On March 29, 2025, Dr. Peter Marks submitted a letter to the U.S. Food and Drug Administration (FDA) Commissioner, Sara Brenner, stating that he would resign by April 5, 2025, as the Director of the Center for Biologics Evaluation and Research. Dr. Marks was responsible for the rapid FDA approval of the COVID-19 vaccines, among other career accomplishments. In his letter, Dr. Marks stated that the Dept. of Health and Human Services Secretary, Robert F. Kennedy Jr., is not allowing sufficient transparency regarding vaccines, and is spreading misinformation.

On March 27, 2025, the Department of Health and Human Services (HHS) announced that they are undergoing a restructuring that is projected to save U.S. taxpayers an estimated $1.8 billion per year. The restructuring is due to the Trump administration’s efforts to drive efficiency within the government by cutting out unnecessary spending. HHS will reduce their workforce by a projected 20,000 employees through termination, early retirement and other measures. The HHS announcement states that the cuts will allow HHS to focus more on the administration’s goal to enhance the nation’s health through focusing on food, water and environmental toxins.

On March 24, 2025, a federal district court judge in Minnesota granted a motion to dismiss without prejudice in favor of the employer/plan sponsor, Wells Fargo, in the case of Navarro v. Wells Fargo, an ERISA fiduciary liability lawsuit. As background, on July 30, 2024, plan participants in the Wells Fargo health plan filed a lawsuit alleging, in a strikingly similar manner to the lawsuit in Lewandowski v. Johnson & Johnson (see our E-Alert here), that the mismanagement of the employer sponsored health plan led to increased costs for participants and diminished wages. Navarro v. Wells Fargo was dismissed due to the plaintiffs lacking Article III standing. That means the plaintiffs failed to adequately state that their injury (i.e., their financial harm) was due to mismanagement of the plan, and that their injury could be redressed by court action. This decision closely parallels the dismissal decision in Johnson & Johnson, which was also dismissed for lack of Article III standing.

On March 13, 2025, a class action lawsuit was filed against the JPMorganChase & Co. (“JPMorgan”) plan fiduciaries by plan participants. This lawsuit comes in the wake of and mirrors Lewandowski v. Johnson & Johnson (see our E-Alert on the subject, here) which alleged that the plan fiduciaries systematically mismanaged the plan to the detriment of its participants. Specifically, the lawsuit alleges that the plan fiduciaries did not do enough in negotiating with their pharmacy benefit manager (PBM) to drive down costs, and that the costs for prescription drugs were, on average, over 211% above what it cost to buy the drugs without insurance. Further, the plaintiffs allege that the CEO, Jamie Dimon, as well as other executives from the company, allowed this mismanagement due to JPMorgan’s holdings within those healthcare companies. The lawsuit further alleges that the mismanagement of the plan has resulted in increased premiums, higher payments for prescription drugs, higher out-of-pocket costs, higher deductibles, higher coinsurance, higher copays and suppressed wages for the plan participants.

On March 10, 2025, the plaintiffs in the ERISA class action lawsuit against Johnson & Johnson filed an amended complaint. As background (explained in our E-Alert, here) on March 12, 2024, this class action suit was filed by participants of the Johnson & Johnson health plan against the plan and the plan fiduciaries alleging that mismanagement of the plan had caused an increase in costs for the participants. On January 25, 2025, the judge dismissed the complaint without prejudice (leaving the ability to bring the suit again) for a lack of Article III standing on the part of the plaintiffs. That is, the alleged injury caused by the plan was not tangible enough to qualify the plaintiff as having Article III standing. The plaintiffs have filed an amended complaint seeking to remedy the standing issues in the first complaint by drawing a clearer connection between the actions of the plan fiduciaries and the increase in costs being passed onto the plan.

On March 10, 2025, the Department of Health and Human Services (HHS) issued a proposed rule (accompanied by a Fact Sheet) that would prohibit health plans subject to the Patient Protection and Affordable Care Act’s (ACA) Essential Health Benefit (EHB) requirements from covering “sex-trait modification services,” or gender affirming care, as an EHB. As background, the ACA requires that certain benefits that fall within the category of EHBs be covered on plans available on ACA Exchanges, and that there cannot be annual dollar limits on the coverage of these benefits for all health plans subject to the ACA EHB requirements. If finalized as proposed, this proposed rule would go into effect for plan years beginning in 2026.

