AMP Rule Answers Questions On Collecting Pricing Data For “5i” Specialty Drugs Raised By Manufacturers
This article was originally published in The Pink Sheet Daily
Manufacturers had asked CMS to explain the law pertaining to collecting average manufacturer prices for inhalation, infusion, instilled, implanted and injectable drugs “not generally dispensed through a retail community pharmacy” and how to identify such “5i” drugs.
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Manufacturers must continue to use their discretion on which line extensions should be subject to inflation-based Medicaid rebates in lieu of guidance from CMS in its recent AMP final rule.
A major regulation that could reshape how the pharmaceutical industry reports drug pricing to the government and pays rebates on Medicaid drugs is slated to be released in final form in 2014. Some Medicaid regulatory experts suggest that CMS could make changes in the final rule that will make it less disruptive to manufacturers’ businesses than they have feared.
AMP Rule Tells Manufacturers To “Make Reasonable Assumptions” In Determining Fair Market Value For Service Fees
CMS’ proposed rule on average manufacturer prices for Medicaid relies on examples given in the Affordable Care Act for its list of “bona fide service fees” that manufacturers should exclude from the AMP calculation, but does not further expand on them. The proposed rule also avoids defining “fair market value” for such fees.