From Washington, DC,

• Roll Call reports,
  • “A dispute over a Trump administration plan to consolidate federal firefighting operations may be close to resolution, in a sign of modest progress toward Senate passage of a major fiscal 2026 spending package.
  • “Sen. Tim Sheehy, R-Mont., said Thursday he was prepared to release his hold on the Interior-Environment bill, a prime candidate for the “minibus” spending package, after cutting a deal to remove language that threatened to delay, if not derail, the firefighting reorganization.
  • “Sheehy, a former firefighting pilot and founder of an aerial firefighting and aerospace services company, is a key backer of the plan and rejected any effort to delay it.
  • “But we’ve cleared that language, so we should be good now,” he said.” * * *
  • “While Sheehy’s hold on the spending package may be lifted, Thune continued to negotiate with several other Republicans who have their own holds as they push for various causes, including a concern from some conservatives that spending levels are too high.
  • “Thune, R-S.D., told reporters Thursday that negotiators were still working “through the concerns that our members have,” but added he’s hopeful they “can land something soon.”
  • “A lot of conversations going on around that, but we just need to — we’ve got to get on the package of bills,” Thune said.
  • “Thune wants to add some combination of the Commerce-Justice-Science, Interior-Environment, Labor-HHS-Education and Transportation-HUD bills to the Defense bill in a package he could bring to the floor in coming days.”

• Fierce Healthcare adds,
  • “As Congress continues to debate next steps on the Affordable Care Act’s enhanced subsidies, insurers are urging legislators to consider an extension with additional program integrity measures in place.
  • “AHIP said in a statement Wednesday that “common sense” steps to promote integrity can help mitigate the risks related to fraudulent enrollment in ACA plans or subsidies. The commentary comes after analysts at the Government Accountability Office were largely able to enroll in coverage and in the tax credits using fake profiles.
  • “GAO notes in the report that when the Centers for Medicare & Medicaid Services took steps to address fraudulent enrollments by improving identity verification and implementing three-way calls to stymie broker misbehavior, which have already had an impact on reducing unauthorized activity, AHIP said.
  • “With open enrollment underway and 24 million Americans facing the largest-ever spike in healthcare costs in 2026, Congress should take bipartisan action to preserve the health care tax credits and further strengthen program integrity,” AHIP said.”

• The American Hospital Association News tells us,
  • “The Advisory Committee on Immunization Practices Dec. 5 recommended individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. If not receiving the vaccine at birth, ACIP recommended infants receive the initial dose no earlier than 2 months of age. However, ACIP made no change to the existing Centers for Disease Control and Prevention recommendations to vaccinate infants born to women who test positive for the virus or have an unknown virus status. The recommendations also maintain consistency with all current health coverage options for payment, according to the Department of Health and Human Services. ACIP’s recommendations must be formally adopted by the director of the CDC before becoming part of the CDC immunization schedule.”
    
• The Wall Street Journal explains what the ACIP recommendations means for readers.
  • “Under these recommendations, parents who wish to have their infants vaccinated at birth, if the mother isn’t infected with hepatitis B, will be able to do so after discussing it with their doctor. Doctors might face additional hurdles in administering the vaccine at birth for some families, including additional time spent counseling. 
  • “Insurers will likely still cover the shots if administered earlier than recommended. AHIP, a group representing insurers, said its members will cover vaccines recommended by ACIP through Sept. 1 until the end of 2026. Insurers typically handle coverage decisions yearly.”

• Healthcare Dive lets us know,
  • “The HHS on Thursday released its plan to deploy and centralize artificial intelligence use within the agency, as part of a broader push by the Trump administration to cut costs and adopt the technology in the federal government.
  • “The agency said it will prioritize sharing AI resources among HHS departments, create a governance structure for new tools and promote use of the technology for public health initiatives.
  • “Although the strategy is internally focused to start, HHS said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools.” 

• FedWeek calls to our attention a hiccup in the relatively new PSHBP Open Enrollment system that may require enrollee work arounds.

