How Pending Health-Related Lawsuits Could be Impacted by the Incoming Trump Administration
Introduction
While much of health policy will be shaped by executive and legislative action under the incoming Trump administration, a variety of pending lawsuits also may be affected by the incoming administration, as it may choose to drop litigation that the Biden administration defended or pursued. The outcomes of these lawsuits could have significant impacts across many aspects of health care, including preventive services, abortion care, gender affirming care, Medicare drug price negotiations, nursing home staffing rules, private coverage consumer protections, and protections and health coverage for Deferred Action for Childhood Arrivals (DACA) recipients. While in many cases President-elect Trump has not commented publicly on the issues in these lawsuits, his record as president, comments on the campaign trail, and proposals from conservative groups suggest he might view these cases differently from the Biden administration. This brief provides an overview of these legal challenges, how they may be affected by the incoming Trump administration, and the implications of their potential outcomes.
Affordable Care Act
ACA Preventive Services
The outcome of a pending federal lawsuit, Braidwood Management Inc v Becerra, which challenges the ACA preventive services requirements, could put coverage of many preventive services at risk. The Biden administration is defending the ACA requirement and fighting the case. President-elect Trump has not publicly voiced an opinion on the case, but Project 2025, a set of policy proposals from conservative groups, calls for the federal government to issue new requirements for contraceptives and other women’s preventive services because of the pending case.
The ACA requires most private health insurance plans to cover a range of preventive services without any patient cost-sharing. In the case, Braidwood Management v. Becerra, Christian owned businesses and six individuals in Texas assert that (1) the requirements in the law for specific expert committees and a federal government agency to recommend covered preventive services is unconstitutional, and that (2) the requirement to cover preexposure prophylaxis (PrEP), medication for HIV prevention, violates their religious rights. In June 2024, the 5th Circuit Court of Appeals affirmed the district court’s ruling that the part of ACA’s preventive services coverage requirement (services recommended by United States Preventive Services Task Force (USPSTF) is unconstitutional) but that only the plaintiffs are permitted to exclude USPSTF recommended services from their plans. The plaintiffs’ claim that the Secretary of HHS’s ratification of HRSA and ACIP recommendations violates the Administrative Procedure Act was sent back to the lower court for further briefing and a judgment. In September 2024, the Biden Administration petitioned the Supreme Court to review the 5th Circuit’s decision. The Supreme Court has not yet decided whether to take the case. If the Trump administration does not defend the case, a state might join the lawsuit to defend the ACA’s preventive services requirement just as California intervened in the case brought by Texas challenging the ACA when the first Trump administration did not defend the federal law.
Private Coverage Consumer Protection Regulations
Lawsuits have recently been filed challenging Biden administration rules that regulate so-called “junk” insurance products that do not provide comprehensive health insurance coverage, which the Trump administration may not defend. For example, designed for people who experience a temporary gap in health insurance coverage, short-term, limited duration (short-term plans) plans typically offer fewer covered benefits and consumer protections compared to plans that meet ACA standards. The duration and renewability of short-term plans have been the subject of changing federal regulations, with the Obama administration in 2016 restricting coverage to less than three months without renewability, and the Trump administration in 2018 expanding the permitted coverage duration to less than 12 months with the ability to renew coverage for up to an additional 24 months. The Biden administration’s 2024 regulation limits short-term plan coverage to three months plus a one-month extension. A lawsuit was recently filed in a Texas federal court, American Association of Ancillary Benefits v. Becerra et. al, challenging this regulation as beyond the authority of the agency under the Administrative Procedure Act. That lawsuit also challenges new standards in the regulation that add consumer protections for fixed indemnity products. Fixed indemnity plans pay a specific amount if someone is sick or hospitalized. Like short-term plans, fixed indemnity plans do not have to meet most of the ACA’s consumer protections. Another lawsuit challenges the same regulation, questioning new consumer notice requirements for fixed indemnity products. The new Trump administration may not defend these actions, instead reinstating Trump-era rules for these plans or seeking to incorporate them into legislation.
