CMS Expands Meaning Of “Retail Community Pharmacy” In AMP Rule
This article was originally published in The Pink Sheet Daily
CMS’ proposed rule on the average manufacturer price for drugs includes specialty and home infusion pharmacies in the law’s definition of “retail community pharmacy” for the purpose of calculating AMP, citing drugs subject to Risk Evaluation and Mitigation Strategies from FDA as the reason.
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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.
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.