Blog | 11/14/2025

Sharp Strategy Spotlight: November 14, 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 November 13, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

U.S. visas can be denied for obesity, cancer and diabetes, Rubio says

  • The Trump administration directed visa officers to consider obesity — and other chronic health conditions such as heart disease, cancer and diabetes — as reasons to deny foreigners visas to the United States.
  • Secretary of State Marco Rubio told U.S. consulates and embassies around the world about the changes in a Nov. 6 cable, according to a copy obtained and verified by The Washington Post.
  • The move broadens current medical screening beyond contagious diseases and gives visa officers new justification to reject applicants, in the Trump administration’s latest effort to curb the flow of immigration.
  • “You must consider an applicant’s health,” the State Department cable said. “Certain medical conditions — including, but not limited to, cardiovascular diseases, respiratory diseases, cancers, diabetes, metabolic diseases, neurological diseases, and mental health conditions — can require hundreds of thousands of dollars’ worth of care.”
  • https://www.washingtonpost.com/business/2025/11/13/obesity-visa-rules-trump-administration/  (subscription required for full text) 

KEY FEDERAL GOVERNMENT NEWS

The shutdown deal doesn’t extend expiring health subsidies

  • A legislative package that appears on track to end the longest government shutdown in U.S. history leaves out any clear resolution on the expiring Affordable Care Act tax credits that have made private health insurance less costly for millions of Americans.
  • The deal agreed to by Senate Republicans and a handful of Democrats on Sunday instead only guarantees a December vote on the enhanced premium tax credits, which are set to expire at the end of the year without congressional action.
  • Some Democratic lawmakers looking to compromise have sought one-or two-year stopgap measures that would keep the subsidies alive, but they’ve failed to get buy-in from Republican leadership.
  • Meanwhile, some Republican lawmakers and President Donald Trump have argued for letting the subsidies expire and suggested alternatives to defray health costs, such as federal flexible spending accounts given to every eligible American.
  • https://www.pbs.org/newshour/politics/the-shutdown-deal-doesnt-extend-expiring-health-subsidies-what-happens-to-them-now

CMS Announces Voluntary Most-Favored-Nation Pricing in Medicaid Through the GENEROUS Model

FDA names longtime oncology chief Richard Pazdur as new CDER director

  • In a surprise move, the FDA has named the longtime leader of its oncology department, Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research, which oversees most prescription drugs.
  • The U.S. Department of Health and Human Services announced the appointment Nov. 11, with FDA Commissioner Marty Makary, M.D., calling Pazdur a “renowned regulatory innovator.”
  • Pazdur takes over from George Tidmarsh, M.D., Ph.D., who resigned from the agency about a week ago amid an internal investigation into alleged misuse of his regulatory authority to act on a personal vendetta.
  • Pazdur, a 26-year veteran of the FDA, is a tall figure at the agency who has had a profound influence on cancer drug development and reviews. He was the founding director of the FDA’s Oncology Center of Excellence, which was established in 2017. He’s one of only two center leaders to have remained in service at the FDA after the agency’s significant leadership shakeup under the Trump administration.
  • He’ll continue to serve as director of the Oncology Center of Excellence for the time being, but the HHS announcement suggests a search is on for Pazdur's successor.
  • https://www.fiercepharma.com/pharma/fda-names-longtime-oncology-chief-richard-pazdur-its-new-cder-director

FDA opens up new approval pathway for personalised rare disease treatments

  • The FDA is making it easier for biopharmas to create — and receive approval for — bespoke medicines made with a single patient in mind.
  • In an article published Wednesday in the NEJM, FDA Commissioner Marty Makary and Vinay Prasad, director of the agency's Center for Biologics Evaluation and Research (CBER), outlined a new "plausible mechanism" pathway that will make it possible for certain cell and gene therapies to receive marketing approval based on data from "appropriately designed" studies involving just a few patients.
  • "The FDA has heard from patients, parents, researchers, clinicians, and developers that current regulations are onerous and unnecessarily demanding, provide unclear patient protection, and stifle innovation," Makary and Prasad wrote. The new initiative is part of broader deregulatory efforts within the FDA.
  • The plausible mechanism pathway is designed to help people with rare diseases that are fatal or associated with severe childhood disability.
  • Press: https://firstwordpharma.com/story/6531718   (subscription required for full text)
  • NEJM article: https://www.nejm.org/doi/full/10.1056/NEJMsb2512695

