DoJ Investigating Lilly's AMP Reporting, Despite Lack Of Final Rule
This article was originally published in The Pink Sheet Daily
Executive Summary
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when reporting average manufacturer price to CMS – one of the topics that is supposed to be addressed in the yet-unpublished final AMP rule.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.
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Calculating AMP: Medicaid Proposed Rule Provides Answers, Some Detailed, Some Vague, To Manufacturers’ Questions
Manufacturers seeking answers on how to comply with the law on calculating average manufacturer price for drugs in Medicaid can turn to CMS’ proposed rule on the topic, published in the Feb. 2 Federal Register. The rule addresses a wide range of issues, including how closely manufacturers must track sales to retail community pharmacies for reporting, how to define a “retail community pharmacy,” how to define “bona fide service fees” and fair market value for them, since they can be excluded from AMP, and how to identify “5i” specialty drugs not generally dispensed at a retail community pharmacy, since they have their own special rules for calculating AMP.
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