September 19, 2023
Reporter, D.C. Diagnosis Writer

Hello and happy Tuesday, D.C. Diagnosis readers! Have you gotten your newest Covid booster shot yet? How was it? Send autumn plans, news and tips to sarah.owermohle@statnews.com.

on the hill

About last night

House leadership last night canceled a scheduled vote on a health care package that included transparency requirements for hospitals and insurers, reforms to some PBM practices, and a small site-neutral payment policy for administering drugs, Rachel writes.

The bill apparently couldn’t reach the two-thirds majority it needed for the fast-track process lawmakers chose. One lobbyist who supported the legislation said the negotiation process was too chaotic, and Democratic members felt confused because their leadership was divided. 

Only one out of three Democratic leaders on health care supported the package. Rachel caught up with the three to get their take on the hiccup last night.  

The most illuminating exchange was with Rep. Richard Neal (D-Mass.), who said he believed every Ways & Means Committee Democrat would have opposed the bill if it had come up for a vote. But he wouldn’t commit to supporting the bipartisan version negotiated in the Energy & Commerce Committee, either, which includes provisions he claims to want. And more importantly, he acknowledged that powerful hospitals in his home state weren’t a fan of the effort anyway.

Education & Workforce ranking member Rep. Bobby Scott (D-Va.) also announced his opposition before the vote, and told Rachel he feared employees wouldn’t have enough privacy about what medicines they take under the data reporting requirements as drafted. Energy & Commerce ranking member Frank Pallone (D-N.J.), who supported the bill, deflected questions and told Rachel to ask Republicans what next steps would be. (Rachel asked them, and they haven’t answered yet.)

The package isn’t necessarily dead. It wasn’t immediately clear whether the bill’s sponsors would pursue a more traditional vote, requiring only a House majority, or tweak the bill to get more Democratic support. The bill was also supposed to fund community health centers and other public health programs, which expire at the end of the month.


At the FDA

Artificial wombs could soon be a reality

Could very premature babies find chances for survival in artificial placentas? The FDA could soon let device makers put the question to the test with humans. The agency is convening a two-day panel, starting today, to debate going forward with the fast-developing field, STAT’s Lizzy Lawrence writes.

Researchers are targeting the tech to babies born at less than 28 weeks, a 2% sliver of new births with abysmal survival rates. But the question before the regulators and developers is how they plan to test with humans, and how it can be done ethically. It’s very difficult to predict extremely premature births, and when they happen, there is a brief but strenuous window for care — including parents’ consent for the untested wombs.

Another major question is which infants to test this technology with. One researcher told Lizzy his group is working on a tool to find infants with an 80% or higher chance of dying without intervention. Read more about the thorny ethical questions before the FDA.


mental health in america

Rep. Smith talks about the mental health crisis, in the wake of his own

GettyImages-945318540Chip Somodevilla/Getty Images

Longtime Washington state Rep. Adam Smith is the latest lawmaker to open up about their struggles with mental health. His story — detailed in a new book, Lost and Broken — is reflective of a national struggle to turn around soaring depression and anxiety rates across age brackets. 

But while Smith and other Capitol Hill lawmakers agree there is a crisis to address, there are growing fissures among lawmakers and mental health experts about how to reverse trends, especially among teens, as everything from social media use to pandemic shutdowns gets thrown into the debate.

I sat down with Smith to talk about his experience, what it taught him about national mental health plans and if the kids are alright. Read here.



medicare price talks

Drug negotiation’s first courtroom clash 

Attorneys for the U.S. Chamber of Commerce and the federal government sparred in oral arguments Friday over the first of many lawsuits that could stall Biden’s signature drug pricing initiative — just weeks after the White House unveiled its first 10 targets.

The initial case is before a Trump-nominated judge in Ohio and centers around whether the program is a violation of drugmakers’ due process rights, Rachel writes. The Chamber argues that the process doesn’t include enough safeguards to make sure drugmakers get a fair return on their investment. They are asking for a preliminary injunction by Oct. 1, or the deadline for when drugmakers have to sign paperwork to participate in negotiation. 

Government lawyers argued that since other drugmakers haven’t filed motions for preliminary injunction, the judge should question how urgent it really was to stop the program imminently. More from Rachel.


drug pricing

A potential drug negotiation loophole

If the government really wants to safeguard Medicare’s new drug price negotiation program, they’re going to have to watch out for backdoor deals between generics companies and pharmaceutical manufacturers, researchers at Harvard Medical School and Brigham and Women’s Hospital’s PORTAL center argue in a new column in JAMA, my colleague Rachel Cohrs writes.

They’re called limited-supply agreements, where brand-drug makers allow generics makers to come on the market, but limit the share of patients they will actually serve. And in some cases, they could exempt drugs from the negotiation program while maintaining profits for the brand pharmaceutical manufacturers, the authors say.

“Without careful attention, these loopholes could jeopardize the success of a powerful mechanism for helping ensure fairer prescription drug prices,” the authors write. They propose that CMS should work with other agencies to root out as many of the deals as possible. 


the business of care

Americans demand changes from antitrust regulators

More than a thousand comments on a recent FTC proposal laid bare Americans’ anger and disillusionment over consolidation’s effects on all sectors of the economy, but especially health care, STAT’s Tara Bannow reports.

The proposed guidelines would challenge anticompetitive mergers and acquisitions. Health care mergers aren’t the only target, but they earned plenty of ire from patients and doctors across America who detailed experiences with rising costs, staff layoffs, and drug shortages.

The FTC is exploring whether to lower its threshold for probing acquisitions, especially vertical mergers. It could be a major move for hospital deals, as Tara details here.


More around STAT
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What we’re reading

  • Medicare wants to increase payments for heart rehab. Hospitals see an opening to get more, STAT
  • Florida Gov. Ron DeSantis injects presidential politics into the Covid vaccine debate, KFF Health News
  • Opinion: Where are HHS and the FTC on online privacy for people with substance use disorder? STAT
  • Expected CDC guidance on N95 masks outrages health care workers, NBC News

Thanks for reading! More on Thursday,


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