Congress nears spending deal with long-awaited PBM reforms

Congress is on the edge of a deal that would reshape pharmacy benefit managers, extend telehealth access, and renew certain public health authorities.

The language of the government funding package has not been publicly released as of Monday night and could still change, but sources indicate some longtime health care policy priorities are making the cut for the year-end spending deal, Rachel Cohrs Zhang reports.

The PBM legislation would increase transparency, regulate Medicaid payments to the middlemen, and prohibit PBMs from linking their payments to drug prices in Medicare. There's also proposed changes to doctors' pandemic-era pay rates and a measure to encourage generic drug approvals, according to sources. More from Rachel.

eye on fda

Which Marty Makary is set to run the FDA?

Marty Makary knows how to captivate an audience. Trump's nominee to lead the FDA has spent his medical career crusading against injustice in the health care system, attracting constant media and political attention.

Some consider him a fearless truthteller and an independent thinker with a deep respect for science and evidence. Others see him as a contrarian for contrarian's sake, opining on matters outside of his expertise for political clout, Lizzy Lawrence writes.

For instance, Makary is part of a group of doctors who vocally disagreed with certain public health policies during the pandemic. That still rankles some health care experts and peers who say he should have admitted error for predictions about herd immunity. Others say he's among the best of Trump's health care picks, and a promising sign for FDA in the upcoming administration. Check out Lizzy's must-read deep dive into Makary.

trump administration

Trump revives PBM talk, reassures about RFK Jr.

The incoming president spoke to reporters in Palm Beach on Monday, in a wide-ranging press conference that hit on vaccine concerns, high health care costs and a first-administration boogeyman: pharmacy benefit managers, who may see several reforms in the latest spending negotiations.

President-elect Trump nodded to a recent Mar-a-Lago meeting with top executives from Pfizer, Eli Lilly, the PhRMA lobby, and his nominee for HHS secretary, Robert F. Kennedy Jr. He characterized the meeting as mostly revolving around high drug costs and the "middlemen" who make a profit.

Trump's first administration advanced a rule that would have eliminated the rebates paid to these PBMs, but lawmakers ultimately sacrificed the rule for hundreds of millions in projected savings during budget talks.

Trump also sought to downplay RFK Jr.'s potential actions on vaccine policy, saying people will find that RFK Jr. is "a very rational guy." He repeated assurances that "you're not going to lose the polio vaccine," but also referenced autism rates (again) and said "we're going to have reports."

transition watch

RFK Jr. heads to the hill

The HHS nominee has a stack of meetings with senators this week as he seeks to secure his confirmation. A number of lawmakers have expressed concern about his record on vaccines, while others want reassurances about his stance on abortion policy (and the pharmaceutical industry is sitting quiet, for now).

Some of those pressures came to the fore late Friday, when polio survivor and outgoing Senate Republican Leader Mitch McConnell put out a statement about reports that an RFK Jr. associate filed a petition to revoke approval of a polio vaccine. That shot "has saved millions of lives and held out the promise of eradicating a terrible disease. Efforts to undermine public confidence in proven cures are not just uninformed — they're dangerous," McConnell said.

RFK Jr. reportedly has 20 meetings scheduled this week, including with Republican staff of the HELP committee.

health care policy

Health care issues to watch in 2025

It wasn't really a health care-focused election. But that doesn't mean Congress and Trump aren't poised for major changes to health care policy in the next year. There are three main arenas where we could see shakeups soon, John Wilkerson writes.

Medicaid is especially vulnerable. Republicans control the White House and both chambers of Congress, enabling them to avoid a Senate filibuster and pass major changes through the budget process. Then, of course, there are enhanced ACA subsidies, which already lost out on a one-year extension in the current spending plan.

Medicare could also be in for policy changes, though Trump has pledged not to cut it. Doctors face a pay rate cut, lawmakers are still hammering out site-neutral reforms, and there could be appetite to tackle overpayments in Medicare Advantage. More from John.

public health

CDC director urges calm, focus ahead of Trump transition

Outgoing CDC Director Mandy Cohen is simultaneously trying to convince critics that the agency has refocused since its pandemic-era missteps, and calm nervous staff about what is to come.

There are multiple CDC critics, including President Trump's director-nominee Dave Weldon, coming in with the next administration. Congressional Republicans have proposed a 22% budget cut that includes eliminating several programs and refocusing the agency on its core priorities. At the same time, a number of 'Make America Healthy Again' advocates want to see the CDC reinvest its resources in tackling chronic illnesses.

Cohen sat down with STAT's Helen Branswell to discuss the climate around public health and jitters about the incoming administration's plans. Her message: We learned from our Covid-19 mistakes. We're not the same agency. More from Helen.

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What we're reading

FDA authorizes many AI devices for use in kids. Are they validated in a pediatric population? STAT
Thom Tillis warns pressure campaign to push Cabinet nominees could backfire, Politico
Broken promises, lax scrutiny: Inside Massachusetts's failure to regulate Steward Health, The Boston Globe
Trump's CDC pick wouldn't let go of false theory that vaccines cause autism, The Washington Post