Medicare picks tech vendors to run AI prior authorization pilot in six states

  • The Centers for Medicare and Medicaid Services has selected the six technology companies that will administer artificial intelligence-powered prior authorization programs for Medicare, STAT has learned.
  • The pilot, called the Wasteful and Inappropriate Services Reduction (WISeR) model, is a CMS effort to reduce waste and abuse within the taxpayer-funded health insurance program that spent more than $1 trillion in 2024. The new prior authorization program will launch in January and run until 2031 in New Jersey, Ohio, Oklahoma, Texas, Arizona, and Washington.
  • CMS’ decision to test the use of AI technology for prior authorizations comes at a time when large private insurers — including UnitedHealthcare and Humana — are facing class action lawsuits and congressional scrutiny over their use of AI for making decisions about care for Medicare Advantage beneficiaries.
  • There is also congressional pushback against the WISeR program; on Friday, a congressional representative from Washington, one of the states where the program will be implemented, is planning to introduce a bill to prevent the Department of Health and Human Services from implementing WISeR.
  • https://www.statnews.com/2025/11/06/medicare-wiser-prior-authorization-pilot-tech-vendors/   (subscription required for full text)

House Dems make push to roll back CMS' AI-powered prior auth model

  • Democrats in the House are making a push to roll back the Trump administration's new prior-authorization demonstration.
  • A group of six Dems, led by Washington Rep. Suzan DelBene, have introduced new legislation that would roll back the Wasteful and Inappropriate Service Reduction, or WISeR, model, which was unveiled earlier this year by the Centers for Medicare & Medicaid Services (CMS).
  • Under the model, the agency will lean on chosen tech vendors to implement new artificial-intelligence-powered prior authorization requirements in six states, beginning in January 2026. The White House argues that this move is aimed at addressing fraud and waste, while the legislators said that it instead amounts to additional red tape in Medicare.
  • The representatives note in an announcement that the model comes in the same year that CMS is touting its role in pushing insurers to make pledges to ease prior authorization burdens.
  • Press: https://www.fiercehealthcare.com/regulatory/house-dems-make-push-roll-back-cms-ai-powered-prior-auth-model
  • Announcement: https://delbene.house.gov/news/documentsingle.aspx?DocumentID=4221

FDA To Proceed With ‘Expert Panels’ Amid HRT Conflict Concerns

Crapo Plans Hearing On Rising Health Costs, New Coalition Launches

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

Providers' lawsuit against RFK Jr. now asks court to nullify ACIP's recent vaccine recommendations

  • A cadre of provider associations that sued Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. over the summer over COVID-19 vaccine recommendation changes have expanded their litigation to encompass the immunization advisory panel he overhauled earlier this year.
  • The plaintiffs filed an updated complaint Wednesday that focuses on the reconstitution of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Council on Immunization Practices (ACIP), the panel of independent experts relied on by the agency to chart changes in vaccine recommendations. All 17 members of the ACIP were fired by RFK Jr. in June and have since been replaced by appointees who, like RFK Jr., predominantly hold vaccine safety criticisms.
  • The provider associations’ amended complaint describes the new appointees as unqualified and improperly appointed. It asks the court to declare the recommendation votes ACIP made that were later adopted by the CDC—including a change for adults from routine COVID-19 vaccination to “shared clinical decision making”—to be vacated, and for the advisory group to again be remade in line with statute and the ACIP Charter.
  • “The current ACIP is not fairly balanced, is not acting independently and is being inappropriately influenced by the Secretary, as evidenced by the ACIP’s discussion and votes at the June and September, 2025 meetings that promoted an anti-vaccine agenda,” the plaintiffs wrote in their amended complaint.
  • Plaintiffs in the case are the American Academy of Pediatrics (AAP), the American College of Physicians, the American Public Health Association, the Infectious Diseases Society of America, the Massachusetts Public Health Alliance and the Society for Maternal-Fetal Medicine.
  • https://www.fiercehealthcare.com/providers/providers-lawsuit-against-rfk-now-asks-court-nullify-acips-recent-vaccine-recommendations

