Tuesday report

Obesity

Tuesday report

David Ermer–ACA, Congress, FDA, Medical / Rx research, Medicare, Obesity, SDOH, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Appropriations Committee Jan. 20 released text of a three-bill minibus for fiscal year 2026 that includes funding for key health programs and other bipartisan health care provisions and extensions. The bill provides a discretionary total of $116.6 billion to the Department of Health and Human Services and maintains funding for key rural health, health care workforce and behavioral health programs. The bill has several priorities supported by the AHA, including one-year extensions of the Medicare-dependent Hospital and low-volume adjustment programs, a two-year extension of telehealth flexibilities, as well as a one-year delay of payment reductions for clinical laboratory services. It also includes a five-year extension of hospital at home flexibilities and eliminates Medicaid Disproportionate Share Hospital cuts until FY 2028. Additionally, the bill includes a provision requiring separate unique health identifiers for off-campus hospital outpatient departments, which the AHA says is redundant as hospitals already disclose care locations, and it would impose unnecessary costs and administrative burden by forcing changes to existing billing systems. The House is expected to vote on the bill this week, with the Senate expected to follow next week before the Jan. 30 funding deadline.”
  • STAT News notes,
    • “Th[is] bill would prohibit PBMs from linking their payments to drug prices in Medicare and increase transparency in that program. The bill would ban PBMs from charging Medicaid more than they pay for drugs, a practice called spread pricing. And in the commercial market, the bill would require PBMs to pass through 100% of rebates to employer-sponsored insurance plans. There also is a measure requiring that PBMs give pharmacies who want to be part of their network reasonable contracts. 
    • “However, some of those measures could be taken out if the nonpartisan Congressional Budget Office determines that they would cost money, Smolinski said. The commercial market requirements and Medicaid spread pricing measures are examples of measures that the CBO could determine would increase government spending.”
  • Per Beckers Hospital Review,
    • [This bill] does not extend the enhanced ACA subsidies that expired at the end of 2025, a point of concern for hospitals as insurance premiums rise for millions of people across the country.
  • Govexec adds,
    • “Negotiators in both chambers of Congress have reached an agreement to fund every federal agency in fiscal 2026, with appropriators announcing a final deal on Tuesday, giving lawmakers 10 days to get the remaining bills to President Trump’s desk before a shutdown would occur.
    • “The Senate last week passed a second “minibus” package of spending bills, sending the measure to Trump to clear out half of the 12 annual must-pass appropriations bills. The House has already passed a third package—funding the departments of State and Treasury, and other governmentwide oversight agencies—and the Senate is expected to pass it next week. 
    • “Lawmakers on Tuesday unveiled the fourth and final minibus, which would fund the departments of Defense, Labor, Health and Human Services, Education, Homeland Security, Transportation and Housing and Urban Development. Those agencies, as well as State and Treasury, are currently funded through a stopgap continuing resolution that is set to expire after Jan. 30. 
    • “The new package marks yet another breakthrough between Republicans and Democrats in both the House and Senate.” * * *
    • “The House is expected to approve the measure this week. The Senate would then take it up next week, when it returns from recess. Lawmakers will have to pass the bill and Trump would then have to sign it into law by Jan. 30 to avoid the second shutdown of the fiscal year.” 
  • Per an HHS news release,
    • The HHS Office of Inspector General released its annual report about “2025 Top Management & Performance Challenges Facing HHS.”
  • Per a CMS news release,
    • “January 20, 2026 – Medicare Secondary Payer and Certain Civil Money Penalties Group Health Plan Webinar Now Available 
    • “The presentation from the January 13th Medicare Secondary Payer and Certain Civil Money Penalties Group Health Plan Webinar is now available in the Download section below.”
  • Beckers Payer Issues ranks the States by Affordable Care Act enrollment change since 2025.
    • “New Mexico has seen the biggest increase in ACA enrollment from 2025 to 2026, while North Carolina has seen the largest decrease, according to KFF.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “French vaccine developer Valneva said it is voluntarily pulling the paperwork underlying the approval of its chikungunya virus shot in the U.S., ending a short-lived marketing run marred by safety concerns. 
    • “In a Monday statement, Valneva said it recently learned that the Food and Drug Administraiton placed a clinical hold on the vaccine, Ixchiq, pending an investigation of a newly reported serious adverse event that occurred outside the U.S. The company has responded by withdrawing its FDA applications altogether.”
  • MedTech Dive tells us,
    • “Boston Scientific has told customers to stop using certain stents linked to three deaths, the Food and Drug Administration said Friday.
    • “The FDA published an early alert about issues with deployment and expansion of certain Axios Stent and Electrocautery Enhanced Delivery Systems.
    • “Boston Scientific wrote to customers about the issues, which the FDA said were linked to 167 serious injuries, late last year to prevent further use of the products.”
  • Radiology Business informs us,
    • “A group of PET scanners manufactured by GE HealthCare are the subject of a new recall from the U.S. Food and Drug Administration (FDA). 
    • “On January 16, the FDA updated its list of medical device recalls to include certain Omni Legend systems from GE. The recall was issued due to the potential for the systems to produce artifacts during PET exams, which could skew readers’ ability to assess images accurately.” * * *
    • “More information regarding the specific systems impacted by the recall can be found here.”  

From the judicial front,

  • The AHA News reports,
    • “The federal government has dropped its appeal of a preliminary injunction blocking implementation of the Department of Health and Human Services’ 340B Rebate Model Pilot Program.
    • “The move comes after the 1st U.S. Circuit Court of Appeals Jan. 7 denied the government’s motion for a stay in a lawsuit filed by the AHA, the Maine Hospital Association and four safety-net health systems challenging the program.
    • “The 1st Circuit ruling follows a Dec. 29 decision from the U.S. District Court of Maine granting a preliminary injunction blocking implementation of the program, which was scheduled to go into effect Jan. 1. The district court held that the Health Resources and Services Administration’s approval of the nine manufacturer applications that collectively comprise the entire program likely violated the Administrative Procedures Act.
    • “In a court filing, the government has signaled it will restart the administrative process related to the program; however, it has not released specific details.” 

From the public health and medical / Rx research front,

  • Pulmonology Advisor reports,
    • “Increased risk for non-small cell lung cancer (NSCLC) in never-smokers is significantly associated with underlying chronic lung disease, a family history of lung cancer, and unemployment, researchers reported in Chest.” * * *
    • “These findings underscore the multifactorial nature of LCINS and highlight the need for a comprehensive, multifactorial risk-assessment approach to better identify high-risk populations among never-smokers,” the researchers concluded.”
  • The American Journal of Managed Care tells us,
    • Colorectal cancer (CRC) incidence is increasing among young adults, with significant survival disparities linked to socio-economic status (SES) and race.
    • Black patients and those from lower SES neighborhoods had poorer 3-year survival rates, but only SES remained significant after adjustment.
    • The study highlights the impact of structural inequities on survival outcomes, emphasizing the need for multilevel interventions.
    • Limitations include small sample sizes for certain racial groups and potential aggregation issues, affecting generalizability.
  • Health Day informs us,
    • “Fingertip blood oxygen monitors return false readings for people with darker skin tones.
    • “The devices might miss low blood oxygen levels among dark-skinned patients.
    • “The darker the skin tone, the more inaccurate the devices become.” * * *
    • “In the linked editorial, Valley and colleagues agreed that for the time being, doctors will have to do their best, while understanding the devices’ flaws.
    • “The goal is not to abandon pulse oximetry but to understand its limits and make it equitable, ensuring that the technology designed to measure oxygen does not itself perpetuate inequalities in those who receive it,” the editorial said.”
  • STAT News points out,
    • “In a new secondary analysis of the larger trial published Monday in the Annals of Internal Medicine, [Mary Elizabeth] Patti [MD] and her colleagues asked how different social determinants of health affected outcomes after bariatric surgery compared to medical therapy for people with type 2 diabetes and obesity.
    • Bariatric surgery was better than medical therapy across all social backgrounds, they found, and not just in areas of higher deprivation. The ancillary study was smaller, and some of the participants randomized in earlier stages crossed over from medical to surgical treatment, and the reverse. The authors acknowledged and accounted for these limitations, along with the rapid development of more powerful obesity drugs not fully captured in the study. 
    • Still, “bariatric surgery remains an underutilized approach. Even in comparison to these really wonderful medications that we now have access to, it is still better,” Patti, director of the hypoglycemia clinic at Joslin Diabetes Center in Boston, told STAT. “I’m not a surgeon, but I think we need to keep in mind that surgery offers an approach which can be a durable therapy for type 2 diabetes and obesity.”
  • and
    • “Corvus Pharmaceuticals reported updated results Tuesday from an early-stage study of an oral treatment for eczema that has the potential to be more effective than currently approved drugs, including the blockbuster therapy Dupixent.
    • “After eight weeks, 75% of participants treated with the Corvus pill, called soquelitinib, achieved at least a 75% improvement in the extent and severity of skin lesions — an efficacy metric known as EASI 75 — compared to 20% of participants offered a placebo, the company said.
    • “The study also found that 33% of treated participants achieved clear or almost clear skin after eight weeks, as assessed by physicians, compared to none of the participants in the placebo group. 
    • “Side effects, all mild, were reported in 42% of participants treated with soquelitinib and did not result in any dose modifications or interruptions. No serious side effects were reported, Corvus said.”
  • The American Medical Association lets us know what doctors wish patients knew about hepatitis A, B and C.
    • “Chronic viral hepatitis affects millions of people worldwide. But the tricky part is that people infected with hepatitis viruses may not show symptoms, causing many to be unaware they have this condition. 
    • “While many patients with an acute infection fully recover after a few weeks, others develop chronic infection. That is why it is vital that patients know the ABCs of viral hepatitis and understand when to seek help.”
  • Genetic Engineering and Biotechnology News relates,
    • “An international team of scientists, headed by a team at Nanyang Technological University, Singapore (NTU Singapore), has discovered a new way that could speed up the healing of chronic wounds infected by antibiotic-resistant bacteria.
    • “Collaborating with researchers at the University of Geneva, the team’s preclinical study showed how a common bacterium, Enterococcus faecalis, actively prevents wound healing. The results of their collective studies in mice and in human cells showed that, unlike other bacteria, which produce toxins when they infect wounds, E. faecalis produces reactive oxygen species (ROS), which impairs the healing process of human skin cells.
    • “The team identified extracellular electron transport (EET) as a previously unrecognized mechanism by which E. faecalis generates ROS, which, in turn, activates the unfolded protein response (UPR) in epithelial cells and impedes their migration following wounding. The study also demonstrated how neutralizing this biological process can allow skin cells to recover and close wounds.
    • “Establishing a direct link between bacterial metabolism and host cell dysfunction, the study points to a potential new therapeutic strategy for chronic wounds. Co-senior and co-corresponding author, NTU associate professor Guillaume Thibault, PhD, at the School of Biological Sciences, and colleagues reported on their findings in Science Advances, in a paper titled “Enterococcus faecalis redox metabolism activates the unfolded protein response to impair wound healing,” in which they concluded, “Our findings establish EET as a virulence mechanism that links bacterial redox metabolism to host cell stress and impaired repair, offering new avenues for therapeutic intervention in chronic infections.”

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute posted its reports about “The Shifting Landscape of Employment-Based Health Benefits: Long-Term Resilience, Small-Employer Erosion, and the Threat of Higher Premiums,” and its “2025 Workplace Wellness Survey.”
    • “Employers’ commitment to worker health dates back to the late 1800s, but it was during World War II that employers began to offer more formal health coverage. Employers today offer health coverage because of their belief that offering it has a positive impact on the overall success of the business. It can be argued that the Employee Retirement Income Security Act of 1974’s (ERISA’s) preemption of state law has created an environment of nationally uniform standards for employee benefit plans, thus giving employers the regulatory means to continue to offer health benefits as they do today. Despite predictions spurred by the Patient Protection and Affordable Care Act of 2010 (ACA) that employers would stop offering coverage, employment-based health insurance remains resilient.”
    • “This edition of the Workplace Wellness Survey found that American workers’ average level of concern about their physical, mental, and workplace well-being was a 5.8 out of 10, up from 5.5 in 2024. Some other the key conclusions in the survey were that 56 percent of workers were very or extremely satisfied with their current job, with a few expressing dissatisfaction; top suggestions for improvement to benefits were a greater employer contribution and more flexibility of benefits to choose from; and half of the workers were open to using AI as a tool to help with benefits, but significant shares remained skeptical.”
  • Beckers Payer Issues informs us,
    • “Sustained GLP-1 use slows medical cost growth, according to findings published Jan. 13 from professional services firm Aon.
    • “The firm analyzed 192,000 GLP-1 users from July 2022 to March 2025, comparing outcomes to non-users, through commercial medical and pharmacy claims data. This research builds off 2025 analyses.
    • “These results provide employers a much clearer view of how GLP‑1 therapies can change the trajectory of both health risks and longer-term costs in their workforce,” Aon North America Health Solutions Leader Farheen Dam said in a news release. “The real impact comes when employers consider not just coverage, but also how these medications are used, supported and sustained over time. By pairing thoughtful GLP-1 strategies with programs that encourage adherence and total well-being, organizations can improve outcomes for their workforce.”
  • Fierce Pharma notes,
    • “Five weeks after telling investors to expect a revenue decline in 2026, Pfizer has found a quick funding fix, selling off its stake in GSK’s ViiV Healthcare.
    • “The New York powerhouse has agreed to surrender its 11.7% interest in the HIV-focused company for $1.875 billion. Under terms of the agreement, Shionogi will pick up Pfizer’s shares for $2.125 billion, with GSK gaining a special dividend of $250 million.
    • “The deal allows majority owner GSK to retain its 78.3% interest in ViiV, while Osaka, Japan-based Shionogi will boost its stake in ViiV from 10% to 21.7%. The companies expect to close the deal in the first quarter of this year.”
  • and
    • “With star checkpoint inhibitors like Keytruda and Opdivo now sporting subcutaneous formulations, GSK has struck a deal aimed at ensuring its own PD-1 stalwart doesn’t miss out on the action.
    • “GSK, through its oncology subsidiary Tesaro, is handing over $20 million upfront to Alteogen for global rights to the Korean biotech’s novel hyaluronidase enzyme ALT-B4. Tesaro plans to use the tech to develop and potentially market a subcutaneous form of Jemperli (dostarlimab).
    • “To sweeten the deal, GSK and Tesaro are offering up to $265 million more tied to certain development, regulatory and sales milestones, Alteogen said in a Jan. 20 press release. Alteogen will also be in line to earn royalties on sales of subcutaneous Jemperli, should it win approval and go to market.”
  • BioPharma Dive adds,
    • GSK on Tuesday said it’s agreed to buy Rapt Therapeutics for $2.2 billion, gaining access to a drug that promises to help a wider population of patients avoid allergic reactions to food.
    • The medicine, ozureprubart, targets the immunoglobulin E, or IgE antibodies that are produced when a patient’s immune system overreacts after encountering allergens. Once released, the IgE antibodies help trigger allergic reactions that can sometimes be deadly for patients. 
    • Ozureprubart is currently in Phase 2b testing, and Rapt believes it has the potential to be administered every eight to 12 weeks, instead of the two-to-four week regimens currently used for Roche and Novartis’ Xolair. The company also expects the drug to be used by a bigger pool of patients, including those with high levels of IgE or a body weight that makes them ineligible to take Xolair.
  • Per Radiology Business,
    • “[Last] week iSono Health—a company that specializes in developing solutions catered to women’s health—announced the commercial launch of its wearable breast ultrasound system.  
    • “ATUSA is an artificial intelligence-enabled ultrasound device that delivers 3D automated imaging of the breast at the point of care. ISono Health developed the system to address the diagnostic gap between women with dense breast tissue and challenges accessing supplemental imaging. The company believes the product has the potential to address shortages of skills sonographers by putting the easy-to-use technology directly in the hands of providers in clinic. 
    • “ATUSA is a systemwide upgrade for women’s breast health,” Neda Razavi, CEO of iSono Health, said in an announcement. “We are putting the power of a world-class radiology suite into the hands of local clinicians, replacing slow, manual workflows with real-time diagnostic images at the point of care.” 

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • By a vote of 82-15, the Senate passed H.R.6938, Commerce, Justice, Science; Energy and Water Development; and Interior and Environment Appropriations. This means that Congress has passed half of the twelve required appropriations bills for fiscal years 2026.
  • President Trump unveiled his healthcare plan today.
    • Here is a link to the related fact sheet.
  • AHIP posted a “Health Care Costs 101” explanation of “What’s Driving Premiums Higher and How to Make Coverage More Affordable.” FWIW, the FEHBlog finds AHIP’s explanation credible.
    • “Health plans are doing everything in their power to shield Americans from the high and rising costs of medical care, and we welcome any opportunity to discuss common-sense solutions to lower costs for everyone.
    • “Health plans are the only part of the health care system whose profits and administrative costs are capped under federal law. Health plans’ profit margin was 0.8% in 2024, NAIC data show. In 2023, the net income of health plans accounted for about 0.5% of U.S. health expenditures ($4.9 trillion that year, per CMS data). By comparison, the pharmaceutical industry averages 15-20% margins.”
  • Fierce Healthcare reports
    • The Trump administration has released new estimates on improper payments in key government insurance programs.
    • The Centers for Medicare & Medicaid Services (CMS) said late Thursday that the estimated improper payment rate in traditional Medicare was 6.55%, or $28.83 billion, in 2025. That’s down from $31.7 billion, or a 7.66% rate, the year prior.
    • The CMS said in a fact sheet that this marks the ninth year in a row in which this figure has been below the 10% threshold required by statute. 
  • STAT News relates,
    • “Last week, the Trump administration unilaterally cut the number of recommended pediatric vaccines, removing shots for diseases like rotavirus, influenza, and hepatitis A from the schedule.
    • “Health secretary Robert F. Kennedy Jr. said the changes were intended to restore trust in public health. But major health systems and clinicians told STAT they plan to ignore the new federal guidelines, placing their trust instead in guidance from the American Academy of Pediatrics, which is similar to previous U.S. policy.” 
  • FEHBlog note — This doesn’t matter to insurers because regardless of whether it’s CDC or AAHP approved, it will be covered without cost sharing when administered in-network.
  • Tammy Flanagan, writing in Govexec, discusses “How federal retirement benefits are calculated and where estimates go wrong. High-three pay, length of service and overlooked reductions can significantly change retirement payouts.”
  • Federal News Network reports,
    • “The Postal Service’s regulator is setting limits on how often the agency can set higher prices for its monopoly mail products.
    • “The Postal Regulatory Commission ruled on Tuesday that the USPS, starting in March, can only raise mail prices once a year. This limit will remain in place through Sept. 30, 2030.
    • “The commission eased restrictions on USPS mail prices in December 2020, when the agency was reeling from the COVID-19 pandemic, and was months away from running out of cash.
    • “Since then, USPS has generally raised mail prices every January and July. Despite setting higher prices, the mail agency is seeing deeper net losses each year, and is far from achieving the “break-even” goal of its 10-year reform plan. In July 2025, USPS raised the price of a first-class stamp to 78 cents.
    • “Members of the commission wrote in their order that the Postal Service’s long-term financial problems “cannot be resolved by using pricing authority alone.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • The Food and Drug Administration quietly removed webpages saying cellphones aren’t dangerous as the Department of Health and Human Services under Robert F. Kennedy Jr. launches a study on cellphone radiation. 
    • Kennedy and some of his allies have long pointed to cellphones as a potential source of illnesses including cancer. Many mainstream scientific institutions, including the FDA, previously concluded that there isn’t adequate proof to link health problems to cellphones or other wireless devices. A vocal group of scientists have said there is reason to worry and to take more precautions, and Kennedy has echoed their concerns.
  • HCPLive tells us,
    • “The FDA approved a new carrying case for OTC naloxone nasal spray, enhancing portability and reducing stigma.
    • “A survey showed 74% of consumers prefer discreet packaging, with higher preference among college students.
    • “Despite OTC approval, naloxone carry rates are low, highlighting the need for increased accessibility and preparedness.
    • “Synthetic opioids in products like THC vapes necessitate immediate availability of naloxone and readiness for repeated dosing.”
  • Cardiovascular Business relates,
    • “Imricor Medical Systems, a Minneapolis-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its Vision-MR Diagnostic Catheter. This represents the company’s first FDA clearance since opening its doors in 2006.
    • “The Vision-MR Diagnostic Catheter was built to be provide real-time electrophysiological mapping during under MRI guidance. According to Imricor, this helps electrophysiologists “harness the unmatched soft tissue imaging of the MRI” to visualize a patient’s cardiac anatomy prior to ablation procedures.”
  • Fierce Pharma tells us,
    • “The steady stream of FDA untitled letters that began in September is showing no signs of letting up in the new year.
    • “The regulator’s Office of Prescription Drug Promotion (OPDP) has already sent out two letters alleging “false or misleading” promotional materials in 2026, both dated Jan. 7 and sent to ImmunityBio and BeOne Medicines. BeOne is also the subject of another letter from December that was belatedly uploaded to the FDA website this month.”

