Medicaid ‘Price Verification’ Audit Proposal Aims To Promote Cell, Gene Therapy Rebate Concessions

CMS proposed rule impact may be ‘modest’ but is framed as ensuring patient access to cutting edge treatments by helping to control Medicaid spending. Biden administration initiative also aims to address misclassification of brand drugs, duplicative 340B discounts, and PBM spread pricing.

CMS Hopes To Pressure Manufacturers With Threat Of Price Transparency • Source: Shutterstock

Manufacturers of up to 10 high-cost treatments including cell and gene therapies could be required to provide data to Medicaid on pricing, clinical benefit and the cost of production in an annual audit as part of an effort by the federal government to provide states with more tools to negotiate price concessions.

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

Leqembi Launch Set For Germany & Austria, EU-Wide Staggered Release Planned

 

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.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By 

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

More from Pink Sheet

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

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By 

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

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.