Health Affairs November 7, 2022
Government negotiation of Medicare drug prices—even for a small set of older, single-source drugs—is a remarkable policy development. But how exactly will the government do it?
The Inflation Reduction Act (IRA), signed into law August 16, contains an 86-page blueprint laying out which drugs are on the table, implementation timelines, “factors” to be considered, and rules of engagement for the government and drug companies. The law also spells out the goal of price negotiation: to establish the maximum “fair prices” that Medicare will pay.
In the months ahead, that 86-page blueprint will turn into an even longer instruction manual through a process of rulemaking and regulatory language, led by the Department of Health and Human Services (HHS). Two key decisions...