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Regulatory Requirements Department of Health and Human Services (HHS)

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

Morgan Lewis - ML Benefits

Executive Order Targets Prescription Drug Pricing: Potential Impact on Group Health Plans

President Donald Trump issued an executive order (EO) on May 12, 2025 to address the high cost of prescription drugs in the United States with the goal of ensuring Americans have access to most-favored-nation (MFN) pricing,...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

Foley & Lardner LLP on

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

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

Epstein Becker & Green

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

Epstein Becker & Green on

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

Seyfarth Shaw LLP

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

Seyfarth Shaw LLP on

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

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

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

Carlton Fields on

President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

Dickinson Wright on

On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Hogan Lovells

HHS & FDA Request Public Comment to Inform Agency’s Infant Formula Nutrient Review

Hogan Lovells on

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more

Morgan Lewis - ML Benefits

US District Court Grants Freeze on Mental Health Parity Enforcement

The US Departments of Health and Human Services, Labor, and the Treasury (together, the Departments) filed a motion to suspend the litigation proceedings in The ERISA Industry Committee vs. HHS et al. on May 9, 2025 while the...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29 | News & Events

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...more

Jackson Lewis P.C.

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

Jackson Lewis P.C. on

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+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more

King & Spalding

Executive Order to Deliver Lower Prescription Drug Prices

King & Spalding on

On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more

Latham & Watkins LLP

Week 15 in Review: Immigration, Tariffs, and Civil Rights

Latham & Watkins LLP on

The Trump administration continued its focus on immigration and indicated progress in trade talks as this week marked the end of its first 100 days....more

Epstein Becker & Green

Similar Language But a Different Outcome: Medicare DSH Payments after Advocate Christ Medical Center v. Kennedy

Hospitals that serve a high number of indigent patients are faced with a dilemma: they must provide high-quality care but fixed Medicare reimbursement rates often do not take into account the higher operating costs that they...more

Rivkin Radler LLP

OIG Audit of MACs Finds Deficiencies

Rivkin Radler LLP on

The 12 regional Medicare Administrative Contractors (MACs) were recently audited by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). Each of the MAC jurisdictions was found by the OIG to...more

McDermott+

The First 100 Days: By the Numbers

McDermott+ on

To state the obvious, a lot has happened in healthcare over the first 100 days of President Trump’s second term. But how much? ...more

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