Medicare Negotiation Second Cycle Draft Guidance Offers Options For ‘Effectuating’ Prices

The mechanics of implementing the new prices is the most significant update in the draft. The few revisions to key elements of the negotiation process in the guidance include alternative approaches to forums for collecting patient input on the selected drugs. 

The Negotiation Process Likely Won't Change Much In the Next Round. • Source: Shutterstock

A key update in the Centers for Medicare and Medicaid Services draft guidance for the second round of the Medicare price negotiations focuses on the mechanics of getting negotiated prices into the supply chain and pharmacy counter in 2026 and 2027.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Access

More from Pink Sheet

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By 

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA