On October 22, 2025, a federal trial court in Mississippi vacated (invalidated) certain parts of Section 1557 of the Affordable Care Act (“ACA”), which generally prohibits discrimination on the basis of gender identity, race, color, national origin, sex, age or disability. In May of 2024, the U.S. Department of Health and Human Services (“HHS”) issued regulations to provide that the definition of “discrimination on the basis of sex” was meant to include discrimination based on sexual orientation, gender identity, sex characteristics, pregnancy and sex stereotypes. The court ruled that these provisions exceeded the statutory authority given to HHS. While the provisions prohibiting discrimination on the basis of gender-identity had previously been blocked from enforcement, this decision fully and permanently invalidates these rules.

On October 17, 2025, the Maryland Department of Labor (“MDOL”) released an updated timeline for the implementation of the Maryland Paid Family Leave Insurance (“FAMLI”) program. As background, FAMLI requires employers to provide eligible employees with up to 12 weeks of job-protected leave and salary continuation of up to $1,000 per week to care for the employee or the employee’s family. Employer contributions to the FAMLI program will begin January 1, 2027 (originally July 1, 2025), while benefits will become available to eligible employees beginning January 3, 2028 (originally, July 1, 2026). Additionally, Maryland published 09.42.05 Dispute Resolution, a set of proposed rules that provide details on dispute resolution for the FAMLI program. Along with the updated guidance, the MDOL released FAQ guidance covering general questions, contributions, claims, commercial plan alternatives, Equivalent Private Insurance Plans and other employer action items. Employers should begin the process of selecting how they would like to implement the FAMLI program.

On October 16, 2025, the U.S. Departments of Labor, Health and Human Services and Treasury jointly issued FAQ guidance about offering fertility benefits as “excepted benefits,” or as part of an Excepted Benefit Health Reimbursement Arrangement (“EBHRA”). As background, excepted benefits are those benefits which provide certain coverages that ordinarily would be subject to ERISA, the Public Health and Safety Act and the Internal Revenue Code, but are not, due to their limited scope. This fertility benefit falls under a category of excepted benefits, referred to as “independent, non-coordinated excepted benefits,” which includes coverage for only a specified disease or illness, such as, in this case, for infertility.

This new fertility excepted benefit can be offered provided that the benefits are offered under a separate insurance arrangement, are not coordinated with any group health plan from the same plan sponsor and are paid without regard to whether other health coverage applies. Additionally, the FAQ guidance indicates that under existing regulations, employers can offer an EBHRA that reimburses out-of-pocket costs related to fertility benefits as a “limited excepted benefit.” This means these benefits cannot be an integral part of a group health plan and must comply with annual limits on the amount that can be made newly available as well as other EBHRA qualification rules.

As additional background, President Trump issued an Executive Order titled “Expanding Access to In Vitro Fertilization,” stating that the administration would take steps to lower the costs associated with fertility treatment. Providing coverage for fertility treatments through the provision of an excepted benefit is a part of this effort.

On October 10, 2025, President Trump announced, along with an accompanying Fact Sheet, that he made a deal with AstraZeneca to bring their prescription drug prices in line with the “most favored nation” (“MFN”) pricing. As background, President Trump’s MFN drug pricing policy aims to lower U.S. prescription drug costs by tying them to the lowest prices paid by comparable developed nations. It pressures pharmaceutical companies to match these international benchmarks through voluntary agreements or regulatory action. This deal comes after the September 30, 2025 announcement of a deal with Pfizer to deliver MFN pricing to America (with the accompanying Fact Sheet). Pfizer and AstraZeneca both agreed to very similar agreements in which they will provide all state Medicaid programs with MFN pricing, utilize increased revenues from foreign countries for domestic investment, and to provide discounts when selling to directly to the American population. This is the first deal of its kind but may be the start of more going forward.

On September 25, 2025, President Trump announced that he will be imposing a 100% tariff on any branded or patented pharmaceutical product entering the country after October 1, 2025. Announced on Truth Social, the President stated that this tariff would not apply to those manufacturers who are building infrastructure in the US, which will be defined as “breaking ground and/or have a factory under construction”. This tariff will not apply to generic drugs being imported.

