Blog | 12/5/2025

Sharp Strategy Spotlight: December 5, 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 December 4, 2025. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

HHS unveils AI strategy

  • The Department of Health and Human Services has released an artificial intelligence strategy aimed at expanding AI use across its workforce and modernizing internal operations, research and public health activities.
  • Here are five things to know about the strategy:
    • Led by Clark Minor, HHS’ acting chief artificial intelligence officer, the strategy outlines five pillars: governance and risk management; infrastructure and platform design; workforce development and burden reduction; research and reproducibility; and modernization of care and public health delivery.
    • The plan fulfills directives from the Trump administration’s AI Action Plan, AI-related executive orders and guidance from the Office of Management and Budget.
    • The “OneHHS” approach invites all HHS divisions - including the CDC, CMS, FDA and NIH - to collaborate.
    •  Lawmakers voiced support for the initiative. Rep. Jay Obernolte, R-Calif., chair of the Bipartisan House Task Force on Artificial Intelligence, said the plan emphasizes transparency, risk management, public trust and respect for Americans’ health data. Sen. Todd Young, R-Ind., and Sen. Mike Rounds, R-S.D., said the strategy reflects a focus on taxpayer value and AI’s potential to strengthen the health system.HHS said the strategy represents an initial step focused on improving internal operations and federal use of AI.
  • Analysis: https://www.beckershospitalreview.com/healthcare-information-technology/ai/hhs-unveils-ai-strategy/
  • HHS Press: https://www.hhs.gov/press-room/hhs-unveils-ai-strategy-to-transform-agency-operations.html

FDA to lower number of trials required for approval of drugs, other medical products

  • The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday.
  • While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval. Makary said that while the agency will still require two in some cases, the default will be one trial.
  • “You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately,” Makary told STAT by phone. 
  • https://www.statnews.com/2025/12/04/fda-considers-single-clinical-trial-for-new-product-approvals   (subscription required for full text)

FDA floats user fee cuts for early-stage US trials, additional fees for overseas development

  • The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad.
  • The proposal is designed to incentivize U.S. drug development by tacking on higher fees for those not running phase 1 trials in the country, according to an FDA and Industry Steering Committee meeting summary shared Dec. 2.
  • The FDA also introduced the idea of companies innovating abroad paying additional yearly fees after submitting an investigational new drug application, according to the agency's document.
  • The meeting centered on Prescription Drug User Fee Act (PDUFA) reauthorization negotiations and took place in early November. Representatives from the FDA’s Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research and the Office of the Chief Counsel partook on the federal side, while the biopharma industry was represented by seven BIO members, seven PhRMA members and three Consumer Healthcare Products Association attendees.
  • Industry participants asked the federal representatives why the plan focuses on user fees instead of harnessing efficiencies that could speed up drug development and reviews.
  • In response, the FDA said those efficiencies are “also of interest to the agency, but outside of scope of the PDUFA negotiations,” according to the federal document.
  • Biopharma leaders also asked for details about how the FDA would operationalize the fee incentives, such as criteria for lowered application fees, payment timing and the expected impact for small companies. The FDA said those aspects would be discussed in future meetings. 
  • https://www.fiercebiotech.com/biotech/fda-floats-user-fee-cuts-early-stage-us-trials-additional-fees-overseas-development

FDA appoints Tracy Hoeg as acting director of drug evaluation center

FDA removes longtime over-the-counter drugs regulator from her position

  • The Food and Drug Administration removed the longtime director of the office of over-the-counter drugs from her position on Wednesday, six agency sources told STAT.
  • Theresa Michele, director of the Office of Nonprescription Drugs, has worked at the FDA since at least 2015. She told staff in an internal meeting on Wednesday afternoon that the agency’s human resources office was transferring her to a leadership position in the FDA’s medical devices center effective Thursday.
  • Michele did not immediately provide a comment. An HHS official confirmed Michele’s transfer and said the agency wants to make the office more focused on affordability under Makary’s leadership.
  • https://www.statnews.com/2025/12/03/theresa-michele-fda-office-of-nonprescription-drugs-transfered-to-new-role/    (subscription required for full text)

