News & Analysis as of

Department of Health and Human Services (HHS) HRSA Enforcement Actions

McDermott Will & Emery

HHS Signals Action on Gender-Affirming Care

On March 5, 2025, the Center for Clinical Standards and Quality (CCSQ) within the Centers for Medicare & Medicaid Services (CMS) released a Quality & Safety Special Alert Memo for hospitals related to President Trump’s...more

McDermott Will & Emery

This Week in 340B: February 18 – 24, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

This Week in 340B: February 4 – 10, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Mintz - Health Care Viewpoints

EnforceMintz — Long Tail of Pandemic Fraud Schemes Will Likely Result in Continued Enforcement for Years to Come

In last year’s edition of EnforceMintz, we predicted that 2024 would bring an increase in False Claims Act (FCA) enforcement activity related to COVID-19 pandemic fraud. Those predictions proved correct. The COVID-19 Fraud...more

McDermott Will & Emery

This Week in 340B: December 17, 2024 – January 6, 2025

Find updates on 340B litigation from December 17, 2024 – January 6, 2025 to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to...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

Sheppard Mullin Richter & Hampton LLP

Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the...

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...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

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

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