By Megan R. Wilson

Listen to this briefing

• Breaking: Federal vaccine advisers are reviewing vaccines given during pregnancy. They could recommend the first major changes to the childhood vaccine schedule under RFK Jr.’s tenure.
• Exclusive: Sen. Angus King (I-Maine) wants HHS to reverse its policy on not taking public comment on some rulemakings. He has the support to force a Senate vote to do just that.
• Organ transplant crackdown: HHS announces it is decertifying Miami organ procurement organization over safety concerns.

Good Thursday afternoon, and welcome to Health Brief. I’m Megan Wilson and I’m bringing you the latest developments in health policy — a lot on the docket at the health agencies today. What are you watching for next week?

Do you have any intel, tips or scoops? Reach out to me at megan.wilson@washpost.com or on Signal at megan.434.

This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from the Washington Post newsroom. Learn more about WP Intelligence.

Joseph Hibbeln, a member of the CDC's Advisory Committee on Immunization Practices, on Thursday in Chamblee, Georgia. (Elijah Nouvelage/Getty Images)

	The Lead Brief

A federal vaccine advisory panel is considering recommendations for changes to the childhood vaccine schedule — which could be the first major modifications to the schedule under Health and Human Services Secretary Robert F. Kennedy Jr.

The Advisory Committee on Immunization Practices makes recommendations to the CDC on vaccine coverage which impacts who can get the shots. The committee consists of members handpicked by Kennedy, including many who have a history of expressing vaccine skepticism.

Here’s what’s on the docket:

The items on the agenda for today are discussions and recommendation votes on the hepatitis B vaccine and the combination shot for measles, mumps, rubella, and varicella (MMRV).

• The panel is considering whether to recommend that children under 4 years old not receive the combined MMRV vaccine, but rather a measles, mumps, and rubella shot and separate varicella vaccine (MMR+V).
• The panel is discussing whether to eliminate a recommendation to provide hepatitis B shots to all infants at birth.
• Catch up on the details around hepatitis B vaccine policy with this report from Lena H. Sun and Paige Winfield Cunningham from the Washington Post newsroom that’s following the ACIP deliberation around the current long-standing recommendation to give the shot to newborns.

Friday, the panel is scheduled to examine recommendations for coronavirus vaccines, including talking about effectiveness and safety data, and vote on recommendations. Experts are warning that the panel could narrow who should get an updated shot or require a prescription before receiving one.

What to watch: States are breaking from the federal government in an unprecedented way. The West Coast Health Alliance — comprising California, Hawaii, Oregon and Washington — released its own vaccine recommendations ahead of the ACIP meeting.

The state coalition has recommended coronavirus shots for all children under 2 and those ages 2 to 18 who either have “risk factors” or have never received a covid shot — guidance that clashes with the Food and Drug Administration’s decision last month to approve the updated coronavirus vaccines for people with health conditions or those ages 65 or older. The alliance said it relies on input from national provider organizations including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians.

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→ Here in the District, the D.C. Council approved an emergency bill last night that would allow anyone to get an updated covid shot without a prescription, according to local media outlet The 51st. It could head to the mayor’s desk as early as this week.

	Under the Radar

Exclusive: Sen. Angus King (I-Maine) has the support to force a vote in the Senate to overturn a Department of Health and Human Services policy that scales back when regulators must seek public feedback on certain actions.

King is using an arcane congressional process to target Kennedy’s decision in March to revoke a Nixon-era department memo known as the Richardson Waiver. In effect since 1971, it instructed the agency to seek public comment on a wide range of proposals related to agency management, grants and benefits — even when not explicitly required under the law.

“He talks about radical transparency, and what he has done in March is the most untransparent action at the Department of Health and Human Services in 50 years,” King told me in a phone call. He views the shift as emboldening Kennedy’s sweeping overhaul at HHS and cancellation of research grants at the National Institutes of Health.

Why it matters: The change could let the agency swiftly finalize rules impacting benefit programs, such as Medicaid, and federal grantmaking — including medical research and family planning funding — without public scrutiny.

→ When Kennedy made the change, he framed it as giving HHS more flexibility “to adapt quickly to legal and policy mandates,” he wrote in the policy statement.

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While agencies generally need to notify the public and collect input when making new rules, the law has an exemption for regulations “relating to agency management or personnel or to public property, loans, grants, benefits.” The Richardson Waiver directed HHS to use standard rulemaking procedure for these types of rules.

Still, the precise impact of Kennedy’s decision remains unclear. There’s little precedent to indicate which existing or future agency actions might be affected. Legal experts that have reviewed HHS’s regulatory actions say the agency hasn’t been taking advantage of it yet.

What’s next: King, who is partnering with Sen. Ron Wyden (D-Oregon), reached the 30 total signatures required in the obscure process to reverse certain federal actions governed by the Congressional Review Act — 31, to be exact, as of this writing. He must now secure 20 additional supporters needed for it to pass by a simple majority — a potentially steep climb in the divided Senate.

King said he’s approached Republicans about supporting the effort, and told me he hasn’t received any pushback. “I think I’ve got ’em thinking,” he said.

	Litigation Report

A federal appeals court blocked the Trump administration from moving forward with key parts of its sweeping reorganization of some federal health agencies while the larger legal fight moves through the courts.

The three-judge panel on the U.S. Court of Appeals for the 1st Circuit denied the administration’s request to lift a lower court injunction that paused the layoffs of 10,000 workers and structural changes across several HHS agencies — including components of the CDC, the FDA’s Center for Tobacco Products, and the Office of Head Start.

Why it matters: Although the larger legal question of whether the administration has the authority to make the massive changes, the action means that the cuts can’t take full effect — and some of the looming job cuts are protected — at least for now.

HHS declined to comment on the ruling.

What’s next: The 19 states that have sued the Trump administration over the restructuring are in for a much longer battle. The judges who have issued the most recent rulings — including the lower court’s preliminary injunction issued in July — have all been Biden appointees.

	Executive Health Brief

The Trump administration is taking actions to reform the nation’s organ donation system, including decertifying a Florida organ procurement organization for alleged safety lapses, HHS announced on Thursday.

Kennedy said that Life Alliance Organ Recovery Agency, part of the University of Miami Health System, will lose its certification. The move follows years of “unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors,” according to the agency.

HHS is implementing additional reforms, including safeguards that prevent line-skipping in organ allocation and a requirement for all organ procurement organizations to have a person in charge of managing patient safety.

My Washington Post colleague Peter Whoriskey was in the room this morning at the Humphrey Building where HHS is HQ’d when the administration made the announcement, and he’s got a dispatch with all the details.

What We’re Reading

“Government lawyers objected to new powers for Kennedy's COVID vaccine adviser,” Julie Steenhuysen and Chad Terhune report for Reuters.

“Team Trump’s Answer to Ballooning Obamacare Premiums: Less Generous Coverage,” Julie Appleby at KFF Health News writes.

“Oz offers recourse if Congress can’t quickly resolve subsidies,” according to Roll Call’s Ariel Cohen.

“FDA Warns Against Dubious Infant Monitors Claiming to Prevent Sudden Infant Death,” Jennifer Henderson writes at MedPage Today.

Jeffrey Davis, Rachel Hollander and Kristen O’Brien at lobbying firm McDermott+ discuss five major themes from public comments sent to the Centers for Medicare and Medicaid about the Physician Fee Schedule proposed rule.