Obamacare exchanges vulnerable to fraud: GAO

  • Federal auditors used fictitious identities and Social Security numbers to obtain subsidized Affordable Care Act coverage in 2024 and this year for almost two dozen individuals who didn't exist, the Government Accountability Office reported on Wednesday.
  • Why it matters: Republicans in Congress have cited waste, fraud and abuse in ACA coverage as a justification for not renewing enhanced tax credits that expire at the end of this year.
    • The report gives GOP policymakers new fodder as they resist a faltering effort to extend the enhanced subsidies.
    • The congressional watchdog agency told three House Republican committee chairs that fraud risks it first identified in 2015 were still plaguing systems the government uses to determine eligibility for ACA coverage.
  • What they found: Auditors used fake identities to successfully obtain ACA coverage worth about $2,300 a month for four fictitious applicants from November through December 2024.
    • They obtained subsidized coverage for 18 of 20 other fictitious applications as of September 2025. Advance premium tax credits for those enrollees total more than $10,000 per month.
    • The applications were made directly through the federal HealthCare.gov portal or with the help of an insurance broker.
    • Republican lawmakers requested the investigation, but GAO has conducted similar testing of ACA coverage in the past, prior to COVID-era subsidy enhancements.
  • Zoom in: The investigation also found that nearly 66,000 Social Security numbers were used multiple times to receive more than one year's worth of health insurance in the marketplace during the 2024 plan year.
  • Analysis: https://www.axios.com/2025/12/04/obamacare-aca-exchange-fraud-gao   (subscription required for full text)
  • GAO report: https://www.gao.gov/products/gao-26-108742

CMS Releases CY 2026 Hospital OPPS and Ambulatory Surgical Center Final Rule

  • The rule finalizes sweeping reforms, including the full phaseout of the Inpatient Only (IPO) list, a significant expansion of site-neutral payment policies, heightened hospital price transparency requirements, permanent authorization of virtual direct supervision and the launch of a nationwide survey of drug acquisition costs for outpatient drugs.
  • CMS finalized most of what it proposed, leaving providers with several immediate operational and compliance priorities.
    • Hospitals should begin planning for the full elimination of the IPO list – starting with 285 procedures removed for CY 2026 – by updating site-of-service decision pathways, physician education, scheduling workflows and patient liability communications.
    • Providers should also assess the expanded site-neutral policies, particularly the application of Physician Fee Schedule (PFS)-equivalent rates to drug administration services in excepted off-campus Provider-Based Departments (PBDs), and model the impact on practice patterns, staffing and utilization.
  • With virtual direct supervision now permanent, hospitals and physician groups should revise supervision policies, telehealth infrastructure and staffing plans to support real-time audio/video oversight.
  • Analysis: https://www.hklaw.com/en/insights/publications/2025/11/cms-releases-cy-2026-hospital-opps-and-ambulatory-surgical-center
  • CMS Press: https://www.cms.gov/newsroom/press-releases/cms-empowers-patients-boosts-transparency-modernizing-hospital-payments

House votes to pass 5-year hospital at home extension, sending bill to the Senate

  • The House of Representatives unanimously voted to pass a bill Monday that extends the Medicare hospital at home program for five years.
  • Hospital at home providers have been mired in uncertainty for years. Though Congress has repeatedly extended hospital at home flexibilities, it often only does so for a handful of months at a time.
  • The Acute Hospital Care at Home program is overseen by the Centers for Medicare & Medicaid Services (CMS) and allows hospitals to transfer qualifying patients from the emergency department or an inpatient to their homes while still delivering inpatient-level care through a combination of telehealth, connected devices and home visits.
  • If the bill passes the Senate, it would be the longest extension the at-home care program has had since it began during the COVID-19 public health emergency in November 2020. Congress is also divorcing the extension of the program from the government funding deadline, which gives the program more stability.
  • Authority for the program lapsed during the recent 43-day government shutdown, and hospital at home providers faced a logistical nightmare trying to move patients back into hospitals in some states or shift them into other at-home care programs.
  • The bill is supported by more than 100 organizations, including the American Hospital Association, Moving Health Home, Advocate Health, the American Telemedicine Association (ATA), Mass General Brigham, Intermountain Health and Yale New Haven Health.
  • https://www.fiercehealthcare.com/regulatory/house-votes-pass-five-year-hospital-home-extension-sending-bill-senate

White House OSTP Issues RFI Regarding “Accelerating the American Scientific Enterprise”

