News & Analysis as of

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

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

Quarles & Brady LLP on

On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

Bricker Graydon LLP

Compliance Still Required During Non-Enforcement of 2024 Mental Health Parity Rule

Bricker Graydon LLP on

Last week, the Departments of Labor, Treasury, and Health and Human Services (the “Departments”)  issued a nonenforcement policy regarding the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA)  final regulations,...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

Polsinelli

Pressing Pause: Federal Agencies Halt Enforcement of Mental Health Parity Rule

Polsinelli on

On May 15, 2025, the Departments of Labor, Health and Human Services and the Treasury (the Departments) announced a non-enforcement policy regarding the final rule issued in September 2024 under the Mental Health Parity and...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

Vedder Price on

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

Epstein Becker & Green

Federal Regulators Announce Non-Enforcement of the 2024 Rule for Mental Health Parity

Epstein Becker & Green on

On May 9, 2025, the Departments of Labor, Health and Human Services, and Treasury (collectively, “the Departments”) asked the D.C. federal court to suspend litigation while they consider whether to rescind or modify the 2024...more

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

ArentFox Schiff

Top 10 Issues in the Cannabis Industry for 2025

ArentFox Schiff on

It is not all doom and gloom for the cannabis industry this year; positive developments across states and the potential (albeit remote) for federal rescheduling means the cannabis industry can expect ongoing advancements....more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

Baker Donelson on

The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

Stevens & Lee

U.S. HHS Announces Closure of Six Regional Locations of the Office of the General Counsel

Stevens & Lee on

On March 11, 2025, the U.S. Department of Health and Human Services (HHS) announced plans for a “reorganization of the Office of the General Counsel” (OGC) “[a]s part of the department’s ongoing efforts to advance the...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

Wiley Rein LLP

Trump Prioritizes Health Care Pricing Transparency in New Executive Order

Wiley Rein LLP on

On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more

Cozen O'Connor

The State AG Report – 02.13.2025

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: ·Republican AGs Have Beef with Nutritional Standards Report...more

Akin Gump Strauss Hauer & Feld LLP

Protecting Children from Chemical and Surgical Mutilation (Trump EO Tracker)

Summary - The Executive Order announces that the United States "will not fund, sponsor, promote, assist, or support the so-called ‘transition’ of a child from one sex to another and will rigorously enforce all laws that...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

Health Care Compliance Association (HCCA)

OCR Ends Year With Settlements That Tread Old Ground, Says New Rules Are Coming—Someday

If the penultimate enforcement settlement of 2023 issued by the HHS Office for Civil Rights (OCR) sounds familiar, that’s with good reason. And the last one of the year should ring some bells, too....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

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

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