CMS’ Long-Awaited AMP Rule Seeks To Clarify Uncertainties In Affordable Care Act’s Definition
This article was originally published in The Pink Sheet Daily
A proposed rule on the calculation of average manufacturer price issued Jan. 27 addresses numerous complex issues for the pharmaceutical industry in its 200 pages, including a proposal that manufacturers report AMP based on their actual sales to retail community pharmacies or to wholesalers for drugs distributed to retail community pharmacies.
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BIO and PhRMA urge CMS to delay making reimbursement rate substitutions for Medicare Part B drugs based on comparing ASP to AMP until the agency finalizes its rules on the methodology for calculating AMP. The final AMP rule is expected in 2013.
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.
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.