Blog | 12/19/2025

Sharp Strategy Spotlight: December 19, 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 18, 2025. The details and broad themes may have changed. Please note the next release will be January 9, 2026.

KEY HEALTH NEWS (Global)

Biosecure Act heads to Trump's desk with defense spending bill after Senate vote

  • Nearly two years after its introduction as a bill during the last U.S. Congress, the Biosecure Act has survived an election and a presidential transition and appears poised to become law. But this version, tucked into the nation's annual defense bill, features some changes from the first iteration.
  • Both the House of Representatives and the Senate have passed the $901 billion defense bill, sending it to the president's desk for a signature. The White House has said President Donald Trump plans to sign the massive defense package, Reuters reports.
  • Within the mammoth bill, the Biosecure Act has the potential to raise new hurdles for certain life sciences companies from China, as well as their partners, although the exact effects of the legislation remain tough to fully assess at this stage.
  • Like the prior version, the updated Biosecure Act prohibits executive U.S. agencies from tapping “biotechnology companies of concern” for equipment or services, according to a summary from the law firm Hogan Lovells.
  • Importantly, the prohibition extends to federal contracts with drugmakers that would involve using equipment and services from those "companies of concern" under certain circumstances and after effective dates that are laid out in the bill's full text.
  • The new bill does not broadly apply to "reimbursement/payer contracts such as those supporting federal health programs," according to Hogan Lovells. But the firm says there could be some "collateral" effects around supplying products that rely on inputs from Biosecure-targeted companies.
  • In addition, under the first version of the Biosecure Act, several China life sciences companies were named and directly targeted. The new bill changes the approach and taps the Office of Management and Budget with coming up with a list of relevant companies "of concern" while also utilizing the Pentagon's Section 1260H list of firms associated with the Chinese military.
  • https://www.fiercepharma.com/pharma/biosecure-act-heads-trumps-desk-defense-spending-bill-after-senate-vote

Kenyan court suspends 'landmark' US health aid deal over data privacy concerns

  • A Kenyan court has suspended the implementation of a "landmark" $2.5bn (£1.9bn) health aid deal signed with the US last week over data privacy concerns.
  • It follows a case filed by a consumer rights lobby seeking to stop the alleged transfer and sharing of Kenyans' personal data under the agreement.
  • The interim ruling now bars Kenyan authorities from taking any steps to put the deal into practice "insofar as it provides for or facilitates the transfer, sharing or dissemination of medical, epidemiological or sensitive personal health data".
  • Health Minister Aden Duale said on Friday that the government would comply with the court's ruling, but that the government would challenge it.
  • According to Duale, the court's ruling only affected parts of the agreement - on data sharing - and not the entire deal as reported.
  • Under its new global health aid strategy, the US prioritises direct deals with governments rather than channelling funding through aid agencies.
  • Countries are required to increase their own health spending. In the Kenya case, the US contributes $1.7bn, with the Kenyan government covering $850m and gradually taking on more responsibility.
  • The US has since entered into similar deals with Rwanda, Lesotho, Liberia and Uganda.
  • https://www.bbc.com/news/articles/ce91degnelko

KEY FEDERAL GOVERNMENT NEWS

House passes healthcare affordability bill without subsidy extension

  • The House of Representatives passed a Republican-led package that seeks to address the affordability of healthcare without an extension of the soon-to-expire Affordable Care Act subsidies.
  • The 216-211 vote averted a last-ditch effort from Democrats and several moderate Republicans to force a vote on a subsidy extension.
  • A similar measure in the Senate failed in a vote last week, and Democrats late Tuesday pushed for an amendment to the House legislation that would include an extension.
  • Republicans in the House of Representatives have unveiled their plan to tackle healthcare costs, though the bill does not address the soon-to-expire enhanced Affordable Care Act (ACA) subsidies.
  • Under the bill, unveiled on Friday, lawmakers would lean on association health plans, which allow employers to pool resources to purchase coverage, and individual coverage health reimbursement arrangements, or ICHRA, to offer additional options for enrollees. In the latter case, an employer offers individuals a stipend to purchase coverage of their choosing on the ACA's exchanges.
  • The bill also seeks to broaden access to stop-loss coverage to mid-size and small employers by clarifying that it is not considered health coverage, which could make it easier for them to mitigate unexpected, high-cost claims.
  • In addition, the legislation aims to address premiums by allocating for cost-sharing reduction payments beginning in 2027. These subsidies help individuals offset their out-of-pocket costs.
  • https://www.fiercehealthcare.com/regulatory/house-gop-healthcare-bill-eschews-subsidy-extension-hsas