From the public health and medical / Rx research front,

  • AAMC informs us about “10 things to know about this year’s surprisingly fierce flu season.”
    • “At least 15 million Americans have come down with the flu — and 7,400, including 17 children, have died from the illness — during the 2025-26 flu season so far, making it one of the most brutal in recent memory.”
  • MedPage Today lets us know,
    • “The FDA and CDC are investigating a multistate outbreak of Salmonella Typhimurium infections linked to Live it Up brand Super Greens dietary supplement powder. A total of 45 people were infected and 12 people were hospitalized.”
  • and
    • “President Donald Trump signed a bill Wednesday allowing schools participating in the National School Lunch Program to serve whole milk again. (AP)”
  • The American Hospital Association News informs us,
    • “A Centers for Disease Control and Prevention report found a drastic increase in alcohol-related emergency department visits from 2003-2004 to 2021-2022. The report said visits rose 101% for males and 96% for females. Visits were for diagnoses that included alcohol-induced psychosis, alcohol abuse, myopathy and liver disease, among others. Additionally, the report said that alcohol was the most common substance involved in substance-related ED visits from 2021-2023, outpacing opioids and cannabis.” 
  • Medscape points out,
    • “The GLP-1 drugs widely prescribed for diabetes and weight loss might also help reduce the risk for colorectal cancer and possibly improve outcomes in people who have the disease, according to a series of studies presented at ASCO Gastrointestinal Cancers Symposium 2026.
    • “In one study, researchers observed a 36% lower risk for colorectal cancer among people who used GLP-1 receptor agonists vs those who used aspirin — a drug long investigated for colorectal cancer primary prevention.
    • “While aspirin has shown “modest efficacy” in that regard, it also carries a bleeding risk that limits its use, Colton Jones, MD, a hematology and oncology fellow with The University of Texas San Antonio, told conference attendees.”
  • Per Health Day,
    • “As teens transition to adulthood, many begin to skip yearly wellness visits with a primary care provider, according to a study published online Dec. 19 in the Journal of Adolescent Health.
    • “Morayo Akande, Ph.D., from Johns Hopkins School of Medicine in Baltimore, and colleagues explored adolescents and young adults’ (AYAs’) longitudinal patterns for annual well-visit attendance (WVA) and associations with WVA. The analysis included data from 2,766 participants in the NEXT Generation Health Study followed annually for seven years (ages 15 to 23 years).
    • “The researchers found that among male participants, 66 percent were “engaged,” 17.7 percent were “engaged with decline,” and 17 percent were “persistently disengaged.” A similar pattern was seen for female participants: 67 percent were “engaged” and 19 percent were “engaged with decline,” but 13 percent were “gradually reengaged.” 
  • Per MedPage Today,
    • “Patients randomized to a self-administered electronic intervention had a significantly greater likelihood of complete benzodiazepine cessation compared with those who received treatment as usual.
    • “However, there was no difference in the second primary endpoint of at least a 25% dose reduction, or in secondary endpoints including self-reported anxiety symptoms and sleep quality.
    • “Experts noted that this intervention may be of interest only to patients already motivated to decrease use, though the findings are encouraging given the prevalence of benzodiazepine dependence.”
  • Genetic Engineering and Biotechnology News relates,
    • “Mucosal surfaces that line the body are embedded with defensive molecules that help keep microbes from causing inflammation and infections. Among these molecules are lectins, proteins that recognize microbes and other cells by binding to sugars found on cell surfaces.
    • “Researchers headed by a team at the Massachusetts Institute of Technology (MIT) have now found that one of these lectins, known as intelectin-2 (hItln2), has broad-spectrum antimicrobial activity against bacteria found in the gastrointestinal tract. Their preclinical studies showed that this lectin binds to sugar molecules found on bacterial membranes, trapping the bacteria and hindering their growth. Additionally, the study found that intelectin-2 can crosslink molecules that make up mucus, helping to strengthen the mucus barrier.”
  • and
    • “Candida auris is an emerging threat, primarily to hospital patients and residents of nursing homes. The fungus easily spreads, colonizes surfaces and objects where it can survive for weeks to months, is often resistant to standard disinfectants, and can cause life-threatening infections. Although those infections, in principle, can be treated with several antifungal medications, strains of the pathogen that have developed antimicrobial resistance (AMR) against those drugs have become a difficult challenge for hospital physicians.
    • “Clinicians need a much more effective diagnostic approach to accurately quantify the abundance of the pathogen in patients and assess its antifungal resistance in order to better respond to C. auris infections in their patients and help prevent future hospital-associated outbreaks,” said Justin Rolando, PhD, a postdoc in the Walt lab at the Wyss Institute. “Current diagnostic methods for detecting C. auris are too costly, slow, and dependent on complex equipment and trained personnel in order to effect real change.”
    • “A new study presents a diagnostic approach that enables fast and accurate quantification of C. aurisstrains from swab samples, as well as the quantification of AMR-causing mutations in fungal populations with mixed antifungal susceptibility.
    • “The findings are published in Nature Biomedical Engineering in the paper, “Digital CRISPR-based diagnostics for quantification of Candida auris and resistance mutations.”
  • Per BioPharma Dive,
    • “Johnson & Johnson’s Tecvayli helped people with multiple myeloma live longer than those who’d received standard drug combinations in a Phase 3 trial, the company said Wednesday. 
    • “J&J enrolled who’d relapsed after receiving frontline therapies and administered either Tecvayli — a dual-targeting antibody drug — or widely used regimens involving medicines like Velcade and Kyprolis. Trial enrollees who got Tecvayli were 71% less likely than those in the comparator group to die or have their disease progress during the trial, J&J said. 
    • “This trial builds on evidence supporting early use of Tecvayli in multiple myeloma. At a medical meeting last year, J&J presented results showing a combination of Tecvayli and another drug it sells called Darzalex might be curative when administered early in a patient’s disease course.”

From the J.P. Morgan healthcare conference which wrapped up today,

  • Fierce Healthcare reports,
    • “Ascension’s $3.9 billion deal to acquire AmSurg and its 34-state footprint is a doorway for the massive nonprofit system to enter 25 additional markets and strike new partnerships with independent physicians and other health systems, President and CEO Eduardo Conrado said this week at the 2026 J.P. Morgan Healthcare Conference.
    • “The newly minted top executive, speaking in a presentation to attendees and in a subsequent interview with Fierce Healthcare, affirmed that the portion of AmSurg’s 250-plus managed ambulatory surgery centers (ASCs) already in Ascension’s 10 existing markets will help the system build out its networks.
    • “This will allow Ascension to capture and serve more patients, shift low-acuity cases out of the hospital to sites that are lower cost and often preferred by patients, and increase case mix index among hospitals where the company is spending big to update its clinical programs and equipment, he said. Ascension’s plans to build new wholly owned ASCs on its home turf also provide an opportunity to better serve the likely influx of uninsured patients on the horizon, he added.”
  • and
    • “Medicare Advantage (MA) insurer Clover Health is leaning on strong performance in the annual enrollment period and financial growth to turbocharge the company in the coming months.
    • “The insurtech presented at the J.P. Morgan Healthcare Conference on Thursday morning, and CEO Andrew Toy told investors that achieving earnings before interest, taxes, depreciation and amortization profitability is a key turning point on the company’s broader goal of reaching net income profitability.
    • “The company announced Wednesday in advance of the session that it is on track for full-year general accepted accounting principles profitability in 2026 for the first time. This is on the back of 53% year-over-year membership growth in the annual enrollment period and high quality scores under the star ratings.
    • “Clover kicks off the year with about 153,000 members, with 97% of them enrolled in the insurer’s central PPO plan, which has a No. 1 ranking nationally on core HEDIS quality measures.”
  • Per Modern Healthcare,
    • “Talkspace plans to launch a mental health support AI agent that is HIPAA protected, and incorporates clinically recognized standards of care.
    • “Mental health support requires something much more specialized and nuanced, including challenging distorted thinking, recognizing delusions and identifying risk in real time,” CEO Dr. Jon Cohen told attendees.
    • “The company has identified depression screening, risk monitoring and additional support between therapy sessions as possible use cases. Its AI agent is in beta testing mode, and is slated to go live in the first half of 2026, Cohen said.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Novo Nordisk started marketing its Wegovy weight loss medication in pill form this month.
    • “Employers which are struggling to manage spending on glucagon-like peptide-1 agonists, or GLP-1s, such as Wegovy, could face higher demand from workers for the pill.
    • “The price for Wegovy pills is comparable to the cost of injectable GLP-1s.
    • “Employers are scaling back GLP-1 coverage as spending rises amid mixed evidence of improved health and lower spending.”
  • and
    • “Sutter Health plans to form new partnerships outside its home base of California. 
    • “The system named Scott Nordlund to lead this initiative as the executive vice president of corporate development and partnerships. 
    • “Nordlund was previously the executive vice president and chief strategy and growth officer for Banner Health.”
  • Kaufmann Hall informs us that “Despite a decline in hospital performance and volume this month, year-to-date revenue, volume, and margins are still strong compared to prior years. The latest issue of the National Hospital Flash Report covers these and other key performance metrics.” and offers a review of 2025 hospital and healthcare system merger and acquisition activities.
  • MedTech Dive relates,
    • “Boston Scientific plans to acquire Penumbra for about $14.5 billion, the companies announced Thursday.
    • “Penumbra makes heart devices to remove clots from blood vessels, treating conditions including pulmonary embolism, stroke and deep vein thrombosis. It also makes an embolization system, designed to stop blood flow to control bleeding.
    • ‘Boston Scientific CEO Mike Mahoney sees an “opportunity to enter new, fast-growing segments within the vascular space,” he said in a statement.”
  • and
    • “Medtronic has partnered with Precision Neuroscience to pair a brain computer interface with its neurosurgical platform.
    • “The agreement, which the companies disclosed Monday, supports co-development of a system that integrates Precision’s Layer 7 cortical interface with Medtronic’s StealthStation surgical navigation system.
    • “Precision said the alliance will shorten the path to widespread clinical use of Layer 7 by enabling surgeons to use its high-resolution electrode technology with a familiar Medtronic system.”

Midweek report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–

From Washington DC

  • The House of Representatives approved an appropriations bill (HR 7006) that includes OPM appropriations by a 341-79 votes this afternoon. The bill now moves onto the Senate for its consideration.
  • Roll Call offers more details on the state of the Congressional effort to pass the twelve appropriations bills in regular orde.
  • Beckers Payer Issues reports,
    • “A bipartisan group of senators working to revive the ACA enhanced tax credits that expired at the end of 2025 said they won’t have their proposal ready until the end of January, Politico reported Jan. 13. 
    • “Sen. Bernie Moreno, R-Ohio, a lead negotiator, previously said the legislative text could be ready as early as Jan. 12, but told Politico, “[W]e have to make sure we get this right.”
    • “Mr. Moreno said Republicans and Democrats involved in the discussions have not yet resolved how to address the Hyde Amendment, which bars federal funding from covering abortions, according to the report. Under the law, ACA marketplace insurers must segregate funds that go toward abortion services from funds that go to all other health services. Republicans and Democrats disagree on whether that segregation complies with the Hyde Amendment.” 
  • Axios adds,
    • “Long-stalled bipartisan priorities that are in play include an overhaul of pharmacy benefit manager practices, as well as a measure that would place more controls on Medicare outpatient spending. 
    • “They’d likely be combined with a renewal of health programs due to expire Jan. 30, including certain Medicare telehealth flexibilities and funding for community health centers.”
  • Healthcare Dive tells us,
    • “National healthcare spending reached $5.3 trillion in 2024 as Americans continued to ravenously consume healthcare coming out of the coronavirus pandemic, according to a new report from CMS actuaries.
    • “Growth in healthcare spending continued to outpace that of the overall economy. As a result, healthcare’s share of the U.S. gross domestic product increased from 17.7% in 2023 to 18% in 2024, researchers said in the report released Wednesday in Health Affairs.
    • “The sharp health spending growth was not driven by increasing costs for goods and services. Instead, it was fueled by intense consumer demand for medical care, and changes in what types of medical care was consumed, CMS actuaries said.
    • “Prices are a factor. They’re part of the equation. But non-price factors were the driver,” Micah Hartman, a statistician with the CMS’ Office of the Actuary, said in a call with press on Wednesday.”
  • Modern Healthcare adds,
    • “Health insurers struggling with rising medical expenses may have less of a cushion in 2026. 
    • “Companies such as UnitedHealth Group reaped gains on their investments over the past several years that bolstered their finances and offset narrowing profit margins or losses from operations.
    • “Broader economic factors are at work though. The Federal Reserve signaled last month that it intends to cut the benchmark interest rate for the fourth time since the beginning of 2025. In addition, Standard & Poor’s Global Ratings projects that yields on 10-year Treasury bonds will continue to decline, which would indicate waning investor confidence in the economy. 
    • “These circumstances would squeeze health insurance company finances at a time when many of the companies are struggling to restore profit margins, said Whit Mayo, senior managing director and senior research analyst at investment bank Leerink Partners.
    • “It’s not a helpful headwind in the context of the challenging, persistent elevated-cost-trend environment,” Mayo said.” 
  • MedPage Today points out,
    • “There’s a reason that the ACA specifies the [U.S. preventive services] task force as the organization insurers must pay attention to, according to Aaron Carroll, MD, president and CEO of AcademyHealth. “No one else has the rigorous transparency in process that the USPSTF has,” he said in an online interview at which a public relations person was present. “They are very clear and transparent in how they gather the evidence, how they grade the evidence, what was actually included, and how they are deliberating. Other organizations may do that, but they do not do it as consistently … which is why the ACA is pegged to them and not to each individual society.”
    • “However, the Trump administration has taken actions recently that have slowed the task force’s work. A planned meeting of the task force in July was canceledopens in a new tab or window, and its November meeting was postponedopens in a new tab or window. No new meeting dates have been announced, according to the New York Timesopens in a new tab or window. In addition, the Timesreported, the terms of five members of the 16-member task force expired on Dec. 31, with no plans announced for their replacements, even as four draft guidelines are set to be finalized. Those guidelines address screening adults for unhealthy alcohol use, self-swabs for cervical cancer screening, counseling for women at increased risk for perinatal depression, and the use of vitamin D supplements to prevent fractures and falls in older people (the task force’s draft guideline recommended against the latter preventive measure).” * * *
    • “Last week, the Health Resources and Services Administration (HRSA) issued guidelines in support of self-swabs to screen for cervical cancer. However, although the ACA also requires insurers to cover preventive services recommended by HRSA, “the difference is in the rigor of the process with high transparency and public input at every stage of the process that the USPSTF adheres to, as opposed to the HRSA process,” Melissa Simon, MD, MPH, vice chair of obstetrics and gynecology research at Northwestern University in Chicago, said in an email. “It is through that highly rigorous and successful methodology that USPSTF adheres to for the decades it has been in existence that lends itself to [being] one of the most trusted preventive services [recommendation bodies] for the U.S.”
  • Fierce Healthcare informs us,
    • “The Paragon Health Institute, a conservative health policy think tank, has launched an AI Initiative that will deliver market-based policy recommendations to the Trump administration and Congress on AI in healthcare. 
    • “Paragon already has an ear with the administration. Its president, Brian Blase, was an economic advisor to President Donald Trump during his first term and formerly worked at the Heritage Foundation. Moreover, several Paragon directors and advisers joined the second Trump administration to lead health policy. Some of the think tank’s proposals, including limits on states’ use of federal Medicaid funds, also made it into the text of last summer’s One Big Beautiful Bill Act.
    • “The Health AI initiative will be led by Kev Coleman, a technologist and healthcare researcher, who has already published several policy papers on the topic as a research fellow at Paragon.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration is expected to decide on approval of Eli Lilly’s obesity pill orforglipron in the second quarter of 2026, Lilly CEO David Ricks said Tuesday, giving it a chance to quickly follow to market an oral version of Wegovy that rival Novo Nordisk launched last week. 
    • “The FDA granted Lilly a “national priority” voucher for orforglipron that could significantly accelerate the agency’s evaluation. While no statutory deadline exists under that program because it’s never been authorized by Congress, Ricks said he expects a “rapid review” that is “moving at pace.”
    • “A second-quarter launch would be well-timed for Lilly to begin selling orforglipron to the millions of people enrolled in Medicare, which will have broad access to obesity medications beginning in April.”
  • MedPage Today relates,
    • “Modern Warrior is recalling all lots of its Modern Warrior Ready supplement, marketed for boosting brain function, after the detection of undeclared 1,4-DMAA, aniracetam, and tianeptine, the latter of which has been linked to suicidal ideation or behavior in kids and young adults, according to the FDA. (The Hill)”
  • and
    • “The FDA requested that manufacturers of GLP-1 receptor agonists remove information regarding risks of suicidal behavior and ideation from drug labels following a detailed review of existing data, the agency announced on Tuesday.
    • “Affected products include those indicated for weight management, including tirzepatide (Zepbound), semaglutide (Wegovy), and liraglutide (Saxenda).
    • “Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 receptor agonist medications,” the agency said in a statement.”
  • and
    • “The FDA told influenza vaccine makers they should add a warning about an increased febrile seizure risk in babies and preschoolers the day after flu vaccination.
    • “The agency made the announcement opens in a new tab or windowin safety labeling notification letters sent Jan. 9 to the manufacturers of six flu vaccines.
    • “The new language in the label would state, “In two separate postmarketing observational studies, an increased risk of febrile seizures was observed during the first day following vaccination with standard dose trivalent (2024-2025) and quadrivalent (2023-2024) influenza vaccines in children 6 months through 4 years of age.”
  • MedTech Dive notes,
    • “Boston Scientific has received Food and Drug Administration approval for a new pulsed field ablation catheter that is indicated for use as an adjunctive device in a type of ablation that is performed when treating persistent atrial fibrillation.
    • “Called Farapoint, the device can deliver linear and focal lesions across complex heart anatomies in a single catheter while preserving surrounding cardiac tissue, the company said in an emailed statement Tuesday. The catheter can be combined with the company’s Faraview software module on the Opal HDx mapping system to enhance visualization of the catheter and lesion formation.
    • “Boston Scientific said clinical data supporting the approval, in cavotricuspid isthmus ablation, demonstrated the device was safe and effective, and showed high effectiveness in preventing atrial flutter recurrence.”

