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FDA in the hot seat, again

April 9, 2024
Reporter, D.C. Diagnosis Writer

Hello D.C. Diagnosis readers, and happy Tuesday! Did you witness yesterday's solar eclipse? How about nearby cows, flamingoes and tortoises? There's always a health (and science) angle. Send news, tips and eclipse pics to sarah.owermohle@statnews.com.

on the hill

Califf returns to Capitol Hill

The FDA commissioner testifies before a House panel this week, and it's not expected to be pretty. Republicans on the Oversight and Accountability panel have already said they plan to ask about "several issues" including the baby formula crisis, drug shortages, tobacco and hemp regulations.

That's pretty familiar territory for Robert Califf, who first testified on the formula shortage in May 2022, months after his confirmation. But the issue has dogged the FDA since and triggered ambitious reorganization plans. Democrats also plan on asking about both drug and formula shortages, but are taking a different tack, a staffer told D.C. Diagnosis. But they'll focus more on what manufacturers can do, and what information they owe, when they have interruptions and issues.

Democrats are also keen to bring up FDA's authority and threats from the mifepristone lawsuit argued before the Supreme Court last month. Califf and other FDA administration officials have been wary of commenting on ongoing litigation, but that won't stop lawmakers on Thursday.


policy

A telehealth bellwether

There's a lot to say about dysfunction in the House of Representatives lately, but it's important to give credit where credit is due — and the House Energy & Commerce Committee has been out front on action on health care this Congress, and has proved unusually committed to regular order.

Its policymaking cycle will begin again tomorrow when the panel's health subcommittee holds a hearing on the new hot topic in health care —  telehealth policy extensions, my co-author Rachel reports. Major pandemic-era telehealth policies are expiring on December 31, and the scope of a potential extension will be crucial to determining how much health policy gets accomplished in other areas to pay for it.

A few of the bills on the docket include proposals that would make various flexibilities expanding where Medicare patients can access telehealth, defining what types of providers can get paid for telehealth services, and ensuring audio-only services are eligible for reimbursement. But more than the details, it will be important to listen for how often lawmakers raise concerns about government spending, fraud, and abuse as an indication of whether Congress can truly make permanent telehealth changes, or whether they're going to do another short-term, small-dollar extension.



2024 watch

Trump courts abortion compromise, angering everyone

Former President Trump has no problem taking credit for the court that overturned Roe. But it's proved slightly harder to lay out what he wants to replace the federal abortion protection. 

Trump's Monday morning video backing states' rights to make abortion limits — rather than the federal government — riled pro- and anti-abortion activists alike. While several Republicans endorse the state-led plan, some longtime Trump allies like Lindsey Graham (R-S.C.) said they disagree and will push for national limits. Susan B. Anthony Pro-Life America also swiftly expressed disappointment; president Marjorie Dannenfelser said the stance "cedes the national debate" to Democrats.

Part of the backlash is that Trump's Monday message that "the states will determine by vote, or legislation, or perhaps both," runs counter to comments he made just weeks ago, suggesting he'd endorse a national ban with exceptions. But he acknowledged in that same earlier interview that the issue had cost Republicans. "We want to take an issue that was very polarizing and make it settled and solved so everyone could be happy," he said.


medicare money

Eye-popping charity care claim 

The country's biggest hospital chain, HCA Healthcare, told CMS it doled out almost $1 billion more in financial assistance to needy patients than it reported on its financial statement in 2022, helping the enormously profitable company extract billions of dollars from taxpayer-funded programs, STAT's Tara Bannow reports.

While it's not unusual for hospitals to report more charity care to CMS — because the agency allows more to count under that umbrella — HCA's billion-dollar gap is pretty unprecedented. And it could have big repercussions not just for HCA but other, struggling hospitals competing for the same national and state funding. Advocates and industry experts have for years said the funds aren't well-targeted to hospitals that truly need the money. 

There also is a slippery slope in some of HCA's math, namely discounts it's counting as charity care. Tara explains.


More around STAT
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What we're reading

  • About half of cancer drugs given accelerated approval don't show improved survival or quality of life, STAT
  • Insurers reap hidden fees by slashing payments. You may get the bill, The New York Times
  • Your dog is probably on Prozac. Experts say that says more about the American mental health crisis than pets, STAT
  •  Biden rips into Trump over abortion statement, Politico

Correction: Rachel is clearly missing our recently departed Washington editor, as she misstated Sen. Elizabeth Warren's name in her last edition. She regrets the error.


Thanks for reading! More on Thursday,


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