Proposed Rule

This document is scheduled to be published in the Federal Register on 07/13/2020 and available online at federalregister.gov/d/2020-14671, and on govinfo.gov [Billing Code: 4120-01-P] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 413 [CMS-1732-P] RIN 0938-AU08 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2021. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program (QIP). DATES: To be assured consideration, comments must be submitted at one of the addresses provided below, no later than September 4, 2020. ADDRESSES: In commenting, please refer to file code CMS-1732-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the "Submit a comment" instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1732-P, P.O. Box 8010 Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1732-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: [email protected], for issues related to the ESRD PPS and coverage and payment for renal dialysis services furnished to individuals with AKI. Delia Houseal, (410) 786-2724, for issues related to the ESRD QIP. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments. Table of Contents To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents. I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Cost and Benefits II. Calendar Year (CY) 2021 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) A. Background B. Provisions of the Proposed Rule C. Proposed Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) for CY 2021 Payment III. Calendar Year (CY) 2021 Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (AKI) A. Background B. Proposed Annual Payment Rate Update for CY 2021 IV. End-Stage Renal Disease Quality Incentive Program (ESRD QIP) A. Background B. Proposed Updates to Requirements Beginning with the PY 2023 ESRD QIP C. Proposals for the PY 2023 ESRD QIP V. Collection of Information Requirements A. Legislative Requirement for Solicitation of Comments B. Requirements in Regulation Text C. Additional Information Collection Requirements VI. Response to Comments VII. Economic Analyses A. Regulatory Impact Analysis B. Detailed Economic Analysis C. Accounting Statement D. Regulatory Flexibility Act Analysis E. Unfunded Mandates Reform Act Analysis F. Federalism Analysis G. Reducing Regulation and Controlling Regulatory Costs H. Congressional Review Act VIII. Files Available to the Public via the Internet Regulations Text I. Executive Summary A. Purpose This rule contains proposals related to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), payment for renal dialysis services furnished to individuals with acute kidney injury (AKI), and the ESRD Quality Incentive Program (QIP). 1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110–275). Section 1881(b)(14) (F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111–148), established that beginning calendar year (CY) 2012, and each subsequent year, the Secretary of the Department of Health and Human Services (the Secretary) shall annually increase payment amounts by an ESRD market basket increase factor, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This rule proposes updates and revisions to the ESRD PPS for CY 2021. 2. Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (AKI) On June 29, 2015, the President signed the Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114–27). Section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual with acute kidney injury (AKI). Section 808(b) of the TPEA amended section 1834 of the Act by adding a new subsection (r) that provides for payment for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) of the Act to individuals with AKI at the ESRD PPS base rate beginning January 1, 2017. This rule proposes to update the AKI payment rate for CY 2021. 3. End-Stage Renal Disease Quality Incentive Program (ESRD QIP) The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is authorized by section 1881(h) of the Act. The Program fosters improved patient outcomes by establishing incentives for dialysis facilities to meet or exceed performance standards established by the Centers for Medicare & Medicaid Services (CMS). This proposed rule proposes several updates for the payment years (PY) 2023 and 2024 ESRD QIP. B. Summary of the Major Provisions 1. ESRD PPS Update to the ESRD PPS base rate for CY 2021: The proposed CY 2021 ESRD PPS base rate is $255.59. This proposed amount reflects the application of the wage index budget-neutrality adjustment factor (.998652), the proposed addition to the base rate of $12.06 to include calcimimetics, and a productivity-adjusted market basket increase as required by section 1881(b)(14)(F)(i)(I) of the Act (1.8 percent), equaling $255.59 (($239.33 x .998652) + $12.06) x 1.018 = $255.59). Annual update to the wage index: We adjust wage indices on an annual basis using the most current hospital wage data and the latest core-based statistical area (CBSA) delineations to account for differing wage levels in areas in which ESRD facilities are located. For CY 2021, we are proposing to update the wage index values based on the latest available data. New Office of Management and Budget (OMB) delineations and 2-year transition policy: We are proposing to adopt the Office of Management and Budget (OMB) delineations as described in the September 14, 2018 OMB Bulletin No. 18-04, beginning with the CY 2021 ESRD PPS wage index. In addition, we are proposing to apply a 5 percent cap on any decrease in an ESRD facility’s wage index from the ESRD facility’s wage index from the prior calendar year. This transition would be phased in over 2 years, such that the estimated reduction in an ESRD facility’s wage index would be capped at 5 percent in CY 2021, and no cap would be applied to the reduction in the wage index for the second year, CY 2022. Update to the outlier policy: We are proposing to update the outlier policy using the most current data, as well as update the outlier services fixed-dollar loss (FDL) amounts for adult and pediatric patients and Medicare allowable payment (MAP) amounts for adult and pediatric patients for CY 2021 using CY 2019 claims data. Based on the use of the latest available data, the proposed FDL amount for pediatric beneficiaries would increase from $41.04 to $47.73, and the MAP amount would increase from $32.32 to $33.08, as compared to CY 2020 values. For adult beneficiaries, the proposed FDL amount would increase from $48.33 to $133.52, and the MAP amount would increase from $35.78 to $54.26. The 1.0 percent target for outlier payments was not achieved in CY 2019. Outlier payments represented approximately 0.5 percent of total payments rather than 1.0 percent. Inclusion of calcimimetics in the ESRD PPS base rate: We are proposing the methodology for modifying the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment.

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