Health Care Week in Review | Senate Parliamentarian Issues Rulings on Budget Reconciliation Provisions; Supreme Court Upholds the Role of the USPSTF under the Affordable Care Act

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.

 Regulations, Notices & Guidance

• On June 23, 2025, the Department of Health and Human Services (HHS) released a notice entitled, Guidance on Referrals for Potential Criminal Enforcement. This notice describes HHS plans to address regulations that impose criminal liability under the recent Executive Order (EO) on Fighting Overcriminalization in Federal Regulations.
• On June 23, 2025, the Food and Drug Administration (FDA) released a notice entitled, Q1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry. FDA is announcing the availability of a draft guidance for industry entitled, Q1 Stability Testing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines stability data expectations for drug substances and drug products to support drug product marketing, including marketing authorization applications and, where applicable, drug master files. This draft guidance is a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July 1996, respectively. The revision also provides stability related guidance for product categories such as advanced therapy medicinal products, vaccines, and other complex biological products including combination products that were not previously covered under the existing stability guidances. The draft guidance is intended to provide an internationally harmonized approach to conducting and presenting data on stability testing for drug substances and drug products, as well as providing alternative, scientifically justified approaches that may be encountered due to scientific considerations and characteristics of the data being evaluated.
  
• On June 24, 2025, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability. This final rule revises standards relating to denial of coverage for failure to pay past-due premium; excludes Deferred Action for Childhood Arrivals (DACA) recipients from the definition of “lawfully present;” establishes the evidentiary standard HHS uses to assess an agent’s, broker’s, or web-broker’s potential noncompliance; revises the Exchange automatic reenrollment hierarchy; revises standards related to the annual open enrollment period and special enrollment periods; and revises standards relating to failure to file and reconcile, income eligibility verifications for premium tax credits and cost-sharing reductions, annual eligibility redeterminations, de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements, and income-based cost-sharing reduction plan variations. This final rule also revises the premium adjustment percentage methodology and prohibits issuers of coverage subject to EHB requirements from providing coverage for “specified sex-trait modification” procedures as an EHB.
  
• On June 24, 2025, CMS released a proposed notice entitled, Medicare and Medicaid Programs: Application from the Accreditation Commission for Health Care (ACHC) for Continued Approval of its Hospice Accreditation Program. This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care, for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
  
• On June 24, 2025, FDA released a notice entitled, Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee. FDA is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of qualified individuals on its advisory committees and therefore encourages nominations of appropriately qualified candidates. Specifically, TPSAC is seeking to fill five vacancies with physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or any other relevant specialty. Included in the five vacancies is one vacancy for a representative of the general public, and one vacancy for an employee of a state or local government or of the Federal Government.
  
• On June 25, 2025, FDA released a notice entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System. FDA is classifying the lysosomal storage disorder newborn screening 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 lysosomal storage disorder newborn screening 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 June 25, 2025, FDA released a notice entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test. FDA is classifying the muscular dystrophy newborn screening 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 muscular dystrophy newborn screening 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 June 25, 2025, FDA released a notice entitled, Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies. FDA is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies 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 fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies’ 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 25, 2025, FDA released a notice entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections. FDA is classifying the herpes simplex virus nucleic acid-based assay for central nervous system infections 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 classification of the herpes simplex virus nucleic acid-based assay for central nervous system infections. 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 25, 2025, FDA released a notice entitled, Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation. FDA is classifying the cream for x-ray attenuation 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 cream for x-ray attenuation’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 25, 2025, FDA released a notice entitled, Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19. FDA is announcing the revocation of the Emergency Use Authorization (EUA) issued to Cepheid for the Xpert Xpress SARS-CoV-2 test. FDA revoked the EUA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the EUA holder.
  
• On June 25, 2025, FDA released a notice entitled, Conducting Remote Regulatory Assessments--Questions and Answers; Guidance for Industry. FDA is announcing the availability of a final guidance for industry entitled, Conducting Remote Regulatory Assessments--Question and Answers. The final guidance describes FDA’s current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help evaluate compliance of FDA-regulated products with applicable regulatory requirements. 
  