ACA subsidy vote on horizon after House petition meets threshold

  • Four House Republicans signed a Democratic-led discharge petition that will force a vote to extend ACA’s enhanced subsidies hours before lawmakers voted to pass a healthcare package that excluded an extension, The Hill  reported Dec. 17.
  • The four Republicans joined all 214 House Democrats in signing the discharge petition. Their signatures came after House Speaker Mike Johnson said Dec. 16 that he wouldn’t call a vote to extend the subsidies.
  • The discharge petition will force a vote on extending the subsidies for three years, but House rules require a waiting period before the bill can be called to the floor. With lawmakers set to leave Washington, D.C., at the end of the week it means the vote is not likely to occur until they return in January.
  • The discharge petition received the required 218 signatures hours before the House voted to pass the healthcare package called the “Lower Health Care Premiums for All Americans Act.” 
  • The legislation would expand access to association health plans by allowing employers — including self-employed workers – to join together to purchase insurance. It would also allow employers to offer their employees tax-advantaged funds to pay for individual health insurance (ICHRA), in place of offering traditional group plans. Tax incentives would be offered for employers who adopt these arrangements.
  • It would also provide funding for cost-sharing reduction payments beginning in 2027 and would require pharmacy benefit managers to provide employers with detailed data on prescription drug spending, rebates, spread pricing and formulary decisions.
  • The bill now heads to the Senate, where it is not expected to pass, according to the report.
  • https://www.beckershospitalreview.com/finance/aca-subsidy-vote-on-horizon-after-house-petition-meets-threshold

CMS unveils new model aimed at functional, lifestyle medicine

  • The Trump administration has unveiled a new payment model that could extend Medicare coverage to functional or lifestyle medicine providers.
  • Under the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence, or MAHA ELEVATE, model, the Centers for Medicare & Medicaid Services (CMS) will make $100 million available to support as many as 30 proposals to promote health and preventive care in three-year agreements.
  • The CMS said on the landing page for the model that it's meant to offer additional options to beneficiaries without replacing their medical services.
  • The CMS said it will launch the initial notice of funding opportunity for the model in early 2026 to secure the first group of participants, with the full launch set for September.
  • The agency added that the programs tested under the MAHA ELEVATE model will help inform future coverage determinations and offer critical feedback the CMMI can use to build future models.
  • The CMS unveiled MAHA ELEVATE shortly after the announcement of its new ACCESS model, which aims to encourage the use of technology in care for Medicare patients. The model has been positively received by health tech companies that have traditionally struggled with Medicare coverage.
  • Press: https://www.fiercehealthcare.com/regulatory/cms-unveils-new-model-aimed-functional-lifestyle-medicine
  • CMS Press: https://www.cms.gov/priorities/innovation/innovation-models/maha-elevate

FDA wants to use more real-world data and calls again for early-phase trials reform

VA to reorganize Veterans Health Administration management

  • The U.S. Department of Veterans Affairs plans to reorganize the management structure of the Veterans Health Administration.
  • The department aims to eliminate redundant layers of bureaucracy, ensure consistent application of policies across all facilities and empower local hospital directors, according to a Dec. 15 VA news release.
  • The department has briefed Congress on its intent and will provide official congressional notification Dec. 16. The department will announce specific organizational and personnel changes in early 2026, which will occur over the next 18 to 24 months.
  • As part of the process, the VHA Central Office will set policy goals and manage finances, oversight and compliance. The Operations Centers and Veterans Integrated Service Networks will implement the central office’s direction and establish operational, quality and performance standards for the department’s more than 1,300 facilities.
  • Staffing and operations at VA medical centers and clinics will not change.
  • It is not intended to reduce staffing levels, and the VA does not expect a significant change in overall staff numbers once complete.
  • Press: https://www.beckershospitalreview.com/workforce/va-to-reorganize-veterans-health-administration-management/
  • VA Press: https://news.va.gov/press-room/va-launches-veterans-health-administration-reorganization/

