legislation & regulation

Small-molecule drugs and biologics may produce similar health benefits, but because small molecules tend to be priced lower than biologics, they often represent better value, according to a recent Health Affairs study. And the study authors argued those findings suggest it could be worth revising how the Medicare Drug Price Negotiation Program is set up.

The Inflation Reduction Act of 2022 requires that Medicare negotiate a Maximum Fair Price for selected small-molecule drugs nine years after they were approved by the FDA. Whereas for selected biologics, the negotiated price takes effect after 13 years.

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.

Copay maximizer programs are gaining popularity among payers while copay accumulators appear to be losing some of their appeal, according to the annual Copay Accumulator & Maximizer Programs Special Report published by AIS Health’s parent company, MMIT. The report was based on surveys of 35 commercial insurers and PBMs representing 121.0 million lives.

About 39% of people were enrolled in plans with copay accumulators in 2024 on average, down from 47% in 2023. And 47% of enrollees were in plans with copay maximizer programs. On average, payers anticipated that about 48% and 57% of plan members will be covered by plans with copay accumulators and maximizers within the next 12 months, respectively.

While changes to the Medicare Part D benefit resulting from the Inflation Reduction Act (IRA) are already underway, Part D plans and manufacturers still face a good deal of uncertainty as to how the Medicare landscape is going to shake out. Changes to Medicare Part D plans in 2025 will almost certainly impact a large swath of beneficiaries, as well as manufacturers’ contracting strategies for 2026, said industry experts at a recent webinar hosted by Avalere.

“We are at an interesting moment for Part D,” observed Ethan Hall, associate principal on the client solutions team for Avalere, during an Oct. 30 webinar that he moderated.

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.

Premiums for many stand-alone Medicare Part D Prescription Drug Plans will go up moderately in 2025, while the number of PDP options for beneficiaries will drop significantly, according to AIS Health’s analysis of the recently released CMS Medicare Advantage and Part D landscape files.

The Inflation Reduction Act, passed in 2022, ushered in a host of policy changes to the Part D benefit that will take effect in 2025: Most notably, Medicare Part D beneficiaries’ out-of-pocket drug costs will be capped at $2,000 annually and Part D plan sponsors will be responsible for 60% (up from 20%) of any costs their enrollees incur beyond that cap. As a result, the Medicare Part D national average monthly bid amount (NAMBA) is projected to increase by $115, nearly 180%, to $179.45 in 2025.

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.”