• On June 25, 2025, FDA released a notice entitled, Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry. FDA is announcing the availability of a final guidance for industry entitled, Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of early Lyme disease as manifested by erythema migrans (EM). This guidance finalizes the draft guidance of the same name issued on February 1, 2023. 
  
• On June 25, 2025, FDA released a notice entitled, Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff. FDA is announcing the availability of a draft guidance for industry and FDA staff entitled, Unique Device Identifier (UDI) Requirements for Combination Products. This draft guidance is intended to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products with device constituent parts.
  
• On June 25, 2025, FDA released a notice entitled, Generic Drug User Fees; Consultation Meetings on Reauthorization of Generic Drug User Fee Amendments for Fiscal Years 2028-2032; Request for Notification of Intention to Participate. FDA is issuing this notice to request that interested parties, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for Fiscal Years (FYs) 2028-2032. At the end of September 2027, new legislation will be required for FDA to continue collecting generic drug user fees for subsequent fiscal years for the generic drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of interested parties in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent representation by interested parties.
  
• On June 25, 2025, HHS released a notice entitled, Secretarial Comments on the CBE’s (Battelle Memorial Institute) 2024 Activities: Report to Congress and the Secretary of the Department of Health and Human Services. This notice acknowledges the HHS Secretary’s receipt and review of Battelle Memorial Institute’s, the consensus-based entity (CBE) under a contract with the Secretary, 2024 Annual Activities Report to Congress, as mandated by section 1890(b)(5) of the Social Security Act (the Act). The HHS Secretary has reviewed CBE’s 2024 Annual Report and is publishing the report in the Federal Register together with the HHS Secretary’s comments on the report not later than six months after receiving the report in accordance with section 1890(b)(5)(B) of the Act. 
  
• On June 26, 2025, FDA released a notice entitled, Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers; Guidance for Industry. FDA is announcing the availability of a final guidance for industry entitled, Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers. This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled, Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1) issued on May 24, 2022.
  
• On June 26, 2025, FDA released a notice entitled, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff. FDA is announcing the availability of a final guidance entitled, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance updates the previous version of the guidance, of the same title, issued on September 27, 2023, and finalizes the draft guidance entitled, Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act issued on March 13, 2024. This guidance provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. Additionally, this guidance has been updated to identify the information FDA generally considers to be necessary for cyber devices to support obligations under the new amendments to the FD&C Act for ensuring cybersecurity of devices.
  
• On June 26, 2025, FDA released a notice entitled, Medical Device User Fee Amendments; Stakeholder Meetings on the Medical Device User Fee Amendments of Fiscal Years 2028 to 2032 Reauthorization; Request for Notification of Stakeholder Intention to Participate. FDA is issuing this notice to request that public stakeholders—including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts—notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Medical Device User Fee Amendments (MDUFA). The statutory authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The FD&C Act requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
  
• On June 26, 2025, the National Institutes of Health (NIH) released a notice entitled, Request for Comments: Division of Cancer Prevention Intellectual Property Option to Collaborators. The National Cancer Institute, an Institute of NIH, is seeking comments on instituting a standard policy on Intellectual Property (IP) developed by certain funding recipients under NCI DCP funding agreements. This standard policy is entitled, The DIVISION OF CANCER PREVENTION INTELLECTUAL PROPERTY OPTION TO COLLABORATORS (IP Option). The proposed policy, if finalized, shall apply to entities that conduct DCP-funded clinical studies under funding agreements which involve an NCI collaborator that provides its proprietary agent or technology for the DCP-supported studies where this IP Option is included as a term of applicable existing and future funding agreements.
  
•  On June 27, 2025, CMS released a notice entitled, Medicare Program; Implementation of Prior Authorization for Select Services for the Wasteful and Inappropriate Services Reduction (WISeR) Model. This notice announces a six-year model focused on reducing fraud, waste (including low-value care), and abuse in Medicare fee-for-service (FFS) via the implementation of technology-enabled prior authorization processes for select services.
  
   

Event Notices

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

• 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 (PDUFA) for FYs 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 GDUFA 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 18, 2025: FDA announced a meeting of the Psychopharmacologic 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, 2025: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. 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 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 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, 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 11-12, 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 (NICHD). 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.
• **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. 
  
