On April 25, 2025, a federal district court in Texas ruled that the Department of Health and Human Services (HHS) must certify Employer Shared Responsibility (ESR) penalties (required under § 1411 of the Affordable Care Act (ACA)), and that a § 1411 certification from the Internal Revenue Service (IRS) provided to an employer was insufficient. As a result, the court ordered the IRS to refund the ESR penalties assessed against an employer who was not provided with a certification notice from HHS (only from the IRS). As background, Faulk Co., Inc. (the “Employer”) received an ESR penalty in 2021. They paid under protest, and then later demanded a refund. The IRS never responded to the Employer’s letter, which prompted the Employer to file suit alleging that the ESR penalty assessment was unlawful as it was the responsibility of HHS to provide a certification of the ESR penalty, and that the IRS certification of the ESR penalty ran afoul of the Employer’s right to due process under the ACA. The Employer asked that the ESR penalty be refunded and that there be a declaration made that an HHS delegation of authority to the IRS to certify the ESR penalty was void and unenforceable. The court agreed with the Employer and held that under § 1411 of the ACA, and § 4980H of the Internal Revenue Code, a certification to an employer from HHS is required.

The deadline for filing the 2024 annual reporting form (ARF) for the San Francisco Health Care Security Ordinance (HCSO) is May 2, 2025. The HCSO requires, among other items, that covered employers report on their total healthcare expenditures for employees for each quarter in 2024. As background, employers with at least one employee within the city of San Francisco who works more than 8 hours per week for more than 90 days are required to spend a certain amount (called an expenditure) on healthcare for their covered employees. These funds can be used for employer-sponsored medical, dental or vision insurance, paid to the city, or contributed toward programs that reduce employee out-of-pocket healthcare costs.

On April 15, 2025, President Trump issued an Executive Order entitled “Lowering Drug Prices by Once Again Putting Americans First,” which instructs government agencies to take actions that would lower healthcare and prescription drug prices. As background, in his first presidency, President Trump took actions to lower the cost of healthcare and prescription drugs through the Consolidated Appropriations Act of 2021, a law that aimed to lower the cost of healthcare through increased transparency. His administration also encouraged the development of generic and biosimilar alternatives to higher cost brand name prescription drugs and established a pathway to expand access to lower cost prescription drugs imported from outside of the country. In this new Executive Order, President Trump states that he is now attempting to continue these efforts in his second term. Specifically, this new Executive Order outlines many proposals and actions that government agencies can take to lower the cost of healthcare and prescription drugs, both within Medicare and Medicaid, as well as for the general population. Among other proposals, the Executive Order outlines proposed improvements to Medicare pricing negotiations, increased healthcare transparency by pharmacy benefit managers and actions designed to reduce anti-competitive behavior by pharmaceutical manufacturers.

On April 15, 2025, the Centers for Medicare and Medicaid Services (CMS) published a final rule (entitled “Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly”) implementing changes to the Medicare Advantage rule proposed by the Biden administration. Notably, CMS removed coverage for GLP-1 weight loss drugs under the Medicare Part D and Medicaid programs, a policy shift that the Biden administration’s proposed rule had included for contract year 2026. Additionally, the new final rule does not include the health equity analysis of utilization management policies and procedures within Medicare that was included in the proposed rule.

On April 8, 2025, President Trump announced that his administration would be putting tariffs in place for pharmaceuticals manufactured outside of the U.S. While the impact of these pharmaceutical tariffs is not yet known, the production of pharmaceuticals, both drugs and devices, is conducted through a web of international connectivity upon which tariffs will have a tremendous impact, potentially driving prices for prescription drugs, including generics, up. President Trump has stated that the goal of this tariff, like others that he has already instituted, is to bring manufacturing back to the U.S., in this instance, for pharmaceuticals.

On April 2, 2025, Kentucky Governor Andy Beshear signed HB 421 (the “Law”) into law. The new Kentucky Law, which goes into effect on January 1, 2026, will expand coverage requirements for colorectal cancer care in the state. Specifically, the new Law will require all health plans in Kentucky to offer first dollar coverage of all colorectal cancer examinations and laboratory tests within the guidelines set forth by the U.S. Multi-Society Task Force on Colorectal Cancer. This coverage requirement will apply for plan participants age 45 and over, or under the age of 45 and at a high risk for colorectal cancer. The Law’s new coverage requirements will not apply to high deductible health plans that would normally be disqualified from health savings account eligibility by providing first dollar coverage of this kind, but it will apply to such plans once the minimum deductible has been satisfied.

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.