each ETC Participant to understand the limits on agency data disclosures. The since the beneficiary has received a basis by which CMS computed their Privacy Act applies when federal living donor transplant, as applicable. MPS. Second, CMS believes that all ETC agencies maintain systems of records by We believe that sharing these data Participants, regardless of size, would which information about an individual have the capability of managing and elements would help the ETC is retrieved by use of one of the meaningfully using the shared data. We Participant understand and, as individual’s personal identifiers (names, would provide the data in a form and appropriate, seek targeted review of Social Security numbers, or any other manner that CMS believes is user- CMS’s calculation of the ETC codes or identifiers that are assigned to friendly. In addition, the ETC Participant’s MPS, and otherwise the individual). The Privacy Act Participant would be able to review the understand how CMS adjusted the ETC generally prohibits disclosure of beneficiary-identifiable data along with Participant’s Medicare payments by the information from a system of records to the aggregated data, which should help PPA. any third party without the prior written the ETC Participant understand the data We recognize there are sensitivities consent of the individual to whom the CMS would share with the ETC surrounding the disclosure of records apply, 5 U.S.C. 552a(b). Participant. Finally, CMS believes that individually-identifiable (beneficiary- ‘‘Routine uses’’ are an exception to this any other approach to making specific) health information, and we general principle. A routine use is a beneficiary-identifiable data available, note that a number of laws place disclosure outside of the agency that is including the alternative proposal constraints on the sharing of compatible with the purpose for which considered by CMS and described individually identifiable health the data was collected. Routine uses are below, would impose additional information. For example, section 1106 established by means of a publication in operational burdens on CMS and of the Act generally bars the disclosure the Federal Register about the administrative burdens on both CMS of information collected under the Act applicable system of records describing and the ETC Participants without without consent unless a law (statute or to whom the disclosure will be made producing any meaningful privacy or regulation) permits for the disclosure. In and the purpose for the disclosure. We security benefit. this instance, the HIPAA Privacy Rule We considered an alternative proposal provides that legal authority and 284 Under 45 CFR 164.103, ‘‘Required by law’’ for making beneficiary-identifiable data authorizes this proposed disclosure of means ‘‘a mandate contained in law that compels available to ETC Participants based on an entity to make a use or disclosure of protected individually identifiable health health information and that is enforceable in a court the data sharing policies currently used information by us to ETC Participants. of law.’’ It includes, among other things, ‘‘statutes in many models tested under section Under the HIPAA Privacy Rule, covered or regulations that require the production of 1115A of the Act, which would involve entities (defined as health care plans, information, including statutes or regulations that ETC Participants formally requesting the require such information if payment is sought health care providers that submit certain under a government program providing public data from CMS before CMS could share transactions electronically, and health benefits.’’ the data. In particular, ETC Participants

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would have the opportunity to request the section title will more accurately discuss in more detail in later sections the data for their own ‘‘health care reflect the contents of the section. of this proposed rule. This agreement operations’’ and CMS would be We solicit public comment on our also potentially would require the ETC permitted to disclose the requested data proposal to require, under proposed Participant to make certain attestations, based on the HIPAA Privacy Rule § 512.390(b)(1), that CMS make for example, if required under the provisions that permit disclosures of available certain beneficiary-identifiable applicable Privacy Act system of records PHI for the recipient’s health care attribution and performance data for notice. An ETC Participant that wishes operations purposes as described in 45 retrieval by ETC Participants no later to retrieve the beneficiary-identifiable CFR 164.506(c)(4) and § 164.501. Under than one month prior to the start of each data would be required to complete and this alternative approach, ETC PPA Period, and on our considered submit a signed ETC Data Sharing Participants that request this alternative to this proposal. Agreement at least annually. CMS information would have to attest to (1) Conditions for Retrieving believes that it is important for the ETC compliance with specific HIPAA Beneficiary-Identifiable Data Participant to complete and submit a requirements in addition to, or as part signed ETC Data Sharing Agreement at of, the data sharing agreement described Given the sensitive nature of the least annually so that CMS has up-to- in the next section of this proposed rule. beneficiary-identifiable data that CMS date information that the ETC After considering this option, we would be required to share under our Participant wishes to retrieve the believe that having the ETC Participant proposal, we are proposing certain beneficiary-identifiable data attestations request the data from CMS would add conditions for ETC Participants to be (if required), and information on the steps in the process that would cause able to retrieve this data and certain designated data custodian(s). As administrative burden for both CMS and protections that would govern use of the described in greater detail below, we ETC Participants, and operational cost data following retrieval. First, we propose that a designated data and burden for CMS. We further believe propose that CMS would only share the custodian would be the individual(s) that adding these steps would not beneficiary-identifiable data on the that an ETC Participant would identify produce a meaningful privacy or condition that the ETC Participant as responsible for ensuring compliance security benefit based on the specific observes all relevant statutory and with all privacy and security circumstances of this ETC Model. Both regulatory provisions regarding the requirements and for notifying CMS of this option and the approach proposed appropriate use of data and the any incidents relating to unauthorized above would require that the ETC confidentiality and privacy of disclosures of beneficiary-identifiable Participant complete and sign a data individually identifiable health data. sharing agreement, and both would information as would apply to a covered CMS believes it is important for the allow an ETC Participant to decline entity under the Health Insurance ETC Participant to first complete and receiving beneficiary-identifiable data Portability and Accountability Act of submit a signed ETC Data Sharing by declining to complete or sign a data 1996 (HIPAA) regulations and agrees to Agreement before it retrieves any sharing agreement. As such, there are no comply with the terms of a separate data beneficiary-identifiable data to help meaningful privacy or security benefits sharing agreement. Although we expect protect the privacy and security of any that this option would create that are ETC Participants are covered entities beneficiary-identifiable data shared by not already realized by the proposed and must comply with the HIPAA CMS with the ETC Participant. As approach to data sharing in the ETC regulations directly, we are including described previously in this section of Model. We also anticipate that all ETC this provision to ensure an ETC the proposed rule, there are important Participants would want and need, and Participant would abide by those rules sensitivities surrounding the sharing of overwhelmingly would request, the data with respect to the data, even if, for this type of individually identifiable described previously in this section, example, the ETC Participant is a hybrid health information, and CMS must would be capable of handling such data, entity under HIPAA and the component ensure to the best of its ability that any and would take the steps necessary to requesting the data has not been beneficiary-identifiable data that it obtain the data. In addition, under an designated as a health care component shares with ETC Participants would be alternative approach based on the under 45 CFR 164.105. The HIPAA further protected in an appropriate HIPAA provisions for the ETC provisions that the ETC Participant fashion. Participant’s ‘‘health care operations,’’ would have to observe would include, We considered an alternative proposal CMS would only be able to disclose the but would not be necessarily limited to, under which ETC Participants would beneficiary-identifiable data for a standards regarding the use and not need to complete and submit a purpose listed in paragraph (1) or (2) of disclosure of PHI; administrative, signed ETC Data Sharing Agreement, the definition of ‘‘health care physical, and technical safeguards and but we concluded that, if we proceeded operations’’ in 45 CFR 164.501. other security provisions; and breach with this option, we would not have However, we also believe it is crucial notification. adequate assurances that the ETC that an ETC Participant has the We propose that, if an ETC Participant Participants would appropriately opportunity to understand how CMS wishes to retrieve the beneficiary- protect the privacy and security of the calculated the ETC Participant’s PPA for identifiable data, the ETC Participant beneficiary-identifiable data that we are a PPA Period, and have the information would be required to first complete, proposing to share with them. We also needed to request a targeted review of sign, and submit—and thereby agree to considered an alternative proposal CMS’s MPS calculation if the ETC the terms of—a data sharing agreement under which the ETC Participant would Participant believes CMS made an error. with CMS, which we would call the need to complete and submit a signed Given the policies proposed in this ETC Data Sharing Agreement. This ETC Data Sharing Agreement only once section and the following sections agreement would include certain for the duration of the ETC Model. related to data sharing, we propose to protections and limitations on the ETC However, we concluded that this modify the title of § 512.390 from Participant’s use and further disclosure similarly would not give CMS adequate ‘‘Notification and targeted review’’ to of the beneficiary-identifiable data, and assurances that the ETC Participant ‘‘Notification, data sharing, and targeted would be provided in a form and would protect the privacy and security review.’’ We propose this change so that manner specified by CMS, which we of the beneficiary-identifiable data from

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CMS. We concluded that it is critical Participants would be further protected prior written authorization from CMS to that we have up-to-date information and by the ETC Participant, and any use for clinical treatment purposes. designated data custodians, and that business associates of the ETC CMS believes that this beneficiary- requiring the ETC Participant to submit Participant, in an appropriate fashion. identifiable data would be important in an ETC Data Sharing Agreement at least CMS believes that these proposals helping the ETC Participant determine annually would represent the best would allow CMS to accomplish that. which of its ESRD Beneficiaries are not means of achieving this goal. CMS seeks public comment on the on the transplant waitlist or have not We solicit public comment on our additional privacy, security, breach received a living donor transplant, to proposal to require, in notification, and other requirements that inform how the ETC Participant engages § 512.390(b)(1)(iii), that the ETC we would include in the ETC Data in clinical care of the subject ESRD Participant agree to comply with all Sharing Agreement. CMS has these Beneficiary. applicable laws and the terms of the types of agreements in place as part of In addition to the previous two uses, ETC Data Sharing Agreement as a the governing documents of other CMS is also considering limiting, in the condition of retrieving the beneficiary- models tested under section 1115A of ETC Data Sharing Agreement, the ETC identifiable data, and on our proposal in the Act and in the Medicare Shared Participant’s use of the beneficiary- § 512.390(b)(1)(iv) that the ETC Savings Program. In these agreements, identifiable data without prior written Participant would need to submit the CMS typically requires the authorization from CMS to care signed ETC Data Sharing Agreement at identification of data custodian(s) and management and coordination, quality least annually if the ETC Participant imposes certain requirements related to improvement activities, and provider wishes to retrieve the beneficiary- administrative, physical, and technical incentive design and implementation, to identifiable data. safeguards relating to data storage and the extent these activities would transmission; limitations on further use constitute ‘‘health care operations’’ that (2) Content of ETC Data Sharing and disclosure of the data; procedures fall within the first and second Agreement Provisions for Beneficiary- for responding to data incidents and paragraphs of the definition of that Identifiable Data breaches; and data destruction and phrase under the HIPAA Privacy Rule We are proposing in new retention. These provisions would be (45 CFR 164.501). As it relates to case § 512.390(b)(iv) that, under the ETC imposed in addition to any restrictions management and coordination and Data Sharing Agreement, ETC required by law, such as those provided quality improvement activates, CMS Participants would agree to certain in the HIPAA privacy, security and believes that this beneficiary- terms, namely: (1) To comply with the breach notification regulations. These identifiable data would help the ETC requirements for use and disclosure of provisions would not prohibit the ETC Participant to conduct the important this beneficiary-identifiable data that are Participant from making any disclosure task of identifying which ESRD imposed on covered entities by the of the data otherwise required by law. Beneficiaries are not currently on the HIPAA regulations and the CMS is considering limiting the use of transplant waitlist and thus better requirements of the ETC Model set forth beneficiary-identifiable data for specific enable the ETC Participant to engage in 42 CFR part 512; (2) to comply with purposes, either alone or in those beneficiaries, as clinically additional privacy, security, and breach combination. For example, in the ETC appropriate, about the process of signing notification requirements to be specified Data Sharing Agreement, CMS is up for the transplant waitlist, thereby by CMS in the ETC Data Sharing considering imposing limits on how the improving the ETC Participant’s Agreement; (3) to contractually bind ETC Participant may use the performance on the transplant waitlist each downstream recipient of the beneficiary-identifiable data without rate, and increasing the likelihood that beneficiary-identifiable data that is a prior written authorization from CMS to the subject ESRD Beneficiaries would business associate of the ETC specific purposes, such as assessing receive a transplant. In addition, CMS Participant or performs a similar CMS’s calculation of the MPS for a believes that sharing this data with the function for the ETC Participant, to the given PPA Period, the ETC Participant’s ETC Participant would help the ETC same terms and conditions to which the clinical care or ‘‘treatment’’ (as that term Participant to conduct the important ETC Participant is itself bound in its is defined at 45 CFR 164.501) of an task of identifying which ESRD data sharing agreement with CMS as a attributed beneficiary, and certain Beneficiaries are receiving dialysis in- condition of the downstream recipient’s ‘‘health care operations’’ (as that term is center, and to consider whether receipt of the beneficiary-identifiable defined at 45 CFR 164.501) of the ETC furnishing kidney disease patient data retrieved by the ETC Participant Participant. As noted previously in this education services or otherwise making under the ETC Model; and (4) that if the section of the proposed rule, CMS such beneficiaries aware of the ETC Participant misuses or discloses the believes that ETC Participants would possibility of receiving home dialysis, beneficiary-identifiable data in a require this data to be able to request a self-dialysis, or nocturnal in-center manner that violates any applicable targeted review of CMS’s calculation of dialysis, as clinically appropriate in the statutory or regulatory requirements or the MPS as it relates to a given PPA ESRD Beneficiary’s individual situation. that is otherwise non-compliant with Period, as understanding and being able We seek public comment on how an the provisions of the ETC Data Sharing to seek review of CMS’s calculation of ETC Participant might need to, and Agreement, the ETC Participant would the MPS, and thus the reason CMS want to, use the beneficiary-identifiable no longer be eligible to retrieve the adjusted the ETC Participant’s Medicare data retrieved from CMS under the ETC beneficiary-identifiable data and may be payments in the manner it did, is Model to accomplish the goals of the subject to additional sanctions and critical for the ETC Model. Importantly, ETC Model in accordance with penalties available under the law. CMS there is no other source of this applicable law. believes that these terms for sharing information outside of CMS. In addition CMS also seeks public comment on beneficiary-identifiable data with ETC to limiting use to reviewing how CMS what further disclosures of the Participants are appropriate and calculated the ETC Participant’s MPS, beneficiary-identifiable data might be important, as CMS must ensure to the CMS is also considering limiting, in the appropriate to permit or prohibit under best of its ability that any beneficiary- ETC Data Sharing Agreement, use of the the ETC Data Sharing Agreement. For identifiable data that it shares with ETC beneficiary-identifiable data without example, CMS is considering

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prohibiting, in the ETC Data Sharing and breach notification requirements for We solicit public comment on this Agreement, any further disclosure, not the data set forth in the ETC Data proposal, to prohibit the ETC otherwise required by law, of the Sharing Agreement; various security Participant from obtaining beneficiary- beneficiary-identifiable data described requirements like those found in other identifiable data pertaining to the ETC previously in this section of the models tested under section 1115A of Model if the ETC Participant fails to proposed rule to anyone who is not a the Act, but no less restrictive than comply with applicable laws and HIPAA covered entity or business those provided in the relevant Privacy regulations, the terms of the ETC Model, associate, as defined in 45 CFR 160.103, Act system of records notices; how and or the ETC Data Sharing Agreement. or to an individual practitioner in a when beneficiary-identifiable data could (3) Process for Retrieving the ETC Data treatment relationship with the subject be retained by the ETC Participant or its Sharing Agreement and Beneficiary- ESRD Beneficiary or Pre-emptive LDT downstream recipients of the Identifiable Data Beneficiary, or that practitioner’s beneficiary-identifiable data; procedures business associates. Such a prohibition for notifying CMS of any breach or other We propose that we would make the would be similar to that imposed by incident relating to the unauthorized ETC Data Sharing Agreement and CMS in other models tested under disclosure of beneficiary-identifiable beneficiary-identifiable data available in section 1115A of the Act in which CMS data; and provisions relating to a form and manner specified by CMS. shares beneficiary-identifiable data with destruction of the data. These are only We expect to provide a web-based model participants. In the alternative, examples, and are not the only terms platform for ETC Participants to use to CMS is also considering including more CMS would potentially include in the retrieve the beneficiary-identifiable restrictive prohibitions in the ETC Data ETC Data Sharing Agreement. data. CMS would provide ETC Sharing Agreement, which would limit We solicit public comment on this Participants further information about further discloses to only some, one, or proposal that CMS, by adding this web-based platform through the none of the categories of individuals or § 512.390(b)(1)(iv)(B), would impose ETC listserv and the ETC Model website entities described above. certain requirements in the ETC Data at a date to be determined by CMS, but CMS is considering all of these Sharing Agreement related to privacy, at least 1 month before the first PPA possibilities because there exist security, data retention, breach Period begins on June 1, 2022. We important legal and policy limitations notification, and data destruction. expect that CMS would notify ETC on the sharing of the beneficiary- Finally, as described above, CMS Participants of each opportunity to identifiable data discussed previously in proposes, at § 512.390(b)(1)(iv)(D), that retrieve a new set of beneficiary- this section of the proposed rule, and the ETC Data Sharing Agreement would identifiable data and the process for CMS must consider carefully the ways include a term providing that if the ETC accessing the web-based platform to in which and reasons for which we Participant misuses or discloses the receive the data through the ETC listserv would provide access to this data for beneficiary-identifiable data in a and on the ETC Model website. Under purposes of the ETC Model. CMS manner that violates any applicable this proposal, the ETC Participant believes that some ETC Participants may statutory or regulatory requirements or would be required to use the form and require the assistance of business that is otherwise non-compliant with manner specified by CMS (which we associates, such as contractors, to the provisions of the ETC Data Sharing expect will be a web-based platform) to perform data analytics or other Agreement, the ETC Participant would retrieve the data. If the ETC Participant functions using this beneficiary- no longer be eligible to retrieve did not use the form and manner identifiable data to support the ETC beneficiary-identifiable data under specified by CMS or did not agree to the Participant’s review of CMS’s MPS proposed § 512.390(b)(1)(i) and may be ETC Data Sharing Agreement, the ETC calculations, care management and subject to additional sanctions and Participant would be unable to retrieve coordination, quality improvement penalties available under law. We also the beneficiary-identifiable data activities, or clinical treatment of propose to make conforming described previously in this section of attributed beneficiaries. CMS also amendments to 42 CFR 512.160. Section the proposed rule. We propose that ETC believes that this beneficiary- 512.160(b) outlines the remedial actions Participants would be permitted to identifiable data may be helpful for any available under the RO Model and ETC retrieve this data at any point during the HIPAA covered entities who are in a Model, and paragraph (b)(8), in relevant PPA Period. We considered treatment relationship with the subject particular provides that, if CMS establishing certain periods of time ESRD Beneficiary or Pre-emptive LDT determines that one or more grounds for within a PPA Period during which the Beneficiary. remedial action specified in § 512.160(a) ETC Participant would be able to We seek public comment on how an has taken place, CMS may discontinue retrieve the data, but we concluded that ETC Participant might need to, and the provision of data sharing and reports permitting the ETC Participant to obtain want to, disclose the beneficiary- to the model participant. We propose to the data at any point during the relevant identifiable data to other individuals add a new § 512.160(a)(9) to specify PPA Period would be relatively and entities to accomplish the goals of that, for the ETC Model only, CMS may operationally low-burden for CMS while the ETC Model, in accordance with take remedial action if the model providing additional flexibility to the applicable law. participant misuses or discloses the ETC Participant. Under our proposal, the ETC Data beneficiary-identifiable data in a CMS believes that it is important that Sharing Agreement would include other manner that violates any applicable the ETC Participant complete and provisions, including requirements statutory or regulatory requirements or submit its signed ETC Data Sharing regarding data security, retention, that is otherwise non-compliant with Agreement, and retrieve the beneficiary- destruction, and breach notification. For the provisions of the applicable data identifiable data, in the same form and example, we are considering including, sharing agreement. This proposed manner (which we expect to be a web- in the ETC Data Sharing Agreement, a change, if finalized, would align the based platform). requirement that the ETC Participant regulatory provision on remedial action In the alternative, we considered designate one or more data custodians with the proposed remedial action we providing the beneficiary-identifiable who would be responsible for ensuring propose to include in the ETC Data data to ETC Participants via paper mail compliance with the privacy, security Sharing Agreement. rather than through a web-based

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platform, but we concluded that making finalized, Health Equity Incentive; the Agreement and beneficiary-identifiable the data available through a web-based ETC Participant’s aggregation group’s data on the same web-based platform, platform would reduce administrative scores on the home dialysis rate, we believe it would be convenient for burden on both CMS and the ETC transplant waitlist rate, living donor the ETC Participant if CMS shared the Participants. We also concluded that transplant rate, and, if finalized, Health aggregate data on the same web-based making this beneficiary-identifiable data Equity Incentive; information on how platform. available through a web-based platform the ETC Participant’s and ETC In the alternative, we considered would allow CMS to provide the data in Participant’s aggregation group’s scores sending this aggregate data to the ETC a manner that is more secure than if relate to the achievement benchmark Participant via paper mail. However, CMS were to make the data available and improvement benchmark (that is, CMS concluded that it would be more through paper mail. By using a web- whether the ETC Participant met or convenient to the ETC Participant to based platform, to be further described exceeded the threshold for each such retrieve this data from a web-based by CMS through the ETC listserv and benchmark); and the ETC Participant’s platform rather than via paper mail, and the ETC Model website, CMS would MPS and PPA for the corresponding that sending this data via paper mail help ensure that only authorized users PPA Period. CMS believes that sharing would represent significant would be able to obtain the data, and this aggregate, de-identified data with administrative and operational burdens would be able to implement a two-factor the ETC Participant would be important for CMS. authentication to help ensure that no to help the ETC Participant better We solicit public comment on our one other than an ETC Participant understand its performance in the ETC proposal to share aggregate data would have access to the data. In Model relative to its aggregation group generally, to share aggregated data in the addition, we concluded that it would be and to the achievement and same form and manner we are more efficient to provide the ETC Data improvement benchmarks against which proposing to use for sharing beneficiary- Sharing Agreement and the beneficiary- CMS is measuring the ETC Participant’s identifiable data. We also solicit public identifiable data itself through the same performance. Whereas the beneficiary- comment on our expectation to use a form and manner (which we expect to identifiable data described previously in web-based platform for this purpose, as be a web-based platform), rather than this section of the proposed rule would well as our considered alternative to using two different processes and that indicate which ESRD Beneficiaries and, share the aggregate data via paper mail. using a web-based platform would be if applicable, Pre-emptive LDT more efficient than paper mail. For 8. Medicare Waivers and Additional Beneficiaries the ETC Participant could Flexibilities these reasons, we believe the best option devote greater resources to, CMS would be for us to use only the web- believes this aggregate, de-identified a. Background on Kidney Disease based platform both for providing the data would better enable the ETC Patient Education Services Waiver ETC Data Sharing Agreement and for Participant to see which performance Pursuant to section 1861(ggg)(1) of the sharing data pertaining to the ETC rates the ETC Participant might need to Act and § 410.48 of our regulations, Model. improve to more generally improve its Medicare Part B covers outpatient, face- We solicit public comment on our performance under the ETC Model. proposal to require the ETC Participant to-face kidney disease patient education to complete and submit a signed ETC We are proposing that CMS would services provided by certain qualified Data Sharing Agreement before the ETC make this data available to the ETC persons to beneficiaries with Stage IV Participant could retrieve the Participant for retrieval in a form and chronic kidney disease. As noted in the beneficiary-identifiable data, and on our manner to be specified by CMS no less Specialty Care Models final rule, kidney proposal that the ETC Participant would than one month prior to each PPA disease patient education services play be required to retrieve the beneficiary- Period. We expect that CMS would an important role in educating patients identifiable data in the same form and make this data available to the ETC about their kidney disease and to help manner as the ETC Participant receives Participant on the same web-based them make informed decisions on the and submits the ETC Data Sharing platform on which CMS would be appropriate type of care and/or dialysis Agreement. We also solicit comment providing the beneficiary-identifiable needed for them (85 FR 61337). In regarding our expectation that we will data described previously in this addition, we noted in the Specialty Care use a web based platform, rather than section. The ETC Participant would be Models final rule that kidney disease paper mail, for these purposes. required to use the form and manner patient education services are designed specified by CMS to retrieve this to educate and inform beneficiaries e. CMS Sharing of Aggregate Data aggregate data, but would not have to about the effects of kidney disease, their In addition to the proposed process agree to the ETC Data Sharing options for transplantation, dialysis for sharing beneficiary-identifiable data Agreement to retrieve this aggregated modalities, and vascular access (85 FR described previously in this section, we data, as it is not beneficiary-identifiable. 61337). Because kidney disease patient are proposing in § 512.390(b)(2) that We believe that using a web-based education services have been CMS would make available certain platform for sharing this aggregate data infrequently billed, we found it aggregate data for retrieval by the ETC would be appropriate for the same necessary for purposes of testing the Participant, in a form and manner to be reasons it would be appropriate for ETC Model to waive select requirements specified by CMS, no later than one sharing the beneficiary-identifiable data. of kidney disease patient education month before each PPA Period. This By using a web-based platform, CMS services authorized in section aggregate performance data, would would help ensure that only authorized 1861(ggg)(1) of the Act and in the include, when available, the following users would be able to obtain the data, implementing regulation at 42 CFR information for each PPA Period, de- and would be able to implement a two- 410.48. Specifically, to broaden the identified in accordance with 45 CFR factor authentication to help ensure that availability of kidney disease patient 164.514(b): The ETC Participant’s no one other than an ETC Participant education services under the ETC performance scores on the home would have access to the data. In Model, we have used our authority dialysis rate, transplant waitlist rate, addition, because CMS would be under section 1115A(d) of the Act to living donor transplant rate, and, if providing the ETC Data Sharing waive certain requirements for

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individuals and entities that furnish and COVID–19. We established several disease patient education services is bill for kidney disease patient education flexibilities to accommodate these consistent with one of the main goals of services. We codified these waivers at changes in the delivery of care. Through the ETC Model, insofar as we believe § 512.397(b). These include waivers to waiver authority under section that education, as delivered through allow more types of beneficiaries to 1135(b)(8) of the Act, in response to the kidney disease patient education have access to kidney disease patient PHE for COVID–19, we temporarily services, helps improve beneficiary education services, as well as greater waived the geographic and site of choice of dialysis modality. flexibility in how the kidney disease service originating site restrictions in In addition, we believe that removing patient education services are section 1834(m)(4)(C) of the Act. For beneficiary cost barriers for kidney performed. For instance, CMS waived example, CMS waived the rural area disease patient education services the requirement that kidney disease requirement at section 1834(m) of the would be helpful. As we demonstrate patient education services are covered Act to allow for telehealth services, below, there is a significant relationship only for Stage IV chronic kidney disease including kidney disease patient between household income or poverty (CKD) patients to permit beneficiaries to education services that can be furnished status and kidney disease, and removing receive kidney disease patient education via telehealth, to be furnished to or mitigating cost barriers to access to services if they are diagnosed with CKD beneficiaries in any geographic area, kidney disease patient education Stage V or are in the first 6 months of regardless of location and in their services would likely increase the starting dialysis to receive the benefit. homes, for the duration of the PHE. number of beneficiaries who would be CMS also waived the requirements in These waivers are set to terminate at the willing to receive kidney disease patient section 1861(ggg)(2)(A)(i) of the Act and end of the COVID–19 PHE. education services. § 410.48(a) and (c)(2)(i) of the applicable We therefore propose that, starting in We believe that, once the PHE ends, MY3, kidney disease patient education regulations pertaining to the definition these waivers removing the geographic of ‘‘qualified person’’ such that services may be furnished to certain and site of service originating site beneficiaries via telehealth in a manner registered dieticians/nutrition restrictions for kidney disease patient professionals, licensed clinical social that is more flexible than that required education services furnished via under existing telehealth requirements. workers, or a clinic/group practice may telehealth would be necessary solely for furnish kidney disease patient In addition, we propose to permit the purposes of testing the ETC Model. education services under the direction reduction or waiver of coinsurance for Except under very limited of, and incident to the services of a the kidney disease patient education circumstances, under section 1834(m) of Managing Clinician who is an ETC services, starting in MY3. the Act and its implementing Participant. regulations, the originating site where (1) Kidney Disease Patient Education Finally, CMS waived two Services Telehealth Waiver requirements relating to the content of the beneficiary is located at the time a kidney disease patient education telehealth service is furnished is limited CMS proposes to amend § 512.397 to services furnished to a beneficiary. CMS to certain, mostly rural, geographic add a waiver of certain telehealth waived the requirement under locations and a site of service that is one requirements to provide qualified staff, § 410.48(d)(1) of our regulations that the of certain types of health care facilities. as we are proposing to define for content of kidney disease patient We believe that allowing qualified staff purposes of the ETC Model at § 512.310, education services include the to furnish kidney disease patient the flexibility to furnish kidney disease management of co-morbidities, education services via telehealth, patient education services via telehealth including delaying the need for dialysis, regardless of the beneficiary’s for the reasons described above. when such services are furnished to geographic area or the site of the Specifically, we propose to waive the beneficiaries with CKD Stage V or beneficiary, and regardless of the site of geographic and site of service ESRD, unless such content is relevant service of the practitioner, would originating site requirements in sections for the beneficiary. In addition, CMS increase access to kidney disease patient 1834(m)(4)(B) and 1834(m)(4)(C) of the waived the requirement under education services for a few reasons. Act, and in our regulations at 42 CFR § 410.48(d)(5)(iii) of our regulations that First, some beneficiaries may not have 410.78(b)(3) and (4), for kidney disease an outcomes assessment designed to access to reliable transportation, patient education services furnished via measure beneficiary knowledge about especially those beneficiaries who telehealth. We believe the kidney chronic kidney disease and its treatment suffered economically during the disease patient education services be performed during one of the kidney ongoing PHE, but may have access to telehealth waiver would allow more disease patient education services, the technology necessary for Medicare beneficiaries to receive kidney requiring instead that such outcomes practitioners to furnish kidney disease disease patient education services via assessment is performed within 1 month patient education services. Moreover, telehealth by removing the originating of the final kidney disease patient some beneficiaries, even those with site restrictions, thus allowing for the education services session furnished by reliable transportation, may be more beneficiary to be located anywhere, and qualified staff. comfortable receiving kidney disease including at a site not specified in patient education services via telehealth § 410.78(b)(3) of our regulations; and by b. Proposed Kidney Disease Patient rather than appearing in person after allowing for the beneficiary to be Education Services Telehealth Waiver over a year of social distancing, even located outside of a rural area. CMS also and Additional Flexibilities when it becomes safe according to proposes to waive the requirement in Many changes took place in 2020 and Federal guidance for such beneficiaries section 1834(m)(2)(B) of the Act and 42 early 2021 due to the COVID–19 PHE. to enter physical spaces with other CFR 414.65(b) such that CMS would not Legislation enacted to address the PHE individuals. This is especially likely to pay an originating site facility fee for for COVID–19 provided the Secretary be the case for instances in which a kidney disease patient education with new authorities under section practitioner would furnish kidney services furnished via telehealth to a 1135(b)(8) of the Act to waive or modify disease patient education services in a beneficiary at a site not specified in Medicare telehealth payment group session rather than an individual § 410.78(b)(3) of our regulations under requirements during the PHE for session. Increasing access to kidney this proposed waiver, if finalized.

