Health Care Week in Review | House Passes Budget Reconciliation Package; MAHA Commission Releases Childhood Chronic Disease Report

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.

Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.

Week in Review Highlight of the Week:

This week, the House of Representatives narrowly passed the budget reconciliation bill in a 215-214-1 vote, and the Make America Healthy Again (MAHA) Commission released its preliminary report assessing the causes of childhood chronic disease.

I. Regulations, Notices & Guidance

• On May 19, 2025, the Food and Drug Administration (FDA) released a notice entitled, Dihydropyrimidine Dehydrogenase Deficiency and the Use of Fluoropyrimidine Chemotherapy Drugs; Establishment of a Public Docket; Request for Comments. FDA is announcing the establishment of a docket to solicit public comment for information on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluorouracil and capecitabine (both fluoropyrimidine chemotherapy drugs). The purposes of the docket establishment are to foster transparency and to solicit input on the currently available information on DPD deficiency and the use of fluorouracil and capecitabine.
• On May 20, 2025, FDA released a notice entitled, Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability. FDA is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Fresenius Medical Care North America for multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048), and to Baxter Healthcare Corp. for REGIOCIT (EUA 068). FDA revoked the Authorizations on January 16, 2025, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in the notice.
• On May 20, 2025, FDA released a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. FDA is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled, Bioequivalence Recommendations for Specific Products that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The draft guidances identified in this notice were developed using the process described in that guidance.
• On May 20, 2025, FDA released a notice entitled, Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry; Availability. FDA is announcing the availability of a new draft guidance for industry entitled, Draft Guidance on Fluticasone Propionate. The new draft guidance, if finalized, will provide product-specific recommendations on, among other things, the design of BE studies to support ANDAs for fluticasone propionate nasal spray, metered.
• On May 20, 2025, FDA released a notice entitled, Product-Specific Guidance on Roflumilast; Draft Guidance for Industry; Availability. FDA is announcing the availability of a new draft guidance for industry entitled, Draft Guidance on Roflumilast. The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of BE studies to support ANDAs for roflumilast topical cream.
• On May 22, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Emergency Medical Services for Children Innovation and Improvement Center (EIIC). HRSA plans to provide additional funds to the University of Texas at Austin, Texas, the current EIIC Program recipient, to extend the recipient’s current period of performance by 12 months. This extension is necessary to support continuity of operations that facilitate pediatric readiness activities in hospital emergency departments (ED) and prehospital emergency medical services (EMS) agencies throughout the country. The current performance period ends June 30, 2025.
• On May 22, 2025, HRSA released a notice entitled, National Vaccine Injury Compensation Program; List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of the Department of Health and Human Services (HHS) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the U.S. Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
• On May 23, 2025, HHS released a rule entitled, World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders. On September 11, 2024, the Centers for Disease Control and Prevention (CDC) published in the Federal Register an interim final rule with request for comment to update existing regulations governing the WTC Health Program to align with statutory changes. The interim final rule expanded eligibility criteria for enrollment of new Pentagon and Shanksville responders, capped at 500 new members, and made various conforming amendments to the WTC Health Program regulations. In this final rule, CDC responds to public comment and finalizes the revisions to the regulation.
• On May 23, 2025, HRSA released a notice entitled, Children's Hospitals Graduate Medical Education Payment Program: Methodology to Determine Full-Time Equivalent Resident Count. HRSA published a notice in the Federal Register on December 30, 2024, soliciting feedback for a proposed update to the Children’s Hospitals Graduate Medical Education (CHGME) Payment Program’s method of determining an eligible children’s hospital’s (as defined within the PHS Act) weighted allopathic and osteopathic full-time equivalent (FTE) resident count when this count exceeds its direct graduate medical education (GME) FTE resident cap. This proposed change is being made to be consistent with the methodology used by the Centers for Medicare & Medicaid Services (CMS) consistent with the CHGME Payment Program’s long-standing practice of using the same methodology in calculating FTE counts as CMS does in Medicare GME and to minimize administrative burden on hospital who participate in both programs. This notice summarizes and responds to the comments received during the 30-day comment period.

Event Notices—NOTE: Due to ongoing HHS changes, many of these meetings may be cancelled or postponed. We are continuing to monitor.