From the judicial front,

  • Beckers Payers Issues discusses ten recent healthcare billing fraud cases.
  • It’s worth adding that the GAO announced today,
    • “The federal government loses hundreds of billions of dollars annually to fraud. We issued the Fraud Risk Framework in 2015 to help managers prevent, detect, and respond to fraud.
    • “However, agencies aren’t doing enough to evaluate their antifraud efforts. In 2023, we surveyed 24 federal agencies and found
      • a third didn’t have regular monitoring or evaluation activities
      • half didn’t regularly make changes based on evaluation results
    • “We are issuing this technical appendix to our framework to help managers evaluate and adapt their antifraud efforts. These efforts can aid program integrity, protect taxpayer dollars, and maintain public trust.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “South Carolina health officials yesterday said the state now has 434 measles cases after 124 new cases have been confirmed. 
    • “There are currently 409 South Carolinians in quarantine and 17 in isolation, with some quarantines extending to February 6. Mobile vaccine units will be active this week, and officials urge local residents to get vaccinated.” * * * 
    • “In other measles news, Utah has 25 new cases, raising the state total to 201. Southwest Utah has the most cases, at 147, followed by Utah County with 24 cases, and Wasatch County with 9 cases. 
    • “Arizona officials yesterday confirmed three new measles cases in the state, all from this year. All three are in Mohave County, which has seen a lingering cross-border outbreak with Southwest Utah for several months. Arizona’s outbreak has now reached 217 infections.”
  • STAT News reports,
    • “U.S. overdose deaths fell through most of last year, suggesting a lasting improvement in an epidemic that had been worsening for decades.
    • “Federal data released Wednesday showed that overdose deaths have been falling for more than two years — the longest drop in decades — but also that the decline was slowing.
    • “And the monthly death toll is still not back to what it was before the Covid-19 pandemic, let alone where it was before the current overdose epidemic struck decades ago, said Brandon Marshall, a Brown University researcher who studies overdose trends.
    • “Overall I think this continues to be encouraging, especially since we’re seeing declines almost across the nation,” he said.”
  • Per Cardiovacular News,
    • “In many ways, cardiovascular health throughout the United States has improved significantly over the years. However, thanks in part to an aging population and the impact of the COVID-19 pandemic, there are certain areas where patient outcomes are trending in the wrong direction.
    • “To learn more about this topic, researchers performed the first comprehensive report of its kind, tracking the latest data on a variety of risk factors and cardiovascular conditions. They published their findings in JACC, the flagship publication of the American College of Cardiology (ACC).[1] 
    • “Progress in cardiovascular health depends on knowing where we stand,” wrote first author Rishi K. Wadhera, MD, MPP, MPhil, associate director and section head of health policy at Richard A. and Susan F. Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center, and colleagues. “To improve, we must measure—not occasionally, but consistently, transparently and with purpose.”
    • “One key takeaway from the report is that there is still plenty of room for improvement in terms of patient outcomes.
    • “Across all risk factors and conditions, persistent disparities by race, geography, and socioeconomic status emerge as a central finding—one that demands focused attention and action,” the authors wrote. “The report also reveals other critical gaps: places where information is incomplete, where our collective understanding falls short, and where new data are urgently needed.”
  • CNN reports,
    • “The Defense Department has spent more than a year testing a device purchased in an undercover operation that some investigators think could be the cause of a series of mysterious ailments impacting US spies, diplomats and troops that are colloquially known as Havana Syndrome, according to four sources briefed on the matter.
    • “A division of the Department of Homeland Security, Homeland Security Investigations, purchased the device for millions of dollars in the waning days of the Biden administration, using funding provided by the Defense Department, according to two of the sources. Officials paid “eight figures” for the device, these people said, declining to offer a more specific number.
    • “The device is still being studied and there is ongoing debate — and in some quarters of government, skepticism — over its link to the roughly dozens of anomalous health incidents that remain officially unexplained.
    • “CNN has asked the Pentagon, HSI and the DHS for comment. The CIA declined to comment.”
  • MedPage Today points out,
    • “Nearly 76% of households with prediabetes patients had additional members who had diabetes risk factors.
    • “Many of these household members had overweight or obesity.
    • “EHR data could identify at-risk households and help target family-centered diabetes prevention strategies, the researchers suggested.”
  • and
    • “Physicians viewed 17% of patient encounters as difficult, according to a meta-analysis.
    • “Patient characteristics associated with perceived difficulty included personality disorders, depression, anxiety, and chronic pain.
    • “The researchers suggested a need for more training in handling difficult encounters.”
  • Healio notes,
    • “Bystander CPR as depicted on TV frequently did not align with correct real-world procedures and experience.
    • “These inaccuracies may skew lay perceptions of cardiac arrest and negatively influence bystander CPR.”

From the. J.P. Morgan healthcare conference,

  • Genetic Engineering and Biotechnology News reports,
    • “They met for the first time in 2018. David A. Ricks, a year into his tenure as Eli Lilly’s Chair and CEO, hosted Jensen Huang at Lilly’s Indianapolis headquarters campus, where the Nvidia founder and CEO gave a talk to the pharma giant’s management team about a new technology called artificial intelligence (AI) and its potential in reshaping drug discovery.” * * *
    • “The two CEOs recalled their first meeting on Monday, when they entertained a packed ballroom at the Fairmont San Francisco hotel, a hilly half-mile north of where the J.P. Morgan 44th Annual Healthcare Conference is taking place. The occasion was a Huang-hosted “fireside chat” in which he and Ricks discussed the companies’ latest partnership, and extolled the promise and potential of AI to reshape not just drug discovery but the development of new treatments and their uptake by patients.
    • “The Silicon Valley microprocessing giant and pharma powerhouse announced a five-year, $1 billion partnership to create a “Co-Innovation AI Lab” designed to address key challenges in AI drug discovery.”
  • STAT News lets us know,
    • “Pfizer CEO Albert Bourla said earlier this week that “the goal in obesity is to become a leading player.” No surprise. But he was also asked about his prediction a year ago that President Trump would be a net positive for the pharmaceutical industry.
    • “Yes,” he said, “but I have to say that I got scared big time” along the way. The big win, from his perspective: The United Kingdom agreeing to raise prices for medicines as part of a trade deal with the U.S. This, he said, changed the dynamic between European companies and the pharmaceutical industry and would not have happened without Trump, who, Bourla also reiterated, deserved a Nobel Prize for supporting the development of Covid vaccines.
    • “But Bourla also expressed some worries about elements of the administration. He continued to say that the pressure it was putting on vaccines is “an anomaly that will correct itself” and reiterated that Pfizer is doing its own vaccine research, including developing a Lyme disease inoculation.
    • “He also expressed concern about developments at the Food and Drug Administration, including the departure of former top official Richard Pazdur. Bourla called Pazdur “a legend in regulatory work globally” and said that he was “very concerned” when Pazdur resigned after only two weeks on the job.”
  • Fierce Healthcare reports,
    • “Surescripts is teaming up with Good Rx to surface key prescription discounts to consumers.
    • “The health information network announced Tuesday at the J.P. Morgan Healthcare Conference that it would launch Script Corner, a new patient experience platform. Script Corner unites key benefit data, medication management tools and personalized engagement to smooth out their medication experience.
    • “The tool is also being built with price transparency in mind, in part through offering discounted cash prices in an exclusive partnership with GoodRx.
    • “Frank Harvey, CEO of Surescripts, said at the conference that while many apps and tools aim to arm patients with key transparency data, but the Script Corner platform is the first to put that in the palm of their hands.”
  • Fierce Healthcare also offers more stories from day 3 of the conference.

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

  • Fierce Healthcare reports,
    • “Insurance giant UnitedHealthcare is rolling out a new program that aims to support the finances of cash-strapped rural hospitals.
    • “Through the pilot, UHC will accelerate the payment timelines in its Medicare Advantage plans by 50% over the next six months, lowering the time from an average of less than 30 days to less than 15 days, according to an announcement from the company.
    • “The insurer said in the announcement that the program is designed to “deliver immediate cash‑flow relief and support the sustainability of these important rural hospitals.” * * *
    • “The pilot will initially launch in four states: Oklahoma, Idaho, Minnesota and Missouri. UnitedHealth said the first participants were selected based on their potential to “maximize impact” and support the future of this initiative and the development of additional interventions in rural healthcare.”
  • Beckers Hospital Review shares “McKinsey’s 2026 healthcare predictions: 5 takeaways for hospital leaders.” 
  • Fierce BioTech relates,
    • “Still riding the high of last year’s twice-yearly HIV PrEP approval of lenacapavir as Yeztugo, Gilead Sciences is approaching dealmaking from a “position of strength” as a more mature biopharma, according to CEO Daniel O’Day.
    • “When you’re a company that’s cured a disease and showed curative potential in another disease and are on the verge of ending an epidemic, you’re kind of bold about your aspirations,” said O’Day, referring to the company’s hepatitis C and HIV medicines.
    • “Since O’Day joined Gilead from Roche in 2018, the California company has built three primary focus areas: virology, cancer and inflammation. In all three, Gilead’s recent successes have given the pharma the luxury of being selective in the external assets it considers, O’Day explained.
  • Healthcare Dive calls attention to the “Top healthcare AI trends in 2026.”
    • “While health systems will continue their AI rollout, use of the technology could evolve amid intensifying competition from EHRs, fragmented regulations and growing M&A opportunities.”

Thursday Report

David Ermer–ACA, CDC, CMS, Congress, FDA, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Healthcare Dive reports,
    • “The House voted 230-196 on Thursday to extend expired subsidies for Affordable Care Act plans for three years, with 17 Republicans joining their colleagues across the aisle in support.
    • “The vote sends the bill to the Senate, where it’s expected to be dead on arrival. Though, some moderate senators are working on a compromise proposal, and the support for an extension could push the group to arrive at a solution.”
  • STAT News adds,
    • “A large bipartisan group of House and Senate lawmakers met hours before the vote to discuss plans for a Senate compromise on the subsidies. They left the meeting sounding optimistic, though there are still important details to be worked out.
    • “From the sounds of it, the Senate is planning on finalizing some text by Monday or Tuesday of next week with what their framework will look like,” said Rep. Rob Bresnahan (R-Pa.) as he left the meeting.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the Federal Workforce Data (FWD) website, a modern platform that replaces the outdated FedScope system and delivers faster, more transparent access to federal workforce data.
    • “The new site, available at data.opm.gov, introduces predictable monthly data updates, interactive visualizations, downloadable datasets, and improved transparency around data quality addressing long-standing challenges with delayed releases and limited usability under FedScope.
    • “The Federal Workforce Data website delivers timely, transparent data in a format that is easy to use and built for the future,” OPM Director Scott Kupor said. “This is a major step forward for accountability and data-driven decision-making across government.”
    • “The FWD website also expands publicly available workforce information, including new data on retirement eligibility, telework and remote work, administrative leave, performance ratings, and federal hiring activity.
    • ‘OPM will continue releasing new data, visuals, and features on the site each month and will iterate on the platform as user feedback is received. This launch represents just the beginning, with regular updates and new enhancements planned on an ongoing basis.”
  • Bloomberg Law tells us,
    • “Eli Lilly & Co. plans to take part in the Trump administration’s drug pricing model that seeks to expand access to diabetes and obesity treatments covered under Medicare and Medicaid.
    • “Consistent with a November 2025 agreement with the Trump administration to expand access to obesity medicines and reduce patient costs, “Lilly plans to participate in the voluntary BALANCE model to expand access to GLP-1s in both Medicare and Medicaid,” a company spokesperson said in an email.
    • “The model “will reflect the same terms we have already agreed to regarding GLP-1 pricing and coverage criteria,” said the company, which manufacturers obesity and diabetes drugs Zepbound and Mounjaro.”
  • The Wall Street Journal informs us,
    • “Sending time-sensitive documents like college applications, check payments, tax returns, insurance appeals and ballots through the mail?
    • “You might want to drop off the letter a few days earlier or head to the post office and ask a mail clerk to manually postmark the letter if getting proof of the date is required for meeting a deadline. Otherwise, you risk missing an important deadline for sending your mail.
    • “Since Dec. 24, a postmark no longer shows the date you deposited a piece of mail with the U.S. Postal Service. That means a letter dropped in a mailbox on Monday could be postmarked on Wednesday, if that was the day it got to a processing facility.”
  • Per a PCMA news release,
    • “Marking a new era for the organization, today the board of directors of the Pharmaceutical Care Management Association (PCMA) [, a PBM trade association,] announced that David Marin has been named its new President and CEO, following a thorough search. Marin brings three decades of public policy and coalition-building experience to PCMA and joins the organization from Viatris, a pharmaceutical manufacturer, where he was global head of government affairs, public policy, and advocacy.
    • “Concurrently, the PCMA board announced that Brendan Buck, a seasoned public affairs leader, will serve in the new role of Chief Communications Officer. Both David and Brendan will begin January 20, 2026.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “FDA exempts more wearable, AI features from oversight. In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.” * * *
    • “The first guidance clarifies the FDA’s thinking on what constitutes a wellness device. It offers broader leeway to wearables that provide readings around heart rate, blood pressure and blood glucose, so long as they are intended solely for wellness purposes.” * * *
    • “In a separate guidance, the FDA unveiled significant changes to how it regulates clinical decision support tools. The biggest change is to a section describing how the FDA interprets whether software is providing recommendations to healthcare providers. Software that provides a sole medical recommendation can now be exempt from regulation. Under a previous guidance, it would have been considered a medical device.” 
  • On related note, Beckers Health IT offers “four takeaways from a Jan. 5 Amazon blog post” concerning Amazon’s development of “wearable health AI since its acquisition of startup Bee.”
  • Cardiovascular Business reports,
    • “Aspire Biopharma, a Florida-based biopharmaceutical company, met with the U.S. Food and Drug Administration (FDA)to discuss the future of its new drug for the emergency treatment of suspected heart attacks.  
    • “The drug in question is acetylsalicylic acid 162 mg sublingual powder (OTASU). Based on feedback from the FDA, Aspire Biopharma plans on completing a planned multicenter clinical trial that compares OTASU with the current standard of care (two chewed aspirin tablets). The company’s next step will involve submitting a Section 505(b)(2) New Drug Application, an approach for new drug approvals that is typically faster than submitting a 505(b)(1) New Drug Application.”
    • “The FDA’s constructive feedback validates our development path and brings us one step closer to providing a faster-acting intervention for heart attack patients,” Kraig Higginson, interim CEO of Aspire Biopharma, said in a prepared statement. “Aligning with the Agency on our clinical requirements significantly de-risks our timeline and we believe the FDA’s response leaves the door open for Aspire to obtain breakthrough therapy status for our OTASA product. We believe OTASA has the potential to become the market-leading emergency treatment, and this regulatory clarity is a vital milestone as we engage in active discussions with potential commercial partners.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The 1st U.S. Circuit Court of Appeals Jan. 7 denied the government’s motion for a stay in a lawsuit filed by the AHA, the Maine Hospital Association and four safety-net health systems challenging the Department of Health and Human Services’ 340B Rebate Model Pilot Program. This means that the program remains on hold. 
    • “The 1st Circuit wrote: “In a careful and thorough decision, the district court granted the preliminary injunction. It determined that the federal government had failed to consider the hospitals’ reliance interests and other important aspects of the problem in enacting the new program and that the hospitals would face irreparable harm, including potential closure, without an injunction during the course of the litigation. … We conclude that the federal government has failed to carry its burden of ‘ma[king] a strong showing that [it is] likely to succeed on the merits’ in this appeal and thus deny its stay request.” 
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The First Circuit recognized that the district court’s decision halting the 340B Rebate Program was ‘careful and thorough’ — and correct. The AHA remains pleased that these courts have put on hold this harmful program that would have a devastating effect on America’s most vulnerable patients and communities, and the hospitals that serve them.” 
    • “The 1st Circuit ruling follows a Dec. 29 decision from the U.S. District Court of Maine granting a preliminary injunction blocking implementation of the program, which was scheduled to go into effect Jan. 1, 2026.”
  • Fierce Healthcare relates,
    • “Anthem’s California companies are suing 11 Prime Healthcare facilities, alleging that the hospitals committed fraud by “knowingly flooding” the No Surprises Act’s dispute resolution process.
    • “The health insurer said in a complaint filed Monday [in the U.S. District Court for the Central District of California, No. 8:26-cv-00023] that the defendant facilities submitted more than 6,000 ineligible claims to the independent dispute resolution, or IDR, which led to millions in “wrongfully obtained awards.” Anthem said that, in aggregate, the Prime hospitals received $15 million more than the insurer would have paid originally.
    • “The typical award through IDR was six times what a contracted provider would have been paid, according to the lawsuit.
    • “Anthem alleged in the complaint that Prime Healthcare has acquired facilities that would then cancel contracts with insurers and that the hospitals under its umbrella “aggressively pursued collection” of out-of-network claims.”