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However, we do not propose to waive regulations. We further seek comment G0420 under the CY2021 Physician Fee the requirement under section on our proposal to waive the originating Schedule is $114.10; for G0421, it is 1834(m)(1) of the Act and 42 CFR site facility fee requirements such that $27.22. As such, a beneficiary would be 410.78(b) that telehealth services be CMS would not pay an originating site required to pay $22.82 for an individual furnished via an ‘‘interactive facility fee for kidney disease patient session of kidney disease patient telecommunications system,’’ as that education services furnished via education services or $5.44 for kidney term is defined in § 410.78(a)(3) to mean telehealth to a beneficiary at a site not disease patient education services multimedia communications equipment specified in § 410.78(b)(3) of our furnished to a group, which may be that includes, at a minimum, audio and regulations. higher or lower depending on certain video equipment permitting two-way, factors, such as the geographic location (2) Kidney Disease Patient Education real-time interactive communication of the beneficiary. Medicare covers up Services Beneficiary Coinsurance between the patient and distant site to six kidney disease patient education Waiver physician or practitioner. Accordingly, services for an individual beneficiary we would continue to require that the Available data and scholarly research during that beneficiary’s lifetime, kidney disease patient education suggest that there is a significant meaning that a beneficiary may be services furnished via telehealth be relationship between socioeconomic required to pay $136.92 if six individual provided through an interactive status and prevalence of CKD. For kidney disease patient education telecommunications system; audio-only example, evidence suggests that CKD is services are clinically appropriate for telehealth services would not be more prevalent among individuals with that beneficiary, or $32.64 if six group permitted. lower income.285 In addition, at least kidney disease patient education We propose that kidney disease one study suggests that as an services are clinically appropriate for patient education services could be individual’s CKD severity increases (for that beneficiary. furnished via telehealth health only by example, from CKD III to CKD IV), the CMS believes that it is necessary, for qualified staff. We used the term likelihood of the CKD patient falling purposes of testing the ETC Model, to ‘‘clinical staff’’ and ‘‘qualified staff’’ in into poverty increases.286 In light of this permit ETC participants the flexibility the Specialty Care Models final rule, but research, CMS believes that cost to reduce or waive the 20 percent did not provide definitions of these represents a meaningful barrier for coinsurance requirement for kidney terms. For clarity, we now propose to beneficiaries in accessing kidney disease patient education services. We define ‘‘clinical staff’’ and ‘‘qualified disease patient education services. believe this patient incentive, if staff’’ in 42 CFR 512.310. We propose to While there does not appear to be any finalized, would increase the provision define ‘‘clinical staff’’ to mean a research that explicitly investigates to of kidney disease patient education licensed social worker or registered what extent cost barriers preclude services to beneficiaries, given the dietician/nutrition professional who access to kidney disease patient relationship between income or poverty furnishes services for which payment education services, the identified and prevalence of CKD, and the may be made under the physician fee relationship between household income relationship between kidney disease schedule under the direction of and or poverty status and prevalence of CKD patient education services and incident to the services of the Managing suggests that cost is an important factor progression of CKD. CMS has Clinician who is an ETC Participant. We when considering a beneficiary’s access determined that, if this proposal were are proposing to define the term clinical to kidney disease patient education finalized, this CMS-sponsored patient staff in this manner to describe those services. incentive would advance the ETC clinicians who are authorized to furnish Under section 1833 of the Act, the Model’s goal of increasing access to kidney disease patient education amounts paid by Medicare for kidney kidney disease patient education services only pursuant to the waiver disease patient education services are services, and to making beneficiaries specified at § 512.390(b)(1)—namely equal to 80 percent of the applicable more aware of their choices in preparing licensed social workers and registered payment amount; beneficiaries are thus for kidney treatment, including the dieticians/nutrition professionals. The subject to a 20 percent coinsurance for choice of receiving home dialysis, self- remaining clinicians currently specified kidney disease patient education dialysis, or nocturnal in-center dialysis, in § 512.390(b)(1)—doctors, physician services. Kidney disease patient rather than traditional in-center dialysis. assistants, nurse practitioners, and education services can be billed under Accordingly, beginning January 1, clinical nurse specialists—fall within G0420 for an individual session, or 2022, we propose at § 512.397(c) to the existing definition of qualified under G0421 for a group session. The permit ETC Participants to reduce or person at 42 CFR 410.48(a). We current national unadjusted payment for waive the beneficiary coinsurance therefore propose to define ‘‘qualified obligations for kidney disease patient staff’’ to mean both clinical staff and any 285 Table 1.2 in United States Renal Data System, education services furnished to an 2020 Annual Report, Chronic Kidney Disease: eligible beneficiary who does not have qualified person (as defined at Chapter 1, CKD in the General Population, available § 410.48(a) of our regulations) who is an at https://adr.usrds.org/2020/chronic-kidney- secondary insurance on the date the ETC Participant. disease/1-ckd-in-the-general-population (indicating kidney disease patient education We seek comment on our proposal to that the prevalence of CKD in those above the services are furnished if certain poverty line is 14.4 percent while the prevalence of waive the originating site requirements CKD in those below the poverty line is 17.4 percent. conditions are satisfied. We refer to this for telehealth services to allow qualified See also McClellan, W.M., et al., Poverty and Racial patient incentive herein as the ‘‘kidney staff to furnish kidney disease patient Disparities in Kidney Disease: The REGARDS Study, disease patient education services education services via telehealth to a Am. J Nephrol, 2010, Volume 32, Issue 1, pages 38– coinsurance patient incentive.’’ As more 46, available at https://www.ncbi.nlm.nih.gov/pmc/ beneficiary regardless of where the articles/PMC2914392/ (providing data suggesting fully explained below, we expect to beneficiary is geographically located that lower household income is associated with make a determination that the anti- such that kidney disease patient higher prevalence of CKD). kickback statute safe harbor for CMS- education services could be furnished 286 Morton, R.L, et al., Impact of CKD on sponsored model patient incentives (42 via telehealth regardless of the Household Income, Kidney International Reports, CFR 1001.952(ii)(2)) would be available Volume 3, Issue 3, 2018, pages 610–618, available beneficiary’s location, including at a site at https://www.sciencedirect.com/science/article/ to protect cost-sharing support that is not specified in § 410.78(b)(3) of our pii/S2468024917304795?via%3Dihub. furnished in compliance with ETC

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Model requirements with respect to receive a referral from their physician is in accordance with 42 CFR 512.135(b) kidney disease patient education important for ensuring that kidney and (c) of this part. services. If CMS makes such a disease patient education services are We further propose in proposed 42 determination, the safe harbor for CMS- furnished only to beneficiaries for CFR 512.160(b)(6)(ii) that, for the ETC sponsored model patient incentives whom it is clinically appropriate. Model only, CMS could suspend or would protect an ETC Participant, as CMS proposes that such coinsurance terminate the ability of an ETC that term is defined at § 512.310, who support would be permitted for the Participant to offer the kidney disease offers a reduction or waiver of kidney disease patient education patient education services coinsurance coinsurance for kidney disease patient services offered either in-person or via patient incentive if CMS determined education services to beneficiaries who telehealth, and that it would be that any grounds for remedial action are eligible to receive kidney disease permitted for both individual sessions exist pursuant to § 512.160(a). patient education services, including and group sessions. However, we are In lieu of a waiver of certain fraud and those eligible pursuant to the waiver considering limiting the kidney disease abuse provisions in sections 1128A and described in § 512.397(b)(2), and who patient education services coinsurance 1128B of the Act, CMS may determine do not have secondary insurance on the patient incentive to kidney disease that the anti-kickback statute safe harbor date that the kidney disease patient patient education services furnished to CMS-sponsored model patient education services were furnished. an individual beneficiary, rather than incentives (42 CFR 1001.952(ii)(2)) is We are proposing that the kidney allowing the kidney disease patient available to protect the reduction or disease patient education services education services coinsurance patient waiver of kidney disease patient coinsurance patient incentive would be incentive for kidney disease patient education services coinsurance available to the ETC Participant for education services furnished either permitted under the ETC Model final kidney disease patient education individually or to a group. The cost rule, if issued. Specifically, we expect to services furnished by an individual or burden on beneficiaries who receive determine that the CMS-sponsored entity who is qualified staff. This kidney disease patient education model safe harbor will be available to proposal would align with the services in a group setting is much protect the reduction or waiver of individuals who may furnish kidney lower than it is on beneficiaries who coinsurance that satisfies the disease patient education services under receive kidney disease patient education requirements of such safe harbor and § 512.397(b) of this subpart, which are services individually. However, we are the provisions of proposed we replacing in its entirety to concerned that any cost barrier to § 512.397(c)(1). We propose that, if we standardize certain terms and add kidney disease patient education make this determination, we would clarity, as described in greater detail services, even if low, represents a specify in regulation text at below. meaningful barrier to some beneficiaries § 512.397(c)(4) that the safe harbor is We are proposing to limit the kidney who would otherwise elect to receive available. disease patient education services such services. We solicit comments on We are also considering prohibiting coinsurance patient incentive to this issue. on an ESRD facility or other entity from beneficiaries who do not have An ETC Participant that offers providing qualified staff or the ETC secondary insurance, as secondary coinsurance support for kidney disease Participant with financial support to insurance typically provides cost- patient education services would be enable such qualified staff or ETC sharing support of the type CMS is required to maintain records of certain Participant to provide the kidney proposing in this proposed rule. We also information. Specifically, an ETC disease patient education services believe that limiting the kidney disease Participant that offers the kidney coinsurance patient incentive. CMS is patient education services coinsurance disease patient education services concerned that permitting such patient incentive to beneficiaries coinsurance patient incentive would be financial support may encourage without secondary insurance would required to maintain records of the unlawful or abusive arrangements better ensure that only beneficiaries following: The identity of the qualified designed to induce or reward referrals who need cost-sharing support would staff who furnished the kidney disease for Federal health care program receive it, rather than permitting cost- patient education services for which the business. We solicit comments on sharing support for all beneficiaries for coinsurance was reduced or waived; the whether this prohibition is a necessary whom kidney disease patient education date the kidney disease patient to safeguard against fraud and abuse or services are clinically appropriate. education services coinsurance patient if other laws effectively provide We are also proposing that the kidney incentive was provided; the identity of sufficient protection. disease patient education services the beneficiary to whom the kidney We also considered waiving Medicare coinsurance patient incentive would be disease patient education services payment requirements such that CMS available only for kidney disease patient coinsurance patient incentive was would pay the full amount of the kidney education services that were furnished provided; evidence that the beneficiary disease patient education services in compliance with the applicable who received the kidney disease patient furnished to a beneficiary who does not provisions of § 410.48 of our education services coinsurance patient have secondary insurance, rather than regulations, which includes a incentive was eligible to receive the just 80 percent of the amount. Under requirement that a beneficiary obtain a kidney disease patient education section 1115A(d)(1) of the Act, the referral from the physician (as defined services and did not have secondary Secretary may waive such requirements in section 1861(r)(1) of the Act) insurance; and the amount of the kidney of titles XI and XVIII and of sections managing the beneficiary’s kidney disease patient education services 1902(a)(1), 1902(a)(13), condition in order for the beneficiary to coinsurance patient incentive reduced 1903(m)(2)(A)(iii) of the Act, and certain be eligible to receive kidney disease or waived by the ETC Participant. We provisions of section 1934 of the Act as patient education services. We are propose to require an ETC Participant may be necessary solely for purposes of proposing to include this requirement that offers this kidney disease patient carrying out section 1115A of the Act because we waived some but not all education services coinsurance patient respect to testing models described in provisions of § 410.48, and we believe incentive to maintain and provide the section 1115A(b) of the Act. This is the that the requirement that the beneficiary government with access to these records authority under which we would waive

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such Medicare payment requirements. who are permitted to furnish kidney proposals. Respondents are advised that Under such a policy, Medicare would disease patient education services under the U.S. Government will not pay for pay 100 percent of the payment amount the ETC model programmatic waivers. any information or administrative costs for kidney disease patient education Specifically, as discussed previously, incurred in response to this RFI; all services furnished by Managing CMS is proposing to add definitions for costs associated with responding to Clinicians who are ETC Participants to ‘‘clinical staff’’ and ‘‘qualified staff’’ in these RFIs will be solely at the beneficiaries who do not have this proposed rule, and CMS believes respondent’s expense. Failing to secondary insurance, and such clarifying how CMS discusses these respond to either RFI will not preclude beneficiaries would have no cost- individuals in § 512.397(b) will enhance participation in any future procurement, sharing obligation for that benefit. clarity. Finally, CMS is proposing to if conducted. However, we determined that this remove the ‘‘clinic/group practice’’ from Please note that CMS will not respond policy would likely represent too large the list of individuals or entities that are to questions about the policy issues an impact to the ETC Model’s savings permitted to furnished kidney disease raised in these RFIs. CMS may or may estimates, and thus would potentially patient education services under the not choose to contact individual jeopardize our ability to continue to test ETC Model programmatic waivers, and respondents. Such communications the ETC Model, if such a policy were to remove the waiver of 42 CFR would only serve to further clarify finalized. 410.48(c)(2)(i) from § 512.397(b)(1) of written responses. Contractor support Given the policies proposed in this this part. CMS believes that its inclusion personnel may be used to review RFI section related to programmatic waivers of clinic/group practices previously was responses. Responses to these RFIs are and additional flexibilities available in error; a clinic/group practice is not not offers and cannot be accepted by the under the ETC Model, we propose to able to furnish or bill for kidney disease U.S. Government to form a binding modify the title of § 512.397 from ‘‘ETC patient education services under contract or issue a grant. Information Model Medicare program waivers’’ to existing law and CMS did not intend for obtained because of this RFI may be ‘‘ETC Model Medicare program waivers the waiver described in § 512.397(b) to used by the U.S. Government for and additional flexibilities.’’ We permit anyone other than a clinican to program planning on a non-attribution propose this change so that the section furnish kidney disease patient basis. Respondents should not include title would more accurately reflect the education services. Because the waiver any information that might be contents of the section if our proposed of the requirements under 42 CFR considered proprietary or confidential. kidney disease patient education 410.48(c)(2)(i) was implemented only to All submissions become U.S. services coinsurance patient incentive is broaden the ‘‘qualified person’’ that Government property and will not be finalized. could furnish kidney disease patient returned. CMS may publicly post the We solicit public comments on our education services pursuant to comments received, or a summary proposal to allow qualified staff, as we § 512.397(b)(1) to include a clinic/group thereof. propose to define the term under practice, we are proposing to remove § 512.310, to offer coinsurance support references to 42 CFR 410.48(c)(2)(i) in 1. Peritoneal Dialysis Catheter for kidney disease patient education § 512.397(b)(1) of this part. Placement services to beneficiaries who are eligible We solicit public comments on these The most common modality of home for such services, including those proposed changes to § 512.397(b) to dialysis is peritoneal dialysis (PD). In eligible under § 512.397(b)(2), and who make conforming and clarifying changes order to perform PD, a beneficiary needs do not have secondary insurance on the to the manner in which CMS discusses placement of a PD catheter. A PD date the kidney disease patient kidney disease patient education catheter is a flexible plastic tube that education services are furnished. We services and the individuals who are enables dialysate to enter the abdomen also solicit comment on our proposal to permitted to furnish kidney disease for blood filtration purposes. The require the ETC Participant to maintain patient education services under the catheter is generally installed via and provide the government with access ETC Model waivers described in outpatient surgery, as it is an invasive to records regarding the use of the § 512.397(b), and to our proposed procedure. kidney disease patient education removal of ‘‘clinic/group practice’’ from However, CMS has heard concerns services coinsurance patient incentive. the list of individuals or entities who from numerous stakeholders about their (3) Revising Language Providing Other may, under the ETC Model waivers ability to effectively get PD catheters ETC Model Medicare Program Waivers described in § 512.397(b), furnish installed in beneficiaries who may be kidney disease patient education otherwise interested in home dialysis. We propose to revise § 512.397(b)(1) services. These stakeholders reported a variety of through (4) in their entirety to issues related to PD catheter placement, accomplish a few goals. First, we C. Requests for Information (RFIs) on Topics Relevant to the ETC Model including the lack of availability of propose to make conforming changes vascular surgeons to perform PD throughout § 512.397(b) to the manner This section includes several requests catheter placements, lack of appropriate in which CMS discusses kidney disease for information (RFIs). In responding to operating room time, and a lack of patient education services. Currently, the RFIs, the public is encouraged to training on PD catheter placement for § 512.397(b) includes references to provide complete, but concise vascular surgeons.287 As many ‘‘KDE services,’’ ‘‘the KDE benefit,’’ responses. These RFIs are issued solely stakeholders have pointed out, the lack ‘‘KDE sessions,’’ and, simply, ‘‘KDE.’’ for information and planning purposes; of timely PD catheter placement is a key CMS would change all of these RFIs do not constitute a Request for barrier preventing many beneficiaries references to ‘‘kidney disease patient Proposal (RFP), application, proposal from being able to use PD as a dialysis education services’’ for clarity and to abstract, or quotation. The RFIs do not modality. conform with the term used elsewhere commit the U.S. Government to contract Based on these issues, we seek in our regulations. In addition, we for any supplies or services or make a feedback about how CMS can test and propose to make conforming changes grant award. Further, CMS is not through § 512.397(b) to the manner in seeking proposals through these RFIs 287 https://www.ncbi.nlm.nih.gov/pmc/articles/ which CMS discusses the individuals and will not accept unsolicited PMC2924406/#B38.

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use Medicare payment policy, under the • How would a patient experience All submissions become U.S. ETC model, to promote placement of PD measure be best used to further the Government property and will not be catheters. Specifically, we are seeking purpose of the ETC Model? returned. CMS may publically post the feedback on the following questions: • How should CMS use a patient comments received, or a summary • What are the key barriers to experience measure to assess the quality thereof. increased placement of PD catheters? of care of beneficiaries? • • How should CMS use a patient A. Informing Payment Reform Under the How can CMS promote placement ESRD PPS of PD catheters in a more timely experience measure to incentivize manner? improved quality of care in the ETC Over the last several years, CMS, in • Should the Innovation Center use Model and/or for other CMS programs? conjunction with its contractor, has its authority to test alternative payment While we will not be responding to been conducting research, including structures to address the barriers to PD specific comments submitted in holding three technical expert panels catheter placement as a part of the ETC response to this Request for Information, (TEPs), to explore possible Model? If so, why and how? CMS intends to use this input to inform improvements to the ESRD payment our future quality measure efforts. model. Additionally, in the CY 2020 2. Beneficiary Experience Measure CMS is considering publishing the ESRD PPS proposed rule (84 FR 38398 The ETC Model uses two ESRD quality outcomes for the ETC Model. through 38400), CMS invited further facility quality measures; Standardized While we seek comments on any aspect comment on a number of topics, Mortality Ratio (SMR) (NQF #0369) and of reporting quality data, we specifically including expanding the outlier policy Standardized Hospitalization Ratio want input on the following: to include composite rate drugs, • What is the frequency with which (NQF #1463). Both measures are laboratory tests and supplies; reporting CMS should disseminate the results? currently calculated and displayed on the length of each dialysis session • What should be the unit of analysis directly on the ESRD claim; patient Dialysis Facility Compare, a public for the reported data? characteristics which contribute reporting tool maintained by CMS. significantly to the cost of dialysis care; Because data collection and measure VI. Requests for Information and improving the quality of facility- reporting are ongoing through claims, This section addresses several level data as reflected in the Medicare there is no additional burden to ETC requests for information (RFIs). Upon cost report. Stakeholders have asked Participants. reviewing the RFIs, respondents are CMS to explore a refined case-mix In the Specialty Care Models encouraged to provide complete, but adjustment model for the ESRD PPS, proposed rule, we considered including concise responses. These RFIs are stating that the existing case mix the In-Center Hemodialysis (ICH) issued solely for information and adjustors may not correlate well with Consumer Assessment of Healthcare planning purposes; RFIs do not the current cost of dialysis treatment. Providers and Systems Survey constitute a Request for Proposal (RFP), ® Under section 632(b) of ATRA, as (CAHPS) survey to monitor beneficiary application, proposal abstract, or amended by section 217(a) of PAMA perceptions of changes in quality of care quotation. The RFIs do not commit the and section 204 of the ABLE Act, oral- as a result of the ETC Model (84 FR United States (U.S.) Government to only drugs cannot be incorporated into 34565). However, the ICH CAHPS contract for any supplies or services or the ESRD PPS bundled payment until survey includes only beneficiaries who make a grant award. Further, CMS is not January 1, 2025. In order to provide receive in-center dialysis, and seeking proposals through these RFIs payment for oral-only renal dialysis specifically excludes the two and will not accept unsolicited service drugs and biologicals under the beneficiary populations that the ETC proposals. Responders are advised that ESRD PPS beginning January 1, 2025, as Model focuses on: Beneficiaries who the U.S. Government will not pay for provided in 42 CFR 413.174(f)(6), we dialyze at home and beneficiaries who any information or administrative costs will need to propose refinements to the receive transplants. incurred in response to this RFI; all payment system through notice-and We are considering the inclusion of a costs associated with responding to comment rulemaking. A refinement measure to capture the beneficiary these RFIs will be solely at the involves revising the patient and experience of home dialysis care. The interested party’s expense. Failing to facility-level adjustments by changing measure could be either an existing respond to either RFI will not preclude the adjustment payment amounts based measure or one that CMS would participation in any future procurement, on updated regression analysis using develop. The measure could assess any if conducted. more recent ESRD claims and cost aspect of the patient experience. The Please note that CMS will not respond report data. When refinements occur, domains could include, but are not to questions about the policy issues due to the nature of regression analysis, limited to, patient satisfaction, patient raised in these RFIs. CMS may or may all patient-level and facility-level activation, and quality of life. If a new not choose to contact individual adjustments are affected which can measure is developed, CMS would like responders. Such communications impact budget neutrality requirements to make it useful to other CMS kidney would only serve to further clarify and impact ESRD facilities differently disease programs. written responses. Contractor support than if adopted incrementally. Payment We seek comments on any aspect of personnel may be used to review RFI system changes can also require a patient experience measure. Questions responses. Responses to these RFIs are extensive efforts by CMS and health to consider include: not offers and cannot be accepted by the care providers to implement. • What domains of a patient U.S. Government to form a binding Consequently, we believe CMS and experience of care with home dialysis contract or issue a grant. Information ESRD facilities would best be served if would be the most useful to assess and obtained because of this RFI may be these major payment methodology why? used by the U.S. Government for changes occur as a unified approach for • Would you prefer the measure to be program planning on a non-attribution CY 2025. newly developed or an update to an basis. Respondents should not include In order to obtain additional feedback existing measure? If an update, which any information that might be from as wide of an audience as possible, existing measure should be updated? considered proprietary or confidential. we are soliciting comments from the

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public through this proposed rule. We During each TEP, the data contractor consideration of public comments, we are seeking comments from all presented to the panelists, and the established an 18.9 percent adjustment perspectives, including differing panelists presented to all the TEP for facilities that furnish less than 4,000 beneficiary populations of ESRD participants, innovative methodological treatments annually with the intention facilities and ESRD facilities located in approaches that addressed stakeholder of encouraging small facilities to remote locations and their infrastructure concerns about the current payment continue providing access to care. issues. Obtaining a variety of model and presented alternative In the CY 2016 ESRD PPS proposed perspectives enables CMS to ultimately approaches with the goal of soliciting rule (80 FR 37819), we analyzed ESRD work toward an improved payment specific input for developing a more facilities that met the definition of low- methodology for the ESRD PPS that is refined case-mix adjusted payment volume under § 413.232(b) as part of the both patient-data focused and accounts system. Panelists discussed potential updated regression analysis and found for the changing landscape in providing approaches while weighing the ESRD that the facilities still had higher costs renal dialysis services to Medicare facility burden those approaches may compared to other facilities. A beneficiaries. require. Alternative approaches were regression analysis of CYs 2012 and We encourage the public, and all presented to solicit feedback from 2013 low-volume facility claims and stakeholders to provide comments and panelists about feasibility and cost report data indicated a multiplier of recommend approaches that will assist acceptability of the options. The TEPs 1.239 percent; therefore, we proposed CMS in making refinements to the ESRD did not provide formal an updated LVPA adjustment factor of PPS through rulemaking in the future. recommendations, but discussion items 23.9 percent in the CY 2016 ESRD PPS We are soliciting comments this year so and suggestions were captured in three proposed rule (80 FR 37819) and that we have time to consider them for subsequent reports. The materials from finalized this policy in the CY 2016 potential proposals in the CY 2023 the TEPs and summary reports can be ESRD PPS final rule (80 FR 69001). In ESRD PPS proposed rule for a CY 2025 found at https://www.cms.gov/ CY 2019, 332 facilities received the implementation. Medicare/Medicare-Fee-for-Service- LVPA and using the most recent available data for CY 2020, the number B. Technical Expert Panels (TEPs) Payment/ESRDpayment/Educational_ Resources. of facilities receiving the LVPA was 344 CMS’ contractor held three TEPs to The following sections of this RFI as of April 2021. discuss refinements to the ESRD PPS. provide information and solicit 2. Current LVPA Methodology The TEPs included panelists feedback specifically on the following representing dialysis providers, Under § 413.232(b), a low-volume topics: Low-volume payment independent researchers, patient facility is an ESRD facility that, based adjustment (LVPA), calculations for advocates, and representatives from on the submitted documentation: (1) case-mix adjustment, the calculation for professional associations and industry Furnished less than 4,000 treatments in the outlier payment adjustment, the groups. The first TEP held in 2018 each of the 3 cost reporting years (based current pediatric dialysis payment explored the components of the existing on as-filed or final settled 12- model, recommendations for ESRD PPS ESRD PPS, and identified limitations of consecutive month costs reports, and hospital cost report modifications, the current model. The TEP discussed whichever is most recent) preceding the recommendations for modifying the topics such as current measures of ESRD payment year; and (2) has not opened, pediatric cost report, and home dialysis PPS costs, costs associated with length closed, or received a new provider of dialysis treatment, variations in cost for Medicare beneficiaries with acute number due to a change in ownership associated with complex patients, kidney injury. While TEP discussions in the three cost reporting years (based facility level drivers of cost, and are noted in each section, CMS on as-filed or final settled 12- additional patient attributes necessary encourages the public to reference the consecutive month cost reports, for developing a revised ESRD payment TEP reports on CMS’ website, noted whichever is most recent) preceding the model. One of the main goals of the TEP above, for more details. payment year. was to identify items and services C. Calculation of the Low-Volume In addition, under § 413.232(c), for potentially appropriate for either Payment Adjustment (LVPA) purposes of determining the number of itemized data collection on claims or treatments furnished by the ESRD improved reporting on the cost reports. 1. Background on the LVPA facility, the number of treatments The second TEP held in 2019 elaborated Section 1881(b)(14)(D)(iii) of the Act considered furnished by the ESRD on the previous TEP’s themes and provides that the ESRD PPS ‘‘shall facility equals the aggregate number of focused on alternative approaches to include a payment adjustment that treatments furnished by the ESRD measuring the cost of a dialysis session reflects the extent to which costs facility and the number of treatments to better reflect treatment-level variation incurred by low-volume facilities (as furnished by other ESRD facilities that in cost. Topics included measurement defined by the Secretary) in furnishing are both under common ownership of costs for determining case-mix renal dialysis services exceed the costs with, and 5 road miles or less from, the adjustments, wage index, low volume incurred by other facilities in furnishing ESRD facility in question. In order to payment adjustments and rural such services, and for payment for renal receive the LVPA, an ESRD facility must adjustments, TDAPA, outlier dialysis services furnished on or after submit a written attestation statement to determinations, TPNIES, and home January 1, 2011, and before January 1, its Medicare Administrative Contractor dialysis. The third TEP held in 2020 2014, such payment adjustment shall (MAC) confirming that it meets all of the focused on aspects of the ESRD PPS for not be less than 10 percent.’’ requirements specified in § 413.232 and which refinements or enhancements In the CY 2011 ESRD PPS final rule qualifies as a low-volume ESRD facility. were being considered. The topics (75 FR 49118 through 49125), we For purposes of determining eligibility discussed included adult and pediatric finalized the methodology used to target for the LVPA, ‘‘treatments’’ mean total case-mix adjustments, low volume the appropriate population of ESRD hemodialysis equivalent treatments payment adjustments, the acute kidney facilities that were low-volume and to (Medicare and non-Medicare). For injury payment system, and cost report determine the treatment threshold for peritoneal dialysis patients, one week of revisions. those facilities identified. After peritoneal dialysis is considered

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equivalent to two hemodialysis In addition, we have heard from b. Low-Volume and Isolated (LVI) treatments (80 FR 68994). Section stakeholders that the eligibility criteria Adjustment 413.232(e) imposes a yearly November 1 for the LVPA are very explicit and leave In its June 2020 report to Congress, deadline for attestation submissions, little room for flexibility in certain MedPAC recommended that the with a few exceptions where the circumstances (85 FR 71442). Finally, Secretary replace the LVPA and rural deadline is December 31. The November some view the attestation process as adjustment under the ESRD PPS with a 1 timeframe provides 60 days for a MAC burdensome to facilities and believe it single payment adjustment, a low- to verify that an ESRD facility meets the may discourage participation by small volume and isolated (LVI) adjustment, LVPA eligibility criteria (76 FR 70236). facilities with limited resources that in an effort to better protect isolated, The ESRD facility would then receive would otherwise qualify for the low-volume ESRD facilities that are the LVPA payment for all the Medicare- LVPA.291 Given these concerns, we have critical to ensure beneficiary access.293 eligible treatments in the payment year. been asked to consider alternative Once a facility is determined to be approaches to the LVPA that would A determination that a facility is low eligible for the LVPA, a 23.9 percent reduce burden, remove negative volume and isolated would be based on increase is applied to the ESRD PPS incentives that may cause gaming, and that facility’s distance from the nearest base rate for all treatments furnished by better target facilities that are critical for facility and its total treatment volume. the facility (80 FR 69001). beneficiary access. MedPAC stated that the facilities that In the CY 2021 ESRD PPS final rule would receive the adjustment would be (85 FR 71443), we finalized a policy to 4. Suggestions for Calculating the LVPA more appropriately targeted. This allow ESRD facilities flexibility for a. Census Tract methodology would be accomplished via a single facility-level regression LVPA eligibility due to the COVID–19 During the 2020 ESRD PPS TEP, PHE. Under § 413.232(g)(4), for approach instead of the current two- panelists discussed alternatives to the regression approach utilized by CMS. purposes of determining ESRD facilities’ current LVPA. One methodology eligibility for payment years 2021, 2022, As an example of how the LVI discussed utilized census tracts to adjustment would more directly target and 2023, we will only consider total identify geographic areas with low isolated, low-volume dialysis facilities, dialysis treatments for any 6 months of demand, which suggested increased the TEP compared the current LVPA their cost-reporting period ending in beneficiary access by incentivizing and suggested LVI methodologies using 2020. ESRD facilities will attest that dialysis organizations to continue 2017 data. In this example, 575 facilities their total dialysis treatments for those operating facilities in otherwise non- would have been eligible for the LVI 6 months of their cost reporting period viable locations.292 As discussed during verses 1,734 facilities under the current ending in 2020 are less than 2,000. The the TEP, an advantage to this approach LVPA and rural adjustment attestation must further include that would be a shift in the focus from methodology. although the total number of treatments identifying low volume facilities to furnished in the entire year otherwise identifying geographical areas, 5. Request for Information on exceeded the LVPA threshold, the specifically census tracts, with low Calculating the LVPA excess treatments furnished were due to demand for dialysis. temporary patient shifting resulting This census tract methodology often CMS is considering alternative from the COVID–19 PHE. MACs will results in a single facility being the only approaches to the LVPA that directly annualize the total dialysis treatments dialysis provider for a number of miles. address stakeholder concerns, and is for the total treatments reported in those The process would involve dividing the issuing a request for information to seek 6 months by multiplying by 2. U.S. into geographic areas based on a feedback on the approaches suggested reasonable assessment of ESRD above, other alternate approaches, and 3. Current Issues and Stakeholder support of the current LVPA Concerns beneficiaries’ ability or willingness to travel. Latent demand is then calculated methodology. We are soliciting ESRD facilities, the Medicare Payment by counting the number of ESRD information that will better inform Advisory Commission (MedPAC), and beneficiaries near each facility. ‘‘Near’’ potential future modifications to the the Government Accountability methodology. In addition to any other 288 is defined by driving time to facilities. Office have recommended that we Latent demand is calculated by input the public wants to provide make refinements to the LVPA to better multiplying the number of beneficiaries regarding the LVPA under the ESRD target ESRD facilities that are critical to near an ESRD facility by average PPS, we are requesting responses to the beneficiary access to dialysis care in number of treatments for ESRD following questions. 289 • remote or isolated areas. These beneficiaries. The LVPA threshold is Should a distinction other than groups have also have expressed then applied by determining the census tract information be considered? concern that the strict treatment count threshold of adjusted latent demand. • What criteria should be used to introduces a ‘‘cliff-effect’’ that may That is, those facilities, which fall below determine the threshold(s) of adjusted incentivize facilities to restrict their the threshold are LVPA eligible. The latent demand (in treatment counts) patient caseload to remain below the panelists noted that this methodology which determine LVPA eligibility (for 4,000 treatments per year for the LVPA example, a threshold of high average 290 appears administratively simple and threshold. could eliminate the burden associated cost per-treatment)? with the LVPA attestation process for • What are the concerns for facilities 288 http://www.medpac.gov/docs/default-source/ that would lose the LVPA under the LVI reports/jun20_ch7_reporttocongress_ facilities and MACs. sec.pdf?sfvrsn=0. methodology? 289 https://www.cms.gov/files/document/end- 291 https://www.cms.gov/files/document/end- • What are the concerns about the stage-renal-disease-prospective-payment-system- stage-renal-disease-prospective-payment-system- potential for gaming within the LVI technical-expert-panel-summary-report-april- technical-expert-panel-summary-report-april- methodology? 2021.pdf. 2021.pdf. 290 https://www.cms.gov/files/document/end- 292 https://www.cms.gov/files/document/end- stage-renal-disease-prospective-payment-system- stage-renal-disease-prospective-payment-system- 293 http://www.medpac.gov/docs/default-source/ technical-expert-panel-summary-report-april- technical-expert-panel-summary-report-april- reports/jun20_ch7_reporttocongress_ 2021.pdf. 2021.pdf. sec.pdf?sfvrsn=0.

