The Centers for Medicare and Medicaid Services (CMS) released the proposed rule for the 2021 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Incentive Program (QIP) on July 6. The proposed rule contains some of the nuts and bolts that run the Medicare ESRD program on the facility side. It contains numerous guardrails to protect kidney failure patients and provide them access to the best modalities.

CMS took a major step, strongly supported by the American Society of Nephrology (ASN), in support of patient access, proposing to create a pathway to advance the use of home dialysis. It did so by including “new and innovative capital-related assets that are home dialysis machines when used in the home for a single patient” in the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES). 

The TPNIES payment, an additional payment to facilities for a limited two-year window, encourages and supports innovation from medical device providers and draws them into the kidney space. ASN also supported the transitional drug add-on payment adjustment (TDAPA) in the Prospective Payment System for similar reasons and to support acquiring the utilization data that is collected through the program.

The second significant step proposed by the agency was to increase to the base payment rate (the bundle) by over $15.00 (as opposed to an approximate $5.00 increase from 2019-2020); however, this increase includes calcimimetics that were not previously included in the base rate. This establishes the adult base rate for 2021 at $255.59 up from the current base rate of $239.33. Perhaps more importantly, CMS proposes to set the base rate dialysis services for individuals with Acute Kidney Injury (AKI) at the same reimbursement rate $255.59.

The highlights of the proposed rule are:

• Adding to the ESRD PPS base rate to include calcimimetics in the bundle;
• Expanding TPNIES to include new and innovative capital-related assets that are home dialysis machines, and changing to the eligibility criteria and determination process for TPNIES;
• Establishing parity between the bundled ESRD rate and the AKI dialysis payment rate;
• Changing the low-volume adjustment eligibility criteria and attestation requirement to account for the COVID-19 PHE; and
• Updating the wage index that helps adjust payments to account for differing wage levels in areas in which ESRD facilities are located.
   

This year’s proposal primarily advances the work of the last several years and CMS gives an indication of future activity in its press release when it states:

Today’s announcement builds on previous actions taken by CMS to improve care for beneficiaries with kidney disease including:

• The proposed ESRD Treatment Choices (ETC) Model that would encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD in order to preserve or enhance their quality of care while reducing Medicare expenditures [1]
   

This language can be interpreted as the ETC Model is forthcoming.

There is a lot here for nephrologists to consider. First of all, the ERSD bundle is here to stay. CMS is once again trying to fine tune the Prospective Payment System for stability and predictability for dialysis providers and nephrologists interacting with those facilities. CMS is still struggling with how much it can do in areas of payment for innovation such as TPNIES and TDAPA. While the agency is trying to support those programs, the agency’s belief that it does not have the authority to add new money to these programs is making them appear anemic – ASN has asked CMS to add new dollars to both innovation payment programs and extend the current two year period to receive these payments to at least three years. This could be frustrating for some medical directors justifying the use of new therapies and devices. Finally, the direction laid out in the Advancing American Kidney Health Executive Order is still a guiding force and greater access to pre-emptive transplants and home dialysis are a couple of the big goal posts ahead.