Health Care Week in Review | Draft MAHA Commission Strategy Document Circulated; President Trump Signs EO Aiming to Fill Drug Ingredient Reserve

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Regulations, Notices & Guidance

• On August 13, 2025, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction. This document corrects typographical and technical errors in the proposed rule that appeared in the July 16, 2025 Federal Register (90 FR 32352) entitled, Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Programspecifying proposed changes to the Medicare physician fee schedule (PFS) that is applicable for calendar year (CY) 2026, and other changes to Medicare Part B payment policies, as well as proposals regarding other Medicare payment policies.
• On August 13, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Notice with Request for Comment: Consideration of Adding Duchenne Muscular Dystrophy to the Recommended Uniform Screening Panel. HRSA is considering recommending to the Secretary of the Department of Health and Human Services (HHS) the addition of Duchenne Muscular Dystrophy (DMD) to the Recommended Uniform Screening Panel (RUSP). HRSA is providing notice and requesting comments from the public on this potential recommendation. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants and children. Non-grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without cost-sharing (e.g., co-payment, coinsurance, etc.). HRSA is particularly interested in comments that address the potential benefit of early screening of DMD within the newborn period, the ability of state newborn screening programs to screen for DMD, and the availability of effective treatments for DMD. In deciding whether to provide recommendations to the HHS Secretary supporting the addition of DMD to the RUSP, HRSA will consider public comments, including evidence-based reports, obtained through this notice.
• On August 13, 2025, HRSA released a notice entitled, Health Center Program Performance Period Extensions; Correction. HRSA is extending health center grantees’ performance periods to a total of four years. The change from a three-year performance period to a four-year performance period will provide current health centers additional time to serve their service area before they apply for a new award and will provide a funding amount consistent with what would have been made available through the Service Area Competition (SAC). The extended performance period supports HRSA’s commitment to continuity in access to comprehensive primary care and will not impact HRSA’s ability to ensure that health centers comply with Health Center Program requirements. This update will not change the statutory requirement that health centers that fail to comply with Health Center Program requirements will receive a one-year performance period if a new project period is awarded.
• On August 13, 2025, HRSA released a notice entitled, Notice of Supplemental Award; Infant-Toddler Court Program – State Awards. HRSA is providing additional award funds to the twelve current Infant Toddler Court Program (ITCP) - State Awards recipients previously funded under HRSA-22-73 to support the continuation and expansion of existing activities to build state and local capacity and implement the infant-toddler court approach in federal fiscal year (FY) 2025.
• On August 14, 2025, the Food and Drug Administration (FDA) released a notice entitled, Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability. FDA is announcing the revocation of the Emergency Use Authorization (EUA) issued to LumiraDx UK Ltd. for the LumiraDx SARS CoV-2 RNA STAR Complete. FDA revoked the EUA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the EUA holder.
• On August 14, 2025, HRSA released a notice entitled, Notice of Supplemental Award; Infant-Toddler Court Program – National Resource Center. HRSA is providing additional award funds of $1,750,000 in federal FY 2025 to ZERO TO THREE National Center for Infant, Toddler and Families, Inc., the current recipient of the Infant-Toddler Court Program (ITCP) – National Resource Center (NRC) cooperative agreement (HRSA-22-074), to support the continuation of existing activities, using the Infant Toddler Court (ITC) approach, to improve child welfare and early childhood systems and advance early developmental health and well-being. The supplemental funding would provide financial and technical support to local infant-toddler court sites that previously received funding under HRSA-18-123, but that do not currently receive HRSA funding under HRSA-22- 073/074, and expand technical assistance (TA) needed to support the continuation and expansion of State Award activities funded under HRSA-22-073/074.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event.