   

Reports, Studies & Analyses

• On June 25, 2025, U.S. Government Accountability Office (GAO) published a report entitled, Medicaid Managed Care: Actions to Improve the Extent to Which Children Receive Medical Screenings and Treatment. The report highlights that children enrolled in Medicaid are entitled to a comprehensive set of screening, diagnostic, and treatment services, but well-child screening rates had not returned to pre-pandemic levels as of FY 2023. About 85 percent of the 33 million children covered by Medicaid in FY 2022 were enrolled in managed care plans, which states often rely on to deliver these services. GAO found that some states, such as Ohio and Washington, used performance-based financial incentives to encourage managed care plans to improve well-child screening rates, while others, like North Carolina, were exploring additional quality measures. Managed care plans also implemented incentives to boost participation in screenings and treatments. The report emphasizes the importance of state and plan-level strategies to improve children’s access to timely and preventive care.
• On June 26, 2025, GAO published a report entitled, Medicaid Managed Care: Improper Payment Estimate. GAO examined how CMS calculates improper payments in Medicaid managed care, which covers over 75 percent of Medicaid beneficiaries. While CMS has reported an improper payment rate near zero percent for this component, GAO, HHS Office of Inspector General (OIG), and state auditors have identified significant risks not captured in the estimate, such as payments from managed care plans to providers for services not delivered or lacking documentation. CMS’s methodology only reviews state payments to managed care plans and does not include payments from managed care plans to providers. In response to GAO recommendations, CMS increased its audit activity, completing 899 provider audits and initiating 155 plan audits between October 2021 and February 2025, identifying over $33 million in overpayments. Some previous GAO recommendations to CMS remain unimplemented, including evaluating the inclusion of managed care payments in recovery audits, using state auditor findings to inform oversight, and improving data collection on state Medicaid financing sources.
• On June 26, 2025, HHS OIG released a report entitled, Availability of Surveyed Behavioral Health Providers to Treat New Patients Enrolled in Medicare and Medicaid. The report assesses whether behavioral health providers actively serving Medicare and Medicaid patients in 2023 were available to accept new patients. OIG found that 45 percent of surveyed providers were not available to treat new enrollees in traditional Medicare, Medicare Advantage (MA), or Medicaid managed care, with most citing full caseloads. Among those accepting new patients, about a quarter reported wait times exceeding 30 days. These findings underscore persistent access challenges and reinforce OIG’s earlier recommendations to address behavioral health provider shortages, improve access for new patients, and reduce appointment wait times.
  
   

Hearings & Markups

• On June 23, 2025, the House Appropriations Committee held a business meeting entitled, Full Committee Markup of the FY2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Bill. The Committee approved the bill by a vote of 35 to 27. 
• On June 24, 2025, the House Energy and Commerce Committee Subcommittee on Health held a hearing entitled, The Fiscal Year 2026 Department of Health and Human Services Budget. The Honorable Robert F. Kennedy, Jr., Secretary of HHS, served as the sole witness. 
• On June 24, 2025, the House Oversight and Government Reform Committee Subcommittee on Delivering on Government Efficiency held a hearing entitled, Locking in the DOGE Cuts: Ending Waste, Fraud, and Abuse for Good. Witnesses included: Mr. Matthew Dickerson, Director of Budget Policy, The Economic Policy Innovation Center (EPIC); Mr. David Burton, Senior Fellow in Economic Policy, The Heritage Foundation; Mr. Dan Lips, Senior Fellow, Foundation for American Innovation; and Ms. Emily DiVito, Senior Advisor for Economic Policy, Groundwork Collaborative. 
• On June 24, 2025, the House Veterans’ Affairs Committee Subcommittee on Disability Assistance and Memorial Affairs held a hearing entitled, Legislative Hearing on 12 Bills. Bills discussed included:
  
