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Medicare CED Update Targets Study ‘Efficiency,’ But May Not Ease Data Collection Burden

 
• By Cathy Kelly

It's not clear that the proposed revisions and additions to the Centers for Medicare and Medicaid Services’ existing coverage with evidence development study design requirements would address what some experts view as a program failure – the fact that sponsors of the vast majority of technologies subject to CED have not generated the data CMS is looking for. 

Latest Update To 17-Year Old CED Policy Underway • Source: Shutterstock

The Centers for Medicare and Medicaid Services is considering a substantive update of the study design requirements for sponsors of treatments that are subject to a Medicare national coverage determination that conditions coverage on further evidence development.

A revised set of requirements was developed for CMS by the Agency for Healthcare Research and Quality and will...

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Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
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How Could MFN Pricing Impact Commercial Market?

 
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Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By Cathy Kelly

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

More from Government Payers

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By Cathy Kelly

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

Trump Administration Closer to Unprecedented Drug Price Transparency Requirements

 
• By Tim Casey

New rules requiring more granular drug pricing data to be disclosed in machine-readable files will go into effect in 2026.

Orphan Drug Relief Still In Budget Bill But Uncertainty Remains

 
• By Cathy Kelly

The budget reconciliation bill nears final passage without pharmacy benefit manager reforms or provisions that would facilitate access to cell and gene therapies for children, but its Medicaid cuts pose a significant threat to prescription drug access.