From the public health, medical / Rx research front,

  • Beckers Hospital Review reports,
    • “Some hospitals are postponing elective procedures to preserve capacity as a severe flu season pushes admissions higher and fills emergency departments across the U.S.
    • “UnityPoint Health-Des Moines said it will delay some surgeries and procedures requiring overnight admission through Jan. 13 amid a sharp rise in flu cases. 
    • “Our priority is to focus resources on patients with the most urgent needs while maintaining the highest standard of care,” the system said in a statement to the Des Moines Register on Jan. 8. “We are closely monitoring hospital capacity and will provide updates as needed.”
    • “Influenza admissions are climbing nationally, and experts say the peak is still weeks away. CDC data shows more than 33,000 people were hospitalized with the flu during the week ending Dec. 27, and hospital leaders are bracing for continued increases.”
  • and
    • “As the U.S. confronts one of its most severe flu seasons, Tamiflu, a common antiviral medication to treat influenza, is in shortage in pockets across the country, Bloomberg reported Jan. 7. 
    • “In Utah, where flu activity is high, pharmacists are not yet reporting supply issues. But in Georgia, where flu activity is very high, drugstores are scrambling for Tamiflu (oseltamivir). 
    • “Hospitals are also asking if we have it,” Parth Patel, PharmD, a pharmacist at an independent pharmacy in Georgia, told Bloomberg.” 
  • Fierce Pharma lets us know,
    • “As evidence of tirzepatide’s efficacy mounts across a range of cardiometabolic conditions, Eli Lilly has shown that taking the incretin medicine alongside another of its drugs, Taltz, could lead to better outcomes for patients living with both psoriatic arthritis (PsA) and obesity.
    • “In an open-label phase 3b trial, the co-administration of Lilly’s IL-17A antagonist Taltz (ixekizumab) and dual GIP/GLP-1 receptor agonist Zepbound (tirzepatide) helped more patients achieve improvements in PsA activity and lose a certain percentage of body weight than Taltz alone, the company reported Thursday.”
  • MedPage Today cautions,
    • “Weight loss and cardiometabolic benefits were fully reversed within 2 years for people who stopped weight management medications, a systematic review and meta-analysis showed.
    • “Adults with overweight or obesity who stopped using weight-loss drugs regained an average of 0.9 lb (95% CI 0.7-1.1) each month and returned to their baseline weight within 1.7 years compared with controls in an analysis of randomized trial data, reported Sam West, PhD, of the University of Oxford in England, and colleagues.
    • “All cardiometabolic markers — HbA1c, fasting glucose, cholesterol, triglycerides, and systolic and diastolic blood pressure — were projected to return to baseline within 1.4 years after cessation, the researchers wrote in The BMJopens in a new tab or window.
    • “Regardless of initial weight loss, people regained weight faster, by 0.7 lb per month, after stopping weight management medications compared with behavioral weight management programs.”
    • “As obesity is a chronic and relapsing condition, prolonged treatment with WMM [weight management medication] may be required to sustain the health benefits,” West and co-authors noted. “This evidence cautions against short term use of WMMs, emphasizes the need for further research into cost effective strategies for long term weight control, and reinforces the importance of primary prevention.”
    • “The results didn’t come as much of a surprise to Qi Sun, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School in Boston. It’s “well documented that reduced adherence to, or cessation of, dietary and lifestyle interventions leads to similar patterns of weight regain,” he wrote in an accompanying editorial.”
  • CNN Health points out,
    • “Common preservatives used to keep food safe and extend shelf life may be linked to a higher risk of several cancers and type 2 diabetes, according to two new studies from France.
    • “These are very important findings for preservatives that are not only widely used in the French and European markets, but also in the United States,” said senior author Mathilde Touvier, principal investigator of the NutriNet-Santé study used to conduct the research.
    • “The NutriNet-Santé study, which began in 2009, compares over 170,000 participants’ web-based reports on diet and lifestyle with their medical data stored in the French national health care system.
    • “These are the two first studies in the world investigating the associations between exposure to these food additives and cancer and type 2 diabetes,” said Touvier, who is also the director of research at France’s National Institute of Health and Medical Research in Paris, “and so we must be very cautious about the message. Obviously, the results need to be confirmed.”
    • “Despite those caveats, “the concern raised about preservatives is one more reason among many to emphasize the personal and public health importance of fresh, whole, minimally processed foods, mostly plants,” Dr. David Katz said in an email.”
  • MedPage Today notes,
    • “Thirty-year outcomes among participants in the Women’s Health Study showed a stepwise increase in major cardiovascular events associated with increasing lipoprotein(a) levels starting around 30-60 mg/dL.
    • “Lipoprotein(a) is a highly atherogenic particle considered to be a genetically determined, unmodifiable cardiovascular risk factor with little contribution from lifestyle.
    • “These findings support screening to identify individuals with very high lipoprotein(a) levels who may benefit from primary prevention therapies.”
  • The Wall Street Journal advises,
    • “One in six seniors were prescribed eight or more drugs simultaneously, with over 3.5 million receiving at least one generally avoidable medicine.
    • “Older adults should annually inventory their medications, research drug labels and interactions, and consult doctors about potential risks.
    • “The Beers Criteria guidelines recommend avoiding certain drugs like benzodiazepines and muscle relaxants for older patients due to side effects.”
  • The Genetic Engineering and BioTechnology News lets us know,
    • More than 50 million Americans live with chronic pain. Drugs are currently available; however, close to 80% of the 600,000 deaths attributed to drug use in 2019 were related to opioids with about 25% of those deaths caused by opioid overdose. In addition, nearly half of Philadelphians who responded to a 2025 Pew survey reported knowing someone with opioid use disorder (OUD) and one-third knew someone who had died as the result of an overdose. Taken together, novel approaches to pain management are a large, unmet need.
    • Now, a gene therapy opens a new avenue for targeting pain centers in the brain while eliminating the risk of addiction from narcotics treatments. This work is published in Nature in the paper, “Mimicking opioid analgesia in cortical pain circuits.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “The Council for Affordable Quality Healthcare is transitioning away from its nonprofit structure, sharing how the country’s biggest health insurance companies are now serving as owners, according to a Jan. 6 news release.” * * *
    • “CAQH was founded by health plans that recognized the need to take unnecessary administrative costs out of the healthcare system,” Mr. Kaja said. “That same determination to solve hard problems and move the industry forward defines CAQH today. The board’s decision reflects our confidence in CAQH’s ability to keep challenging convention and improving how the healthcare system works for everyone.”
    • “The release added the restructuring will allow CAQH to further advance products and interoperability.”
  • Fierce Healthcare informs us,
    • “Pomelo Care launched in 2021 with a virtual maternity care model that supplements traditional pregnancy care by proactively predicting and addressing risk factors.
    • “The startup is expanding beyond maternity care to more broadly to serve women’s and children’s health needs and it picked up $92 million in series C funding to fuel its growth. Pomelo Care’s services now span reproductive care, pregnancy, pediatrics and hormonal health as well as perimenopause and menopause. The company also supports long-term preventive care and condition management.
    • “The funding round was led by Stripes and backed by Andreessen Horowitz, PLUS Capital, Atomico, BoxGroup and SV Angel. With the series C funding, Pomelo Care is now valued at $1.7 billion, the company said.”
  • Fierce Pharma notes,
    • “It’s been more than 10 years since the FDA signed off on the U.S.’ first biosimilar product, opening up what was originally expected to be an easily accessible, cheaper drug market featuring heightened competition and potential new savings for patients.
    • “Now, more than 80 biosimilar approvals later, the promise of broad biosimilar adoption and lower drug prices hasn’t played out as initially anticipated, leaving the biosimilar market at a critical inflection point as it enters 2026, with policy changes and major patent cliffs creeping ever closer. 
    • “2025 was marked by “extraordinary change and progress within the biosimilar landscape,” highlighting both the opportunities and the challenges facing the field, Samsung Bioepis’ head of U.S. commercial, Thomas Newcomer, said in the company’s fourth-quarter biosimilar market report.” 
  • Healthcare Dive identifies “the top healthcare provider trends in 2026. Health systems that address costs, workforce planning and portfolio strategy may be better positioned as reimbursement headwinds intensify this year.”
  • MedTech Dive calls attention to “4 medtech topics to watch in 2026. From insurance coverage questions to M&A and tariffs, here are the top storylines to watch in the medical device space in 2026.”

Tuesday report

David Ermer–CDC, Congress, FDA, Government Contracting, Medical / Rx research, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “President Donald Trump said Tuesday he wants Republicans to reach a deal on health care insurance assistance by being willing to bend on a 50-year-old budget policy that bars federal money from being spent on abortion services.
    • “You have to be a little flexible” on the Hyde Amendment, Trump told House Republicans as they gathered in Washington for a caucus retreat to open the midterm election year. “You gotta be a little flexible. You gotta work something. You gotta use ingenuity.”
    • “With his suggestion, Trump, who supported abortion rights before he entered politics in 2015, is asking conservatives to abandon or at least ease up on decades of Republican orthodoxy on abortion and spending policy — something lawmakers and conservatives pushed back on immediately.
    • “At the same time, he is demonstrating his long-standing malleability on abortion and acknowledging that Democrats have the political upper hand on health care after Republicans, who control the White House, the Senate and the House, allowed the expiration of premium subsidies for people buying Affordable Care Act insurance policies. As negotiations on Capitol Hill continue on the matter, some Democrats are pushing to end the Hyde restrictions as part of any new agreements on health care subsidies.”
  • The Wall Street Journal relates,
    • “Republican Rep. Doug LaMalfa, who represented a district in Northern California for 13 years, has died, shocking colleagues and further narrowing the GOP’s slim majority. 
    • “Colleagues of LaMalfa, 65 years old, praised the farmer and former state legislator for his long record of advocating for rural communities and farmers.” * *. *
    • “LaMalfa’s death further shrinks the already thin House GOP majority to 218-213. Rep. Marjorie Taylor Greene (R., Ga.) formally resigned from the House in the middle of her term this week. There are now four empty seats—two in red-leaning districts, and two in blue districts. 
    • “Also, Rep. Jim Baird (R., Ind.) was in a car accident, sidelining him at least temporarily. His office said he was in the hospital and is expected to make a full recovery.”
  • Federal News Network gives us an update on implementation of the Federal Acquisition Regulation overhaul.
    • “The Office of Federal Procurement Policy (OFPP) and the FAR Council have issued FAR Companion guides and practitioner albums to help the training and education of the acquisition workforce on the new rules.
    • “Additionally, OFPP Administrator Kevin Rhodes held a series of roundtables with contractors, industry associations and others to gain their perspectives of the FAR overhaul. OFPP says these contractors and associations “shared feedback on five priority goals: increasing competition, reducing costs, accelerating the acquisition system, changing cultural norms and deploying best practices.”
    • “Rhodes said in a statement that “the feedback we received will help inform our efforts for the next phase of the RFO.”
    • “OFPP is accepting more feedback through Jan. 12 through its IdeaScale on ways to continue to improve the FAR across the five priorities.”
  • The American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration has released updated resources on the 988 Suicide and Crisis Lifeline. An updated fact sheet features an overview of the 988 hotline and what people can expect when using the service. It also includes testimonials from individuals who have used it and an FAQ. Another resource highlights key differences between 988 and 911 and explains when the use of each service is appropriate. SAMHSA also provides digital assets on the 988 hotline for sharing on social media.” 

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Amneal Pharmaceuticals received FDA approval for two denosumab biosimilars referencing Prolia and Xgeva.
    • “The approval, announced Dec. 22, covers Boncresa (denosumab-mobz) and Oziltus (denosumab-mobz), both used to treat conditions related to bone loss and cancer. The drugs are administered by a healthcare provider and are intended to improve access to lower-cost biologic therapies.
    • “With the addition of the new products, Amneal expects to commercialize six biosimilars across eight presentations by 2027. U.S. sales for Prolia and Xgeva totaled about $5.3 billion in the 12 months ending October 2025.” 

From the public health and medical / Rx research front,

  • AP reports,
    • “U.S. flu infections surged over the holidays, and health officials are calling it a severe season that is likely to get worse.
    • “New government data posted Monday [January 5] — for flu activity through the week of Christmas — showed that by some measures this season is already surpassing the flu epidemic of last winter, one of the harshest in recent history.
    • “The data was released the same day that the Trump administration said it will no longer recommend flu shots and some other types of vaccines for all children.
    • “Forty-five states were reporting high or very high flu activity during the week of Christmas, up from 30 states the week before.
    • “The higher numbers appear to be driven by the type of flu that’s been spreading, public health experts say.
    • “One type of flu virus, called A H3N2, historically has caused the most hospitalizations and deaths in older people. So far this season, that’s the type most frequently reported. Even more concerning, more than 90% of the H3N2 infections analyzed were a new version — known as the subclade K variant — that differs from the strain in this year’s flu shots.”
  • STAT News adds,
    • “Australia’s 2025 flu season lasted weeks longer than it normally does. Hong Kong’s hit so early that the rollout of seasonal flu shots hadn’t yet started. New York has reported record-breaking flu hospitalizations for the past two weeks. 
    • “Welcome to the winter of subclade K.” * * *
    • “Influenza viruses come in many forms, but the ones that cause the most disease in humans are the flu A viruses H1N1 and H3N2, and influenza B. 
    • “Subclade K is a variant of the H3N2 family of viruses, which can trigger more severe seasons and which seem to be harder on older people, who are among the most vulnerable to flu.” * * *
    • “Subclade K viruses weren’t on the radar when influenza experts from around the globe gathered last February to select the strains the 2025-2026 flu shots should target. 
    • “Even when the vaccine contains viruses that are well matched to those that are circulating, the H3N2 component often under-performs. It offers protection against severe disease, but may not prevent infection.”
  • Beckers Hospital Review informs us,
    • “The U.S. has recorded 7,045 clinical Candida auris cases as of Dec. 20 — a 56.1% increase from the 4,514 cases logged in 2023, according to CDC data. 
    • “About half of those cases are in Nevada and California, which each reported about 1,500 C. auris clinical cases in 2025. 
    • “C. auris is an emerging multidrug-resistant fungus that can cause infections and spread quickly in healthcare settings, particularly among immunocompromised patients.”
    • The article lists the number of 2025 C. auris cases in each State.
  • Health Day lets us know,
    • “Telehealth might not be the best option for a parent with a sick baby or toddler, a new study says.
    • “Children 3 months to 2 years of age are nearly 50% more likely to land in an ER within three days of a virtual doctor’s visit than those who have an in-person visit, researchers recently reported in JAMA Network Open.
    • “Our study showed that children under 2, whose communication of their needs and symptoms is more subtle, should probably be seen in person,” senior investigator Dr. Natasha Saunders said in a news release. She’s a pediatrician and senior associate scientist with The Hospital for Sick Children in Ontario, Canada.”
  • Per a National Institutes of Health news release,
    • “In a world first, a team of researchers at the National Institutes of Health (NIH) and Emory School of Medicine, Atlanta, has successfully performed a coronary artery bypass — a normally open-heart surgery — without cutting the chest wall. The team employed a novel intervention to prevent the blockage of a vital coronary artery, which is a very rare but often lethal complication following a heart-valve replacement. The results suggest that, in the future, a less traumatic alternative to open-heart surgery could become widely available for those at risk of coronary artery obstruction.
    • “Achieving this required some out-of-the-box thinking but I believe we developed a highly practical solution,” said first author of the study Christopher Bruce, MBChB, an interventional cardiologist at WellSpan York Hospital and NIH’s National Heart, Lung, and Blood Institute (NHLBI), as well as an adjunct assistant professor of cardiology at Emory School of Medicine.”
  • The Washington Post relates,
    • “The stimulants Ritalin and Adderall have been used to treat attention-deficit/hyperactivity disorder (ADHD) for decades, but research shows they don’t act on the brain’s attention circuitry as had long been assumed.
    • “Instead, the medications primarily target the brain’s reward and wakefulness centers, according to a new study published in the journal Cell. The research, which used brain imaging data from almost 5,800 children ages 8 to 11, also pointed toward the important role that lack of sleep plays in the disorder.
    • “When I first saw the results, I thought I had just made a mistake because none of the attention systems are changing here,” said Benjamin Kay, one of the study’s authors and a professor of neurology at Washington University School of Medicine in St. Louis.
    • “It’s not that the stimulants are ineffective.
    • “The paper clearly shows that they help,” said Nico Dosenbach, another of the authors and a professor of neurology at the university. “They help kids who have a diagnosis of ADHD do better in school and do better on tests, and they help kids who don’t sleep enough ― and a lot of Americans don’t sleep enough.”
  • STAT News points out,
    • “Arrowhead Pharmaceuticals said Tuesday that its gene-silencing candidates helped people with obesity lose fat, very early results that could intensify the competition among biotechs to develop longer-lasting weight loss drugs.
    • “In an ongoing Phase 1/2 study, a cohort of patients took two doses of a candidate called ARO-INHBE, spaced one month apart, in combination with Eli Lilly’s Zepbound. They lost 9.4% of their weight after 16 weeks, while those on Zepbound alone lost 4.8%. These data were from patients with obesity and diabetes, who typically don’t lose as much weight on treatments as those who don’t have diabetes.”
    • “Participants on the combination also lost 23% of their visceral fat, the most harmful type of fat that’s stored around the organs, as well as 15% of their total fat and 77% of their liver fat. Excess liver fat can lead to inflammation and scarring in the organ. Meanwhile, those taking Zepbound alone lost 7%, 5%, and 20%, respectively.
    • “While the drug was effective in combination with Zepbound, it’s not clear yet if it can be a viable product on its own. Obese patients taking only two doses of ARO-INHBE experienced a 16% placebo-adjusted reduction in visceral fat, but that has not yet translated into significant overall weight loss, CEO Christopher Anzalone said.”
  • Per BioPharma Dive,
    • “Immune drug developer Alumis said on Tuesday that its top prospect has succeeded in two Phase 3 trials, helping people with psoriasis eliminate most of their skin lesions after four months of treatment. 
    • “Called envudeucitinib, the drug is a newer type of medicine aimed at a popular target known as TYK2. The first TYK2 blocker, Bristol Myers Squibb’s Sotyktu, was approved in 2022. But Alumis, Takeda and many other biotechs are working on successor drugs and testing them against psoriasis and other immune disorders. Takeda’s medicine produced positive Phase 3 results in December.
    • “Alumis’ data, though, suggest that envudeucitinib has the potential for “class-leading” TYK2 inhibition and a treatment effect approaching what’s observed with injectable biologics, wrote Leerink Partners analyst Thomas Smith. Company shares more than doubled in morning trading, changing hands at around $17 apiece. The company intends to seek U.S. approval of envudeucitinib later this year.” 
  • Per Fierce Pharma,
    • “Fresh off of a European approval for a subcutaneous version of Saphnelo, AstraZeneca is doubling down on the benefits of the self-administered drug formulation in lupus patients with a positive phase 3 showing.
    • “In the phase 3 Tulip-SC trial, 56.2% of patients with systemic lupus erythematosus (SLE) who received a subcutaneous dose of Saphnelo experienced a reduction in disease activity at week 52, the company reported Tuesday. In the placebo group, the result was 37.1%.
    • “The readout adds more detail to the trial’s prior interim analysis, which confirmed a statistically significant result for subcutaneous Saphnelo and a safety profile on par with the currently marketed intravenous infusion version.” 

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

  • The Wall Street Journal reports,
    • “Eli Lilly is in advanced talks to acquire Ventyx Biosciences for over $1 billion.
    • “Ventyx specializes in one of the hottest spaces in drug development, developing pills to treat diseases like Crohn’s and rheumatoid arthritis.
    • “The acquisition would enhance Eli Lilly’s portfolio in autoimmune conditions, obesity, and related disorders.”
  • Modern Healthcare tells us,
    • The University of Alabama at Birmingham Health System acquired Southview Medical Group Jan. 1, the system said Jan. 5. 
    • Under the agreement, UAB Health owns all of Southview Medical’s facilities and will employ its more than 30 providers. 
    • Southview Medical had locations at two UAB facilities, UAB St. Vincent’s Birmingham and UAB Medicine St. Vincent’s One Nineteen, prior to the acquisition.
  • and
    • RWJBarnabas Health announced Jan. 5 that it signed a definitive agreement to make Englewood Health part of its system. 
    • Financial details were not disclosed, but RWJBarnabas said it plans to make “significant capital investments” that will improve care access and quality. The transaction is pending regulatory approval. 
    • A timeline for when the deal would be completed was not disclosed.
  • and
    • “A joint venture between Kaiser Permanente and healthcare investment firm Town Hall Ventures has launched a second integrated program for older adults in California.
    • “Habitat Health opened its Program of All-Inclusive Care for the Elderly center in Compton, California, on Thursday. It began enrolling eligible adults older than age 55 last month, a Habitat Health spokesperson said. 
    • “The company plans to roll out other PACE programs in California and expand to Illinois, the spokesperson said.”
  • Fierce Healthcare informs us,
    • “Health system and hospital executives see the promise of automation and artificial intelligence to customize patient outreach and help address persistent engagement challenges.
    • “AI-powered personalization technology can nudge patients to take action, which could help address long-standing challenges with medication adherence while also reducing no-show rates and closing care gaps. 
    • “According to a recent survey from Lirio and Sage Growth Partners, 60% of executives from U.S. health systems, independent hospitals and physician groups cited automating patient outreach to ease administrative burden as their top priority. Most executives (96%) said AI and automation can reduce administrative burden related to patient engagement. About half of executives said their organizations struggle to personalize engagement content, such as text messages or emails, at the patient level.
    • “But this operational priority doesn’t currently match up with AI investment strategies.
    • “Among the surveyed executives, 35% said their organizations have yet to make investments in AI tools for patient outreach. At the same time, most health systems are channeling AI investment into operational efficiency. The majority of executives (83%) said their organization has invested in AI-based solutions for automated documentation and other tasks to improve clinician workflows.
    • “The disconnect between AI priorities and investments often comes down to the speed at which different technologies demonstrate value,” Amy Bucher, M.D., chief behavioral scientist at Lirio, told Fierce Healthcare.” 

Weekend update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

Happy Winter Solstice!