  • H.R. 3951, Rural Veterans’ Improved Access to Benefits Act of 2025
  • H.R. 3983, Veterans Claims Quality Improvement Act of 2025
• On June 25, 2025, the House Ways and Means Committee Subcommittee on Health held a hearing entitled, Health at Your Fingertips: Harnessing the Power of Digital Health Data. Witnesses included: Dr. Kristen Holmes, Global Head of Human Performance and Principal Scientist, WHOOP; Mr. Josh Phelps, President, Winchester Metals Inc.; Andrew Zengilowski, CEO and Co-Founder, CoachCare; Dr. Jackie Gerhart, Chief Medical Officer and VP of Clinical Informatics, Epic Systems; and Ms. Sabrina Corlette, Research Professor and Co-Director, Center on Health Insurance Reforms, Georgetown University McCourt School of Public Policy. 
• On June 25, 2025, the House Budget Committee held a hearing entitled, Reversing the Curse: Rooting Out Waste and Fraud and Restoring the Dignity of Work. Witnesses included: Dr. Brian Blase, President, Paragon Health Institute; Mr. Nick Stehle, Vice President of Communications, Foundation for Government Accountability; Ms. Leslie Ford, Senior Fellow, Alliance for Opportunity; Mr. Matthew Dickerson, Director of Budget Policy, Economic Policy Innovation Center; and The Honorable Robert Gordon, Doris Duke Distinguished Visiting Fellow, McCourt School of Public Policy, Georgetown University. 
• On June 25, 2025, the Senate Health, Education, Labor and Pensions Committee held a hearing entitled, Nomination of Susan Monarez to be Director of the Centers for Disease Control and Prevention, Department of Health and Human Services. Dr. Susan Monarez, Nominee for Director, CDC, served as the sole witness. 
• On June 25, 2025, the House Oversight and Government Reform Committee Subcommittee on Health Care and Financial Services held a hearing entitled, Sacrificing Excellence for Ideology: The Real Cost of DEI (Diversity, Equity, and Inclusion). Witnesses included: Mr. Dan Lennington, Managing Vice President and Deputy Counsel, Wisconsin Institute for Law & Liberty; Dr. Judge Glock, Director of Research and Senior Fellow, Manhattan Institute; Dr. Erec Smith, Research Fellow, Cato Institute; and Dr. Shaun Harper, Provost Professor of Public Policy, Business, and Education, University of Southern California.
• On June 25, 2025, the Senate Special Committee on Aging held a hearing entitled, Lessons from the Field: How Sports Medicine Can Improve Health Outcomes for Seniors. Witnesses included: Dr. E. Lyle Cain Jr., Orthopedic Surgeon and Team Physician, Andrews Sports Medicine & Orthopaedic Center, University of Alabama; Dr. Paul S. Legg, Orthopaedic Surgeon and Team Physician, University of Charleston; Matt Hasselbeck, Former NFL Quarterback; and Jennifer Raymond, Chief Strategy Officer, AgeSpan. 
  
   

Other Health Policy News

• On June 23, 2025, HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz convened a roundtable with major health insurers to announce a new industry pledge to reform the prior authorization process across MA, Medicaid Managed Care, Marketplace, and commercial plans. The insurers, which collectively represent the majority of covered Americans, committed to six reforms: (1) adopting standardized Fast Healthcare Interoperability Resources (FHIR)-based electronic prior authorization; (2) reducing the number of services requiring prior authorization by 2026; (3) honoring existing authorizations during coverage transitions; (4) improving transparency in authorization decisions and appeals; (5) expanding real-time approvals by 2027; and (6) ensuring clinical review of all denials. An HHS press release following the roundtable can be found here. 
• On June 26, 2025, the Senate Parliamentarian advised that several provisions in the proposed One, Big, Beautiful Bill would be subject to a 60-vote threshold if they remain in the bill. While budget reconciliation bills have the advantage of only requiring a majority vote of 51 in the Senate instead of the 60 votes usually required for passage, they must comply with the “Byrd Rule”, which treats any provisions that do not directly change the level of spending or revenue as extraneous. If a provision is declared in violation of the Byrd Rule, it must be revised in sufficient detail to be declared no longer in violation of the Byrd Rule or else it is subject to a point of order that can result in the provision being struck from the bill. The following provisions have been determined to be subject to a 60-vote point of order under the Byrd Rule:
  
