News & Analysis as of

Advisory Opinions Pharmaceutical Industry Section 340B

Foley Hoag LLP - Medicaid and the Law

District Courts Issue Key Decisions in 340B Contract Pharmacy Cases

Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA, the agency responsible for...more

Foley Hoag LLP - Medicaid and the Law

Summer Reruns: ‘340B Contract Pharmacy Saga’ Back in the Spotlight as OGC Withdraws Advisory Opinion

Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies.  Given the link between the Medicaid drug rebate...more

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

Foley & Lardner LLP on

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

Cozen O'Connor

AstraZeneca Sues HHS over Drug Pricing Program Advisory Opinion Regarding Contract Pharmacies

Cozen O'Connor on

On January 12, 2021, AstraZeneca Pharmaceuticals LP filed a complaint in Delaware federal court against the Department of Health and Human Services (HHS) for issuing an invalid Advisory Opinion. The 340B Drug Pricing Program,...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Verrill

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

Verrill on

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

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