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Healthcare Reform Enforcement Actions Department of Health and Human Services (HHS)

Foley & Lardner LLP

CMS Finalizes Rule Change Applying Preponderance of the Evidence Standard to Agent, Broker, and Web-Broker Exchange Agreement...

Foley & Lardner LLP on

In its recently issued Final Rule (CMS-9884-F; 90 FR 27074-01; the Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized revisions to 45 C.F.R. § 155.220(g)(2) to specify a standard of proof for...more

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Sheppard Mullin Richter & Hampton LLP

DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

McDermott Will & Schulte

Enforcement of Mental Health Parity Regulations Suspended: Takeaways for Plan Sponsors and Health Insurance Issuers

In January 2025, The ERISA Industry Committee (ERIC) filed a complaint against the US Departments of Labor, Health and Human Services, and the Treasury (the departments) seeking to invalidate the 2024 final regulations under...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Warner Norcross + Judd

Executive Order Directs Enhanced Enforcement of Group Health Plan Transparency Rules

Among the many Executive Orders issued by President Donald Trump’s administration, Executive Order 14221 (the “Order”) reinforces and expands healthcare price transparency enforcement. This Order builds on Executive Order...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

McDermott Will & Schulte

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 & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

McDermott Will & Schulte

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

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 & Schulte

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | December 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more

McDermott+

No Surprises Act Implementation Under the Trump Administration

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The No Surprises Act, a law that ended the practice of “balance billing” by certain out-of-network providers, was enacted as part of the Consolidated Appropriations Act of 2021 on December 27, 2020. While the law passed...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | October 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | November 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

Bass, Berry & Sims PLC

HHS Proposes Rule to Establish Disincentives for Healthcare Providers That Engage in Information Blocking

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In 2020, when the U.S. Department of Health and Human Services (HHS) published its Final Rule to implement the information blocking prohibitions of the 21st Century Cures Act, HHS left healthcare providers wondering what...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

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