This document is scheduled to be published in the Federal Register on 11/14/2018 and available online at https://federalregister.gov/d/2018-24238, and on govinfo.gov DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 413 and 414 [CMS-1691-F] RIN 0938-AT28 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments to Correct Existing Regulations Related to the CBP for Certain DMEPOS AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, it updates and rebases the ESRD market basket for CY 2019. This rule also updates requirements for the ESRD Quality Incentive Program (QIP), and makes technical amendments to correct existing regulations related to the Competitive Bidding Program (CBP) for certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). Finally, this rule finalizes changes to bidding and pricing methodologies under the DMEPOS competitive bidding program; adjustments to DMEPOS fee schedule amounts using information from competitive bidding for items furnished from January 1, 2019 through December 31, 2020; new payment classes for oxygen and oxygen equipment and a new methodology for ensuring that new payment classes for oxygen and oxygen equipment are budget neutral; payment rules for multi-function ventilators or ventilators that perform functions of other durable medical equipment (DME); and revises the payment methodology for mail order items furnished in the Northern Mariana Islands. This rule also includes a summary of the feedback received for the request for information related to establishing fee schedule amounts for new DMEPOS items and services. DATES: These regulations are effective January 1, 2019, except the amendments to 42 CFR 413.234, which are effective January 1, 2020. 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. [email protected], for issues related to DMEPOS payment policy. Julia Howard, (410) 786-8645, for issues related to DMEPOS CBP technical amendments only. 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 U.S. Government Printing Office. This database can be accessed via the internet at http://www.gpo.gov/fdsys/. Addenda Are Only Available Through the Internet on the CMS Web Site The Addenda for the annual ESRD PPS proposed and final rules will no longer appear in the Federal Register. Instead, the Addenda will be available only through the Internet on the CMS website at http://www.cms.gov/ESRDPayment/PAY/list.asp. In addition to the Addenda, limited data set (LDS) files are available for purchase at http://www.cms.gov/Research- Statistics-Data-and-Systems/Files-for- Order/LimitedDataSets/EndStageRenalDiseaseSystemFile.html. Readers who experience any problems accessing the Addenda or LDS files, should contact [email protected]. Table of Contents To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents. 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 B. Summary of the Major Provisions C. Summary of Cost and Benefits II. Calendar Year (CY) 2019 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) A. Background B. Summary of the Proposed Provisions, Public Comments, and Responses to Comments on the Calendar Year (CY) 2019 ESRD PPS C. Solicitation for Information on Transplant and Modality Requirements D. Miscellaneous Comments III. CY 2019 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 2019 Payment for Renal Dialysis Services Furnished to Individuals with AKI C. Annual Payment Rate Update for CY 2019 IV. End-Stage Renal Disease Quality Incentive Program (ESRD QIP) 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) C. Requirements for the PY 2022 ESRD QIP D. Requirements Beginning with the PY 2024 ESRD QIP V. Changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) A. Background B. Current Method for Submitting Bids and Selecting Winners C. Current Method for Establishing SPAs VI. Adjustments to DMEPOS Fee Schedule Amounts Based on Information from the DMEPOS CBP A. Background B. Summary of the Proposed Provisions, Public Comments, and Responses to Comments on DMEPOS CBP VII. New Payment Classes for Oxygen and Oxygen Equipment and Methodology for Ensuring Annual Budget Neutrality of the New Classes A. Background B. Summary of the Proposed Provisions, Public Comments, and Responses to Comments on New Payment Classes for Oxygen and Oxygen Equipment and Methodology for Ensuring Annual Budget Neutrality of the New Classes VIII. Payment for Multi-Function Ventilators A. Background B. Summary of the Proposed Provisions, Public Comments, and Responses to Comments on Payment for Multi-Function Ventilators IX. Northern Mariana Islands in Future National Mail Order CBPs A. Background B. Summary of the Proposed Provisions, Public Comments, and Responses to Comments on Including the Northern Mariana Islands in Future National Mail Order CBPs X. Summary of the Request for Information on the Gap-filling Process for Establishing Fees for New DMEPOS Items XI. DMEPOS CBP Technical Amendments A. Background B. Proposed Technical Amendments XII. Burden Reduction on Comorbidities A. Background B. Final Documentation Requirements XIII. Requests for Information A. Request for Information on Promoting Interoperability and Electronic Healthcare Information Exchange through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers B. Request for Information on Price Transparency: Improving Beneficiary Access to Provider and Supplier Charge Information XIV. Collection of Information Requirements A. Legislative Requirement for Solicitation of Comments B. Requirements in Regulation Text C. Additional Information Collection Requirements XV. Economic Analyses A. Regulatory Impact Analysis B. Detailed Economic Analysis C. Accounting Statement XVI. Regulatory Flexibility Act Analysis XVII. Unfunded Mandates Reform Act Analysis XVIII. Federalism Analysis XIX. Reducing Regulation and Controlling Regulatory Costs XX. Congressional Review Act XXI. Files Available to the Public via the Internet Regulations Text I. Executive Summary A. Purpose 1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) On January 1, 2011, we implemented the End-Stage Renal Disease (ESRD) Prospective Payment System (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). 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 updates and makes revisions to the ESRD PPS for CY 2019. 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 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 updates the AKI payment rate for CY 2019. 3. End-Stage