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Third Circuit Denies 340B Program Contract Pharmacy Arrangements

Wednesday, July 7, 2021
Recent court decisions and the subsequent rescission of a key advisory opinion have left the status of contract pharmacy programs in continued flux. On 30 December 2020, the Department of Health and Human Services (HHS) released Advisory Opinion 20-06 (the Advisory Opinion) stating that drug manufacturers are required to deliver drugs to contract pharmacies and charge no more than the 340B ceiling price. On 16 June 2021, the U.S. District Court for the District of Delaware issued a Memorandum Opinion (Decision) in
AstraZeneca Pharmaceuticals LP v. Becerra, a case that challenged the validity of the Advisory Opinion, narrowly holding that Congress has not clearly and unambiguously spoken regarding the unlimited use of contract pharmacies by covered entities under the 340B Program. ....

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340B Update: HRSA Issues Final Warning Letter to Pharmaceutical Manufacturers That Their Contract Pharmacy Actions Violate 340B Statute | K&L Gates LLP

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On 17 May 2021, the Acting Administrator of the Health Resources and Services Administration (HRSA), Diana Espinosa, sent letters to six pharmaceutical manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for covered entities that dispense medications through contract pharmacies have resulted in overcharges and are in direct violation of the 340B statute.
1 The letters order the manufacturers to immediately begin offering 340B pricing to covered entities through their contract pharmacy arrangements or be subject to civil monetary penalties.
2 The letters represent the next key move by HRSA in the now nearly year-long battle over HRSA’s longstanding contract pharmacy guidance, which the manufacturers in question are challenging through refusing to replenish at 340B Program pricing. The letters led to a flurry of additional filings in the on-going litigation between ....

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HRSA Issues Warning Letter to Pharma Companies on 340B Program Pricing

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340B Update: HRSA Issues Final Warning Letter to Pharmaceutical Manufacturers that Their Contract Pharmacy Actions Violate 340B Statute
Wednesday, May 26, 2021
On 17 May 2021, the Acting Administrator of the Health Resources and Services Administration (HRSA), Diana Espinosa, sent letters to six pharmaceutical manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for covered entities that dispense medications through contract pharmacies have resulted in overcharges and are in direct violation of the 340B statute.
1 The letters order the manufacturers to immediately begin offering 340B pricing to covered entities through their contract pharmacy arrangements or be subject to civil monetary penalties. ....

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2020 final price reporting developments: stimulus legislation, 340B contract pharmacy Advisory Opinion | Hogan Lovells

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As we begin the new year, we wanted to highlight two final developments from December 2020:
First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260 (Act), was signed into law. The Act includes several changes relevant to government price reporting. Some of the provisions were first introduced as part of S. 2543, the Prescription Drug Pricing Reduction Act of 2019 (link) (PDPRA) – the bipartisan drug pricing bill that was passed by the Senate Finance Committee in September 2019, but that was never voted upon by the Senate. ....

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