Beginning January 1, 2026 (previously July 1, 2025), the State of California will put into effect a new law, SB 729, which requires large fully insured group health plans (plans with 101 or more participants), as well as large group, non-specialized disability insurance plans within the state, to provide coverage for fertility and infertility services for any California residents. The new law requires large group policies to provide coverage for the diagnosis and treatment of infertility, including coverage for up to three completed egg retrievals with unlimited embryo transfers. 

On June 9, 2025, Secretary of Health and Human Services, Robert F Kennedy announced that he would be removing all 17 members of the Center for Disease Control and Prevention’s Advisory Committee for Immunization Practices (ACIP) and replacing them with new members. Kennedy stated that the committee was full of conflicts of interest and that a new slate of members was necessary to restore public trust in the Committee. This ACIP reformation comes on the heels of Kennedy announcing that the COVID 19 vaccine would no longer be recommended for healthy children and pregnant women.

On May 27, 2025, the State Attorney General for Rhode Island, Peter Neronha, filed a lawsuit against the major pharmacy benefit managers (PBMs), including CVS Caremark, Express Scripts and Optum RX, along with their group purchasing organizations (GPOs), alleging that the PBMs and the GPOs conspired to unfairly increase the cost of prescription drugs. The lawsuit alleges that although the PBMs marketed their operations as saving money for consumers, they were unfairly profiting from drug price increases. The lawsuit also alleges that the PBMs make formulary decisions that unfairly restrict access to certain medications for participants.

On May 22, 2025, the U.S. House of Representatives passed a budget bill titled “One Big Beautiful Bill” (BBB). This bill, if passed, would have wide ranging implications for health and welfare benefits, including expanding health savings account (HSA) availability, expanding availability of individual coverage health reimbursement arrangements (ICHRAs), and putting in place new eligibility requirements for Medicaid.

As explained in the new FAQ guidance, the Agencies intend to release schema version 2.0 for the MRF requirements. This will exclude duplicative data, eliminate unnecessary data fields and/or files, and will include updates to better contextualize the data. 

On May 20, 2025, The U.S. Department of Health and Human Services (HHS) announced in a press release that it is taking steps to achieve the Most-Favored-Nation Price Targets for prescription drugs in line with President Trump’s executive order “Delivering Most-Favored-Nation (MFN) Prescription Drug Pricing to American Patients.” HHS laid out its expectation that each manufacturer commits to aligning U.S. pricing for all brand name drugs across all markets that do not have generic or biosimilar competition with the lowest price from similarly developed countries. Specifically, the MFN target price is the lowest price in an Organization for Economic Co-operation and Development (OECD) country with a Gross Domestic Product (GDP) per capita of at least 60 percent of the U.S. GDP per capita. These price targets are meant to bring down U.S. drug prices while preserving innovation by evening out the price burden between American patients and patients receiving the same drug in other countries.

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) rescinded its 2021 guidance regarding Section 1557 of the Affordable Care Act (ACA). Among other things, the 2021 guidance announced that HHS would interpret Section 1557’s prohibition on discrimination “on the basis of sex” to include discrimination the basis of sexual orientation and gender identity. HHS has now announced that, to reduce regulatory burden, the guidance has been rescinded, effective immediately.

On May 12, 2025, President Trump issued an Executive Order entitled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” along with an accompanying Fact Sheet providing additional information. The Executive Order aims to lower the costs of prescription drug pricing in the U.S. by implementing a “most-favored-nation” policy. This would tie U.S. drug prices to the lowest prices paid by other comparable developed countries. The Executive Order directs agencies, including HHS and FDA, to take actions that will lower prescription drug costs for Americans. This would include direct-to-consumer purchasing from drug manufacturers and the development of a pricing index that establishes and communicates price targets comparable with the rest of the developed world. In addition, the Executive Order states that if pharmaceutical manufacturers do not bring down their prices to be in line with the new standards, the agencies must propose new regulations to create a pathway for safe importation of prescription drugs from other developed nations. The Executive Order also directs the U.S. Attorney General to review anticompetitive behavior by prescription drug manufacturers and remedy any violations through the Sherman Act.