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• To the extent that the LVI equations). Weights are the fraction of In a comment letter to the Acting CMS methodology captures more isolated costs that are composite rate versus Administrator on July 29, 2016,294 (and most often rural) facilities, should formerly separately billable. The MedPAC noted the current ESRD PPS a separate rural adjustment be regression equations and weighted does not have patient-level variation of maintained? averages are calculated using 2012 composite rate (resource) costs and suggested CMS move to a ‘‘one-equation D. Calculation of the Case-Mix through 2013 claims and cost report model’’ (that is, a patient-data focused Adjustments data. Case-mix factors in the current model include age categories, body model). MedPAC specifically stated that 1. Background on the Case-Mix surface area (BSA), low body mass CMS should develop payment Adjustments index (BMI) indicator, onset status, and adjustment factors using a single- Section 1881(b)(14)(D)(i) of the Act comorbidities (that is, pericarditis, equation methodology that accounts for mandates that the single payment gastrointestinal tract bleeding, variation in the cost of providing the system under the ESRD PPS hereditary hemolytic or sickle cell full PPS payment bundle. CMS is not implemented by the Secretary ‘‘shall anemia, and myelodysplastic syndrome) currently able to implement this include a payment adjustment based on (80 FR 68989 through 68992). Facility recommendation for the ESRD PPS case mix that may take into account adjusters include wage index, low because we do not have data on the patient weight, body mass index, volume status, and rural status (80 FR charges associated with the components comorbidities, length of time on 68972 and 69001). of dialysis treatment costs that vary dialysis, age, race, ethnicity, and other across patients in the use of the formerly appropriate factors.’’ The ESRD PPS 3. Current Issues and Stakeholder composite rate services. Concerns includes facility-level and patient-level 4. Suggestions for Allocating Composite adjustments to the base rate associated Over the last several years, Rate Costs with resource utilization and the cost of stakeholders have asked CMS to explore CMS has been carefully studying providing dialysis treatment. The goal of a refined case-mix adjustment model for case-mix adjustment is to ensure that MedPAC’s suggestion to base the ESRD the ESRD PPS, arguing that the existing PPS on a ‘‘one-equation model’’ (that is, payment for a dialysis treatment reflects case-mix adjustors may not correlate expected resource use. Payment a patient-data focused model). CMS has well with the current cost of dialysis over the years publicly discussed adjustments protect access to care for treatment. They stated that: the most costly beneficiaries by potential changes with our stakeholders • mitigating financial disincentives to The current adult case-mix who support a patient-data focused providing that care. The ESRD PPS is a adjustors were calculated using old data model. For instance, during the 2018 case-mix adjusted, bundled payment (that is, 2012–2013 claims and cost and 2019 TEP meetings discussions model intended to reflect total treatment report data); included using time on machine to address allocation of composite rate costs, which consist of formerly • current adjustors may not align separately billable costs and composite costs, case mix, and patient level with resource-intensive patient-level adjustments. Time on machine would rate costs (75 FR 49032). As required by services such as isolation rooms, section 1881(b)(14) of the Act, formerly not be used to directly adjust payment; behavioral issues, or neurocognitive rather, it would be used to apportion separately billable services were issues; included in the ESRD PPS bundled composite rate costs (such as labor and • apportioned composite rate costs payment, effective January 1, 2011. capital-related costs) that are currently (such as labor and capital related costs), Refinements to the current case-mix only observable at the facility level to adjusters were implemented in the CY from the cost reports, used in the case- the patient or treatment level for use in 2016 ESRD PPS final rule, effective mix adjustment are currently only the case-mix adjustment. Data on the January 1, 2016, and are currently in observable at the facility level and do time on machine receiving dialysis use. not include patient or treatment level would allow for a proportionately variations; and higher amount of composite rate costs to 2. Current Case-Mix Methodology • composite rate items are not be allocated to patients with longer The current model uses two individually collected on the claim, dialysis treatment times. During the equations, including a patient-level resulting in the payment not December 2019 TEP, a panelist indicated that this option would reduce equation for formerly separately billable differentiating between the cost of burden since dialysis treatment time costs and a facility-level equation for hemodialysis verses peritoneal dialysis, (that is, time on machine) is composite rate costs (75 FR 49083 which are affected by different labor and automatically generated by the dialysis through 49127). Formerly separately equipment costs. billable services are itemized on the machine and easily entered into the Other stakeholders raised similar ESRD Facility claim, (Type of Bill: 72x) patient’s medical record. Under this and include injectable drugs and their concerns during the TEP meetings. option, a single aggregate number would oral equivalents plus certain laboratory Additionally, panel members be reported on each claim. That number tests and supplies. Composite rate questioned the magnitude/significance corresponds to the total number of services, which are captured on the cost of age, BMI, and BSA coefficients; the minutes the beneficiary spent on report, constitute approximately 90 validity of taking weighted average of dialysis during that claim period. A percent of a treatment’s cost and include estimates across the two equations when panelist noted that reporting a single capital, labor, and administrative costs the joint distribution of composite rate number would minimize provider plus certain drugs, laboratory tests, and and formerly separately billable costs is burden. Panelists reached consensus supplies (75 FR 49036; 84 FR 38396). not accounted for in the case-mix; and that the reporting of actual time on Final case-mix adjusters for adults are logistical challenges in obtaining the 294 the weighted average of estimated accurate diagnosis and comorbidity data http://medpac.gov/docs/default-source/ that it is not routinely reported in the comment-letters/medpac-comment-on-cmss-/ coefficients from these two equations proposed-rule-on-the-esrd-prospective-payment-/ (that is, patient level and facility level 72x claims. system-and-the-dmepos-competiti.pdf?sfvrsn=0.

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machine offered the best solution for value code. Specifically, the suggested any additional approaches not yet capturing patient-level differences in method includes the costs per considered. the cost of dialysis sessions and would beneficiary-facility-month which are the 5. Request for Information on be superior to the current case-mix sum of formerly separately billable Calculation of the Case-Mix adjusters. costs, directly calculated from claims Adjustments We included discussions about (quantities) and from Part B prices, and expanding the data elements, moving to composite rate costs for each CMS welcomes the opportunity to a patient-data focused model, and the beneficiary-facility-month, calculated by inform the public and solicit use of time on machine to determine allocating annual facility costs (less stakeholder feedback on potential patient level variation in dialysis formerly separately billable costs) to the changes to the modeling used to develop the case-mix payment treatment costs in the CY 2019 ESRD beneficiary-facility-month level using adjustments under the ESRD PPS, in PPS final rule (83 FR 56963 through time on machine (duration of all order to inform future model 56970) as well as the CY 2020 ESRD treatments). For some modalities and PPS proposed rule (84 FR 38396 refinements. CMS is considering settings, time on machine is not through 38400) A comment letter from alternative approaches to calculating the available and must be imputed. Finally, a large dialysis organization in response case-mix adjustment that directly a regression is run of beneficiary- to the CY 2019 ESRD PPS proposed rule address stakeholder concerns, and more stated that costs in the remaining facility-month costs on case-mix appropriately reflects resource use and category—wages, salaries, and adjusters and facility characteristics. costs, and is issuing this RFI both to benefits—account for nearly 40 percent Following a presentation by the data seek feedback on the suggested of the market basket weight. contractor, the panelists agreed that this approach discussed previously, and to Additionally, the large dialysis method would identify a magnitude of solicit information that will better organization noted that these costs factors that best reflect variation in this inform future modifications to this represent the majority of expenses measure of total cost per treatment. This methodology. In particular, we are associated with dialysis treatment and method would select a set of case-mix soliciting comments on the will vary by patient because they are adjusters that account for a significant methodology to collect data to reflect dependent on dialysis treatment times. portion of the variance of total costs, patient-level differences in composite The large dialysis organization stated subject to intuitive clinical relationship rate costs, including the use of a value that time on machine was a good proxy to dialysis treatment costs, reasonable code to collect time on machine on the for costs in dialysis. number of risk adjusters, easy to claim. In addition to any other input the Based on information gathered from diagnose, identify, or report, and not public wants to provide regarding the our stakeholders and panelists from the gameable. calculation of the case-mix adjustment, first two TEP meetings and comments Panelists at the TEPs and stakeholder we are requesting responses to the received based on RFIs in the CY 2020 comments received in response to the following questions. • Which of the five composite rate ESRD PPS proposed rule, CMS took CY 2019 ESRD PPS proposed rule cost components (that is, age, BSA, BMI, steps towards developing a patient-data believe this one-equation model is more focused model. Based on stakeholder onset of dialysis, comorbidities) are intuitive than current ESRD PPS case- input, CMS chose to utilize time on most likely to vary with treatment mix adjusters.296 The suggested case- machine to determine patient level duration? mix adjusters discussed during the • variation in dialysis treatment costs. In Should new information for these December 2019 and 2020 TEPS are order to collect this information from cost components be collected on cost ESRD facilities, CMS petitioned the derived relative to variation in total cost reports, for use in better inferring the National Uniform Billing Committee of case and that the change in reporting composite rate costs associated with burden is small and would change treatment duration? (NUBC) for a new value code for time • on machine. This value code allows claims in two ways, including reporting What are the advantages and CMS to add time on machine to the total machine reported treatment disadvantages of obtaining treatment ESRD claim. In April 2020, NUBC minutes and reporting codes for new duration information from blood urea approved the request. CMS included a comorbidities. Finally, stakeholders nitrogen time on dialysis through the requirement to collect time on machine believe that a magnitude of case-mix End Stage Renal Disease Quality data effective January 1, 2021 in two adjusters appears to be significantly Reporting System (EQRS) (our new technical direction letters and two attenuated relative to the existing ESRD system that has replaced the Medicare Learning Network articles. PPS adjusters. As discussed in the TEP Consolidated Renal Operations in a CMS later rescinded the time on Report for the December 2020 TEP,297 a Web-enabled Network (CROWNWeb)), machine requirement,295 but we are budget neutral implementation of such versus collecting treatment duration through new fields on claims? discussing this potential requirement in a system would result in a 5–10 percent • What challenges would be this RFI as a possible future refinement increase in the base rate. Options encountered in reporting treatment of the ESRD PPS to address allocation discussed by the panelists included the duration on claims, using one of the of composite rate costs, case mix, and one-equation model and keeping the current ESRD PPS case-mix options discussed? patient level adjustments. • Are there alternative proxies for During the 2020 TEP, the data adjustments. CMS is seeking feedback resource utilization that can be reported contractor for CMS presented and the from the public on these options and at the patient/treatment level? panelists discussed potential refinement to concerns regarding the current case- 296 https://www.cms.gov/files/document/end- E. Calculation of the Outlier Payment mix adjustment. One of the refinements stage-renal-disease-prospective-payment-system- Adjustment discussed was collecting time on technical-expert-panel-summary-report-april- 2021.pdf. 1. Background on the Outlier Payment machine data on the 72x claim using a 297 https://www.cms.gov/files/document/end- Adjustment stage-renal-disease-prospective-payment-system- 295 https://www.cms.gov/files/document/ technical-expert-panel-summary-report-april- Section 1881(b)(14)(D)(ii) of the Act mm11871.pdf. 2021.pdf. requires that the ESRD PPS include a

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payment adjustment for high-cost loss-sharing percentages in other 2018 to 2020. Consequently, outlier outliers due to unusual variations in the Medicare payment systems. payments for CY 2020 claims comprised type or amount of medically necessary In the CY 2011 ESRD PPS final rule only 0.6 percent of total ESRD PPS care, including variations in the amount and codified in § 413.220(b)(4), using payments, demonstrating that the use of of ESAs necessary for anemia 2007 data, we established the outlier 2018 data results in thresholds too high management. As discussed in section percentage, which is used to reduce the to achieve the targeted 1.0 percent II.B.1.c of this proposed rule, we per treatment base rate to account for outlier payment. Outlier payments for recognize that the utilization of ESAs the proportion of the estimated total the adult population have constituted and other outlier services have payments under the ESRD PPS that are less than 1.0 percent of total ESRD PPS continued to decline under the ESRD outlier payments, at 1.0 percent of total payments since such payments began in PPS, and that we have lowered the MAP payments (75 FR 49142 through 49143). 2011.299 amount and FDL amounts every year The policy provides that the following 3. Current Issue and Stakeholder under the ESRD PPS. As discussed in ESRD outlier items and services are Concerns the CY 2021 ESRD PPS final rule (85 FR included in the ESRD PPS bundled 71439), we acknowledge that, even with payment: (1) Renal dialysis drugs and As the outlier payments have annually adjusting the MAP and FDL to biological products that were or would consistently landed below the targeted reflect the most recent utilization and have been, prior to January 1, 2011, 1.0 percent of total ESRD PPS payment costs of ESRD PPS eligible outlier separately billable under Medicare Part threshold, stakeholders have noted that services, total outlier payments have not B; (2) Renal dialysis laboratory tests that the methodology currently used to yet reached the 1 percent target. were or would have been, prior to calculate the outlier results in January 1, 2011, separately billable underpayment to the providers, as 2. Current Outlier Payment Adjustment under Medicare Part B; (3) Renal money was removed from the base rate Methodology dialysis medical/surgical supplies, to balance the outlier payment (85 FR The current outlier policy was including syringes, used to administer 71409, 71438 through 71439; 84 FR implemented in the CY 2011 ESRD PPS renal dialysis drugs and biological 60705 through 60706; 83 FR 56969). final rule (75 FR 49134 through 49145) products that were or would have been, Therefore, they have urged us to adopt and codified at § 413.237. Under prior to January 1, 2011, separately an alternative modeling approach, one § 413.237, an ESRD facility will receive billable under Medicare Part B; (4) that accounts for declining trends in an outlier payment if its actual or Renal dialysis drugs and biological outlier-eligible items and services imputed Medicare Allowable Payment products that were or would have been, spending over time. MedPAC echoed (MAP) amount per treatment for ESRD prior to January 1, 2011, covered under these concerns in a comment letter in outlier services exceeds a threshold. The Medicare Part D, including renal response to the CY 2021 ESRD PPS MAP amount represents the average dialysis oral-only drugs effective proposed rule, where it also suggested incurred amount per treatment for January 1, 2025; and (5) Renal dialysis that the introduction of calcimimetics as services that were or would have been equipment and supplies that receive the outlier-eligible items could perpetuate considered separately billable services transitional add-on payment adjustment the pattern of underpayment. MedPAC prior to January 1, 2011. The threshold as specified in § 413.236 after the stated that if calcimimetic use decreases is equal to the ESRD facility’s predicted payment period has ended. Beginning between 2019 (when the products were ESRD outlier services MAP amount per January 1, 2021, calcimimetics became paid under the ESRD PPS using the treatment (which is case-mix adjusted) outlier services (85 FR 71405). TDAPA) and 2021 (when the products plus the FDL amount, set each year by In the CY 2011 ESRD PPS final rule will be paid as part of the ESRD PPS CMS.298 The predicted outlier service (75 FR 49064 through 49065), CMS base rate), the outlier threshold will be MAP amount is the outlier MAP amount explained that it estimates an ESRD set too high, and outlier payments will published by CMS adjusted for the case facility’s costs based on most recent be lower than the 1 percent of total 2021 mix in the payment year; that is, it is available data. Since the rulemaking is payments. done in the year prior to the effective calculated by multiplying the separately 4. Suggestions for Outlier Payment date, the most complete available data billable case mix multipliers by the Adjustment outlier MAP amount. The outlier MAP would be from the year before. This and FDL amounts are estimated using means that for CY 2022 (as discussed in During the second and third annual the most recent, complete data set section II.B.1.c of this proposed rule), TEP meetings convened by the CMS available, which are data from 2 years CMS is proposing to recalibrate the contractor in 2019 and 2020, panelists prior to the payment year in question. outlier MAP and FDL amounts for each discussed concerns regarding the The predicted outlier MAPamounts calendar year using data from 2 years current outlier adjustment policy and and FDLs create thresholds where, if the prior, which is the most recent and alternative methodologies to achieve the outlier MAP amount per treatment on complete claims data. This methodology 1 percent outlier target. Some TEP the claim is above the threshold, there assumes consistent utilization over panelists and stakeholders have strongly will be a per-treatment outlier payment time, that is, it assumes that 2020 advocated that we establish a new equal to 80 percent of the amount utilization rates for ESRD PPS outlier outlier threshold using alternative exceeding the threshold. The loss- items and services are the same as those modeling approaches that account for sharing percentage was set at 80 percent for 2018. However, the use of ESRD PPS trends in separately billable spending in the CY 2011 ESRD PPS final rule (75 outlier items and services has in fact over time. Overall, panelists expressed FR 49144) to make it consistent with the declined each year since the support for any change to outlier implementation of the ESRD PPS. calculations that result in total outlier 298 The FDL amount is the amount by which an For example, the CY 2020 FDL payments closer to the target. ESRD facility’s per-treatment Medicare allowable amount ($48.33 for adult patients) was payment amount for furnishing ESRD outlier calculated and added to the predicted 299 Outlier percentages for the pediatric services to an adult/pediatric beneficiary must population have high variability from year to year, exceed the adult/pediatric predicted ESRD outlier MAP to determine the outlier thresholds but have consistently met or exceeded the 1.0 services Medicare allowable payment amount to be using 2018 data. However, ESRD PPS percent target. The methodological modifications in eligible for an outlier payment. outlier spending continued to fall from this RFI do not apply to the pediatric population.

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Panelists noted that the underlying may begin as early 2011. Additionally, Below we discuss the current ESRD PPS basis of an alternative methodology it must end with the most recent year with regard to ESRD facilities that could be to re-examine the assumption with complete data (typically 2 years furnish renal dialysis services to of constant utilization over time. Unlike before the year in which the FDL will pediatric patients, and request the current outlier methodology that take effect).300 information on specific approaches as predicts FDL amounts using a single ++ How many years of data should be well as other topics related to year of claims data, this approach included in calculation of this trend to developing a pediatric payment allows for the modeling of the MAP best capture changes in treatment adjustment under the ESRD PPS. amounts as they change over a longer patterns? Prior to implementation of the ESRD period of time. CMS has received a • The simulation of the FDL can be PPS, payment for dialysis treatments number of suggested techniques that improved by better anticipating changes was made through a composite rate per could be employed to reach the 1.0 in utilization of ESRD outlier services. treatment that was based on cost report percent target more predictably. What are the factors that affect the use data and did not account for differences One of these suggestions is a of ESRD outlier services over time, and among patients with ESRD (48 FR calculation of ‘‘after the fact’’ FDLs that to what extent should CMS try to 21254). The initial payment rates were would achieve the 1.0 percent outlier forecast the effect of these factors? established at $127 per treatment for target for each year included in the FDL • ESRD beneficiaries can now choose independent facilities and $131 for calculation. This has been referred to as to enroll in Medicare Advantage. hospital-based facilities, which reflect the retrospective FDL, which would be ++ Please describe any anticipated the costs incurred by dialysis facilities lower than the FDLs published in the effects of this enrollment change on the furnishing outpatient maintenance final rule for each corresponding year. use of ESRD outlier services in the dialysis, including some routinely This calculation would be used for ESRD PPS. provided drugs, laboratory tests, and future outlier calculations. For more • Adoption of the suggested supplies, whether furnished by hospital- information, please refer to the TEP methodology may account for based and independent facilities in a reports here: https://www.cms.gov/ systematic changes in the use of high- facility or at home. Medicare/Medicare-Fee-for-Service- cost outlier items. However, inherently In addition, we provided a process Payment/ESRDpayment/Educational_ unpredictable changes may still push under which facilities with costs per Resources. the outlier payment off the 1.0 percent treatment in excess of their composite Data presented during the TEP target. rates could seek exceptions to those meeting showed that using the three ++ Please comment on the rates under specified circumstances in most recent years to simulate FDLs and acceptability of the below payment §§ 413.182 and 413.184. For example, outlier payments for 2020 resulted in an adjustment methods. when a substantial proportion of the FDL amount for adults of $33.83 and a ++ Payment reconciliation—in the facility’s outpatient maintenance MAP amount of $37.41, respectively. By form of an add-on payment adjustment dialysis treatments involve atypically contrast, the 2020 FDLs and MAPs or a payment reduction—might be intense dialysis services, special published in the CY 2020 ESRD PPS necessary to bring payments in line with dialysis procedures, or supplies final rule (84 FR 60649) were $48.33 the 1 percent target. necessary to meet special medical needs and $35.78, respectively. The simulated ++ An add-on payment adjustment of the facility’s patients could qualify outlier percentage for 2020 using the would be distributed after sufficient for an exception rate. Under § 413.182, alternative methodology was 0.8 data reveal the magnitude of the CMS could approve exceptions if the percent. The actual outlier payment deviation (1 year after the end of the facility demonstrates, by convincing percentage made for 2020 claims was payment year). The distribution of these objective evidence, that its total per 0.6 percent. Therefore, the alternative monies could be done via a lump sum treatment costs are reasonable and methodology results in an outlier or via a per-treatment payment add-on allowable under the relevant cost percentage that is closer to the 1.0 effective for 1 year. This add-on reimbursement principles of part 413 percent target in the adult population. payment adjustment would be paid and that its per treatment costs in excess of its payment rate are directly 6. Request for Information irrespective of the outlier claim status in that year. attributable to its patient mix. As a CMS is considering potential ++ A payment reduction could take result of these provisions, many revisions to the calculation of the outlier the form of a reduction in the base rate, pediatric facilities secured an exception threshold to address stakeholder also to be applied 1 year after the end rate and were paid the exception rate concerns, and is issuing a request for of the payment year. until the transition to the ESRD PPS information both to seek feedback on ended in CY 2014. the approach suggested above, and to F. Calculation of the Pediatric Dialysis Section 1881(b)(12) of the Act, added solicit information that will better Payment Adjustment by section 623(d) of the Medicare inform future modifications to the 1. Background on the Pediatric Dialysis Prescription Drug, Improvement, and methodology. In addition to any other Payment Adjustment Modernization Act of 2003 (MMA) input the public wants to provide for required the Secretary to implement a calculating the outlier payment Section 1881(b)(14)(D)(iv)(I) of the Act basic case-mix adjustment to an ESRD adjustment, we are requesting responses provides that the ESRD PPS may facility’s composite payment rate to the following questions. include such other payment reflecting a limited number of patient • An alternative approach could be to adjustments as the Secretary determines characteristics. On August 5, 2004 and estimate the retrospective FDL trend by appropriate, such as a payment November 15, 2004, we published a using historical utilization data. The adjustment for pediatric providers of proposed rule and final rule with example above was constructed by services and renal dialysis facilities. comment period (69 FR 47487 through using 2016–2018 data. There is 47730 and 69 FR 66235 through 66915), 300 The example uses CY 2020 to judge the flexibility in the time used to estimate performance of the alternative methodology. The respectively, implementing the this trend. The data must contain at most recent year with complete data when the 2020 provisions affecting the composite least 2 years’ worth of claims data and FDL was determined was 2018. payment system. The development and

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application of the basic case-mix payments per treatment between individual hospitals and ESRD facilities adjustments, using regression-based pediatric and adult dialysis patients for with their own payment rate based on adjustment factors for the patient composite rate services in CY 2007 their costs. We note that this approach variables of age, BSA and BMI are based on the 872 pediatric dialysis would require a statutory change explained in each of those rules (69 FR patients reflected in the data. That is, because section 1881(b)(14)(A)(i) of the 47529 through 47531 and 69 FR 66323 the average CY 2007 MAP for composite Act requires the Secretary to implement through 66324, respectively). The rate services for pediatric dialysis a payment system under which a single product of the specific adjusters for each patients was $216.46, compared to payment is made to all ESRD facilities. patient, multiplied by the otherwise $156.12 for adult patients. We used CY Stakeholders have informed us that applicable composite payment rate, 2007 data consistent with our costs unique to pediatric dialysis are not yielded the basic case-mix adjustment determination that 2007 represented the adequately captured in current cost as required by statute. The basic case- year with the lowest per patient reports or claims, and therefore are not mix adjusted composite payment system utilization of dialysis services in accounted for in the pediatric was effective April 1, 2005 and accordance with section adjustments. In addition, they have continued until the ESRD PPS was 1881(b)(14)(A)(ii) of the Act. We explained that pediatric dialysis often implemented on January 1, 2011. developed payment adjusters using the requires developmental and behavioral As we explained in the CY 2005 ESRD variables of age (that is, <13 and 13–17) specialists, pediatric dieticians, and PPS final rule with comment period (69 and modality (peritoneal dialysis or social workers, and that pediatric FR 66326 through 66327), we attempted hemodialysis). comorbidities require unique to develop case-mix adjusters for In the CY 2016 ESRD PPS final rule specialized care. Further, pediatric outpatient patients with ESRD under (80 FR 68968), we refined the ESRD PPS nephrologists have told CMS that age 18. However, we found that for the in accordance with section 632(c) of pediatric patients disproportionately approximately 600 Medicare pediatric ATRA, which required CMS to conduct receive treatment in hospital-based patients for whom claims were available an analysis and make appropriate facilities, but the hospital cost report from 2000 through 2002, the results revisions to the case mix payment (CMS Form 2552–10) does not were highly variable and statistically adjustments. We analyzed the case-mix distinguish pediatric and adult dialysis unstable, and therefore, inappropriate payment adjustments under the ESRD cost. for the development of case-mix PPS and revised the payment adjusters One organization suggested that we adjusters in accordance with the same using CYs 2012 and 2013 ESRD claims expand the pediatric age groups and methodology otherwise applicable to and cost report data. For pediatric create either pediatric modifiers or a adult Medicare patients with ESRD. dialysis, we used the same methodology pediatric add-on payment by age group. For this reason, we described an that was used for the CY 2011 ESRD Alternatively, the organization alternative methodology we used to PPS final rule, except for the use of suggested that we create a pediatric- develop a 62 percent pediatric increase more recent data years (2012 through specific ESRD bundle that would allow (that is, an adjustment factor of 1.62) 2013) and in the method of obtaining for full accounting of costs for pediatric applied to the composite payment rate payment data. Specifically, we used the staffing and specialized equipment, and per treatment for any facility furnishing projected MAP based on 2013 claims to the economic implications of pediatric outpatient dialysis services to pediatric calculate the ratio of pediatric total medical comorbidities that are not patients. That factor was based on the MAP per session to adult total MAP per addressed in the current PPS. In order average amount of the atypical services session. The resulting adjustment to engage dialysis stakeholders in exceptions granted for 20 ESRD factors reflected an 8.21 percent advance of rulemaking, CMS’ data facilities, each of which sought and increase to account for the overall contractor conducted TEP discussions received an exception for the atypical difference in average payments per for the past three years on various costs incurred for the treatment of treatment for pediatric patients. The dialysis payment approaches and issues. outpatient pediatric patients, compared pediatric adjusters that were finalized For the 2020 TEP, one of the discussion to the average unadjusted composite for CY 2016 and are currently in effect topics was pediatric dialysis. Based on payment rate (that is, the payment are: discussions and meetings with without regard to exception amounts) <13 peritoneal dialysis = 1.063 stakeholders and TEP panelists, the for these same 20 facilities. We <13 hemodialysis = 1.306 contractor performed several analyses explained that application of the 13–17 peritoneal dialysis = 1.102 on pediatric dialysis to inform the TEP pediatric adjustment factor of 1.62 in 13–17 hemodialysis = 1.327 discussion. The analyses confirmed lieu of an explicit pediatric case-mix many of the challenges reflected in 2. Current Issues and Stakeholder adjustment was temporary, and would stakeholder comments regarding Concerns be eliminated once an appropriate pediatric dialysis. methodology, preferably one applicable Since 2015, we have continued to For example, a small number of to both pediatric and adult Medicare hear from organizations associated with facilities provide 95 percent of pediatric patients, could be developed. pediatric dialysis about the dialysis treatments (approximately 100) In the CY 2011 ESRD PPS proposed undervaluation of pediatric ESRD care, and those pediatric facilities are rule (74 FR 49986 through 49987), we which requires significantly different hospitals, mostly children’s hospitals. proposed a pediatric payment staffing and supply needs from those Pediatric treatments are split between methodology with comorbidity required to deliver ESRD care to adults. home peritoneal dialysis (mostly for adjusters. However, in the CY 2011 These organizations support CMS efforts children younger than 13) and in-center ESRD PPS final rule (75 FR 49130 to explore ways to improve collecting hemodialysis (for older children 13–17). through 49134), in response to public pediatric-specific data to better One analysis, using cost report data, comments, we explained that instead of characterize the necessary resources and found that the median registered nurse/ using the regression-based composite associated costs of delivering pediatric licensed practical nurse hours per- rate multiplier of 1.199, we established ESRD care. Commenters have also treatment is higher in pediatric facilities the pediatric payment adjusters using suggested that we reinstate the and pediatric comorbidities require the overall difference in average exceptions process that would provide more (specialized) staffing. Dialysis for

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pediatric patients is furnished in pre-implementation data collection, However, another panelist described hospitals, primarily children’s hospitals which providers may find burdensome. their facility’s success in securing or in large dialysis organization The TEP panelists also discussed additional funding for their pediatric facilities. For more information, please several modifications to the cost reports dialysis unit as a result of a time and refer to the TEP reports. that they believe would better capture motion study. The contractor performed analyses resources utilized in the pediatric Panelists affirmed that accounting and using the expanded age groupings dialysis setting. These include adding billing departments at children’s suggested by the commenters and found lines itemizing pediatric specific labor hospitals are not well equipped to that finer stratification of the age groups categories and pediatric specific accurately complete Medicare cost reveals differences in cost per treatment. supplies, clarifying cost report reports and suggest that this may be due The contractor found that the median instructions as they pertain to pediatric both to their general lack of familiarity cost per treatment for the pediatric dialysis, and better aligning the with Medicare (one panelist noted that population using the same methodology freestanding facility cost report with the only 30 percent of pediatric patients are used in the 2016 refinement but using hospital cost report. Although these Medicare beneficiaries) and the cost more recent data (2018 and 2019) changes have the advantage of being report’s current structure. highly feasible to implement, resulted in significant differences in One panelist cautioned that because stakeholders have noted that uptake cost among the pediatric age categories. most pediatric dialysis is delivered in may take additional time, as pediatric The contractor also found that the the hospital setting, if the revised facility accounting and billing staff are median cost per treatment for the hospital cost report does not include the pediatric population using the national not generally familiar with Medicare cost reports. Furthermore, stakeholders modifications recommended for the average treatment duration, the dialysis facility’s cost report, pediatric relationship between total cost per- have noted that changes to the freestanding facility cost report would expertise for dieticians, social workers, treatment and age is consistent with child life specialists, and behavioral stakeholder comments. be of limited value, since pediatric dialysis primarily takes place in specialists may remain overlooked. 3. Suggestions for the Pediatric Dialysis hospital-based facilities. Despite this, panelists expressed the Payment Adjustment Panelists generally favored the desire to move forward with the addition of pediatric case-mix suggested cost report modifications to During the December 2020 TEP, three improve pediatric payment, which is approaches were discussed among the adjustment multipliers. One panelist noted that prior to the current case-mix presented later on in the preamble in panelists that could potentially lead to section VI.H of this proposed rule. a more accurate estimate of pediatric adjustment; the multiplier applied to dialysis costs under a revised payment pediatric facilities was based on actual 4. Request for Information for Pediatric model: (1) The addition of pediatric- costs incurred during treatment that Dialysis Payment were more accurate than the costs being specific case-mix adjustment CMS is soliciting feedback from the multipliers; (2) the creation of a separate reported currently. The case-mix adjustment multipliers presented during public on pediatric dialysis payment. In payment bundle for pediatric ESRD addition to any other input the public treatment costs; and (3) revisions to the TEP were similar to the multipliers from the prior payment method, which wants to provide for the pediatric current data collection practices. dialysis payment adjustment, we are To illustrate how the refined model the panelist found encouraging. However, there was shared concern requesting responses to the following would incorporate the pediatric among TEP panelists that there will questions. population, the contractor applied the continue to be underpayment for • model using each of the two current age Does the magnitude of total costs pediatric dialysis patients. One panelist groupings, resulting in an increased and pediatric multipliers reflect ESRD noted that time on dialysis may not effect of age on costs, with multipliers facilities’ actual incurred costs? If not, accurately reflect all costs, and may be what specific costs are not being of 1.61 and 1.74 for age <13 years and especially misleading for those under 2 age 13 to 17 years, respectively, reported on claims and/or cost reports? years of age. For this patient population, • compared to the reference adult Is there sufficient variation in expenditures on some fixed costs (for composite rate costs among pediatric population. Please refer to the TEP example, dialysate) will decrease, but 301 patients to justify use of a proxy to report for more specific information staffing costs would be considerably on the analyses and discussion. distribute facility-level composite rate higher, as they require one-on-one costs to individual treatments? Stakeholders suggest that the nursing and child life specialists and are • If duration of treatment is not a variables affecting pediatric dialysis more difficult to initiate on dialysis. valid proxy for composite rate costs per costs are sufficiently different from Therefore, panelists expressed the treatment, what are alternative proxies those associated with adult dialysis concern that the multipliers based on costs, and that a separate payment to consider? duration of treatment would not • system may be warranted. Although the accurately reflect costs. Another What, if any, are the specific creation of a pediatric bundle or panelist noted that certain state laws concerns about incorporating pediatric separate pediatric ESRD PPS may with personnel requirements for patients into the estimation of improve cost estimates for the pediatric pediatric dialysis could also increase multipliers for both the adult and population, if there were a statutory costs. pediatric populations? change to authorize this separate Panelists supported moving forward • What are the issues facing pediatric payment system, the time required for with the cost report and case-mix billing and accounting staff with regard implementation would be substantial multiplier modifications due to the to completion of claims and cost due to the subsequent need for new, burden of implementing a new bundle. reports? How can these problems be One panelist noted that a time and remedied? 301 https://www.cms.gov/files/document/end- • stage-renal-disease-prospective-payment-system- motion study attempted by their dialysis Are there additional costs factors technical-expert-panel-summary-report-april- organization failed, as there was a high for pediatric patients that are not 2021.pdf. degree of variation among facilities. adequately captured on the 72X claim?