HHS Officially Rescinds Nursing Home Minimum Staffing Rule

  • The Trump administration on Tuesday rescinded a Biden-era rule that required a minimum number of healthcare staff in nursing homes.
  • The Department of Health and Human Services (HHS) said Tuesday in a press release it is taking the action "after determining the final rule imposed by the Biden administration disproportionately burdened facilities, especially those serving rural and tribal communities, and jeopardized [patients'] access to care."
  • The rule, enacted in May 2024 by the Biden administration, required nursing homes that participate in federal programs such as Medicare and Medicaid to meet a total nurse staffing standard of 3.48 hours per resident day (HPRD), which must include at least 0.55 HPRD of direct registered nurse (RN) care and 2.45 HPRD of direct nurse aide care, according to a CMS fact sheet.
  • Facilities could use any combination of nurse staff (RNs, licensed practical nurses [LPNs] and licensed vocational nurses, or nurse aides) to account for the additional 0.48 HPRD needed to comply with the total nurse staffing standard, the agency said.
  • The rule also required nursing homes to have an RN on site 24 hours a day, 7 days a week, to provide skilled nursing care.
  • CMS gave nursing homes 2 years to comply with some parts of the rule and 3 years for other parts; rural facilities were given extra time.
  • Nursing home and hospital groups praised the rule's rescission.
  • The American Hospital Association (AHA) also applauded the move.
  • But nursing home consumer groups felt otherwise. "We were very disappointed by CMS's announcement today," Sam Brooks, director of public policy for the National Consumer Voice for Quality Long-Term Care, a patient advocacy group, wrote in an email to MedPage Today.
  • Press: https://www.medpagetoday.com/geriatrics/generalgeriatrics/118802
  • HHS Press:  https://www.hhs.gov/press-room/hhs-cleanup-federal-nursing-home-minimum-staffing-standards-rule-expands-access-rural-tribal-health-care.html

FDA to raise hurdles for vaccines, faulting COVID shots for 10 kids' deaths

  • The Food and Drug Administration intends to get tougher on vaccine approvals, as top officials raised concerns about the risk of COVID vaccines for children.
  • Speaking on Fox News Saturday morning, FDA Commissioner Marty Makary said the agency would no longer "rubber-stamp new products that don't work," claiming it made a "mockery of science."
  • Makary's comments came the day after FDA's top vaccine regulator, Dr. Vinay Prasad, told his team the agency would change its annual flu vaccine framework, update vaccine labels to be "honest," and make other changes to how it reviews vaccines, according to contents of an internal email reviewed by NPR and reported on first by a PBS News Hour correspondent and later by The Washington Post.
  • Prasad wrote that the FDA would also no longer authorize vaccines for pregnant women without stricter requirements. And for pneumonia vaccines, manufacturers will have to prove they reduce disease rather than show they generate antibodies. He also raised questions about giving multiple vaccines at the same time, which is standard practice.
  • The changes could make it much more difficult and expensive for vaccines to get approved, further limiting the availability of vaccines, which are considered among the safest and most effective tools for protecting people against infectious diseases.
  • While all vaccines carry some risks, most public health experts argue the current process for vetting vaccines before marketing has long assured that the benefits of vaccines outweigh their risks. Studies required after vaccines are approved and surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS), also flag potential safety issues once vaccines are in use.
  • Makary said on Fox News that 10 children had died from the COVID shot during the Biden administration, but did not offer specifics about how the FDA came to that conclusion. Millions of children have received the vaccine. 
  • Officials with the Department of Health and Human Services and Food and Drug Administration didn't immediately respond to requests for comment on the COVID analysis and changes to vaccine review standards.
  • Press on hurdles: https://www.npr.org/sections/shots-health-news/2025/11/29/nx-s1-5624998/fda-vaccines-covid-children-safety
  • Press about vaccine deaths: https://endpoints.news/fda-says-it-wont-release-details-of-claimed-covid-vaccine-deaths-in-near-term/   (subscription required for full text)

Medicare Advantage plans to gain $13 billion under Trump changes to star ratings

  • Medicare Advantage insurers scored a Thanksgiving gift, as President Trump’s Medicare agency added back a bonus system that rewards health plans with consistently high marks.
  • The Centers for Medicare and Medicaid Services also is proposing to eliminate a dozen star ratings measures that it deemed too administrative. Notably, one of those star ratings measures focuses on the performance of an insurance company’s call centers - the exact metric that Humana and UnitedHealth Group have sued over, alleging that CMS unfairly downgraded them because of missed phone calls.
  • Medicare said the changes would cost taxpayers $13.2 billion between 2028 and 2036, as more insurers get higher star ratings and bonus payments. That’s a relatively small amount of money for the Medicare Advantage program, which is expected to cost more than $750 billion just in 2028. But it still amounts to large extra sums for individual health insurers that are looking to boost their slimmed-down Medicare profit margins.
  • Press: https://www.statnews.com/2025/11/28/medicare-advantage-rules-change-13-billion-windfall-insurers/   (subscription required for full text)
  • Federal Register: https://public-inspection.federalregister.gov/2025-21456.pdf