Less clear is the what the Trump administration will do to defend various lawsuits challenging Biden administration regulations that implement surprise billing protections in the 2020 No Surprises Act. The No Surprises Act (NSA), signed into law by President Trump in 2020, protects patients with private insurance from surprise medical bills in certain situations when the patient receives care from an out-of-network hospital or clinician that they did not choose. The law requires health plans to cover surprise bills at in-network rates and prohibits out-of-network providers at certain in-network facilities from billing patients directly for the remainder of the bill. Biden administration regulations implementing these protections have been challenged in several lawsuits. Many of these cases are still working their way through lower courts, but two recent Fifth Circuit decisions in separate lawsuits brought by the Texas Medical Association throw out some parts of Biden administration regulations that set out how disputes between providers and insurers about out-of-network rate are resolved, while retaining other parts of Biden administration regulations on other aspect of the NSA. While consumers are still shielded from receiving surprise balance bills in many instances, the end result of these legal challenges could be an increase in insurance premiums and out-of-pocket costs for consumers.
DACA Program and ACA Marketplace Coverage Expansion
The future of the DACA program and the ACA Marketplace coverage expansion to DACA recipients remain uncertain due to ongoing litigation, and during his first term, President-elect Trump attempted to end DACA. DACA was established via executive action in June 2012 to protect certain undocumented immigrants who were brought to the U.S. as children from removal proceedings and provide them work authorization. The first Trump administration sought to end DACA but was blocked by the Supreme Court in 2020. The Biden administration issued regulations in 2022 to preserve DACA, but in September 2023, a district court in Texas ruled the DACA program unlawful, preventing implementation of the regulations while the case awaits a decision in the Fifth Circuit Court of Appeals. Under the pending ruling, the Department of Homeland Security is processing DACA renewal requests and related employment authorizations but not initial DACA requests. In May 2024, the Biden administration issued regulations to extend eligibility for ACA Marketplace coverage with subsidies to DACA recipients, who were previously ineligible for federally funded health coverage. The regulation became effective November 1, 2024. In August 2024, a group of states filed a lawsuit against the federal government alleging that the coverage expansion for DACA recipients violates the Administrative Procedure Act. The case is currently under review at a district court in North Dakota. The Trump administration said that it would try again to eliminate DACA protections after the first attempt failed in 2020. Given its views generally on immigration issues and DACA specifically, the Trump administration is presumably unlikely to appeal any ruling against DACA or the coverage expansion. Elimination of the coverage expansion could leave the nearly 100,000 uninsured DACA recipients it is estimated to cover without an affordable coverage option, while elimination of the DACA program would put the over half a million DACA recipients, a majority of whom are working and many of whom have U.S.-born children, at risk of deportation.
Reproductive Health and Abortion Care
Medication Abortion
Access to mifepristone, one of the pills used in the medication abortion regimen, could be limited if the Trump administration does not defend pending litigation, amends the FDA rules, or enforces the Comstock Act. In November 2022, Alliance for Hippocratic Medicine (a group of anti-abortion medical organizations) challenged the FDA’s 2000 approval of mifepristone on procedural grounds, as well as recent changes to the regulation of the medication that eliminated the in person dispensing requirement by a physician and enabled to be mailed to patients following a telehealth consultation, as being beyond the FDA’s authority. In addition, they contended that an 1873 anti-obscenity law, the Comstock Act, prohibits the mailing of medications used for abortion. In June 2024, the Supreme Court unanimously ruled that the Alliance for Hippocratic Medicine and the individual doctors lacked legal standing to sue the FDA, but did not address the claims made by the anti-abortion challenges. However, the case continues at the district court with three state interveners (Kansas, Idaho, and Missouri) who may have legal standing. The Trump administration is not expected to defend the FDA’s actions challenged in this lawsuit. While President-elect Trump does not have a stated position on the case or on medication abortion, Project 2025 is clear in its opposition to the FDA’s approval of mifepristone and also endorses enforcement of the Comstock Act, which would effectively ban the mailing and distribution of abortion pills within the country, even in states that currently allow abortion without restrictions.