Two rare diseases added to newborn screening recommendations

Medicare routes $16 billion to insurers to offset high drug costs

  • The federal government has sent a record $16 billion to health insurers that sell Medicare drug plans, a flashing red sign that prescription drug spending is blowing up far beyond what government officials and insurance experts had expected.
  • The good news for Medicare patients: They are shielded from higher drug costs because the Inflation Reduction Act has limited their out-of-pocket spending. Concerns arise, however, for the broader public: Pharmaceutical companies get bigger sales as more people fill their medications, and insurers remain protected from sizable losses — while taxpayers are left holding the bag.
  • Every year, Medicare looks at drug spending data and calculates whether the insurers’ drug plans, known as Part D plans, spent more or less than what they had projected at the start of the year. If insurers’ costs were more than expected, the government gives them an infusion to help subsidize the losses, known as reconciliation payments.
  • https://www.statnews.com/2025/12/12/medicare-part-d-costs-soar-insurers-get-16-billion-reconciliation-payment/   (subscription required for full text)

Dr. Harvey Risch Appointed Chairman of President Trump’s Cancer Panel

  • The U.S. Department of Health and Human Services (HHS) today announced the appointment of Harvey Risch, M.D., Ph.D., as chairman of the President’s Cancer Panel. The panel, part of the National Institutes of Health’s (NIH) National Cancer Institute, is charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the president on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.
  • Dr. Risch is Professor Emeritus and Senior Research Scientist in Epidemiology at the Yale School of Public Health and Yale School of Medicine.
  • HHS Press: https://www.hhs.gov/press-room/dr-harvey-risch-appointed-chairman-president-trumps-cancer-panel.html

CDC formally stops recommending hepatitis B vaccines for all newborns

  • Instead of recommending the hepatitis B vaccine for all newborns, the Centers for Disease Control and Prevention now officially advises women who test negative for the virus to consult health care providers about whether their babies should get their first doses within 24 hours of birth.
  • The CDC now suggests waiting until at least 2 months of age for babies’ first hepatitis B shots if they do not receive the birth dose. However, it still recommends that babies born to mothers who test positive for hepatitis B or whose infection statuses are unknown get hepatitis B vaccines within the first day of life.
  • The agency is still reviewing a secondary recommendation from the panel: that parents consult with health care providers about the possibility of testing children for antibodies to hepatitis B before they decide whether to get second doses of the vaccine. The hepatitis B vaccine is typically given to babies as a three-dose series.
  • https://www.nbcnews.com/health/health-news/cdc-stops-recommending-hepatitis-b-vaccines-newborns-rcna248035

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

American Academy of Pediatrics loses HHS funding after criticizing RFK Jr.

  • The Department of Health and Human Services has terminated seven grants totaling millions of dollars to the American Academy of Pediatrics, including for initiatives on reducing sudden infant deaths, improving adolescent health, preventing fetal alcohol syndrome and identifying autism early, according to documents obtained by The Washington Post.
  • The abrupt loss of funds this week surprised the professional pediatrician association, which has been one of the harshest critics of Health Secretary Robert F. Kennedy Jr.’s changes to federal vaccine policy.
  • Administration officials cited a range of reasons for cutting off the funding to AAP, including the group’s use of “identity-based language,” including references to racial disparities and “pregnant people,” and insufficient focus in at least one grant program on nutrition and chronic disease prevention, which they said runs afoul of HHS’s priorities.
  • https://www.washingtonpost.com/health/2025/12/17/aap-hhs-funding-rfk/  (subscription required for full text)

