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Group Purchasing Organizations Orphan Drugs

Polsinelli

Orphan Drug Ruling Disrupts the 340B Program

Polsinelli on

On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

King & Spalding on

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

Baker Donelson

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

Baker Donelson on

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

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