Blog | 9/26/2025

Sharp Strategy Spotlight: September 26, 2025

Strategic perspectives on the trends, policies, and ideas shaping healthcare.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on September 25, 2025. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

Bipartisan bill introduced to speed up Medicare Advantage payments to providers

  • A bipartisan group of lawmakers has introduced legislation in both chambers of Congress requiring Medicare Advantage (MA) plans to promptly pay out providers’ claims, with up to a $25,000 fine and interest accrual.
  • The Medicare Advantage Prompt Pay Act would apply to covered services regardless of whether a provider and plan have a network contract. It also requires plans submit information on their compliance with the prompt payment requirements and other details around a submitted claim and authorizes regulators to consult those reports when weighing a civil monetary fine.
  • The legislation was unveiled late last week by Sen. Catherine Cortez Masto, D-Nev.; Sen. Marsha Blackburn, R-Tenn.; Rep. Jodey Arrington, R-Texas; and Rep. Linda Sánchez, D-Calif. In their announcement, the lawmakers said the provisions would ensure hospitals and doctors’ payments arrive more reliably and protect seniors on MA plans from unexpected bills sent well after they had received care.
  • “This bipartisan legislation makes commonsense fixes to Medicare Advantage’s billing practices that will help healthcare providers and patients by bringing transparency and stability to the program,” Cortez Masto said in the announcement.
  • Specifically, the bill gives plans a 14-day deadline to pay electronically submitted, in-network claims and a 30-day requirement for paper or out-of-network claims. To avoid a fine, they must provide these prompt payments for 95% of “clean claims” they receive.
  • https://www.fiercehealthcare.com/regulatory/bipartisan-bill-introduced-require-medicare-advantage-plans-promptly-pay-claims

CMS Medicaid tax funding rule struck down by judge following Texas challenge

  • A federal judge in Texas on Wednesday struck down a U.S. Centers for Medicare & Medicaid Services rule on how states fund their share of Medicaid costs after finding that the agency had overstepped its authority.
  • U.S. District Judge Jeremy Kernodle in Tyler, Texas, permanently barred CMS from enforcing regulations that changed how states calculate their share of Medicaid costs. Kernodle agreed with Texas, which had challenged the measures, that the agency lacked congressional approval to implement the changes. The ruling applies nationwide.
  • Texas had argued the regulations, which bar certain payments to healthcare providers, could reduce state funding for Medicaid, force states to return funds they had already received and saddle them with millions in compliance costs, putting $10 billion in funding at risk.
  • Representatives for the Texas Attorney General’s Office did not immediately respond to a request for comment. Neither did representatives for CMS.
  • Medicaid, a healthcare program for low-income and disabled people, is jointly funded by states and the federal government.
  • https://www.reuters.com/legal/litigation/cms-medicaid-tax-funding-rule-struck-down-by-judge-following-texas-challenge-2025-09-24/

Trump links autism to Tylenol and vaccines, claims not backed by science

  • U.S. President Donald Trump on Monday linked autism to childhood vaccine use and the taking of popular pain medication Tylenol by women when pregnant, elevating claims not backed by scientific evidence to the forefront of U.S. health policy.
  • In an extraordinary news conference at the White House, the Republican president delivered medical advice to pregnant women and parents of young children, repeatedly telling them not to use or administer the painkiller and suggesting that common vaccines not be taken together or so early in a child's life.
  • The advice from Trump, who acknowledged he is not a doctor, goes against that of medical societies, which cite data from numerous studies showing that acetaminophen, the active ingredient in Tylenol, plays a safe role in the well-being of pregnant women.
  • "I want to say it like it is, don't take Tylenol. Don't take it," Trump said. "Other things that we recommend, or certainly I do anyway, is ... don't let them pump your baby up with the largest pile of stuff you've ever seen in your life," he said, referring to vaccines.
  • The widely used over-the-counter pain relief medication is also known generically as paracetamol elsewhere.
  • Press: https://www.reuters.com/business/healthcare-pharmaceuticals/trump-expected-link-autism-with-tylenol-experts-say-more-research-needed-2025-09-22/
  • White House Press:  https://www.whitehouse.gov/articles/2025/09/fact-evidence-suggests-link-between-acetaminophen-autism/

F.D.A.’s Approval of a Drug for Autism Upends Review Process

  • In taking the unusual step of approving an old generic drug as a treatment for autism, the Food and Drug Administration stunned some experts by departing sharply from the agency’s typical standard for reviewing drugs.
  • The drug, leucovorin, has long been used to treat the toxic effects of chemotherapy, but it was endorsed as a therapy for some people with autism by President Trump and top U.S. health officials during a White House briefing on Monday.
  • The move flipped the standard process: Typically, a pharmaceutical company carefully studies a drug, often with input from the F.D.A. on the design of rigorous studies, and then files a formal application for approval.
  • But in this case, the agency said it reviewed medical research and made the approval decision to expand the drug’s use on its own.
  • Dr. Makary announced the sudden change during the president’s briefing on autism, which Mr. Trump repeatedly used to directly link Tylenol, the brand-name version of acetaminophen, to the disorder — a connection that is still unproven.
  • The F.D.A. was more cautious in a letter to doctors, saying evidence suggested a link between Tylenol and autism, though the agency added that the association remained an “area of scientific debate.”
  • The health officials promised to fund more studies to explore a potential connection.
  • https://www.nytimes.com/2025/09/23/health/fda-autism-treatment-leucovorin.html   (subscription required for full text)

