THIS WEEK’S DOSE
- A government shutdown looms. No progress was made this week to fund the government beyond the September 30, 2025, deadline.
- HHS takes action on autism causes and treatments. The US Department of Health and Human Services (HHS) released findings on a link between acetaminophen use during pregnancy and childhood autism.
- GAO releases reports on provider consolidation and urban hospital closures. One report examines the impact of provider consolidation on quality, cost, and access, and the other reviews causes of urban hospital closures.
- OSTP requests information on AI regulatory reform. The Office of Science and Technology Policy (OSTP) request follows the administration’s July 2025 artificial intelligence (AI) action plan.
- Federal court vacates Biden-era RADV rule. The 2023 rule modified how CMS recovers overpayments from Medicare Advantage plans after risk adjustment data verification (RADV) audits.
CONGRESS
A government shutdown looms. After the Republican-led bill to fund the government through November 21, 2025, passed the House but failed in the Senate last week, both chambers have been out of session all week for a scheduled recess. As the stalemate between the two parties stretched into this week, President Trump initially agreed to meet with Democratic leaders Schumer (NY) and Jeffries (NY) on Thursday to potentially negotiate an agreement on the short-term continuing resolution (CR), but he later cancelled the meeting after reported pushback from Republican leaders Thune (SD) and Johnson (LA).
Democratic leadership continues to state that they will not vote for a CR unless it addresses policies to protect healthcare access, such as repealing Medicaid provisions in the One Big Beautiful Bill Act (OBBBA) or making the Marketplace enhanced advanced premium tax credits (APTCs) permanent. While some moderate Republicans support a short-term APTC extension or some version of an extension, others are firmly opposed. This week, some Republicans also began to discuss a need to address Hyde protections regarding abortion if enhanced APTCs were to be extended. This issue is a non-starter for Democrats, who have noted that Hyde protections are already included in the Affordable Care Act.
The Senate will return from recess on Monday. The House is not currently scheduled to be back in session until after the fiscal year (FY) deadline (although House Minority Leader Jeffries has called Democrats back to Capitol Hill early next week), making a government shutdown of some duration very likely as of this moment. Some healthcare programs and policies, known as extenders, will also expire on September 30, 2025, if a funding bill does not pass. These include Medicare telehealth flexibilities, the hospital at home waiver, and community health center funding. Federal agencies began work this week on contingency plans in case of a shutdown, but public HHS contingency plans haven’t been updated since 2024. On Wednesday, the Office of Management and Budget sent a memo directing agencies to create a list of workers to be laid off in the case of a shutdown, increasing existing concerns about how a shutdown would play out.
ADMINISTRATION
HHS takes actions on autism causes and treatments. Following a press conference, HHS released a fact sheet outlining interagency findings and action plans to address increasing rates of autism:
- HHS reported a correlation between acetaminophen use in pregnancy and increased risk of autism in children, and the US Food and Drug Administration (FDA) announced its intention to change the safety label for acetaminophen.
- FDA released a formal notice to physicians informing them of the correlation between acetaminophen and autism and asking them to consider minimizing its use for pregnant patients, while also acknowledging that acetaminophen is “the safest over-the-counter alternative in pregnancy” compared to other over-the-counter painkillers and fever reducers.
- FDA announced its initiative to update labeling for leucovorin calcium tablets, used to treat cerebral folate deficiency, to authorize access for children with speech-related deficits associated with autism.
- The National Institutes of Health Autism Data Science Initiative announced 13 new awards totaling more than $50 million to research autism prevalence, etiology, and treatment.
The HHS press release can be found here.
GAO releases reports on provider consolidation and urban hospital closures. The US Government Accountability Office (GAO) issued a report showing increased physician consolidation with hospital systems, corporate entities, and private equity firms, and finding that all 10 of the largest health insurers have acquired physician practices or management services organizations in recent years. While studies reviewed by GAO found that such consolidation generally led to higher spending in traditional Medicare, they showed no change in the quality of care provided. The GAO report was required by the FY 2023 Labor-HHS appropriations report.
GAO also issued a report detailing the factors contributing to closures of urban hospitals, including financial declines, aging physical infrastructure, declining volume of inpatient admissions, challenges operating independently without the support of a multihospital system, poor management practices, and separate ownership interests. Sen. Grassley (R-IA), Rep. Sewell (D-AL), and Rep. Sanchez (D-CA) requested the study.
OSTP requests information on AI regulatory reform. The request for information notes that “the realization of the benefits from AI applications cannot be done through complete de-regulation, but require policy frameworks, both regulatory and nonregulatory” to foster innovation while protecting the public interest. OSTP seeks information on federal regulations that hinder AI development, deployment, or adoption, particularly rules that were established before current AI capabilities were anticipated. OSTP invites responses to one or more of the following questions:
- What AI activities, innovations, or deployments are currently inhibited, delayed, or otherwise constrained because of federal statutes, regulations, or policies?