** - New addition

• May 28, 2025: The National Institutes of Health (NIH) announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• May 29, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• June 2, 2025:  NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a hybrid meeting with some sessions open to the public.
• June 2-3, 2025: The CDC announced a meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding. This is a hybrid meeting open to the public.
• June 3, 2025: NIH announced a meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This is a hybrid meeting with some sessions open to the public.
• June 3, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 3-4, 2025: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
• **June 4, 2025: FDA announced a meeting of the National Research Advisory Council. This is a virtual meeting open to the public.
• June 5, 2025: NIH announced a meeting of the National Advisory Environmental Health Sciences Council. This is a hybrid meeting with some sessions open to the public.
• June 6, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a virtual meeting with some sessions open to the public.
• June 9, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
• June 10, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with one session open to the public.
• June 11, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is an in-person meeting with some sessions open to the public.
• **June 12, 2025: The Department of Veterans’ Affairs (VA) announced a meeting of the Cooperative Studies Scientific Evaluation Committee. This is a virtual meeting partially open to the public.
• June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a virtual meeting with some sessions open to the public.
• June 17, 2025: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• June 17, 2025: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• June 17, 2025: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• June 25, 2025: CMS announced a meeting of the Medicare Evidence Development and Coverage Advisory Committee. This is a virtual meeting open to the public.
• **June 26, 2025: NIH announced a meeting of the Office of the Director. This is a virtual meeting open to the public.
• June 27, 2025: CMS announced a meeting regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year (CY) 2026. This is a hybrid meeting open to the public.
• July 1, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a virtual meeting with some sessions open to the public.
• July 7, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
• July 14, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act for FY 2028 through 2032. This is a hybrid meeting open to the public.
• July 14, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for FYs 2028 to 2032. This is a hybrid meeting open to the public.
• July 23-24, 2025: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
• August 6-7, 2025: HRSA announced a meeting of National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
• August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a hybrid meeting 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.
• December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.

2. Reports, Studies, & Analyses

• On May 20, 2025, the Congressional Budget Office (CBO) released a report entitled, Preliminary Analysis of the Distributional Effects of the One Big Beautiful Bill Act. CBO estimates that if the proposed H.R.1 legislation were enacted, U.S. households, on average, would see an increase in the resources provided to them by the government over the 2026–2034 period. The changes would not be evenly distributed among households. CBO estimates that in general, resources would decrease for households in the lowest decile (tenth) of the income distribution, whereas resources would increase for households in the highest decile.
• On May 22, 2025, the Office of Inspector General (OIG) released a report summary document entitled, Potential Cost Savings in HHS Programs. The analysis used 35 previous OIG reports to identify around $50 billion in potential savings through recovery of payments and program improvements based on HHS-OIG work. Examples of potential savings include $7.7 billion by paying for Critical Access Hospital (CAH) swing-bed services based on rates or nearby facilities with similar services, $6.9 billion by improving risk adjustment in Medicare Advantage (MA), $6.6 billion by preventing Medicare from paying providers for services that hospices are paid to provide for their enrollees, and $1 billion by preventing duplicate Medicaid payments for individuals enrolled in managed care plans in more than one state, among others.
• On May 22, 2025, OIG released a report entitled, Department of Health and Human Services Met Many Requirements, but It Did Not Fully Comply With the Payment Integrity Information Act of 2019 and Applicable Improper Payment Guidance for Fiscal Year 2024. The Payment Integrity Information Act of 2019 (PIIA) requires OIG to review improper payment reporting across federal agencies to assess compliance. In response, OIG conducted a performance audit to evaluate the accuracy and completeness of HHS’s reporting and determine adherence to Office of Management and Budget (OMB) guidelines. While the report found that HHS met many requirements, it concluded that HHS did not fully comply with PIIA. It found that HHS failed to conduct risk assessments for some high-expenditure programs, did not report improper payment estimates for Temporary Assistance for Needy Families (TANF), and used statistically invalid processes in Foster Care program calculations. The report also noted that improper payment rates exceeded acceptable levels in Head Start, and recovery audits for MA were delayed or lacked cost-effectiveness documentation. Additionally, HHS did not fully demonstrate improvements in payment integrity for Medicare Fee-for-Service (FFS), and its methodology did not comprehensively assess key characteristics of the Uninsured Program.
• On May 22, 2025, the Government Accountability Office (GAO) released a report entitled, Recommendations for Congress: Action Can Produce Tens of Billions of Dollars in Future Financial and Other Benefits. GAO makes recommendations to Congress to address findings from GAO’s work, identifying 54 open matters that could result in financial benefits. Examples of open recommendations to Congress with potential financial benefits of $1 billion or more include the following GAO reports: Medicare: Increasing Hospital-Physician Consolidation Highlights Need for Payment Reform, which suggests equalizing payment rates across different medical settings to address hospital-physician consolidation; and Public-Safety Broadband Network: Congressional Action Required to Ensure Network Continuity, which recommends reauthorizing FirstNet to ensure its long-term continuity.

