The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off this week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine the “maximum fair price” for the drug under Medicare. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29th.
In anticipation of this announcement, below is a recap of the IRA’s Drug Price Negotiation Program and pending legal challenges to various aspects of the program. For those interested in more detail about the IRA, please visit our Goodwin IRA webpage, where you can view and download material from our previous webinars covering additional detail and background on the IRA, including guidance from the Centers for Medicare & Medicaid Services (CMS) on implementation of the Program, presented by Goodwin Life Sciences Regulatory & Compliance partner Matt Wetzel.
We will be monitoring pending legal challenges to the IRA and tracking updates on Goodwin’s IRA resource page.