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CMS Expands Meaning Of “Retail Community Pharmacy” In AMP Rule

 
• By Scott Steinke

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.

FDA’s Risk Evaluation and Mitigation Strategy program is having an unexpected influence on how CMS plans to define “retail community pharmacy” for the purpose of calculating average manufacturer prices for drugs. Because some REMS drugs may be limited to distribution through specialty and home infusion pharmacies, CMS is proposing to add them to the list of entities mentioned in the Affordable Care Act as a retail community pharmacy.

In CMS’ proposed rule on covered outpatient drugs in Medicaid issued Jan. 27, the agency implements a number of provisions pertaining to AMP and drug rebates from ACA, and in...

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More from United States

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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

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More from North America

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

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• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.