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G. Modifying the ESRD PPS and c. Adjustments e. Treatments Hospital Cost Reports Using the HCRIS data, of the 1,395 The total number of treatments not 1. Special Audit Adjustment Summary ESRD freestanding facilities analyzed, a billed to Medicare and furnished total of $147.5 million of unallowable directly (Worksheet S–1, Line 1) a. Background decreased by an average of 2.6 percent. costs were removed from the total costs However, the total number of treatments Throughout the years, we have reported on Worksheet A. Noteworthy not billed to Medicare and Furnished adjustment areas included $136.5 received comments about updating the under Arrangement (Worksheet S–1, million of the unallowable costs Medicare Renal Cost Reports (CMS- Line 2) had no change. The average cost Form-265–11). Data from the Medicare initially reported in the administrative per treatment among the various types Renal Cost Reports is received by the and general cost center on Worksheet A, of treatments and categories appears to Hospital Cost Report Information with $75 million of this $136.5 million have decreased by an average of 1.75 System (HCRIS). Stakeholders have pertaining to related-party adjustments percent. However, some of the adult asserted that the cost reports need more recorded on Worksheet A–3. Of the $75 average costs per treatment related to granularity to align resource use with million, $72 million were for Home home program continuous ambulatory payment. In addition, section 217(e) of Office costs, including disallowed peritoneal dialysis increased after the PAMA mandated an audit of Medicare related party costs associated with audit by an average of 1.5 percent. cost reports beginning during 2012 for a Home Office and management fee Based on this audit, our cost report representative sample of providers of adjustments. Some of the major data was corrected. services and renal dialysis facilities adjustments noted at the Home Office furnishing renal dialysis services. The level reviews included the following: 2. Suggestions for Modifying the ESRD following discusses CMS’s audit process Unsupported documentation; related- PPS and Hospital Cost Reports and findings. party management fees; lobbying a. Independent Dialysis Facility Cost Organizations that consist of multiple expense; taxes for items not related to Report ESRD facilities or business entities may patient care; executive compensation in During the 2020 ESRD PPS TEP, the have Home Offices that furnish central excess of reasonable guidelines, and data contractor engaged the panelists in management and administrative related party laboratory costs, which a discussion regarding potential services (for example, centralized were reduced to cost. Other certain non- revisions to the Independent Dialysis accounting, purchasing, personnel allowable items included: Advertising, Facility Cost Report (CMS Form 265– services, and management) to other legal fees interest expense and financing 11). (See https://www.cms.gov/ fees, corporate travel/lodging/relocation, organizations within the chain. To the Research-Statistics-Data-and-Systems/ various consulting fees, business extent that the Home Office furnishes Downloadable-Public-Use-Files/Cost- development expenses; insurance services related to patient care to a Reports/Renal-Facility-265-2011-form.) settlement payments; insurance provider, the reasonable costs of such These potential revisions, which would expenses (malpractice, etc.). services are included in the ESRD support the efforts to develop a refined facility’s cost report and are d. Drugs case-mix model for the ESRD PPS, are reimbursable as part of the ESRD described in this section. CMS seeks facility’s costs. The CMS’ Office of the In general, there were minimal input from the public on the feasibility Actuary (OACT) selected a sample of adjustments to drugs cost and these of implementing these suggestions in 1,479 freestanding ESRD facilities from were made to both drug expense and freestanding ESRD facilities. These five Home Offices of large dialysis drug rebates (<1.0 percent in aggregate). potential reporting changes would organizations for the cost audit. A The top five ESRD dialysis require facilities to allocate composite contractor performed cost audits of organizations were examined based on rate costs across settings and modalities. these ESRD facilities in September of total reimbursable cost and average cost Taken together, the resulting cost report 2015. All audits were completed by per treatment for adult hemodialysis data would enable the determination of September of 2018. (the most common treatment type). No variation in costs across patient types material adjustment was made to total (by risk groups and dialysis modalities). Upon completion of the audits, number of treatments. However, there In the CY 2020 ESRD PPS proposed adjustments for unallowable costs were was a significant decrease in the average rule (84 FR 38396 through 38400) CMS made by CMS’s Office of Financial cost per treatment because of material sought input on identifying components Management to the ESRD cost reports adjustments made to the total allowable of composite rate costs, including and reflected in the HCRIS data. As of costs. The number of Epoetin Units specific facility-level costs that, in March 2020, 1,395 of the 1,479 ESRD furnished during the Cost Reporting combination with treatment-level data, facilities had complete HCRIS data (that Period (reported on Worksheet S–1, could be used to understand variation in is, containing both pre-and post-audit Line 14) was reduced by approximately dialysis treatment costs across patients. information). A summary of the audit 13 percent in aggregate. However, the While composite rate costs constitute adjustments include Home Office costs, majority of these adjustments related to nearly 90 percent of total treatment drugs, and treatments, which are two specific facilities, with one of the costs, they are not itemized on claims, discussed in this section. facilities having the total amount leaving facility cost reports as the only b. Home Office Cost reported reduced to zero. The number of source of information on these costs. Aranesp Units furnished during the cost Commenters’ suggestions included Of the ESRD facilities sampled, 1,278 reporting period (reported on Worksheet adding detail and stratifying the of 1,479 received an allocation of Home S–1, Line 15) was reduced by reporting detail of selected composite Office costs from the five Home Offices approximately 18 percent in aggregate. rate costs by setting and modality and selected for review. Any adjustments of However, the majority of these providing additional data to determine unallowable Home Office costs would adjustments related to two specific variation in treatment costs across flow down and be reflected in the ESRD facilities, both of which were reduced to patient risk groups and treatment facilities’ cost reports. zero. modalities.

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The facility-level cost components of • Improve the instructions related to correspond to staffing patterns in ESRD interest include capital costs related to the reporting of dialysis machine capital facilities than the currently used dialysis machines and other equipment costs. Inpatient Prospective Payment System used in dialysis treatment, labor costs, ++ For purchased equipment: Specify job categories. Selecting BLS and supply costs. Based on the input purchase price, depreciation, occupational categories for outpatient received and further analysis conducted maintenance, repair, insurance, care centers could be added or by the data contractor, several specific replacement. substituted in Lines 23–31 on changes to the cost reports were ++ For rented equipment: Specify Worksheet S–1 of CMS Form 265–11 to suggested. These include changes in the rental rates, maintenance, repair, reflect current staffing patterns, and insurance, rent escalators. columns could be added to separately reporting of composite rate components: • (1) Capital costs for dialysis machines List and stratify the costs of capital report home dialysis FTE and in-facility and related equipment, (2) direct patient equipment used in dialysis treatment by dialysis FTE for each relevant labor costs, (3) administrative and setting and modality. occupational category. Additional labor ++ Differentiate between rented and managerial costs, and (4) differentiation categories might include registered purchased equipment. of separately billable from composite nurses with varying credentials, ++ Differentiate among machines used dieticians, pharmacists, and nurse rate laboratory and supply costs. The in-facility and in the home setting. practitioners and other intermediate- suggested changes would also require ++ Differentiate machine costs in the level providers, as appropriate. reporting of these costs by modality. home setting by modality for home While the ‘‘step down’’ worksheet hemodialysis and home peritoneal d. Managerial and Administrative Labor (Worksheet B–1) in the current cost dialysis. Allocation report separates capital and labor costs ++ Include water treatment machines The data contractor and TEP panelists by modality, this separation is based on and indicate location of use: Home discussed Medicare cost report’s non- proportionally allocating costs versus in-facility. direct patient care positions, specifically according to a specified statistical basis • Location in Form 265–11 the current managerial and labor (for example, treatment counts), rather ++ Expand Worksheet A, Line 6. allocation. They made than the reporting of actual capital and ++ Revise instructions for Worksheet recommendations for differentiating labor resources associated with each A–1, adding specificity corresponding high-cost management from lower-cost modality. The data contractor and to item definitions discussed earlier in administrative and clerical functions, panelists agreed that changing the the preamble. which included a set of potential specifications in the instructions to the c. Direct Patient Labor Allocation revisions to bring management and cost report to indicate that the administrative labor categories up to allocations be made on the basis of Currently, the cost report does not date using occupational categories that actual resource use, would allow for a stratify full-time equivalent (FTE) hours reflect current usage in dialysis better estimation of component costs per for direct patient care staff by dialysis facilities. treatment and analysis of how these modality. It also does not include As with the direct patient labor costs vary among patient groups and several job classifications that are allocation above, suggestions include across modalities. commonly found in present-day ESRD the use of BLS occupational categories facilities. for outpatient care centers that b. Costs for Capital-Related Assets That At present, the statistical basis for correspond to the roles employed in Are Dialysis Machines allocating direct patient care costs is contemporary dialysis facilities. hours of service (as seen in Worksheet Suggested additions to these job Based on stakeholder feedback, CMS B–1, Column 5). Using this metric and categories might include business and would like to understand difficulties allocating resource (or labor) use financial operations personnel, office ESRD facilities have in reporting capital proportionally by labor hour and administrative workers, facility costs, particularly as they relate to (independent of labor type) can result in support workers, and programmers and dialysis machines. Both TEP panelists miscalculation of labor costs by analysts. With more accurate data, it and dialysis associations have suggested modality. For example, if labor for the may be possible to determine how that modifications to reporting of the provision of home dialysis is on average management and administrative costs capital costs of dialysis machines focus more expensive than labor for in-facility are differentially allocated across on two goals. The first goal is to hemodialysis, then a strict by-hour cost facilities (by region and treatment-type improve the fidelity and comparability allocation will result in a calculation of specialization). These suggested changes of dialysis machine capital cost home dialysis labor costs that is less to managerial and administrative job reporting across individual facilities. costly per-hour than in practice. categories would be made to Worksheet They suggested that this would be Suggestions have included that by S–1, Lines 31–34. achieved with more specific substituting FTE for hours for each instructions for completing the cost appropriate direct patient care labor e. Supplies and Laboratory Services report. The second goal is to ensure category, and using labor categories that While composite rate and separately CMS’s ability to distinguish between more accurately reflect current staffing billable drug costs are differentiated on dialysis machine capital costs among patterns in ESRD facilities, any potential the cost report, supplies and laboratory various modalities and dialysis settings misrepresentations of relative labor tests are not differentiated. Supplies in a way that preserves fidelity and costs across modalities can be remedied. comprise approximately 10 percent of comparability among facilities. This To this end, CMS has received a composite rate costs. To bring could be achieved with revisions to the suggestion to consider the use of Bureau uniformity to the reporting of drugs, cost report itself. As suggested by of Labor Statistics (BLS) occupational laboratory tests, and supplies, we have panelists and some stakeholders, to categories for outpatient care centers to received suggestions that supplies and achieve these ends, revisions to the cost remedy this situation, as it would laboratory tests be similarly stratified. report related to dialysis machine provide up-to-date job classifications These costs are currently reported on capital costs might include: that the comment believes would better Worksheet B/B–1. Specifically,

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stakeholders have suggested the • What categories of direct patient hospital cost reports, while some following changes: (1) Add separate care labor, such as registered nurses pediatric-specific costs are itemized on columns differentiating composite rate (North American Classification System the existing free-standing cost report. from separately billable supplies (NAICS) 29–1141) and dieticians Using CY 2019 cost report data, CMS’ (Worksheet B/B–1, Column 7–8); (2) add (NAICS 29–1031), are routinely data contractor computed total and separate columns differentiating employed by your dialysis facility and component specific cost per treatment composite rate from separately billable which can be documented in cost for hemodialysis-equivalent treatments, laboratory services (Worksheet B/B–1, reports? Please provide the specific stratified by modality, and obtained the Column 9–10). Bureau of Labor Statistics NAICS code ratio of pediatric to adult cost per associated with each labor category for treatment for each dialysis facility that 3. Request for Information on outpatient care centers found at this reported both adult and pediatric Independent Facility Cost Report website: https://www.bls.gov/oes/ treatments. The results indicate that CMS invites comments on the current/naics4_621400.htm. there is variation in costs across suggested changes to the Independent • Please detail the specific categories composite rate cost components for Facility Cost Report (CMS Form 265– of administrative and management pediatric and adult treatments. Overall 11), as described earlier in this section personnel currently employed by your the cost ratio of pediatric to adult of the proposed rule. In addition to any ESRD facility and which can be reported treatment costs is 1.58,302 indicating other input the public wants to provide on CMS Form 265–11. Please provide that pediatric treatments are more on modifying the Independent Facility the specific Bureau of Labor Statistics expensive to administer than adult Cost Report, we are requesting NAICS code associated with each labor treatments. For one cost component in responses to the following questions. category for management (https:// particular, supplies, the ratio is 7.30,303 • What challenges, including www.bls.gov/oes/current/naics4_ indicating much higher costs for operational difficulties, do ESRD 541600.htm#11-0000) and pediatric dialysis supplies than for adult facilities currently face in reporting administrative (https://www.bls.gov/oes/ supplies. Further analysis, however, capital costs: 2018/may/naics3_561000.htm). Please revealed that a substantial portion of ++ In general. indicate if relevant labor categories are facilities does not differentiate between ++ Due to inadequate instructions: not represented here and how these adult and pediatric costs in their cost —Which instructions should be categories can be documented and report accounting. Overall, we found revised for clarity? reported on CMS Form 265–11. that 13 percent of facilities that treat —Of those above, which are most • Stakeholders have commented on both pediatric and adult dialysis problematic? other categorical costs that are not patients do not differentiate costs ++ In responding, please indicate reported on the cost report. These between the two age groups. whether you are representing the views include missed treatments and use of of a isolation rooms. 2. Suggestions for the Pediatric Cost —Large dialysis organization. ++ Specifically, please comment on Report —Regional organization. adding reporting of (1) missed In response, CMS is considering that —Independent and/or rural facility or treatments, and (2) maintenance of two types of changes be made to the another entity. isolation rooms. hospital and free-standing ESRD facility ++ What level of expertise do ++ Where on CMS Form 265–11 cost report that would facilitate the personnel typically filling out cost should these items be inserted (if at all)? separate reporting of adult and pediatric reports have: • What challenges would hospital- —With cost accounting principles and treatment costs: (1) Changes that based facilities face were the hospital- differentiate pediatric from adult practices? based cost report to be revised to —With health care cost accounting composite rate component costs, and (2) harmonize with the changes suggested changes that allow for further principles and practices? for the independent facility cost report? —With operational details of how differentiation of component costs by How can the two cost reporting forms be capital equipment is used in their ESRD modality and age group within the brought into congruence as related to: facility? pediatric population. The potential ++ Are accounting record-keeping Dialysis related equipment, direct revisions for which stakeholder input is systems currently used by ESRD patient care, administrative labor, drugs, being sought include the addition of facilities adequate to the task of laboratory services, and supplies? select direct patient care labor • Costing accuracy is difficult to responding to current and contemplated categories, which correspond to the type achieve for home dialysis. The (in this RFI) cost reporting of labor typically employed by pediatric suggested revisions described above dialysis facilities, and the differentiation requirements? strive to differentiate costs among the • What challenges, including of pediatric supplies and equipment. different modalities. Are there other operational difficulties, would ESRD Specifically, CMS is considering means for facilities to report more facilities face: adding the following staff categories to ++ In reporting dialysis-related accurate cost data for home dialysis CMS Form 265–11, Worksheet S–1, machine costs by modality and modalities? Specifically, how can staff Lines 21–31 (Renal Dialysis Facility— location? time dedicated to home dialysis Number of Employees (Full Time treatment be better reported? Equivalents)): Pediatric dialysis nurses ++ In determining the facility level • distribution of direct patient labor FTE What other changes might be made and nurse practitioners, pediatric social across modalities for each type of direct to the cost report to better differentiate workers, pediatric dieticians, child life patient labor? costs across modalities and patient risk specialists, teachers, and pediatric ++ In reporting separate costs for groups? composite rate supplies and separately H. Modifying the Pediatric Cost Report 302 The fraction would be 158/100, that is $1.58 billable supplies? is spent overall on pediatric dialysis treatments for 1. Background every $1.00 spent for adult patients. ++ In reporting separate costs for 303 $7.30 is spent, overall, on supplies for a composite rate laboratory services and Pediatric composite rate costs are not pediatric dialysis treatment for every $1.00 spent on separately billable laboratory services? differentiated from adult costs on supplies for an adult treatment.

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dialysis unit coordinator. We have also reports include additional specific items renal dialysis services for Medicare received recommendations that for pediatric supplies or a separate beneficiaries with AKI. A patient additional columns be added to this section for supply costs associated with advocacy organization supported the section of the cost report to differentiate pediatric dialysis? proposal in the CY 2017 ESRD PPS pediatric home dialysis and in-facility ++ To what extent can providers proposed rule to adjust the AKI dialysis. differentiate dialysis labor costs for payment rate by only the geographic With regard to pediatric supplies and adult versus pediatric patients? and wage indices, and stated that some equipment, stakeholders have suggested • Are there potential revisions that patients with AKI can safely dialyze at that there be clear differentiation of could be made to the cost report, other home and have their urine and blood supplies used in dialysis treatment of than those described above, that would tests performed for the assessment of pediatric patients, which vary in type help identify costs unique to the kidney function in a location closer to and size, from those used with adult pediatric population (for example, home. The organization recommended dialysis patients. Stakeholders have revisions to items and services being that home training be paid separately, further indicated that there is added reported; format revisions to help without dollars removed from the base cost involved with the stocking of the facilitate reporting on pediatric costs)? rate. In the CY 2017 ESRD PPS final range of sizes and types of supplies • What obstacles do providers face in rule, we finalized several coverage and needed for this population. Categories of reporting pediatric specific costs of payment policies in order to implement supplies for which there is a dialysis treatment? How can these subsection (r) of section 1834 of the Act significantly increased cost for the obstacles be overcome? and the amendments to section pediatric population include: Dialyzers, • Pediatric dialysis patients comprise 1881(s)(2)(F) of the Act, including the catheter kits, fistula needles, saline a small number of patients in ESRD payment rate for AKI dialysis (81 FR flushes, monitors for vitals, blood facilities other than children’s hospitals 77866 through 77872). We interpreted pressure cuffs and items used to occupy or medical centers. How can pediatric section 1834(r)(1) of the Act to mean the children during their treatment. dialysis costs be reported in non- amount of payment for AKI dialysis Pediatric nephrologists have noted specialized ESRD facilities that services is the base rate for renal that these suggested revisions would predominantly serve adult patients dialysis services determined for such have the greatest impact on the hospital without undue burden on the provider? year under the ESRD base rate as set cost report, which currently does not forth in § 413.220, updated by the ESRD differentiate pediatric from adult I. Modifying Site of Services Provided to bundled market basket percentage dialysis patients. Approximately two- Medicare Beneficiaries With Acute increase factor minus a productivity thirds of pediatric dialysis treatments Kidney Injury (AKI) adjustment as set forth in take place in the hospital or medical 1. Background on Medicare Payment for § 413.196(d)(1), adjusted for wages as set center setting. AKI forth in § 413.231, and adjusted by any other amounts deemed appropriate by 3. Request for Information on the On June 29, 2015, the TPEA was the Secretary under § 413.373. We Pediatric Cost Report enacted. In the TPEA, Congress codified this policy in § 413.372 and CMS invites comments on the amended the Act to include coverage finalized a CY 2021 payment rate for potential changes to cost reports, and provide for payment for dialysis renal dialysis services furnished by described previously in this section of furnished by an ESRD facility to an ESRD facilities to individuals with AKI the proposed rule, as these changes (if individual with AKI. Specifically, as $253.13 (85 FR 71399). proposed and finalized in the future) section 808(a) of the TPEA amended In the CY 2017 ESRD PPS final rule, would apply to ESRD facilities treating section 1861(s)(2)(F) of the Act to we stated that we do not expect that AKI pediatric dialysis patients. In addition provide coverage for renal dialysis beneficiaries will dialyze at home (81 to any other input the public wants to services furnished on or after January 1, FR 77871). We affirmed in the CY 2017 provide regarding the cost reports, we 2017, by a renal dialysis facility or a ESRD PPS final rule that payment will are requesting responses to the provider of services paid under section only be made for in-center peritoneal following questions. 1881(b)(14) of the Act to individuals dialysis or hemodialysis treatments for • What degree of specificity is needed with AKI at the ESRD PPS base rate, as AKI beneficiaries. CMS also stated in in the reporting of pediatric dialysis adjusted by any applicable geographic the CY 2017 ESRD PPS final rule that costs? adjustment applied under section we would monitor this policy to • Are there dialysis supply costs 1881(b)(14)(D)(iv)(II) of the Act and may determine if changes are necessary in associated with the treatment of be adjusted by the Secretary on a budget the future, understanding that there may pediatric patients that cannot be neutral basis for payments under section be a subset of patients for whom AKI reported currently on the cost reports? 1834(r) of the Act by any other dialysis at home is an appropriate If so, please specify. adjustment factor under section treatment. Currently, CMS continues to • For ESRD facilities that administer 1881(b)(14)(D) of the Act. In CY 2017 believe that this population requires dialysis to both adult and pediatric ESRD PPS final rule (81 FR 77870 close medical supervision by qualified patients: through 77872), we finalized the AKI staff during their dialysis treatment. ++ To what extent can ESRD facilities dialysis payment rate. Due to the COVID–19 PHE and an differentiate dialysis supply costs for increase in the number of hospitalized 2. Current Issues and Stakeholder adult versus pediatric patients? patients with AKI receiving peritoneal Concerns —Are there specific high-cost dialysis, stakeholders have raised supplies unique to the treatment of Over the years, we have received concerns about patients with AKI pediatric patients that could be used to several comments, including concerns having to both travel to, and be present isolate additional costs related to from ESRD facilities; national renal in, an ESRD facility post hospitalization. pediatric dialysis? groups, nephrologists and patient CMS received comments that patients —When differentiating pediatric organizations; patients and care with AKI require more vigilant dialysis supply costs on the cost reports, partners; manufacturers; health care monitoring, particularly in infection would providers prefer that the cost systems; and nurses regarding the site of prevention, blood pressure

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management, more frequent laboratory especially in light of the COVID–19 ability of patients with AKI to perform testing, additional medication PHE. home dialysis safely. We request any administration and increased Members of the TEP commented on additional comments regarding educational needs. Commenters stated the similar treatment frequencies potentially modifying site of renal that patients with AKI are distinct from observed for patients with AKI and dialysis services and payment for AKI in regular patients with ESRD in that they ESRD, stating that the payment system the home setting. need specific critical treatment. CMS is currently constructed to facilitate the observed treatment patterns for patients VII. Collection of Information continued to receive comments in Requirements response to the CY 2021 ESRD PPS with AKI. Panelists stressed that the proposed rule regarding this concern, payment system should continue to be A. Legislative Requirement for including the recommendation that flexible in terms of number of Solicitation of Comments CMS allow patients with AKI to be treatments for patients with AKI so that Under the Paperwork Reduction Act dialyzed at home. Specifically, the those who need more frequent of 1995, we are required to provide 60- commenters requested that CMS allow treatments are not impeded from day notice in the Federal Register and patients with AKI to pursue peritoneal receiving them. solicit public comment before a Panelists expressed support for the dialysis in the home if the patient and collection of information requirement is CMS guidance temporarily allowing nephrologist agree it is safe to do so and submitted to the Office of Management dialysis facilities to send dialysis the home setting is the patient’s choice. and Budget (OMB) for review and facility staff to furnish 72x dialysis to We also received comments from approval. In order to fairly evaluate their patients in nursing homes, from organizations requesting that CMS whether an information collection both a cost and patient health remove barriers that make it difficult for requirement should be approved by perspective. (See https://www.cms.gov/ patients who want to select home OMB, the Paperwork Reduction Act of dialysis. They specifically requested files/document/covid-19-emergency- declaration-waivers.pdf.) Panelists 1995 (44 U.S.C. 3506(c)(2)(A)) requires that, for the duration of the COVID–19 that we solicit comment on the PHE, CMS waive the requirement that noted that it was more efficient to send ESRD facility staff to the skilled nursing following issues: health care providers are paid for • The need for the information facilities rather than the costly routine providing care to patients with AKI only collection and its usefulness in carrying and ambulance-required transportation when they receive in-center out the proper functions of our agency. and physical isolation expenses hemodialysis. • The accuracy of our estimate of the incurred during the public health The 2020 TEP included a session on information collection burden. emergency. Panelists stated that the full AKI and the current Medicare payment • The quality, utility, and clarity of spectrum of care provided in the SNF system. The panelists discussed cost the information to be collected. setting is invaluable, particularly for the • and utilization of AKI related dialysis Recommendations to minimize the patients with multiple comorbidities. services since the policy change in information collection burden on the Panelists commented on the costs per affected public, including automated 2017, including the incorporation of treatment observed for patients with payment for dialysis treatment for collection techniques. AKI, expressing that the higher observed We are soliciting public comment on patients with AKI into the ESRD PPS, costs compared to ESRD treatments assessment of the accuracy of the each of these issues for the following aligns with their expectations. Members sections of this document that contain reported data and the effectiveness of of the panel noted that patients with the current AKI payment parameters for information collection requirements AKI receive more laboratory tests to (ICRs): accurately capturing the costs of this monitor for recovery, but typically are population. not prescribed calcimimetics or ESAs. B. Requirements in Regulation Text Panelists agreed that some patients Some panelists also noted that due to In sections V through V.B of this with AKI could benefit from different the very small population size of proposed rule, we are proposing treatment regimens. In particular, they Medicare beneficiaries with AKI, changes to the regulatory text for the noted that more frequent, gentler reporting AKI costs and statistics on ETC Model. However, the changes that dialysis would be a viable option for cost reports at a granular level are being proposed do not impose any some patients, possibly preventing introduces an outsized reporting burden new information collection hypotension. During the COVID–19 on the part of the providers. requirements. PHE, many patients received acute Overall, panelists expressed that the peritoneal dialysis treatments in the current AKI payment structure is C. Additional Information Collection hospital upon developing AKI, and effective and benefits both patients and Requirements panelists expressed support for allowing facilities. One panelist pointed out that This proposed rule does not impose patients with AKI to continue receiving the AKI policy change, which we any new information collection acute peritoneal dialysis once they are implemented in the CY 2017 ESRD PPS requirements in the regulation text, as discharged from the hospital. One final rule (81 FR 77866 through 77872), specified above. However, there are panelist noted that their hospital tries to helps hospitals, as they can send changes in some currently approved get patients with AKI accustomed to a patients with AKI requiring dialysis to information collections. The following more standard treatment regimen such ESRD facilities and consequently free is a discussion of these information as three treatments per week before up capacity at the hospital. collections. discharging them to an ESRD facility. Another panelist expressed support for 4. Request for Information on Modifying 1. ESRD QIP—Wage Estimates (OMB the implementation of transitional care the Site of Services Provided to control numbers 0938–1289 and 0938– units, noting they would help patients Medicare Beneficiaries With AKI 1340) new to dialysis adjust to dialysis and CMS is soliciting feedback from the To derive wages estimates, we used the lifestyle changes that accompany it. public on the differences in care for data from the U.S. Bureau of Labor Panelists also advocated for allowing patients with AKI versus patients with Statistics’ May 2020 National patients with AKI to be treated at home, ESRD and whether it has bearing on the Occupational Employment and Wage

