News & Analysis as of

Administrative Procedure Act Pharmaceutical Industry HRSA

McDermott Will & Emery

Loper Bright and the 340B Statute

McDermott Will & Emery on

In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more

Robinson+Cole Health Law Diagnosis

Delaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA

A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...more

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

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Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more

ArentFox Schiff

340B Entities Sue HHS Over Lack of Dispute Resolution Process

ArentFox Schiff on

Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more

Jones Day

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

Jones Day on

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

Arnall Golden Gregory LLP

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

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A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

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