- What specific federal statutes, regulations, or policies present barriers to AI development, deployment, or adoption in your sector?
- Where existing policy frameworks are not appropriate for AI applications, what administrative tools (e.g., waivers, exemptions, experimental authorities) are available but underutilized?
- Where specific statutory or regulatory regimes are structurally incompatible with AI applications, what modifications would be necessary to enable lawful deployment while preserving regulatory objectives?
- Where barriers arise from a lack of clarity or interpretive guidance on how existing rules cover AI activities, what forms of clarification (e.g., standards, guidance documents, interpretive rules) would be most effective?
- Are there barriers that arise from organizational factors that impact how federal statutes, regulations, or policies are used or not used? How might federal action appropriately address them?
Comments are due October 27, 2025.
COURTS
Federal court vacates Biden-era RADV rule. The US Northern District of Texas District Court sided with plaintiffs to overturn the February 2023 final rule, which eliminated an adjuster used in RADV audits. Plaintiffs claimed the rule was arbitrary and capricious and that CMS abused its discretion by applying the new policy retroactively. It is unclear if the Trump Administration will appeal the ruling and what impact it will have on the May 2025 announcement to audit all MA contracts annually and expedite remaining RADV audits.
QUICK HITS
- USDA terminates future Household Food Security Reports. The US Department of Agriculture (USDA) announced it will terminate future Household Food Security Reports, a 30-year study initiated under the Clinton administration to support expanded Supplemental Nutrition Assistance Program eligibility and benefit allotments.
- USDA swears in Ben Carson as health advisor. Ben Carson, MD, former US Department of Housing and Urban Development secretary and a retired pediatric neurosurgeon, will serve as USDA’s national advisor for nutrition, health, and housing. He will advise both President Trump and USDA Secretary Rollins on nutrition and rural healthcare matters and will join Secretary Rollins on the Make America Healthy Again (MAHA) Commission.
- CMS approves temporary Georgia work requirements waiver extension. The Centers for Medicare & Medicaid Services (CMS) approved an extension of Georgia’s Section 1115 waiver, which provides Medicaid coverage to the expansion population as long as beneficiaries meet specified work requirements, through December 31, 2026. CMS stated it will work with Georgia to ensure compliance with the OBBBA work requirements provision, which is effective January 1, 2027. This approval follows a recent GAO report on Georgia’s waiver, requesting that CMS implement recommendations to improve federal oversight of administrative costs.
- CMS increases supplemental benefit information listed on Medicare Plan Finder. For contract year 2026, CMS will expand the display of Medicare Advantage (MA) supplemental benefits on the MA Medicare Plan Finder (MPF). CMS’s notice follows last week’s final rule requiring plans to submit provider directory information for the MPF and CMS’s announcement of a special enrollment period for 2026 for individuals who enrolled in a plan through the MPF and later learned that the provider directory information was incorrect.
- Senate Democrats urge CMS to halt WISeR Model. In a letter, 18 Democratic senators urged CMS to halt the Wasteful and Inappropriate Service Reduction (WISeR) Model pending a full analysis of the program’s impact on patient access, including input from beneficiaries, advocates, providers, and suppliers. The senators expressed concerns that the model isn’t voluntary and relies on AI.
- ACF expands supplemental nutrition funding for Head Start. The Administration for Children and Families (ACF) announced a $61.9 million investment in supplemental nutrition funding for more than 290 Head Start programs across the country. The funding follows the recently published MAHA strategy, which aims to promote access to nutritional foods for children and families. The full list of grantees and award amounts can be found here.
- SAMHSA provides more than $1.5 billion in substance use grants. The Substance Abuse and Mental Health Services Administration (SAMHSA) announced $1.5 billion in FY 2025 funding for State Opioid Response (SOR) and Tribal Opioid Response grants. The agency also announced $45 million in supplemental funding for SOR recipients to focus on sober or recovery housing for young adults following the “Ending Crime and Disorder on America’s Streets” executive order.
- US Department of Commerce initiates investigation into medical device imports. The investigation will focus on the national security impact of imports of personal protective equipment, medical consumables, and medical equipment and devices. The investigation could lead to the imposition of, or increase in, tariffs on such imports.
BIPARTISAN LEGISLATION SPOTLIGHT
| A bipartisan group of five representatives and 19 senators reintroduced the Safe Step Act (H.R. 5509/S.2903). The legislation, which was introduced in previous Congresses, would require group health plans to implement an exemptions process for medication step therapy protocols. |
NEXT WEEK’S DIAGNOSIS
Any congressional action next week will likely be focused on government funding; no healthcare hearings are currently scheduled. The Senate is scheduled to return to session on Monday. At present, the House is not scheduled to be in session next week, although that is subject to change should the government shut down. If a funding deal is not reached, the government will shut down on October 1, 2025. The parameters of government agency operations during a shutdown remain unclear as we await publicly available contingency staffing plans.
