Health Care Week in Review | Senate HELP Committee Releases Budget Reconciliation Text; White House Issues Memo on Medicaid State Directed Payments

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 Senate HELP Committee released its budget reconciliation bill text, while the White House issued a memo directing HHS to ensure Medicaid state directed payments don’t exceed Medicare rates.

1. Regulations, Notices & Guidance

• On June 10, 2025, the Food and Drug Administration (FDA) released a proposed rule entitled, Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product. The FDA is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
• On June 10, 2025, the Department of Veterans Affairs (VA) released a final rule entitled, Reporting to the National Practitioner Data Bank. The VA adopts as final, without changes, a proposed rule to remove its regulations governing the National Practitioner Data Bank (NPDB). Instead, VA will rely on Department of Health and Human Services (HHS) regulations that govern the NPDB, a Memorandum of Understanding (MOU) between VA and HHS, and VA policy and procedures.
• On June 11, 2025, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Patient Safety Organizations: Delistings for the Michigan Surgical Quality Collaborative and Proximate PSO. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO’s listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Michigan Surgical Quality Collaborative, PSO number P0143, of its status as a PSO, and has delisted the PSO accordingly. AHRQ delisted the proximate PSO, PSO number P0244, due to its failure to correct a deficiency.
• On June 12, 2025, FDA released a notice entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing. FDA is classifying the cellular analysis system for multiplexed antimicrobial susceptibility testing 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 cellular analysis system for multiplexed antimicrobial susceptibility testing’s classification. FDA is taking this action because they have 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 June 12, 2025, FDA released a notice entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System. FDA is classifying the clinical mass spectrometry microorganism identification and differentiation 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 clinical mass spectrometry microorganism identification and differentiation 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 June 12, 2025, FDA released a notice entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Fungal Nucleic Acids Directly in Respiratory Specimens. FDA is classifying the device to detect and identify fungal nucleic acids directly in respiratory specimens 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 and identify fungal nucleic acids directly in respiratory specimens’ 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 June 12, 2025, FDA released a notice entitled, Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software. FDA is classifying the radiological computer-assisted detection and diagnosis software 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 computer-assisted detection and diagnosis software’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 June 12, 2025, FDA released a notice entitled, Rare Disease Innovation, Science, and Exploration Public Workshop Series; Request for Comments. FDA is announcing the following request for comments for a future public workshop series entitled “Rare disease Innovation, Science, and Exploration (RISE) Workshop.” The purpose of the public workshops will be to focus on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions. The workshops will primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the Agency.
• On June 12, 2025, FDA released a notice entitled, Request for Nominations for Individuals and Consumer Organizations for Advisory Committees. FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee selected without regard to race, color, national origin, religion, age, or sex.
• On June 13, 2025, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee to the Director. In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the Advisory Committee to the Director (ACD). ACD consists of not more than 15 experts in the fields associated with the health disciplines including, but not limited to, public health, infectious disease, data science and Artificial Intelligence (AI), lab science, global health, public health preparedness, and related fields.
• On June 13, 2025, FDA released a notice entitled, Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Industry. FDA is announcing the availability of a final guidance for industry entitled “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.” This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA will use this information to set a review goal for a priority abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter). This guidance finalizes for implementation the draft guidance of the same title issued on December 5, 2022.
• On June 13, 2025, the Government Accountability Office (GAO) released a notice entitled, Request for Nominations for the Physician-Focused Payment Model Technical Advisory. The Medicare Access and CHIP Reauthorization Act of 2015 established the Physician-Focused Payment Model Technical Advisory Committee to provide comments and recommendations to the Secretary of HHS on physician payment models and gave the Comptroller General responsibility for appointing its members. GAO is now accepting nominations of individuals for this committee. Letters of nomination and resumes should be submitted no later than July 15, 2025, to ensure adequate opportunity for review and consideration of nominees prior to appointment. Appointments will be made in October 2025.