Emergency Medical Treatment and Labor Act (EMTALA) and Emergency Abortion Care
Pending litigation could determine whether states can implement abortion bans without health exceptions. Shortly after Roe v Wade was overturned, the Biden administration issued guidance in July 2022 regarding the enforcement of EMTALA, a federal law requiring hospitals to provide stabilizing treatment to patients. The guidance clarified that hospitals and physicians have obligations to provide stabilizing care, including abortion, to preserve the health of a pregnant person, not only in situations where abortion is necessary treatment to save a patient’s life. Six states (AR, ID, MS, OK, SD, and TX) have no health exception to their state abortion ban. After the guidance was issued, the Biden administration sued the state of Idaho to block the state law’s enforcement to the extent it conflicts with EMTALA, a challenge that ultimately reached the Supreme Court. In June 2024, the Supreme Court dismissed the case, Moyle v. United States (consolidated with United States v. Idaho) and returned the case to the lower court. While this case proceeds, Idaho is blocked from enforcing its abortion ban when abortion is necessary to prevent serious harm to the patient’s health. However, in a similar case, Texas successfully sued the Biden administration to block enforcement of the EMTALA guidance in Texas. The Biden administration asked the Supreme Court to review the Texas case, but the Court declined. President-elect Trump says he believes in exceptions for “life of the mother” but has not weighed in on health exceptions. Project 2025 authors call for the reversal of the Biden administration’s EMTALA guidance, which the new Trump administration could do right away, and withdrawal of federal lawsuits challenging state abortion bans without health exceptions.
Reproductive Health Privacy Regulation
A Biden administration regulation on reproductive health privacy is at risk, as the Trump administration may not defend legal challenges to the rule, as well as to parts of the HIPAA privacy regulation. In April 2024, HHS finalized a regulation adding a new category of protection to HIPAA privacy regulations for the use and disclosure of reproductive health information in certain circumstances. The rule prohibits health care providers, health plans and others from disclosing, for example, information about reproductive health care such as abortion or contraception counseling obtained legally, to a law enforcement agency seeking to investigate or impose legal liability related to that care. The state of Texas has challenged these rules and existing HIPAA standards as preventing the state from enforcing its own laws restricting abortion and other reproductive health care, including gender affirming care. The state argues in a lawsuit filed in September that HHS went beyond its authority provided in the HIPAA law and seeks to set aside these protections. Another lawsuit by a Texas physician against HHS makes similar allegations, and is also pending in a Texas federal court. Most of the reproductive health privacy rule will be effective on December 23, 2024, unless blocked by the court in these cases. If the rule becomes effective, the Trump administration could take administrative action to rescind this rule and perhaps alter existing HIPAA protections so states have greater leeway to require disclosure of reproductive health information.
Pregnant Workers Fairness Act
The outcome of pending litigation and potential regulatory changes under the new Trump administration will determine whether employers must provide accommodations to employees after an abortion. The Biden administration issued a final rule and interpretive guidance to implement the Pregnant Workers Fairness Act, which requires a covered entity to provide reasonable accommodations to a qualified employee’s or applicant’s known limitations related to, affected by, or arising out of pregnancy, childbirth, or related medical conditions, unless the accommodation will cause an undue hardship on the operation of the business of the covered entity. The Biden administration includes abortion in the definition of “pregnancy, childbirth or related medical conditions.” There are several ongoing lawsuits in federal courts challenging this rule that the incoming Trump administration is not likely to defend. The Trump administration may issue new rules that do not include abortion in the definition of “pregnancy, childbirth or related medical conditions.”
