Lexology October 6, 2022
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the Department of Health and Human Services’ (HHS) implementation of the IRA, with changes to Medicare reimbursement for biosimilars going into effect as of October 1, 2022. On October 3rd, HHS and the Centers for Medicare & Medicaid Services (CMS) announced the implementation of the temporary increase in biosimilar add-on payments under Medicare Part B. Qualifying biosimilars will be paid the average sales price (ASP) plus 8 percent of the reference product’s ASP (rather than plus 6 percent) for a five-year period. For existing qualifying biosimilars...