CMS Releases the Proposed 2027 Medicare Advantage and Part D Rules

  • As is common for the annual proposed rules, the Proposed 2027 Rules cover a broad range of topics. In the last few years, the agency has lost multiple legal cases challenging the validity of its rules and/or how it implements its rules – it has lost cases relating to Star Ratings, its updated marketing and communications rules that were adopted for 2025, and most recently, the risk adjustment extrapolation rule.
  • The Proposed 2027 Rules broadly touch on all of these regulatory areas.
  • In its very brief summary of the Proposed 2027 Rules, CMS also highlights changes to Part D drug coverage, the enrollment process, and special needs plans.
  • The Proposed 2027 Rules also include multiple Requests for Information (RFI). Below are some initial takeaways:
    • Star Ratings: It proposes to refocus the measure set on clinical care, outcomes, and patient experience measures where plans have not topped out performance and believes that decreasing the number of measures will allow more focus on the measures that remain, including those aligned with the Make America Healthy Again initiative.
    • Marketing and Communications: CMS proposes changes to the definition of third-party marketing organizations (TPMOs) and changes to rules regarding translations, enrollment verification, and the use of testimonials.
    • Risk Adjustment: CMS proposes changes to the permissible uses for risk adjustment data.
    • IRA: Over 25% of the Proposed 2027 Rules address the many changes that aim to fully implement the redesign of Medicare Part D that was adopted in the Inflation Reduction Act (IRA).
    • Reporting and Data Simplification: CMS is exploring ways that current Medicare reporting obligations can be simplified.
    • Very Broad RFI: includes a broad RFI regarding the future direction of the Medicare Advantage program and specifically focus on risk adjustment and quality bonus payments.
  • Analysis: https://www.mintz.com/insights-center/viewpoints/2146/2025-12-02-cms-releases-proposed-2027-medicare-advantage-and-part-d#page=1
  • CMS Press: https://www.cms.gov/newsroom/fact-sheets/contract-year-2027-medicare-advantage-part-d-proposed-rule

FDA adopts agentic artificial intelligence in latest push to infuse AI into agency

  • The FDA is continuing its push to adopt emerging artificial intelligence tools, this time unveiling an agentic AI program that employees can choose to use in their work.
  • The agency intends for staff to use AI agents for complicated tasks like meeting management, premarket reviews, post-market surveillance and inspections, the FDA said in a Dec. 1 release.
  • In agentic AI, models are designed to generate outputs in furtherance of a specific goal. Different parts of the model complete different steps in the process, with outputs ultimately integrated through a decision-making process with human oversight.
  • “We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” FDA Commissioner Marty Makary, M.D., said in the release. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”
  • The new AI model has not been trained on data submitted to the FDA, the regulator said, and is hosted on a high-security GovCloud environment.
  • Press: https://www.fiercebiotech.com/ai-and-machine-learning/fda-adopts-agentic-ai-latest-push-infuse-agency-artificial-intelligence
  • FDA Press: https://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment

President Trump launches Genesis Mission to unleash AI innovation & discovery

  • The White House released an Executive Order (EO) on November 24th launching the “Genesis Mission,” a national effort to “unleash a new age of AI‑accelerated innovation and discovery that can solve the most challenging problems of this century.”
  • The EO directs a whole-of-government effort - with opportunities for involvement by the private sector - to leverage the power of AI to accelerate scientific research in several key domains.
  • The EO explains that the benefits of the Genesis mission will be myriad, as it will “dramatically accelerate scientific discovery, strengthen national security, secure energy dominance, enhance workforce productivity, and multiply the return on taxpayer investment into research and development, thereby furthering America’s technological dominance and global strategic leadership.”
  • The Genesis Mission’s goal is to build an integrated AI platform to harness federal scientific datasets to train scientific foundation models and create AI agents to test new hypotheses, automate research workflows, and accelerate scientific breakthroughs.
  • Analysis: https://www.hoganlovells.com/en/publications/president-trump-launches-genesis-mission-to-unleash-ai-innovation-discovery
  • Executive Order: https://www.whitehouse.gov/presidential-actions/2025/11/launching-the-genesis-mission/

