Medicare Price Negotiation Under CMS Chief Oz May See Early 2025 Test

The next round of the negotiation program is scheduled to begin in February unless the new administration delays the start of the process.

Is Medicare Ready For Dr. Oz? (Shutterstock)

Dr. Mehmet Oz, the expected nominee for US Centers for Medicare and Medicaid Services administrator, and other lower-level appointees could be in position to substantially alter the second round of Medicare drug pricing negotiation.

More from Agency Leadership

All US FDA Product Centers May Merge Under Planned Agency Reorganization

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

Pink Sheet Podcast: Understanding The US FDA Reduction-In-Force And Its Long-Term Impact

Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.

‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 

Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People

 

The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.

More from Legislation

EU Clinical Trials Regulation Failing To Harmonize Requirements, But UK Has ‘Great Opportunity’

 

The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.

GOP Hill Staffer Joins US FDA As Senior Advisor, But Competing With MAHA For Legislative Position

 

Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.

Germany: Standardized Clauses In Clinical Trial Agreements Bring Opportunities But Also Tougher Negotiations

 

Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.