From the Food and Drug Administration front,

• Per an FDA news release,
  • “The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.
  • “Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
  • “We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”

• Per MedTech Dive,
  • “Advisers to the Food and Drug Administration on Wednesday voted 15-0 against use of Johnson & Johnson’s V-Wave shunt for heart failure patients not helped by medications.
  • “Members of the circulatory system devices panel were unanimously opposed to recommending approval of the implant based on effectiveness and its benefit-risk profile. On the question of safety, the panelists voted 9-6 in favor of the device.
  • “J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions.
  • “Following the vote, a J&J spokesperson said the company is reviewing the FDA advisory panel’s recommendation for additional clinical evidence on the device.
  • “We will continue to work closely with the FDA, clinicians and other stakeholders to determine next steps,” the spokesperson wrote in an email.”

From the public health and medical/Rx research front,

• The Centers for Disease Control and Prevention announced today,
  • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country. COVID-19 activity is low nationally.
  • “COVID-19
    • “COVID-19 activity is low nationally.
  • “Influenza
    • “Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country.
    • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
  • “RSV
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
  • “Vaccination
    • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”

• The University of Minnesota’s CIDRAP adds
  • “Although this year’s flu season could be challenging, fewer adults have been vaccinated against influenza, a new study shows.
  • “Much less than half of US adults have been immunized against any respiratory virus, according to a survey of 1,015 adults released this week by the National Foundation for Infectious Diseases (NFID).
  • “Just 34% of adults have gotten a flu shot; 25% have had a COVID-19 shot; 8% have received a vaccine to prevent pneumococcal disease, caused by bacteria that can lead to pneumonia, meningitis, and sepsis; and 6% have been vaccinated against respiratory syncytial (RSV), a leading cause of hospitalization in infants and older adults.
  • “New data from IQVIA, which provides health care statistics, show similar declines over the past year. Retail pharmacies have seen falling numbers of vaccinations for three major respiratory viruses:
    • “34% decline in RSV vaccinations
    • “27% drop in COVID-19 vaccinations
    • “6% reduction in flu shots
  • “Pneumococcal vaccinations are the one bright spot in IQVIA’s data, with vaccinations rising 27% in the past year. The uptick is likely due to the Centers for Disease Control and Prevention’s (CDC’s) decision last year to lower the age at which people are eligible for pneumococcal vaccine from 65 to 50, said Robert Hopkins, NFID’s medical director.

• Beckers Clinical Leadership tells us,
  • “Twelve percent of nearly 3,000 norovirus tests during the week ending Nov. 22 came back positive — a notable increase from the 6.82% positivity rate three months earlier, according to CDC data. 
  • “During the week ending Aug. 23, 6.82% of 4,034 norovirus tests were positive. A CDC system that tracks viral activity in the U.S. shows a 12% positivity rate among 2,825 norovirus tests, as of Nov. 22, the most recent data available.” 

• Per Medscape,
  • “A newly cleared point-of-care test will enable rapid identification of whooping cough, according to a press release from manufacturer Roche.
  • “The molecular test uses the cobas liat system and earned an FDA clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for the detection of Bordetella infections, including pertussis.
  • “The CLIA waiver means that the test is approved for use in settings outside of a traditional lab, including a doctor’s office or pharmacy, and is considered sufficiently simple that it can be performed by healthcare personnel without extensive medical training.
  • “The test is currently available and provides polymerase chain reaction (PCR) results after approximately 15 minutes at the point of care, according to the company. Early symptoms of pertussis are similar to other respiratory illnesses, and a quick-turn test can confirm a diagnosis and facilitate timely treatment to prevent further spread of illness and protect patients from severe complications.”
• and
  • “Current cardiac screening tools used to prevent myocardial infarction (MI) failed to identify nearly half of people who are at risk for MI, according to a new study. Those patients had low or borderline risk as per both standard and newer risk calculators for atherosclerotic cardiovascular disease (ASCVD). Most developed symptoms within 48 hours before the event, and many would not have been recommended statins or further testing if evaluated 2 days earlier.”

• MedPage Today informs us,
  • “In a French cohort, the incidence of all-cause mortality among those who received a first dose of an mRNA COVID vaccine was 0.4% after a median follow-up of 45 months, compared with 0.6% of those who were unvaccinated.
  • “After standardizing characteristics between the two groups, all-cause mortality incidence was 25% lower in those who had received a COVID shot.
  • “Vaccinated people were 74% less likely to die in a hospital because of COVID-19 compared with those who weren’t vaccinated.”
• and
  • “Three ancillary studies to the U.S. POINTER trial collectively demonstrated that a structured 2-year lifestyle intervention for older adults at increased risk of cognitive decline led to better overall health.
  • “In main results from the U.S. POINTER trial released in July, two lifestyle interventions — one structured, the other self-guided — improved cognitive scores in over 2,000 older adults, said Rema Raman, PhD, of the University of Southern California in Los Angeles, who co-chaired a symposium at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting.
  • “Both 2-year interventions in U.S. POINTER encouraged physical activity, cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but they differed in structure, intensity, and accountability.

