Trump admin rescinds EMTALA guidance

The Trump administration on Tuesday rescinded guidance to U.S. hospitals that directed them to provide emergency abortions for women when necessary to stabilize their medical condition.

Following the overturning of Roe v. Wade in Dobbs v. Jackson, the Biden administration issued guidance saying the Emergency Medical Treatment and Labor Act (EMTALA) provided federal protections to providers performing abortions in emergency situations, even in states with abortion restrictions. EMTALA was passed in 1986 to prevent hospitals from refusing emergency care to patients who couldn't pay.

Soon after, the Department of Justice (DOJ) filed a lawsuit challenging an Idaho law that only allows for abortions to save the life of a pregnant person, arguing the exception was "extremely narrow" and violated EMTALA.

The case went to the Supreme Court which ruled that abortions in medical emergencies are legal in Idaho despite its strict abortion ban.

In a news release, CMS said that the previous guidance doesn't reflect the policy of the Trump administration.

"CMS will continue to enforce EMTALA, which protects all individuals who present to a hospital emergency department seeking examination or treatment, including for identified emergency medical conditions that place the health of a pregnant woman or her unborn child in serious jeopardy," CMS said in the release. "CMS will work to rectify any perceived legal confusion and instability created by the former administration’s actions."

Some experts said the unclear policy could discourage doctors from performing emergency abortions in states where abortions are banned or restricted.

"We've already seen since the overturn of Roe that uncertainty and confusion tends to mean physicians are unwilling to intervene, and the more unwilling physicians are to intervene, the more risk there is in pregnancy," said Mary Ziegler, a professor at the University of California-Davis.

"This is not just withdrawing what the Biden administration did," she added. "It's creating a lot of unanswered questions about what hospitals are supposed to do going forward. So more confusion means more risk."

Abortion opponents praised the move. Roger Severino, VP for domestic policy at the Heritage Foundation, who served in the first Trump administration, said that President Trump "promised to dismantle the abortion radicalism left by his predecessor, and today another abortion mandate bites the dust."

(Seitz/Mulvihill, Associated Press, 6/3; Stolberg, New York Times, 6/3; Kacik, Modern Healthcare, 6/3)

CDC recommends 'shared clinical decision-making' for COVID-19 shots for children

CDC last week issued updated immunization schedules saying that COVID-19 vaccines are still recommended for healthy children provided their doctors approve. Late last month, HHS Secretary Robert F. Kennedy Jr. said CDC would no longer recommend the shots for healthy children and pregnant women.

CDC kept the shots on the immunization schedule for healthy children ages 6 months to 17 years old but added the condition that children and their caregivers would only be able to get the vaccines in consultation with a doctor or healthcare provider, which the agency referred to as "shared clinical decision-making."

"Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," CDC said.

The vaccines will also be available under those same terms for the roughly 38 million low-income children who rely on the Vaccines for Children program.

The revisions also confirmed that COVID-19 vaccines are no longer advised during pregnancy, which Kennedy said would happen.

"The CDC and HHS encourage individuals to talk with their healthcare provider on any medical decisions," said HHS spokesperson Andrew Nixon. "Under the leadership of Secretary Kennedy, HHS is restoring the doctor-patient relationship. If a parent desires their healthy child to be vaccinated or if a pregnant woman desires to be vaccinated, their decision should be based on informed consent through the clinical judgment of their healthcare provider."

Nixon added that there is no contradiction between Kennedy's position and CDC's action. "The old recommendation that was on the vaccine schedule that said get a COVID shot for a healthy kid is no longer there," he said. "The only recommendation is go talk to a health-care provider."

Experts said maintaining a "shared clinical decision-making" recommendation for COVID-19 vaccines for children should preserve parental choice and compel insurers to pay for the shots. However, they also cautioned it could lead to more confusion than a simple blanket recommendation, leading some parents to pay out of pocket or prompting some providers not to vaccinate their patients.

"At least how some clinicians perceive it is, 'You guys are the experts, and if you don't know what the right thing to do is, how are we supposed to have that conversation in a 10-minute office visit?'" said Sean O'Leary, chair of the American Academy of Pediatrics' committee on infectious diseases.

