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 VerDate Sep<11>2014 19:30 Jul 08, 2021 Jkt 253001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\09JYP2.SGM 09JYP2 jbell on DSKJLSW7X2PROD with PROPOSALS2 Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules 36323 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.