Insights

The Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (the “Tri-Agencies”) have signaled that changes may be coming to the Mental Health Parity and Addiction Equity Act (“MHPAEA”) Final Rule issued on September 8, 2024. On May 9, 2025, the Tri-Agencies filed a Motion for Abeyance in a lawsuit brought by the ERISA Industry Committee (“ERIC”) challenging the 2024 final MHPAEA regulations in the United States District Court for the District of Columbia.[1] The Motion, which was granted by the Court, indicated that the Tri-Agencies intend to “reconsider” the Final Rule, including “whether to issue a notice of proposed rulemaking rescinding or modifying the Final Rule.” Yesterday, on May 15, 2025, the Tri-Agencies issued a notice of non-enforcement stating that they “will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months.”

On January 17, 2025, the Departments of Labor, Health and Human Services, and Treasury (the “Tri-Agencies”) released the 2024 Mental Health Parity and Addiction Equity Act (“MHPAEA”) Report to Congress (the “Report”). The Report is the third report made by the Tri-Agencies to Congress in accordance with the mandate set forth in the 2021 Consolidated Appropriations Act (“CAA”). The CAA requires that, each year starting in 2021, the Tri-Agencies submit a report to Congress summarizing their activity in the prior year to collect comparative analyses from plans and issuers and any findings made with respect to noncompliance with MHPAEA.[1] Under the CAA, the Report is due by October 1 of each year. This year’s version was published on the last working day of the Biden Administration.

On Monday, September 8, 2024, the United States Department of the Treasury, Department of Labor, and Department of Health and Human Services (collectively, the “Tri-Agencies”) issued a final rule (“the Final Rule”) implementing new regulations applicable to nonquantitative treatment limitations (“NQTLs”) under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (“MHPAEA”). The Final Rule codifies many of the requirements set forth in the (the “Proposed Rule”), while pulling back on some of the Tri-Agencies’ more controversial proposals. 

On January 25, 2022, the Departments of Labor, Health and Human Services (“HHS”), and the Treasury (the “Tri-agencies”) released their 2022 annual report to Congress on the Mental Health Parity and Addiction Equity Act (“MHPAEA”).

Congress added additional compliance and oversight requirements focused on nonquantitative treatment limitations (“NQTLs”) in Division BB, Title II, Section 203 of the Consolidated Appropriations Act, 2021. The law formalizes the four-step NQTL compliance analysis outlined in sub-regulatory guidance, obligates health plans and health insurance issuers (“plans/issuers”) to make the compliance analysis available to state regulators, DOL, or HHS upon request, and charges DOL and HHS with conducting at least 20 reviews of such analysis each year. And the law directs the federal government to finalize interim guidance and regulations and update compliance guidance with de-identified, real-world examples of compliant and non-compliant NQTLs with sufficient detail to show whether the processes, factors, or other criteria hit or missed the mark.

The Antitrust Division recently settled civil antitrust claims against Henry Ford Allegiance Health (Allegiance) for agreeing with a competitor to allocate marketing territories. In a complaint filed in June 2015 in the Eastern District of Michigan (Case No. 5:15-cv-12311), the DOJ and the Michigan Attorney General (the Government Plaintiffs) alleged that four hospital systems agreed not to market their services in each other’s territory. The complaint came after Allegiance’s merger talks with two other health systems (including one of the other defendants in the suit) ended and about five months before Allegiance agreed to be acquired by Henry Ford. This case highlights several important considerations for in-house hospital counsel and their outside legal advisors as hospitals are drawing a lot of scrutiny from federal antitrust enforcers.

False Claims Act liability based on a violation of the Anti-Kickback Statute requires evidence linking the alleged kickback to a specific claim for payment, according to the Third Circuit. The Third Circuit’s January 19, 2018 opinion in U.S. ex rel. Greenfield v. Medco Health Solutions, Inc. et al., No. 17-1152 comes amidst a broad DOJ investigation of pharmaceutical manufacturers’ charitable donations to organizations operating patient assistance programs and sheds light on the evidence necessary to prove that a charitable donation that allegedly violates the Anti-Kickback Statute also gives rise to FCA liability.

On November 28, 2017, CMS issued a notice of a proposed rulemaking for contract year 2019 policy and technical changes for the Medicare Advantage and Medicare Prescription Drug Programs. The major provisions of the Proposed Rule address implementation of the Comprehensive Addiction and Recovery Act of 2016 to combat the opioid epidemic, updating Part D E-prescribing standards, revisions to disclosure requirements, and the development of a preclusion list for providers. Additionally, the Proposed Rule modifies the medical loss ratio (MLR) requirement to allow Medicare Advantage organizations (MAOs) and Part D Plan (PDP) sponsors to include the full value of fraud reduction expenses, fraud prevention activities and medication therapy management programs as quality improvement activities in the numerator of the MLR. The Proposed Rule also simplifies the MLR reporting obligation for MAOs and PDP sponsors. CMS characterizes many of the proposed changes as implementation of President Trump’s Inauguration Day Executive Order directing agencies to alleviate regulatory burdens and costs imposed by the Affordable Care Act. Comments on the Proposed Rule, summarized below, are due January 16, 2018.

This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring. If you have questions or need assistance on managed care law matters, please contact Chris Flynn, Peter Roan, or any member of the Health Care Group.

This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring. If you have questions or need assistance on managed care law matters, please contact Chris Flynn, Peter Roan, or any member of the Health Care Group.

This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring. If you have questions or need assistance on managed care law matters, please contact Chris Flynn, Peter Roan, or any member of the Health Care Group.