News & Analysis as of

Department of Health and Human Services (HHS)

Proskauer - Health Care Law Brief

Disproportionate Impact: Supreme Court Narrows Disproportionate Share Hospital Reimbursement to Supplemental Security Income Cash...

The U.S. Supreme Court has issued a significant ruling affecting hospitals that serve low-income Medicare beneficiaries, narrowing the interpretation of the Disproportionate Share Hospital (“DSH”) payment formula. In...more

Foley & Lardner LLP

Unpacking the Federal Anti-Kickback Statute’s Application to Payments to Medicare Advantage Agents and Brokers

Foley & Lardner LLP on

On December 11, 2024, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG), issued a Special Fraud Alert (Alert) focusing on financial arrangements involving Medicare Advantage (MA) Organizations...more

Polsinelli

The Trump Administration Announces Price Targets as It Takes a Second Swing at “Most Favored Nation” Drug Pricing Model

Polsinelli on

At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more

Holland & Knight LLP

Holland & Knight Health Dose: May 20, 2025

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The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21, 2025, at which time additional...more

McDermott Will & Emery

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

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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

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

Woodruff Sawyer

​​​​​​Agencies Push Pause Button on Enforcement of MHPAEA 2024 Final Rule

Woodruff Sawyer on

On May 15, 2025, the Department of Labor, Department of Health and Human Services, and the Treasury Department (collectively, the “Agencies”) released a statement regarding the Agencies’ recent request for abeyance of a...more

Polsinelli

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

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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

Ogletree, Deakins, Nash, Smoak & Stewart,...

2025 Enforcement Trends: Risk Analysis Failures at the Center of HHS’s Multimillion-Dollar HIPAA Penalties

In the first five months of 2025, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced it had entered into ten Health Insurance Portability and Accountability Act (HIPAA) resolution...more

Ropes & Gray LLP

Tri-Agencies Stay Enforcement of the 2024 MHPAEA Final Rules

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On May 15, 2025, the Departments of Labor, Health and Human Services (“HHS”) and the Treasury (“the Departments”) issued a nonenforcement policy of the final rules under the Mental Health Parity and Addiction Equity Act of...more

Hogan Lovells

FDA Announces Plans for Post-Market Chemical Review Program

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The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more

Morgan Lewis - As Prescribed

Bipartisan Drug Pricing Reform: The FPDP Act and Revival of Most-Favored-Nation Pricing

As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription...more

Bradley Arant Boult Cummings LLP

What Means Means for Mushrooms and Marijuana: How Might Trump’s Surgeon General Nominee Shift the Conversation for Cannabis and...

Earlier this month, President Trump tapped “physician-turned wellness influencer” Casey Means as his nominee for surgeon general. Means has close ties to Health and Human Services Secretary Robert F. Kennedy Jr., and Trump...more

Amundsen Davis LLC

Court Ruling Hamstrings IRS Enforcement of ACA Employer Mandate

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On April 10, 2025, a federal court in Texas issued an opinion in the case of Faulk Co. v. Becerra that significantly impacts how the Affordable Care Act’s (ACA) employer mandate can be enforced. The ruling effectively...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - May 2025 #2

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

McDermott+

Healthcare Preview for the Week of: May 19, 2025

McDermott+ on

MAHA and More Medicaid - Late Sunday night, May 18, 2025, the House Budget Committee voted to advance the reconciliation package drafted by the Energy and Commerce Committee and Ways and Means Committee last week. The four...more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

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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

McGuireWoods Consulting

Summary of the House Energy and Commerce Committee’s Reconciliation Provisions on Energy, Environment, Communications and Health

On Tuesday, May 13, 2025, the House Energy and Commerce Committee started their 26-hour consideration of their portion of the budget reconciliation bill. The House Energy and Commerce Committee budget reconciliation...more

Chambliss, Bahner & Stophel, P.C.

What Impact Could the HHS Downsizing Have on Older Adults?

The U.S. Department of Health and Human Services (HHS) has been undergoing organizational changes and layoffs in recent weeks. These changes include the dismantling of such agencies as the Administration for Community...more

Epstein Becker & Green

The Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms

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When the current federal administration took office, it issued a memorandum requiring, among other things, that federal agencies delay the issuance of new or proposed rules to the Office of the Federal Register until further...more

Alston & Bird

Health Care Week in Review | President Trump Announces Actions to Lower Prescription Drug Costs; House Committees Mark Up Their...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #2

News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more

Seyfarth Shaw LLP

Parity in Peril? Plan Sponsors Breathe Easier As Trump Administration Hits Pause on Enforcement of Mental Health Parity Final Rule

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On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Regulators Pause Mental Health Parity Rules Enforcement

Federal regulators recently indicated they will not enforce parts of the final regulations issued in September 2024 under the Mental Health Parity and Addiction Equity Act (MHPAEA) and may soon propose new rules altogether....more

Venable LLP

Operation Stork Speed Update: FDA Issues RFI for Infant Formula Nutrition Review

Venable LLP on

On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last...more

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