Pardon Our Dust
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In August 2022, McGuireWoods Consulting senior vice president Stephanie Kennan commented in three different media outlets on the new Infrastructure Act of 2022, which, among many things, allows the U.S. government to negotiate the price of prescription drugs used by the Medicare program.
FDANews quoted Stephanie in the article “House Passes Landmark Bill Allowing U.S. to Negotiate Drug Prices for Medicare”; she authored “The Next Step for Medicare Drug Negotiations” for Think Advisor; and the The Pharma Letter podcast featured her in the episode “Inflation Reduction Act: Quick Take.”
Stephanie noted that the legislation adds to the ambiguity and complexity of government negotiations with drugmakers and that it will require the Centers for Medicare & Medicare Services (CMS) to set up new processes, hire new employees and determine which high-priced drugs will be negotiated first.
CMS likely will need these processes and employees in place by late 2024; however, regulations around the new law are expected to start taking shape immediately, Stephanie noted. The “historic authority to negotiate drug prices for the Medicare population will not be easy for CMS to wield.”
The pharmaceutical industry also will face changes. Stephanie told FDANews: “It’s a new day for [the pharmaceutical industry] in the U.S. They’re used to negotiating in Europe. But this is a different style of negotiating, so I think they’ll have a lot to get used to. This is a whole different structure.”