Event Notices

** - New addition

• June 17, 2025: The National Institutes of Health (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 18, 2025: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting 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 25, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). 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 9, 2025: FDA announced a meeting of the Pediatric Advisory Committee. This is a virtual meeting open to the public.
• July 10, 2025: CMS announced a meeting of the Air Ambulance Quality & Patient Safety Advisory Committee. This is a virtual meeting 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 Fiscal Year 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 17, 2025: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is an in-person meeting open to the public.
• **July 23, 2025: FDA announced a meeting entitled, “Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population.” 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 4, 2025: FDA announced a meeting entitled, “Medical Device User Fee Amendments.” This is a hybrid meeting open to the public.
• August 6-7, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
• **August 7-8, 2025: NIH announced a meeting of the National Heart, Lung, And Blood Institute. 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 9, 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 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting 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.
• October 8-9, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual 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 NACNEP. This is a hybrid meeting open to the public.

2. Reports, Studies, & Analyses

• On June 10, 2025, the HHS Office of Inspector General (OIG) released a report entitled, CMS Use of Staffing Data to Inform State Oversight of Nursing Homes. The report evaluated how states are using new CMS data and guidance to identify staffing shortages in nursing homes. While states found the Payroll Based Journal (PBJ) data helpful, OIG found that CMS only flags facilities with zero registered nurse (RN) hours, not those falling short of the required 8 hours. Additionally, CMS does not clarify which staffing categories contribute to low staffing ratings. OIG recommended that CMS notify states of all facilities appearing to fall short of the RN requirement and provide more detailed analysis and guidance to help states identify staffing risks. CMS did not concur with the first recommendation and stated it had already implemented the second.
• On June 11, 2025, the HHS OIG released a report entitled, NIH Recipients Conducting Biospecimen Research: Gaps in Emergency Planning and Reporting. The report examined how NIH-funded institutions prepare for and report the effects of emergencies on biospecimen-based research. All 23 recipients reviewed were located in high-risk areas and reported having emergency plans, but most had not conducted formal risk assessments to guide those plans. This could lead to ineffective preparedness or misallocated resources. Additionally, five of six recipients that experienced emergency-related disruptions may not have reported them to NIH in a timely or complete manner. OIG concluded that NIH should issue more detailed guidance to help recipients strengthen emergency planning and clarify how and when to report emergency impacts, so NIH can better support recovery efforts and provide accurate information to stakeholders.
• On June 12, 2025, the Congressional Budget Office (CBO) released a report entitled, Distributional Effects of H.R. 1, the One Big Beautiful Bill Act.  CBO found that the legislation would affect household resources from 2026 to 2034 through four channels: federal taxes and cash transfers; federal and state in-kind benefits; states’ fiscal responses; and other spending and revenues. Federal taxes and cash transfers would increase household resources by $3.1 trillion, largely due to tax changes and reductions in health insurance subsidies. In-kind benefits would decrease household resources by $1.0 trillion, primarily from reduced Medicaid and Supplemental Nutrition Assistance Program (SNAP) spending. States’ fiscal responses would increase household resources by $10 billion, as states reallocated savings from Medicaid to other spending or tax reductions, partially offset by new SNAP matching requirements. Other spending and revenues would increase household resources by $129 billion, reflecting federal investments in defense, border security, and infrastructure, offset by reductions in pensions and other receipts. On average, household resources would increase, but the effects would vary: the lowest income decile would see a $1,600 annual decrease, middle-income households would gain $500 to $1,000, and the highest income decile would gain $12,000 annually.

