Health Care Week in Review | Senate Finance Committee Releases Budget Reconciliation Text; SCOTUS Upholds TN Ban on Gender-Affirming Care for Minors

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.

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 Regulations, Notices & Guidance

• On June 17, 2025, FDA released a rule entitled, Medical Devices: Exemptions from Premarket Notification: Class II Devices; Clinical Electronic Thermometers. This rule sets forth FDA’s determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• On June 18, 2025, the Food and Drug Administration (FDA) released guidance entitled, Post-Warning Letter Meetings Under GDUFA. This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain facilities, a program enhancement agreed upon by FDA and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in the “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023––2027” (GDUFA III commitment letter). A Post Warning Letter Meeting, as described in section VII.D.1 of the GDUFA III commitment letter, is a meeting with FDA regarding the facility’s remediation of deficiencies identified in a warning letter. This guidance specifically describes the process in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the facility’s ongoing remediation efforts to address current good manufacturing practice (CGMP) deficiencies described in a warning letter, how to prepare and submit a complete meeting request package, and how FDA intends to conduct the Post-Warning Letter Meeting.
• On June 20, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Application from The Joint Commission for Continued CMS Approval of its Hospital Accreditation Program. This final notice announces CMS’s decision to approve The Joint Commission for continued CMS-recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
• On June 20, 2025, 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 recipients from the definition of “lawfully present;” establishes the evidentiary standard the Department of Health and Human Services (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; 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.

Event Notices

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

• 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 25, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
• June 26, 2025: The National Institutes of Health (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 (PDUFA) for fiscal years (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 11-12, 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.

Reports, Studies & Analyses

• On June 16, 2025, the Congressional Research Service (CRS) released a report entitled, Recent Developments Regarding New and Existing Payment Models at the Center for Medicare and Medicaid Innovation. The report provides an overview of the latest strategies and updates from the Center for Medicare and Medicaid Innovation (CMMI). It focuses on the evolution on the alternative payment models (APMs) designed to transition the U.S healthcare system from volume-based to value-based care. The report highlights both new and ongoing initiatives, such as the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, the Enhancing Oncology Model, and the Cell and Gene Therapy Access Model. These models aim to improve care quality, enhance patient outcomes, and reduce healthcare costs. Additionally, the report outlines strategic adjustments to CMMI’s portfolio to promote equity, scalability, and alignment with broader healthcare transformation goals.
• On June 17, 2025, the HHS Office of Inspector General (OIG) released a report entitled, HHS-OIG's Spring 2025 Semiannual Report to Congress. HHS-OIG’s Spring 2025 Semiannual Report highlights key activities and accomplishments from October 1, 2024, through March 31, 2025. This critical work protects HHS programs and the people it serves. Through enforcement and oversight, OIG safeguards taxpayer dollars and strengthens program performance and efficiency. During this period, OIG’s efforts resulted in a total monetary impact of $16.61 billion, underscoring its role in promoting integrity and accountability in government.
• On June 18, 2025, CRS released a report entitled, Financing Cost-Sharing Reduction Reimbursements to Private Health Plans. The report outlines the potential fiscal and policy implications of Section 44202 of H.R. 1, which proposes indefinite appropriations for cost-sharing reduction (CSR) reimbursements to private health plans starting in 2026. CSRs are subsidies that lower out-of-pocket costs for low-income enrollees in silver-tier health plans under the Affordable Care Act (ACA). Although insurers are legally required to provide CSRs, federal reimbursements were halted in 2017, prompting insurers to raise premiums—a practice known as “silver loading.” This, in turn, increased federal spending on premium tax credits (PTCs), which are tied to silver plan premiums. The CRS report notes that reinstating CSR reimbursements through direct appropriations could reduce federal deficits by lowering silver plan premiums and, consequently, PTC expenditures. The Congressional Budget Office (CBO) estimates that Section 44202 would reduce federal outlays by $30.8 billion and increase revenue by $2.8 billion over a 10-year period. CMS has advised insurers to prepare for potential legislative changes, which could significantly affect 2026 premium rates.
• On June 20, 2025, OIG released a report entitled, Part D Plans Generally Include Drugs Commonly Used by Dual Eligible Enrollees: 2025. The report found that a majority of 2025 Part D plan formularies covered almost all commonly used drugs, and only a small number of commonly used drugs were not covered by most formularies. OIG found that out of 378 distinct formularies, 333 covered at least 97 percent of these drugs. Among benchmark plans, six out of 10 formularies met this 97 percent threshold, while the remaining four covered at least 92 percent. However, seven commonly used drugs were not widely covered, appearing in fewer than 75 percent of formularies. These drugs were primarily used to treat conditions like diabetes, chronic obstructive pulmonary disease (COPD), gastroesophageal reflux disease (GERD), and muscle pain, though alternative medications in the same therapeutic classes were generally available. Dual-eligible enrollees have monthly opportunities to switch plans and can pursue exceptions or appeals for non-covered drugs, but these processes can be burdensome and don’t guarantee access. These findings are consistent with OIG’s annual findings since 2011.
• On June 20, 2025, the Bipartisan Policy Center (BPC) released a report entitled, Oversight Beyond the FDA: Understanding the Regulation of Health AI Tools. The report examines health artificial intelligence (AI) tools that fall outside formal FDA oversight, including administrative systems, certain clinical decision support software, and consumer-facing wellness apps. It outlines how these technologies function, how they fit within existing oversight structures, and where regulatory responsibilities may be unclear or overlapping. The report emphasizes how, as federal policymakers consider ways to accelerate the adoption of high-value AI, a clear understanding of the current oversight landscape is essential.

