AstraZeneca, Teva, Biogen Stung By 'Bona Fide' Service Fees; Settle Medicaid Rebate Suit
This article was originally published in The Pink Sheet Daily
Feds and the states aren’t getting large settlements (just over $55 mil. total) but the whistleblower case underscores how murky the definition of AMP remains; litigation against Genzyme is ongoing.
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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when reporting average manufacturer price to CMS – one of the topics that is supposed to be addressed in the yet-unpublished final AMP rule.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.
A major regulation that could reshape how the pharmaceutical industry reports drug pricing to the government and pays rebates on Medicaid drugs is slated to be released in final form in 2014. Some Medicaid regulatory experts suggest that CMS could make changes in the final rule that will make it less disruptive to manufacturers’ businesses than they have feared.
“Bona Fide Service Fees” Lawsuit Underscores Need For Care In Distributor Contracts, Medicaid AMP Calculations
Litigation being pursued by former drug wholesale association exec alleges that manufacturers inappropriately classed bona fide service fees as discounts, causing them to report inaccurate average manufacturer prices to CMS.