In a June 30 news release, the agency revised the guidance to “improve transparency and foster an effective negotiation process.”
Updated changes include:
- Only considering active designations and approvals for drugs to be considered “orphan drugs”
- Allowing drug manufacturers to speak publicly about the negotiation process at their discretion
- Adding additional opportunities for drug manufacturers and the public to weigh in during the negotiation process
CMS will publish the list of the first 10 drugs selected to negotiate with the government for pricing on Sept. 1.
The Inflation Reduction Act established Medicare’s authority to negotiate with drug manufacturers over the cost of medications. Negotiated prices for the first 10 drugs will take effect in 2026, eventually expanding to 60 drugs by 2029.
The U.S. Chamber of Commerce, two drugmakers and three healthcare organizations have filed lawsuits challenging the drug price negotiations.
Read the full updated guidance here.
