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Advisory Opinions Department of Health and Human Services (HHS) Drug Pricing

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January - April 2022 Recap

McDermott Will & Emery on

This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

Goodwin

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

Goodwin on

In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...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

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

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

Holland & Knight LLP

OIG Rescinds Advisory Opinion

Holland & Knight LLP on

The Department of Health and Human Services Office of Inspector General (the OIG), on November 28, 2017, issued a Rescission Letter terminating Advisory Opinion Number 06-04 (Advisory Opinion 06-04). In Advisory Opinion...more

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