Home Dialysis and CMS Payment Policy: July 2020 Proposal and 2021 Final Rule

Historical Medicare rulemaking context (July 2020; reviewed November 2026): This article discusses CMS proposals for the calendar year 2021 End-Stage Renal Disease (ESRD) Prospective Payment System. CMS issued its 2021 final rule on November 2, 2020, expanding eligibility for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) to certain qualifying home dialysis machines. TPNIES is an equipment-specific payment policy, not blanket Medicare reimbursement for telehealth or remote-monitoring services. See the CMS 2021 final-rule fact sheet and current CMS TPNIES guidance. This archived reporting is not clinical or billing advice.

In July 2020, CMS proposed changes to the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) that would support innovative equipment for certain home dialysis treatment.

Originally reported by Eric Wicklund for mHealthIntelligence (now TechTarget), July 21, 2020.

July 21, 2020 – In July 2020, federal officials backed proposals for equipment that could enable more kidney dialysis treatment at home.

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) unveiled proposed changes to the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) that, among other things, encourages the use of “new and innovative equipment” for home dialysis.

The announcement follows up on President Donald Trump’s 2019 executive order that called on the nation’s healthcare system to expand home-based dialysis care, including using connected health platforms and tools. It also takes into account the move toward telehealth and home-based care to address the coronavirus pandemic.

“CMS data shows that those with ESRD have the highest rate of hospitalization of any single group, a trend consistent with having to frequently leave home to receive dialysis,” CMS Administrator Seema Verma said in a press release. “In the midst of a deadly pandemic that poses a particular threat to those with serious underlying conditions, President Trump’s call for increased access to home dialysis has never been more urgent. Unfortunately, government rules too often stand in the way. Today’s action represents a sorely needed course direction, making it easier for ESRD facilities to make new and innovative home dialysis machines available to patients who need them.”

Roughly 30 million Americans, or 15 percent of the adult population, are affected by chronic kidney disease. Of that number, more than 660,000 have kidney failure, and almost 470,000 are on dialysis. More than 193,000, meanwhile, have a functioning kidney transplant, which requires them to follow a very strict daily medication regimen.

According to the agency, more than 85 percent of Medicare fee-for-service beneficiaries living with ESRD travel to a facility three times a week for dialysis, spending an average of 12 hours a week connected to a machine that, under the right circumstances, could be located at home.

According to the National Kidney Foundation, telemedicine offers a promising alternative to in-person care, most often delivered in a doctor’s office or dialysis clinic. Clinicians can remotely monitor a patient’s blood pressure and other vital signs, as well as offering resources for medication adherence and diet plans.

More importantly, nephrologists and nephrology nurses can coordinate care online with a patient’s primary care provider (a model now being used by the Indian Health Service) and interact at home with patients undergoing hemodialysis and peritoneal dialysis, offering on-demand care between regularly scheduled office visits.

CMS is proposing to expand the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES), which was introduced in 2019. The proposed adjustment concerned eligible innovative dialysis equipment and supplies, not a general payment for telehealth services.

The agency pointed out that this latest effort builds on previous actions to improve care for people living with kidney disease, including:

• A proposed ESRD Treatment Choices (ETC) Model that would encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD;
• The Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Options of the Kidney Care Choices (KCC) Model, which would test whether new care delivery and Medicare payment options can improve the quality of care and reduce the total cost of care for patients with kidney disease; and
• Eligibility amendments to the transitional drug add-on payment adjustment (TDAPA) under the ESRD PPS to better target the additional payment to innovative renal dialysis drugs and biological products based on the Food and Drug Administration’s New Drug Application Classifications.