MDRP multiple best prices option and territory exclusion update plus Part B discarded drug refund – JD Supra

  1. On November 17, 2021 the Centers for Medicare & Medicaid Services (CMS) issued a final rule delaying the effective date of two previously-adopted regulatory provisions:
  • Multiple Best Prices (BPs) Reporting Option: The final rule delays by six months, from January 1, 2022, to July 1, 2022, the effective date of the multiple best prices reporting option for value-based purchasing (VBP) arrangements under the MDRP.

  • Territories: The final rule further delays by nine months, from April 1, 2022, to January 1, 2023, the effective date of the changes to the definitions of “States” and “United States” to include American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the Virgin Islands.

The final rule was published in the Federal Register on November 19, 2021. We previously issued an alert on CMS’s proposal to the multiple BPs reporting option final rule, available here; an alert on the changes to the definitions of “States” and “United States”, available here; and two alerts on previous delays of the effective date of the addition of the territories to the definitions of “States” and “United States”, and available here.

  1. On November 15, 2021, the federal Infrastructure Investment and Jobs Act, H.R. 3684 was signed into law. The law includes a provision that requires manufacturers of certain single-dose container or single-use package drugs payable under Medicare Part B to provide refunds to Medicare with respect to discarded amounts of such drugs.

Each of the above changes are described in more detail,