• August 20, 2025: VA announced a meeting of the Rehabilitation Research and Development Service Scientific Merit Review Board. This is a virtual meeting with some sessions open to the public.
• August 26-27, 2025: VA announced a meeting of the Veterans’ Advisory Committee on Rehabilitation. This is a virtual meeting open to the public.
• August 27, 2025: VA announced a meeting of the Health Systems Research Scientific Merit Review Board. This is a virtual meeting with some sessions open to the public.
• September 3-4, 2025: The National Institutes of Health (NIH) announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a hybrid meeting with some sessions open to the public.
• September 4, 2025: NIH announced a meeting of the National Institute on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
• September 4, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 4, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is an in-person meeting with some sessions open to the public.
• September 4-5, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 5, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a hybrid meeting with some sessions open to the public.
• September 9, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a hybrid meeting with some sessions open to the public.
• **September 9, 2025: NIH announced a meeting of the National Council on Drug Abuse. This is a hybrid meeting with some sessions open to the public.
• September 9-10, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
• September 9-10, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the National Center for Health Statistics ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• September 10, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• September 10, 2025: FDA announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a hybrid meeting with some sessions open to the public.
• September 11, 2025: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting with some sessions open to the public.
• **September 11, 2025: NIH announced a meeting of the National Institute of Mental Health. This is a virtual meeting with some sessions open to the public.
• September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting open to the public.
• September 11-12, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• September 11-12, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting open to the public.
• September 16, 2025: NIH announced a meeting of the National Human Genome Research Institute. This is a hybrid meeting open to the public.
• September 17-18, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• September 17-18, 2025: NIH announced a meeting of the National Institute on Aging. This is a virtual meeting with some sessions open to the public.
• September 18, 2025: NIH announced a meeting of the National Center for Advancing Translational Sciences. This is a hybrid meeting with some sessions open to the public.
• **September 18, 2025: FDA announced a meeting entitled, Biosimilar User Fee Act (BsUFA) III Regulatory Science Program Interim Public Meeting. This is a hybrid meeting open to the public.
• September 19, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a hybrid meeting with some sessions open to the public.
• **September 19, 2025: FDA announced a public workshop entitled, Advancing the Development of Interchangeable Products: Identifying Future Needs. This is a hybrid workshop open to the public.
• September 25, 2025: NIH announced a meeting of the National Institute of Allergy and Infectious Diseases. This is a virtual meeting open to the public.
• September 30, 2025: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a virtual meeting open to the public.
• October 7, 2025: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
• October 8-9, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• October 27-28, 2025: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• October 27-29, 2025: NIH announced a meeting of the Board of Scientific Counselors of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• December 1-2, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• December 4-5, 2025: HRSA announced a meeting of National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver NICHD. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On August 11, 2025, the Congressional Budget Office (CBO) released a report entitled, Distributional Effects of Public Law 119-21. CBO found that the budgetary effects of the law will affect household resources through four channels between 2026 and 2034. First, it will increase federal tax and cash transfer household resources by $3.3 trillion, on net in 2025 dollars. Changes to federal tax provisions, especially extensions of provisions of Public Law 115-97 and limitations on eligibility for subsidies for health insurance under the Affordable Care Act (ACA) and changes to student loan programs, will affect household resources. Second, federal and state in-kind transfers will decrease household resources by $900 billion, on net, primarily because federal spending on benefits provided through Medicaid and the Supplemental Nutrition Assistance Program (SNAP) will be lower. Changes to program benefits that states make in response to changes in federal policy will also reduce household resources. Third, states’ fiscal responses, which consist of the tax spending changes implemented by states, will increase household resources by $11 billion, on net. In CBO's assessment, Medicaid eligibility changes under the legislation will reduce states’ spending on Medicaid benefits. Those decreases will be largely offset by the new matching requirements for SNAP, which will increase states’ spending. In CBO's analysis, states, in the aggregate, will use the resulting overall reduction in benefit spending to increase spending in other areas and reduce taxes, both of which will increase household resources. Finally, other spending and revenues such as federal spending on defense, border security, and infrastructure will increase household resources by $308 billion, on net. Those outlays are partially offset by receipts and outlays associated with spectrum auctions and changes to emissions regulations.
• On August 15, 2025, CBO released a report entitled, CBO's Estimates of the Statutory Pay-As-You-Go Effects of Public Law 119-21. CBO estimates that under Public Law 119-21 deficits will increase by $2.1 trillion between 2025 and 2029 and by $3.4 trillion between 2025 and 2034 relative to CBO's January 2025 baseline, excluding any macroeconomic or debt-service effects. Under the Statutory Pay-As-You Go Act (S-PAYGO), the Office of Management and Budget (OMB) is required to maintain 5- and 10-year scorecards that it updates with the estimated cumulative changes in revenues and outlays generated by newly enacted legislation. If either scorecard indicates a net increase in the deficit, OMB is required to order a sequestration to eliminate the overage. The balance used to determine the amount of a sequestration is not the projected increase in the deficit for that particular year. Rather, OMB's 5- and 10-year scorecards identify the average annual effects of a piece of legislation over those periods and assign the average to each year in the period. Before an average is calculated, any current-year effects are combined with those for the budget year. The amount of a sequestration would equal the larger of the two averages.

Other Health Policy News

• On August 13, 2025, the White House issued an executive order (EO) entitled, Ensuring American Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve. The EO directs the HHS Assistant Secretary for Preparedness and Response (ASPR) to develop a list of 26 drugs deemed especially critical to national health and security interests. In addition, ASPR is tasked with identifying existing, available funds to support the SAPIR, which was established during President Trump’s first term, to stockpile Active Pharmaceutical Ingredients (APIs) for the 26 aforementioned critical drugs. The EO further instructs ASPR to update the 2022 list of 86 essential medicines and medical countermeasures and to propose a plan to procure a six-month supply of the APIs necessary for drugs included in the updated essential medicines list. Finally, the EO calls on ASPR to develop a proposal for establishing a second SAPIR repository within one year of the EO’s issuance. The full text of the EO is available here. A fact sheet is available here.
• On August 14, 2025, HHS announced the reinstatement of the Task Force on Safer Childhood Vaccines, which was originally created by Congress in 1986 as part of legislation to address childhood vaccine safety. The original Task Force on Safer Childhood Vaccines was disbanded in 1998 and released a report that year recommending the expansion of research on vaccine safety and surveillance of injuries. The reinstated Task Force on Safer Childhood Vaccines will work closely with the Advisory Commission on Childhood Vaccines to produce regular recommendations focused on improving childhood vaccines by developing safer formulations with fewer adverse reactions and enhancing vaccine production, distribution, and safety monitoring through targeted research. The Task Force on Safer Childhood Vaccines is tasked with releasing its first formal report to Congress within two years, with updates every two years thereafter. The Task Force on Safer Childhood Vaccines report from 1998 is available here. A press release is available here.
• On August 15, 2025, the press reported that a draft strategy document from the Make America Healthy Again (MAHA) Commission was circulating. The leaked document, entitled the Make Our Children Healthy Again Strategy, outlines a strategic approach for executive actions to address the childhood chronic disease crisis through (1) advancing critical research to drive innovation; (2) realigning incentives and systems to drive health outcomes, (3) increasing public awareness and knowledge; and (4) fostering private sector collaboration. Although the official strategy deadline was August 12, 2025, as outlined in EO 14212, Establishing the President’s Make America Healthy Again Commission, reports indicate that the public may have to wait several more weeks for the official strategy document to be released. The leaked draft strategy document is available here. EO 14212 is available here.

[View source.]