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.
Continue Reading CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and Supplies

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.


Continue Reading CMS Proposes 2021 End-Stage Renal Disease Prospective Payment System Rule

On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law (Section 1877(h)(1) of the Social Security Act) and impact other provisions governing Medicare Part B.

The bill would amend the Stark Law:

  • to provide that the writing requirement for certain compensation arrangements may be satisfied by means determined by the HHS Secretary, including “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties;”
  • to include provisions for “indefinite” holdovers involving certain personal service arrangements and leases of office space or equipment; and
  • to provide for up to 90 days to obtain missing signatures in certain compensation arrangements that have become noncompliant.

These changes codify certain Stark Law changes previously made by the Centers for Medicare and Medicaid Services in the Medicare Physician Fee Schedule that took effect on January 1, 2016 (see related article here). 
Continue Reading House Bipartisan Act Would Amend Stark Law and Medicare Part B