First Circuit reverses block on Trump's Planned Parenthood funding cuts

  • The appeals panel said that a provision of the "Big, Beautiful Bill" that stripped Medicaid funding to Planned Parenthood didn't violate the reproductive health care giant's rights.
  • A three-judge panel of the First Circuit ruled Friday that Planned Parenthood is unlikely to succeed in its claims that a new federal law denying it Medicaid funds is unconstitutional.
  • The panel overturned a lower court’s order that had temporarily blocked a provision of President Donald Trump’s “Big, Beautiful Bill,” signed into law on July 4, which removes federal Medicaid funding for one year from abortion providers that received more than $800,000 in Medicaid funds in fiscal year 2023, as well as any entities affiliated with such providers.
  • In practice, the law applies almost exclusively to Planned Parenthood-affiliated providers, with only two other unrelated organizations meeting the criteria for defunding.
  • In Friday’s ruling, the panel disagreed with U.S. District Judge Indira Talwani’s reasoning for her preliminary injunction, and found that the law doesn’t constitute a bill of attainder — a law that punishes a specific individual or group without a trial — because it doesn’t issue a punishment.
  • https://courthousenews.com/first-circuit-reverses-block-on-trumps-planned-parenthood-funding-cuts/

Former NIH scientist sues Trump administration, claims illegal firing over research cuts

  • A former leading scientist at the National Institutes of Health sued the Trump administration Tuesday, saying she was illegally fired for warning that abrupt research cuts were endangering patients and public health.
  • The NIH has cut billions of dollars in research projects since President Donald Trump took office in January, bypassing the usual scientific funding process. The cuts included clinical trials testing treatments for cancer, brain diseases and other health problems that a recent report said impacted over 74,000 people enrolled in the experiments.
  • Dr. Jeanne Marrazzo is a well-known HIV expert who led NIH’s National Institute of Allergy and Infectious Diseases. Last spring, Marrazzo was put on administrative leave after she challenged NIH officials about the cuts. Among her objections were that some cuts would endanger clinical trial participants while others curtailing infectious disease and vaccine research would harm public health, according to Tuesday’s lawsuit.
  • https://apnews.com/article/trump-kennedy-nih-lawsuit-marrazzo-health-e8210ddfe9ea79ff0f7bb478f3c13e2d

KEY BIOPHARMA NEWS

Several companies expected to announce ‘most favored nation’ deals Friday at White House, sources say

  • The White House is preparing to unveil several new deals with large drugmakers on Friday as part of the administration’s “most favored nation” pricing push, according to sources familiar with the plans.
  • The announcement is likely to mimic other recent most favored nation unveilings, with company CEOs and President Donald Trump in the Oval Office, said the sources, all of whom spoke on condition of anonymity because the announcement isn’t yet public.

Trump signs order labeling fentanyl ‘weapon of mass destruction’

FDA has no plans to put most serious warning on COVID vaccines, Bloomberg News reports

  • The U.S. Food and Drug Administration has no plans to put a "black box" warning on COVID-19 vaccines, Bloomberg News reported on Monday, citing the agency's top official Marty Makary.
  • Some agency officials had recommended putting the most serious warning on the shots, but agency leaders, including top vaccine regulator Vinay Prasad, did not think it was necessary, FDA commissioner Makary told Bloomberg News in an interview.
  • The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment.
  • CNN reported last week that the agency was planning to put a boxed warning on these vaccines, and that it was being orchestrated by Prasad, the FDA's chief medical and scientific officer.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/fda-has-no-plans-put-most-serious-warning-covid-vaccines-bloomberg-news-reports-2025-12-15/

Major drug pricing regulation moves forward

  • A regulation with potentially major implications for the pharmaceutical industry has cleared its review, teeing it up for imminent proposal should the Trump administration decide to move forward.
  • Why it matters: The regulation, which appears to tie what the U.S. pays for some drugs to the prices in other countries, would be the administration's most aggressive step yet to lower U.S. drug prices.
    • The so-called most-favored-nation regulation would also have enormous financial implications for manufacturers.
  • Driving the news: The proposed regulation, titled the "Global Benchmark for Efficient Drug Pricing (GLOBE) Model," completed review on Wednesday, according to OMB's website.
    • The listing notes the proposal is "economically significant."
  • Details: It's unclear what exactly the proposal would do, but there has been widespread speculation by lobbyists and analysts that it could resemble the first Trump administration's attempt to tie prices in Medicare Part B to foreign prices through a Centers for Medicare and Medicaid demonstration model.
  • Analysis: https://www.axios.com/2025/12/18/major-drug-pricing-regulation-trump   (subscription required for full text)