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Estimates. In the CY 2016 ESRD PPS the methodology we would use to combined annual burden hours for these final rule (80 FR 69069), we stated that validate CROWNWeb data for all facilities per year would be 1,500 hours it was reasonable to assume that payment years, beginning with PY 2021 (300 facilities × 5 hours). Since we Medical Records and Health (83 FR 57001 through 57002). Although, anticipate that Medical Records and Information Technicians, who are as noted in section IV.B.2 of this Health Information Technicians or responsible for organizing and managing proposed rule, we are now using EQRS similar staff would submit these data, health information data, are the to report data that was previously using the newly available wage estimate individuals tasked with submitting reported in CROWNWeb, the data of a Medical Records and Health measure data to CROWNWeb (now validation methodology remains the Information Technician, we estimate EQRS) and NHSN, as well as compiling same. Under this methodology, 300 that the aggregate cost of the NHSN data and submitting patient records for facilities are selected each year to validation each year would be purpose of the data validation studies, submit 10 records to CMS, and we approximately $63,600 (1,500 hours × rather than a Registered Nurse, whose reimburse these facilities for the costs $42.40), or a total of approximately $212 duties are centered on providing and associated with copying and mailing the ($63,600/300 facilities) per facility in coordinating care for patients. We stated requested records. The burden the sample. While the burden hours that the median hourly wage of a associated with these validation estimate will not change, the burden Medical Records and Health requirements is the time and effort cost updates associated with these Information Technician is $21.20 per necessary to submit the requested requirements will be revised in the hour.304 We also stated that fringe records to a CMS contractor. In this information collection request (OMB benefit and overhead are calculated at proposed rule, we are updating these control number 0938–1340). 100 percent. Therefore, using these estimates using a newly available wage 3. EQRS Reporting Requirements for PY assumptions, we estimated an hourly estimate of a Medical Records and 2024 and PY 2025 (OMB Control labor cost of $42.40 as the basis of the Health Information Technician. In the Number 0938–1289) wage estimates for all collections of CY 2020 ESRD PPS final rule, we information calculations in the ESRD estimated that it would take each To determine the burden associated QIP. We adjusted these employee hourly facility approximately 2.5 hours to with the EQRS reporting requirements wage estimates by a factor of 100 comply with this requirement. If 300 (previously known as the CROWNWeb percent to reflect current HHS facilities are asked to submit records, we reporting requirements), we look at the total number of patients nationally, the department-wide guidance on estimated that the total combined number of data elements per patient- estimating the cost of fringe benefits and annual burden for these facilities would year that the facility would be required overhead. We stated that these are be 750 hours (300 facilities x 2.5 hours). to submit to EQRS for each measure, the necessarily rough adjustments, both Since we anticipate that Medical amount of time required for data entry, because fringe benefits and overhead Records and Health Information the estimated wage plus benefits costs vary significantly from employer Technicians or similar administrative applicable to the individuals within to employer and because methods of staff would submit these data, we facilities who are most likely to be estimating these costs vary widely from estimate that the aggregate cost of the entering data into EQRS, and the study to study. Nonetheless, we stated EQRS data validation each year would that there is no practical alternative and × number of facilities submitting data to be approximately $31,800 (750 hours EQRS. In the CY 2021 ESRD PPS final we believe that these are reasonable $42.40), or an annual total of estimation methods. rule, we estimated that the burden approximately $106.00 ($31,800/300 associated with CROWNWeb (now We used this updated wage estimate, facilities) per facility in the sample. The along with updated facility and patient EQRS) reporting requirements for the burden cost increase associated with PY 2024 ESRD QIP was approximately counts to re-estimate the total these requirements will be revised in information collection burden in the $208 million (85 FR 71400). information collection request (OMB As discussed in section IV.C and ESRD QIP for PY 2024 that we control number 0938–1289). discussed in the CY 2021 ESRD QIP section IV.D of this proposed rule, we In the CY 2021 ESRD PPS final rule, final rule (85 FR 71473 through 71474) are proposing measure suppressions we finalized our policy to reduce the and to estimate the total information that would apply for PY 2022 and number of records that a facility collection burden in the ESRD QIP for updates to the scoring methodology and selected to participate in the NHSN data PY 2025. We provide the re-estimated payment reductions for the PY 2022 validation must submit to a CMS information collection burden ESRD QIP. We also announce an contractor, beginning with PY 2023 (85 associated with the PY 2024 ESRD QIP extension of EQRS reporting FR 71471 through 71472). Under this and the newly estimated information requirements for facilities due to finalized policy, a facility is required to collection burden associated with the systems issues. However, we believe submit records for 20 patients across PY 2025 ESRD QIP in section VII.C.3 of that none of the policies proposed in any two quarters of the year, instead of this proposed rule. this proposed rule would affect our 20 records for each of the first two estimates of the annual burden 2. Estimated Burden Associated With quarters of the year. The burden associated with the Program’s the Data Validation Requirements for PY associated with this policy is the time information collection requirements, as 2024 and PY 2025 (OMB Control and effort necessary to submit the facilities are still expected to continue Numbers 0938–1289 and 0938–1340) requested records to a CMS contractor. to collect measure data during this time In the CY 2020 ESRD PPS final rule, Applying our policy to reduce the period. We are not proposing any we finalized a policy to adopt the number of records required from each changes that would affect the burden CROWNWeb data validation facility participating in the NHSN associated with EQRS reporting methodology that we previously validation, we estimated that it would requirements for PY 2024 or PY 2025. adopted for the PY 2016 ESRD QIP as take each facility approximately 5 hours However, we have re-calculated the to comply with this requirement. If 300 burden estimate for PY 2024 using 304 https://www.bls.gov/oes/current/ facilities are asked to submit records updated estimates of the total number of oes292098.htm. Accessed on June 7, 2021. each year, we estimated that the total dialysis facilities, the total number of

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patients nationally, and wages for environmental, public health and safety c. ESRD QIP Medical Records and Health effects, distributive impacts, and This proposed rule proposes to Information Technicians or similar staff equity). Section 3(f) of Executive Order implement requirements for the ESRD as well as a refined estimate of the 12866 defines a ‘‘significant regulatory QIP, including a proposal to adopt a number of hours needed to complete action’’ as an action that is likely to measure suppression policy and to data entry for EQRS reporting. result in a rule: (1) Having an annual suppress several ESRD QIP measures Consistent with our approach in the CY effect on the economy of $100 million under that proposed measure 2021 ESRD PPS final rule (85 FR 71474), or more in any 1 year, or adversely and suppression policy, proposals regarding in this proposed rule we estimated that materially affecting a sector of the the scoring methodology and payment the amount of time required to submit economy, productivity, competition, reductions for the PY 2022 ESRD QIP, measure data to EQRS was 2.5 minutes jobs, the environment, public health or a proposed update to the SHR measure, per element and did not use a rounded safety, or state, local or tribal and a proposed update to the PY 2024 estimate of the time needed to complete governments or communities (also performance standards. This proposed data entry for EQRS reporting. There are referred to as ‘‘economically rule also includes a request for public 229 data elements for 532,931 patients significant’’); (2) creating a serious comment on closing the gap in health across 7,610 facilities. At 2.5 minutes inconsistency or otherwise interfering equity, as well as a request for public per element, this yields approximately with an action taken or planned by comment on potential actions and 668.21 hours per facility. Therefore, the another agency; (3) materially altering priority areas that would enable the PY 2024 burden is 5,085,050 hours the budgetary impacts of entitlement continued transformation of our quality (668.21 hours × 7,610 facilities). Using grants, user fees, or loan programs or the measurement enterprise toward greater the wage estimate of a Medical Records rights and obligations of recipients and Health Information Technician, we digital capture of data and use of the thereof; or (4) raising novel legal or FHIR standard. estimate that the PY 2024 total burden policy issues arising out of legal cost is approximately $215 million mandates, the President’s priorities, or d. ETC Model (5,085,050 hours × $42.40). There is no the principles set forth in the Executive Beneficiaries with ESRD are among net incremental burden change from PY Order. the most medically fragile and high-cost 2024 to PY 2025 because we are not A regulatory impact analysis (RIA) populations served by the Medicare changing the reporting requirements for must be prepared for major rules with program. One of CMS’ goals in PY 2025. economically significant effects ($100 designing the ETC Model is to test ways VIII. Response to Comments million or more in any 1 year). We to incentivize home dialysis and kidney estimate that this rulemaking is Because of the large number of public transplants, to enhance beneficiary ‘‘economically significant’’ as measured comments we normally receive on choice of modality for renal replacement by the $100 million threshold, and Federal Register documents, we are not therapy, and improve quality of care hence also a major rule under the able to acknowledge or respond to them and quality of life while reducing Congressional Review Act. Accordingly, individually. We will consider all Medicare program expenditures. The we have prepared a Regulatory Impact comments we receive by the date and substantially higher expenditures, Analysis that to the best of our ability time specified in the ‘‘DATES’’ section mortality, and hospitalization rates for presents the costs and benefits of the of this preamble, and, when we proceed dialysis patients in the U.S. compared to rulemaking. We solicit comments on the with a subsequent document, we will those for individuals with ESRD in regulatory impact analysis provided. respond to the comments in the other countries indicate a population preamble to that document. 2. Statement of Need with poor clinical outcomes and potentially avoidable expenditures. This IX. Economic Analyses a. ESRD PPS proposed rule would refine the A. Regulatory Impact Analysis This rule proposes a number of methodology for setting and updating routine updates to the ESRD PPS for CY achievement and improvement 1. Introduction 2022. The proposed routine updates benchmarks for participating ESRD We have examined the impacts of this include the CY 2022 wage index values, facilities and Managing Clinicians rule as required by Executive Order the wage index budget-neutrality serving the ESRD population over the 12866 on Regulatory Planning and adjustment factor, and outlier payment remaining years of the ETC Model, Review (September 30, 1993), Executive threshold amounts. Failure to publish among other proposed changes. Order 13563 on Improving Regulation this proposed rule would result in ESRD Notwithstanding the proposed changes, and Regulatory Review (January 18, facilities not receiving appropriate we continue to anticipate improvement 2011), the Regulatory Flexibility Act payments in CY 2022 for renal dialysis in quality of care for beneficiaries and (RFA) (September 19, 1980; Pub. L. 96– services furnished to ESRD reduced expenditures under the ETC 354), section 1102(b) of the Social beneficiaries. Model inasmuch as the Model is Security Act, section 202 of the designed to create incentives for b. AKI Unfunded Mandates Reform Act of 1995 beneficiaries, along with their families (March 22, 1995; Pub. L. 104–4), This rule also proposes routine and caregivers, to choose the optimal Executive Order 13132 on Federalism updates to the payment for renal kidney replacement modality. (August 4, 1999), and the Congressional dialysis services furnished by ESRD As noted in section IV.B of the Review Act (5 U.S.C. 801(2)). facilities to individuals with AKI. Specialty Care Models final rule (85 FR Executive Orders 12866 and 13563 Failure to publish this proposed rule 61264), Medicare payment rules and a direct agencies to assess all costs and would result in ESRD facilities not deficit in beneficiary education result in benefits of available regulatory receiving appropriate payments in CY a bias toward in-center hemodialysis, alternatives and, if regulation is 2022 for renal dialysis services which is often not preferred by patients necessary, to select regulatory furnished to patients with AKI in or physicians relative to home dialysis approaches that maximize net benefits accordance with section 1834(r) of the or kidney transplantation. We provided (including potential economic, Act. evidence from the published literature

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to support the projection that higher validation study (previously known as rule. We acknowledge that this rates of home dialysis and kidney the CROWNWeb validation study), the assumption may understate or overstate transplants would likely reduce NHSN validation study, and EQRS the costs of reviewing this rule. It is Medicare expenditures, and, not only reporting. As discussed in section IV.C possible that not all commenters enhance beneficiary choice, and section IV.D of this proposed rule, reviewed last year’s rule in detail, and independence, and quality of life, but we are proposing measure suppressions it is possible that some reviewers chose also preserve or enhance the quality of that would apply for PY 2022 and not to comment on the proposed rule. care for ESRD beneficiaries. updates to the scoring methodology and For these reasons, we thought that the As described in detail in section V of payment reductions for the PY 2022 number of past commenters would be a this proposed rule, we believe it is ESRD QIP. We also announce an fair estimate of the number of reviewers necessary to propose certain changes to extension of EQRS reporting of this rule. We welcome any comments the ETC Model. Under the proposed requirements for facilities due to on the approach in estimating the changes to the ETC Model, ETC systems issues. However, we believe number of entities, which will review Participants would continue to receive that none of the policies proposed in this proposed rule. We also recognize adjusted payments but beginning for this proposed rule would affect our that different types of entities are in MY3, certain aspects of the ETC Model estimates of the annual burden many cases affected by mutually that determine those payment associated with the Program’s exclusive sections of this proposed rule, adjustments would change. The information collection requirements, as and therefore for the purposes of our proposed change to the achievement facilities are still expected to continue estimate we assume that each reviewer benchmarking methodology is necessary to collect measure data during this time reads approximately 50 percent of the to the ETC Model as this change period. rule. We seek comments on this maintains the ETC Model’s expectation We also updated the payment assumption. of savings. The proposed changes to the reduction scale using more recent data Using the wage information from the transplant rate, the achievement for the measures in the ESRD QIP BLS for medical and health service benchmarking methodology, and the measure set. We estimate approximately managers (Code 11–9111), we estimate improvement benchmarking and scoring $215 million in information collection that the cost of reviewing this rule is methodology are necessary to increase burden, which includes the cost of $110.74 per hour, including overhead accuracy and fairness of performance complying with this rule, and an and fringe benefits https://www.bls.gov/ assessment. The proposed changes to additional $17 million in estimated oes/current/oes_nat.htm. Assuming an the home dialysis rate, data sharing, and payment reductions across all facilities average reading speed, we estimate that kidney disease patient education for PY 2024. it would take approximately 6.25 hours services waivers are necessary to For PY 2025, we estimate that the for the staff to review half of this support ETC Participants operating in proposed revisions to the ESRD QIP proposed rule. For each entity that the ETC Model. would result in $215 million in reviews the rule, the estimated cost is information collection burden, and $17 $692.13 (6.25 hours × $110.74). 3. Overall Impact million in estimated payment Therefore, we estimate that the total cost a. ESRD PPS reductions across all facilities, for an of reviewing this regulation is $ 78,903 We estimate that the proposed impact of $232 million as a result of the ($692.13 × 114). policies we have previously finalized revisions to the ESRD PPS would result B. Detailed Economic Analysis in an increase of approximately $140 and the policies we have proposed in million in payments to ESRD facilities this proposed rule. 1. CY 2021 End-Stage Renal Disease Prospective Payment System in CY 2022, which includes the amount d. ETC Model associated with updates to the outlier a. Effects on ESRD Facilities thresholds, and updates to the wage We estimate that the proposed index. changes to the ETC Model would To understand the impact of the increase the Model’s projected direct changes affecting payments to different b. AKI savings from payment adjustments categories of ESRD facilities, it is We estimate that the proposed alone by $7 million over the duration of necessary to compare estimated updates to the AKI payment rate would the Model. We estimate that the Model payments in CY 2021 to estimated result in an increase of approximately would generate $38 million in direct payments in CY 2022. To estimate the $1 million in payments to ESRD savings related to payment adjustments impact among various types of ESRD facilities in CY 2022. over 6.5 years with the proposed facilities, it is imperative that the changes, and would generate $31 estimates of payments in CY 2021 and c. ESRD QIP million in savings in the absence of the CY 2022 contain similar inputs. For PY 2024 and PY 2025, we have re- proposed changes. Therefore, we simulated payments only estimated the costs associated with the for those ESRD facilities for which we information collection requirements 4. Regulatory Review Cost Estimation are able to calculate both current under the ESRD QIP with updated If regulations impose administrative payments and new payments. estimates of the total number of dialysis costs on private entities, such as the For this proposed rule, we used CY facilities, the total number of patients time needed to read and interpret this 2020 data from the Part A and Part B nationally, wages for Medical Records proposed rule or final rule, we should Common Working Files as of February and Health Information Technicians or estimate the cost associated with 12, 2021, as a basis for Medicare dialysis similar staff, and a refined estimate of regulatory review. Due to the treatments and payments under the the number of hours needed to complete uncertainty involved with accurately ESRD PPS. We updated the 2020 claims data entry for EQRS reporting. We have quantifying the number of entities that to 2021 and 2022 using various updates. made no changes to our methodology will review the rule, we assume that the The updates to the ESRD PPS base rate for calculating the annual burden total number of unique commenters on are described in section II.B.1.d of this associated with the information last year’s proposed rule will be the proposed rule. Table 9 shows the impact collection requirements for the EQRS number of reviewers of this proposed of the estimated CY 2022 ESRD PPS

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payments compared to estimated payments to ESRD facilities in CY 2021.

TABLE 9: Impact of Proposed Changes in Payments to ESRD Facilities for CY 2022 ESRD PPS Pro osed Rule

Number Effect of Effect of Effect of Effect of Numbe of 2022 2022 2022 Total 2022 rof Treatmen Changes in Changes Payment Facility Type Proposed Facilitie ts (in Outlier in Wage Rate Changes s (A) millions) Policy Index Update (F) (B) (C) (D) (E)

Large dialysis organization 5,886 33.6 0.2% 0.0% 1.0% 1.2% Regional chain 887 5.3 0.3% 0.1% 1.0% 1.4% Independent 515 2.8 0.3% -0.1% 1.0% 1.1% Hospital based1 378 1.7 0.4% -0.1% 1.0% 1.3%

East North Central 1,213 5.6 0.2% -0.1% 1.0% 1.1% East South Central 609 3.2 0.3% -0.6% 1.0% 0.7% Middle Atlantic 859 5.1 0.3% -0.2% 1.0% 1.1% Mountain 428 2.3 0.1% -0.1% 1.0% 1.1% New England 201 1.3 0.2% -0.5% 1.0% 0.6% Pacific2 955 6.3 0.2% 0.5% 1.0% 1.6% Puerto Rico and Virgin Islands 52

Less than 4,000 treatments 1.248 2.4 0.2% 0.0% 1.0% 1.1% 4,000 to 9,999 treatments 2,905 11.9 0.2% 0.0% 1.0% 1.2% 10,000 or more treatments 3,384 28.9 0.2% 0.0% 1.0% 1.2% Unknown 180 0.2 0.2% -0.2% 1.0% 1.0%

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BILLING CODE 4120–01–C percent increase in estimated payments results that would justify potentially Column A of the impact table in CY 2022. The categories of types of deviating from our longstanding policy indicates the number of ESRD facilities facilities in the impact table show to use the latest available data. Analysis for each impact category and column B impacts ranging from a 0.4 percent suggested that ESRD utilization did not indicates the number of dialysis increase to a 1.6 percent increase in change substantially during the treatments (in millions). The overall their CY 2022 estimated payments. pandemic, likely due to the patients’ effect of the proposed changes to the vulnerability and need for these b. Effects on Other Providers outlier payment policy described in services. Consequently, we proposed to section II.B.1.c of this proposed rule is Under the ESRD PPS, Medicare pays use the CY 2020 data because it does not shown in column C. For CY 2022, the ESRD facilities a single bundled negatively impact ESRD facilities and impact on all ESRD facilities as a result payment for renal dialysis services, keeps with our longstanding policy to of the proposed changes to the outlier which may have been separately paid to make updates using the latest available payment policy would be a 0.2 percent other providers (for example, ESRD claims data. increase in estimated payments. All laboratories, durable medical equipment ESRD facilities are anticipated to suppliers, and pharmacies) by Medicare 2. Proposed Payment for Renal Dialysis experience a positive effect in their prior to the implementation of the ESRD Services Furnished to Individuals With estimated CY 2022 payments as a result PPS. Therefore, in CY 2022, we estimate AKI of the proposed outlier policy changes. that the proposed ESRD PPS would a. Effects on ESRD Facilities Column D shows the effect of the have zero impact on these other annual update to the wage index, as providers. To understand the impact of the described in section II.B.1.b of this changes affecting payments to different proposed rule. That is, this column c. Effects on the Medicare Program categories of ESRD facilities for renal reflects the update from the CY 2021 We estimate that Medicare spending dialysis services furnished to ESRD PPS wage index using 2018 OMB (total Medicare program payments) for individuals with AKI, it is necessary to delineations as finalized in the CY 2021 ESRD facilities in CY 2022 would be compare estimated payments in CY ESRD PPS final rule, with a basis of the approximately $8.9 billion. This 2021 to estimated payments in CY 2022. FY 2022 pre-floor, pre-reclassified IPPS estimate takes into account a projected To estimate the impact among various hospital wage index data in a budget decrease in fee-for-service Medicare types of ESRD facilities for renal neutral manner. The total impact of this dialysis beneficiary enrollment of 5.9 dialysis services furnished to change is 0.0 percent; however, there percent in CY 2022. individuals with AKI, it is imperative that the estimates of payments in CY are distributional effects of the change d. Effects on Medicare Beneficiaries among different categories of ESRD 2021 and CY 2022 contain similar facilities. The categories of types of Under the ESRD PPS, beneficiaries are inputs. Therefore, we simulated facilities in the impact table show responsible for paying 20 percent of the payments only for those ESRD facilities changes in estimated payments ranging ESRD PPS payment amount. As a result for which we are able to calculate both from a 0.7 percent decrease to a 0.5 of the projected 1.2 percent overall current payments and new payments. percent increase due to the annual increase in the proposed CY 2022 ESRD For this proposed rule, we used CY update to the ESRD PPS wage index. PPS payment amounts, we estimate that 2020 data from the Part A and Part B Column E shows the effect of the there would be an increase in Common Working Files as of February proposed CY 2022 ESRD PPS payment beneficiary co-insurance payments of 12, 2021, as a basis for Medicare for rate update as described in section 1.2 percent in CY 2022, which translates renal dialysis services furnished to II.B.1.a of this proposed rule. The to approximately $30 million. individuals with AKI. We updated the proposed ESRD PPS payment rate e. Alternatives Considered 2020 claims to 2021 and 2022 using update is 1.0 percent, which reflects the various updates. The proposed updates proposed ESRDB market basket CY 2022 Impacts: 2019 Versus 2020 to the AKI payment amount are percentage increase factor for CY 2022 Claims Data described in section III.B of this of 1.6 percent and the proposed Each year CMS uses the latest proposed rule. Table 10 shows the productivity adjustment of 0.6 percent. available ESRD claims to update the impact of the estimated CY 2022 Column F reflects the overall impact, outlier threshold, budget neutrality payments for renal dialysis services that is, the effects of the proposed factor, and payment rates. Due to the furnished to individuals with AKI outlier policy changes, the proposed COVID–19 PHE, we compared the compared to estimated payments for updated wage index, and the payment impact of using CY 2019 claims against renal dialysis services furnished to rate update. We expect that overall CY 2020 claims to determine if there individuals with AKI in CY 2021. ESRD facilities would experience a 1.2 was any substantial difference in the BILLING CODE 4120–01–P

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TABLE 10: Impact of Proposed Changes in Payment for Renal Dialysis Services Furnished to Individuals with AKI for CY 2022 ESRD PPS Pro osed Rule

Number of Effect of Number Effect of 2022 Treatments 2022 of Payment Effect of Total 2022 Facility Type (in Changes in Facilities Rate Update Proposed Changes (E) thousands) Wage Index (A) (D) (B) (C)

Large dialysis organization 4,'.B2 256.0 0.0% 1.0% 1.0% Regional chain 576 31.6 0.1% 1.0% 1.1% Independent 206 13.3 0.0% 1.0% 1.0% Hospital based1 122 5.2 0.1% 1.0% 1.1% Unknown 11 0.2 0.3% 1.0% 1.3%

East North Central 881 55.1 -0.2% 1.0% 0.8% East South Central 425 22.5 -0.5% 1.0% 0.5% Middle Atlantic 587 33.1 -0.3% 1.0% 0.7% Mountain 303 18.8 -0.2% 1.0% 0.8% New England 141 6.4 -0.7% 1.0% 0.3% Pacific2 646 47.5 0.6% 1.0% 1.6% Puerto Rico and Virgin Islands 3 0.0 0.0% 1.0% 1.0% South Atlantic 1,236 74.5 0.2% 1.0% 1.2% West North Central 340 16.0 0.1% 1.0% 1.1% West South Central 685 32.4 -0.3% 1.0% 0.7%

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Less than 4,000 treatments 643 28.8 -0.1% 1.0% 0.9% 4,000 to 9,999 treatments 2,0ll 108.4 0.0% 1.0% 1.0% 10,000 or more treatments 2,525 167.2 0.0% 1.0% 1.0% Unknown 68 1.9 0.0% 1.0% 1.0%

Less than2% 5,247 306.3 0.0% 1.0% 1.0% Between2% and 19% 0 0.0 0.0% 0.0% 0.0% Between20% and49% 0 0.0 0.0% 0.0% 0.0% More than 50% 0 0.0 0.0% 0.0% 0.0% 1Includes hospital-based ESRD facilities not reported to have large dialysis organization or regional chain ownership. 2Includes ESRD facilities located in Guam, American Samoa, and the Northern Mariana Islands This information should not be deleted.

BILLING CODE 4120–01–C c. Effects on the Medicare Program may not be applicable to AKI patients Column A of the impact table and as such, including those policies indicates the number of ESRD facilities We estimate approximately $52 and adjustment would be inappropriate. for each impact category and column B million would be paid to ESRD facilities We continue to monitor utilization and indicates the number of AKI dialysis in CY 2022 as a result of patients with treatments (in thousands). Column C AKI receiving renal dialysis services in trends of items and services furnished to shows the effect of the proposed CY the ESRD facility at the lower ESRD PPS individuals with AKI for purposes of 2022 wage indices. Column D shows the base rate versus receiving those services refining the payment rate in the future. effect of the proposed CY 2022 ESRD only in the hospital outpatient setting This monitoring would assist us in PPS payment rate update. The proposed and paid under the outpatient developing knowledgeable, data-driven ESRD PPS payment rate update is 1.0 prospective payment system, where proposals. services were required to be percent, which reflects the proposed 3. ESRD QIP ESRDB market basket percentage administered prior to the TPEA. a. Effects of the PY 2022 ESRD QIP on increase factor for CY 2022 of 1.6 d. Effects on Medicare Beneficiaries percent and the proposed productivity ESRD Facilities adjustment of 0.6 percent. Currently, beneficiaries have a 20 Column E reflects the overall impact, percent co-insurance obligation when The ESRD QIP is intended to prevent that is, the effects of the updated wage they receive AKI dialysis in the hospital reductions in the quality of ESRD index and the payment rate update. We outpatient setting. When these services dialysis facility services provided to expect that overall ESRD facilities are furnished in an ESRD facility, the beneficiaries. Although the general would experience a 1.0 percent increase patients would continue to be methodology that we use to determine in estimated payments in CY 2022. The responsible for a 20 percent a facility’s TPS is described in our categories of types of facilities in the coinsurance. Because the AKI dialysis regulations at 42 CFR 413.178(e), we are impact table show impacts ranging from payment rate paid to ESRD facilities is proposing to codify special scoring an increase of 0.0 percent to 1.6 percent lower than the outpatient hospital PPS’s policies for PY 2022 at 42 CFR in their CY 2022 estimated payments. payment amount, we would expect 413.178(h). Under these proposed beneficiaries to pay less co-insurance b. Effects on Other Providers regulations, we would calculate when AKI dialysis is furnished by ESRD measure rates for all measures but Under section 1834(r) of the Act, as facilities. would not calculate achievement and added by section 808(b) of TPEA, we improvement points for any measures. propose to update the payment rate for e. Alternatives Considered We would also not calculate or award a renal dialysis services furnished by As we discussed in the CY 2017 ESRD ESRD facilities to beneficiaries with PPS proposed rule (81 FR 42870), we TPS for any facility. Finally, we would AKI. The only two Medicare providers considered adjusting the AKI payment not reduce payment to any facility for and suppliers authorized to provide rate by including the ESRD PPS case- PY 2022. these outpatient renal dialysis services mix adjustments, and other adjustments If these policies are finalized as are hospital outpatient departments and at section 1881(b)(14)(D) of the Act, as proposed, we believe there will be no ESRD facilities. The patient and his or well as not paying separately for AKI effects of the PY 2022 ESRD QIP on her physician make the decision about specific drugs and laboratory tests. We ESRD Facilities, as no facilities will where the renal dialysis services are ultimately determined that treatment for receive a TPS or payment reductions for furnished. Therefore, this proposal will AKI is substantially different from PY 2022. have zero impact on other Medicare treatment for ESRD and the case-mix providers. adjustments applied to ESRD patients

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b. Effects of the PY 2024 ESRD QIP on For the PY 2024 ESRD QIP, we through 71483). If our proposals are ESRD Facilities estimate that, of the 7,610 dialysis finalized as proposed, the total facilities (including those not receiving estimated payment reductions for all the Any reductions in the ESRD PPS a TPS) enrolled in Medicare, 1,799 facilities expected to receive a payments as a result of a facility’s approximately 24.4 percent or 1,799 of payment reduction in PY 2024 would performance under the PY 2024 ESRD the facilities that have sufficient data to decrease from $18,247,083.76 to QIP will apply to the ESRD PPS calculate a TPS would receive a approximately $17,154,657.12. Facilities payments made to the facility for payment reduction for PY 2024. We are that do not receive a TPS do not receive services furnished in CY 2024, as presenting an estimate for the PY 2024 a payment reduction. codified in our regulations at 42 CFR ESRD QIP to update the estimated Table 11 shows the overall estimated 413.177. impact that was provided in the CY distribution of payment reductions 2021 ESRD PPS final rule (85 FR 71481 resulting from the PY 2024 ESRD QIP.