3. Hearings & Markups

• On May 19, 2025, the House Committee on Veterans’ Affairs held a hearing entitled, Improving Software Licensing Management. Witnesses included: Mr. Don Carter, Executive Director for Contract and Operations Management, U.S. Department of Veterans’ Affairs, Office of Information Technology (OIT); Ms. Carol Harris, Director, Information Technology and Cybersecurity Issues, U.S. Government Accountability Office; and Mr. Jeff VanBemmel, Executive Director of End User Operations, U.S. Department of Veterans Affairs, OIT.
• On May 20, 2025, the Senate Appropriations Committee Subcommittee on Labor, Health and Human Services, and Education held a hearing entitled, A Review of the President’s Fiscal Year 2026 Budget Request for the Department of Health and Human Services. The Honorable Robert F. Kennedy Jr., Secretary of HHS, served as the sole witness.
• On May 20, 2025, the House Committee on Oversight and Government Reform held a hearing entitled, Mandates, Meddling, and Mismanagement: The IRA’s Threat to Energy and Medicine. Witnesses included: Mr. Ben Lieberman, Senior Fellow, Competitive Enterprise Institute; Dr. Erin Trish, Ph.D., Co-Director, USC Schaeffer Center; Dr. William McBride, Ph.D., Chief Economist and Stephen J. Entin Fellow in Economics Tax Foundation; and Dr. Emily Gee, Senior Vice President for Inclusive Growth, Center for American Progress.
• On May 22, 2025, the Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee held a hearing entitled, A Review of the President’s Fiscal Year 2026 Budget Request for the Food and Drug Administration. The Honorable Martin A. Makary, M.D., M.P.H, FDA Commissioner, served as the sole witness.