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Secretary Kennedy Convenes Lyme Disease Patients and Providers to Announce New Diagnostic Efforts

  • The U.S. Department of Health and Human Services (HHS) today convened Lyme disease patients, clinicians, and researchers for a roundtable on diagnostics and clinical needs moderated by HHS Secretary Robert F. Kennedy, Jr.
  • Participants shared their experiences and recommendations on improving care and advancing research.
  • Senator Susan Collins (R-ME) and Representatives Morgan Griffith (R-VA) and Chris Smith (R-NJ) also engaged in the discussions.
  • As part of today’s event, HHS announced the renewal of the LymeX Innovation Accelerator with the Steven & Alexandra Cohen Foundation that began during President Trump’s first term. Established in 2020, LymeX is the largest public-private partnership ever built to improve Lyme disease diagnostics and care.
  • The $10 million initiative will advance artificial intelligence tools that support earlier and more accurate detection across stages of infection.
  • Lyme has infected an estimated five to seven million Americans over the past decade. CDC estimates that 476,000 Americans are diagnosed and treated for Lyme disease each year.
  • Current tests often miss early or late-stage infection, which limits access to appropriate evaluation and care. For up to 20 percent of patients, symptoms persist and progress into Lyme infection-associated chronic conditions and illnesses.
  • The updated LymeX effort will expand patient-centered innovation and next-generation diagnostics.
  • HHS Press on New Diagnostic Efforts for Lyme Disease: https://www.hhs.gov/press-room/wtas-secretary-kennedy-convenes-lyme-disease-patients-providers-announce-new-diagnostic-efforts.html
  • Comments from the event: https://www.hhs.gov/press-room/wtas-secretary-kennedy-convenes-lyme-disease-patients-providers-announce-new-diagnostic-efforts.html

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Key digital health and device leaders depart FDA

  • Sources tell us Jessica Paulsen, a 15-year veteran of FDA and acting deputy director of its Digital Health Center of Excellence is leaving the agency. She’s been leading the center since last summer when the last acting head, Sonja Fulmer, left FDA for Mayo Clinic. Fulmer took over for Troy Tazbaz who left in January to return to Oracle. The center’s work includes communicating with industry and developing guidances relevant to digital health.
  • FDA did not respond to a request for comment
  • Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of neurological and physical medicine devices, which is in charge of regulating Neuralink. McMullen spent three years atop the office and previously worked at the National Institute for Mental Health.
  • https://www.statnews.com/2025/12/16/fda-key-digital-device-leaders-depart-health-tech/   (subscription required for full text)

CMS Plans To Have Third Parties Vet Health Apps Promoted On Medicare.gov

KEY MEDTECH NEWS

Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process

  • The Food and Drug Administration monitors the safety of about 200,000 medical devices—such as pacemakers and joint replacements.
  • From 2020 to 2024, nearly 4,000 of these devices needed to be recalled. Using recalled medical devices can lead to serious injury, death, or other adverse effects.
  • FDA's oversight of the recall process includes reviewing manufacturers' recall plans and verifying that recalls were carried out according to plan. FDA's challenges—such as insufficient staffing—can create inefficiencies in the process and potentially put lives at risk.
  • Why This Matters
    • The Food and Drug Administration (FDA) oversees recalls of medical devices that may present a risk to the health of users. The ramifications of using recalled devices—such as defective ventilators or pacemakers—include the potential for serious injury or death.
    • FDA’s oversight of medical products, including devices, has been on GAO’s high-risk list since 2009.
  • GAO Key Takeaways
    • From fiscal years 2020 to 2024, FDA oversaw the recall of 3,934 medical devices. All were voluntarily recalled by manufacturers. FDA can mandate a recall, although it rarely does so.
    • Insufficient staff limit FDA’s ability to conduct oversight activities, according to officials.
    • According to officials, FDA cannot require manufacturers to adopt its recommendations for how to carry out certain recalls. Some stakeholders said manufacturers and FDA communicating different information can be confusing.
  • https://www.gao.gov/products/gao-26-107619

KEY ACRONYMS

  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • GAO = Government Accountability Office
  • HHS = Department of Health and Human Services
  • NIH = National Institutes of Health
  • OMB = Office of Management and Budget

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