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PHSA Section 340B

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

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The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

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Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Polsinelli

Special Update: OPA Sends 340B Program Omnibus Guidelines to Office of Management and Budget

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On Wednesday, May 6, the Health Resources and Services Administration, Office of Pharmacy Affairs (“OPA”) forwarded a draft copy of its 340B Program Omnibus Guidelines (“Guidelines”) to the Office of Management and Budget for...more

BakerHostetler

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

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On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

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