KEY BIOPHARMA NEWS

FDA unveils second batch of commissioner voucher winners, including Lilly's GLP-1 pill

  • Eli Lilly’s oral obesity pill orforglipron was among the next six drugs to win the FDA’s National Priority Voucher, offering the GLP-1 drug candidate a path to potential approval in as little as one month.
  • The FDA on Thursday unveiled the batch of recipients under the new voucher program, which aims to significantly shorten the typical 10 to 12-month review times.
  • The second batch, following October’s rollout of the first nine vouchers, will go to:
    • Boehringer Ingelheim’s zongertinib for HER-2 lung cancer. The drug, known commercially as Hernexeos, won FDA accelerated approval in August as a once-daily, orally-administered TKI targeting HER2 (ERBB2)-mutant mNSCLC after prior systemic therapy.
    • Johnson & Johnson’s bedaquiline for drug-resistant tuberculosis in young children. Known commercially as Sirturo, the drug won approval in 2024 as part of combination therapy in adults and children 5 years and older and weighing at least 15 kg, with pulmonary TB due to Mycobacterium tuberculosis resistance to at least rifampicin and isoniazid.
    • GSK’s dostarlimab for rectal cancer. Sold under the brand name Jemperli, the monoclonal antibody won approval in July 2023 as a treatment for endometrial cancer.
    • Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease. The gene therapy won FDA approval in December 2023.
    • Eli Lilly’s orforglipron for obesity and related health conditions. The oral GLP-1 is currently in clinical trials for the treatment of type 2 diabetes and obesity.
    • Novo Nordisk’s Wegovy for obesity and related health conditions. Wegovy first won FDA approval in 2017.
  • Press: https://endpoints.news/fda-unveils-second-batch-of-commissioner-voucher-winners/   (subscription required for full text)

Hormone replacement therapy will no longer carry a warning label, FDA says

Law to end government shutdown also seeks to accelerate prescription-to-OTC drug switches

  • President Donald Trump on Wednesday evening signed into law a short-term government funding deal to end the longest shutdown in government history, which also includes several provisions for the FDA.
  • The new law sets up another round of user-fee funding for over-the-counter drugs at the FDA through October 2030, and it also calls on the FDA to improve the process for companies looking to switch a prescription drug to a nonprescription, or OTC, drug.
  • The broader funding agreement in the law, however, only lasts until Jan. 30, setting up the possibility of another showdown that could again disrupt many government operations.
  • Under the new OTC provision, companies seeking an OTC switch can submit a written request for a meeting with the FDA to talk through how to address potential risks, and what evidence and studies might be needed.
  • Within the next year, that law calls on the FDA to set up a meeting with stakeholders to discuss how to identify approved prescription drugs “that may be promising candidates” for a switch from prescription to OTC status.
  • And within the next 18 months, the FDA will have to publish guidance “to increase the clarity and predictability of the process and standards for approval” of OTC drugs and those switching from prescription drugs, particularly if they have well-established safety profiles.
  • https://endpoints.news/law-to-end-government-shutdown-also-seeks-to-accelerate-prescription-to-otc-switches/   (subscription required for full text)

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Temporary Delay in PAMA Reductions Provides Labs More Time to Plan

