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Manufacturers See AMP Rule’s “Presumed Inclusion” Proposal As Certainly Challenging

 
• By Scott Steinke

As manufacturers prepare comments on CMS’ proposed Medicaid pricing rule, areas of concern include the prohibition of “presumed inclusion” for drug sales to retail community pharmacies when calculating average manufacturer price, the definition of drug line extensions for rebate purposes, and definition of which drugs are “not generally dispensed through a retail community pharmacy.”

Drug manufacturers could be forced to undertake a major retooling of their Medicaid price reporting procedures under CMS’ proposed stance on how average manufacturer price calculations should account for drugs distributed through wholesalers, two experts who work with pharma stakeholders say. Possible outcomes of all that effort might be little change in reported AMPs and concerns about risk of non-compliance if the new procedures are carried out incorrectly.

At issue is a proposal to prohibit manufacturers from presuming how much of the drugs they sell to wholesalers end...

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More from United States

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• By Derrick Gingery

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• By Sue Sutter

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More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.