U.S. Department of Health & Human Services

Judge's gavel on table in office

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 enforcement of the September 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule. In the letter, ERIC urged the Departments to exercise their authority under 5 U.S.C. § 705 to postpone the effective date of the Final Rule while litigation challenging its validity is ongoing. This request marks a significant development in the legal landscape surrounding mental health parity laws and could have far-reaching implications for employers, health plans, and other stakeholders in the health insurance industry.

On March 7, 2025, the U.S. Department of Health and Human Services (HHS) announced that its Office for Civil Rights (OCR) had initiated four investigations into unnamed medical schools and hospitals over allegations that the schools and hospitals “discriminate on the basis of race, color, national origin, or sex” by continuing to implement “DEI” programs.

This blog post explains what HHS OCR is investigating, what laws are at issue, and what those operating medical schools and hospitals with DEI programs should consider, given this and other federal attention to DEI.

Judge's gavel on table in office

On January 17, 2025, the ERISA Industry Committee (ERIC) filed a lawsuit in the U.S. District Court for the District of Columbia, claiming that the 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule oversteps legal bounds, breaches the Administrative Procedure Act (APA), improperly delegates the Departments of Labor, Health and Human Services and Treasury’s (Departments) executive power to private entities, and violates the Due Process Clause. ERIC argues that under the Mental Health Parity Act of 1996, the plan was not obligated to assess any disparate impact that a term, applicable to both medical/surgical (M/S) and mental health and substance use disorder (MH/SUD) benefits, might have had on access to MH/SUD benefits. The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) similarly maintained the disparate treatment standard of liability, rather than the disparate impact standard. Moreover, the Departments acknowledged in the 2013 regulations that “disparate results alone” did not constitute a parity violation.

Healthcare-Data-HIPAA

On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), issued proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule (the Proposed Rule) to strengthen the cybersecurity protections that HIPAA-regulated entities are required to maintain for electronic protected health information (ePHI).

Close up of doctor working on computer in doctor's office. Physician doing paperwork and administration.

Keypoint: With the increased frequency and severity of cyberattacks against healthcare systems, state and federal agencies strive to improve cybersecurity controls with varied success.

In November 2023, New York Governor Kathy Hochul announced proposed regulations that would be the first state regulations for hospitals in New York. The governor described the proposed regulation as a “nation-leading blueprint” that would complement the federal Health Insurance Portability and Accountability Act (HIPAA) Security Rule enforced by the U.S. Department of Health and Human Services (HHS).

Doctor writing survey, insurance and claim form for medical paperwork, document and script for patient records, test result and research in a hospital. Physician hands signing and planning healthcare

On September 9, 2024, the U.S. Department of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued a Final Rule clarifying and adding additional requirements on health plans to provide equitable access to health insurance coverage for treatment of mental health and substance use disorders (SUDs), as required by the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and implementing regulations at 45 C.F.R. Part 146 and 147 (the 2024 Final Rule).

MHPAEA is a federal law that prevents group health plans and health insurance issuers (collectively, Health Plans) that provide mental health or substance use disorder benefits from imposing less favorable benefit limitations on those benefits than it does for a medical condition or surgical procedure. This means that Health Plans cannot impose additional financial requirements or apply non-quantitative treatment limitations (NQTLs) to these benefits more stringently than those applied to medical/surgical benefits.

What Are the Changes?

On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) issued a final rule (the “Final Rule”) along with guidance updating the Health Insurance Portability and Accountability Act (“HIPAA”) regulations at 45 C.F.R. Parts 160 and 164 (the “Privacy Rule”). The Final Rule prohibits the use or disclosure of protected health information (“PHI”) for the purpose of (1) conducting criminal, civil, or administrative investigations into, or (2) imposing criminal, civil, or administrative liability on any person for the mere act of seeking, obtaining, providing, or facilitating reproductive health care that is legal when provided. The Final Rule also prohibits the use or disclosure of PHI in order to (3) identify any person for any of those purposes (the “Prohibition”).[1]

On February 8, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) finalized long-awaited modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2, which requires individuals or entities that receive federal funding and provide SUD treatment to implement additional privacy protections and obtain specific consent before using and disclosing SUD treatment records (see 42 C.F.R. § 2.11).

Medication

On October 14, 2022, President Joe Biden signed Executive Order 14036, directing the Department of Health and Human Services (“HHS”) to consider innovative actions to drive down certain single-source prescription drug costs as the Biden-Harris Administration works to implement the Inflation Reduction Act of 2022 (the “Act”).

Laboratory Testing

On August 4, 2020, the Office of Inspector General for the United States Department of Health and Human Services (OIG) released an FAQ regarding whether a clinical laboratory may provide free antibody testing to federal health care program beneficiaries (e.g. Medicare/Medicaid beneficiaries). In its FAQ, the OIG acknowledged that providing such testing would implicate two federal anti-fraud statutes–the federal Anti-Kickback Statute (AKS) and the federal Civil Monetary Penalties Law (CMPL). However, so long as the laboratory implemented certain safeguards, the arrangement would pose a sufficiently low risk that OIG would not pursue an enforcement action.