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Lilly, Novartis, other pharmas could face fines for violating 340B law
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Takeaways for Entities from the 340B in 2021 Webinar
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Eli Lilly Prevails In Blocking Immediate Implementation Of HHS s 340B Drug Discount Rule Involving Dispute Resolution Between Manufacturers And Covered Entities - Food, Drugs, Healthcare, Life Sciences
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On December 14, 2020, the U.S. Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register defining an administrative dispute resolution (ADR) process for the 340B Drug Pricing Program (340B Program). The Final Rule takes effect 30 days after that date of publication, on January 13, 2021. The Final Rule establishes an ADR process for two types of disputes:
“Claims by covered entities that may have been overcharged for covered outpatient drugs purchased from manufacturers”; and
“Claims by manufacturers of 340B drugs, after a manufacturer has conducted an audit of a covered entity . . . . that a covered entity may have violated the prohibitions against duplicate discounts [i.e., that a Medicaid rebate was invoiced for a drug purchased at the 340B ceiling price] or diversion [i.e., that the covered entity transferred 340B drugs to a person that is not a 340B ‘patie