WASHINGTON, D.C. — The Department of Health and Human Services rolled out a wide-ranging set of actions in mid-December that signal a major shift in federal health policy, spanning chronic disease research, newborn screening, vaccine guidance, artificial intelligence in medicine, and tighter federal standards for pediatric care.
At the center of the announcements was a high-profile roundtable on Lyme disease, convened by HHS Secretary Robert F. Kennedy, Jr., that brought together patients, clinicians, researchers, and lawmakers to address long-standing gaps in diagnosis and treatment. The meeting followed commitments outlined in the Make America Healthy Again Commission Strategy Report and focused on improving testing accuracy and care for a disease that affects hundreds of thousands of Americans annually.
HHS announced the renewal of the LymeX Innovation Accelerator, a $10 million public-private partnership with the Steven & Alexandra Cohen Foundation first launched during President Trump’s initial term. The initiative, the largest of its kind for Lyme disease, will expand the use of artificial intelligence and next-generation diagnostics to improve detection across all stages of infection. Federal estimates suggest between five and seven million Americans have been infected with Lyme disease over the past decade, with as many as 20 percent developing persistent, chronic symptoms.
The department also said the Centers for Medicare & Medicaid Services has clarified support for Lyme patients through the Chronic Care Management program, expanding access to coordinated care for Medicare beneficiaries with long-term complications.
In a separate move, Kennedy approved the addition of Duchenne Muscular Dystrophy and Metachromatic Leukodystrophy to the Recommended Uniform Screening Panel, the list of conditions recommended for universal newborn screening. Health officials said early detection of both rare diseases allows children to access FDA-approved therapies sooner, slowing disease progression and reducing years of uncertainty for families. States ultimately decide whether to adopt the screenings, but inclusion on the panel is expected to influence policy nationwide.
The Centers for Disease Control and Prevention also adopted a new approach to hepatitis B vaccination for infants born to mothers who test negative for the virus. Under the updated guidance, parents and clinicians will use shared clinical decision-making to determine whether to administer the birth dose or begin the vaccine series later in infancy. The policy does not apply to infants born to mothers who test positive or whose status is unknown, who will continue to receive the vaccine and immunoglobulin shortly after birth.
Beyond clinical care, HHS announced an agency-wide initiative to strengthen partnerships with historically Black colleges and universities, including the launch of the Roy Wilkins Fellowship to place HBCU students in paid public-service roles within the department and expanded career engagement across major health agencies.
The department also moved aggressively on regulatory and enforcement fronts. HHS outlined proposed rules to bar hospitals participating in Medicare and Medicaid from performing sex-rejecting procedures on children and to prohibit federal Medicaid and CHIP funding for such procedures. The FDA simultaneously issued warning letters to manufacturers and retailers accused of illegally marketing breast binders to minors, while HHS proposed revisions to civil rights regulations clarifying that gender dysphoria not resulting from physical impairments is excluded from the definition of disability.
Rounding out the week, HHS released a request for public input on accelerating the adoption of artificial intelligence in health care. The department is seeking guidance on how regulation, reimbursement, and research can better support AI tools that improve patient outcomes, reduce provider burden, and lower costs, while maintaining data security and interoperability.
Taken together, the announcements mark one of the most expansive policy pushes by HHS in years, touching nearly every corner of the health system as the administration advances its vision to reshape care, regulation, and innovation nationwide.
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