Health workers sound alarm on Trump loan caps

  • A Trump administration plan to limit student loan borrowing for graduate education is drawing fire for excluding nurses, physician assistants and other types of health workers from higher loan caps.
  • Why it matters: The Department of Education's classification plan could exacerbate medical workforce shortages by putting a more stringent limit on what students in certain advanced health provider programs can borrow from the federal government, professional groups say.
    • The cap is $200,000 per student in degree programs considered professional, but just $100,000 for other graduate programs.
  • State of play: An administration-convened panel charged with implementing the law last month proposed to adopt a narrow definition of graduate health care programs meeting the definition "professional."
    • On the list: M.D.s, osteopathic doctors, veterinarians, pharmacists, optometrists, podiatrists, chiropractors and clinical psychologists.
    • Not on the list: advanced degree nurses, PAs, physical therapists, nutritionists, audiologists and other categories of health workers.
  • What they're saying: "This is going to critically decrease the amount of health care professionals entering the workforce at a time where we know that more care is going to be needed," said Sondra DePalma, vice president of reimbursement and professional practice at the American Academy of Physician Associates.
  • https://www.axios.com/2025/12/02/trump-health-worker-limits-student-loan-borrow   (subscription required for full text)

CMS to end historic kidney disease payment experiment two years early

  • The Centers for Medicare and Medicaid Services will cut short a big experiment to try and change the way dialysis is done in the U.S. The agency, led by Mehmet Oz, will end its End-Stage Renal Disease Treatment Choices (ETC) model on Dec. 31, according to a final rule published in the Federal Register last week.
  • The trial, run by the CMS Innovation Center, was testing whether giving financial incentives to providers would move more patients with end-stage kidney disease onto home dialysis and through the transplant process. It was the largest such experiment in the history of American health care, and required 30% of the country’s dialysis providers to participate.
  • However, ETC hasn’t proven that approach works. An analysis after the first year, 2021, showed no impact on home dialysis or transplantation. A study last summer found a similar result.
  • Providers participating in the new payment model weren’t getting more patients onto home dialysis or to transplant than those in the control group, the paper reported.
  • https://www.statnews.com/2025/12/01/cms-dialysis-payment-experiment-ends-two-years-early/   (subscription required for full text)

KEY REVERSALS – RESCINDED ITEMS – LAWSUITS – COURT FILINGS

Trump admin moves to resume sharing Medicaid data with ICE

  • The Trump administration informed a federal judge it intends to resume giving immigration officials access to personal information about Medicaid recipients from 22 states, over objections from Democratic state attorneys general.
  • The notice from the Centers for Medicare and Medicaid Services opens the door for the administration to potentially resume transferring tranches of confidential Medicaid data, including phone numbers, addresses and immigration statuses, to Immigrations and Customers Enforcement as soon as next month.
  • It comes despite California and 21 other states suing in July to prevent the transfers and initially winning a temporary freeze, though states will have another opportunity to challenge the move at a court hearing scheduled for Dec. 9.
  • Justice Department attorney Michael Gerardi said during a court hearing Friday that the CMS notice, as well as a related Nov. 17 ICE memo, met court-imposed requirements to resume sharing Medicaid info with immigration officials.
  • Press: https://www.politico.com/news/2025/11/21/trump-medicaid-data-ice-00665923
  • Court Reporter Notice: https://storage.courtlistener.com/recap/gov.uscourts.cand.452203/gov.uscourts.cand.452203.131.1.pdf

Judge blocks provision of law that strips Medicaid funding for Planned Parenthood affiliates

  • A federal judge has again blocked a provision Congress passed in July that stripped federal Medicaid funding from Planned Parenthood affiliates, ruling that the language likely places an unconstitutional burden on states to apply vague criteria about the scope of the ban.
  • Acting on a lawsuit filed in July by 22 Democratic-led states, U.S. District Judge Indira Talwani issued a preliminary injunction Tuesday prohibiting the Trump administration from requiring states to figure out which of their health care providers are covered by the ban and stop funding the non-abortion services the clinics provide to Medicaid patients.
  • Talwani said the Constitution requires Congress to be clear when imposing requirements related to federal funding, so state officials can decide whether to accept what amounts to a restriction on their usual authority.
  • Talwani also said the ban appeared to be unconstitutional because it applies retroactively by requiring states to redo agreements they’ve already reached with federal Medicaid officials or managed care providers. The judge concluded that some states are so dependent on Planned Parenthood affiliates to serve Medicaid patients that trying to comply with the limits in the law could cause irreparable harm.
  • https://www.politico.com/news/2025/12/02/judge-blocks-provision-of-law-that-strips-medicaid-funding-for-planned-parenthood-affiliates-00673962

