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HRSA Releases Final Rule Establishing Dispute Resolution Process for the 340B Program | McDermott Will & Emery

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On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes between drug manufacturers and 340B covered entities.
The establishment of a 340B ADR process was mandated by the Affordable Care Act (ACA) more than 10 years ago. Nevertheless, the timing of the release has raised concerns regarding the effectiveness of the Final Rule in light of recent efforts by drug manufacturers to limit access to 340B drugs for dispensing under contracted pharmacy arrangements. Questions also remain as to when ADR panels will be established and begin hearing claims. ....

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New HHS Board Will Hear 340B Drug Pricing Disputes | Foley & Lardner LLP

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On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing Program (340B Program). The ADR process will allow covered entities and drug manufacturers to formally request agency review of alleged 340B violations.
The ADR process will begin amid contentious disputes about the scope and future of the 340B Program. In recent months, multiple drug manufacturers have taken unilateral action to curtail the availability of 340B pricing dispensed through a covered entity’s contracted pharmacies. HRSA, the agency responsible for overseeing the 340B Program, has not yet issued a final opinion on those actions. Members of Congress have urged HRSA to take enforcement action against the manufacturers for violations of the Public Health Services Act. Covered entitie ....

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HRSA Dispute Resolution Process for the 340B Program

Tuesday, December 15, 2020
On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes between drug manufacturers and 340B covered entities.
The establishment of a 340B ADR process was mandated by the Affordable Care Act (ACA) more than 10 years ago. Nevertheless, the timing of the release has raised concerns regarding the effectiveness of the Final Rule in light of recent efforts by drug manufacturers to limit access to 340B drugs for dispensing under contracted pharmacy arrangements. Questions also remain as to when ADR panels will be established and begin hearing claims. ....

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New HHS Board Will Hear 340B Drug Pricing Disputes

New HHS Board Will Hear 340B Drug Pricing Disputes
Tuesday, December 15, 2020
On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing Program (340B Program). The ADR process will allow covered entities and drug manufacturers to formally request agency review of alleged 340B violations.
The ADR process will begin amid contentious disputes about the scope and future of the 340B Program. In recent months, multiple drug manufacturers have taken unilateral action to curtail the availability of 340B pricing dispensed through a covered entity’s contracted pharmacies. HRSA, the agency responsible for overseeing the 340B Program, has not yet issued a final opinion on those actions. Members of Congress have urged HRSA to take enforcement action against the manufacturers for violations of the Publ ....

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HRSA's 340B Program Administrative Dispute Resolution Procedures

Tuesday, December 15, 2020
The U.S. Health Resources and Services Administration (HRSA) recently released a draft final rule (Final Rule) that establishes a binding administrative dispute resolution (ADR) process concerning drug costs under the Federal 340B Drug Discount Program (340B Program). As per its terms, the Final Rule will be formally published on Dec. 13, 2020 and will take effect on Jan. 13, 2021.
The Final Rule comes after a nearly 10-year wait for HRSA to establish an ADR process as required under 42 U.S.C. § 256b (the 340B Program Statute). However, HRSA’s Final Rule appears mostly motivated by two recent lawsuits filed by groups representing 340B Program-eligible health centers and HIV/AIDS clinics that participate in the 340B Program. In brief, these lawsuits asserted recent actions taken by drug manufacturers to restrict access to 340B Program discounted medications violated the 340B Program Statute and HRSA violated administrative procedure o ....

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