Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid Benefits for Undocumented Immigrants

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 Trump Administration proposed $94.7 billion in the HHS discretionary budget authority for FY 2026, and CMS announced steps to review potential misuse of federal Medicaid funding to cover care for undocumented immigrants. 

1. Regulations, Notices & Guidance

• On May 23, 2025, the Executive Office of the President (EOP) released an executive order (EO) entitled, Restoring Gold Standard Science. This EO directs the Director of the Office of Science and Technology Policy (OSTP) to work with agency heads to issue guidance for adopting principles of Gold Standard Science. The EO defines Gold Standard Science as research conducted in a manner that is reproducible; transparent; communicative of error and uncertainty; collaborative and interdisciplinary; skeptical of its findings and assumptions; structured for falsifiability of hypotheses; subject to unbiased peer review; accepting of negative results as positive outcomes; and without conflicts of interest. The EO establishes that federal employees must “not engage in scientific misconduct nor knowingly rely on information resulting from scientific misconduct.” The EO directs agencies to restore the scientific integrity policies in place on January 19, 2021.
• On May 28, 2025, the Food and Drug Administration (FDA) released a rule entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System. FDA is classifying the plazomicin test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the plazomicin test system’s classification. FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 28, 2025, FDA released a rule entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia. FDA is classifying the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia’s classification. FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 28, 2025, FDA released a rule entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test. FDA is classifying the inherited nucleotide repeat disorder DNA test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the inherited nucleotide repeat disorder DNA test’s classification. FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 28, 2025, FDA released a rule entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents. FDA is classifying the Zika virus serological reagents into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Zika virus serological reagents’ classification. FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices in part by reducing regulatory burdens.
• On May 28, 2025, FDA released a notice entitled, Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry. FDA is reopening the comment period for this draft guidance, which was announced in the Federal Register of January 7, 2025. FDA is taking this action in response to requests to allow interested persons additional time to submit comments before FDA begins work on the final guidance.
• On May 28, 2025, FDA released a notice entitled, Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff. FDA is issuing this draft guidance to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to FDA. This draft guidance, if finalized, will represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.
• On May 28, 2025, FDA released a notice entitled, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff. This guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This guidance supersedes the document entitled, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” issued on June 2, 2023, and provides clarification and additional information on the scope of Q-Sub types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre-Submission or other Q-Sub types), and improved examples.
• On May 28, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy. HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).
• On May 29, 2025, FDA released a notice entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System. FDA is classifying the anti-mullerian hormone test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the anti-mullerian hormone test system’s classification. FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 30, 2025, the Departments of Labor, Health and Human Services (HHS), and the Treasury issued a request for information (RFI) entitled, Request for Information Regarding the Prescription Drug Machine-Readable File Requirement in the Transparency in Coverage Final Rule. The Departments are issuing this RFI to gather input regarding implementation of the prescription drug machine-readable file disclosure requirements under the Transparency in Coverage final rules, including what modifications to the disclosure requirements or additional technical implementation guidance might be necessary to better ensure the accurate and timely completion of the prescription drug file.
• On May 30, 2025, FDA released a rule entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect Bacterial Protease Activity in Chronic Wound Fluid. FDA is classifying the device to detect bacterial protease activity in chronic wound fluid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect bacterial protease activity in chronic wound fluid’s classification. FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices in part by reducing regulatory burdens.
• On May 30, 2025, FDA released a rule entitled, Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System. FDA is classifying the radiological acquisition and/or optimization guidance system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological acquisition and/or optimization guidance system’s classification. FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices in part by reducing regulatory burdens.
• On May 30, 2025, FDA released a notice entitled, M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver. FDA is announcing the availability of a draft guidance for industry entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is the second in the ICH M13 series of guidances and describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for additional strengths of orally administered immediate-release (IR) solid oral dosage forms (i.e., tablets, capsules, and granules/powders for oral suspension), including considerations for biowaivers. The intent of this draft guidance is to provide harmonized criteria and data that support waivers for drug applications with multiple strengths when in vivo BE has been demonstrated for at least one strength using the principles outlined in the final guidance “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” published in October 2024.

