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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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