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Department of Health and Human Services (HHS) OGC

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

King & Spalding

HHS Advisory Opinion Rejects Drug Manufacturers’ Attempts to Limit Contract Pharmacy Use by 340B Covered Entities

King & Spalding on

On December 30, 2020, the HHS Office of General Counsel (OGC) issued Advisory Opinion No. 20-06 finding the 340B Federal Drug Pricing Program requires drug manufacturers to extend 340B pricing to covered outpatient drugs...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

Foley & Lardner LLP

New HHS Board Will Hear 340B Drug Pricing Disputes

Foley & Lardner LLP on

On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing...more

Arnall Golden Gregory LLP

More Uncertainty for Uncertain Times: HHS Proposes Good Guidance Practices Rule

With regulatory overreach in the spotlight since the early days of the Trump Administration, a proposed rule published in the Federal Register on Aug. 20, 2020 (the “Proposed Rule”) seeks to establish “good guidance...more

Husch Blackwell LLP

HHS Clarification On PREP Act Impact On State Licensing Laws: What it Means For Pharmacists’ COVID-19 Testing Capabilities

Husch Blackwell LLP on

On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including...more

Seyfarth Shaw LLP

HHS Advisory Opinion Concludes that the PREP Act Preempts Any State or Local Law that Prohibits Pharmacists from Administering...

Seyfarth Shaw LLP on

On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more

McDermott Will & Emery

New Guidance on Medicare Payment Rule Enforcement

McDermott Will & Emery on

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more

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