50738 Federal Register /Vol. 82, No. 210/Wednesday ...

1 50738 Federal Register / Vol. 82, No. 210 / wednesday , november 1, 2017 / rules and Regulations DEPARTMENT OF HEALTH AND HUMAN services Centers for Medicare & Medicaid services 42 CFR Parts 413 and 414 [CMS 1674 F] RIN 0938 AT04 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: Final rule. SUMMARY: This rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2018.

2 It also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also sets forth requirements for the ESRD Quality Incentive Program (QIP), including for payment years (PYs) 2019 through 2021. DATES: These regulations are effective January 1, 2018. FOR FURTHER INFORMATION CONTACT: 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.

3 Joel Andress, (410) 786 5237, for measure related issues with ESRD QIP. SUPPLEMENTARY INFORMATION: Electronic Access This Federal Register document is also available from the Federal Register online database through Federal Digital System (FDsys), a service of the Government Printing Office. This database can be accessed via the internet at Addenda Are Only Available Through the Internet on the CMS Web site In the past, a majority of the Addenda referred to throughout the preamble of our proposed and final rules were available in the Federal Register .

4 However, the Addenda of the annual proposed and final rules will no longer be available in the Federal Register . Instead, these Addenda to the annual proposed and final rules will be available only through the Internet on the CMS Web site. The Addenda to the end-stage renal disease (ESRD) prospective payment system (PPS) rules are available at: Readers who experience any problems accessing any of the Addenda to the proposed and final rules of the ESRD PPS that are posted on the CMS Web site identified above should contact Table of Contents To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents.

5 Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the Code of Federal Regulations (CFR). I. Executive Summary A. Purpose 1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) 2. Coverage and Payment for Renal Dialysis services Furnished to Individuals With Acute Kidney Injury (AKI) 3. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) B. Summary of the Major Provisions 1. ESRD PPS 2. Payment for Renal Dialysis services Furnished to Individuals With AKI 3.

6 ESRD QIP C. Summary of Cost and Benefits 1. Final Impacts of the ESRD PPS 2. Final Impacts of Payment for Renal Dialysis services Furnished to Individuals With AKI 3. Final Impacts of the ESRD QIP II. Calendar Year (CY) 2018 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) A. Background 1. Statutory Background 2. Description of the System for Payment of Renal Dialysis services 3. Updates to the ESRD PPS B. Summary of the Proposed Provisions, Public Comments, and Responses to Comments on the Calendar Year (CY) 2018 ESRD PPS 1.

7 Pricing Eligible Outlier Drugs and Biologicals That Were or Would Have Been, Prior to January 1, 2011, Separately Billable Under Medicare Part B a. Summary of Outlier Calculation b. Use of ASP Methodology Under the ESRD PPS c. Pricing Methodologies Under Section 1847A of the Act d. Pricing Eligible Outlier Drugs and Biologicals That Were or Would Have Been, Prior to January 1, 2011, Separately Billable Under Medicare Part B 2. CY 2018 ESRD PPS Update a. CY 2018 ESRD Bundled Market Basket Update, Productivity Adjustment, and Labor-Related Share for the ESRD PPS b.

8 Final CY 2018 ESRD PPS Wage Indices i. Annual Update of the Wage Index ii. Application of the Wage Index Under the ESRD PPS c. CY 2018 Update to the Outlier Policy i. CY 2018 Update to the Outlier services MAP Amounts and FDL Amounts ii. Outlier Percentage d. Final Impacts to the CY 2018 ESRD PPS Base Rate i. ESRD PPS Base Rate ii. Annual Payment Rate Update for CY 2018 C. Miscellaneous Comments III. Calendar Year (CY) 2018 Payment for Renal Dialysis services Furnished to Individuals With Acute Kidney Injury (AKI) A. Background B. Summary of the Proposed Provisions, Public Comments, and Responses to Comments on CY 2018 Payment for Renal Dialysis services Furnished to Individuals With AKI 1.

9 Annual Payment Rate Update for CY 2018 a. CY 2018 AKI Dialysis Payment Rate b. Geographic Adjustment Factor IV. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for Payment Year (PY) 2021 A. Background B. Summary of the Proposed Provisions, Public Comments, Responses to Comments, and Newly Finalized Policies for the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) 1. Accounting for Social Risk Factors in the ESRD QIP 2. Change to the Performance Score Certificate (PSC) Beginning With PY 2019 ESRD QIP 3. Requirements Beginning With the PY 2020 ESRD QIP a.

10 Clarification on the Minimum Data Policy for Scoring Measures Finalized for the PY 2020 ESRD QIP b. Changes to the Extraordinary Circumstances Exception (ECE) Policy c. Solicitation of Comments on the Inclusion of Acute Kidney Injury (AKI) Patients in the ESRD QIP d. Estimated Performance Standards, Achievement Thresholds, and Benchmarks for the Clinical Measures Finalized for the PY 2020 ESRD QIP e. Policy for Weighting the Clinical Measure Domain for PY 2020 f. Payment Reductions for the PY 2020 ESRD QIP g. Data Validation 4. Requirements for the PY 2021 ESRD QIP a.