On September 9, 2025, the U.S. Court of Appeals for the 11^th Circuit (the “Court”) in Lange v. Houston County, held that a denial of gender affirming surgery was not discriminatory on the basis of sex under Title VII of the Civil Rights Act of 1964 (“Title VII”). As background, this case arose when an employee sued Houston County for the denial of coverage for gender affirming surgery, an exclusion that was explicitly contained in her plan. The employee alleged that the exclusion was discriminatory on the basis of gender identity, a form of discrimination deemed unlawful under Title VII, and the lower court granted summary judgement in the employee’s favor. Houston County appealed this decision to the 11^th Circuit Court which overturned the lower court’s decision and held that because the exclusion applied to all participants equally, regardless of sex or gender identity, it did not amount to unlawful discrimination under Title VII. This ruling comes in the wake of President Trump’s January Executive Order entitled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government,” which stated that the Trump Administration would take steps to unwind certain protections for gender ideology that were implemented under the Biden Administration. This case will likely be appealed again to the U.S. Supreme Court.

On August 27, 2025, the U.S. Food and Drug Administration (FDA) updated their approval and recommendations for COVID-19 vaccines, which has caused confusion for insurers, plan sponsors and plan participants. The shots from Moderna and Novavax are now only approved for seniors and individuals with high-risk medical conditions, and for the rest of the population, only Moderna’s vaccine remains available after doctor recommendation. This comes right as the beginning of cold and flu season arrives. Guidance is still needed (and is expected in late September) from the Advisory Committee on Immunization Practices (ACIP), as insurers utilize their guidance to determine which immunizations to cover. It will be important to see what ACIP recommends after they meet later this month to determine what next steps should be.

On August 26, 2025, in response to the U.S. Supreme Court’s June ruling in the case of Braidwood v. Becerra, the U.S. Fifth Circuit Court of Appeals has directed the federal trial court that initially heard the case to address whether the Health Resources and Services Administration (HRSA) and the Advisory Committee on Immunization Practices (ACIP) have proper authority to issue preventive health service recommendations under the Affordable Care Act (ACA). As background, the ACA requires group health plans and insurers to provide specified preventive services without cost-sharing, including certain evidence-based items and services recommended by the United States Preventive Services Task Force (USPSTF), the HRSA and the ACIP. The Supreme Court’s ruling in June held that the USPSTF was constitutionally appointed, but it did not rule on the constitutionality of the appointment of the members of ACIP and HRSA. Accordingly, the federal trial court is expected to rule on this remaining issue.

On August 13, 2025, the U.S. District Court for the Eastern District of Pennsylvania (the “District Court”) vacated the expanded exemptions (“The Religious Exemption Rule” and “The Moral Exemption Rule”) to the Affordable Care Act’s (ACA) requirement that non-grandfathered group health plans cover contraceptives and contraceptive services without imposing cost-sharing requirements (the “Contraceptive Coverage Mandate” or “CCM”). As background, there is an exemption to the CCM in place for certain religious employers and employers who have religious or moral objections to the CCM (subject to an approval process) that allows such employers to not have to cover those services on a first dollar basis. The regulations that expanded these exemptions to the CCM were enjoined by a federal district court, and that decision was then upheld by the U.S. Third Circuit Court of Appeals, but the U.S. Supreme Court reversed the decision, rejecting arguments that the exemption regulations were invalid. The Supreme Court held that the ACA gives the agencies broad discretion to define preventive care and screenings, and to create or expand religious and moral exemptions. The Supreme Court then sent the case back to the District Court, which vacated (invalidated) the regulations in their entirety, ruling that they are arbitrary and capricious under the Administrative Procedures Act (APA), and that the agencies that promulgated them did not provide a satisfactory explanation for the religious beliefs rule and considered improper factors in creating the moral objections rule.

On August 1, 2025, the city of San Francisco released the updated rates for the Health Care Expenditure (“Expenditure”) for the 2026 calendar year. As background, the City of San Francisco has an extraterritorial law called the Health Care Security Ordinance (HCSO) for all employers with at least 20 employees in any location if at least one employee works within San Francisco. The HCSO requires that covered employers spend a minimum amount on healthcare (the Expenditure amount) for each hour worked by an employee within San Francisco, provided that the employee worked for at least 90 days and averages at least 8 hours worked per week within the city. The 2026 Expenditure rates by employer size have increased to $4.11 per hour, with a maximum of $706.92 per month (for employers with 100 or more employees), $2.74 per hour with a maximum of $471.28 per month (for employers with 20-99 employees or 50-99 employees for non-profits) respectively. Additionally, employees who are considered managerial, supervisory and confidential, and who make more than $128,861 per year ($61.95 per hour), are exempt from the Expenditure requirement in 2026. Covered employers should ensure they are using the updated rates in 2026.