The second administration of Donald Trump may well run the gamut as far as its impact on health care and pharma. Biotech companies may benefit from a good business environment, prompting more mergers and acquisitions, but they may also experience challenges in working with what could be somewhat unconventional leaders of federal agencies, such as Robert F. Kennedy Jr., whom President-elect Trump tapped on Nov. 14 to run HHS.

RFK Jr., a politician and environmental activist who has questioned the safety and efficacy of vaccines and spread misinformation about them, has said that “there are entire departments, like the nutrition department, at FDA that have to go, that are not doing their job.”

With Donald Trump set to be the 47th president and Republicans in control of both chambers of Congress, 2025 is shaping up to be a year in which the GOP has enough political might to pass PBM reform — if it has the political will.

Yet two pharmaceutical industry trade groups do not appear to be counting on Republicans’ ability to quickly prioritize a health care issue. Instead, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Association of Manufacturers (NAM) are both launching ad blitzes aimed at pressing Congress to target PBMs before the year is over.

HealthCare.gov enrollees have more health plan options in 2025 compared to previous years, yet the average benchmark plan premium in states that use the federal enrollment platform increased modestly, according to CMS.

In most states, the open enrollment period for Affordable Care Act marketplace coverage runs from Nov. 1, 2024, to Jan. 15, 2025. Out of the 31 states that are using HealthCare.gov, eight have more Qualified Health Plan (QHP) issuers in 2025 than in 2024, and 97% of enrollees have access to three or more issuers, compared to 78% in 2021. Seven HealthCare.gov states have counties with a single QHP issuer in 2025, compared to nine states in 2024. Georgia stopped using HealthCare.gov in 2024 and transitioned to a state-run exchange, and Illinois is scheduled to move to a state-based marketplace for the 2026 plan year.

On Sept. 19, the Biden administration filed a petition asking the U.S. Supreme Court to review the case Braidwood Management, Inc. v. Becerra, which challenges the legality of the Affordable Care Act’s requirement that nearly all health insurers must cover a slew of preventive services without cost sharing.

Legal experts tell AIS Health, a division of MMIT, that the case could have significant ramifications for patients and the health care industry alike. And they say how it plays out may partly depend on who wins the upcoming elections.

“We’re getting close to four years in terms of when it was filed, but the stakes of this case remain really significant for tens of millions of Americans,” says Zachary Baron, director of the Health Policy and the Law Initiative at the O'Neill Institute. More than 150 million Americans have benefited from no-cost coverage of preventive services, he says, including lung cancer screenings, statins used to lower cholesterol, mammograms, vaccines and birth control.

Enhanced Affordable Care Act subsidies reduce out-of-pocket premiums mostly for adults ages 50 and older and for those living in states where monthly premiums for ACA marketplace plans are high, according to a recent Urban Institute study.

Enhanced advance premium tax credits (APTCs) were initially implemented as part of the 2021 American Rescue Plan Act and extended through 2025 by the Inflation Reduction Act. They offer more generous subsidies than were available under the original ACA rules for people with incomes at or below 400% of the federal poverty level (FPL), which for 2024 are $60,240 for an individual and $81,761 for a couple. Additionally, the enhanced APTCs limit premium contributions to 8.5% of income for marketplace enrollees with incomes above 400% of FPL.

With five weeks to go until election day, the vice presidential candidates sparred over health care during their Oct. 1 debate. There were no new revelations, but the Affordable Care Act was top of mind for both Minnesota Gov. Tim Walz (D) and Sen. JD Vance (R-Ohio), despite some industry observers’ belief that Republicans might want the candidates to steer clear of any major reforms.

Vance briefly touched on his idea to move higher-risk people into separate risk pools in the individual market and allow states to “experiment a little bit” on coverage for healthier people and those with pre-existing conditions. Vance claimed protections for pre-existing conditions would remain in place but that he would also try to “make the health insurance marketplace function a little bit better.”

In the latest twist in Arizona’s controversial quest to implement new statewide long-term care contracts with Centene Corp. and UnitedHealth Group, a Republican state senator said he is looking into the potential mismanagement of state taxpayer dollars by Gov. Katie Hobbs (D). That includes the questionable procurement of Medicaid contracts serving approximately 26,000 elderly and disabled members conducted by the Arizona Health Care Cost Containment System (AHCCCS).

The agency on Dec. 1, 2023, said it selected subsidiaries of Centene and UnitedHealth for contracts that would begin on Oct. 1, 2024. The contracts are worth an estimated $15 billion over seven years. An administrative law judge (ALJ), however, last month agreed with three local not-for-profit plans that the request for proposals process was flawed and should be redone. In a move that sources say is extremely rare, the state ignored the ALJ ruling and said it intends to move forward with the contracts after a one-year delay.

Although the November elections may alter the balance of power in Congress and change which party controls the White House, Democratic lawmakers this week introduced legislation that would advance a key policy priority for Affordable Care Act supporters and health insurers alike: Making enhanced ACA subsidies permanent.

One health policy expert says the timing of the move makes sense, despite the imminent elections.

“It’s good to kind of get the bill on the table and get people talking about the issue,” says Katherine Hempstead, Ph.D., senior policy adviser at the Robert Wood Johnson Foundation. She also tells AIS Health, a division of MMIT, that it’s important to “raise the profile of…how there will be chaotic [rate] filing next year if there’s uncertainty about whether the tax credits are going to be there or not.”

Sen. Bernie Sanders (I-Vt.) said during a Senate hearing that major PBMs promised to expand access to Ozempic and Wegovy if Novo Nordisk agrees to lower the list price. In a tense hearing on Sept. 24 held by the Senate Health, Education, Labor and Pensions Committee, Sanders, the committee chair, sought answers from Novo CEO Lars Jorgenson as to why the company’s semaglutide list prices top $1,000 a month in the U.S., noting that the drugs can cost anywhere from $130 to even $59 in other countries. Ozempic and Wegovy, both GLP-1 drugs, treat Type 2 diabetes and obesity, respectively. Sanders challenged Jorgenson to lower the U.S. list price, noting that The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx pledged to expand coverage of the diabetes and obesity medications. Jorgenson did not commit to a price reduction, saying “I don’t know under which conditions such a promise comes,” but he seemed to remain open to the idea if it helps patients access more affordable medicine. Jorgenson also noted that the $1,000 drug list price is a starting point for payer negotiations and said the company pays 75 cents per dollar received due to discounts, fees and rebates.

Health policy experts appear to largely agree that regardless of the partisan makeup of Congress and the White House next year, PBM reform will continue to be a key priority. Opinions are mixed, however, as to whether Democrats or Republicans would be more likely to take the hardest line against a highly scrutinized industry.

During a recent webinar hosted by Faegre Drinker Consulting, Nick Manetto, a principal at the firm, said Democrats are “maybe a hair” more likely to embrace PBM reforms that go beyond enacting new transparency requirements. PBM critics have said that while they support transparency, more data-reporting requirements aren’t enough to drive meaningful change in the industry.