From Washington, DC,

  • The Hill reports
    • President Trump said Friday he plans to hold a meeting with major insurance companies in the coming days in a bid to pressure them to lower prices for consumers who are set to see premium costs soar when ObamaCare’s enhanced subsidies expire at the end of the year.
    • “I’m going to call in the insurance companies that are making so much money, and they have to make less, a lot less,” Trump said during an Oval Office announcement on drug pricing. “I’m going to see if they get their price down, to put it very bluntly. And I think that is a very big statement.”
  • AHIP responded
    • “Health plans are doing everything in their power to shield Americans from the high and rising costs of medical care, and we welcome any opportunity to discuss common-sense solutions to lower costs for everyone.” – Mike Tuffin, President & CEO, AHIP
    • Health insurance premiums reflect the underlying cost of medical care, plus a modest, regulated risk margin.
    • Health plans’ profit margin was 0.8% last year, 2024 NAIC data show. In 2023, the net income of health plans accounted for about 0.5% of U.S. health expenditures ($4.9 trillion, per CMS data). By comparison, the pharmaceutical industry averages 15-20% margins.
    • Health plans are the only part of the health care system whose profits and administrative costs are capped under federal law. Health insurers must spend at least 85% of group premiums and 80% of individual premiums on medical care. If those thresholds are not met, health insurers must pay rebates to consumers. Since 2012, consumers have received nearly $12 billion back from insurers, with more than $1 billion in 2024 alone, according to KFF.
    • Learn more about where Americans’ health care dollars go by clicking here or on the infographic below.
  • Federal News Network lets us know who was and was not included in the en bloc nominations resolution (S. Res. No. 532) that the Senate passed last Thursday.
  • The American Hospital Association News informs us,
    • “The Assistant Secretary for Technology Policy has issued new FAQs regarding information blocking. The updates are intended to provide clarifying guidance regarding revenue sharing, the role of a “requestor” under the alternative manner condition of the Manner Exception, the scope of electronic health information to satisfy the Manner Exception, and whether interference with an automation technology’s ability to access, exchange or use electronic health information implicates information blocking regulations.”
  • and
    • “The Department of Health and Human Services today [December 19] issued a request for information seeking public comments on how the department can accelerate the adoption and use of artificial intelligence in clinical care. The notice follows the agency’s Dec. 4 announcement of its strategy on integrating AI across internal operations, research and public health efforts. The RFI focuses on questions in three areas: AI regulation, reimbursement, and research and development. Comments will be accepted for 60 days following publication of the notice in the Federal Register.”
  • and
    •  The Centers for Medicare & Medicaid Services Dec. 19 announced the creation of the Office of Rural Health Transformation. The office will oversee management of the Rural Health Transformation Program and includes a Division of State Rural Engagement that will provide policy and operational guidance to states and other stakeholders. The office will monitor states’ implementation of the program’s initiatives to ensure compliance. 
  • and
    • “The Centers for Medicare & Medicaid Services has allocated 400 Medicare-funded residency slots to 169 teaching hospitals. Of those slots, 200 are the fourth allocation from 1,000 new residency positions authorized over five years under Section 126 of the Consolidated Appropriations Act of 2021. The other 200 are allocated under Section 4122 of the law. At least 100 of those positions must be available for psychiatry or psychiatry subspecialty residency training programs. Applications for the next round of slots under both provisions open in January and close March 31.” 
  • STAT News relates,
    • “Brand drugmakers have agreed to donate bulk ingredients to a national stockpile as part of deals with the Trump administration focused on lowering U.S. drug prices to levels available to other wealthy countries.
    • The administration announced Friday [December 19] that nine more drugmakers agreed to so-called most favored nation prices, bringing the total number of companies to sign such deals this year to 14. The agreements are similar to those shared earlier this year: brand drugmakers will lower prices and boost domestic manufacturing in return for avoiding tariffs.
    • “But the stockpile is a new aspect. Some of the nine companies agreed to donate six months’ worth of certain drug ingredients to the Strategic Active Pharmaceutical Ingredient Reserve and to make finished-dose products from those ingredients during emergencies. Among them, Merck will supply the bulk ingredients for its antibiotic ertapenem; Bristol Myers Squibb will provide the blood thinner apixaban, commonly sold under the brand name Eliquis; and GSK will donate albuterol.
    • “Few details are available, including how many active pharmaceutical ingredients are being donated, their value, and whether companies are sending actual products to the government or maintaining their own reserves of ingredients.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “It took 27 years, but Cytokinetics secured its first U.S. drug approval.
    • “On Friday, the Food and Drug Administration cleared the new medicine, called Myqorzo, to treat patients with obstructive hypertrophic cardiomyopathy, an inherited heart disorder. 
    • “Cytokinetics said it will begin selling Myqorzo in late January at a price not yet disclosed. It will compete against a similar drug from Bristol Myers Squibb that was approved in 2022 and is now bringing in more than $1 billion in sales on an annualized basis, and growing.” * * *
    • “The clearance of Myqorzo ends one of the longest R&D droughts in biotech. Cytokinetics began operations in 1998 with the goal of developing drugs based on an emerging field of science that involved inhibiting or activating certain proteins that affect the function of cardiac and skeletal muscles. Earlier programs in heart failure and ALS, among other diseases, either failed outright or produced suboptimal results.” 

From the public health and medical / Rx research front,

  • Health Day tells us “what Older Adults Should Know About Calcium and Vitamin D.”
  • The New York Times points out “Older Americans Quit Weight-Loss Drugs in Droves. In some studies, half of patients stopped taking GLP-1s within a year despite the benefits, citing the expense and side effects.”
  • Health Day tells us,
    • “Manage stress. 
    • “Get your Zzzzzs. 
    • “And build a strong social support system.
    • “New research shows that these factors — all of which are within your control — are powerful anti-aging tools. 
    • “You can learn how to perceive stress differently,” said study co-leader Jared Tanner, a research associate professor of clinical health and psychology at the University of Florida. “Poor sleep is very treatable. Optimism can be practiced.”
    • “Using MRI-based estimates of brain age, his team found that people who adhered to healthy lifestyle habits had brains that were up to 8 years younger than expected. And that was true even for folks beset with chronic pain.
    • “The findings — recently published in the journal Brain Communications — add to evidence that taking good care of yourself reaps big-time dividends.”
  • The Wall Street Journal discusses the problems confronted by parents with adult children having addiction problems.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “ChristianaCare and Virtua Health have called off talks to combine after mutually deciding a merger was no longer in their best interests, the regional health systems said Thursday. 
    • “The hospital operators determined “they can best fulfill their missions to serve their communities by continuing to operate independently,” Wilmington, Delaware-based ChristianaCare and Marlton, New Jersey-based Virtua said in a press release.
    • “ChristianaCare and Virtua first said they were exploring a merger in July. The deal would have created a health system with more than $6 billion in annual revenue and a footprint spanning 10 contiguous counties in New Jersey, Delaware, Pennsylvania and Maryland.”
  • HR Dive makes five benefit predictions for 2026.
    • “Employers will take a proactive role in reshaping wellness benefits.”
    • “There will be a spotlight on fertility and parental benefits.”
    • “‘She-cession’ to continue unless women receive the flexibility and benefits they need.”
    • “Paid family leave will be up to employers.”
    • “Employers will effectively reduce insurance coverage.”
  • The Wall Street Journal relates,
    • “As wellness influencers proliferate and high sleep scores are considered status symbols, 2025 is the year of the health gift. 
    • “Among the presents family and friends will be unwrapping: microbiome tests, which detail the types of bacteria living in your gut, and services that use continuous glucose monitoring devices, which measure blood sugar. Some will get panels of blood tests that examine everything from hormone levels to thyroid and liver function. 
    • “Kristina Velkova-Levine purchased a membership for regular lab testing, tracking and insights, for her husband. The membership, from a firm called Function Health, charges $365 a year for two rounds of testing, and assesses hormone, metabolic and other biomarkers. 
    • “She plans to buy one for herself, as well. Velkova-Levine, 34, and her husband plan to try to conceive next year. She says the results will help.
    • “I’ll probably just print something out, and put a cute note that it’s our moment to check all of our health thoroughly,” says Velkova-Levine, who co-founded a showerhead brand, Vitaclean, and lives in New York City and Aspen, Colo.
    • “Also coveted: devices such as the Oura ring and Whoop that track sleep, physical activity and other health metrics. The giving spirit has even seized Quest Diagnostics: The lab-testing company started selling gift cards on its consumer site in April 2024.“

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Nine pharmaceutical companies including Bristol-Myers Squibb, GSK and Merckagreed to lower the prices that certain federal government programs and patients pay, in a new round of industry pacts with the Trump administration.
    • “The companies said they would reduce U.S. prices on drugs to levels comparable with prices charged in other wealthy countries, which are generally much lower. In return, the companies get administration-backed reprieves from potential new U.S. tariffs for three years.
    • “President Trump announced the deals Friday at the White House, joined by top executives of the nine companies. * * *
    • Under the terms, the “most-favored nation” prices offered by companies would apply to the U.S. Medicaid program for lower-income patients, direct-to-patient services including the planned TrumpRx.gov and to newly launched drugs in the future.
    • “Merck said it would make diabetes drugs Januvia and Janumet available to eligible American patients at a cash price that is 70% off the current list price through a direct-to-patient program. 
    • “Amgen said it would sell its migraine drug Aimovig for $299 a month, nearly 60% off the list price.
    • “Some of the companies in the new round of deals also agreed to donate the main ingredients for certain medicines to a national stockpile, to be available in the event of a national emergency. 
    • “GSK is donating six-months’ supply of a respiratory inhaler, and Bristol-Myers will donate six-months’ worth of the blood thinner Eliquis.
    • “Bristol-Myers said it would provide Eliquis free to Medicaid programs.”
  • The Hill adds,
    • “Medicare enrollees could save roughly half of what they usually pay for certain drugs next year, according to a study from the AARP.
    • “The study, published Thursday, found that the out-of-pocket cost of 10 drugs included in the first round of Medicare drug price negotiation will decrease substantially in five states with high enrollment in the program — California, Florida, New York, Pennsylvania and Texas — once negotiated prices go into effect on Jan. 1, 2026.” 
  • Roll Call sums up Congress’s activities in the final week of this term of Congress and looks forward to January.
    • “The Senate followed the House in leaving for the Christmas break on Thursday, clearing another batch of President Donald Trump’s nominations but kicking to January the fate of the next handful of spending bills.
    • “The Senate confirmed, 53-43, an en bloc package of 97 nominations. Senators also by unanimous consent confirmed the nomination of Kevin E. Lunday to be commandant of the Coast Guard. And they reached an agreement to set up confirmation of additional Trump nominees when they return in January.” * * *
    • “[T]he aspiration of Thune and Senate Republican appropriators to get the ball rolling on a package of fiscal 2026 spending bills was not to be. The rules require unanimous consent to combine more than one regular appropriations measure into a single bill — and that agreement proved elusive despite talks that went on throughout the day Thursday.
    • “That sets the stage for January, when lawmakers will have less than a month to figure out how to fund the government and avoid another partial government shutdown. Thune said he thought another shutdown would be “toxic” for Democrats and Republicans alike.
    • “I don’t think either side wants to see that happen,” Thune said. “So I’m hoping that there will be goodwill and we’ll figure out how to fund the government.”
  • Per a Centers for Medicare and Medicaid Service press release,
    • “The Centers for Medicare & Medicaid Services (CMS), in partnership with the Department of Labor and the Department of the Treasury (collectively, the Departments), today jointly proposed major updates to the historic health care price transparency rules established during President Trump’s first term.” * * *
    • “In line with Executive Order 14221, this proposed rule reflects the Department’s commitment to ensuring that health care pricing data is not only public but maximally impactful and actionable.
    • “Key improvements include:
      • “Requiring plans and issuers to exclude from the In-network Rate Files certain data for services providers would be unlikely to perform.
      • “Reorganizing In-network Rate Files by provider network rather than by plan, cutting redundancy, and aligning with how most hospitals report data pursuant to the Hospital Price Transparency requirements.
      • “Requiring Change-log and Utilization Files so users can easily identify what has changed from one In-network Rate File to the next and have clear information on which in-network providers are actively furnishing which items and services.
      • “Reducing reporting cadence for In-network Rate and Allowed Amount Files from monthly to quarterly, significantly reducing burden while maintaining meaningful transparency.
      • ‘Increasing the amount of out-of-network pricing information reported by reorganizing Allowed Amount files by health insurance market type, reducing the claims threshold to 11 or more claims, and increasing the reporting period from 90 days to 6 months and the lookback period of data from 180 days to 9 months. 
    • “The Departments seek feedback from stakeholders during the 60-day comment period on all elements of the proposed rule, including opportunities for further standardization and burden reduction. The deadline to submit comments is February 21, 2026.
    • “To access the proposed rule, visit: https://www.federalregister.gov/public-inspection/2025-23693/transparency-in-coverage
    • “To read the CMS fact sheet, visit: cms.gov/newsroom/fact-sheets/transparency-coverage-proposed-rule-cms-9882-p” 
  • Beckers Payer Issues informs us,
    • “CMS has proposed two new models aimed at curbing Medicare drug spending by linking payments to international benchmarks. The proposals — GUARD for Part D drugs and GLOBE for Part B — are the latest in the CMS Innovation Center’s efforts to make prescription drugs more affordable for beneficiaries while preserving the long-term sustainability of the Medicare program.” * * *
    • “The models were published via a notice of proposed rulemaking and are now open for public comment [for sixty days] through the Federal Register.” 
  • MedCity News delves into “CMS’ new ACCESS model [mentioned in yesterday’s post and], slated to begin on July 1, aims to shift traditional Medicare fee-for-service toward value-based care by tying payments to patient outcomes and encouraging tech-enabled, preventive care. Experts say it could benefit digitally mature, value-focused providers first, but its overall success will hinge on clear metrics, better data sharing and sustained participation.”
  • Per a Commitee for a Responsible Budget news release,
    • “Health care spending represents about 18% of the nation’s economy and the largest area of federal spending. High and rising health care costs are driven in part by the prices for medical care, which have risen 130% since 2000, compared to 93% for overall inflation.1 This is particularly true in commercial insurance – including large employers, the Affordable Care Act marketplaces, and public employers such as states and the federal government – where rising costs place a growing burden on workers, employers, and the federal government.2 To manage costs, many employers attempt to work with insurance plans to reduce spending, but many lack the market power to command lower prices from providers, such as hospitals.3
    • “Some public employers have looked to reference pricing to address rising employee health care costs in state plans. Under a reference pricing approach, the employer sponsoring the plan establishes a maximum price for certain services. States that have launched reference pricing programs for state employees have been able to reduce costs for state budgets, as well as for enrollees.
    • “In order to reduce health care costs more broadly, policymakers could consider adopting or encouraging reference pricing for federally subsidized insurance. A possible place to start would be the Federal Employees Health Benefits (FEHB) program, which is the largest employer-sponsored commercial insurance program in the country and costs the federal government roughly $50 billion per year.4
    • “In this brief, we discuss an option to adopt a version of reference pricing for hospital reimbursement rates in FEHB, with the reference price based on Medicare rates. Doing so could save billions of dollars for enrollees and the federal government.”
  • Tammy Flanagan, writing in Govexec, discusses “key decisions every federal employee [nearing retirement] must make. From survivor benefits and health coverage to leave payouts and TSP choices, federal employees nearing retirement face deadlines that can permanently shape their finances.”
  • The New York Times lets us know that “President Trump on Thursday ordered cannabis to be downgraded to a lower category of drugs, a change that would allow for more widespread use by patients and permit cannabis producers to take advantage of standard business tax breaks.” The article explains why “moving cannabis to a category of drugs that includes some common medicines will have implications for research, businesses and patients.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Seven years after the FDA’s accelerated approval of bleeding reversal agent Andexxa, which was then under the ownership of Portola Pharmaceuticals, the drug’s round trip on the U.S. market is coming to an end. 
    • “Andexxa, now under AstraZeneca’s stewardship, is slated to be pulled from the U.S. market next week, according to a Dec. 18 update from the FDA. 
    • “In the FDA communication, the agency notes that it has “received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa.” Based on the available data, the agency “considers the risks of the product to outweigh its benefits,” it said.”
  • BioPharma Dive relates,
    • “The Food and Drug Administration has put a partial clinical hold on one of Merck & Co. and Daiichi Sankyo’s antibody-drug conjugates following an unexpected number of deaths in a late-stage clinical trial.
    • “Daiichi initiated a voluntary pause recruiting and enrolling the trial, called IDeate-Lung02, after “higher than anticipated incidence of grade 5 interstitial lung disease events,” a spokesperson for Merck and Daiichi said in a statement to BioPharma Dive. Following the pause, the FDA verbally placed the trial on a partial clinical hold in October. The spokesperson did not say the number of deaths recorded.
    • “During the hold, Daiichi, along with the FDA and an independent committee will review the safety data and “decide on any necessary further actions.” Trial enrollees will be able to continue treatment, but no new participants will be recruited.
    • “The experimental drug, called ifinatamab deruxtecan, or I-DXd, is one of three ADCs Merck gained the rights to through a major licensing deal with Daiichi in 2023. ADCs, which link an antibody to a toxic payload, are meant to more effectively target and destroy cancer cells while sparing the surrounding healthy tissue.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.
    • “The products are:
      • Enlicitide decanoate — an oral PCSK9 inhibitor for lowering LDL cholesterol
      • Sacituzumab Tirumotecan — a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate
    • “High health care costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re pleased to grant these vouchers to two products that may significantly contribute to our goal of improving the accessibility and affordability of healthcare in America.”
    • “With these awards,18 products have now received a voucher under the CNPV pilot program since it was established in June 2025. On December 9, the agency announced its first review decision under the program, achieving significant time savings compared to a typical review timeline.”
  • and
    • “The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies. 
    • “The FDA recognizes that many breakthrough technologies and innovative solutions relevant to its public health mission — including artificial intelligence, biotechnology, medical devices, and regulatory technology — are being developed by firms within venture capital portfolios. However, longstanding challenges, have limited engagement with innovative companies. Many existing federal contracting mechanisms favor large systems integrators and intermediaries that focus on labor-based work rather than scalable technologies. In addition, small business set-aside programs can be difficult for early-stage companies to access and have faced concerns about misuse.  
    • “We should be harnessing the incredible talent of America’s innovators, instead of relying on middlemen and D.C. insiders,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA is exploring a new approach that enables us to harness innovative capabilities and work directly with American entrepreneurs.”
  • Per Cardiovascular Business,
    • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for its Amplatzer Piccolo Delivery System. The device was developed for clinicians to use when implanting the company’s Amplatzer Piccolo Occluder in a premature baby with a patent ductus arteriosus (PDA).
    • “PDAs are holes between two blood vessels that typically close when a baby is born. In rare instances, however, the hole stays open after birth, directing too much blood toward the lungs and impacting the neonate’s ability to breathe.
    • “The Amplatzer Piccolo Occluder first secured FDA approval and CE mark approval in 2019. It is the first transcatheter treatment to gain FDA clearance for closing a PDA in a premature infant. The device is smaller than a pea and delivered through a tiny incision in the child’s leg before it is guided to the heart using the newly cleared Amplatzer Piccolo Delivery System.
    • “We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier,” Sandra Lesenfants, senior vice president of Abbott’s structural heart business, said in a prepared statement. “With the Amplatzer Piccolo Occluder, which is the world’s smallest heart device, and now with the new delivery system to complement it, we’re continuing to advance how we meet the needs of our tiniest patients with structural heart disease.”