  • Medicaid and the Children’s Health Insurance Program (CHIP) Eligibility Restrictions: Sections 71109 and 71110 of Title VII of the Senate Finance Committees proposed reconciliation bill text would prohibit federal financial participation for individuals whose citizenship or immigration status cannot be verified and deny federal funding for Medicaid coverage for certain non-citizen immigrants.
  • Federal Medical Assistance Percentage (FMAP) Adjustment: Section 71111 would reduce the FMAP from 90 percent to 80 percent for states covering undocumented individuals with state funds.
  • Medicaid Pharmacy Reimbursement: Section 71116 would mandate that Medicaid managed care contracts with pharmacy benefit managers adopt state reimbursement methodologies, ensuring full pass-through of payments to pharmacies.
  • Gender-Affirming Care: Section 71117 would prohibit federal Medicaid and CHIP funding for gender-affirming medical care. 
  • Provider Tax: Section 71120 would restrict non-expansion states from increasing provider tax rates or expanding the tax base and gradually reduces the hold harmless threshold for expansion states.
  • Medicare Eligibility Restrictions: Section 71201 would revoke Medicare eligibility for certain non-citizen immigrants, including refugees and individuals with temporary protected status.
  • Premium Tax Credit Limitations: Sections 71301 and 71302 would restrict access to premium tax credits and cost-sharing reductions for non-citizen immigrants, including during periods of Medicaid ineligibility due to immigration status.
  • Ending Silver Loading: Section 87001 of the proposed bill text would appropriate funding for federal cost-sharing reduction payments to Affordable Care Act (ACA) Marketplace Insurers beginning in 2026, changing the financing arrangement from the longstanding practice of “silver loading” to direct payments, which would make coverage less affordable for many. 
  • Abortion Restrictions for Cost-Sharing Reduction Payments: Section 87001 also contains Hyde amendment language that would prohibit federal cost-sharing reduction payments to qualified health plans that cover abortion services. Several other provisions remain under review for Byrd Rule compliance:
  • Repeal of Medicare Savings Program Rule: Section 71101 would block implementation of a rule streamlining eligibility for Medicare Savings Programs.
  • Repeal of Medicaid and CHIP Enrollment Rule: Section 71102 would prevent enforcement of a rule aimed at simplifying enrollment processes for Medicaid, CHIP, and Basic Health Programs.
  • Nursing Home Staffing Regulations: Section 71113 proposes to repeal staffing and transparency requirements for nursing homes.
  • Defunding prohibited entities, as defined by the legislation: Section 71118 would prohibit entities providing family planning services, reproductive health, and related medical care from receiving federal Medicaid funds. 
  More information on provisions under Senate Parliamentarian review is available here. 
• On June 25 and 26, 2025, the CDC Advisory Committee on Immunization Practices (ACIP) held a meeting to review scientific data and vote on vaccine recommendations. This was the first meeting of ACIP since HHS Secretary Robert F. Kennedy, Jr. dismissed all 17 sitting ACIP members on June 9, 2025. The meeting proceeded with seven new members after one appointee withdrew from ACIP. The Committee held its first votes on June 26, recommending use of Merck’s RSV monoclonal antibody clesrovimab for certain infants and approving its inclusion in the Vaccines for Children program. ACIP also reaffirmed its recommendation for annual influenza vaccination for individuals over six months of age and advised that all flu vaccines be administered in single-dose, thimerosal-free formulations for children, pregnant women, and adults. ACIP Chair Martin Kulldorff announced two new ACIP work groups to examine the cumulative effects of the childhood and adolescent vaccine schedules and to re-evaluate vaccines that have not been reviewed in the past seven years. Recordings of the meetings can be found here and here.
• On June 27, 2025, the U.S. Supreme Court issued a 6–3 decision in Kennedy v. Braidwood Management, holding that “Task Force members are inferior officers whose appointment by the Secretary of HHS is consistent with the Appointments Clause”. The ruling preserves the legal foundation for the ACA’s preventive services coverage requirements, which mandate that most insurers cover services recommended by the U.S. Preventive Services Task Force (USPSTF) without patient cost-sharing. The USPSTF is an independent body convened by the federal government to make recommendations on preventive services. Nearly all private insurers and government payers are required to follow its recommendations without patient cost-sharing. The Supreme Court’s decision also affirms that “the Secretary may remove Task Force members at will, enabling him to supervise and direct them”, and “[b]eyond at-will removal, the Secretary has statutory authority to directly review and block Task Force recommendations before they take effect.” The decision is available here.

View our Health Care Legislative & Public Policy team.

Did you miss a week? Browse our Health Care Week in Review archive.