News & Analysis as of

Regulatory Requirements 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

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...more

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

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A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Snell & Wilmer

Limited Mental Health Parity Relief for Plan Sponsors

Snell & Wilmer on

On January 17, 2025, the ERISA Industry Committee (“ERIC”) filed suit in the U.S. Court of Appeals for the D.C. Circuit asking the court to hold various key provisions under the 2024 Mental Health Parity Addiction Equity Act...more

Holland & Hart - The Benefits Dial

No Shoes, No Shirt, No Problems… But Nonenforcement Policy Doesn’t Make Mental Health Parity Compliance Optional

The Departments of Labor, Treasury, and Health and Human Services (the “Departments”) recently announced a nonenforcement policy with respect to the 2024 Mental Health Parity and Addiction Equity Act (“MHPAEA”) regulations or...more

Groom Law Group, Chartered

Departments Pause Enforcement of MHPAEA Final Rule and Reconsider MHPAEA Enforcement Program

In a widely anticipated and welcome move, the Departments of Health and Human Services (“HHS”), the Treasury, and Labor (“DOL”) (collectively, the “Departments”), sought an abeyance of a lawsuit challenging the Mental Health...more

Bond Schoeneck & King PLLC

Administration Grants Welcome Reprieve From Certain NQTL Requirements

Administration Grants Welcome Reprieve From Certain NQTL Requirements - Earlier this month, the Departments of Labor, Health and Human Services and Treasury (the “Departments”) announced that for the foreseeable future...more

Warner Norcross + Judd

Delayed Enforcement of Mental Health Parity NQTL Comparative Analysis Final Regulations

Warner Norcross + Judd on

Under the Mental Health Parity and Addiction Equity Act (MHPAEA), as amended by the Consolidated Appropriations Act (CAA), 2021, group health plans and health insurance issuers must conduct comparative analyses to show that...more

Foley & Lardner LLP

Mental Health Parity Alert - Non-Enforcement of Final Rules

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The Mental Health Parity and Addiction Equity Act (MHPAEA), and its implementing regulations and guidance, prohibits health insurance policies and group health plans that cover mental health and substance use disorder...more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

Quarles & Brady LLP on

The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more

Jackson Lewis P.C.

UPDATE – Departments issue nonenforcement policy statement!

Jackson Lewis P.C. on

On May 15, 2025, the Departments of Labor, Treasury, and Health and Human Services issued their anticipated nonenforcement policy regarding the 2024 Mental Health Parity regulations. As expected, nonenforcement is applicable...more

Morgan Lewis - ML Benefits

Mental Health Parity Non-Enforcement Statement Released

The US Departments of Labor, Health and Human Services, and the Treasury (the Departments) announced their non-enforcement policy on May 15, 2025, indicating they will not enforce any new requirements imposed by the...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29

Clark Hill PLC on

Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Virginia Governor Signs Bill Restricting Minor’s Use of Social Media:...more

Jackson Lewis P.C.

A Bit of Mental Health Parity Relief for Employers Sponsoring Group Health Plans

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The Department of Labor (DOL), together with the Departments of Treasury and Health and Human Services) have decided to suspend enforcement of certain provisions of the nonquantitative treatment limitations (NQTL) final...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Emery on

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

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

Morgan Lewis on

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Health Care Compliance Association (HCCA)

OCR Loses Staff, Faces Move to New ‘Enforcement’ Office; Will HIPAA Focus, Independence Suffer?

Today, the HHS Office for Civil Rights (OCR) stands shoulder-to-shoulder with the likes of the Office of Inspector General and Office of General Counsel, one of just a dozen or so agencies reporting directly to the secretary....more

Clark Hill PLC

Right To Know - April 2025, Vol. 28

Clark Hill PLC on

Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. ...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

Husch Blackwell LLP

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement

Husch Blackwell LLP on

On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of...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

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

Arnall Golden Gregory LLP

HHS to Close 6 of 10 Regional OGC Offices, With Potentially Significant Impacts on Providers and Suppliers

On Tuesday, March 11, 2025, the U.S. Department of Health and Human Services (“HHS”) announced plans to close six of the nation’s 10 regional offices for the HHS Office of the General Counsel (“OGC”). These closures, which...more

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