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 continues to increase across the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “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.
  • Beckers Clinical Leadership tells us,
    • “Flu hospitalization cases are evenly split between children and older adults, Northwell said, and its Cohen Children’s Medical Center in New York City is at capacity. 
    • “Flu is rising a lot faster than it did last year,” Dwayne Breining, MD, senior vice president of lab services at Northwell, said during a Dec. 18 news conference. 
    • “The other two [COVID-19 and RSV] are rising but not as fast as they did last year,” Dr. Breining said. “That’s driven by a couple of things. What’s very concerning for us is the cases of flu are rising at like 35% per week; the hospitalizations are rising at 75% per week. So we’re keeping a close eye on that trend. It could mean the flu is more severe.”
    • “Experts have said a mutated version of H3N2, “subclade K,” could be fueling the current uptick in flu activity amid earlier and more intense outbreaks abroad. The strain is a version of the influenza A virus, which is generally known to cause more severe illness, particularly in older adults and young children.
    • “At Northwell, more than one-third of flu tests for the week ending Dec. 14 were positive for influenza A’s H3 subtype. The same week period in 2024 saw a 10% flu positivity rate.”
  • Per a National Institutes of Health news release from its Director Dr. Jay Bhattacharya,
    • “At the National Institutes of Health (NIH), engendering trust and confidence in the research we support is one of our top priorities. Three things guide these efforts: engaging in open, honest dialogue, acting in transparency, and delivering on our commitment to advancing science and improving health.
    • “To help guide this work, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) recently undertook a multi-year effort to provide the NIH with a roadmap for incorporating public voices in clinical research (see NExTRAC report).  Deliberations were informed by a team of multi-disciplinary experts and community conversations across the country, specifically asked to think about strategies for incorporating public voices at every stage of the clinical research process.
    • “I am pleased to endorse these recommendations, which focus on:
      • “providing a clear vision and framework for maximally involving patients and communities in clinical research;
      • “ensuring that people and communities have meaningful input into the agenda and direction of research that is relevant and impactful for them; and
      • “increasing transparency for how research participant data are utilized in moving the scientific enterprise forward.
    • “NIH is eager to begin implementing this roadmap, starting in 2026.”
  • The University of Minnesota’s CIDRAP adds,
    • Today [December 17] the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and NEJM Evidencelaunched their new Public Health Alerts initiative with reports on potential local transmission of clade 1b mpox virus (MPXV) in California and on influenza viruses circulating during the 2024-25 flu season.
    • Public Health Alerts is designed to deliver information and early warnings about emerging health threats, enabling swift, informed responses across the United States and globally.
    • “The new collaboration between NEJM Evidence and CIDRAP fills a gap in reliable data, offering expert-reviewed reports that translate frontline observations into actionable public health evidence. An NEJM Evidence editorial today explains the initiative further.
    • “Access to emerging public health data saves lives,” said infectious disease doctor Eric J. Rubin, MD, Editor-in-Chief of the New England Journal of Medicine and NEJM Group, publisher of NEJM Evidence, in a news release. “By providing this new, rigorous pathway for public health information, NEJM Group is delivering on its commitment to equip physicians with reliable information to support evidence-based care.”
    • “Rapid, credible communication has always been essential to an effective public health response,” added CIDRAP Director Michael Osterholm, PhD, MPH. “With this new collaboration, we hope to restore and strengthen that early-warning function, providing timely, evidence-based alerts that can help local and state health leaders act quickly to protect the health of people in their communities.” 
  • Health Day informs us,
    • “It’s beside the point to debate whether vaping or nicotine pouches can be more healthy than smoking a cigarette, a major new report argues.
    • “Nicotine is toxic to the heart and blood vessels regardless of how it’s consumed, according to an expert consensus report published today in the European Heart Journal.
    • “Nicotine is not a harmless stimulant; it is a direct cardiovascular toxin,” said lead researcher Dr. Thomas Münzel, a senior professor of cardiology at University Medical Center at Johannes Gutenberg University in Mainz, Germany.
    • “Across cigarettes, vapes, heated tobacco and nicotine pouches, we consistently see increased blood pressure, damage to blood vessels and a higher risk of heart disease,” Münzel said in a news release. “No product that delivers nicotine is safe for the heart.”
  • and
    • “Young adults are inheriting a world filled with turmoil and unrest, and this instability is leaving its mark on their mental and emotional health.
    • “A single half-hour course, however, could help them feel less anxious and depressed, by helping them increase their tolerance of uncertainty, a new study says.
    • “Young adults who took the course titled “Uncertainty-Mindset Training” continued to feel better a month after taking it, researchers reported Dec. 15 in the journal Psychological Medicine.
    • “Young people today are coming of age amid great climate, economic, social and health uncertainty,” senior researcher Susanne Schweizer, an associate professor with the University of New South Wales in Sydney, said in a news release.”
  • The Washington Post points out that “feeling wonder every day improves our health and explains how to do it.
  • Health Day calls attention to
    • “A new rapid test [that] could improve treatment of urinary tract infections (UTIs), by identifying the most effective antibiotic for each individual patient.
    • “The test applies different antibiotics to bacteria found in urine samples, to see which one best suppresses bacterial growth, researchers recently reported in the journal Microbiology Spectrum.
    • “This new method could cut a full day off the time between testing and prescription, researchers said, and arm a patient with the best means of clearing their infection.
    • “The sooner we know which antibiotic is effective, the more targeted our treatment can be,” senior researcher Oliver Hayden, a professor of biomedical electronics at the Technical University of Munich in Germany, said in a news release.”
  • Beckers Hospital Review lets us know about GLP-1 drugs that are poised to enter the U.S. market.
  • Per BioPharma Dive,
    • “An experimental anti-inflammatory drug being developed by Belgium-based Galapagos met its main goal in one Phase 2 clinical trial but missed in another, the company said Thursday.
    • “The drug, which blocks an inflammation-signaling enzyme called TYK2, helped significantly improve disease signs and symptoms in people with a muscle and skin condition called dermatomyositis. But it didn’t help people with lupus, missing statistical significance on a broad measure of clinical response.
    • “Called GLPG3667, the drug is Galapagos’ biggest remaining asset following a decision to wind down the company’s cancer cell-therapy business after an unsuccessful attempt to sell it. Galapagos may seek a partner to help further develop GLPG3667, which has some competition in the form of a Roivant medicine that could be under Food and Drug Administration review for dermatomyositis early next year.”
  • Per the Genetic Engineering and Biotechnology News,
    • “As the number of antibiotic-resistant infections continues to rise, scientists are looking to bacteriophages (“phages”), viruses that infect bacteria, as an approach to tackling antibiotic resistance. A new study by researchers at the Hebrew University of Jerusalem has revealed how bacteriophages use a tiny piece of genetic material to hijack bacterial cells and make more copies of themselves.
    • “Focusing on infection of Escherichia coli by phage lambda, a bacteriophage that scientists have been studying for decades, research lead Sahar Melamed, PhD, and colleagues identified a virus-encoded small RNA molecule (sRNA) called phage replication enhancer sRNA (PreS) that acts like a hidden genetic “switch.” The team’s research indicated that this switch rewires bacterial genes to help the virus copy its DNA more efficiently and boost viral replication.
    • “The team said that understanding how phages control bacterial cells is important both for basic science and to help inform future medical applications. By uncovering how phages use tools such as PreS to take control of bacterial cells, the newly reported study provides important basic knowledge that could help scientists design new phage-based therapies targeting drug-resistant bacteria.”

From the U.S. healthcare business front,

  • Kaufman Hall discusses “key health system enterprise strategy trends in 2025… and our predictions for 2026.”
  • Radiology Business reports,
    • “Commercial insurer Anthem is defending a controversial new plan to penalize hospitals who use out-of-network radiologists and other physicians. 
    • “Word of the new administrative policy first surfaced in October and is slated to take effect Jan. 1 across 11 states. Anthem plans to punish hospitals by charging a 10% penalty of the allowed amount for claims that involve docs outside of its networks. 
    • Radiologists and other physicians have roundly criticized the change, labeling the policy as “deeply flawed and operationally unworkable.” The American Hospital Association also joined the chorus on Wednesday with its own sternly worded letter, calling for Anthem parent Elevance Health to rescind the policy. 
    • “However, the Indianapolis-headquartered conglomerate is standing its ground and refusing to honor such requests. Radiologists have charged that the No Surprises Act and its independent dispute resolution process already addresses concerns raised by Elevance. 
    • “We agree that the federal NSA has fulfilled its intent of protecting patients from unexpected medical bills at the point of care,” Catherine Gaffigan, MD, president of health solutions for Elevance Health, detailed in a Dec. 9 response letter to the American Medical Association and others who wrote to the company in November. “At the same time, our experience shows it has also created incentives for many care providers to remain out-of-network due to extremely high, unsustainable IDR awards—on average around nine times in-network commercial reimbursement rates—resulting from the NSA’s IDR arbitration process.” 
  • Amen to that.
  • Fierce Pharma relates,
    • “Pharma marketers enter 2026 asking where DTC fits in the DTP era. 
    • “That question, which few foresaw 12 months ago, reflects the fast rise of direct-to-patient (DTP) programs. In the last few months alone, Amgen, Bristol Myers Squibb, AstraZeneca, Genentech, Novartis and Boehringer Ingelheim have all launched DTP services with discounts for self-pay patients on certain popular medications, joining earlier adopters Eli Lilly, Pfizer and Novo Nordisk.
    • “The programs are changing how patients access medicines—and how patients hear about medicines could therefore evolve to reflect the emerging sales channel.” 
  • and
    • “Sixteen months after luring former Roche dealmaker James Sabry, M.D., Ph.D., out of retirement and signaling a shift in its business development approach, BioMarin has announced the largest transaction in the company’s 28-year history.
    • “In a merger of rare disease specialists, BioMarin has agreed to acquire Amicus Therapeutics for $4.8 billion. The California biopharma will pay $14.50 per share, which is a 33% premium on the $10.89 Thursday closing price of the New Jersey-based biopharma and a 46% premium on its 30-day average.
    • “With the deal, BioMarin gains two rapidly growing products—Fabry disease drug Galafold and Pompe disease combination treatment Pombiliti-Opfolda. BioMarin also acquires the U.S. rights to DMX-200, a potential first-in-class small molecule in phase 3 development for the rare kidney disease focal segmental glomerulosclerosis (FSGS).”
  • and
    • “Regeneron has had its hands full this year contending with regulatory setbacks, Amgen’s marketed Eylea biosimilar and Roche’s hard-charging ophthalmology rival Vabysmo. Next year, the biosimilar competition to the New York drugmaker’s blockbuster eye drug Eylea is only likely to ratchet up.
    • “Regeneron has inked another settlement related to Eylea biosimilars, this one with Alvotech and Teva, enabling the partners to launch their product “in the fourth quarter of 2026, or earlier under certain circumstances,” according to a Dec. 19 press release from Alvotech.”

Thursday report

David Ermer–ACA, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Society for Human Resource Management tells us,
    • “In an address to the nation on Dec. 17, President Donald Trump spoke about the economy, efforts to lower prescription drug prices, and his plans for the year ahead. He noted the pending launch of a new website, TrumpRx.gov, in January 2026, highlighted economic progress, and announced a bonus payment of $1,776 to every military service member as a “Warrior Dividend.” He also touted his economic record and predicted the country is “poised for an economic boom the likes of which we’ve never seen.”
  • STAT News adds,
    • When HCA Healthcare, one of the largest hospital systems in the U.S., recently told employees it would stop covering blockbuster obesity drugs Zepbound and Wegovy next year, it pointed them to an alternative way to get the treatments: Buy them themselves.
    • In a notice viewed by STAT, HCA said use of the GLP-1 weight loss drugs surged 90% this year, “significantly” raising costs. It instead suggested employees enroll in discount programs introduced by the drugs’ manufacturers, Eli Lilly and Novo Nordisk, which allow patients to buy the medicines without using insurance at cash prices that are lower than the list prices.
  • The Wall Street Journal reports,
    • “Millions of Americans are facing higher healthcare premiums and lingering uncertainty about whether help might still arrive, with Congress set to break for the rest of the year without renewing enhanced Affordable Care Act subsidies. 
    • “Supporters of the subsidies insist the fight isn’t over. But prospects of a bipartisan deal remain slim, even as some lawmakers and people close to the Trump administration signaled that voter pressure could lead to a retroactive fix when Congress reconvenes in the new year.
    • “I’m not ruling anything out,” Senate Majority Leader John Thune (R., S.D.) told reporters Thursday.”  
  • Modern Healthcare adds,
    • “Health insurance exchange shoppers facing huge premium hikes are scrambling for deals during this sign-up season.
    • “Insurance brokers report high interest in bottom-tier, lower-cost Bronze plans, policies only available outside the exchanges and alternatives such as short-term plans. Some of those consumers are downgrading from Silver or higher amid skyrocketing prices tied to the expiration of enhanced subsidies at the end of the year.
    • “Yet enrollment in Affordable Care Act of 2010 plans was outpacing last year as of Dec. 5, when sign-ups reached 5.8 million, a 7% increase from the same period in 2024, the Centers for Medicare and Medicaid Services reported. Notably, 950,000 enrollees were new to the exchanges. Open enrollment began Nov. 1 and runs until Jan. 15 in most states, although Monday was the last day to choose a plan that would be in place on Jan. 1.
    • ​“All of the attention that has been paid to the market has actually helped enrollment,” said Wesley Sanders, founder and principal consultant at the health insurance consulting firm Evensun Health.” 
  • Govexec informs us,
    • “President Trump on Thursday issued an executive order implementing his plan to provide civilian federal workers with a 1% across-the-board pay raise next month.
    • “As first proposed in August, the increase is entirely being applied to buttress federal workers’ basic pay, with no changes to locality pay rates coming next year. Though the White House skipped outlining its pay raise plans as part of its annual budget proposal, officials initially planned on issuing a pay freeze for 2026. * * *
    • “The administration published pay tables outlining the 2025 pay raise across the General Schedule, along with tables for VA health workers, senior executives, and military service members on the White House website.”
    • [The executive order further states “Additionally, the Director of the Office of Personnel Management (Director) is directed to assess whether to provide up to a total increase of 3.8 percent (inclusive of the increase provided under Section 1) to the rates of pay of certain Federal civilian law enforcement personnel, as determined by the Director following coordination with agencies and consistent with 5 U.S.C. 5305.”}
  • and
    • “President Donald Trump in an executive order on Thursday gave the federal workforce a holiday on Dec. 24 and 26. Because Christmas falls on a Thursday this year, this provides government workers with a five-day weekend. 
    • “According to the directive, agency heads can require certain offices to remain open on either day due to national security, defense or other public need.” 
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services announced Dec. 18 that it will launch a voluntary payment model designed to broadly reach more health care providers who have not joined accountable care organizations, including those with specialized patient populations and others such as small, independent or rural-based practices. The Long-term Enhanced ACO Design Model will begin Jan. 1, 2027, and continue for 10 years. CMS said ACOs can apply for participation in March following the release of a request for applications.”
  • and
    • “The Department of Health and Human Services Dec. 18 announced three regulatory actions related to the practice of “sex-rejecting procedures” on children.
    • “The Centers for Medicare & Medicaid Services issued a proposed rule that would prohibit hospitals participating in the Medicare and Medicaid programs from performing SRPs on individuals under 18 years of age. The proposed condition of participation defines SRPs as “any pharmaceutical or surgical intervention that attempts to align an individual’s physical appearance or body with an asserted identity that differs from the individual’s sex …” and would include procedures that would intentionally disrupt, suppress or alter the development of an individual’s biological functions, physical appearance or body. The proposed rule provides exceptions for the treatment of an individual with a verifiable disorder of sexual development, for uses other than attempting to align an individual’s physical appearance or body with an identity other than the individual’s sex, or to treat complications arising from, or exacerbated by, previous performance of an SRP. The proposed rule did not specify how the proposed prohibitions would be enforced.
    • “Separately, CMS published a proposed rule that would prohibit states from receiving federal matching funds for SRPs provided to Medicaid and separate Children’s Health Insurance Program beneficiaries under the age of 19. CMS notes that these proposed changes would not prevent states from providing coverage for SRPs with state-only funds. The exceptions outlined in the COP proposed rule are also applied to the Medicaid/CHIP rule.
    • “Comments on the proposed rules are due Feb. 16.
    • “HHS’ Office for Civil Rights also proposed to revise its regulations implementing Section 504 of the Rehabilitation Act of 1973 to clarify that the definitions of “disability” and “individual with a disability” exclude “gender dysphoria” not resulting from physical impairments. Comments on HHS OCR’s rule are due Jan. 20.”
  • Per Healthcare Dive,
    • “The Federation of American Hospitals has tapped Charlene MacDonald as its next CEO, the for-profit hospital association said Tuesday.
    • “MacDonald is succeeding Chip Kahn, who announced his retirement earlier this year. Kahn is stepping down after almost 25 years at the helm of the FAH.
    • “MacDonald previously led the FAH’s lobbying, public affairs and communications efforts, and oversaw its finance and operations teams. She’ll start as CEO on Jan. 1.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “Eli Lilly’s experimental obesity pill orforglipron helped people maintain their weight following a 72-week course of the GLP-1 shots Zepbound or Wegovy in a Phase 3 clinical trial, opening up a potential new use for drugs of its kind.
    • “People taking orforglipron after Wegovy gained less than one kilogram over the span of a year, while those who got Zepbound regained five kilograms. Both ended up at the same average at the end of the study period, however, and placebo recipients regained more than nine kilograms before being offered “rescue” orforglipron.
    • ‘Lilly also said it has officially asked the Food and Drug Administration to approve orforglipron. The pill was awarded one of the FDA’s new “national priority” vouchers, making a decision likely within weeks rather than the standard six to 10 months.”
  • Fierce Pharma reports,
    • “A year after an FDA rejection, Johnson & Johnson has won approval for a more convenient version of its lung cancer drug Rybrevant to better challenge AstraZeneca’s Tagrisso.
    • “Rybrevant Faspro, a subcutaneous formulation of Rybrevant, is now cleared in the same indications as the original intravenous infusion, including its use alongside J&J’s Lazcluze for the first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).
    • “Compared with the original Rybrevant, the under-the-skin version reduces the antibody drug’s administration time from several hours to about five minutes, which J&J suggests is more convenient for patients and less burdensome for healthcare resources.
    • “This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment,” Joelle Fathi, chief healthcare delivery officer at GO2 for Lung Cancer, a patient support group, said in a Dec. 17 statement.”
  • MedTech Dive points out,
    • “Pulse Biosciences said Thursday it got the Food and Drug Administration’s go-ahead to begin an investigational device exemption study of its cardiac catheter ablation system to treat drug-resistant paroxysmal, or intermittent, atrial fibrillation.
    • “The company has developed technology that delivers nanosecond electrical pulses to treat the heart rhythm condition. Nanosecond pulses are briefer in duration than the microsecond pulses used in other pulsed field ablation systems, which could offer advantages. The Pulse Biosciences catheter is designed to deliver a complete lesion in a single energy application.
    • “Pulse Biosciences will evaluate the safety and effectiveness of its nPulse ablation catheter in the single-arm, multicenter NANOPULSE-AF study.:
  • and
    • “CMR Surgical said Tuesday it received 510(k) clearance from the Food and Drug Administration for its next-generation robotic system to perform gallbladder removal procedures.
    • “The Cambridge, England-based company said more than 40,000 surgical procedures have been completed with its robotic platforms outside of the U.S., across multiple specialties and care settings.
    • “CMR said it is on track to begin launching the new system, called Versius Plus, in the U.S. in 2026.”