(Jewett, New York Times, 5/30; Nirappil, Washington Post, 5/30)

"I can confirm that I, and my co-authors, did not write that paper," Keyes said in a statement. "I was surprised to see what seems to be an error in the citation of my work in the report, and it does make me concerned given that citation practices are an important part of conducting and reporting rigorous science."

Robert Findling, chair of the department of psychiatry at Virginia Commonwealth University, said he also didn't write a study that was credited to him in the initial report, according to a spokesperson for the university. The study was cited to suggest pharmaceutical ads rely on vague symptom lists that overlap with normal teenage behaviors and could be driving overprescription of drugs to teens.

When asked about the errors in the report, White House press secretary Karoline Leavitt said the report will be updated.

"I understand there was some formatting issues with the MAHA report that are being addressed and the report will be updated," she said. "But it does not negate the substance of the report, which, as you know, is one of the most transformative health reports that has ever been released by the federal government."

"Minor citation and formatting errors have been corrected," said HHS spokesperson Andrew Nixon in a statement. Nixon described the report as a "historic and transformative assessment by the federal government to understand the chronic disease epidemic afflicting our nation's children."

(Goodman, et. al., CNN, 5/29; Seitz, Associated Press, 5/29)

RFK Jr. says 'corrupt' medical journals need to change or NIH will publish in-house

HHS Secretary Robert F. Kennedy Jr. said in an interview that government scientists may stop publishing in major medical journals, which Kennedy said were "corrupt."

"We're probably going to stop publishing in the Lancet, New England Journal of Medicine, JAMA, and those other journals because they're all corrupt," Kennedy said in a podcast interview, adding that the journals publish studies that are funded by the pharmaceutical industry.

Kennedy specifically called out The Lancet during the interview.

"Richard Horton who's the head [of] The Lancet, who really disgraced himself during COVID with the Lancet letter … says 'Yeah we're not, we are no longer a science journal, we are about promoting pharmaceutical products and that's what we do," Kennedy said. According to STAT, Kennedy was likely referring to a comment published in 2015 by Horton, who is editor in chief of The Lancet, in which he wrote that "much of the scientific literature, perhaps half, may simply be untrue," partly because of "flagrant conflicts of interest."

Instead, Kennedy said that NIH will establish medical journals for its various institutes and centers unless current journals change "radically."

A spokesperson for the New England Journal of Medicine said that the journal "is focused on publishing scientific breakthroughs to improve the health of Americans and people around the world. We have strict processes in place to ensure scientific rigor and editorial independence, including peer review of research by external experts."

(Oza, STAT+ [subscription required], 5/27)

HHS proposes shifting 340B oversight to CMS

HHS in a budget plan issued last week said it plans to shut down the Health Resources and Services Administration (HRSA) and redistribute its responsibilities, including shifting management of the 340B Drug Pricing Program to CMS.

Under the proposed budget, CMS would get $12 million to run 340B in fiscal year 2026, the same amount that was allotted to HRSA this year, to "provide oversight and auditing of covered entities and drug manufacturers, support operational improvements, and increase operational efficiencies." Meanwhile, HRSA would be absorbed into the new Administration for a Healthy America.

The 340B program requires drug manufacturers to provide discounts on outpatient prescription drugs to certain eligible safety-net hospitals.

Given that CMS has significantly greater regulatory authority than HRSA and that the budget proposal repeatedly emphasizes oversight and program integrity, it's possible drugmakers and providers could face stricter scrutiny if CMS is placed in charge of 340B, according to Greg Fliszar, a shareholder at the law and lobbying firm Baker Donelson.

"For covered entity providers, I think they're going to have to focus a lot more on compliance, let's put it that way," Fliszar said.

However, Elizabeth Lee, a policy advisor at Advocates for Community Health, said one potential benefit would be streamlining oversight by having one agency manage several prescription drug programs. Currently, CMS handles Medicare outpatient drug price negotiations and Medicare Part B inpatient medication pricing while also regulating duplicate discount restrictions.

"If moving the program to CMS helps bring accountability and transparency to the program, I think that's a good thing," Lee said.

(Murphy, Becker's Hospital Review, 6/2; Early, Modern Healthcare, 6/2)