Federal Title X Family Planning Program
The structure of the Title X program could be reshaped by ongoing litigation, and the incoming Trump administration could reinstate their prior regulations that were rescinded by Biden. For more than 50 years, the federal Title X program has provided family planning services to nearly four million low-income people a year through a national network of clinics. The first Trump administration issued Title X regulations that prohibited grantees from referring clients for abortion services or having co-located family planning and abortion services which led to the withdrawal or disqualification of almost a quarter of the sites from the Title X network. The Biden administration issued regulations to reverse the first Trump administration’s policies.
The ability of states to ban abortion has added a new layer of litigation to the program. Several states that ban abortion are challenging counseling and referrals for abortion requirements under Title X. There is also ongoing litigation brought by Ohio and 11 other states contending that the Biden administration rules violate a section of the Title X law that states “none of the funds appropriated under Title X can be used in programs where abortion is a method of family planning.” In a 1991 decision, Rust v Sullivan, the Supreme Court deferred to the agency’s interpretation of that provision. However, in June 2024, the Supreme Court overturned the Chevron deference to agency interpretation of federal laws, and it is likely that the Supreme Court will ultimately decide the “correct” interpretation of that provision in a future case.
Finally, a provision requiring confidentiality–including for minors–as a criterion for receiving federal Title X funding nationally could be at risk. As a result of a privately filed lawsuit (Deanda v. Becerra) minors in Texas must receive parental consent before obtaining contraceptive services at Title X clinics to comply with the state’s parental consent law. The Texas Attorney General recently filed a new lawsuit seeking to block nationwide enforcement of this provision. Ten states (AZ, IA, FL, MO, MT, NV, SD, TX, UT & WY) require parental consent to get contraception for those who are not married or legally emancipated. Project 2025 calls for the reinstatement of the first Trump administration rules. The new administration could also revise the rules to eliminate the requirement for confidential services to minors, which would likely end the litigation on all these cases.
Gender Affirming Care
Gender Affirming Care Ban
The Trump administration may not support a pending challenge to a Tennessee law prohibiting gender affirming care services for minors. In the wake of a proliferation of laws curtailing minor access to gender affirming care and litigation challenging these state restrictions, the Supreme Court agreed to hear a case challenging the Tennessee ban (United States v. Skrmetti). Both the plaintiffs in the Tennessee case and the Biden administration, as an intervener, requested review. The Supreme Court granted the Biden administration’s request for review and scheduled oral argument on December 4, 2024. The Court is presented with the question of whether Tennessee’s law, which prohibits core gender affirming care services for minors, violates the equal protection clause of the 14th Amendment. Given President-elect Trump’s record to date, his administration would presumably be unlikely to support the plaintiffs as the Biden administration has. As the Court accepted the petition from the Biden administration’s Department of Justice, the future of the case is uncertain. The Court might hear the case as scheduled in December, before the administration changes, and issue its’ decision in June 2025. It’s also possible that the state of Tennessee will ask for the court to reconsider its review given the impending change of administrations.
Gender Identity Protections (Section 1557)
The outcome of pending litigation, and how the incoming Trump administration engages with it, as well as regulatory changes, will determine the reach of nondiscrimination protections for LGBTQ people. A group of 15 states sued HHS (Tennessee et al. v. Becerra et al.), challenging the Biden administration’s final rule implementing section 1557 of the ACA. Section 1557 holds the law’s major nondiscrimination protections, including those on the basis of sex, which the Biden administration interpreted to include protections on the basis of sexual orientation and gender identity. In July 2024, the district court (S.D. Miss) granted the plaintiffs’ request to block HHS from enforcing provisions of the rule related to gender identity nationwide while the case proceeds. HHS appealed the ruling to the 5th Circuit and also asked the lower court to stay proceedings pending the outcome of their appeal. The Trump administration could drop the appeal and halt any intervention with the lower court, favoring the ruling currently in place, at least until the administration issues a revised regulation.