From the judicial front,

  • ABC News reports,
    • “The evidence suppression hearing in the case against accused CEO killer Luigi Mangione concluded Thursday after the defense signaled it would call no witnesses.
    • “The defense rests,” defense attorney Karen Agnifilo said after prosecutors indicated they, too, rested.
    • “The nine-day hearing will determine what evidence will be used against Mangione when he goes on trial on charges of gunning down UnitedHealthcare CEO Brian Thompson on a Manhattan sidewalk last year.
    • “New York Judge Gregory Carro gave the defense until Jan. 29 to make its final argument about the evidence in writing.  Prosecutors have until March 5.  The defense then has two weeks after that to submit a reply.
    • “Carro said he expected to issue his decision about what, if any, evidence to exclude on May 18, at which point he would also set a date for trial.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The Los Angeles wildfires of nearly a year ago took an unexpectedly heavy toll on residents’ health, a new study found. 
    • “An unusually large number of people suffered from heart attacks, lung conditions and a perplexing rise in unexplained illnesses, according to an analysis by researchers of emergency-department data at Cedars-Sinai, the largest hospital in Los Angeles County. 
    • “Their findings offer clues into the potential cost to human health of massive wildfires that spread quickly from wild lands into urban areas, said Dr. Susan Cheng, vice chair for research affairs at Cedars-Sinai’s Smidt Heart Institute and senior author of the study.
    • “Such wildfires are increasing in frequency and scope, and release heavy metals and other toxins into the air as they engulf homes and cars. 
    • “You have a much greater magnitude and a much greater complexity of toxins being produced by the disaster affecting a very large, large population of people,” she said.” 
  • NBC News relates,
    • “As of Dec. 6, the Centers for Disease Control and Prevention had logged 26,632 cases of whooping cough in 2025. The last time the U.S. saw so many cases was more than a decade ago, in 2014, according to CDC data.
    • “But an NBC News/Stanford University investigation has found that DTaP vaccination rates are plummeting across the country, as part of a larger, troubling trend of growing vaccine hesitancy that is fueling a resurgence of preventable diseases, including measles.”
  • Managed Healthcare Executive adds,
    • “While most (82%) primary care physicians (PCPs) in the United States understand the risk factors for shingles, far fewer (29%) are fully aware of current shingles vaccine recommendations, according to a recent study published in Human Vaccines and Immunotherapeutics. The study was sponsored by GSK, the manufacturer of the recombinant zoster vaccine (RZV).”
  • BioPharma Dive notes,
    • “An experimental drug Takeda acquired in a multibillion-dollar deal has succeeded in a pair of late-stage trials, positioning the company to seek clearance of a therapy it expects to become a future blockbuster.
    • “The therapy, known as zasocitinib, met its co-primary and top secondary objectives in two Phase 3 studies testing it against a placebo or Amgen’s Otezla in patients with plaque psoriasis. Without disclosing specifics, Takeda said Thursday that, after four months, zasocitinib demonstrated “superiority” on both top study goals, which involved meaningfully reducing disease severity on two different measures. Respiratory tract infections, colds and acne were the most common side effects, according to the company.
    • “Takeda will provide detailed results at an upcoming medical meeting and intends to file for approvals in the U.S. and elsewhere during its 2026 fiscal year. Zasocitinib is also being evaluated in multiple other indications, as well as in a head-to-head study testing it against Bristol Myers Squibb’s similar, rival drug Sotyktu.”
  • and
    • “A streak of positive news that pushed Insmed into the ranks of the most valuable biotechnology companies ended this week with the announcement of a failed clinical trial.
    • “The company’s share price dropped almost 17% to about $165 early Thursday, following the announcement late Wednesday. The stock, which was worth around $25 a year and a half ago, had vaulted above $200 in trading this week.
    • “The Phase 2b study focused on a drug called brensocatib, which Insmed already sells under the brand name Brinsupri to treat a lung disease known as non-cystic fibrosis bronchiectasis. The company had hoped to expand use of the medicine to include a chronic nasal condition, but researchers found no benefit for either of the two doses they tested.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “All community pharmacies in Optum Rx’s network have transitioned over to a cost-based reimbursement model as the massive pharmacy benefit manager tries to reduce variation in how pharmacies are paid.
    • “Optum Rx first launched the model across roughly 1,400 community pharmacies in March. Now, the PBM, which is owned by healthcare conglomerate UnitedHealth, has notched agreements with three additional pharmacy services administration organizations representing more than 17,000 community pharmacies to transition them to cost-based contracts, Optum Rx said Thursday.
    • “Optum Rx aims to move all of its pharmacy partners to the new model, which should result in pharmacies being paid more for brand-name drugs and less for generics, by January 2028. The PBM is still working on those owned by retail chains and grocers, a network contracting executive said.”
  • Beckers Payer Issues tells us,
    • “UnitedHealthcare is delaying a coverage policy that would have sharply restricted remote physiologic monitoring services for most chronic conditions.
    • “The policy, which had been scheduled to take effect Jan. 1, will now be implemented later next year, the insurer confirmed to Becker’s.
    • “After listening to feedback from care providers, medical societies and other stakeholders, we are postponing the Remote Physiologic Monitoring (RPM) policy scheduled to take effect on Jan. 1, 2026. We still intend to implement this policy in 2026 and will share an updated timeline once it is finalized,” a UnitedHealthcare spokesperson said.”
  • BioPharma Dive notes,
    • “Moderna said Thursday its experimental bird flu vaccine, which was cut from federal funding earlier this year, will receive up to $54.3 million from a global coalition to advance the candidate.
    • “The Coalition for Epidemic Preparedness Innovations, or CEPI, a public-private global partnership working to develop vaccines against pandemics, agreed to fund Moderna’s candidate mRNA-1018 against H5 avian influenza into Phase 3 testing. As part of the agreement, if the shot is approved and in the event of an influenza pandemic, Moderna will allocate 20% of its production capacity for low- and middle-income countries, “at affordable pricing.”
    • “Under the Biden administration, the experimental vaccine was awarded over $700 million in government contracts from the Biomedical Advanced Research and Development Authority, or BARDA. Those contracts were later canceled by the Department of Health and Human Services under Secretary Robert F. Kennedy Jr., a major critic of messenger RNA technology.”
  • MedTech Dive relates,
    • “Editor’s note: This is the fourth article in a series of stories profiling medtech companies that are changing the field of robotic surgery. You can read the first three stories here, here and here.
    • “XCath is developing a robot-assisted approach to brain aneurysm treatment that could bring greater precision to procedures and enable more physicians to perform them.
    • “A cerebral aneurysm is a bulge in a weakened area of an artery in the brain. To prevent a life-threatening rupture of the vessel wall, endovascular interventions that access the aneurysm from inside the artery are increasingly preferred over traditional open surgery.
    • “While less invasive than open surgical repair, the intricate procedures are not free from complications and require significant technical skills to perform. A global shortage of neurointerventionists with expertise to perform the procedures has raised concerns about limited patient accessto critical stroke care.
    • “XCath, a Houston-based startup, is working on a robotic system that it expects to standardize endovascular brain aneurysm treatment. The goal is to facilitate consistent performance among a wider field of physicians, minimize complications and improve clinical outcomes.”

Thursday report

David Ermer–ACA, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “A Democratic effort to extend expiring healthcare subsidies drew some Republican votes but failed to advance in the Senate on Thursday, leaving no clear path in Congress for aiding millions of Americans facing soaring costs for their Affordable Care Act coverage next year.
    • “The proposal would have extended the enhanced Covid-era ACA subsidies for three years. The bill was backed by 51 senators—including Republican Sens. Lisa Murkowski and Dan Sullivan of Alaska, Susan Collins of Maine and Josh Hawley of Missouri—with 48 opposed, short of the 60 votes needed to advance under the Senate’s filibuster rule.
    • “Republicans, who control the chamber 53-47, put forward an alternative healthcare bill that wouldn’t extend the subsidies but instead offers federal funds to some households to put toward out-of-pocket healthcare costs. That proposal failed with 51 in favor and 48 opposed. All Republicans except Sen. Rand Paul of Kentucky supported the measure, while no Democrat voted for it.
    • “The lack of progress in Congress has left many of the nation’s ACA enrollees in a precarious situation. With open enrollment closing on Dec. 15 for plans starting Jan. 1, households are signing up now for coverage with sharply higher costs, with no guarantee that Congress will act to restore subsidies and bring the price tag down. Others are expected to skip coverage altogether.
    • “With the failure of the two votes Thursday, hope is fading for any deal to extend the subsidies before the end of the year, if at all. The next major legislative deadline is Jan. 30, when lawmakers need to pass a new bill funding the government. Still, some lawmakers believed a deal could still be reached.
    • “I hope that there are enough people on both sides who want to come to the table and get a compromise,” said Sen. Jeanne Shaheen (D., N.H.).”
  • Tammy Flanagan, writing in Govexec, tells us,
    • “OPM’s retirement application pile remains large as the year draws to a close
    • “New retirees awaiting full benefits may face holiday heartache as the backlog swelled to nearly 50,000 by the end of November.”

From the Food and Drug Administration front.

  • The Washington Post reports,
    • “An in-home headset that allows people with depression to send mild electrical current to their brains has been cleared by the Food and Drug Administration, in what medical experts consider a milestone for expanding mental health treatment beyond drugs.
    • “The prescription device, made by Flow Neuroscience, is designed to counteract moderate to severe depression in adults by delivering electric stimulation to an area of the brain that controls mood and stress. While such stimulation is widely used to treat depression, Flow is aiming to fill a niche with a product that delivers a relatively low dose of current at home, instead of at specialized clinics. The FDA said testing showed “modest” results for patients.”
  • Per MedTech Dive,
    • “Intuitive Surgical said Wednesday its da Vinci SP surgical robot received Food and Drug Administration clearance for use in inguinal hernia repair, gallbladder removal and appendectomy procedures.
    • “The clearances add to the single port robot’s indications in urology, colorectal, thoracic and transoral procedures, as Intuitive works to expand adoption of the platform, launched in the U.S. in 2018.
    • “The SP system, for surgery through a single incision or natural orifice, is designed to help surgeons access narrow or deep spaces within the body to perform more complex procedures. The surgeon can control up to three multi-jointed instruments and a 3D-HD imaging endoscope through the entry point.”
  • Fierce Pharma relates,
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • “The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • “Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.
    • ‘At the core of the guidance is a call for all promotional materials to be “accurate, truthful, and non-misleading.”
  • STAT News tells us,
    • “Exactly a month after it announced the removal of black box warning labels on estrogen therapy products used in menopause, the Food and Drugs Administration hosted an expert panel to discuss the other sexual hormone with a potentially outdated black box: testosterone. 
    • “Nine experts, including academics, clinicians, and the CEO of a pharmaceutical startup focused on testosterone products, delivered lectures and answered questions highlighting the importance of testosterone as a marker of broader male health. They also promoted increased engagement with its therapeutic value and recommended changes in labeling and substance control.” 
  • Beckers Hospital Review shares background about and FDA review process.
    • “The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency has not formally issued draft guidance, recent public comments, advisory committee discussions and internal policy memos outline a framework that is intended to streamline clinical trials, tighten manufacturing oversight and modernize postmarket safety monitoring.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “South Carolina’s measles outbreak is “accelerating” in the wake of Thanksgiving travel and a lack of vaccinations, an epidemiologist for the state’s Department of Public Health (DPH) warned Wednesday, after authorities traced a sizable outbreak to a church in the state’s northwest.
    • “Of the 111 measles cases recorded in that area, known as the Upstate region, 105 involved people who were unvaccinated while three involved those who were partially vaccinated, state epidemiologist Linda Bell said at a news briefing. One dose of the vaccine is 93 percent effective against measles, while the full two-dose regimen is 97 percent effective, according to the Centers for Disease Control and Prevention.
    • “At least 254 people had been placed in quarantine as of Tuesday, 16 of whom are in isolation, the DPH said in a news release.
    • “Bell said that 27 new cases had been reported since Friday, bringing the total reported to the DPH this year to 114. “Accelerating is an accurate term. That is a spike in cases we are concerned about,” she said in response to a question from a reporter, adding that South Carolina has “lower than hoped for” vaccination coverage.”
  • NBC News tells us,
    • “Heart disease has long been the top killer of women in the United States, but new research suggests uterine fibroids, which many may not even be aware they have, could be putting them at a significantly greater risk.
    • “A large, 10-year study found that women with leiomyomas had an 81% higher long-term risk of heart disease than those without the common condition. Women with fibroids — generally benign tumors that can form on or in the uterus — also had higher individual risks of cerebrovascular, coronary artery and peripheral artery diseases a decade after diagnosis.
    • “The study involved more than 2.7 million U.S. women and was led by scientists at the University of Pennsylvania Perelman School of Medicine. It was published Wednesday in the Journal of the American Heart Association.
    • “We do hope that our study adds to this growing evidence that reproductive health may provide important insights into cardiovascular health,” said lead author Julia DiTosto, a doctoral candidate in epidemiology at Penn. “There is a need for more information on how exactly, biologically, these conditions are related and also identifying potential strategies for cardiovascular prevention.”
  • Per Healio,
    • “Younger age at diagnosis did not appear to affect outcomes among women with breast cancer who harbor BRCA mutations, according to study results presented at San Antonio Breast Cancer Symposium.
    • “In addition, survival did not differ between very young women — defined as 30 years or younger — and those aged 31 to 40 years.
    • “Age per se should not be considered a negative prognostic factor in BRCA carriers when appropriate treatment is provided,” Matteo Lambertini, MD, PhD, associate professor of medical oncology and consultant in medical oncology at University of Genova-IRCCS Policlinico San Martino Hospital in Italy, said during a presentation.”
  • Per Radiology Business,
    • “Targeting women who are eligible for both lung and breast cancer screening pays off, according to new research.  
    • “Numerous studies have explored poor LCS adherence, a problem less pronounced in screening mammography. One previous study estimated about 58% of LCS-eligible women reported having a mammogram over the past two years versus just 8% who underwent low-dose CT for lung cancer. 
    • “This presents a potential opportunity, experts detailed Dec. 1 in the Journal of the American College of Radiology. Researchers at two academic medical centers recently aimed to leverage mammography adherence to bolster LCS uptake and are finding success, with a significant uptick in total LDCT examinations. 
    • “It has been more than 10 years since annual screening for lung cancer was recommended, and screening rates still are disappointingly low. There are many reasons for these low rates, but mostly identifying eligible individuals is challenging in the primary care setting, and there is evidence showing a surprising lack of awareness about lung cancer screening among eligible individuals,” study co-investigator Robert Smith, PhD, with the American Cancer Society, which funded the analysis, said in a statement. “There is enormous potential here, and the ACS is thrilled with the outcome of this study.” 
  • Medscape discusses the rising number of double diabetes cases and “What Doctors Should Know About Viral Sleep Trends.”
  • Per Health Day,
    • “Many young Americans are still smoking nicotine, tobacco or cannabis, even as edibles and vapes continue to grow in popularity.
    • “A University of Michigan study looked at how 12- to 34-year-olds are using these substances today. Researchers examined data from 8,722 individuals who had used at least one of these products within the last 30 days.
    • “On average, users tried about two products during that time, and researchers identified six main patterns of use:
      • “Combustible tobacco: 31%
      • “Multiple forms of cannabis: 27%
      • “Vaping nicotine: 18%
      • “Using multiple forms of nicotine, tobacco and cannabis: 14%
      • “Cannabis edibles only: 5%
      • “Multiple forms of nicotine and tobacco: 5%
    • “The largest group, and still the most concerning, were people who smoked tobacco, researchers said.”
  • BioPharma Dive relates,
    • “An experimental Eli Lilly obesity medicine helped patients lose more than a quarter of their body weight while offering relief from knee osteoarthritis in a Phase 3 study released Wednesday.
    • “Patients on the highest dose of retatrutide lost an average of 28.7% of their body weight after 68 weeks of treatment, compared with 26.4% on the lower dose and 2.1% on placebo, Lilly said. Additionally, 39% of patients on the highest dose achieved weight loss of 30% or more and 24% of those on that dose saw their weight drop by 35% or more, Lilly said.
    • “Lilly has now produced a drug with the best weight loss results of any medication to date, Leerink Partners analyst David Risinger wrote in a note to clients. Before the release, Risinger said he was looking for weight loss in the mid-high 20% range, which would surpass the effects seen with Lilly’s tirzepatide, the world’s best-selling drug, sold as Zepbound for obesity.”
  • Per Genetic Engineering and Biotechnology News,
    • “In 2022, monkeypox virus (mpox) caused more than 150,000 cases—causing flu-like symptoms and painful rashes and lesions. The outbreak resulted in almost 500 deaths. At the time, vaccines developed to fight smallpox were repurposed to help the most vulnerable patients. But that vaccine—manufactured from a whole, weakened virus—is complicated and costly to make.
    • “Now, a major inroad towards a new and more effective way to fight monkeypox virus has been published. A team used the AlphaFold 3 model to identify a viral surface protein—OPG153—as a good target for developing new antibody therapies to treat mpox or for use in a vaccine. When mice were injected with the viral surface protein, the animals produced antibodies that neutralized the monkeypox virus, suggesting the breakthrough could be used in a new mpox vaccine or antibody therapy.
    • “This work is published in Science Translational Medicine in the paper, “Antigen-agnostic identification of poxvirus broadly neutralizing antibodies targeting OPG153.”
    • “Unlike a whole-virus vaccine that’s big and complicated to produce, our innovation is just a single protein that’s easy to make,” said Jason McLellan, PhD, professor of molecular biosciences at The University of Texas at Austin.”
  • and
    • “Findings from a new study led by scientists at Stanford University School of Medicine and their colleagues elsewhere show that a single signaling pathway controls whether immune cells attack or befriend cells that they encounter in the body. By manipulating this pathway, scientists may be able to tweak the immune response to treat a range of diseases, including cancers, autoimmune disorders, and more. Full details are provided in a new Nature paper titled “Erythropoietin receptor on cDC1s dictates immune tolerance.”  
    • “The findings build on work published in an earlier study by the same research group that described a role for erythropoietin (EPO) in the immune system—specifically, controlling how dendritic cells respond to real or perceived threats. The current study, which was performed in mice, helps to illuminate an aspect of peripheral immune tolerance, which is responsible for preventing inappropriate attacks on healthy tissue. The scientists who discovered regulatory T cells (Tregs), which are the key cellular players in peripheral immune tolerance, were awarded the 2025 Nobel Prize in physiology or medicine.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark and Blue Cross and Blue Shield Kansas City have announced plans to affiliate.
    • “The insurers revealed on Thursday that they will enter into an affiliation where Blue Cross KC will maintain its local brand and operations, but will be able to tap into Highmark’s resources to accelerate innovation for its members. Highmark is the fifth-largest Blues plan in the U.S.
    • “Through the affiliation, Blue Cross KC’s financial reserves and earnings will remain within its organization, and Highmark will support its evolution through administrative capabilities, technology and new tools to enable the insurer to build new products and operational efficiencies.
    • “Erin Stucky, CEO of Blue Cross KC, said in the announcement that after a “comprehensive” process to find a partner, the team is “confident” that Highmark was the right choice to “help us deliver greater value for our community.”
  • and
    • “Connecticut’s Office of Health Strategy (OHS) approved on Wednesday Hartford HealthCare’s Emergency Certificate of Need application to acquire two hospitals and related assets from the bankrupt Prospect Medical Holdings. 
    • “The expedited decision ensures continuity of care for Eastern Connecticut residents, while imposing specific conditions designed to ensure preservation of healthcare access and quality and control cost growth,” Amy Porter, the state regulator’s acting commissioner, said in an announcement. “The OHS staff conducted a rigorous and highly efficient process made possible by the emergency [certificate of need] statute.”
    • “Hartford HealthCare’s $86.1 million bid was the only one received for Manchester Memorial and Rockville General, and had previously been accepted by Prospect and green lit by a bankruptcy judge. The facilities had been at the heart of a now-settled legal dispute between bankrupt Prospect Medical Holdings and Yale New Haven Health, which prior to the bankruptcy had offered hundreds of millions more for the locations.”
  • and
    • “Aradigm Health, a new benefits platform aimed at easing the financial sting of coverage for cell and gene therapies, has launched out of stealth.
    • “The company is making its debut backed by a $20 million series A funding round that it intends to use to further enhance platform development, building out its team and growing its partnerships with payers and providers. The round was led by Frist Cressey Ventures with backing from Andreessen Horowitz and Morgan Health.
    • “Andreessen Horowitz led the company’s $5 million seed round in 2024 as well, according to an announcement.”
  • Healthcare Dive tells us,
    • “Elevance has added a former Pfizer executive to its board, the latest addition of pharmaceutical industry veteran as the insurer focuses on building its pharmacy services.
    • “Amy Schulman will start as an independent director of Elevance effective Jan. 12, the insurer announced Wednesday. Schulman will serve on the board’s audit and finance committees.
    • “Schulman’s “insight into the intersection of science, technology, and patient care makes her an exceptional addition as we continue to advance and expand our services,” Ramey Peru, chair of Elevance’s board, said in a statement.”
  • Beckers Hospital Review reports,
    • “Austin, Texas-based UT Health Austin intends to go live with a new inpatient Epic EHR on the same day it opens its new multibillion-dollar academic medical center.
    • “With the net-new implementation, the health system will be able to easily adopt many of the vendor’s latest AI and automation features.
    • “It is a really unique opportunity to build this from scratch, from the ground up,” UT Health Austin CIO Michael Ryan told Becker’s. “We’re really taking a fresh-eyes look at it. … We don’t have many existing legacy processes or legacy ways of working.”
    • “The $2.5 billion University of Texas at Austin Medical Center, slated to break ground in 2026, will include a new UT hospital and MD Anderson Cancer Center. Austin is currently the largest American city without an academic medical center.”
  • and
    • “U.S. News & World Report released its 2026 Best Hospitals for Maternity Care ratings Dec. 9, which also recognize hospitals providing services to underserved communities.
    • “The media company used self-reported maternity care data to identify 147 hospitals as Maternity Care Access Hospitals for providing maternity services in areas that would otherwise lack adequate access to such care.:”
    • The article lists all 147 identified hospitals by State.
  • and
    • “Many health systems are expanding their participation in value-based care models over the next few years, though few have substantial revenue at risk in value-based contract arrangements, according to a new Sage Growth Partners report. 
    • “The report, published Dec. 11, is based on a survey of 101 hospital and health system C-suite leaders from academic medical centers, integrated delivery networks and independent hospitals.’
  • Per an Institute for Clinical and Economic Research news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation. Our primary comparison was with the smoking cessation drug varenicline.
    • “Smoking cigarettes is the number one cause of preventable deaths in the US, and so any new therapy to assist with smoking cessation is extremely important,” said ICER’s Chief Medical Officer, David Rind, MD. “The drug we reviewed for this assessment, cytisinicline, is the same molecule as cytisine, a drug long used for smoking cessation in Eastern Europe. Our analyses show that cytisine/cytisinicline has similar efficacy but significantly fewer gastrointestinal side effects than varenicline, a common prescription drug used for smoking cessation in the US. We heard from experts that they are hopeful cytisinicline will be priced so as to be widely available to those who need it.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), on January 15, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • Per MedTech Dive,
    • “Natera last week said it completed the acquisition of Foresight Diagnostics, expanding the company’s position in solid tumor molecular residual disease detection, particularly in lymphoma, a cancer of the lymphatic system.
    • “The all-stock transaction was valued at $275 million upfront, plus up to $175 million in revenue- and reimbursement-based milestone payments.
    • “Foresight’s PhasED-Seq technology will be integrated into Natera’s Signatera platform to further differentiate performance in solid tumors.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Hill reports,
    • “President Trump on Tuesday said he would prefer not to extend Affordable Care Act subsidies that are set to expire at the end of the year, but he acknowledged it may be necessary to reach an agreement on health care legislation.
    • “Trump, in response to a question from The Hill, told reporters his preference was to pass legislation that gave money directly to Americans to allow them to purchase their own health care plan.
    • “I like my plan the best. Don’t give any money to the insurance companies, give it to the people directly. Let them buy their own health care plan. And we’re looking at that. If that can work. We’re looking at that,” Trump said.
    • “Asked if he is planning to extend the Affordable Care Act subsidies that were at the heart of the government shutdown debate, Trump said he’d “rather not.”
    • “Somebody said I want to extend them for two years. I don’t want to extend them for two years. I’d rather not extend them at all,” Trump said. “Some kind of extension may be necessary to get something else done, because the un-Affordable Care Act has been a disaster.”
    • “Trump told reporters he was talking with Democrats about health care, but when asked who specifically, he would not say.”
  • Roll Call adds,
    • “The front-runner to be the next top Republican on the House Budget Committee is eyeing a potential second reconciliation bill that could include tax and health care provisions that were dropped from the GOP’s “big, beautiful” package last summer.
    • “Rep. Lloyd K. Smucker, R-Pa., the first entrant and heavy favorite in the race to succeed retiring Budget Chairman Jodey C. Arrington, R-Texas, said he would like to see an extension of the Work Opportunity Tax Credit as part of a future reconciliation bill.
    • “That credit goes to employers who hire individuals from groups that face barriers to employment, such as veterans, ex-felons and recipients of Supplemental Nutrition Assistance Program benefits, among others. The credit is set to expire at the end of this year.
    • “I think there were a number of pieces of tax policy that were not included in the bill that we did, and I’d love to see some of those provisions passed,” he said.
    • “Speaker Mike Johnson, R-La., has pushed to do a second — and even a third — reconciliation package before the midterm elections, although the contours of a follow-up bill are still far from clear. But President Donald Trump has said he believes the reconciliation law that he signed in July is sufficient and that additional legislation is not necessary.”
  • The Wall Street Journal relates,
    • “The U.S. government negotiated lower prices in the federal Medicare program for 15 high-selling medicines including Ozempic, widening an effort to rein in drug costs.
    • “The new prices, which will take effect in 2027, shave 38% to 85% off the list prices for drugs for diseases including asthma, cancer and diabetes. The reductions are estimated to save Medicare, the health-insurance program for the elderly, $12 billion.
    • “For some patients, the lower prices could reduce spending on copays or other out-of-pocket charges imposed by their particular plan. Other patients taking the drugs might not see a direct savings, however, because they have fixed monthly copays. 
    • “Also, Medicare members now have a $2,000 annual cap on out-of-pocket drug costs. Yet the savings could help curb growth in plan premiums.
    • “In addition to Ozempic, other drugs that will cost Medicare less thanks to the negotiations include GSK’s Trelegy asthma treatment, Pfizer’s breast-cancer therapy Ibrance and Merck diabetes pill Janumet—all of them huge sellers.
    • “The price cuts apply to Medicare, not to private health-insurance plans. Medicare spends more than $150 billion a year on prescription drugs, and the cuts will mean reduced revenue for drugmakers. Yet some companies say the impact will be modest. 
    • “Some of the muted effect is because drugmakers already provide rebates and discounts to Medicare drug-benefit plans on many drugs. So, the negotiated prices aren’t as much of a discount off net prices as they are from list prices.”
  • Here’s a link to the CMS news release about the 2027 Medicare drug price negotiations.
  • Bloomberg adds,
    • “The Trump administration on Tuesday proposed a rule cementing changes to patient cost-sharing in Medicare’s Part D prescription drug benefit and updating the methodology used to rate private Medicare Advantage plans.
    • “If finalized, the rule, RIN 0938-AV63, would implement changes to Part D that Congress enacted as part of the Inflation Reduction Act under President Joe Biden, and update the methodology used to award insurers quality “star ratings” that determine bonuses and marketing privileges. The changes would take effect in 2027.” * * *
    • “The CMS also proposed eliminating star ratings measures that it said were based on “administrative processes” and not indicative of a plan’s quality. The agency is also proposing to forgo a change related to enrollees with social risk factors, and to add new measures focused on treating depression.
    • “The proposal would also allow Medicare Advantage members a special enrollment period when their doctor leaves their network.”
  • Here’s a link to the CMS fact sheet on this proposed rule.
  • Healthcare Dive offers a good summary of the Medicare changes found in the outpatient facility pricing final rule released last Friday. For example,
    • “Hospital outpatient departments currently receive higher reimbursement for providing the same services compared with freestanding physician offices and ambulatory surgery centers — a policy critics say drives up costs for patients and Medicare. 
    • “In the latest payment rule, the CMS finalized a regulation that would reimburse off-campus outpatient departments owned by hospitals at the same rates as physician offices for drug administration services. 
    • “That change should cut outpatient spending by $290 million in 2026, with $220 million of the savings going to Medicare and $70 accruing to beneficiaries, according to the CMS. 
    • “Additionally, the agency is moving to phase out the inpatient only list, a list of which surgical procedures have to be furnished in hospitals, over three years. The CMS will start with removing 285 mostly musculoskeletal procedures next year.
    • “The American Hospital Association lambasted the site-neutral policy changes, arguing they ignore the differences between care delivery at hospital outpatient departments and other care sites.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention appointed Louisiana surgeon general Dr. Ralph Abraham as the second in command, the latest move in a year of upheaval for the agency.
    • “Abraham, a vaccine skeptic, has been named the deputy principal director of the CDC. The agency has shuffled through multiple leaders since Health Secretary Robert F. Kennedy Jr., also a vaccine skeptic, began overseeing the CDC earlier this year.
    • “Kennedy’s views on vaccines have caused turmoil at the agency. Susan Monarez, the former CDC director, said she was ousted after refusing to approve all future recommendations from a vaccine advisory panel filled with Kennedy’s appointees and refusing to fire CDC vaccine-policy officials. Jim O’Neill, Kennedy’s deputy, is currently serving as the CDC’s acting director.
    • ‘Most recently, a CDC webpage that previously said vaccines don’t cause autism now says they might—an assertion former CDC employees and doctors outside the agency have fervently disagreed with.
    • “Abraham was appointed the Louisiana surgeon general last year and later criticized government vaccine mandates. He condemned Covid-19 vaccine mandates earlier this year as “an offense against personal autonomy that will take years to overcome.” * * *
    • “The family-medicine doctor and veterinarian also represented Louisiana in Congress from 2015 to 2021.”
  • Tammy Flanagan, writing in Govexec, opens her Mailbag: Retirement applications and processing/ A look at common retirement-processing snags, what causes delays and where OPM’s newer systems fit into the picture.”

