Medicare Price ‘Negotiation’ : Manufacturer Compliance Gets Tougher Enforcement Provision

As legislation authorizing Medicare price 'negotiation' clears the Senate and appears on its way toward enactment after years of efforts by US congressional Democrats, and opposition by Republicans and the pharmaceutical industry, the bill continues to be tweaked.

VP Harris casts the tie-breaking vote
VP Harris casts the tie-breaking vote on Medicare drug pricing bill • Source: C-SPAN

Manufacturers who choose not to comply with the Medicare price negotiation process for one of their drugs either face an up to 95% excise tax on the drug’s revenues or the prospect that none of their drugs will be covered by Medicare or Medicaid, under landmark drug pricing legislation approved by the US Senate on 7 August.

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 Pricing Debate

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
• By 

The preliminary budget document supports legislation clawing back funds appropriated for the program.

Medicare Price Negotiation: Trump Order Adds Momentum To ‘Pill Penalty’ Fix

 
• By 

Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By 

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

 
• By 

Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.

More from Market Access

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

African Medicines Agency Set To Launch With New Leader In April

 

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.