TABLE 11: Estimated Distribution of PY 2024 ESRD QIP Payment Reductions

Percent of Payment Reduction Number of Facilities Facilities* 0.0% 5,570 75.59o/c 0.5% 1,343 18.22o/c 1.0% 363 4.93o/c 1.5% 71 0.96o/c 2.0% 22 0.30o/c *241 facilities not scored due to insufficient data

To estimate whether a facility would previously finalized and for which there 12) in accordance with the policies receive a payment reduction for PY were available data from EQRS and proposed in this proposed rule. 2024, we scored each facility on Medicare claims. Payment reduction Measures used for the simulation are achievement and improvement on estimates are calculated using the most shown in Table 12. several clinical measures we have recent data available (specified in Table

TABLE 12: Data Used to Estimate PY 2024 ESRD QIP Payment Reductions

Period of time used to calculate achievement thresholds, 50th Measure percentiles of the national performance, Performance period benchmarks, and improvement thresholds ICH CARPS Survey Jan 2018-Dec 2018 Jan 2019-Dec 2019 SRR Jan 2018-Dec 2018 Jan 2019-Dec 2019 SHR Jan 2018-Dec 2018 Jan 2019-Dec 2019 PPPW Jan 2018-Dec 2018 Jan 2019-Dec 2019 Kt/V Dialysis Adequacy Jan 2018-Dec 2018 Jan 2019-Dec 2019 Comprehensive VAT Standardized Fistula Ratio Jan 2018-Dec 2018 Jan 2019-Dec 2019

% Catheter Jan 2018-Dec 2018 Jan 2019-Dec 2019 Hypercalcemia Jan 2018-Dec 2018 Jan 2019-Dec 2019

For all measures except the SHR measure, facilities were required to have facility’s TPS was compared to an clinical measure, the Standardized at least 5 patient-years at risk and 11 estimated mTPS and an estimated Readmission Ratio (SRR) clinical index discharges, respectively, in order payment reduction table that were measure, and the STrR reporting to be included in the facility’s TPS. For consistent with the proposals outlined measure, measures with less than 11 the STrR reporting measure, facilities in sections IV.E and IV.F of this patients for a facility were not included were required to have at least 10 proposed rule. Facility reporting in that facility’s TPS. For the SHR patient-years at risk in order to be measure scores were estimated using clinical measure and the SRR clinical included in the facility’s TPS. Each available data from CY 2019. Facilities

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were required to have at least one the ESRD QIP, yielding a total payment facility type (hospital based and measure in at least two domains to reduction amount for each facility. freestanding facilities). Given that the receive a TPS. Table 13 shows the estimated impact performance period used for these To estimate the total payment of the finalized ESRD QIP payment calculations differs from the reductions in PY 2024 for each facility reductions to all ESRD facilities for PY performance period we are using for the resulting from this final rule, we 2024. The table also details the PY 2024 ESRD QIP, the actual impact of multiplied the total Medicare payments distribution of ESRD facilities by size the PY 2024 ESRD QIP may vary to the facility during the 1-year period (both among facilities considered to be significantly from the values provided between January 2019 and December small entities and by number of here. 2019 by the facility’s estimated payment treatments per facility), geography (both reduction percentage expected under rural and urban and by region), and

TABLE 13: Estimated Impact of QIP Payment Reductions to ESRD Facilities for PY 2024

Number of Payment Facilities Reduction Number of Number of Expected to (percent Treatments Facilities Receive a change in Number of 2019 (in with QIP Payment total ESRD Facilities millions) Score Reduction payments) All Facilities 7,610 44.8 7,369 1,799 -0.16% Facility Type: 7,224 43.1 7,024 1,691 -0.15% Freestanding Hospital-based 386 1.8 345 108 -0.26% Ownership Type: 5,809 34.8 5,686 1,200 -0.12% Large Dialysis Regional Chain 944 5.7 921 268 -0.20% Independent 534 2.9 491 240 -0.38% Hospital-based (non-chain) 299 1.3 264 89 -0.29% Unknown 24 0.0 7 2 -0.21% Facility Size: 6,753 40.6 6,607 1,468 -0.13% Large Entities Small Entities1 833 4.3 755 329 -0.35% Unknown 24 0.0 7 2 -0.21% Rural Status: 1,292 6.5 1,237 203 -0.09% I) Yes 2)No 6,318 38.4 6,132 1,596 -0.17% Census Region: 1,046 6.7 1,000 261 -0.16% Northeast Midwest 1,734 8.3 1,663 431 -0.18% South 3,452 20.6 3,364 909 -0.17% West 1,318 8.7 1,283 165 -0.08% US Territories2 60 0.4 59 33 -0.36% Census Division: 8 0.1 8 4 -0.37% Unknown East North Central 1,220 6.0 1,171 355 -0.21% East South Central 604 3.3 592 135 -0.13% Middle Atlantic 845 5.4 806 227 -0.17% Mountain 419 2.4 405 52 -0.08% New England 201 1.4 194 34 -0.10% Pacific 899 6.3 878 113 -0.08% South Atlantic 1,746 10.7 1,700 494 -0.19% West North Central 514 2.3 492 76 -0.10% West South Central 1,102 6.7 1,072 280 -0.17% US Territories2 52 0.3 51 29 -0.36% Facility Size(# oftotal treatments) 1,315 2.6 1,195 265 -0.17% Less than 4,000 treatments 4, 000-9 ,999 treatments 2,803 12.2 2,771 555 -0.13% Over 10,000 treatments 3,246 29.7 3,240 947 -0.17% Unknown 246 0.3 163 32 -0.18% 1Small Entities include hospital-based and satellite facilities, and non-chain facilities based on DFC self-reported status. 2Includes American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and Virgin Islands.

c. Effects of the PY 2025 ESRD QIP on facilities (including those not receiving calculate a TPS would receive a ESRD Facilities a TPS) enrolled in Medicare, payment reduction for PY 2025. The approximately 24.4 percent or 1,799 of total payment reductions for all the For the PY 2025 ESRD QIP, we the facilities that have sufficient data to 1,799 facilities expected to receive a estimate that, of the 7,610 dialysis

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payment reduction is approximately receive a TPS do not receive a payment Table 14 shows the overall estimated $17,154,657.121. Facilities that do not reduction. distribution of payment reductions resulting from the PY 2025 ESRD QIP.

TABLE 14: Estimated Distribution of PY 2025 ESRD QIP Payment Reductions

Percent of Payment Reduction Number of Facilities Facilities* 0.0% 5,570 75.59o/c 0.5% 1,343 18.22o/c 1.0% 363 4.93o/c 1.5% 71 0.96o/c 2.0% 22 0.30o/c *Note: 241 facilities not scored due to insufficient data

To estimate whether a facility would and for which there were available data accordance with the policies finalized receive a payment reduction in PY 2025, from EQRS and Medicare claims. in this proposed rule. Measures used for we scored each facility on achievement Payment reduction estimates were the simulation are shown in Table 15. and improvement on several clinical calculated using the most recent data measures we have previously finalized available (specified in Table 14) in

TABLE 15: Data Used to Estimate PY 2025 ESRD QIP Payment Reductions

Period of time used to calculate achievement thresholds, 50th Measure percentiles of the national Performance period performance, benchmarks, and improvement thresholds ICH CARPS Survey Jan 2018-Dec 2018 Jan 2019-Dec 2019 SRR Jan 2018-Dec 2018 Jan 2019-Dec 2019 SHR Jan 2018-Dec 2018 Jan 2019-Dec 2019 PPPW Jan 2018-Dec 2018 Jan 2019-Dec 2019 Kt/V Dialysis Adequacy Jan 2018-Dec 2018 Jan 2019-Dec 2019 Comprehensive VAT Standardized Fistula Ratio Jan 2018-Dec 2018 Jan 2019-Dec 2019

% Catheter Jan 2018-Dec 2018 Jan 2019-Dec 2019 Hypercalcemia Jan 2018-Dec 2018 Jan 2019-Dec 2019

For all measures except the SHR incorporates the policies outlined in the ESRD QIP, yielding a total payment clinical measure, the SRR clinical section IV.E and IV.F of this proposed reduction amount for each facility. measure, and the STrR reporting rule. Facility reporting measure scores Table 16 shows the estimated impact measure, measures with less than 11 were estimated using available data of the finalized ESRD QIP payment patients for a facility were not included from CY 2019. Facilities were required reductions to all ESRD facilities for PY in that facility’s TPS. For SHR and SRR, to have at least one measure in at least 2025. The table details the distribution facilities were required to have at least two domains to receive a TPS. of ESRD facilities by size (both among 5 patient-years at risk and 11 index To estimate the total payment facilities considered to be small entities discharges, respectively, in order to be reductions in PY 2025 for each facility and by number of treatments per included in the facility’s TPS. For the resulting from this proposed rule, we facility), geography (both rural and STrR reporting measure, facilities were multiplied the total Medicare payments urban and by region), and facility type required to have at least 10 patient-years to the facility during the 1-year period (hospital based and freestanding at risk in order to be included in the between January 2019 and December facilities). Given that the performance facility’s TPS. Each facility’s TPS was 2019 by the facility’s estimated payment period used for these calculations compared to an estimated mTPS and an reduction percentage expected under differs from the performance period we estimated payment reduction table that are proposing to use for the PY 2025

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ESRD QIP, the actual impact of the PY 2025 ESRD QIP may vary significantly from the values provided here. BILLING CODE 4120–01–P

TABLE 16: Estimated Impact of QIP Payment Reductions to ESRD Facilities for PY 2025

Number of Payment Facilities Reduction Number of Number of Expected to (percent Treatments Facilities Receive a change in Number of 2019 (in with QIP Payment total ESRD Facilities millions) Score Reduction payments) All Facilities 7,610 44.8 7,369 1,799 -0.16% Facility Type: 7,224 43.1 7,024 1,691 -0.15% Freestanding Hospital-based 386 1.8 345 108 -0.26% Ownership Type: 5,809 34.8 5,686 1,200 -0.12% Large Dialysis Regional Chain 944 5.7 921 268 -0.20% Independent 534 2.9 491 240 -0.38% Hospital-based (non-chain) 299 1.3 264 89 -0.29% Unknown 24 0.0 7 2 -0.21% Facility Size: 6,753 40.6 6,607 1,468 -0.13% Large Entities Small Entities 1 833 4.3 755 329 -0.35% Unknown 24 0.0 7 2 -0.21% Rural Status: 1,292 6.5 1,237 203 -0.09% I) Yes 2)No 6,318 38.4 6,132 1,596 -0.17% Census Region: 1,046 6.7 1,000 261 -0.16% Northeast Midwest 1,734 8.3 1,663 431 -0.18% South 3,452 20.6 3,364 909 -0.17% West 1,318 8.7 1,283 165 -0.08% US Territories2 60 0.4 59 33 -0.36% Census Division: 8 0.1 8 4 -0.37% Unknown East North Central 1,220 6.0 1,171 355 -0.21% East South Central 604 3.3 592 135 -0.13% Middle Atlantic 845 5.4 806 227 -0.17% Mountain 419 2.4 405 52 -0.08% New England 201 1.4 194 34 -0.10% Pacific 899 6.3 878 113 -0.08% South Atlantic 1,746 10.7 1,700 494 -0.19% West North Central 514 2.3 492 76 -0.10% West South Central 1,102 6.7 1,072 280 -0.17% US Territories2 52 0.3 51 29 -0.36% Facility Size(# oftotal treatments) 1,315 2.6 1,195 265 -0.17% Less than 4,000 treatments 4,000-9,999 treatments 2,803 12.2 2,771 555 -0.13% Over I 0,000 treatments 3,246 29.7 3,240 947 -0.17% Unknown 246 0.3 163 32 -0.18% 1Small Entities include hospital-based and satellite facilities, and non-chain facilities based on DFC self-reported status. 2Includes American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and Virgin Islands.

d. Effects on Other Providers unplanned readmissions and e. Effects on the Medicare Program The ESRD QIP is applicable to hospitalizations. We are exploring For PY 2025, we estimate that the dialysis facilities. We are aware that various methods to assess the impact ESRD QIP would contribute several of our measures impact other these measures have on hospitals and approximately $17,154,657.12 in providers. For example, with the other facilities, such as through the Medicare savings. For comparison, introduction of the SRR clinical impacts of the Hospital Readmissions Table 17 shows the payment reductions measure in PY 2017 and the SHR Reduction Program and the Hospital- that we estimate will be applied by the clinical measure in PY 2020, we Acquired Condition Reduction Program, ESRD QIP from PY 2018 through PY anticipate that hospitals may experience and we intend to continue examining 2025. This includes our PY 2022 scoring financial savings as dialysis facilities the interactions between our quality and payment proposals as described in work to reduce the number of programs to the greatest extent feasible. section IV.D of this proposed rule.

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TABLE 17: Estimated Payment Reductions Payment Years 2018 through 2025

Payment year Estimated payment reductions PY 2025 $17,154,657 PY 2024 $17,154,657 PY 2023 $15,770,179 (85 FR 71483) PY 2022 NIA PY 2021 $32,196,724 (83 FR 57062) PY 2020 $31,581,441 (81 FR 77960) PY 2019 $15,470,309 (80 FR 69074) PY 2018 $11,576,214 (79 FR 66257)

BILLING CODE 4120–01–C of the PY 2022 ESRD QIP measures, as and dialysis-related claims submitted by f. Effects on Medicare Beneficiaries described more fully in section IV.C. of ETC Participants, as described in this proposed rule. This approach §§ 512.375(a) and 512.380 for ESRD The ESRD QIP is applicable to would help to ensure that a facility facilities and §§ 512.375(b) and 512.380 dialysis facilities. Since the Program’s would not be penalized due to for Managing Clinicians, which will inception, there is evidence on extraordinary circumstances beyond the apply to claims with claim service dates improved performance on ESRD QIP facility’s control. beginning on July 1, 2022 and increase measures. As we stated in the CY 2018 in magnitude over the duration of the ESRD PPS final rule, one objective 4. ETC Model ETC Model. We will assess each ETC measure we can examine to demonstrate (1) Overview Participant’s home dialysis rate, as the improved quality of care over time described in § 512.365(b), and is the improvement of performance Under the ESRD PPS under Medicare transplant rate, as described in standards (82 FR 50795). As the ESRD Part B, a single per-treatment payment § 512.365(c), for each MY. The ETC QIP has refined its measure set and as is made to an ESRD facility for all of the Participant’s transplant rate will be facilities have gained experience with renal dialysis services defined in section aggregated, as described in § 512.365(e), the measures included in the Program, 1881(b)(14)(B) of the Act and furnished and the ETC Participant’s home dialysis performance standards have generally to individuals for the treatment of ESRD rate will be aggregated, as described in continued to rise. We view this as in the ESRD facility or in a patient’s § 512.365(e). The ETC Participant will evidence that facility performance (and home. Under the Physician Fee receive a Modality Performance Score therefore the quality of care provided to Schedule, medical management of an (MPS) based on the weighted sum of the Medicare beneficiaries) is objectively ESRD beneficiary receiving dialysis by a higher of the ETC Participant’s improving. We are in the process of physician or other practitioner is paid achievement score or improvement monitoring and evaluating trends in the through the MCP. The ETC Model is a score for the home dialysis rate and the quality and cost of care for patients mandatory payment model designed to higher of the ETC Participant’s under the ESRD QIP, incorporating both test payment adjustments to certain achievement score or improvement existing measures and new measures as dialysis and dialysis-related payments, score for the transplant rate, as they are implemented in the Program. as discussed in the Specialty Care described in § 512.370(d). We will provide additional information Models final rule (85 FR 6114), for about the impact of the ESRD QIP on ESRD facilities and for Managing For MY1 and MY2 (January 1, 2021 beneficiaries as we learn more. Clinicians for claims with dates of through July 6, 2022), the achievement However, in future years we are service from January 1, 2021 to June 30, scores will be calculated in relation to interested in examining these impacts 2027. The requirements for the ETC a set of benchmarks based on the through the analysis of available data Model are set forth in 42 CFR part 512, historical rates of home dialysis and from our existing measures. subpart C. The changes proposed in this inclusion on the transplant waitlist proposed rule (discussed in detail in among ESRD facilities and Managing g. Alternatives Considered section V.B of this proposed rule) would Clinicians located in Comparison In section IV.D. of this proposed rule, impact model payment adjustments for Geographic Areas. The improvement we are proposing a special rule to PPA Period 3, starting in July 1, 2023. scores will be calculated in relation to modify the scoring methodology such Under the current ETC Model, there a set of benchmarks based on the ETC that no facility would receive a payment are two payment adjustments designed Participant’s own historical reduction for PY 2022. Under this to increase rates of home dialysis and performance. The ETC Participant’s special rule for PY 2022, we would kidney transplantation through financial MPS for a MY will determine the calculate measure rates for all measures incentives. The HDPA is an upward magnitude of its PPA during the for that payment year, but would not payment adjustment on certain home corresponding 6-month PPA Period, use those measure rates to generate an dialysis claims for ESRD facilities, as which will begin 6 months after the end achievement or improvement score, described in §§ 512.340 and 512.350, of the MY. An ETC Participant’s MPS domain scores, or a TPS. We considered and to certain home dialysis-related will be updated on a rolling basis every retaining our current scoring policy for claims for Managing Clinicians, as 6 months. PY 2022. However, we concluded that described in §§ 512.345 and 512.350, As mentioned in section IV.C.2.b(1) of this was not feasible because of the during the initial 3 years of the ETC the Specialty Care Models final rule (85 EQRS system issues described in section Model. FR 61351), the intention was to increase IV.B.2, and additionally, due to the The PPA is an upward or downward these benchmarks over time through impact of the COVID–19 PHE on some payment adjustment on certain dialysis subsequent notice and comment

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rulemaking. In this proposed rule, the available. Both datasets and the risk- dialysis, condition code 72 (§ 512.365) changes listed with bullets are being adjustment methodologies for the ETC and in-center nocturnal dialysis, based proposed for MY3 (beginning January 1, Model were developed by the CMS on any of the claims’ lines 1–5 HCPCS 2022) through the final MY of ETC Office of the Actuary (OACT). codes equal to the ‘‘UJ’’ modifier. Self- Model (MY10). More detail on these The ESRD facilities and Managing care in training and ESRD self-care changes is provided in section V.B of Clinicians datasets were restricted to the retraining, condition codes 73 and 87, this proposed rule. The proposed following eligibility criteria. respectively, were only included in the changes that are most likely to affect the Beneficiaries must be residing in the denominator for the home dialysis rate impact estimate for the ETC Model are: United States, 18 years of age or older, calculation. For consistency with the • Include nocturnal in-center dialysis and enrolled in Medicare Part B. exclusion in § 512.385(a), after grouping in the home dialysis rate calculation for Beneficiaries enrolled in Medicare within each HRR, aggregated ESRD Managing Clinicians and ESRD facilities Advantage or other cost or Medicare facilities with less than 132 total not owned in whole or in part by an managed care plans, who have elected attributed beneficiary months during a ETC LDO. hospice, are receiving dialysis for acute given MY were excluded. When • Exclude beneficiaries with a kidney injury (AKI) only, with a constructing benchmarks, for diagnosis of and who are receiving diagnosis of dementia, who are consistency with the methodology for chemotherapy or radiation for vital solid receiving dialysis in a nursing facility, aggregating performance for purposes of organ cancer from the transplant rate or reside in a skilled nursing facility the PPA calculation, we aggregated all calculation. were excluded. In addition, ESRD facilities owned in whole or in • Modify the PPA achievement beneficiaries who have a diagnosis of part by the same dialysis organization benchmarking methodology: and are receiving treatment with located in the same HRR. ++ Stratify the home dialysis and chemotherapy or radiation for a vital The Managing Clinicians’ transplant rate benchmark by the solid organ cancer were excluded from performance data were aggregated to the proportion of beneficiaries who are the transplant rate calculations. Tax Identification Number (TIN) level dual-eligible for Medicare and Diagnosis of a vital solid organ cancer (for group practices) and the individual Medicaid, or, receive the Low-Income was defined as a beneficiary that had a National Provider Identifier (NPI) level Subsidy (LIS), resulting in two strata. claim with any of 39 ICD–10–CM codes (for solo practitioners). For purposes of ++ Increase the home dialysis and ranging from C22.0 through C79.02. calculating the home dialysis rate, transplant rate benchmarks by 10 Treatment of a vital solid organ cancer beneficiaries on home dialysis were percent for each MY couplet (that is, was defined as a beneficiary with a identified using outpatient claims with 1.10 for MY3 and MY4, 1.20 for MY5 claim with any of 2,087 radiation CPT® codes 90965 and 90966 and MY6, 1.30 for MY7 and MY8, and administration ICD–10–PCS codes, 19 (§ 512.345). Beneficiaries receiving in- 1.40 for MY9 and MY10). chemotherapy administration CPT center dialysis were identified by • Modify the PPA improvement codes, or 41 radiation administration outpatient claims with CPT® codes benchmarking methodology: CPT codes. Last, the HRR was matched 90957, 90958, 90959, 90960, 90961, and ++ Health Equity Incentive: to the claim service facility zip code or 90962 (§ 512.360). Last, following the Participants can earn 0.5 improvement the rendering physician zip code for low-volume threshold described in points in addition to their improvement ESRD facility and Managing Clinician, § 512.385(b), after grouping within each score for a significant increase in the respectively. HRR, Managing Clinicians with less rate of dual eligible or LIS recipient For the modeling exercise used to than 132 total attributed beneficiary beneficiaries. estimate changes in payment to months during a given MY were ++ Modify improvement calculation providers and suppliers and the excluded. to ensure that the Benchmark Year rate resulting savings to Medicare, OACT The Scientific Registry of Transplant cannot be zero, such that improvement maintained the previous method to Recipients (SRTR) transplant waitlist is calculable for all participants. identify ESRD facilities with common data were obtained from the Center for The ETC Model is not a total cost of ownership, the low-volume exclusion Clinical Standards and Quality (CCSQ). care model. ETC Participants will still threshold, and the aggregation To construct the transplant waitlist rate, bill FFS Medicare, and items and assumptions as CMS has not proposed the numerator was based on per-patient services not subject to the ETC Model’s changes to these model policies. To counts and included every addition to payment adjustments will continue to clarify OACT’s methodology, the ESRD the waitlist for a patient in any past be paid as they would in the absence of facilities’ data were aggregated to the year. The waitlist counts for the the Model. CMS Certification Number (CCN) level numerator included waitlists for kidney for beneficiaries on dialysis identified transplants, alone or with another organ, (2) Data and Methods by outpatient claims with Type of Bill active and inactive records, multi-organ A stochastic simulation was created to 072X to capture all dialysis services listings, and patients that have estimate the financial impacts of the furnished at or through ESRD facilities. subsequently been removed from the proposed changes to the ETC Model Beneficiaries receiving home dialysis waitlist. The denominator was a unique relative to baseline expenditures, where services were defined as condition count of prevalent dialysis patients as of baseline expenditures were defined as codes 74 and 76 (§ 512.340). Condition the end of the year. Only patients on data from CYs 2018 and 2019 without code 75 was removed from the home dialysis as of December 31st for the the proposed changes applied. The dialysis definition because that billing selected year were included. Facility simulation relied upon statistical code is no longer in use. Condition code attribution was based on the facility the assumptions derived from 80 was removed because we want to patient was admitted to on the last day retrospectively constructed ESRD exclude beneficiaries who received of the year. facilities’ and Managing Clinicians’ home dialysis furnished in a SNF or For MY1 and MY2, the home dialysis Medicare dialysis claims, transplant nursing facility. Beneficiaries receiving score and transplant score for the PPA claims, and transplant waitlist data in-center dialysis services were defined were calculated using the following reported during 2018 and 2019, the using condition code 71. Two new methodology for the ESRD facilities and most recent years with complete data variables were created: In-center self- Managing Clinicians. ETC Participant

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behavior for each year was simulated by modifier code did not become effective Medicare Qualified Medicare adjusting the ETC Participant’s baseline until January 1, 2017; therefore, there Beneficiary (QMB) and Medicaid home dialysis (or transplant) rate for a were insufficient data to generate coverage including prescription drugs, simulated statistical fluctuation and growth rate assumptions. The in-center 04=Eligible is entitled to Medicare then summing with the assumed nocturnal dialysis beneficiary growth Specified Low-Income Medicare increase in home dialysis (or transplant) rate decreased by 91.3 percent in 2020. Beneficiary (SLMB) and Medicaid rate multiplied by a randomly generated As a solution to these data limitations, coverage including prescription drugs, improvement scalar. The achievement to simulate the impact of incorporating or 08=Eligible is entitled to Medicare and improvement scores were assigned in-center self-dialysis and in-center Other dual eligible with Medicaid by comparing the ETC Participant’s nocturnal dialysis for the purpose of the coverage including prescription drugs. simulated home dialysis (or transplant) savings to Medicare estimate, the Separately, a yes/no indicator was rate for the MY to the percentile simulation assumed any given ESRD created for any beneficiary that was distribution of home dialysis (or facility or Managing Clinician would either deemed or determined by the transplant) rates in the prior year. Last, have a one percent chance of receiving Social Security Administration (SSA) to the MPS was calculated using the an increased achievement score due to be receiving the LIS. The home dialysis weighted sum of the higher of the this policy proposal. rate and transplant waitlist rate achievement or improvement score for The overall process for generating achievement benchmarks were then the home dialysis rate and the achievement and improvement scoring stratified by the proportion of attributed transplant waitlist rate. The home followed modeling from section VI.C.2 beneficiaries who are dual-eligible or dialysis rate constituted two-thirds of of the Specialty Care Models final rule receive the LIS. Two strata were created the MPS, and the transplant rate one- (85 FR 61352), with the exception of the with a cutpoint of approximately 50 third of the MPS. following changes. percent for participants with any dual- For MY3 through MY10, the home Beginning for MY3 and beyond, the eligible or LIS recipient beneficiaries dialysis rate calculation accounts for achievement benchmarking and those who do not have beneficiaries modifications proposed in this proposed methodology had two proposed meeting the socioeconomic status rule. For Managing Clinicians, the modifications. First, the home dialysis proxies. proposed revisions include changing the rate and transplant waitlist rate Third, a Health Equity Incentive was numerator for the home dialysis rate benchmarks were increased by a total of proposed for improvement scoring from the home dialysis beneficiary 10 percent relative to ESRD facilities starting in MY3. For the purpose of the months to the home dialysis beneficiary and Managing Clinicians not selected estimates in this Regulatory Impact months + 0.5(in-center self-dialysis for participation, every two MYs. To Analysis, we incorporated a random beneficiary months) + 0.5*(nocturnal in- clarify, no changes to the achievement variable to simulate each ETC center dialysis beneficiary months), benchmarking methodology were made Participant’s baseline variation and such that 1-beneficiary year is to MYs 1 and 2. The latter MY couplets’ behavioral improvement for each MY. If comprised of 12-beneficiary months. achievement benchmarking included the participant’s simulated The proposed revision for the numerator the following preset benchmark improvement behavior in MY3 through of the home dialysis rate for ESRD updates: MY10 was greater than 5 percent, then facilities varied if the facility was • MYs 3 and 4: Comparison the participant received a 0.5 point owned in whole or in part by an ETC Geographic Area percentiles*1.10, increase on their improvement score, LDO, as identified by ownership • MYs 5 and 6: Comparison allowing for a maximum of 2.0 total information for the associated CCN. If Geographic Area percentiles*1.20, points. the CCN had facilities owned by an ETC • MYs 7 and 8: Comparison For all MYs, the transplant waitlist LDO, then the proposed numerator for Geographic Area percentiles*1.30, and benchmarks were annually inflated by the home dialysis rate was the home • MYs 9 and 10: Comparison approximately 3-percentage points dialysis beneficiary months + 0.5*(in- Geographic Area percentiles*1.40. growth. This was a modification from center self-dialysis beneficiary months); The percentiles represented the 30th, section VI.C.2 of the Specialty Care therefore, not including nocturnal in- 50th, 75th, and 90th percentile of the Models final rule (85 FR 61352), where center dialysis months from the home dialysis rate and transplant rate the waitlist benchmarks were annually numerator. Otherwise, if the CCN did for ESRD facilities and Managing inflated by approximately 2-percentage not have facilities owned by an ETC Clinicians not selected for participation. points growth observed during years LDO, then the numerator was the same The preset benchmark updates method 2017 through 2019 in the CCSQ data, to as described above for Managing provides greater certainty to ETC project rates of growth. The additional Clinicians, such that the numerator for Participants than the rolling updates in 1 percentage point growth in this the home dialysis rate was home section IV.C.2.b(3) of the Specialty Care proposed rule was included to account dialysis beneficiary months + 0.5*(in- Models final rule (85 FR 61353), which for uncertainty from the COVID–19 PHE center self-dialysis beneficiary months) would have involved updating disruption and section 17006 of the 21st + 0.5*(nocturnal in-center dialysis benchmarks based on emerging trends Century Cures Act (Cures Act) (Pub. L. beneficiary months). over the most recent experience periods 114–255), which amended the Act to The number of beneficiaries on in- for which data were available. increase enrollment options for center self-dialysis who met the Second, in this proposed rule, we individuals with ESRD into Medicare eligibility criteria for the ETC Model proposed to incorporate two proxies for Advantage. To clarify, applying the 3- was very small, ranging from 102 to 277 socioeconomic status, dual eligibility percentage point annual growth from over the period 2012–2019 and status or receipt of the Low Income the median transplant waitlist rate decreasing 89.9 percent to 22 Subsidy (LIS), as part of the across HRR condensed facilities grew beneficiaries in 2020 (based on achievement benchmarking starting for from 8 percent in 2017 to 11 percent in preliminary 2020 data at CMS). With MY3 and beyond. Dual eligibility status 2018 to 14 percent in 2019 (that is, not such a small sample size, the growth was defined as a Medicare beneficiary a growth rate of 1.03 percent per year). rate vacillated significantly. In addition, with any of the following full-time dual To assess the impact of the COVID– the in-center nocturnal dialysis UJ type codes: 02=Eligible is entitled to 19 PHE on the kidney transplant

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waitlist, we analyzed data from the to the kidney transplant waitlist adjusted by decreasing amounts (3, 2, United Network for Organ Sharing remained at approximately pre- and 1 percent) during each of the first (UNOS).305. The UNOS data suggest that pandemic rates. Therefore, we assume 3 years of the Model. the number of new patients added to the that the number of new patients added The kidney disease patient education kidney transplant waitlist steadily to the waitlist will not decrease as a services utilization and cost data were decreased between the weeks of March result of the pandemic and the linear identified by codes G0420 and G0421, to 15, 2020 through May 10, 2020, when 2-percentage point growth rate for the capture face-to-face individual and between 16 to 81 percent of patients transplant waitlist calculated using group training sessions for chronic listed on the weekly kidney transplant years 2017 through 2019 CCSQ data kidney disease beneficiaries on waitlist became inactive due to COVID– remains a reasonable assumption for treatment modalities. The home dialysis 19 precautions. During July through baseline growth going forward. In the training costs for incident beneficiaries December 2020, the number of new proposed rule, we also included a 1 on home dialysis for Continuous patients added to the kidney transplant percent increase to the standard error to Ambulatory Peritoneal Dialysis (CAPD) waitlist increased to near pre-pandemic account for a new variation assumption or Continuous Cycler-Assisted levels with an average of less than 3 to address how year-over-year changes Peritoneal Dialysis (CCPD) were defined percent of patients listed as inactive due could fluctuate at the ESRD facility or using CPT® codes 90989 and 90993 for to COVID–19. Anomalous dips in the Managing Clinician level, which was complete and incomplete training number of new patients added to the potentially exacerbated by the exclusion sessions, respectively. kidney transplant waitlist were criteria (that is, residents of a nursing Data from CY 2019 were used to observed during the weeks of November facility, receiving dialysis in a skilled project baseline expenditures (that is, 22, 2020 and December 27, 2020, which nursing facility, dialysis for AKI only) expenditures before the proposed correspond with federal holidays in applied to the updated model data changes were applied) and the addition to a period that Americans source used for estimates in this traditional FFS payment system billing were asked to social distance to slow the proposed rule. patterns were assumed to continue spread of COVID–19. Continuing into No changes were proposed to the under current law. the first quarter of 2021, new additions payment structure for the HDPA calculation described in the final rule (3) Medicare Estimate—Primary (§ 512.350). As such, the HDPA was Specification, Assume Proposed 305 UNOS. 2021. COVID–19 and Solid Organ Benchmark Updates Transplants. Transplant and Waitlist Data calculated using the home dialysis and Visualizations. https://unos.org/covid/. home dialysis-related payments BILLING CODE 4120–01–P

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TABLE 18. Estimates of Medicare Program Savings (Rounded $M) for ETC MODEL

Year of Model 2021 2022 2023 2024 2025 2026 2027 6.5 Year Total* Net Impact to 14 8 -3 -12 -14 -21 -11 -38 Medicare Soendin2

Overall PPA Net & 13 6 -5 -14 -17 -24 -14 -53 HDPA

Clinician PPA -1 -2 -2 -3 -4 -2 -14 Downward Adiustment Clinician PPA 0 1 1 1 1 1 5 Uoward Adiustment Clinician PPA Net 0 -1 -1 -2 -2 -1 -9 Clinician HDPA 0 0 0 0

Facility Downward -9 -21 -26 -32 -40 -22 -149 Adiustment Facility Upward 5 11 14 17 18 9 75 Ad.iustment Facility PPA Net -3 -10 -12 -15 -22 -12 -74 Facility HDPA 13 10 6 29

Total PPA Downward -9 -23 -29 -35 -44 -24 -163 Adiustment Total PPA Upward 6 12 15 18 19 10 80 Adjustment Total PPA Net -4 -11 -14 -17 -24 -14 -83 TotalHDPA 13 10 6 29

Kidney Disease 0 1 1 1 1 1 1 5 Patient Education Services Costs

HD Trainin!! Costs 1 1 1 1 2 2 2 10 *Totals may not sum due to rounding and from beneficiaries that have dialysis treatment spanning multiple years. Negative spending reflects a reduction in Medicare spending. The Kidney Disease Patient Education Services Costs are less than $IM each year, but are rounded up to $IM to show what years they apply to. Similarly, the HD Training Costs are less than $ IM for years 2021-2024, but are rounded up to $ IM to indicate that costs were applied those years.

