News & Analysis as of

Enforcement Appeals Department of Health and Human Services (HHS)

Ropes & Gray LLP

Closeout Requirements During Appeals of Terminations of NIH Research Grants

Ropes & Gray LLP on

On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more

Pullman & Comley - Labor, Employment and...

Federal Court Decision Reshapes ACA Enforcement by HHS and IRS

The recent federal district court decision in Faulk Company, Inc. v. Xavier Becerra, et al., No. 24-cv-00609-P (N.D. Tex. 2025) significantly alters the primary mechanism used by the U.S. Department of Health and Human...more

McCarter & English, LLP

Federal Courts Decide on FCA Claims Actions

There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more

Zuckerman Spaeder LLP

Whither Insurance Coverage for Preventive Health Services? District Court Decision Striking Down Affordable Care Act’s Preventive...

Zuckerman Spaeder LLP on

On May 15, 2023, the Fifth Circuit temporarily stayed a district-court ruling that struck down a key part of the Affordable Care Act (ACA). As a result of the stay, the ACA’s health insurance coverage requirements for...more

Foley & Lardner LLP

The Future of the 340B Program: 2023 Key Decisions

Foley & Lardner LLP on

Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more

McDermott Will & Emery

McDermott’s Healthcare Enforcement Quarterly - Q1 2022

McDermott Will & Emery on

The healthcare enforcement landscape is shifting quickly. This issue of McDermott’s Healthcare Enforcement Quarterly examines emerging trends and key issues for organizations that may become subject to enforcement scrutiny,...more

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

Bass, Berry & Sims PLC on

On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more

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