Event Notices

** - New addition

• June 2, 2025:  The National Institutes of Health (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 Centers for Disease Control and Prevention (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: The Centers for Medicare & Medicaid Services (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 15, 2025: FDA announced a meeting entitled, “Second Annual Animal Drug User Fee Educational Conference.” 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 29, 2025, the Government Accountability Office (GAO) released a report entitled, Medicare Advantage: CMS Oversight of Prior Authorization Criteria Should Target Behavioral Health Services. GAO examined the reported prior authorization requirements and criteria for behavioral health services of nine selected Medicare Advantage (MA) organizations that covered about 45 percent of MA beneficiaries in 2024. GAO interviewed CMS officials, provider and beneficiary representatives, and reviewed CMS guidance and regulations. Eight of nine MA organizations reviewed required prior authorization for inpatient and specialized behavioral health care, with seven using internal coverage criteria. GAO recommended that CMS target behavioral health services in its audit and review processes. CMS did not concur, citing that behavioral health services make up a small percentage of MA services. CMS emphasized that its audits and oversight are focused on the services most likely to be denied and negatively impact access to care for large numbers of beneficiaries.
• On May 29, 2025, GAO released a report entitled, National Institutes of Health: Monitoring of External Research Can Be Improved. GAO examined NIH’s oversight of extramural research funding, which makes up over 80 percent of the agency’s budget. GAO examined the agency’s funding trends, policies for ensuring proper use of these funds, and procedures for managing unused award balances. In FY 2023, NIH supported nearly 65,000 ongoing research grants and other awards to external entities, totaling more than $35 billion. NIH also increased its oversight staff by approximately 20 percent during this period. GAO found that NIH did not consistently close out awards when recipients failed to submit final reports, with nearly 1,000 reports outstanding as of August 2024. GAO recommended that NIH address the factors contributing to late reports, develop an informational resource for managing unused award balances, and require tracking of unused balances across award portfolios. NIH agreed to all GAO recommendations.

3. Other Health Policy News

• On May 27, 2025, CMS issued a letter to state Medicaid programs that it would be taking steps to limit the provision of Medicaid-covered services to undocumented immigrants. While CMS acknowledged that it would permit Medicaid payments for “emergency medical services for noncitizens with unsatisfactory immigration status who would otherwise be Medicaid-eligible,” including emergency labor and delivery, it noted that it would seek to eliminate all other benefits through focused reviews of states’ quarterly CMS-64 reports, reviews of states’ financial management systems, and closing all available loopholes.
• A press release on the announcement can be viewed here. The letter CMS sent to state Medicaid agencies can be viewed here.
• On May 27, 2025, HHS Secretary Robert F. Kennedy, Jr. announced in a video posted to social media that the CDC would no longer recommend COVID-19 vaccines for “healthy children and healthy pregnant women.” The CDC’s Advisory Committee on Immunization Practices (ACIP) had been considering modifications to its universal vaccine recommendation but had not yet issued a formal decision. Susan Monarez, the nominee for CDC Director, remains unconfirmed by the Senate. In a statement, the CDC stated that, “with pending confirmation of a new CDC Director, the recommendations were adopted by the HHS Secretary on May 13, 2025, and are now official recommendations of the CDC.
• On May 29, 2025, CDC posted the updated child vaccination schedule, which recommended that COVID-19 vaccines for children aged six months to seventeen years were recommended through shared clinical decision-making, which called for a decision “informed by the clinical judgment of a healthcare provider and personal preference and circumstances.”
• The full video announcement can be viewed here.
• On May 28, 2025, CMS issued a letter to select hospitals regarding “pediatric sex trait modification procedures.” In the letter, CMS raised concerns about compliance with quality standards and financial practices related to these treatments. The letter requests detailed information on how hospitals obtain informed consent, the extent of parental involvement, updates to clinical guidelines, documentation of adverse outcomes including cases of patient regret and “de-transitioning,” and financial records such as billing codes and actual and projected revenue for these procedures.
• The full letter to the hospitals can be viewed here.
• On May 30, 2025, the Trump Administration released its FY 2026 budget proposal, requesting $94.7 billion in discretionary budget authority, a reduction of approximately 22 percent from current levels. The proposal from HHS outlines major reorganizations, including the creation of the Administration for a Healthy America and the Administration for Children, Families, and Communities through consolidation of other agencies, such as HRSA, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Administration for Community Living (ACL). HHS states that this reorganization is aimed at streamlining operations and improving service delivery. The budget prioritizes initiatives in primary care, behavioral health, environmental health, nutrition, tribal health services, and reforming scientific research while deprioritizing global health initiatives and some programs centered on diversity and equity.
• The HHS FY 2026 Budget in Brief can be viewed here.

4. 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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