4. Other Health Policy News

• On May 20, 2025, HHS Secretary Robert F. Kennedy Jr. appeared before the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education. Lawmakers raised concerns over a 26 percent reduction in HHS funding, including $18 billion in NIH cuts, warning of potential consequences for cancer, Alzheimer’s, and ALS research. Senators also addressed Medicaid reforms, questioning the impact on coverage loss and healthcare accessibility. Of note, Senator Jack Reed (D-RI) challenged the Administration’s position that reductions target fraud and abuse, warning of strain on emergency rooms and community health centers, while Senator Jeff Merkley (D-OR) cautioned that eligibility barriers could reduce enrollment instead of improving oversight. Secretary Kennedy defended the changes, asserting that no direct cuts were made, only a slowed rate of program expansion.
• Research modernization and drug pricing were also debated. Senator Mike Rounds (R-SD) urged updates to NIH’s outdated data systems, advocating for artificial intelligence (AI)-driven accessibility to medical studies. Secretary Kennedy confirmed efforts to digitize research and streamline public access to findings. Senator Merkley criticized high drug prices, pushing for international price parity, and Secretary Kennedy expressed support for Trump’s executive order (EO) on drug pricing reforms.
• Senators also questioned NIH staffing and research grants, with Senator Patty Murray (D-WA) pressing for budget transparency, demanding clarity on over 530 program funding levels included in the proposed HHS operational plan. Secretary Kennedy acknowledged departmental decisions to withhold certain funds but avoided direct answers regarding research grant terminations. More information on this hearing is available here.
• On May 20, 2025, the Improving Seniors’ Timely Access to Care Act was re-introduced in both the Senate and House of Representatives. This bill would establish electronic prior authorization (PA) processes for MA plans, increase transparency into how PA is used through mandatory reporting and publication of denial data, and authorize the HHS Secretary to establish mandatory timeframes for when plans must respond to PA requests. The full text of the bill can be found here.
• On May 21, 2025, CMS announced an expansion of its auditing efforts for MA plans, aiming to increase oversight and recover potential overpayments. Beginning immediately, CMS will audit all eligible MA contracts for each payment year and accelerate audits for payment years 2018 through 2024. MA plans receive risk-adjusted payments based on patient diagnoses, with higher payments allocated for individuals with serious or chronic conditions. To ensure billing accuracy, CMS conducts Risk Adjustment Data Validation (RADV) audits, verifying that diagnoses used for payment are supported by medical records. However, CMS has fallen years behind in completing these audits, with the last major recovery of MA overpayments dating back to payment year 2007. Federal estimates suggest that MA plans may overbill the government by up to $17 billion annually, with some estimates reaching $43 billion per year. To address this backlog, the current Administration introduced a plan to finalize all outstanding audits by early 2026. Additionally, CMS will collaborate with HHS OIG to recover identified past audits.
• On May 22, 2025, the House of Representatives narrowly passed a Republican-backed reconciliation package in a 215-214-1 vote, advancing President Donald Trump’s domestic agenda after days of negotiations and last-minute amendments. The legislation includes tax cuts, increased military and border security funding, and significant reforms to Medicaid, food assistance, education, and clean energy programs. It also would raise the debt ceiling by $4 trillion, allowing the government to continue borrowing to meet financial obligations.
• To garner the support of conservative Republican holdouts, Republican leadership had to modify the bill after it was voted out of the Budget Committee, which would include accelerating Medicaid work requirements, now set to begin by the end of 2026 instead of 2029. The changes to the bill also prohibit federal healthcare subsidies for plans covering elective abortions and restrict Medicaid and CHIP coverage for gender transition procedures. Further, one major revision was an expansion of the state and local tax (SALT) deduction, a priority for Republicans from high-tax states such as New York, New Jersey, and California.
• Despite its passage in the House, the bill, as written, may face substantial hurdles in the Senate, where Republicans are likely to push for further modifications. The debate will likely focus on tax policy, healthcare reforms, and funding priorities, with some senators expressing concerns over the projected increase in the national debt. The full H.R.1 bill text is available here.
• The budget reconciliation package passed by the House of Representatives on May 22, 2025 includes the Student Success and Taxpayer Savings Plan, which introduces significant changes to federal student loan programs impacting medical education.
• If enacted, the bill would eliminate the Grad PLUS loan program, restricting access to federal loans for graduate and professional students beginning in the 2026-2027 academic year for new borrowers and the 2029-2030 academic year for existing borrowers. Under the Grad PLUS loan program, graduate and professional students, including those in medical fields, can secure federal loans for tuition and living expenses.
• The bill would also impose a borrowing cap of $150,000 on federal loans for professional programs and revises payment policies, including the exclusion of medical residency from the definition of “qualifying jobs” under the Public Service Loan Forgiveness (PSLF) program. Under this provision, physicians in training at public and non-profit hospitals would not receive PSLF credit, lengthening their repayment period. Additionally, the bill includes language similar to the Resident Education Deferred Interest (REDI) Act, which would defer the accrual of interest on federal student loans during residency. However, the reconciliation package limits this deferral to four years, which does not cover longer residencies.
• The budget reconciliation package now moves to the Senate for further consideration.
• On May 22, 2025, the MAHA Commission, established by the Trump Administration to “address the childhood chronic disease crisis,” released its preliminary report, which consisted of an assessment of the causes of childhood chronic disease. The report identifies four primary causes: poor diet and ultra-processed foods, environmental chemicals, a digital lifestyle, and overmedicalization. This includes a section criticizing the expansion of the childhood vaccine schedule and purports a lack of safety studies and ineffective vaccine safety warning system. To combat the various causes of childhood chronic disease, the MAHA Commission recommends ten research initiatives, including, in part, increasing the replication of scientific studies; enhancing post-marketing surveillance of drugs; expanding autism tracking through linking NIH and CMS systems to electronic health records; launching a “large-scale” lifestyle intervention initiative; and enhancing long-term drug safety research and alternatives to animal models in drug testing.
• The MAHA Commission is directed to next develop a strategy for making children healthy again that is due in August 2025. The report ends by inviting “all of America, especially the private sector and academia, to be part of the solution.” The full report can be read here.
• On May 22, 2025, CMS announced new measures to strengthen hospital price transparency requirements, mandating that hospitals post actual prices for items and services rather than estimates. CMS also issued a Request for Information (RFI) to gather input on enforcement strategies and ensure that pricing data remains accurate and complete. These actions align with Executive Order (EO) 14221, which builds on healthcare price transparency regulations launched during President Donald Trump’s first term. The initiative aims to empower patients with clearer pricing information, promote competition, and curb rising healthcare costs. The full RFI is available here. More information on EO 14221 is available here.

5. Additional Alston & Bird Publications

• We maintain an online tracker for all executive orders issued by the Trump Administration, which is updated regularly and can be found here.

View our Health Care Legislative & Public Policy team.

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