News & Analysis as of

Final Rules Enforcement Actions Department of Health and Human Services (HHS)

Hogan Lovells

Compliance considerations following Texas Court decision vacating key provisions of 2024 HIPAA Privacy Rule protecting...

Hogan Lovells on

The U.S. District Court for the Northern District of Texas vacated key portions of the 2024 updates to the HIPAA Privacy Rule that had strengthened protections for reproductive health care information. HIPAA-regulated...more

Saul Ewing LLP

Federal District Court Issues Opinion Vacating HHS Rule Protecting Reproductive Health Information

Saul Ewing LLP on

On June 18, 2025, U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas (the “District Court”) vacated a 2024 final rule issued by the U.S. Department of Health and Human Services (“HHS”) under the Biden...more

Morgan Lewis - ML Benefits

Reproductive Healthcare Privacy Final Rule Vacated by Texas Court

The US District Court for the Northern District of Texas on June 18, 2025 vacated portions of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Rule) related to reproductive healthcare privacy....more

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

Quarles & Brady LLP on

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

Stoel Rives - Health Law Insider®

In Case You Missed It: Federal Agencies Pause Enforcement of the 2024 MHPAEA Final Rule; Prior Regulations and Comparative...

On May 15, the U.S. Departments of Labor, Health and Human Services, and the Treasury (“the Departments”) released a statement announcing a temporary non-enforcement period regarding their final rule issued on September 9,...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

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 & Emery

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

McDermott Will & Emery on

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

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

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

Proskauer - Employee Benefits & Executive...

Departments Press Pause on Final Mental Health Parity Regulations

Yesterday, the Departments of Labor, Treasury, and Health and Human Services announced a non-enforcement policy with respect to final regulations issued under the Mental Health Parity and Addiction Equity Act of 2008...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

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

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 & Emery

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

McDermott Will & Emery on

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

Quarles & Brady LLP

HIPAA Reproductive Health Care Privacy - New Administration Evaluating Its Position

Quarles & Brady LLP on

As the Trump administration stakes dramatically new positions on matters across the federal government, we are waiting to learn its view on the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule,...more

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

Troutman Pepper Locke on

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

Goodwin on

On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

King & Spalding

HHS Finalizes Disincentives for Healthcare Providers That Have Committed Information Blocking

King & Spalding on

Last week, HHS published its final rule outlining disincentives for certain healthcare providers that have committed information blocking (the Final Rule). The Final Rule also provides information related to OIG’s...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | November 2023 Recap

McDermott Will & Emery on

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 & Emery

[Webinar] How Not to Lose $1M: Preparing for HHS-OIG Info Blocking Enforcement - August 15th, 1:00 pm - 2:00 pm EDT

The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more

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