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Lilly, Novartis, other pharmas could face fines for violating 340B law

Lilly, Novartis, other pharmas could face fines for violating 340B law
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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

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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HRSA Releases Final Rule Establishing Dispute Resolution Process For The 340B Program - Food, Drugs, Healthcare, Life Sciences

To print this article, all you need is to be registered or login on Mondaq.com. On December 10, 2020, the U.S. Department of Health and Human Services ( HHS ), Health Resources and Services Administration ( HRSA ) issued a long-anticipated regulation of interest to drug makers and providers: the 340B Drug Pricing Program Alternative Dispute Resolution Final Rule ( ADR Final Rule ). 1 The ADR Final Rule establishes an alternative dispute resolution ( ADR ) process that offers manufacturers and 340B covered entities a means of negotiating certain disputes in a more formal setting without resorting to litigation or private arbitration. In the ADR Final Rule, HRSA notes that its intention

340B Program: HRSA Issues Administrative Dispute Resolution Final Rule | Hogan Lovells

To embed, copy and paste the code into your website or blog: 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

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