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TABLE 19: Difference from Baseline (Rounded $M)

Year of Model 2021 2022 2023 2024 2025 2026 2027 4.5 Year Total* Net Impact to -2 -2 0 -1 -1 -7 Medicare Spendin2

Overall PPA Net & -2 -2 0 -1 -1 -7 HDPA

Total PPA Downward -1 0 3 4 2 8 Ad.iustment TotalPPA Upward -1 -2 -3 -5 -3 -15 Adjustment Total PPA Net -2 -2 0 -1 -1 -7 TotalHDPA 0 0 * Model changes proposed effective for MY 3. Payments adjusted beginning in PPA Period 3, effective July 1, 2023 going forward. No changes to the HDPA. No changes to the Kidney Disease Patient Education Services Costs or the HD Training Costs. See Table El for additional footnotes.

BILLING CODE 4120–01–C until MY3. In addition, the proposed variation in those facility/practice level Table 18 summarizes the estimated changes did not apply to the HDPA or measures and simulated the effect of the impact of the ETC Model when the Kidney Disease Patient Education payment policy assuming providers and assuming preset benchmark updates Services Costs and HD Training Costs. suppliers respond by marginally where the achievement benchmarks for As expected, Table 19 shows that the increasing their share of patients each year are set using the average of the proposed changes had a very small utilizing home dialysis. Random home dialysis rates for year t-1 and year effect on Medicare savings; only $7 variables were used to vary the t-2 for the HRRs randomly selected for million in savings for the net impact to effectiveness that individual providers participation in the ETC Model. We Medicare spending over the 4.5-year and suppliers might show in such estimate the Medicare program will save period can be attributed to the changes progression over time and to simulate a net total of $53 million from the PPA proposed in this rule. the level of year-to-year variation and HDPA between January 1, 2021 and As was the case in the Specialty Care already noted in the base multi-year June 30, 2027 less $15 million in Models final rule (85 FR 61353), the data that was analyzed. The uncertainty increased training and education projections do not include the Part B in the projection was illustrated in expenditures. Therefore, the net impact premium revenue offset because the sections VII.C.2.b.(3)(a) and to Medicare spending is estimated to be payment adjustments under the ETC VII.C.2.b.(3)(b) of the Specialty Care $38 million in savings. In Table 18 and Model will not affect beneficiary cost- Models final rule (85 FR 61354), Table 19, negative spending reflects a sharing. Any potential effects on respectively, through alternate scenarios reduction in Medicare spending, while Medicare Advantage capitation assuming that the benchmarks against positive spending reflects an increase. payments were also excluded from the which ETC Participants are measured The results for both tables were projections. This approach is consistent were to not be updated. In those generated from an average of 400 with how CMS has previously conveyed sensitivity analyses, we analyzed a simulations under the assumption that the primary FFS effects anticipated for modified version of the model that benchmarks are rolled forward with a an uncertain model without also included a fixed benchmark for the 1.5-year lag. assessing the potential impact on home dialysis and transplant waitlist Table 19 is provided to isolate the Medicare Advantage rates. rates as well as a separate sensitivity total impact of the changes proposed in Returning to Table 18, as anticipated, analysis that assumed a rolling this proposed rule for years 2023 going the expected Medicare program savings benchmark for the home dialysis rate forward by calculating the difference were driven by the net effect of the and a fixed benchmark for the from our final estimates in Table 18 less Facility PPA; a reduction in Medicare transplant waitlist rate. totals from our current baseline spending of $74 million over the period For this proposed rule, we are estimates that used the same years of from July 1, 2022 through June 30, 2027. modeling a preset benchmark growth data, but without the model changes In comparison, the net effect of the rate as proposed in this rule but applied. To clarify, the baseline Clinician PPA was only $9 million in continue to incorporate sensitivity to a estimates are not the estimates reported Medicare savings. This estimate was range of potential behavioral changes for in Table 19 of the Specialty Care Models based on an empirical study of the home dialysis rate and transplant final rule (85 FR 61354); the final rule historical home dialysis utilization and waitlist rate for ETC facilities and used data from CYs 2016 and 2017 and transplant waitlist rates for Medicare Managing Clinicians assumed to this proposed rule used the most recent FFS beneficiaries that CMS virtually participate in the model. Kidney disease data available, from CYs 2018 and 2019. attributed to ESRD facilities and to patient education services on treatment There was no impact reported in years Managing Clinicians based on the modalities and home dialysis (HD) 2021 and 2022 since the proposed plurality of associated spending at the training for incident dialysis payment adjustments were not effective beneficiary level. We analyzed the base beneficiaries are relatively small outlays

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and were projected to represent only a different savings scenario if the ETC pandemic. The low historical take-up relatively modest increases in Medicare Learning Collaborative described in for self-dialysis and shortage of spending each year. VI.C.2.b.(6) of the Specialty Care Models historical years for nocturnal dialysis The key assumptions underlying the final rule (85 FR 61355) were to be (that is, a nocturnal dialysis claims line impact estimate are that each successful in decreasing the discard rate instruction became effective in 2017) consolidated ESRD facility or Managing of deceased donor kidneys and result in these proposed modifications Clinician’s share of total maintenance increasing the utilization rate of having an insignificant impact on the dialysis provided in the home setting deceased donor kidneys that have been savings to Medicare. was assumed to grow by up to an retrieved. Two of the changes proposed in this assumed maximum growth averaging proposed rule have the potential to 3-percentage points per year. Factors (a) Sensitivity Analysis: Medicare generate higher PPA scores for a limited underlying this assumption about the Savings Estimate—Results for the 10th subset of providers and therefore a small home dialysis growth rate include: and 90th Percentiles negative impact on estimated savings for Known limitations that may prevent Using the primary specification for the model. First, we proposed two strata patients from being able to dialyze at the Medicare estimate with preset for the achievement and improvement home, such as certain common disease benchmark updates for home dialysis benchmarking based on a 50 percent types that make peritoneal dialysis and transplant waitlist rates, we cutpoint for the proportion of attributed impractical (for example, obesity); compare the results for the top 10th and beneficiaries with dual eligibility status current equipment and staffing 90th percentiles of the 400 individual or receipt of the LIS. This proposed constraints; and the likelihood that a simulations to the average of all modification would allow participants patient new to maintenance dialysis simulation results reported in Table 18. to be compared to participants who starts dialysis at home compared to the Since the impact on Medicare spending serve ESRD patients with a similar likelihood that a current dialysis patient for the ETC Model using the present socioeconomic status, essentially who dialyzes in center switches to benchmark updates is estimated to be in making the comparison groups fairer dialysis at home. In any given trial of savings rather than losses, the top 10th and potentially increasing the cost to the simulation, the maximum growth and 90th percentiles represent the most Medicare. Second, the proposed Health rate was chosen from a uniform optimistic and conservative projections, Equity Incentive rewarded participants distribution of 0 to 5-percentage points respectively. The overall net PPA and with 0.5 points to their improvement per year. Preliminary data from CMS HDPA for the top 10th and 90th score who demonstrated a sufficiently show that the growth rate for home percentiles using the present benchmark significant improvement on the home dialysis was 3.9 percent in CY 2020 for updates method are $117 million in dialysis rate among their attributed beneficiaries meeting the eligibility savings and $3 million in losses beneficiaries who are dual eligible or criteria for the ETC Model. This growth (encompassing the mean estimate of $53 receive the LIS. rate is within range to what was million in savings in Table 18). The Furthermore, we modeled the home observed prior to the establishment of overall uncertainty of the impact of the dialysis rate achievement and the Advancing American Kidney Health model is further illustrated in Table 18, improvement benchmarks by initiative in 2019 and it also shows that the change from baseline, where the incrementally increasing every two the COVID–19 PHE did not cause the mean $7 million dollars in savings measurement periods the benchmarks home dialysis growth assumption to reported for the Overall PPA Net & by 10 percent relative to ESRD facilities become invalid. The 3-percentage point HDPA has $83 million in savings and and Managing Clinicians not selected per year average max growth rate will, $75 million in losses, for the top 10th for participation. Applying the preset in effect, move the average market and 90th percentiles, respectively. benchmarks update method balanced out the negative impact to Medicare peritoneal dialysis rate (about 10 (4) Effects on the Home Dialysis Rate percent) to the highest market baseline savings generated from stratification and peritoneal dialysis rate (for example, This proposed rule proposes to the Health Equity Incentive, essentially Bend, Oregon HRR at about 25 percent), modify the home dialysis rate equation preserving the overall savings level which we believe is a reasonable upper by adding 0.5 multiplied by the sum of reported in the Specialty Care Models bound on growth over the duration of the self-dialysis beneficiary months and final rule. the in-center nocturnal dialysis the ETC Model for the purposes of this (5) Effects on Kidney Transplantation actuarial model. beneficiary months to the numerator Consolidated ESRD facilities at the such that 1-beneficiary year is Kidney transplantation is considered HRR level or Managing Clinicians were comprised of 12-beneficiary months. the optimal treatment for most ESRD assumed to achieve anywhere from zero The proposed modification was beneficiaries. The PPA includes a one- to 100 percent of such maximum growth different for ESRD facilities with an third weight on the ESRD facilities’ or in any given year. Thus, the average aggregation group that had facilities Managing Clinician’s transplant waitlist projected growth for the share of owned by an ETC LDO, for which the rate, with the ultimate goal of increasing maintenance dialysis provided in the nocturnal dialysis months were not the rate of kidney transplantation. home was 1.5-percentage points per included in the numerator. However, the changes proposed in this year (expressed as the percentage of Less than 1 percent of beneficiaries proposed rule do not impact our total dialysis). In contrast, we do not eligible for attribution into the ETC decision in the previous final rule to not include an official assumption that the Model were receiving either self-dialysis include an assumption that the overall overall number of kidney transplants or nocturnal in-center dialysis in CY number of kidney transplants will will increase and provide justification 2019. In addition, in CY 2020, the increase. The number of ESRD patients for this assumption in sections annual growth rate decreased by 89.9 on the kidney transplant waitlist has for VI.C.2.b.(4) and VI.C.2.b.(5) of the and 91.3 percent for beneficiaries many years far exceeded the annual Specialty Care Models final rule (85 FR receiving self-dialysis or nocturnal number of transplants performed. 61355). However, as part of the dialysis, respectively. The sharp decline Transplantation rates have not increased sensitivity analysis for the savings in these dialysis modalities is to meet such demand because of the calculations for the model, we laid out potentially in response to the COVID–19 limited supply of deceased donor

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kidneys. The U.S. Renal Data System 306 score who demonstrated a sufficiently same under the ETC Model. However, reported 22,393 kidney transplants in significant improvement on the we will waive certain requirements of 2018 compared to a kidney transplant transplant rate among their attributed title XVIII of the Act as necessary to test waiting list 307 of over 98,000. Refer to beneficiaries who are dual eligible or the PPA and HDPA under the ETC section VI.C.2.b(4) in the Specialty Care receive the LIS. Model and to hold beneficiaries Models final rule (85 FR 61355) for a Furthermore, we proposed to modify harmless from any effect of these detailed justification for our assumption the transplant waitlist rate achievement payment adjustments on cost sharing. In that the overall number of kidney and improvement benchmarks by addition, the Medicare beneficiary’s transplants will not increase in response incrementally increasing the quality of life has the potential to to ESRD facilities and Managing benchmarks every two measurement improve if the beneficiary elects to have Clinicians participating in the ETC periods by 10 percent relative to ESRD home dialysis as opposed to in-center Model. facilities and Managing Clinicians not dialysis. Studies have found that home selected for participation. Applying the (6) Effects of the Transplant Waitlist dialysis patients experienced improved Rate preset benchmarks update method quality of life as a result of their ability balanced out the negative impact to to continue regular work schedules or This proposed rule includes the Medicare savings generated from the life plans; as well as better overall, transplant waitlist rate described in the proposed stratification and the Health physical, and psychological health in Specialty Care Models final rule Equity Incentive, roughly preserving the comparison to other dialysis options. (§ 512.365) with the following proposed overall savings level estimated at modifications. First, we are proposing to baseline for the model parameters c. Alternatives Considered exclude Medicare beneficiaries with a previously finalized before the changes Throughout this proposed rule, we diagnosis of and treatment with offered in this proposed rule. have identified our policies and chemotherapy or radiation for vital solid alternatives that we have considered, organ cancers. In our analysis of (7) Effects on Kidney Disease Patient and provided information as to the beneficiaries’ eligible for the ETC Education Services and HD Training likely effects of these alternatives and Model, we found that less than 1 Add-Ons the rationale for each of our policies. percent of the beneficiaries had claims The changes in this proposed rule do for any vital solid organ cancers. not impact the findings reported for the This proposed rule addresses a model Therefore, the effect of this proposed effects of the ETC Model on the Kidney specific to ESRD. It provides exclusion criterion is to make the Disease Patient education services and descriptions of the requirements that we beneficiaries included in the calculation HD training add-ons described in would waive, identifies the performance of the transplant rate an improved section VI.C.2.b(6) in the Specialty Care metrics and payment adjustments representation of beneficiaries who are Models final rule (85 FR 61355). proposed to be tested, and presents able to join the transplant waitlist and/ rationales for our proposals, and where or receive pre-emptive living donor b. Effects on Medicare Beneficiaries relevant, alternatives that we kidney transplantation. But, due to the The changes in this proposed rule considered. We carefully considered the very low number of ETC Model could incentivize ESRD facilities and alternatives to this proposed rule, potential beneficiaries with these types Managing Clinicians serving dual including the degree that benchmark of cancer, the exclusion criterion is eligible or LIS recipient Medicare targets should be prospectively updated unlikely to have any significant impact beneficiaries to potentially improve to provide greater transparency to ETC on the transplant waitlist rate. access to care for those beneficiaries. Participants while preserving the Two of the changes proposed in this The changes could also marginally expectation for model net savings for proposed rule have the potential to improve take-up of the in-center the program. For context related to generate higher scores for a limited nocturnal dialysis treatment modality alternatives previously considered when subset of health care providers and compared to how the model was establishing the ETC Model we refer therefore a small negative impact on finalized previously since these dialysis readers to the Specialty Cares Model estimated savings for the model. First, methods were not directly incentivized final rule (85 FR 61114) for more we proposed two strata for the (that is, accounted for in the home information on policy-related achievement and improvement dialysis rate and in-center self dialysis stakeholder comments, our responses to benchmarking based on a 50 percent rate numerator) in the Specialty Care those comments, and statements of final cutpoint for the proportion of attributed Models final rule. policy preceding the limited beneficiaries with dual eligibility status As previously noted in section modifications proposed here. or receipt of the LIS. This proposed VI.C.3.B of the Specialty Care Models C. Accounting Statement modification allowed participants to be final rule (85 FR 61357), we continue to compared to participants who serve anticipate that the ETC Model would As required by OMB Circular A–4 ESRD patients with a similar have a negligible impact on the cost to (available at https://www.whitehouse. socioeconomic status, essentially beneficiaries receiving dialysis. Under gov/sites/whitehouse.gov/files/omb/ making the comparison groups fairer current policy, Medicare FFS circulars/A4/a-4.pdf), in Table 20, we and potentially increasing the cost to beneficiaries are generally responsible have prepared an accounting statement Medicare. Second, the proposed Health for 20 percent of the allowed charge for showing the classification of the Equity Incentive rewarded participants services furnished by providers and transfers and costs associated with the with 0.5 points to their improvement suppliers. This policy will remain the various provisions of this proposed rule.

306 United States Renal Data System. 2020. ‘‘ADR 307 Organ Procurement and Transplantation by Organ.’’ https://optn.transplant.hrsa.gov/data/ Reference Table E6 Renal Transplants by Donor Network. 2021. ‘‘Current US Waiting List, Overall view-data-reports/national-data/#. Type.’’ https://adr.usrds.org/2020/reference-tables.

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TABLE 20: Accounting Statement: Classification of Estimated Transfers and Costs/Savings ESRD PPS and AKI (CY 2022) Category Transfers Annualized Monetized Transfers $110 million From Whom to Whom Federal government to ESRD providers Category Transfers Increased Beneficiary Co-insurance Payments $30 million From Whom to Whom Beneficiaries to ESRD providers ESRD QIP for PY 2024 Category Transfers Annualized Monetized Transfers -$1 7 million From Whom to Whom Federal government to ESRD providers. ESRD QIP for PY 2025 Category Transfers Annualized Monetized Transfers -$1 7 million From Whom to Whom Federal government to ESRD providers

ETC Model for Jan 1, 2023 through June 30, 2027 Impacts of Changes in the Proposed Rule Category Transfers Annualized Monetized Transfers -$1.27 million From Whom to Whom Federal government to ESRD facilities and Managing Clinicians

In accordance with the provisions of jurisdictions. Approximately 11 percent size-standards (Kidney Dialysis Centers Executive Order 12866, this proposed of ESRD dialysis facilities are are listed as 621492 with a size standard rule was reviewed by the Office of considered small entities according to of $41.5 million). Management and Budget. the Small Business Administration’s When viewed as individual entities, D. Regulatory Flexibility Act Analysis (SBA) size standards, which classifies as opposed to being a part of an LDO, (RFA) small businesses as those dialysis there are approximately 643 (∼12 facilities having total revenues of less The Regulatory Flexibility Act (RFA) percent of total number of ESRD than $41.5 million in any 1 year. requires agencies to analyze options for facilities) ESRD facilities that provide regulatory relief of small entities, if a Individuals and states are not included fewer than 4,000 treatments per year. rule has a significant impact on a in the definitions of a small entity. For With a low volume payment substantial number of small entities. For more information on SBA’s size adjustment, each facility generates purposes of the RFA, small entities standards, see the Small Business revenue from dialysis treatments of include small businesses, nonprofit Administration’s website at http:// ∼$1.26 million per year per facility. This organizations, and small governmental www.sba.gov/content/small-business- is shown in the Table 21.

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TABLE 21: Revenue Table for Low Volume ESRD Facilities for CY 2022 ESRD PPS Proposed Rule

ESRD Facility size #of low %of ~Individual ESRD facility ~Annual ~ Total annual based on # of dialysis volume total revenue per treatment total treatment revenue treatments ESRD number (including low volume treatment to all low volume Facilities of adjustment) revenue ESRD facilities per Table ESRD perESRD 9 facilities facility based on 3999 treatments or less

<4000 643 ~12% $311 $1.26M $800M

We do not believe ESRD facilities are treatments that could potentially be The aggregation methodology groups operated by small government entities furnished in ESRD facilities. ESRD facilities owned in whole or in such as counties or towns with For ETC Model, this proposed rule part by the same dialysis organization populations of 50,000 or less, and includes as ETC Participants Managing within a Selected Geographic Area and therefore, they are not enumerated or Clinicians and ESRD facilities required Managing Clinicians billing under the included in this estimated RFA analysis. to participate in the Model pursuant to same TIN within a Selected Geographic Individuals and states are not included § 512.325(a). We assume for the Area. This aggregation policy increases in the definition of a small entity. purposes of the regulatory impact the number of beneficiary months, and For purposes of the RFA, we estimate analysis that the great majority of thus statistical reliability, of the ETC that approximately 11 percent of ESRD Managing Clinicians are small entities Participant’s home dialysis and facilities are small entities as that term and that the greater majority of ESRD transplant rate for ESRD facilities that are owned in whole or in part by the is used in the RFA (which includes facilities are not small entities. same dialysis organization and for small businesses, nonprofit Throughout the proposed rule we Managing Clinicians that share a TIN organizations, and small governmental describe how the adjustments to certain with other Managing Clinicians. jurisdictions). This amount is based on payments for dialysis services and Taken together, the low volume the number of ESRD facilities shown in dialysis-related services furnished to threshold exclusions and aggregation the ownership category in Table 9. ESRD beneficiaries may affect Managing policies previously described, coupled Using the definitions in this ownership Clinicians and ESRD facilities with the fact that the ETC Model would category, we consider 515 facilities that participating in the ETC Model. The affect Medicare payment only for select are independent and 378 facilities that great majority of Managing Clinicians services furnished to Medicare FFS are shown as hospital-based to be small are small entities by meeting the SBA beneficiaries; we have determined that entities. The ESRD facilities that are definition of a small business (having the provisions of the proposed rule owned and operated by Large Dialysis minimum revenues of less than $8 would not have a significant impact on Organizations (LDOs) and regional million to $41.5 million in any 1 year, spending for a substantial number of chains would have total revenues of varying by type of provider and highest more than $41.5 million in any year small entities (defined as greater than 5 for hospitals) with a minimum percent impact). when the total revenues for all locations threshold for small business size of Therefore, the Secretary has are combined for each business $41.5 million (https://www.sba.gov/ (individual LDO or regional chain), and determined that this proposed rule document/support--table-size-standards would not have a significant economic are not, therefore, included as small http://www.sba.gov/content/small- entities. impact on a substantial number of small businesssize-standards). The great entities. The economic impact For the ESRD PPS updates proposed majority of ESRD facilities are not small assessment is based on estimated in this rule, a hospital-based ESRD entities, as they are owned, partially or Medicare payments (revenues) and facility (as defined by type of entirely by entities that do not meet the HHS’s practice in interpreting the RFA ownership, not by type of dialysis SBA definition of small entities. is to consider effects economically facility) is estimated to receive a 1.3 The HDPA in the ETC Model is a ‘‘significant’’ only if greater than 5 percent increase in payments for CY positive adjustment on payments for percent of providers reach a threshold of 2022. An independent facility (as specified home dialysis and home 3 to 5 percent or more of total revenue defined by ownership type) is estimated dialysis-related services. The PPA in the or total costs. We solicit comment on to receive a 1.1 percent increase in ETC Model, which includes both the RFA analysis provided. payments for CY 2022. positive and negative adjustments on In addition, section 1102(b) of the Act For AKI dialysis, we are unable to payments for dialysis services and requires us to prepare a RIA if a rule estimate whether patients would go to dialysis-related services, excludes may have a significant impact on the ESRD facilities, however, we have aggregation groups with fewer than 132 operations of a substantial number of estimated there is a potential for $52 attributed beneficiary-months during small rural hospitals. This analysis must million in payment for AKI dialysis the relevant year. conform to the provisions of section 603

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of the RFA. For purposes of section G. Congressional Review Act ■ 2. Section 413.177 is amended by 1102(b) of the Act, we define a small revising paragraph (a) introductory text rural hospital as a hospital that is These proposed rules are subject to to read as follows: located outside of a metropolitan the Congressional Review Act provisions of the Small Business § 413.177 Quality incentive program statistical area and has fewer than 100 Regulatory Enforcement Fairness Act of payment. beds. We do not believe this proposed 1996 (5 U.S.C. 801 et seq.) and has been (a) With respect to renal dialysis rule would have a significant impact on transmitted to the Congress and the services as defined under § 413.171, operations of a substantial number of Comptroller General for review. except for those renal dialysis services small rural hospitals because most furnished during payment year 2022, in X. Files Available to the Public via the dialysis facilities are freestanding. the case of an ESRD facility that does Internet While there are 122 rural hospital-based not earn enough points under the dialysis facilities, we do not know how The Addenda for the annual ESRD program described at § 413.178 to meet many of them are based at hospitals PPS proposed and final rulemakings or exceed the minimum total with fewer than 100 beds. However, will no longer appear in the Federal performance score (as defined at overall, the 122 rural hospital-based Register. Instead, the Addenda will be § 413.178(a)(8)) established by CMS for dialysis facilities would experience an available only through the internet and a payment year (as defined at estimated 1.0 percent increase in is posted on the CMS website at http:// § 413.178(a)(10)), payments otherwise payments. www.cms.gov/ESRDPayment/PAY/ made to the facility under § 413.230 for Therefore, the Secretary has list.asp. In addition to the Addenda, renal dialysis services during the determined that this proposed rule limited data set files are available for payment year, will be reduced by up to would not have a significant impact on purchase at http://www.cms.gov/ 2 percent as follows: the operations of a substantial number Research-Statistics-Data-and-Systems/ ■ 3. Section 413.178 is amended by of small rural hospitals. Files-for-Order/LimitedDataSets/End adding paragraph (h) to read as follows: StageRenalDiseaseSystemFile.html. § 413.178 ESRD quality incentive program. E. Unfunded Mandates Reform Act Readers who experience any problems Analysis (UMRA) accessing the Addenda or LDS files, * * * * * (h) Special rule for payment year Section 202 of the Unfunded should contact ESRDPayment@ cms.hhs.gov. 2022. (1) CMS will calculate a measure Mandates Reform Act of 1995 (UMRA) rate for all measures specified by CMS also requires that agencies assess Chiquita Brooks-LaSure, under paragraph (c) of this section for anticipated costs and benefits before Administrator of the Centers for the PY 2022 ESRD QIP but will not issuing any rule whose mandates Medicare & Medicaid Services, score facility performance on any of require spending in any 1 year of $100 approved this document on June 16, those measures or calculate a TPS for million in 1995 dollars, updated 2021. any facility under paragraph (e) of this annually for inflation. In 2021, that List of Subjects section. threshold is approximately $158 (2) CMS will not establish a mTPS for million. This proposed rule does not 42 CFR Part 413 PY 2022. mandate any requirements for state, Diseases, Health facilities, Medicare, PART 512—RADIATION ONCOLOGY local, or tribal governments in the Puerto Rico, Reporting and MODEL AND END STAGE RENAL aggregate, or by the private sector. recordkeeping requirements. Moreover, HHS interprets UMRA as DISEASE TREATMENT CHOICES applying only to unfunded mandates. 42 CFR Part 512 MODEL We do not interpret Medicare payment Administrative practice and ■ 4. The authority citation for part 512 rules as being unfunded mandates, but procedure, Health facilities, Medicare, continues to read as follows: simply as conditions for the receipt of Reporting and recordkeeping payments from the federal government Authority: 42 U.S.C. 1302, 1315(a), and requirements. 1395hh. for providing services that meet federal standards. This interpretation applies For the reasons set forth in the ■ 5. Section 512.160 is amended by whether the facilities or providers are preamble, the Centers for Medicare & adding paragraph (a)(9), and by revising private, state, local, or tribal. Medicaid Services proposes to amend paragraph (b)(6) as follows: 42 CFR chapter IV as follows: F. Federalism § 512.160 Remedial action. PART 413—PRINCIPLES OF (a) * * * Executive Order 13132 establishes REASONABLE COST (9) For the ETC Model only, has certain requirements that an agency REIMBURSEMENT; PAYMENT FOR misused or disclosed the beneficiary- must meet when it promulgates a END-STAGE RENAL DISEASE identifiable data in a manner that proposed rule (and subsequent final SERVICES; PROSPECTIVELY violates any applicable statutory or rule) that imposes substantial direct DETERMINED PAYMENT RATES FOR regulatory requirements or that is requirement costs on state and local SKILLED NURSING FACILITIES; otherwise non-compliant with the governments, preempts state law, or PAYMENT FOR ACUTE KIDNEY provisions of the applicable data sharing otherwise has federalism implications. INJURY DIALYSIS agreement. We have reviewed this proposed rule (b) * * * under the threshold criteria of Executive ■ 1. The authority citation for part 413 (6) In the ETC Model only: Order 13132, Federalism, and have continues to read as follows: (i) Terminate the ETC Participant determined that it would not have Authority: 42 U.S.C. 1302, 1395d(d), from the ETC Model. substantial direct effects on the rights, 1395f(b), 1395g, 1395l(a), (i), and (n), (ii) Suspend or terminate the ability of roles, and responsibilities of states, local 1395x(v), 1395hh, 1395rr, 1395tt, and the ETC Participant, pursuant to or Tribal governments. 1395ww. § 512.397(c), to reduce or waive the

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coinsurance for kidney disease patient excluded based on the criteria in beneficiary years for attributed ESRD education services. paragraph (b) of this section is attributed Beneficiaries during the MY. For MY3 ■ 6. Section 512.310 is amended by to the Managing Clinician who through MY10, the numerator for ESRD adding the definitions of ‘‘Clinical submitted the most claims for services facilities not owned in whole or in part staff’’, ‘‘Health Equity Incentive’’, furnished to the beneficiary in the 365 by an ETC LDO is the total number of ‘‘Kidney disease patient education days preceding the date in which the home dialysis treatment beneficiary services coinsurance patient incentive’’, beneficiary received the transplant. years, plus one half the total number of and ‘‘Qualified staff’’ in alphabetical (A) If no Managing Clinician has had self dialysis treatment beneficiary years, order to read as follows: the most claims for a given Pre-emptive plus one half the total number of LDT Beneficiary such that multiple nocturnal in center dialysis beneficiary § 512.310 Definitions. Managing Clinicians each had the same years for attributed ESRD Beneficiaries * * * * * number of claims for that beneficiary in during the MY. Clinical staff means a licensed social the 365 days preceding the date of the (A) Home dialysis treatment worker or registered dietician/nutrition transplant, the Pre-emptive LDT beneficiary years included in the professional who furnishes services for Beneficiary is attributed to the numerator are composed of those which payment may be made under the Managing Clinician associated with the months during which attributed ESRD physician fee schedule under the latest claim service date at the claim Beneficiaries received maintenance direction of and incident to the services line through date during the 365 days dialysis at home, such that 1-beneficiary of the Managing Clinician who is an preceding the date of the transplant. year is comprised of 12-beneficiary ETC Participant. (B) If no Managing Clinician had the months. Months in which an attributed * * * * * most claims for a given Pre-emptive ESRD Beneficiary received maintenance ETC Large Dialysis Organization (ETC LDT Beneficiary such that multiple dialysis at home are identified by claims LDO) means a legal entity that owns, in Managing Clinicians each had the same with Type of Bill 072X and condition whole or in part, 500 or more ESRD number of claims for that beneficiary in codes 74 or 76. facilities. the 365 days preceding the date of the (B) Self dialysis treatment beneficiary * * * * * transplant, and more than one of those years included in the numerator are Health Equity Incentive means the Managing Clinicians had the latest composed of those months during amount added to the ETC Participant’s claim service date at the claim line which attributed ESRD Beneficiaries improvement score, calculated as through date during the 365 days received self dialysis in center, such described in § 512.370(c)(1) of this preceding the date of the transplant, the that 1-beneficiary year is comprised of chapter, if the ETC Participant’s Pre-emptive LDT Beneficiary is 12-beneficiary months. Months in aggregation group demonstrated randomly attributed to one of these which an attributed ESRD Beneficiary sufficient improvement on the home Managing Clinicians. received self dialysis are identified by dialysis rate or transplant rate for (C) The Pre-emptive LDT Beneficiary claims with Type of Bill 072X and attributed beneficiaries who are dual is considered eligible for attribution condition code 72. eligible or Medicare Low Income under this paragraph (c)(2)(iii) if the (C) Nocturnal in center dialysis Subsidy (LIS) recipients between the Pre-emptive LDT Beneficiary has at least beneficiary years included in the Benchmark Year and the MY. 1-eligible month during the 12-month numerator are composed of those period that includes the month of the * * * * * months during which attributed ESRD Qualified staff means both clinical transplant and the 11 months prior to Beneficiaries received nocturnal in staff and any qualified person (as the month of the transplant. An eligible center dialysis, such that 1-beneficiary defined at § 410.48(a)) who is an ETC month refers to a month during which year is comprised of 12-beneficiary Participant. the Pre-emptive LDT Beneficiary not months. Months in which an attributed does not meet exclusion criteria in ESRD Beneficiary received nocturnal in * * * * * paragraph (b) of this section. ■ 7. Section 512.360 is amended by center dialysis are identified by claims ■ 8. Section 512.365 is amended by— with Type of Bill 072X and modifier UJ. revising paragraph (c)(2)(ii) introductory ■ a. Revising paragraphs (b)(1)(ii) and * * * * * text and adding paragraph (c)(2)(iii) to (b)(2)(ii), and read as follows: ■ b. Revising paragraphs (c)(1)(i)(A), (2) * * * (c)(1)(ii)(A), (c)(2)(i)(A), and (ii) For MY1 and MY2, the numerator § 512.360 Beneficiary population and is the total number of home dialysis attribution. (c)(2)(ii)(A)(1) and (2). The revisions read as follows: treatment beneficiary years for * * * * * attributed ESRD Beneficiaries during the (c) * * * § 512.365 Performance assessment. MY plus one half the total number of (2) * * * * * * * * self dialysis treatment beneficiary years. (ii) For MY1 and MY2, a Pre-emptive (b) * * * For MY3 through MY10, the numerator LDT Beneficiary who is not excluded (1) * * * is the total number of home dialysis based on the criteria in paragraph (b) of (ii) For MY1 and MY2, the numerator treatment beneficiary years, plus one this section is attributed to the is the total number of home dialysis half the total number of self dialysis Managing Clinician with whom the treatment beneficiary years plus one treatment beneficiary years, plus one beneficiary has had the most claims half the total number of self dialysis half the total number of nocturnal in between the start of the MY and the treatment beneficiary years for center dialysis beneficiary years for month in which the beneficiary received attributed ESRD Beneficiaries during the attributed ESRD Beneficiaries during the the transplant for all months between MY. For MY3 through MY10, the MY. the start of the MY and the month of the numerator for ESRD facilities owned in (A) Home dialysis treatment transplant. whole or in part by an ETC LDO is the beneficiary years included in the * * * * * total number of home dialysis treatment numerator are composed of those (iii) For MY3 through MY10, a Pre- beneficiary years plus one half the total months during which attributed ESRD emptive LDT Beneficiary who is not number of self dialysis treatment Beneficiaries received maintenance

