On July 6, 2020, the Centers for Medicare and Medicaid Services (CMS) proposed its calendar year 2021 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) rule. ESRD PPS rules are promulgated on an annual basis, providing updates to payment policies and rates for renal dialysis services furnished to beneficiaries. The 2021 proposed rule also proposes to update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI, and proposes changes to the ESRD Quality Incentive Program. In addition to the annual technical updates, the 2021 rule proposes, at a high level:
- Changes to the eligibility criteria and determination process for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES), and defining “new” to be within three years, beginning on the date of the FDA marketing authorization;
- Expansion of the TPNIES to include new and innovative capital-related assets that are home dialysis machines, used in the home for a single patient;
- Updates to the outlier policy and outlier services fixed-dollar loss amounts as well as the Medicare allowable payment amounts;
- An addition to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment;
- A change to the low-volume payment adjustment eligibility criteria and attestation requirement to account for the COVID-19 public health emergency; and
- An update to the ESRD PPS wage index to adopt the new Office of Management and Budget (OMB) delineations with a transition period.