From the Food and Drug Administration front,

  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil Speed Control Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a design issue that can lead to unexpected behavior of the SmartDrive motor. The FDA said Max Mobility/Permobil reported two serious injuries associated with the issue.
    • “In addition, the FDA issued an early alert for certain Fresenius Kabi Ivenix LVP Primary Administration Sets due to an assembly defect.”
  • Per Fierce Pharma,
    • “AstraZeneca’s Imfinzi is adding yet another landmark perioperative label to its belt with a new FDA approval that gives the drug the title of the first and only immunotherapy marketed to treat early-stage stomach cancer patients both before and after surgery.
    • “With the nod, Imfinzi can be added to standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) to treat adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The approval specifically allows Imfinzi to be used with chemotherapy before surgery, then after surgery with chemotherapy and eventually on its own as a monotherapy.”
  • and
    • “When the FDA reworked the prescribing information for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen designed to reduce liver-associated risks and potentially reach patients left off of the drug’s new label. Now, with the FDA’s go-ahead, the company is commencing with that effort.
    • “The FDA gave Sarepta the green light to use an “enhanced immunosuppressive regimen” in the planned Cohort 8 of its Endeavor study, the company announced in a Tuesday press release. The regimen, which features the administration of sirolimus prior to and after the Elevidys infusion, will be studied in non-ambulatory individuals with DMD or those who can no longer walk independently.”
  • MedTech Dive relates,
    • “Ceribell has received 510(k) clearance to use its Clarity seizure-detection algorithm in neonates, the company said Monday.
    • “The algorithm processes data captured by a headcap with electroencephalography sensors to detect electrographic seizures. Subclinical seizures can go undetected without EEG monitoring.
    • “Ceribell executives have estimated that the neonatal and pediatric markets will add $400 million to its current $2 billion addressable market opportunity.” 
  • STAT News points out,
    • “The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with chronic, autoimmune kidney disease, according to a notice on the agency’s website.
    • “The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared it to treat IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Trump administration will continue to fight in court over a Biden-era regulation that would audit Medicare Advantage plans and claw back billions of dollars in overpayments.
    • “In a Friday filing, the federal government said it would appeal a judge’s decision from September that vacated the Medicare Risk Adjustment Data Validation, or RADV, rule for violating the Administrative Procedures Act.
    • “The move to take the case to the Fifth Circuit Court of Appeals comes as regulators have said they’ll crack down on MA overpayments, including through a plan this spring to increase audits.”
  • Per Fierce Healthcare,
    • “Humana will appeal a court loss over the Medicare Advantage star ratings, according to a filing issued Tuesday.
    • “The insurer filed a notice that it will appeal the District Court ruling to the Fifth Circuit Court of Appeals. The filing doesn’t offer further details on the grounds to appeal.
    • “Humana first filed suit to challenge the star ratings methodology in October 2024 after the number of people enrolled in plans with four or more stars dropped from 94% in 2024 to 25% in 2025. In the most recent round of scores, the number of enrollees in plans with at least four stars decreased further to 20% for 2026.
    • “In the lawsuit, Humana argues that the Centers for Medicare & Medicaid Services determined that three test phone calls were poor, which drove the score drop.
    • “Texas Judge Reed O’Connor tossed the case in mid-October, saying that these determinations were not “arbitrary and capricious” and instead complied with federal law.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A new study found people with untreated obstructive sleep apnea could have an increased risk of developing Parkinson’s disease.
    • “Researchers studied medical records for more than 11 million military veterans between 1999 and 2022 and found those with obstructive sleep apnea had a higher chance of developing Parkinson’s disease compared with those without the disorder, according to the study published in JAMA Neurology on Monday. 
    • “It’s not at all a guarantee that you’re going to get Parkinson’s, but it significantly increases the chances,” said Dr. Gregory Scott, a co-author of the study and assistant professor at the Oregon Health & Science University School of Medicine, or OHSU.”
  • A commentator in STAT News tells us,
    • “For years, federal policymakers have tweaked lung cancer screening guidelines as if the barrier to saving lives is a math problem. Add a few years to the eligibility age. Drop a few pack-years — a measure combining how much and how long someone has smoked. Remove a quit-time rule. Repeat.
    • “But it was never really a math problem. A new study in JAMA Network Open makes clear what many of us in cancer prevention and control have been warning for over a decade: No amount of technical adjusting will fix a system built on stigma.
    • “I see the effects of this every day. As a behavioral scientist and nurse practitioner, I’ve sat with hundreds of patients confronting the potential of a lung cancer diagnosis. I’ve watched people brace themselves before they say the words “I used to smoke,” even when they quit decades ago. I have watched people who have never smoked rush to explain why they got lung cancer at all.
    • “These reactions aren’t personal quirks. They are predictable responses to a system that has taught people to expect judgment.”
    • “That system is failing on its own terms. The new study examined nearly 1,000 people diagnosed with lung cancer at a major academic medical center and found that 65% would not have qualified for screening under today’s U.S. Preventive Services Task Force (USPSTF) criteria.” * * *
    • “The population ineligible for screening is not random. It is disproportionately women, Asian Americans, and people who have never smoked. These are groups the current framework structurally misclassifies as “lower risk,” despite real-world evidence to the contrary.
    • “Only one approach captures nearly all of them: age-based screening. The test itself is straightforward: a low-dose CT scan that takes about 10 minutes and exposes patients to minimal radiation. Screen everyone ages 40 to 85, regardless of smoking history, and you detect 94% of cancers and prevent more than 26,000 deaths every year.  The cost is lower than what we routinely pay for breast or colorectal cancer screening. The number needed to screen to prevent one lung cancer death is 320. For comparison, mammography requires screening about 1,339 women to prevent one breast cancer death, and colonoscopy requires screening about 455 people to prevent one colorectal cancer death. Yes, broader screening means more false positives and follow-up imaging, but these trade-offs are manageable — and far less burdensome than the status quo, which misses two-thirds of cases entirely.”MedP
  • MedPage Today lets us know,
    • “Guidelines recommend a single dose of RSV vaccine for older adults, but long-term data on the duration of protection is limited.
    • “In this study of U.S. veterans, effectiveness slid from over 80% in the month following vaccination to about 60% through 18 months. Among the immunocompromised individuals, vaccine effectiveness fell from 75% to 40%.
    • “The potential benefits and risks of a second vaccine dose in certain groups should be examined,” according to the authors.”
  • The New York Times reports,
    • “Danish researchers were examining the use of medications during and after pregnancy when they noticed a clear trend: The number of women using weight-loss drugs like Ozempic and Wegovy soon after childbirth had risen sharply.
    • ‘In 2018, few women were using the drugs during the first six months after having a baby, with fewer than five prescriptions for every 10,000 new mothers. By mid-2022, that figure had increased to 34 prescriptions for every 10,000 new mothers, and by mid-2024, it had jumped to 173 prescriptions for every 10,000, or almost 2 percent of postpartum mothers. Most of the women were over 30, and two-thirds had more than one child. A majority were overweight, but they did not have diabetes, and they had no history of using the drugs, known as GLP-1s, the researchers wrote.
    • “In a period characterized by natural weight loss and marked hormonal change, this was unexpected,” said Mette Bliddal, a pharmacologist and researcher at University of Southern Denmark in Odense, Denmark, and the paper’s first author.
    • “The new study was published online on Monday in JAMA Network Open.” * * *
    • “Although semaglutide, the active ingredient in Wegovy and Ozempic, aids in weight loss, little is known about the drug’s effects after childbirth, when new mothers are experiencing hormonal changes.
    • “The American College of Obstetricians and Gynecologists has not issued a guidance about the use of weight-loss drugs postpartum because the drugs are so new and the data is insufficient. But First Exposure, a digital information hub and research network at the University of Toronto that provides evidence-based information about drug safety during pregnancy, recommends that patients avoid taking the drugs while breastfeeding. (First Exposure also recommends not taking the medications during pregnancy and stopping them a month or two before a planned pregnancy).”

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

  • The American Hospital Association News notes,
    • “The Trump administration issued an executive order Nov. 24 launching the Genesis Mission, an artificial intelligence initiative focusing on scientific research. The program will focus on efforts related to national, economic and health security, among other areas. The order adds to other White House actions in recent months regarding AI innovation and infrastructure to support health care and other sectors.”
  • Bloomberg points out,
    • “Thousands of health providers that treat lower-income and uninsured patients are scrambling to adjust to a new program to access steeply discounted medicines from drugmakers that stands to overhaul their operations and finances.
    • “The 340B Rebate Model Pilot Program, administered by the US Health Resources & Services Administration, is set to significantly change how the 340B Drug Pricing Program operates after the Trump administration approved rebate models from pharmaceutical companies such as Bristol Myers Squibb Co., Johnson & Johnson, and Novo Nordisk A/S.
    • “Drugmakers under the federal program currently provide up-front drug discounts to covered safety-net hospitals, clinics, and health centers that treat a disproportionate number of low-income and uninsured patients. But under the pilot, covered providers, starting on Jan. 1, 2026, will buy certain medicines at full price and then submit data to drugmakers to receive a rebate.
    • “Health providers are now preparing for the pilot—grappling with nine unique drugmaker models, weighing operational changes, and analyzing the financial risks with purchasing drugs at commercial prices.”
  • Per Beckers Payer Issues,
    • “UnitedHealth Group has purchased a four-story, 79,000 square foot medical office building in Henderson, Nevada.
    • “The $46.1 million building houses Optum Nevada’s new Cactus Healthcare Center and marks the largest medical office transaction in the Las Vegas market this year, according to real estate firm Colliers.
    • “UnitedHealth purchased the building through its Sierra Health and Life Insurance subsidiary in October, the Las Vegas Review-Journal reported.”
  • Fierce Healthcare informs us,
    • “Capital Rx has unveiled Capital Equilibrium, a new level-funding pharmacy benefit management offering.
    • “The program leans on an A-rated stop-loss carrier for reinsurance as well as Capital Rx’s PBM services to provide a fixed monthly payment plan that covers anticipated claims, administrative costs and stop-loss. The pricing is often below market rates, according to the announcement.
    • “The stop-loss insurance manages claims that exceed monthly limits, while the PBM piece is built on a “fair” pricing structure that eschews traditional discounts and rebates, Capital Rx said.
    • ‘Plan sponsors in all 50 states can sign on with Capital Equilibrium, according to the announcement.”
  • Genetic Engineering and Biotechnology News identifies the “Top 20 Drugs Heading for the Patent Cliff, 2026-2029. Last year, these treatments accounted for 75% of the $236B in annual sales set to vanish with the loss of exclusivity.”
  • McKinsey & Co. delves into the five dimensions of the wellness economy.
  • Per BioPharma Dive,
    • “Gilead Sciences is looking at a new way to attack cancer, buying into a preclinical program from the Swedish biotech Sprint Bioscience.
    • “The deal announced Monday centers on a target known as TREX1. Research suggests a healthy TREX1 gene can help prevent overactivation of the immune system that leads to conditions such as lupus, but it may also help cancer cells hide from the body’s natural attackers. In oncology, researchers are trying to inhibit TREX1 to unleash anti-tumor immune activity.
    • “TREX1 has demonstrated significant potential in the preclinical phase,” Sprint Bioscience CEO Johan Emilsson said in a statement. The new agreement calls for Gilead to pay Sprint $14 million up front and as much as $400 million more if the program meets certain clinical, regulatory and commercial milestones.”