3. Hearings & Markups

• On June 10, 2025, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, A Review of the President’s Fiscal Year 2026 Budget Request for the National Institutes of Health. The Honorable Jayanta Bhattacharya, M.D., Ph.D., Director, National Institutes of Health, served as the sole witness.
• On June 10, 2025, the House Committee on Oversight and Government Reform held a hearing entitled, Securing Americans’ Genetic Information: Privacy and National Security Concerns Surrounding 23andMe’s Bankruptcy. Witnesses included: Ms. Anne Wojcicki, Founder and Board Member, 23andMe, Inc.; Mr. Joe Selsavage, Interim Chief Executive Officer and Chief Financial and Accounting Officer, 23andMe, Inc.; and Margaret Hu, Professor of Law, William & Mary Law School.
• On June 11, 2025, the House Appropriations Committee held a Full Committee Markup of the Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill. The bill was approved by voice vote. The legislation would provide $25.523 billion in discretionary funding, prioritizing food safety, rural broadband, and agricultural research. The full Committee Print can be found here.
• On June 11, 2025, the House Energy and Commerce Committee Subcommittee on Health held a hearing entitled, Made in America: Strengthening Domestic Manufacturing and Our Health Care Supply Chain. Witnesses included: Mr. Patrick Cashman, President, USAntibiotics; Dr. Ronald T. Piervincenzi, PhD,Chief Executive Officer, United States Pharmacopeia; Mr. Josh Bolin, Associate Executive Director, Government Affairs and Innovation, National Association of Boards of Pharmacy; Ms. Dawn O’Connell, Former Assistant Secretary for Preparedness and Response; and Mr. John Murphy, III, President and Chief Executive Officer, Association for Accessible Medicines.
• On June 11, 2025, the Senate Judiciary Committee held a hearing entitled, 23 and You: The Privacy and National Security Implications of the 23andMe Bankruptcy. Witnesses included: Mr. Joe Selsavage, Interim Chief Executive Officer and Chief Financial and Accounting Officer, 23andMe Holding Co.; I. Glenn Cohen, Deputy Dean and Professor; Harvard Law School; Brook Gotberg, Professor of Law, Brigham Young University Law School; and Adam Klein, Director and Senior Lecturer, Robert S. Strauss Center for International Security and Law (University of Texas–Austin).
• On June 11, 2025, the House Committee on Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Restoring Balance: Ensuring Fairness and Transparency at the NLRB. Witnesses included: Mr. Aaron Solem, Staff Attorney, National Right to Work Legal Defense Foundation; Mr. F. Vincent Vernuccio, President, Institute for the American Worker; Ms. Jennifer A. Abruzzo, Senior Advisor to the President, Communications Workers of America; and Mr. Roger King, Senior Labor and Employment Counsel, HR Policy Association.
• On June 11, 2025, the House Committee on Veterans’ Affairs Subcommittee on Oversight and Investigations held a markup of seven bills, including:
  • H.R. 3455, Veterans Affairs Distributed Ledger Innovation Act of 2025;
  • H.R. 3482, Veterans Community Care Scheduling Improvement Act;
  • H.R. 3483, Forcing Real Accountability for Unlawful Distributions (FRAUD) Act of 2025;
  • H.R. 3494, VA Hospital Inventory Management System Authorization Act;
  • Discussion Draft, to authorize modernization of the VA electronic health record system; and
  • Discussion Draft, to prohibit delayed copayment collections due to VA system failures.
• On June 12, 2025, the House Committee on Veterans’ Affairs Subcommittee on Health held a markup of eight bills, including:
  • R. 2068, The Veterans Patient Advocacy Act;
  • R. 3643, The VA Data Transparency and Trust Act;
  • R. 3400, The Territorial Response and Access to Veterans’ Essential Lifecare (TRAVEL) Act of 2025;
  • Discussion Draft: To direct the Secretary of Veterans Affairs to conduct a study to determine whether RNA sequencing can be used to effectively diagnose PTSD in veterans;
  • Discussion Draft: The Health Professionals Scholarship Program Improvement Act of 2025;
  • Discussion Draft: The VA Mental Health Outreach and Engagement Act.

