The Trump Administration recently announced that, effective January 1, 2026, it will be launching a new online prescription drug program called “TrumpRx,” which will attempt to lower the cost of prescription drugs for Americans. TrumpRx is a website that functions similarly to a search engine for purchasing prescription drugs where Americans will be able to purchase their prescriptions directly from manufacturers at discounted rates that are closer to “most-favored nation” (MFN) prices. 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 other comparable developed nations. It pressures pharmaceutical companies to match these international benchmarks through voluntary agreements or regulatory action. TrumpRx will provide individuals the opportunity to purchase these discounted medications without insurance or Pharmacy Benefit Manager involvement. The prescriptions available through TrumpRx will be from manufacturers who have struck deals with the administration to lower their prices for this program, including AstraZeneca and Pfizer.

On November 6, 2025, the Trump Administration announced via White House live stream, along with an accompanying Fact Sheet, a new set of deals with drug manufacturers Eli Lilly and Novo Nordisk to reduce the price of their popular GLP-1 drugs. When purchased through TrumpRx, Ozempic and Wegovy will cost $350 per month, down from their current price of $1,000 and $1,350 per month respectively. The price through TrumpRx of Zepbound and Orforglipron (if approved) will fall from $1,086 per month to an average of $346. Additionally, if the U.S. Food and Drug Administration approves an oral GLP-1 tablet produced by either of these companies, the price will be $150 for the initial dose through TrumpRx. Further, the deal will lower prices for Medicare and state Medicaid programs for each of the previously listed drugs. Additionally, Eli Lilly and Novo Nordisk will provide discounts on their other popular drugs such as Emgality, Trulicity, NovoLog and Tresiba. Eli Lilly and Novo Nordisk have each pledged further investment in American drug manufacturing and research as a part of the deal.

On November 3, 2025, the Internal Revenue Service (IRS) released updated Patient Centered Outcome Research Institute (PCORI) fee amounts. As background, the PCORI fee has been in place since September 30, 2012, and is paid annually by self-insured health plan sponsors on a “per covered life” basis. For plan and policy years ending on or after October 1, 2025, and before October 1, 2026, the new PCORI fee amount is $3.84 per covered life, which is an increase from the previous amount of $3.47 per covered life. The fee is due annually on July 31.

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.