On March 4, 2025, a federal district court in Maryland issued a nationwide preliminary injunction in PFLAG, Inc. v. Donald J. Trump (“PFLAG”) blocking two Executive Orders (here and here) that stopped federal funding for medical providers providing gender affirming care for minors. In its opinion supporting the injunction, the court stated that the plaintiffs were likely to succeed with their arguments that the Executive Orders violated the separation powers and the Equal Protection Clause of the U.S. Constitution. As background, the PFLAG case was started by a group of families with transgender or nonbinary children who filed a lawsuit claiming that the pausing of federal funds to these medical facilities had already caused injury to their children through their compromised medical care. This injunction will be in place for the remainder of the litigation.

On February 25, 2025, the Trump Administration issued an Executive Order to enhance healthcare transparency by hospitals and insurers with the aims of increasing patient choice and driving down costs. This Executive Order continues the push for transparency that President Trump spearheaded in his first term with the passage of various transparency laws and regulations, including the Consolidated Appropriates Act of 2021. Additionally, this order builds upon Executive Order 13877 from President Trump’s first term. It directs the Secretaries of Treasury, Labor and Health and Human Services to (1) mandate the disclosure of the actual prices of items and services; (2) issue updated guidance or proposed regulatory action to make pricing information easily comparable across hospitals and health plans; and (3) issue guidance updating enforcement policies that ensure compliance with the reporting of complete, accurate and meaningful data.

On February 21, 2025, the Internal Revenue Service (IRS) issued Notice 2025-15, which provides guidance on how employers and insurers can satisfy the “alternative manner” of furnishing Forms 1095-C and 1095-B (the “Forms”) in accordance with the recently-enacted Paperwork Burden Reduction Act (PBRA). As background, on December 11, 2024, Congress passed the PBRA to ease Affordable Care Act (ACA) requirements for furnishing the Forms to employees and covered individuals. Specifically, the PBRA provides that employers and insurers are no longer required to automatically furnish Forms 1095-C and 1095-B to employees and covered individuals, so long as timely notice has been provided to such individuals. However, the PBRA failed to explain how employers and insurers must provide this notice, and the required content of such a notice. Notice 2025-15 clarifies these rules for this notice requirement. Specifically, this new IRS guidance clarifies that the notice must be posted on the employer or insurer website clearly and conspicuously with a statement that individuals may receive a copy of their Forms upon request. The notice must include an email address, a physical address and a telephone number that individuals can contact if they have questions. The notice must be posted by the due date for furnishing the Form, including the automatic 30-day extension. For example, for 2024 Forms, the employer or insurer providing the coverage must post the notice by March 3, 2025. If requested, the Form must be provided to the individual by January 31 of the year following the year to which the Form relates, or 30 days after request. So, for example, an employee who requests a copy of her Form 1095-C in August of 2025 must be furnished a copy of the 2024 Form 1095-C within 30 days, but would not be entitled to receive the 2025 Form 1095-C until January 31, 2026.

Beginning in 2025, New York insurers will be increasing their premium rates for private employer-sponsored health plans due to New York state’s recent implementation of the Managed Care Organization (MCO) Provider tax. As background, the state of New York enacted the MCO Provider tax on April 20, 2024. This tax on MCOs, HMOs and other insurers in the state, aims to increase the state’s Medicaid reimbursement rates from the Centers for Medicare and Medicaid Services (CMS). After CMS reimburses the state of New York, New York then reimburses these insurers for the taxes assessed on Medicaid plans. For private plans, however, these insurers face an additional cost—ranging from $1.50 to $13 per enrollee per month—with no state or federal offset, unlike with Medicaid.  Accordingly, these insurers are now passing these additional costs on to employers and other sponsors of private health plans in New York.

On February 20, 2025, the U.S. Department of Health and Human Services (HHS) announced that they would rescind previous guidance issued (under the Biden Administration) regarding gender affirming care. As background, on March 2, 2022, HHS published guidance which outlined ways that gender affirming care for minors could be beneficial for medical and mental health outcomes. The decision to rescind comes as an outgrowth of the recently-signed Executive Order by President Trump entitled “Protecting Children from Chemical and Surgical Mutilation”—an Order that directs HHS to issue policies limiting gender affirming care for children under age 19.

On February 18, 2025, President Trump issued an Executive Order entitled “Expanding Access to In Vitro Fertilization,” aiming to reduce costs and promote accessibility to In Vitro Fertilization (IVF). The Order directs the Assistant to the President for Domestic Policy to propose “a list of policy recommendations on protecting IVF access and aggressively reducing out-of-pocket and health plan costs for IVF treatment” within 90 days.