4. Other Health Policy News

• On June 6, 2025, President Trump issued a presidential memorandum entitled “Eliminating Waste, Fraud, and Abuse in Medicaid.” In the memo, the President criticizes instances where state Medicaid payments are “almost three times the Medicare amount” and states that the growth in state directed payments (SDPs) “threatens the Federal Treasury and Medicaid’s long-term stability.” The President directs the HHS Secretary to “take appropriate action…by ensuring Medicaid payments rates are not higher than Medicare, to the extent permitted by applicable law.” White House memorandums typically reflect statements of intent rather than action, but on Monday the CMS submitted a proposed rule related to Medicaid state directed payments to the Office of Management and Budget for review. The details remain unknown, but it is anticipated that the proposal will reflect the goals outlined in the June 6 Presidential memorandum to apply new restrictions on these types of arrangements.
• Meanwhile, the House-passed budget reconciliation bill contains a provision lowering the permissible SDP rate from the average commercial rate (ACR) to either (1) the Medicare rate for states that have expanded Medicaid under the ACA or (2) 110 percent of the Medicare rate for non-expansion states. However, the package passed by the House also grandfathers in existing (and pending preprint) SDPs if submitted to CMS prior to enactment. It is unclear how the Administration’s memorandum and proposed rule would affect any grandfathered SDPs.  The Senate deliberations on these issues are underway and their Medicaid related proposals are expected to be released by early next week.
• The full memo issued by President Trump can be viewed here.
• On June 9, 2025, HHS Secretary Robert F. Kennedy, Jr. announced that he was dismissing all 17 of the sitting members of the Advisory Committee on Immunization Practices (ACIP). In an op-ed published in the Wall Street Journal, Secretary Kennedy said that this move was “a bold step in restoring public trust” and criticized ACIP as “plagued with persistent conflicts of interest.” He noted that the Committee has never recommended against a vaccine, even those eventually withdrawn for safety reasons.
• On June 11, 2025, Secretary Kennedy announced eight individuals he would be appointing to replace the departed ACIP members, including several individuals who have questioned the safety of COVID-19 vaccines.
• The op-ed written by Secretary Kennedy can be viewed here and the press release from HHS on the ACIP dismissals can be viewed here. A full list of the new ACIP appointees can be viewed here.
• On June 11, 2025, the Senate HELP Committee released its portion of the budget reconciliation bill, which includes several provisions identical to the reconciliation bill passed by the House of Representatives on May 22. Both bills would eliminate the GRAD Plus loan program and revise the Public Service Loan Forgiveness Program to exclude medical and dental internship and residency programs from qualifying repayment for new borrowers. While both versions of the reconciliation text propose limits on unsubsidized Stafford loan borrowing, the Senate bill sets fixed annual and aggregate caps by degree level, whereas the House version ties annual limits to the median cost of the student’s program of study.
• The HELP Committee text also adopts House language to fund Affordable Care Act cost-sharing reduction payments, which is expected to reverse plans “silver loading” since Federal regulations prohibit premium adjustments to offset cost-sharing when a plan receives Federal subsidies. The text also includes a new restriction barring those subsidies in states that permit coverage of non-elective abortion services.
• The Senate HELP Committee reconciliation text can be found here.
• On June 11, 2025, a bipartisan bill to permit registered nurses (RNs) to independently conduct annual wellness visits (AWVs) for the Medicare program at Rural Health Clinics (RHCs) was introduced in the House of Representatives by Congresswoman Ashley Hinson (R-IA-02) and Congresswoman Hillary Scholten (D-MI-03). Currently, RNs may conduct AWVs in provider-based settings under a physician’s supervision. However, in RHCs, Medicare rules stipulate that only approved practitioners may conduct AWVs, regardless of the supervision present. RNs are not currently included in the list of approved practitioners – the RNs for Rural Health Act would amend this rule to include RNs on the list.
• The full text of the bill can be viewed here. A press release on the bill’s introduction can be viewed 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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