The Trump administration has released a draft guidance outlining the third round of Medicare drug price negotiations, targeting both prescription drugs covered under Medicare Part D and medications administered in a doctor’s office or hospital under Medicare Part B. According to the Centers for Medicare & Medicaid Services (CMS), 15 drugs will be eligible for negotiation by February 2026, with new negotiated prices taking effect in 2028. This marks the first time CMS will negotiate prices on behalf of beneficiaries receiving treatments through Part B.
Key Changes and Considerations
The draft guidance outlines several key changes and considerations for future rounds of pharmaceutical cost-cutting negotiations:
- Eligible Drugs: The third round will target both prescription drugs covered under Medicare Part D and medications administered in a doctor’s office or hospital under Medicare Part B.
- Negotiation Timeline: New negotiated prices will take effect in 2028.
- Renegotiation: Previously agreed-upon prices may be renegotiated if they have gained approval from regulators since their initial agreement or have experienced changes in monopoly status.
- Public Feedback: CMS is soliciting public feedback on various aspects related to determining an initial offer price for a drug, including profit margins and factors influencing negotiation strategies.
- International Reference Pricing Benchmarks: The agency is considering allowing some flexibility when setting targets based on international reference pricing benchmarks.
- Biologic Medicines: Manufacturers can avoid participating until after their products have been sold commercially outside the US market without competition from similar products produced elsewhere within three years after launch; however, this period has been extended indefinitely unless lawmakers intervene again next year.
Additional Developments
In other news, UnitedHealth Group Chairman Stephen Hemsley has returned as interim chief executive officer following Andrew Witty’s resignation amid challenges faced by UnitedHealthcare, including disappointing quarterly results and increased scrutiny surrounding its business practices.
Separately, OpenAI has introduced HealthBench, an evaluation tool designed specifically to assess artificial intelligence models’ performance across diverse healthcare scenarios, ranging from routine check-ups to emergency situations requiring immediate attention.
These developments come as part of ongoing efforts to address rising healthcare costs and improve access to affordable medication options for millions of Americans enrolled in Medicare programs.
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