On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) finalized its 2021 End-Stage Renal Disease Prospective Payment System Rule. Among other things, the final rule expands Medicare payments for in-home dialysis equipment and supplies as part of an effort to encourage in-home care for populations vulnerable to COVID-19. We previously wrote about the proposed rule here.

To accomplish this, CMS will expand the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) “to include certain capital-related assets that are home dialysis machines when used in the home for a single patient.” CMS will evaluate TPNIES applications to determine whether the home dialysis machine represents an advance that substantially improves the diagnosis or treatment of Medicare beneficiaries, and meets the other requirements under 42 CFR 413.236(b).

In addition to expanding the TPNIES, the finalized rule also:

  • Updates the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) wage index to adopt the 2018 Office of Management and Budget (OMB) delineations with a transition period;
  • adds to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment; and
  • changes the low-volume payment adjustment eligibility criteria and attestation requirement to account for the COVID-19 Public Health Emergency (PHE).

A CMS fact sheet on the rule is available here. The final rule is set to be published in the Federal Register on November 9, 2020 and goes into effect on January 1, 2021.

This post was co-authored by Michael Lisitano, Law Clerk at Robinson+Cole. Michael is not yet admitted to practice law.

Photo of Melissa (Lisa) Thompson Melissa (Lisa) Thompson

Lisa Thompson advises companies, senior management, and boards of directors, with a focus on the health care, life sciences, technology, and food and beverage industries. She is a member of the firm’s Health Law Group, Government Investigations, Food and Beverage Industry Group, and…

Lisa Thompson advises companies, senior management, and boards of directors, with a focus on the health care, life sciences, technology, and food and beverage industries. She is a member of the firm’s Health Law Group, Government Investigations, Food and Beverage Industry Group, and Data Privacy + Cybersecurity Team. Lisa is co-chair of the Health Law Section of the Boston Bar Association. She also serves as an international and domestic arbitrator on the Commercial, Life Sciences, and Health Care panels of the American Arbitration Association. She is a member of the AAA Life Sciences Advisory Council and the advisory committee for the Boston International Arbitration Council (BIAC).

Lisa has represented domestic and international clients in the health care, life sciences, technology, and food and beverage industries. Lisa handles a range of matters, including corporate law and contracting, government investigations and audits, clinical research law, and matters involving Institutional Review Boards (IRBs). She has extensive experience representing clients on matters involving privacy and security including HIPAA, reimbursement, Medicare and Medicaid, state and federal surveys and termination actions, managed care disputes, pharmacy and compounding laws, fraud and abuse, Stark Law, anti-kickback, and federal program exclusions. Read her full rc.com bio here.