Tri-Agencies Directed to Expand Regulation and Enforcement of Healthcare Price Transparency 

On February 25, 2025, President Trump issued an executive order (E.O.), "Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information," aimed at increasing healthcare price transparency for patients "across hospitals and health plans." The E.O. outlines actions taken by president and his administration in his first term, including E.O. 13877 and the 2019 Hospital Price Transparency Rule, to increase healthcare price transparency, but states the full economic impact of these measures was never fully realized due to lack of full implementation. According to the president: 

...progress on price transparency at the Federal level has stalled since the end of my first term. Hospitals and health plans were not adequately held to account when their price transparency data was incomplete or not even posted at all. The Biden Administration failed to take sufficient steps to fully enforce my Administration's requirement that would end the opaque nature of drug prices by ensuring health plans publicly post the true prices they pay for prescription drugs. 

The E.O. directs the federal government to improve and potentially expand existing price transparency requirements, increase enforcement of those requirements, and identify opportunities to further empower patients with meaningful price information. The E.O. especially calls on the Secretaries of the Treasury, Labor, and Health and Human Services to "rapidly implement and enforce" existing healthcare price transparency regulations and, within 90 days:

• Require the disclosure of the actual prices of items and services, not estimates 
• Issue updated guidance or proposed regulatory action ensuring pricing information is standardized and easily comparable across hospitals and health plans
• Issue guidance or proposed regulatory action updating enforcement policies designed to ensure compliance with the transparent reporting of complete, accurate, and meaningful data

The No Surprises Act (NSA), enacted in December 2020, included several price transparency provisions that have not yet been implemented, including requirements on hospitals and other providers to share "good faith estimates" of healthcare costs with uninsured, self-pay patients for many services, and requirements on health plans and issuers to provide "advanced explanations of benefits" to participants and enrollees prior to receiving care. In 2020, the Departments of the Treasury, Labor (DOL), and Health and Human Services (HHS) (collectively, the Departments) issued the Transparency in Coverage Rule that requires group health plans and issuers to disclose detailed pricing information on their websites and price and cost-sharing information to plan participants upon request.

Trump Administration Issues Executive Order on In Vitro Fertilization

On February 18, 2025, President Trump issued an executive order relating to in vitro fertilization (IVF), stating that "it is the policy of my Administration to ensure reliable access to IVF treatment, including by easing unnecessary statutory or regulatory burdens to make IVF treatment drastically more affordable." The order directs the Assistant to the President for Domestic Policy to provide "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. In a fact sheet issued by the White House on the same day, the administration asserted that the recommendations will prioritize current policies that "exacerbate the cost of IVF treatments," which can range from $12,000 to $25,000 per cycle. Under its statement that more affordable avenues to receive IVF treatments are needed, the fact sheet notes that "IVF is often not fully covered by health insurance." The fact sheet states that the order is in keeping with the Trump administration's support for "more babies and expanding American families."

The order does not have any immediate legal impact on the availability or cost of IVF treatments, but it may signal White House alignment with the pro-IVF policies of Trump's Secretary of Labor nominee, Lori Chavez-DeRemer. As we recently discussed, during her time in Congress, Chavez-DeRemer sponsored multiple initiatives aimed at reducing barriers to IVF. Of note, she was one of the lead sponsors of the Helping to Optimize Patients' Experience (HOPE) with Fertility Services Act (H.R. 8821), which would require group health plans to cover fertility services in certain circumstances. The HOPE with Fertility Services Act and other IVF-related bills did not go far in the last Congress and the Trump administration will likely require congressional support to directly impact coverage requirements or federal funding for IVF services.

DOJ Files Opening Merits Brief in Kennedy v. Braidwood

On February 18, 2025, the Department of Justice (DOJ) filed the government's merits brief in Kennedy v. Braidwood Management, Inc., No. 24-316 (U.S.), defending the position that the Court of Appeals for the Fifth Circuit erred in holding that the members of the U.S. Preventive Services Task Force (PSTF) are "principal officers" who were improperly appointed in violation of the Appointments Clause of the Constitution. Members of the PSTF are authorized under the Public Health Service (PHS) Act, as amended by the Affordable Care Act (ACA), to recommend with "A" or "B" ratings certain preventive services required to be covered without cost-sharing by the majority of health insurance issuers and group health plans. 

The government's brief argues that PSTF members are inferior officers because the Secretary of HHS, a principal officer, supervises the PSTF and its members are removable at will. The government focuses on its first argument – the Secretary's supervisory authority – because the Fifth Circuit agreed that PSTF members are removable at will but disagreed that there was adequate supervision by the Secretary to render the members inferior. On the question of supervision, the government contends that the Secretary remains responsible for final decisions about whether PSTF recommendations will be legally binding on issuers and group health plans, pointing to language in the PHS Act that the Secretary can "establish a minimal interval" before "A" and "B" recommendations become effective. The government also argues that the Secretary can even set a longer interval to review any concerning recommendations and cites to the Secretary's power more generally to supervise and direct the PHS, which includes the PSTF. According to the government, the Secretary's at-will removal power is further evidence of his constitutionally adequate supervision over the PSTF. Lastly, the government asserts that any Appointments Clause violation may be cured by severing the problematic provision. 

We previously discussed the implications of the court's decision in Braidwood. As warned by the government's petition for certiorari, "a future plaintiff with Article III standing could bring an [Administrative Procedure Act (APA)] claim in a district court within the Fifth Circuit, challenge the Task Force's recommendations on Appointments Clause grounds, and obtain a sweeping remedy that would render the Task Force preventive-services scheme inoperative nationwide." The petition puts a finer point on this: "Under that remedy, issuers and group health plans could eliminate coverage (or impose cost-sharing requirements) for any preventive services recommended by the Task Force since March 23, 2010."

The Fifth Circuit's decision underscores that the government's warnings have teeth, specifically stating that if a plaintiff brings an APA claim, under Fifth Circuit precedent, universal vacatur is the "'default' remedy for unlawful agency action" and courts need not consider "the various equities at stake before determining whether a party is entitled to vacatur." Several amici have filed briefs in support of the government's position, including the state of Illinois joined by 22 other state attorneys general. The Supreme Court set oral argument in this case for April 21, 2025. 

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