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ARTICLE · 17 AUGUST 2016

HHS Proposes Administrative Dispute Resolution Process For 340B-Related Claims

McDermott Will & Emery
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On August 12, 2016, the US Department of Health and Human Services Health Resources and Services Administration issued a notice of proposed rulemaking related to the 340B Drug Pricing Program.

United StatesLitigation, Mediation & Arbitration
Emily Cook
Emily Cook
David Ivill
David Ivill
Eric Zimmerman
Eric Zimmerman
Joseph M. Parise
Joseph M. Parise
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Summary

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for claims brought by both covered entities and drug manufacturers related to the purchase and sale of covered outpatient drugs pursuant to the 340B Drug Pricing Program. HHS will accept public comments on the proposed rule until October 11, 2016.

In Depth

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Proposed Rule) related to the 340B Drug Pricing Program. Specifically, the Proposed Rule establishes an administrative dispute resolution (ADR) process for claims brought by hospitals and other entities participating in the 340B Program (Covered Entities), as well as by drug manufacturers, arising from the purchase and sale

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