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dialysis at home, such that 1-beneficiary C34.92, C38.0, C38.8, C46.50–C46.52, DW033Z0, DW033ZZ, DW034ZZ, year is comprised of 12-beneficiary C64.1, C64.2, C64.2, C78.00–C78.02, DW035ZZ, DW036ZZ, DW1397Z, months. Months in which an attributed C78.7, C79.00–C79.02, C7A.090, DW1398Z, DW1399Z, DW139BZ, ESRD Beneficiary received maintenance C7A.093, or C7B.02. DW139CZ, DW139YZ, DW13B6Z, dialysis at home are identified by claims (2) Months in which an attributed DW13B7Z, DW13B8Z, DW13B9Z, with CPT codes 90965 or 90966. ESRD Beneficiary received treatment DW13BB1, DW13BBZ, DW13BCZ, (B) Self-dialysis treatment beneficiary with chemotherapy or radiation for vital DB13BYZ, DW23DZZ, DW23HZZ, years included in the numerator are solid organ cancer are months during DW23JZZ, DWY37ZZ, DWY38ZZ, composed of those months during which the beneficiary had a claim with DWY3FZZ, DW050ZZ, DW051ZZ, which attributed ESRD Beneficiaries any of the following procedure codes: DW052ZZ, DW053Z0, DW053ZZ, ® received self dialysis in center, such (i) CPT 96401–96402, 96405–96406, DW054ZZ, DW055ZZ, DW056ZZ, that 1-beneficiary year is comprised of 96409, 96411, 96413, 96415–96417, DWY57ZZ, DWY58ZZ, DWY5FZZ, 12-beneficiary months. Months in 96420, 96422–26423, 96425, 96440, DWY5GDZ, DWY5GFZ, DWY5GGZ, which an attributed ESRD Beneficiary 96446, 96549, 77373, 77401–77402, DWY5GHZ, DWY5GYZ. 77407, 77412, 77423, 77424–77425, received self dialysis are identified by * * * * * claims with Type of Bill 072X and 77520, 77522–77523, 77525, 77761– (ii) * * * condition code 72. 77763, 77770–77772, 77778, 77789, (A) The denominator is the total (C) Nocturnal in center dialysis 77799, 79005, 79101, 79200, 79300, dialysis treatment beneficiary years for beneficiary years included in the 79403, 79440, 79445, 79999. attributed ESRD Beneficiaries during the (ii) ICD–10–PCS® DB020ZZ, numerator are composed of those MY. Dialysis treatment beneficiary years DB021ZZ, DB022ZZ, DB023Z0, months during which attributed ESRD included in the denominator are DB023ZZ, DB024ZZ, DB025ZZ, Beneficiaries received nocturnal in composed of those months during center dialysis, such that 1-beneficiary DB026ZZ, DB1297Z, DB1298Z, DB1299Z, DB129BZ, DB129CZ, which an attributed ESRD Beneficiary year is comprised of 12-beneficiary received maintenance dialysis at home months. Months in which an attributed DB129YZ, DB12B6Z, DB12B7Z, DB12B8Z, DB12B9Z, DB12BB1, or in an ESRD facility, such that 1- ESRD Beneficiary received nocturnal in DB12BBZ, DB12BCZ, DB12BYZ, beneficiary year is comprised of 12- center dialysis are identified by claims DB22DZZ, DB22HZZ, DB22JZZ, beneficiary months. For MY1 and MY2, with Type of Bill 072X and modifier UJ. DBY27ZZ, DBY28ZZ, DBY2FZZ, months during which an attributed * * * * * DBY2KZZ, DB070ZZ, DB071ZZ, ESRD Beneficiary received maintenance (c) * * * DB072ZZ, DB073Z0, DB073ZZ, dialysis are identified by claims with (1) * * * DB074ZZ, DB075ZZ, DB076ZZ, Type of Bill 072X, excluding claims for (i) * * * DB1797Z, DB1798Z, DB1799Z, beneficiaries who were 75 years of age (A) The denominator is the total DB179BZ, DB179CZ, DB179YZ, or older at any point during the month. dialysis treatment beneficiary years for DB17B6Z, DB17B7Z, DB17B8Z, For MY3 through MY10, months during attributed ESRD Beneficiaries during the DB17B9Z, DB17BB1, DB17BBZ, which an attributed ESRD Beneficiary MY. Dialysis treatment beneficiary years DB17BCZ, DB17BYZ, DB27DZZ, received maintenance dialysis are included in the denominator are DB27HZZ, DB27JZZ, DBY77ZZ, identified by claims with Type of Bill composed of those months during DBY78ZZ, DBY7FZZ, DBY7KZZ, 072X, excluding claims for beneficiaries which an attributed ESRD beneficiary DF000ZZ, DF001ZZ, DF002ZZ, who were 75 years of age or older at any received maintenance dialysis at home DF003Z0, DF003ZZ, DF004ZZ, point during the month, or had a vital or in an ESRD facility, such that 1- DF005ZZ, DF006ZZ, DF1097Z, solid organ cancer diagnosis and were beneficiary year is comprised of 12- DF1098Z, DF1099Z, DF109BZ, receiving treatment with chemotherapy beneficiary months. For MY1 and MY2, DF109CZ, DF109YZ, DF10B6Z, or radiation for vital solid organ cancer months during which an attributed DF10B7Z, DF10B8Z, DF10B9Z, during the MY. Months in which an ESRD Beneficiary received maintenance DF10BB1, DF10BBZ, DF10BCZ, attributed ESRD Beneficiary had a dialysis are identified by claims with DF10BYZ, DF0DZZ, DF20HZZ, diagnosis of vital solid organ cancer are Type of Bill 072X, excluding claims for DF20JZZ, DFY07ZZ, DFY08ZZ, identified as described in paragraph beneficiaries who were 75 years of age DFY0CZZ, DFY0FZZ, DFY0KZZ, (c)(1)(i)(A)(1) of this section. Months in or older at any point during the month. DT000ZZ, DT001ZZ, DT002ZZ, which an attributed ESRD Beneficiary For MY3 through MY10, months during DT003Z0, DT003ZZ, DT004ZZ, received treatment with chemotherapy which an attributed ESRD Beneficiary DT005ZZ, DT006ZZ, DT1097Z, or radiation for vital solid organ cancer received maintenance dialysis are DT1098Z, DT1099Z, DT109BZ, are identified as described in paragraph identified by claims with Type of Bill DT109CZ, DT109YZ, DT10B6Z, (c)(1)(i)(A)(2) of this section. 072X, excluding claims for beneficiaries DT10B7Z, DT10B8Z, DT10B9Z, * * * * * who were 75 years of age or older at any DT10BB1, DT10BBZ, DT10BCZ, (2) * * * point during the month, or had a vital DT10BYZ, DT20DZZ, DT20HZZ, (i) * * * solid organ cancer diagnosis and were DT20JZZ, DTY07ZZ, DTY08ZZ, (A) The denominator is the total receiving treatment with chemotherapy DTY0CZZ, DTY0FZZ, DW020ZZ, dialysis treatment beneficiary years for or radiation for vital solid organ cancer DW021ZZ, DW022ZZ, DW023Z0, attributed ESRD Beneficiaries during the during the MY. DW023ZZ, DW024ZZ, DW025ZZ, MY. Dialysis treatment beneficiary years (1) An attributed ESRD Beneficiary DW026ZZ, DW1297Z, DW1298Z, included in the denominator are had a diagnosis of vital solid organ DW1299Z, DW129BZ, DW129CZ, composed of those months during cancer in an MY if the beneficiary had DW129YZ, DW12B6Z, DW12B7Z, which an attributed ESRD Beneficiary any of the following diagnosis codes on DW12B8Z, DW12B9Z, DW12BB1, received maintenance dialysis at home any claim during the MY or the 6 DW12BBZ, DW12BCZ, DW12BYZ, or in an ESRD facility, such that 1- months prior to the start of the MY: DW22DZZ, DW22HZZ, DW22JZZ, beneficiary year is comprised of 12- C22.0–C22.9, C34.10–C34.12, C34.2, DWY27ZZ, DWY28ZZ, DWY2FZZ, beneficiary months. For MY1 and MY2, C34.30–C34.32, C34.80–C34.82, C34.90– DW030ZZ, DW031ZZ, DW032ZZ, months during which an attributed

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ESRD Beneficiary received maintenance 90961, 90962, 90965, or 90966, receiving treatment with chemotherapy dialysis are identified by claims with excluding claims for beneficiaries who or radiation for vital solid organ cancer CPT codes 90957, 90958, 90959, 90960, were 75 years of age or older at any during the MY. Months in which an 90961, 90962, 90965, or 90966, point during the month. For MY3 attributed ESRD Beneficiary had a vital excluding claims for beneficiaries who through MY10, months during which an solid organ cancer diagnosis are were 75 years of age or older at any attributed ESRD Beneficiary received identified as described in paragraph point during the month. For MY3 maintenance dialysis are identified by (c)(1)(i)(A)(1) of this section. Months in through MY10, months during which an claims with CPT codes 90957, 90958, which an attributed ESRD Beneficiary attributed ESRD Beneficiary received 90959, 90960, 90961, 90962, 90965, or received treatment with chemotherapy maintenance dialysis are identified by 90966, excluding claims for or radiation for vital solid organ cancer claims with CPT codes 90957, 90958, beneficiaries who were 75 years of age are identified as described in paragraph 90959, 90960, 90961, 90962, 90965, or or older at any point during the month, (c)(1)(i)(A)(2) of this section. Pre- 90966, excluding claims for or had a vital solid organ cancer emptive LDT Beneficiaries are identified beneficiaries who were 75 years of age diagnosis and were receiving treatment using information about living donor or older at any point during the month, with chemotherapy or radiation for vital transplants from the SRTR Database and or had a vital solid organ cancer solid organ cancer during the MY. Medicare claims data. diagnosis and were receiving treatment Months in which an attributed ESRD * * * * * with chemotherapy or radiation for vital Beneficiary had a vital solid organ ■ solid organ cancer during the MY. cancer diagnosis are identified as 9. Section 512.370 is amended by Months in which an attributed ESRD described in paragraph (c)(1)(i)(A)(1) of revising paragraphs (b), (c), and (d) to Beneficiary had a diagnosis of vital solid this section. Months in which an read as follows: organ cancer are identified as described attributed ESRD Beneficiary received § 512.370 Benchmarking and scoring. in paragraph (c)(1)(i)(A)(1) of this treatment with chemotherapy or * * * * * section. Months in which an attributed radiation for vital solid organ cancer are ESRD Beneficiary received treatment identified as described in paragraph (b) Achievement scoring. CMS with chemotherapy or radiation for vital (c)(1)(i)(A)(2) of this section. assesses ETC Participant performance at solid organ cancer are identified as (2) MY1 and MY2, Pre-emptive LDT the aggregation group level on the home described in paragraph (c)(1)(i)(A)(2) of beneficiary years included in the dialysis rate and transplant rate against this section. denominator are composed of those achievement benchmarks constructed based on the home dialysis rate and * * * * * months during which a Pre-emptive (ii) * * * LDT Beneficiary is attributed to a transplant rate among aggregation (A) * * * Managing Clinician, from the beginning groups of ESRD facilities and Managing (1) Dialysis treatment beneficiary of the MY up to and including the Clinicians located in Comparison years included in the denominator are month of the living donor transplant. Geographic Areas during the Benchmark composed of those months during For MY3 through MY10, Pre-emptive Year. Achievement benchmarks are which an attributed ESRD Beneficiary LDT beneficiary years included in the calculated as described in paragraph received maintenance dialysis at home denominator are composed of those (b)(1) of this section and, for MY3 or in an ESRD facility, such that 1- months during which a Pre-emptive through MY10, are stratified as beneficiary year is comprised of 12- LDT Beneficiary is attributed to a described in paragraph (b)(2) of this beneficiary months. For MY1 and MY2, Managing Clinician, from the beginning section. months during which an attributed of the MY up to and including the (1) Achievement benchmarks. CMS ESRD Beneficiary received maintenance month of the living donor transplant, uses the following scoring methodology dialysis are identified by claims with excluding beneficiaries who had a vital to assess an ETC Participant’s CPT codes 90957, 90958, 90959, 90960, solid organ cancer diagnosis and were achievement score. TABLE 1 TO § 512.370(B)(1)—ETC MODEL SCHEDULE OF PPA ACHIEVMENT BENCHMARKS BY MEASUREMENT YEAR

MY1 and MY2 MY3 and MY4 MY5 and MY6 MY7 and MY8 MY9 and MY10 Points

90th+ Percentile of bench- 1.1 * (90th+ Percentile of 1.2 * (90th+ Percentile of 1.3 * (90th+ Percentile of 1.4 * (90th+ Percentile of 2 mark rates for Comparison benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- Geographic Areas during parison Geographic Areas parison Geographic Areas parison Geographic Areas parison Geographic Areas the Benchmark Year. during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year). Year). Year). Year). 75th+ Percentile of bench- 1.1 * (75th+ Percentile of 1.2 * (75th+ Percentile of 1.3 * (75th+ Percentile of 1.4 * (75th+ Percentile of 1.5 mark rates for Comparison benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- Geographic Areas during parison Geographic Areas parison Geographic Areas parison Geographic Areas parison Geographic Areas the Benchmark Year. during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year). Year). Year). Year). 50th+ Percentile of bench- 1.1 * (50th+ Percentile of 1.2 * (50th+ Percentile of 1.3 * (50th+ Percentile of 1.4 * (50th+ Percentile of 1 mark rates for Comparison benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- Geographic Areas during parison Geographic Areas parison Geographic Areas parison Geographic Areas parison Geographic Areas the Benchmark Year. during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year). Year). Year). Year). 30th+ Percentile of bench- 1.1 * (30th+ Percentile of 1.2 * (30th+ Percentile of 1.3 * (30th+ Percentile of 1.4 * (30th+ Percentile of 0.5 mark rates for Comparison benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- Geographic Areas during parison Geographic Areas parison Geographic Areas parison Geographic Areas parison Geographic Areas the Benchmark Year. during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year). Year). Year). Year).

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TABLE 1 TO § 512.370(B)(1)—ETC MODEL SCHEDULE OF PPA ACHIEVMENT BENCHMARKS BY MEASUREMENT YEAR— Continued

MY1 and MY2 MY3 and MY4 MY5 and MY6 MY7 and MY8 MY9 and MY10 Points

<30th Percentile of bench- 1.1 * (<30th Percentile of 1.2 * (<30th Percentile of 1.3 * (<30th Percentile of 1.4 * (<30th Percentile of 0 mark rates for Comparison benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- benchmark rates for Com- Geographic Areas during parison Geographic Areas parison Geographic Areas parison Geographic Areas parison Geographic Areas the Benchmark Year. during the Benchmark during the Benchmark during the Benchmark during the Benchmark Year). Year). Year). Year).

(2) Stratifying achievement (iii) Greater than 0 percent (c)(2) of this section. If the ETC benchmarks. For MY3 through MY10, improvement relative to the Benchmark Participant earns the Health Equity CMS stratifies achievement benchmarks Year rate: 0.5 points Incentive for the home dialysis rate based on the proportion of beneficiary (iv) Less than or equal to the improvement score, CMS adds 0.5 years attributed to the aggregation group Benchmark Year rate: 0 points points to the ETC Participant’s home for which attributed beneficiaries are (v) For MY3 through MY10, when dialysis rate improvement score, dual eligible or LIS recipients during the calculating improvement benchmarks calculated as specified in paragraph MY. An ESRD Beneficiary or Pre- constructed based on the ETC (c)(1) of this section, unless the ETC emptive LDT Beneficiary is considered Participant’s aggregation group’s Participant is ineligible to receive the to be dual eligible or an LIS recipient for historical performance on the home Home Equity Incentive as specified in a given month if at any point during the dialysis rate and transplant rate during paragraph (c)(2)(iii) of this section. month the beneficiary was dual eligible the Benchmark Year, CMS adds one (ii) The ETC Participant earns the or an LIS recipient based on Medicare beneficiary month to the numerator of Health Equity Incentive for the administrative data. CMS stratifies the the home dialysis rate and adds one transplant rate improvement score if the achievement benchmarks into the beneficiary month to the numerator of home dialysis rate for the MY, following two strata: the transplant rate, such that the calculated as specified in paragraph Benchmark Year rates cannot be equal (c)(2) of this section, is at least 5- (i) Stratum 1: 50 percent or more of to zero. percentage points higher than the attributed beneficiary years during the (2) Health Equity Incentive. CMS transplant rate for the Benchmark Year, MY are for beneficiaries who are dual calculates the ETC Participant’s calculated as specified in paragraph eligible or LIS recipients. aggregation group’s home dialysis rate (c)(2) of this section. If the ETC (ii) Stratum 2: Less than 50 percent of and transplant rate as specified in Participant earns the Health Equity attributed beneficiary years during the §§ 512.365(b) and 512.365(c), Incentive for the transplant rate MY are for beneficiaries who are dual respectively, using only attributed improvement score, CMS adds 0.5 eligible or LIS recipients. beneficiary years comprised of months points to the ETC Participant’s (c) Improvement scoring. CMS during the MY in which ESRD transplant rate improvement score, assesses ETC Participant improvement Beneficiaries and, if applicable, Pre- calculated as specified in paragraph on the home dialysis rate and transplant emptive LDT Beneficiaries, are dual (c)(1) of this section, unless the ETC rate against benchmarks constructed eligible or LIS recipients. CMS also Participant is ineligible to receive the based on the ETC Participant’s calculates the threshold for earning the Home Equity Incentive as specified in aggregation group’s historical Health Equity Incentive based on the paragraph (c)(2)(iii) of this section. performance on the home dialysis rate ETC Participant’s aggregation group’s (iii) An ETC Participant in an and transplant rate during the historical performance on the home aggregation group with fewer than 11- Benchmark Year to calculate the ETC dialysis rate and transplant rate during attributed beneficiary years comprised Participant’s improvement score, as the Benchmark Year, using only of months in which ESRD Beneficiaries specified in paragraph (c)(1) of this attributed beneficiary years comprised and, if applicable, Pre-emptive LDT section. For MY3 through MY10, CMS of months during the Benchmark Year Beneficiaries, are dual eligible or LIS assesses ETC Participant improvement in which ESRD Beneficiaries and, if recipients, during either the Benchmark on the home dialysis rate and transplant applicable, Pre-emptive LDT Year or the MY is ineligible to earn the rate for ESRD Beneficiaries and, if Beneficiaries, are dual eligible or LIS Health Equity Incentive. applicable, Pre-emptive LDT recipients. An ESRD Beneficiary or Pre- (d) Modality Performance Score. (1) Beneficiaries, who are dual eligible or emptive LDT Beneficiary is considered For MY1 and MY2, CMS calculates the LIS recipients to determine whether to to be dual eligible or an LIS recipient for ETC Participant’s MPS as the higher of add the Health Equity Incentive to the a given month if at any point during the ETC Participant’s achievement score or ETC Participant’s improvement score, as month the beneficiary was dual eligible improvement score for the home specified in paragraph (c)(2) of this or an LIS recipient. CMS determines dialysis rate, together with the higher of section. whether a beneficiary was dual eligible the ETC Participant’s achievement score or an LIS recipient based on Medicare or improvement score for the transplant (1) Improvement score calculation. administrative data. rate, weighted such that the ETC CMS uses the following scoring (i) The ETC Participant earns the Participant’s score for the home dialysis methodology to assess an ETC Health Equity Incentive for the home rate constitutes 2⁄3 of the MPS and the Participant’s improvement score. dialysis rate improvement score if the ETC Participant’s score for the (i) Greater than 10 percent home dialysis rate for the MY, transplant rate constitutes 1⁄3 of the improvement relative to the Benchmark calculated as specified in paragraph MPS. Year rate: 1.5 points (c)(2) of this section, is at least 5- CMS uses the following formula to (ii) Greater than 5 percent percentage points higher than the home calculate the ETC Participant’s MPS for improvement relative to the Benchmark dialysis rate for the Benchmark Year, MY1 and MY2: Year rate: 1 point calculated as specified in paragraph Modality Performance Score

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= 2 × (Higher of the home dialysis by ETC Participants no later than one agreement with CMS as a condition of achievement or improvement score) month before the start of each PPA the downstream recipient’s receipt of + (Higher of the transplant achievement Period, in a form and manner specified the beneficiary-identifiable data or improvement score) by CMS. ETC Participants may retrieve retrieved by the ETC Participant under (2) For MY3 through MY10, CMS this data at any point during the the ETC Model. calculates the ETC Participant’s MPS as relevant PPA Period. (D) That if the ETC Participant the higher of the ETC Participant’s (ii) This beneficiary-identifiable data misuses or discloses the beneficiary- achievement score for the home dialysis includes, when available, the following identifiable data in a manner that rate or the sum of the ETC Participant’s information for each PPA Period: violates any applicable statutory or improvement score for the home (A) The ETC Participant’s attributed regulatory requirements or that is dialysis rate calculated as specified in beneficiaries’ names, Medicare otherwise non-compliant with the paragraph (c)(1) of this section and, if Beneficiary Identifiers, dates of birth, provisions of the data sharing applicable, the Health Equity Incentive, dual eligible status, and LIS recipient agreement, the ETC Participant will no calculated as described in paragraph status. longer be eligible to retrieve beneficiary- (c)(2)(i) of this section, together with the (B) Data regarding the ETC identifiable data under paragraph higher of the ETC Participant’s Participant’s performance under the (b)(1)(i) of this section and may be achievement score for the transplant ETC Model, including, for each subject to additional sanctions and rate or the sum of the ETC Participant’s attributed beneficiary, as applicable: penalties available under the law. improvement score for the transplant The number of months the beneficiary (2) Aggregate data. CMS shares rate calculated as specified in paragraph was attributed to the ETC Participant, aggregate performance data with ETC (c)(1) of this section and, if applicable, home dialysis months, self-dialysis Participants as follows: the Heath Equity Incentive, calculated months, nocturnal in-center dialysis (i) CMS will make available certain as described in paragraph (c)(2)(ii) of months, transplant waitlist months, and aggregate data for retrieval by the ETC this section, weighted such that the ETC months following a living donor Participant, in a form and manner to be Participant’s score for the home dialysis transplant. specified by CMS, no later than one (iii) CMS shares this beneficiary- rate constitutes 2⁄3 of the MPS and the month before each PPA Period. identifiable data on the condition that ETC Participant’s score for the (ii) This aggregate data includes, the ETC Participants observe all relevant transplant rate constitutes 1⁄3 of the when available, the following statutory and regulatory provisions MPS. information for each PPA Period, de- CMS uses the following formula to regarding the appropriate use of data identified in accordance with 45 CFR calculate the ETC Participant’s MPS for and the confidentiality and privacy of 164.514(b): MY3 through MY10: individually identifiable health (A) The ETC Participant’s information as would apply to a covered Modality Performance Score performance scores on the home entity under the Health Insurance = 2 dialysis rate, transplant waitlist rate, × (Higher of the home dialysis Portability and Accountability Act of living donor transplant rate, and the achievement or (home dialysis 1996 (HIPAA) regulations, and comply Health Equity Incentive. improvement score + Health Equity with the terms of the data sharing (B) The ETC Participant’s aggregation Bonus †)) agreement described in paragraph group’s scores on the home dialysis rate, + (Higher of the transplant achievement (b)(1)(iv) of this section. transplant waitlist rate, and living donor or (transplant improvement score (iv) Data sharing agreement. If an ETC transplant rate, and the Health Equity + Health Equity Bonus †)) Participant wishes to retrieve the Incentive. † The Health Equity Incentive is applied beneficiary-identifiable data specified in (C) Information on how the ETC to the home dialysis improvement paragraph (b)(1)(ii) of this section, the Participant’s and ETC Participant’s score or transplant improvement ETC Participant must complete and aggregation group’s scores relate to the score only if earned by the ETC submit, on at least an annual basis, a achievement benchmark and Participant. signed data sharing agreement, to be improvement benchmark. ■ 10. Section 512.390 is amended by provided in a form and manner (D) The ETC Participant’s MPS and revising the section heading, specified by CMS, under which the ETC PPA for the corresponding PPA Period. redesignating paragraph (b) as (c) and Participant agrees: * * * * * adding new paragraph (b) to read as (A) To comply with the requirements ■ 11. Section 512.397 is amended by follows: for use and disclosure of this revising the section heading and beneficiary-identifiable data that are paragraph (b) and adding paragraph (c) § 512.390 Notification, data sharing, and imposed on covered entities by the to read as follows: targeted review. HIPAA regulations and the * * * * * requirements of the ETC Model set forth § 512.397 ETC Model Medicare program (b) Data sharing with ETC in this part. waivers and additional flexibilities. Participants. CMS shares certain (B) To comply with additional * * * * * beneficiary-identifiable data as privacy, security, breach notification, (b) CMS waives the following described in paragraph (b)(1) of this and data retention requirements requirements of title XVIII of the Act section and certain aggregate data as specified by CMS in the data sharing solely for purposes of testing the ETC described in paragraph (b)(2) of this agreement. Model: section with ETC Participants regarding (C) To contractually bind each (1) CMS waives the requirement their attributed beneficiaries and downstream recipient of the beneficiary- under section 1861(ggg)(2)(A)(i) of the performance under the ETC Model. identifable data that is a business Act and § 410.48(a) of this chapter that (1) Beneficiary-identifiable data. CMS associate of the ETC Participant or only doctors, physician assistants, nurse shares beneficiary-identifiable data with performs a similar function for the ETC practitioners, and clinical nurse ETC Participants as follows: Participant, to the same terms and specialists can furnish kidney disease (i) CMS will make available certain conditions to which the ETC Participant patient education services to allow beneficiary-identifiable data for retrieval is itself bound in its data sharing kidney disease patient education

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services to be provided by clinical staff kidney disease patient education (2) The ETC Participant must (as defined at § 512.310) under the service. maintain and provide the government direction of and incident to the services (5) Beginning January 1, 2022, CMS with access to records of the following of the Managing Clinician who is an waives the geographic and site of information in accordance with ETC Participant. The kidney disease service originating site requirements in § 512.135(b) and (c) of this part: patient education services may be sections 1834(m)(4)(B) and (i) The identity of the qualified staff furnished only by qualified staff (as 1834(m)(4)(C) of the Act and who furnished the kidney disease § 410.78(b)(3) and (4) of this chapter for defined at § 512.310). patient education services for which the purposes of kidney disease patient coinsurance was reduced or waived and (2) CMS waives the requirement that education services furnished by the date such services were furnished. kidney disease patient education qualified staff via telehealth in services are covered only for Stage IV accordance with this section, regardless (ii) The identity of the beneficiary chronic kidney disease (CKD) patients of the location of the beneficiary or who received the kidney disease patient under section 1861(ggg)(1)(A) of the Act qualified staff. Beginning January 1, education services for which the and § 410.48(b)(1) of this chapter to 2022, CMS also waives the requirement coinsurance was reduced or waived. permit beneficiaries diagnosed with in section 1834(m)(2)(B) of the Act and (iii) Evidence that the beneficiary who CKD Stage V or within the first 6 § 414.65(b) of this chapter that CMS pay received the kidney disease patient months of starting dialysis to receive a facility fee to the originating site with education services coinsurance waiver kidney disease patient education respect to telehealth services furnished was eligible to receive the kidney services. to a beneficiary in accordance with this disease patient education services under (3) CMS waives the requirement that section at an originating site that is not the ETC Model and did not have the content of kidney disease patient one of the locations specified in secondary insurance. education services include the § 410.78(b)(3). (c)(1) Beginning January 1, 2022, an (iv) The amount of the kidney disease management of co-morbidities, patient education coinsurance reduction including for the purpose of delaying ETC Participant may reduce or waive the 20 percent coinsurance requirement or waiver provided by the ETC the need for dialysis, under Participant. § 410.48(d)(1) of this chapter when such under section 1833 of the Act if all of services are furnished to beneficiaries the following conditions are satisfied: (3) The Federal anti-kickback statute with CKD Stage V or ESRD, unless such (i) The individual or entity that safe harbor for CMS-sponsored model content is relevant for the beneficiary. furnished the kidney disease patient patient incentives (42 CFR education services is qualified staff. 1001.952(ii)(2)) is available to protect (4) CMS waives the requirement that (ii) The kidney disease patient the kidney disease patient education an outcomes assessment designed to education services were furnished to a coinsurance waivers that satisfy the measure beneficiary knowledge about beneficiary described in § 410.48(b) or requirements of such safe harbor and CKD and its treatment be performed as § 512.397(b)(2) who did not have paragraph (c)(1) of this section. part of a kidney disease patient secondary insurance on the date the education service under services were furnished. Xavier Becerra, § 410.48(d)(5)(iii) of this chapter, (iii) The kidney disease patient Secretary, Department of Health and Human provided that such outcomes education services were furnished in Services. assessment is performed by qualified compliance with the applicable [FR Doc. 2021–14250 Filed 7–1–21; 4:15 pm] staff within one month of the final provisions of § 410.48 and § 512.397(b). BILLING CODE 4120–01–P

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