FDA unveils trio of new draft guidances to help cell and gene therapy developers

CDC advisors recommend that people consult a provider before getting the Covid-19 vaccine

  • The Advisory Committee on Immunization Practices voted unanimously to support that recommendation, with a non-binding emphasis that the risk-benefit profile favors people at higher risk of severe disease.
  • Once the acting CDC director signs off on it, the adult and childhood vaccine schedules will be updated for Covid-19 to reflect that adults 65 and older, and people 6 months to 64 years, can receive a vaccine under shared clinical decision-making, a process where patients see a provider before making a decision.
  • The panel also backed two additional recommendations that operated more like statements on behalf of the committee.
  • Those statements include that the CDC engage “in an effort to promote more consistent and comprehensive informed consent processes” and that healthcare providers give clear details around the benefits and risk of vaccination.
  • A third statement, that states and jurisdictions provide prescriptions for the vaccines, was not supported after a tie-breaking vote.
  • https://endpoints.news/acip-recommends-that-people-consult-a-provider-before-getting-covid-shots/   (subscription required for full text)

Censorship Returns to the CDC: At Least 22 Websites Are Down

  • Censorship is back at the CDC, Inside Medicine learned, from an active agency employee who listed nearly two dozen websites that are now offline.
  • Many of the 22 removed sites appear to have been taken down recently, having been online as recently as earlier this month, an Inside Medicine analysis revealed.
  • Some of the sites may have been removed within the last few days, while others may have been offline for far longer, but flew under the radar.
  • In some cases, agency staffers have been specifically instructed to remove websites, I was told. Others were discovered by employees in the course of their work, such as a seemingly random respiratory syncytial virus (RSV) surveillance page that is now offline.
  • https://www.medpagetoday.com/opinion/faustfiles/117572

Public Health Service Officers Deployed to Address Critical Staffing Shortages at Indian Health Service Facilities

HHS Provides More Than $1.5 Billion in State and Tribal Opioid Response Grants

  • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today allocated more than $1.5 billion in FY25 continuation funding awards for the State Opioid Response (SOR) and Tribal Opioid Response (TOR) grants. This funding provides critical resources to states and Tribal communities to address the overdose crisis through prevention, opioid overdose reversal medications, treatment (including medications for opioid use disorder, or MOUD), and recovery support.
  • The allocations include $1.48 billion for State Opioid Response and nearly $63 million for Tribal Opioid Response.
  • https://www.samhsa.gov/newsroom/press-announcements/20250922/hhs-state-tribal-opioid-response-grants-2025

RFK Jr. says FDA will "study" new safety limits on abortion pill

  • The Food and Drug Administration said it will conduct a "study" of the safety protocol around the widely used abortion drug mifepristone, in a move that could lead to new dispensing restrictions.
  • Why it matters: New rules around the drug, especially those addressing its widespread availability through telehealth, could severely limit access in states with abortion bans.
  • What they're saying: "Through the FDA, HHS will conduct a study of the safety of the current [safety protocol], in order to determine whether modifications are necessary," Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary wrote in a letter dated Sept. 19 to Republican attorneys general.
    • The state officials had pressed the administration to put new safety limits on the pills.
    • One of the most consequential potential changes is reviving a requirement that the drug be dispensed in person. That would effectively cut off tele-prescribing and mailing of the abortion drugs, which now account for more than 60% of all abortions in the health system.
  • https://www.axios.com/2025/09/25/fda-aboriton-pill-safety-limits-rfk   (subscription required for full text)

Federal advisory committee restricts access to MMRV shot for some low-income children

  • A federal advisory panel that recommends vaccines for the public voted Friday to restrict access to the combined measles, mumps, rubella, and varicella shot for low-income children under the age of 4.
  • Those children will still be able to receive separate MMR and varicella shots, which the Centers for Disease Control and Prevention has already said it prefers as there is a very small but higher seizure risk when giving a combined first dose.
  • The vote came during a meeting of the Advisory Committee on Immunization Practices. It centered on whether the combined shot should be covered by the Vaccines for Children (VFC) program, which provides low-cost or free vaccines for about half of the children in the country who are uninsured or on Medicaid.
  • https://www.statnews.com/2025/09/19/mmrv-vaccine-acip-vote-vfc/   (subscription required for full text)

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

House Democrat introduces articles of impeachment against RFK Jr.