HHS officially rescinds shutdown layoffs

  • The Department of Health and Human Services (HHS) has brought back everyone it laid off during the government shutdown, a top official told a California federal court Friday.
  • The agency’s Office of Human Resources on Nov. 17 emailed the 954 employees who received reduction in force (RIF) notices during the shutdown informing them that those notices had been rescinded and that they “should return to work on their next regularly scheduled workday,” wrote Thomas Nagy Jr., HHS deputy assistant secretary for human resources, in a court filing.
  • The layoffs were concentrated in the Centers for Disease Control and Prevention, though they hit all areas of HHS.
  • https://thehill.com/policy/healthcare/5620380-hhs-restores-laid-off-employees/

Hospital groups file lawsuit to enjoin pharma-supported 340B rebate pilot

  • The hospital lobby has filed a lawsuit seeking to block the federal government’s 340B Rebate Model Pilot Program, which is set to swap out safety-net providers’ longstanding upfront drug discounts for after-the-fact rebates beginning Jan. 1.
  • The complaint and an accompanying motion for a temporary restraining order was filed Monday in the U.S. District Court for the District of Maine by the American Hospital Association (AHA), the Maine Hospital Association and four individual safety-net health systems.
  • In these, plaintiffs said the Health Resources and Services Administration’s (HRSA’s) one-year test run of a drugmaker-friendly rebate process been hastily rolled out and would impose “hundreds of millions of dollars’ worth of annual costs” for providers due to new administrative burdens.
  • https://www.fiercehealthcare.com/providers/hospital-groups-file-lawsuit-enjoin-pharma-supported-340b-rebate-pilot

US commission recommends federal research revamp to avoid losing global biotech edge

  • A federal commission is warning that the U.S. is losing its innovative edge, arguing that the nation needs to “reimagine the federal science enterprise” by streamlining funding and incorporating artificial intelligence (AI) into processes.
  • The new recommendations come from the National Security Commission on Emerging Biotechnology (NSCEB), a congressionally created entity tasked with providing strategies to strengthen U.S. biotechnology leadership for both national security and economic resilience.
  • Created in 2022, the commission released its first set of recommendations this April, including a call for a $15 billion government commitment to the sector over the next five years.
  • Now, the group is back with specific policies aimed at securing the U.S. position as the global innovation leader and using taxpayer dollars more efficiently.
  • For the new report, NSCEB met with thousands of scientists, company executives, academic leaders, philanthropists and government officials, writing that the discussions revealed “clear warning signs” that the U.S. is relinquishing its innovative edge.
  • “American leadership in scientific innovation is no longer guaranteed,” the commission report reads. “While U.S. funding stagnates and researchers are bogged down in complex funding application processes, China is doubling down on science, racing to position itself as the innovation engine of the world.”
  • Press: https://www.fiercebiotech.com/biotech/us-commission-recommends-federal-research-revamp-avoid-losing-global-biotech-edge
  • Report: https://www.biotech.senate.gov/wp-content/uploads/2025/11/NSCEB-%E2%80%93-The-Future-of-Science-Nov-2025.pdf

KEY BIOPHARMA NEWS

Lawmakers dig in on biopharma manufacturing with bill proposing US center of excellence

  • Lawmakers are proposing a new effort to strengthen biopharma manufacturing in the U.S., leveraging a bill that seeks to create a dedicated center of excellence in the country.
  • The bill, dubbed the “Biomanufacturing Excellence Act of 2025,” was introduced on Nov. 18 to the House Committee on Science, Space and Technology by a bipartisan group of lawmakers, including Rep. Chrissy Houlahan, D-Pa., Rep. Jim Baird, R-Ind., Rep. Deborah Ross, D-N.C., and Rep. David Rouzer, R-N.C.
  • Sen. Chris Coons, D-Del., and Sen. Ted Budd, R-N.C., proposed the same bill in the Senate.
  • In essence, the legislation seeks to reduce U.S. dependence on foreign supply chains and to ensure a smoother road to commercialization through a national public-private biopharmaceutical manufacturing center of excellence. The production hub would be designed to “facilitate and accelerate manufacturing innovation, support good manufacturing practices” and provide training for workers to “bolster talent” throughout the industry, according to the bill.
  • Press: https://www.fiercepharma.com/manufacturing/lawmakers-look-support-domestic-manufacturing-bill-proposing-us-center-excellence
  • Bill: https://www.congress.gov/bill/119th-congress/house-bill/6089/text

