AMP Rule Tells Manufacturers To “Make Reasonable Assumptions” In Determining Fair Market Value For Service Fees
This article was originally published in The Pink Sheet Daily
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.
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Lilly revealed that the US Department of Justice is investigating how it treats distribution service agreements with wholesalers when reporting average manufacturer price to CMS – one of the topics that is supposed to be addressed in the yet-unpublished final AMP rule. The government is also looking into contracting and pricing of Merck's Dulera.
“Bona Fide Service Fees” Lawsuit Underscores Need For Care In Distributor Contracts, Medicaid AMP Calculations
Litigation being pursued by former drug wholesale association exec alleges that manufacturers inappropriately classed bona fide service fees as discounts, causing them to report inaccurate average manufacturer prices to CMS.
AMP Rule Answers Questions On Collecting Pricing Data For “5i” Specialty Drugs Raised By Manufacturers
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.