  • Rep. Haley Stevens (D-Mich.) announced Thursday she would introduce articles of impeachment against Health and Human Services Secretary Robert F. Kennedy Jr. due to “health care chaos” under his watch.
  • On social platform X, Stevens wrote, “Health care chaos. Reckless cuts. Rising costs. Michiganders and families across the country are paying the price for RFK Jr.’s agenda. Enough is enough, which is why I’m drafting articles of impeachment against @SecKennedy.”
  • The move to impeach Kennedy comes amid federal health policies and recommendations that major medical organizations have spoken out against, including recommendations to alter childhood vaccination schedules and President Trump telling pregnant women not to take Tylenol.
  • https://thehill.com/policy/healthcare/5521385-kennedy-health-care-impeachment/

KEY BIOPHARMA NEWS

Drugmakers meet Trump only halfway on pricing plan

  • Big drug companies so far are responding to President Trump's demand they commit to his "most favored nation" pricing policy by raising prices abroad without cutting them in the U.S.
  • Why it matters: That only gets halfway toward Trump's goal of ending what he calls "global freeloading" and getting other developed countries to foot more of the cost while lowering costs for Americans.
  • Driving the news: Bristol Myers Squibb became the latest company to make a pricing move on Monday, when it said it would sell its schizophrenia drug Cobenfy in the United Kingdom at the higher U.S. list price.
    • There was no corresponding move to cut U.S. prices, though.
    • The announcement came ahead of Trump's deadline next week for 17 major drug companies to take action on prices. There could be more moves amid ongoing industry talks with the administration.
  • The Trump administration is currently in talks with drug companies ahead of the Sept. 29 deadline for action.
  • https://www.axios.com/2025/09/24/trump-drug-prices-cobenfy-schizophrenia   (subscription required for full text)

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

FDA rescinds lab-developed test rule after court order

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

September 2025 Telehealth Cliff: How Four Bills Could Shape Virtual Care

  • Four congressional telehealth bills are bipartisan and widely endorsed.
  • CONNECT for Health Act aims to make core Medicare telehealth flexibilities permanent, while the Telehealth Modernization Act serves as a bridge extending them through September 30, 2027, and Hospital at Home to 2030.
  • The CONNECT for Health Act and the Telemental Health Care Access Act would repeal Medicare’s 6-month in-person telemental requirement, while the Modernization Act delays it until September 30, 2027.
  • The TREATS Act would allow telehealth (including audio-only) evaluations to satisfy prescribing requirements for Schedule III–V SUD medications, including buprenorphine.
  • https://telehealth.org/blog/september-2025-telehealth-cliff-how-four-bills-could-shape-virtual-care/

KEY MEDTECH NEWS

FDA finalizes device production and quality system software guidance

  • The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section clarifying terms used in the guidance.
  • However, the agency did not implement stakeholder suggestions to align it more closely with similar guidances or address some of the concerns regarding the validation of certain kinds of software or tools.
  • FDA said the guidance is intended help agency staff and sponsors use a “risk-based approach to establish confidence in the automation used for production or quality systems, identify where additional rigor may be appropriate” as well as approaches to gauge computer software assurance for medical devices subject to quality system regulation under 21 CFR Part 820.
  • It replaces section 6 of the “General Principles of Software Validation” final guidance published in January 2002.
  • https://www.raps.org/News-and-Articles/News-Articles/2025/9/FDA-finalizes-device-production-and-quality-system

FDA Consolidating Sentinel Safety Surveillance Systems

US opens investigation into medical equipment, device imports

  • The Trump administration is reviewing the national security implications of personal protective equipment, medical equipment and device imports, per a Federal Register notice to be published Friday.
  • According to the notice, the Commerce Department initiated a Section 232 investigation on Sept. 2 covering a wide swath of healthcare-related products. The goods under review range from surgical masks and other PPE to syringes, intravenous bags, pacemakers, blood glucose monitors, wheelchairs and hospital beds.
  • As part of the investigation, the agency is evaluating U.S. demand for the various medical equipment and devices under review as well as domestic manufacturing capacity and the impact of imports and foreign trade practices on the sector. The investigation will also review whether tariffs or quotas should be considered to protect national security.
  • https://www.medtechdive.com/news/trump-tariffs-medical-devices-equipment-ppe-section-232-investigation/761118/

KEY ACRONYMS

  • CBER = Center for Biologics Evaluation and Research
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • MA = Medicare Advantage
  • MAHA = Make America Healthy Again
  •  MOUD = medications for opioid use disorder
  • NIH = National Institutes of Health
  • SAMHSA = Substance Abuse and Mental Health Services Administration
  • SOR = State Opioid Response
  • TOR = Tribal Opioid Response
  • USPHS = U.S. Public Health Service
  • VSD = Vaccine Safety Datalink

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