What to Watch: Continued DTC Advertising Enforcement

  • Just before Thanksgiving, the Food and Drug Administration’s (“FDA’s”) Office of Prescription Drug Promotion (“OPDP”) silently published three untitled letters, furthering this administration’s promise to crack down on direct-to-consumer (“DTC”) prescription drug advertising.
  • The letters (which we’ll call “Letter 1,” “Letter 2,” and “Letter 3”) addressed familiar enforcement themes, such as omission or minimization of risk information, ad presentation and form, and promotion consistent with FDA-required labeling (“CFL”).
  • The letters appeared to have been leftovers from the shutdown, dated from earlier in September when the crackdown was in full swing.
    • Letter #1: OPDP found a television ad for an oral cardiovascular medication misleading and, therefore, misbranded under the Food, Drug, and Cosmetics Act (“FDCA”), because it overstated the drug’s approved indication.
    • Letter #2: OPDP found a webpage for a ketamine injection intended for surgical pain management misleading and, therefore, misbranded under the FDCA, because it promoted the benefits of the drug without communicating risk information and overstated the drug’s approved indication.
    • Letter #3: OPDP found a television ad for an oral seizure medication misleading and, therefore, misbranded under the FDCA, because it promoted the benefits of the drug with minimized presentation of risk information.  
  • Analysis:  https://www.fdalawblog.com/2025/12/articles/fda/what-to-watch-continued-dtc-advertising-enforcement/#page=1

Medicare negotiated lower prices for 15 drugs, including 71% off Ozempic and Wegovy

FDA 'Priority Voucher' Program Comes Under Congressional Scrutiny

  • Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program "could undermine public confidence in FDA's decisions and raise safety concerns."
  • "We have significant concerns that this program will enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump," Sen. Bernie Sanders (I-Vt.) and Rep. Frank Pallone (D-N.J.) wrote last Thursday in a letter to Makary. "This program could undermine public confidence in FDA's decisions and raise safety concerns, including rushed reviews by an agency whose staff have been decimated by this administration's cuts."
  • Under the program, known officially as the Commissioner's National Priority Voucher (CNPV), the review time for a new drug application will be shortened from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission, according to an FDA press release.
  • The letter asks Makary to respond to a series of questions related to the program, including the standards for determining award recipients, the process for selecting reviewers, and how the FDA will monitor for adverse events and contraindications of products approved under this process. It also asks for "all communications, including but not limited to emails, internal messages, calendar invitations, and meeting notes, with or regarding CNPV recipients from January 1, 2025 onward."
  • Sanders and Pallone gave Makary a deadline of December 11 for a response.
  • https://www.medpagetoday.com/publichealthpolicy/fdageneral/118690

House endorses bill that would revive FDA's rare pediatric review voucher program

  • The U.S. House of Representatives has given a unanimous thumbs-up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last year.
  • Rep. Michael McCaul, R-Texas, introduced the legislation in February alongside support from five other Republican Congressmen and five Democrats. The bill now advances to a Senate vote.
  • The initiative, which was established in 2012, offered drugmakers a financial incentive in the form of a priority review voucher (PRV) to develop rare disease treatments for children.
  • After the rare pediatric review program expired, there were calls from the industry to reestablish it, while critics raised concerns that the ability to sell PRVs at high prices distorted the program's original purpose.
  • Meanwhile, in June of this year, the FDA introduced a new PRV program designed to shorten drug review time to as little as one or two months. The commissioner’s National Priority Voucher (CNPV) coupon is given to “companies aligned with U.S. national priorities,” the FDA said. Unlike existing PRVs, CNPVs are nontransferable.
  • https://www.fiercepharma.com/pharma/house-endorses-bill-would-revive-fdas-rare-pediatric-review-voucher-program

US announces zero tariff pharmaceutical deal with Britain

  • The United States and Britain announced a deal on Monday to secure zero tariffs on British pharmaceutical products and medical technology in return for Britain spending more on medicines and overhauling how it values drugs.
  • Under the agreement, Britain will raise the net price it pays for new U.S. medicines by 25%. In return, UK-made medicines, drug ingredients and medical technology will be exempt from Section 232 sectoral tariffs and any future Section 301 country tariffs.
  • The deal includes a significant change to the value appraisal framework at NICE, the UK body that determines whether new drugs are cost-effective for the NHS.
  • NICE's "quality-adjusted life year" threshold, currently 30,000 pounds ($39,789) per year, will rise to 35,000 pounds.
  • The British government said the change to NICE would let it "keep pace with the commercial and economic environment in which pharmaceutical companies are operating in today."
  • The revised framework will apply to all new medicines, not just U.S. drugs, but will not affect prices of existing treatments.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-uk-agree-zero-tariffs-pharmaceuticals-announcement-expected-sources-say-2025-12-01/