• Per Health Day,
  • “Your brain health might be linked to how well your kidneys are working, a new study says.
  • “People with impaired kidney function have higher levels of proteins in their blood that are linked to Alzheimer’s disease, researchers reported Dec. 4 in the journal Neurology.
  • “Our study found that when the kidneys are not functioning properly, there may be higher levels of Alzheimer’s biomarkers in the blood,” lead researcher Dr. Francesca Gasparini, a geriatrician with the Karolinska Institutet in Stockholm, Sweden, said in a news release.
  • “While we did not find that having reduced kidney function increased the risk of developing dementia, we did find that impaired kidney function may accelerate the onset of dementia in people who have higher levels of biomarkers.,” Gasparini said. “This highlights the need for doctors to consider kidney function when interpreting results of Alzheimer’s biomarkers in the blood.”

• STAT News reports,
  • “Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for clearance.
  • “Developed with Click Therapeutics, the app, CT-155, is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. Schizophrenia affects millions of people in the U.S. and is commonly associated with psychotic behavior and delusions. However, there are other common and often serious negative symptoms, including lack of motivation and the inability to experience pleasure, for which there are no approved drugs.”

From the U.S. healthcare business and artificial intelligence front,

• Tech Target relates,
  • “Navigating an evolving regulatory landscape is top-of-mind for healthcare payers heading into 2026, with health plan executives saying changing requirements stemming from the Trump tax law has driven new priorities, according to a new HealthEdge report.
  • “The report, based on survey responses from 550 health plan executives in the United States, also flagged rising costs, better member engagement, investment in artificial intelligence (AI) and more collaborative payer-provider relationships as key priorities.”

• McKinsey & Co. points out,
  • “Women in the United States face steeper barriers to healthcare than men, causing preventable suffering and costing billions each year. The health of women—encompassing the entire care continuum and extending beyond reproductive and sexual health—represents an approximately $50 billion missed annual opportunity for health systems nationally. Addressing the gap in women’s healthcare requires a fundamental transformation in care delivery, with preventive care playing a pivotal role to ensure accessibility, continuity, and comprehensive care.”

• BioPharma Dive notes,
  • “Hemophilia gene therapies are struggling on the market, even as innovation soars. The business case for hemophilia gene therapy still isn’t adding up due to persistent market barriers.”

• Per Fierce Healthcare,
  • “It’s been just over a year since Oura announced a partnership with Medicare Advantage insurer Essence Healthcare, and, now, the partners are looking to continue building on that foundation.
  • “The partnership initially launched for Essence’s PPO plan members, and, over the course of the year, grew into HMO plans as well. Saria Saccocio, M.D., chief medical officer for Essence, told Fierce Healthcare that a third of members who were eligible for an Oura ring chose to sign up, and two-thirds of that group was willing to share biometric data with the insurer.
  • “She said the effort began with sleep health and, over time, has shown members are improving their sleep scores. That’s translating to other areas as well, such as an increase in the amount of time engaging in light exercise.
  • “It’s that level of awareness and nudge that I think is helping improve the overall health of our members,” Saccocio said.”
• and
  • “Wellvana has struck a 20-year affiliation with Mercy that will offer the system’s nonemployed primary care physicians and advanced practice providers participation in value-based care.
  • “The arrangement will give those independent clinicians access to Wellvana’s electronic-health-record-integrated practice tools and clinical and operational care teams, which the new partners say will reduce administrative burdens and help coordinate patient care.
  • “The providers’ participation in value-based arrangements will also bring financial incentives for better patient outcomes within Mercy’s service area and across Medicare, Medicare Advantage and commercial plans, they said. The organizations expect their clinically integrated network to be among the country’s largest.
  • “Mercy has built one of the nation’s most respected systems, and together we’re creating sustainable paths for independent providers to see the rewards of accountable care,” Wellvana CEO Susan Diamond said in Thursday’s announcement. “The more we grow participation in value-based care, the more patients and communities benefit from a better, more connected health experience.”

• The Wall Street Journal offers readers six questions to ask their doctors before their doctors use AI to record their visits.