Other Health Policy News

• On June 16, Senate Finance Committee Republicans unveiled their draft of the budget reconciliation bill. Notably, the Senate’s health provisions make more aggressive Medicaid cuts than the House of Representatives version. It eliminates previous “grandfathered” protections for state Medicaid financing mechanisms – notably by lowering the cap on provider taxes that states can use to fund Medicaid (e.g., a phase down of provider taxes for expansion states to 3.5 percent) and by capping Medicaid managed-care payments to providers at Medicare rates (100 percent of Medicare rates in expansion states, 110 percent in non-expansion states), effectively phasing out higher state-directed payments. These policies especially impact states that expanded Medicaid, as they must scale back supplemental payments to hospitals and other providers.
• Further, the Senate plan broadens Medicaid work requirements, extending them to parents with children over 14 (a broader population than the House-passed bill) and provides limited funds to help implement this new requirement. It also reduces federal support for certain providers and services: for example, it lowers the threshold allowing states to exclude certain family planning providers (widely seen as targeting organizations like Planned Parenthood). The draft would also reduce federal matching funds for emergency Medicaid care for individuals ineligible due to immigration status, further restrict Medicaid coverage for some immigrant populations, and limit retroactive Medicaid coverage for enrollees. Additionally, similar to the House bill, the Senate draft retains provisions that would add new burdens on ACA Marketplace carriers, through new enrollment and eligibility verification. Analysts warn these changes could destabilize ACA Marketplaces, making coverage harder to obtain and maintain for millions of Americans.
• Republican leaders are rushing to advance the reconciliation bill, but intra-party divisions over the depth of health care cuts remain. Some GOP lawmakers argue that the current provider tax system is being misused to inflate Medicaid reimbursements, while others warn that the proposed changes could harm essential rural health services. Of note, Senators such as Senators Susan Collins (R-ME) and Josh Hawley (R-MO) are leading discussions on creating a relief fund to support rural hospitals, nursing homes, and community health centers that could be affected by the tax changes.
• Senate Majority Leader John Thune (R-SD) and the White House have maintained their original goal of passing the bill by July 4 despite other Senators seeing that as an unlikely event. Senate leadership has been planning for an initial procedural vote as soon as Wednesday, June 25, which would set up a “vote-a-rama” in later in the week with a final passage vote over the weekend. However, on June 19, the Senate Parliamentarian advised that certain provisions in the bill will be subject to the Byrd Rule, meaning they will need to be stripped from the bill or gather 60 votes to overcome a point of order against the rule. The Parliamentarian’s rulings on the Senate Finance Committee’s text will be the last to be decided and could begin rolling out mid-next week The next week will be pivotal as Senate Republicans negotiate final health policy details ahead of the anticipated vote. Senate Finance Committee bill text is available here.
• On June 18, 2025, the U.S Supreme Court ruled (6-3) in United States v. Skrmetti that Tennessee’s law (SB1) prohibiting certain medical treatments for transgender minors is not subject to heightened scrutiny under the Equal Protection Clause of the Fourteenth Amendment and satisfies rational basis review. Thus, the Court upheld the Sixth Circuit’s ruling that the Tennessee law that bans hormonal treatments for minors diagnosed with gender dysphoria but explicitly allows those same treatments for minors with birth defects and delayed or early puberty does not violate the Constitution. The decision is available here.

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