As discussed in the final rule (81 FR 5250), if a specialty pharmacy meets the definition of a retail community pharmacy at section 1927(k)(10) of the Act, sales for such drugs would be included in AMP. This is true even in the event there are a low number of AMP eligible sales. Because CMS is permitting manufacturers to use a presumed inclusion approach when calculating AMP, and to make reasonable assumptions, an AMP will likely be generated for such drugs.
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Date
Sub Topic
FAQ ID
94786
FAQ Page
FAQ Question
How are AMPs determined for drugs not available from retail community pharmacies that are also not considered 5i drugs, such as oral oncology or topical products only available from mail order specialty pharmacies?