Health Affairs June 14, 2024
Frederick McElwee, Amanda Cole, Louis P. Garrison, Jr. Adrian Towse

The Inflation Reduction Act (IRA) introduces new powers for the Centers for Medicare and Medicaid Services (CMS) to negotiate drug prices and is designed to lower prices for the highest spend Medicare Parts B and D drugs that have been on the market for several years (at least nine for small molecule drugs and 13 for biologics). Manufacturers of drugs selected for negotiations over a maximum fair price must submit specified information to CMS. The required data elements are enumerated in the Information Collection Request Form under IRA Sections 11001 and 11002. CMS has not yet specified the weights or decision criteria to be applied in consideration of manufacturers’ costs and the drugs’ clinical benefits.

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