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

CMS unveils ACCESS model to expand digital care for Medicare patients

  • The Center for Medicare and Medicaid Services (CMS) Innovation Center has launched ACCESS, a model that expands access to technology-supported care for individuals on Original Medicare with obesity, diabetes, musculoskeletal pain and depression.
  • Dr. Mehmet Oz, administrator for CMS, said in a video that the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model will support two out of every three people on Medicare and will run for 10 years starting July 1, 2026.
  • "ACCESS introduces a way of paying for care that focuses on results. It offers clinicians a new predictable payment option, giving them the flexibility to use digital tools that help people take charge of their health," Dr. Oz said. 
  • The program focuses on four clinical tracks: 1) early cardio-kidney-metabolic conditions (eCKM), such as hypertension, dyslipidemia, obesity and prediabetes; 2) cardio-kidney-metabolic conditions like diabetes, chronic kidney disease and atherosclerotic cardiovascular disease; 3) musculoskeletal conditions; and 4) behavioral health conditions, including depression and anxiety.
  • It will utilize an Outcome-Aligned Payments option for Medicare-enrolled care organizations, meaning organizations that achieve measurable health outcomes, such as lowering blood pressure for patients with hypertension, will receive payments tied to those achievements. 
  • Press: https://www.mobihealthnews.com/news/cms-unveils-access-model-expand-digital-care-medicare-patients
  • CMS Press: https://www.cms.gov/priorities/innovation/innovation-models/access

KEY MEDTECH NEWS

Lawmakers propose Medicare reimbursement pathway for AI devices

  • Bipartisan legislators have introduced a bill to create a Medicare reimbursement pathway for algorithm-based healthcare services.
  • The text of the House bill, which lawmakers introduced last week, was unavailable, but AdvaMed said it mirrors a Senate proposal for five years of cost-based reimbursement for certain medical devices.
  • AdvaMed applauded the bill, explaining that the proposal “seeks to improve health outcomes for Medicare patients through creation of a clear and consistent reimbursement pathway.”
  • The Senate bill covers certain devices that are cleared or approved by the Food and Drug Administration.
  • Eligible devices deliver services using artificial intelligence, machine learning or other similarly designed software. The services yield clinical outputs or generate clinical conclusions that physicians can use to screen, detect, diagnose or treat health conditions.
  • Press: https://www.medtechdive.com/news/lawmakers-medicare-reimbursement-ai-devices/806517/
  • Bill: https://www.congress.gov/bill/119th-congress/house-bill/6197/all-actions

OIG report finds Medicare overpaying for CGMs and supplies

KEY ACRONYMS

  • ACA = Affordable Care Act
  • ACCESS = Advancing Chronic Care with Effective, Scalable Solutions
  • AI = artificial intelligence
  • CDC = Centers for Disease Control and Prevention
  • CBER = Center for Biologics Evaluation and Research
  • CDRH = Center for Devices and Radiological Health
  • CDER = Center for Drug Evaluation and Research
  • CGMs = for continuous glucose monitors and supplies
  • CMS = Centers for Medicare & Medicaid Services
  • CNPV = Commissioner's National Priority Voucher
  • DTC = direct-to-consumer
  • EO = Executive Order
  • ETC = End-Stage Renal Disease Treatment Choices
  • FDA = Food and Drug Administration
  • FDCA = Food, Drug, and Cosmetics Act
  • GAO = Government Accountability Office
  • HHS = Department of Health and Human Services
  • HPRD = hours per resident day
  • HRSA = Health Resources and Services Administration
  • ICE = Immigrations and Customers Enforcement
  • IPO = Inpatient Only
  • LPN = licensed practical nurses
  • MAHA = Make America Healthy Again
  • NIH = National Institutes of Health
  • NSCEB = National Security Commission on Emerging Biotechnology
  • OPDP = Office of Prescription Drug Promotion
  • OSTP = Office of Science and Technology Policy
  • PA = physician assistant
  • PBDs = Provider-Based Departments
  • PDUFA = Prescription Drug User Fee Act
  • PFS = Physician Fee Schedule
  • RFI = Request for Information
  • RN = registered nurse

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