RFK Names Leucovorin Startup Co-Founder to Chair Autism Panel. Posted Draft Omits ABA

WASHINGTON – Health Secretary Robert F. Kennedy Jr. named Dr. John Gaitanis, a pediatric neurologist and co-founder of a leucovorin telehealth company, to chair the Interagency Autism Coordinating Committee (IACC). He replaces Dr. Sylvia Fogel, who remains a member, Reuters reported. HHS confirmed the change took effect Sept. 18, three weeks after the committee adopted a strategic plan to increase federal autism funding.

Gaitanis became director of the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on Aug. 23. Meadow Biosciences named him co-founder and chief medical officer when it launched in April. Becker’s Behavioral Health, citing MedPage Today, reported that Meadow CEO John Slattery said Gaitanis divested his financial interest before becoming NICHD director. This divestment has not been independently verified for this article.

The 336-page working draft posted for the committee’s Aug. 27 vote never mentions applied behavior analysis. It mentions Medicaid more than 100 times and calls for a confirmatory leucovorin trial in a defined subgroup of autistic people. Members received additional revisions shortly before the vote, STAT reported. This review covers the posted working draft and proposed revisions but could not confirm the adopted text.

What Kennedy Told the Committee

Kennedy told members the committee had traditionally been chaired by a federal representative, according to two people who described the meeting to Reuters. HHS spokesperson Emily Hilliard said a federal chair would strengthen plan implementation and coordination across agencies. Fogel, a Harvard Medical School psychiatry instructor and parent of an autistic adult, had chaired the committee since January.

Kennedy praised Fogel’s work and said she would help with the transition, Reuters reported. “I think your recommendations have been excellent. I would have been even more aggressive if I were there, but only slightly so,” he said, according to one of the people who spoke to Reuters.

HHS appointed 21 new public members in January. On Aug. 27, the committee adopted the plan 26 to 1, with 13 abstentions, STAT reported. One member said more than 1,000 pages of public comments and revisions arrived the afternoon before the vote. Twelve advocacy groups, including the Autism Society of America, Autism Speaks, The Arc, and the Autistic Self Advocacy Network, said in a Sept. 2 statement that the process was not “transparent, accessible, scientifically rigorous, and responsive to public input.” Eleven groups, including the National Autism Association, endorsed the plan and process on Sept. 9.

Gaitanis’s Role at Meadow

Meadow announced its launch April 14, advertising virtual consultations and, when prescribed, compounded leucovorin delivered by a licensed pharmacy in all 50 states. Prices started at $199 a month, according to its launch release. The company, operating as Meadow Health, now advertises $249 a month plus $13 shipping. Its launch release quoted Gaitanis: “I have been caring for children for over three decades and prescribing leucovorin for two decades.”

Evidence for routine use of leucovorin for autism remains limited. President Trump, Kennedy, and senior health officials promoted the folate-based drug at a White House event in September 2025. On Jan. 29, the European Journal of Pediatrics retracted a randomized autism trial that enrolled 80 children, citing errors in reported results and problems with statistical analysis. In March, the FDA added an indication for cerebral folate transport deficiency in adults and children with a confirmed FOLR1 gene variant. It did not approve leucovorin for autism. “Right now, we don’t have sufficient data to say that we can establish efficacy for autism more broadly,” a senior FDA official said at the time, according to CNN. The American College of Medical Toxicology also advises against routine use for autism.

The weekly number of U.S. children filling leucovorin prescriptions rose from 734 at the start of 2025 to 5,858 at year’s end, an increase of about 700%, University of Michigan researchers reported in August. Dispensing was increasing before the September event and rose further during the week of the announcement. The data do not establish that every prescription was for autism.

Reuters reported that Gaitanis met NIH Director Jay Bhattacharya with Fogel and others in August 2025 to discuss leucovorin research. He has also served as a paid medical expert in vaccine-injury cases, including those involving the MMR vaccine, and signed a January 2025 letter supporting Kennedy’s nomination, Reuters reported. NIH described NICHD’s annual budget as about $1.7 billion when announcing his appointment in August; the institute’s remit extends well beyond autism.

ABA, Medicaid, and Leucovorin in the Draft

Neither the July 17 working draft nor the posted updated draft names “applied behavior analysis,” “ABA,” or “behavior analyst.” Each mentions “behavioral services” twice and discusses delays in access to early intensive behavioral intervention. These omissions do not change Medicaid coverage or reimbursement for ABA. States cover ABA through Medicaid, although their policies differ.

The July draft asks the Centers for Medicare & Medicaid Services to issue guidance on payment and coverage policies that delay diagnosis and evaluation of co-occurring conditions. It proposes reviews of blanket claim edits, prior authorization, denials, and payment rates, with a 12-month target and a first-year planning target of $2 million. Proposed revisions posted in August soften the language to encourage states to review payment barriers. These are advisory proposals, not a binding deadline or a new ABA coverage rule.

On leucovorin, the working draft asks NIH to fund “an adequately powered, multicenter, biomarker-defined trial of leucovorin” in autistic people with evidence of disrupted folate transport. It proposes launching the trial within 24 to 36 months, after work to standardize relevant tests and define the study population. The draft says a confirmed genetic indication “should not be extrapolated to a broader diagnostic population,” and withholds a recommendation for autism.

“This Plan does not recommend leucovorin as a treatment for autism, population-level folate-receptor-autoantibody screening, clinician treatment guidance, or coverage determination in advance of confirmatory evidence.” – IACC Strategic Plan 2026–2028, working draft.

The draft recommends $747.444 million in annual funding by fiscal 2028, compared with the $390.444 million authorized annually for specified programs under the Autism CARES Act for fiscal 2025 through 2029. The proposed increase is $357 million. These figures are recommendations and statutory authorizations, not appropriated or committed funds.

The committee advises the federal government on autism research and services. Its recommendations do not themselves fund the proposed trial, require CMS to issue guidance, or change what states pay ABA providers. Those steps would require separate government action.

AT A GLANCE

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