Louis P. Garrison

Collaborators of the HEOR Visioning Group: Josephine Mauskopf, PhD, MHA, RTI Health Solutions, Durham, North Carolina, United States [author]; Amanda Cole, PhD, Office of Health Economics, London, UK[author]; Paolo Angelo Cortesi, PhD, Research Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy & Laboratory of Public Health, IRCCS Istituto Auxologico Italiano, Milan, Italy [author]; Vivian WY Lee, PharmD, Centre for Learning Enhancement And Research, The Chinese...

The Inflation Reduction Act (IRA) of 2022 includes a complex set of provisions that will have the effect of reducing and reorienting federal spending on medicines for the elderly and disabled. The IRA marks a transformative shift in US policy by authorizing the Centers for Medicare and Medicaid Services (CMS) to implement a Medicare Drug Price Negotiation Program (MDPNP) to decrease spending on eligible drugs in Medicare Parts B and D by establishing a Maximum Fair Price (MFP) for them.

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.