News & Analysis as of

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

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

Mintz - Health Care Viewpoints

Federal Healthcare Agencies Aim to Prioritize Information Blocking Enforcement in 2022

The United States Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) leadership announced during last week’s HIMSS 2022 Conference that the agencies will be focusing on...more

King & Spalding

HHS Proposes Repeal of Two Trump Administration Rules on Guidance, Enforcement, and Adjudication Procedures

King & Spalding on

On October 20, 2021, HHS published in the Federal Register a proposal to repeal two final rules issued during the Trump administration. The final rules up for repeal are the “Department of Health and Human Services Good...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

Sheppard Mullin Richter & Hampton LLP

Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of...

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially...more

Morgan Lewis

HHS Last-Minute Final Rule Restricts Use of Guidance Standards in Civil Enforcement Actions

Morgan Lewis on

The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Akin Gump Strauss Hauer & Feld LLP

Interoperability and Information Blocking: What Providers, Payers and IT Developers Need to Know about New Enforcement Timelines

- On May 1, 2020, the ONC Interoperability, Information Blocking, and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule were published in the Federal Register, marking the...more

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