  • The Senate’s government funding proposal includes a 30-day delay in PAMA cuts, giving clinical labs more time to prepare for reduced Medicare reimbursement rates.
  • Tucked into the Senate’s government funding proposal is a modest yet impactful measure that gives clinical laboratories a brief reprieve from PAMA reimbursement cuts.
  • On Nov. 10, the Senate amended and passed a version of a House funding bill, H.R. 5371, designed to reopen the government and allocate funding across multiple agencies.
  • Among its 394 pages is a 30-day stopgap measure delaying PAMA reimbursement cuts, pushing the effective date from January 1 to January 31, 2026.
  • According to an article from our sibling publication G2 Intelligence, under the Protecting Access to Medicare Act (PAMA) of 2014, laboratories face up to 15% cuts in reimbursement rates for approximately 800 commonly ordered diagnostic tests.
  • Press: https://www.darkdaily.com/2025/11/12/temporary-delay-in-pama-reductions-provides-labs-more-time-to-plan/
  • G2 Press: https://www.g2intelligence.com/pama-cuts-to-clinical-labs-may-get-brief-delay/ 

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Wearables could see HIPAA-style regulation

  • Despite voicing some uncertainty about Robert F. Kennedy Jr., Sen. Bill Cassidy (R-La.) wants to regulate one of the Health secretary’s favored components of his Make America Healthy Again agenda to combat chronic disease: wearable health devices.
  • What’s new: Cassidy, chair of the Senate Health, Education, Labor and Pensions Committee, wants to safeguard health data collected by wearables and health apps, which he says are “helpful tools, but present new privacy concerns that didn’t exist when it was just a patient and a doctor in an exam room.”
  • Wearable devices — such as smartwatches, rings and fitness trackers — monitor health and exercise metrics including step count, sleep quality and heart rate.
  • The devices align with Kennedy’s belief that people should take ownership of their health. As Health secretary, he’s criticized weight-loss drugs as a solution for obesity and instead endorsed lifestyle changes. In June, he told House members he wanted all Americans to sport a health-tracking device within the next four years.
  • The Health Insurance Portability and Accountability Act doesn’t include protections for health data collected by wearable technology. Cassidy’s legislation, the Health Information Privacy Reform Act, would require developers to inform users that HIPAA doesn’t protect their data and offer an option to prevent their data from being shared.
  • Press: https://www.politico.com/newsletters/future-pulse/2025/11/11/wearables-could-see-hipaa-style-regulation-00646152
  • Bill: https://www.help.senate.gov/imo/media/doc/health_information_privacy_reform_act.pdf

How much damage did the federal shutdown do to telehealth?

KEY MEDTECH NEWS

U.S. FDA and CMS Actions on Generative AI-Enabled Mental Health Devices Yield Insights Across AI Product Development

  • The FDA held a Digital Health Advisory Committee to address “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices.” This is the second meeting of the Committee, following the inaugural meeting that took place last year on November 20-21, 2024 on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices.”  The meeting offered insights not only into FDA’s approach to regulating generative AI in mental health medical devices, but also medical devices more generally.
  • Key takeaways from last week’s meeting include:
    • FDA acknowledged that certain use cases, such as general wellness devices, are not medical devices subject to FDA’s oversight and that it plans to provide further regulatory clarity for products that are medical devices;
    • FDA continues to focus on a risk-based approach and a total product lifecycle approach (TPLC);
    • FDA is thinking critically about how clinical trial design may need to differ to account for the unique considerations for generative AI-enabled therapeutic devices;
    • FDA and Committee members raised the importance of physician / human oversight and intervention in mental health based generative AI tools; and
    • FDA stated that it intends to exercise its oversight over products that are medical devices and noted that enforcement would be prioritized towards use cases with a higher potential for harm.
  • https://www.sidley.com/en/insights/newsupdates/2025/11/us-fda-and-cms-actions-on-generative-ai-enabled-mental-health-devices-yield-insights-across-ai

KEY ACRONYMS

  • ACA = Affordable Care Act
  • ACIP = Advisory Council on Immunization Practices
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CHIP = Children's Health Insurance Program
  • CMS = Centers for Medicare & Medicaid Services
  • CODs = covered outpatient drugs
  • DOJ = Department of Justice
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • HIPAA = Health Insurance Portability and Accountability Act
  • HRT = hormone replacement therapy
  • MFN = most-favored-nation
  • NIH = National Institutes of Health
  • WISeR = Wasteful and Inappropriate Service Reduction

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