Gender Dysphoria Disability Protections
Disability law nondiscrimination protections for people with gender dysphoria could be weakened if the Trump administration chooses not to defend a Biden regulation currently being challenged and/or issues new rules without protections. A group of 17 states sued HHS (State of Texas et al v. Becerra et al), over a nondiscrimination rule implementing amendments to its section 504 of the Rehabilitation Act of 1973 (section 504) regulation. In the preamble to the final rule, HHS states that in certain circumstances, gender dysphoria may be protected under section 504, a federal law proving nondiscrimination protections for people who have disabilities. In adopting this protection, HHS agreed with a recent Fourth Circuit case, Wiliams v. Kincaid, which concluded that gender dysphoria may constitute a disability under section 504 and the Americans with Disabilities Act, if certain conditions are met. The plaintiffs challenging the regulation argue that HHS exceeded its statutory authority with the rule, that the rule was arbitrary and capricious, and unconstitutional. The Trump administration could choose not to defend the regulation and/or issue new rules without explicitly naming these protections.
Medicare
Medicare Drug Price Negotiation Program
The new Medicare drug price negotiation program is the subject of several pending lawsuits, and it is uncertain whether the Trump administration will continue to defend the program. The Inflation Reduction Act of 2022, signed into law by President Biden in August 2022, includes a requirement for the Secretary of HHS to negotiate prices with drug companies for certain drugs covered under Medicare. The Centers for Medicare & Medicaid Services is due to announce the list of up to 15 Part D drugs to be selected for the second round of price negotiation by February 1, 2025, after concluding the first round of negotiation for 10 Part D drugs in August 2024.
Since June 2023, several lawsuits have been filed challenging the drug price negotiation program by manufacturers of selected drugs and entities representing the pharmaceutical industry. These lawsuits – nine of which remain, as of November 2024 – have raised several constitutional and statutory challenges against the program. To date, none of these lawsuits have been decided in favor of the pharmaceutical industry plaintiffs and HHS has prevailed on the substantive questions at hand, but most cases are either in the briefing stage or awaiting decisions before various U.S. appellate courts. In the event of conflicting rulings, an eventual hearing of one or more of these cases by the Supreme Court would likely be the outcome, but the timing of that is uncertain. If the plaintiffs were to prevail in one or more of these lawsuits, HHS could be blocked from continuing to implement some or all aspects of the program, which would negate savings to the Medicare program and people with Medicare associated with drug price negotiation. It is unknown to what extent HHS under the incoming Trump administration will continue to defend the Medicare drug price negotiation program in court, since the Trump campaign articulated no position on it.
Nursing Homes
Nursing Home Staffing
Several ongoing lawsuits are challenging new nursing home staff rules issued by the Biden administration, and it is unclear whether the Trump administration will defend the rule, support litigation opposing the rule, or issue new regulations. In response to longstanding staffing shortages in nursing facilities and quality concerns, the Centers for Medicare & Medicaid Services released a highly anticipated final rule in April 2024 that created new requirements for nurse staffing levels in nursing facilities. The final rule requires facilities to have a registered nursing on staff 24 hours per day, 7 per days per week and to meet minimum levels of nursing care per resident per day starting in 2026 for urban facilities and in 2027 for rural facilities. KFF estimates that only 19% of nursing facilities would currently meet the required number of staffing hours in the final rule if it took effect immediately.
Several lawsuits have been filed in opposition to the final rule, including lawsuits filed by nursing home industry groups, Texas’ attorney general, and a group of Republican state attorneys general. The legal challenges have overlapping claims including that the rule exceeds CMS’s statutory authority, the rule needs Congressional rather than agency action, and the rule is arbitrary and capricious, in violation of the Administrative Procedure Act. Opponents of the staffing rule have expressed concerns about the expected impact of the rule on costs for nursing homes and states. It is not clear whether the Trump administration will defend the nursing home staffing final rule in court, support the litigation in opposition to the rule, or issue new regulations to scale back the provisions in the staffing rule.