Monday report

Patient safety

Monday report

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

From Washington, DC,

  • Govexec reports,
    • “Republicans are renewing their push to fully fund and reopen the Homeland Security Department, suggesting the war the United States launched against Iran over the weekend has heightened the need to end the single-agency shutdown that entered its third week on Monday. 
    • “House Republicans will bring up another vote on a DHS appropriations bill this week, Majority Leader Steve Scalise, R-La., announced, saying it was dangerous for Democrats to continue holding up the funding due to concerns over the Trump administration’s immigration enforcement crackdown. 
    • “The legislation would “end the DHS shutdown so we can ensure agencies can protect America during this dangerous time,” Scalise said, noting the FBI has warned of an elevated threat of terrorist activity domestically.” * * *
    • “Most of the department’s employees have continued to work during the shutdown, with only about 8% of the workforce home on furlough. Many employees, such as law enforcement and other personnel at Immigration and Customs Enforcement and Customs and Border Protection, are receiving their normal paychecks thanks to funding Congress provided in the One Big Beautiful Bill Act. Others, such as Transportation Security Administration and Federal Emergency Management Agency workers, have started to receive partial paychecks or will do so this week. The U.S. Coast Guard is paying its uniformed personnel on time, but civilians will face delayed pay.” 
  • Healthcare Dive relates,
    • “The American Medical Association is overhauling how U.S. doctors report and bill for pregnancy services, bulldozing the current system of bundled payments and replacing it with more granular, itemized codes next year.
    • “The changes, shared exclusively with Healthcare Dive, could help improve poor maternity health outcomes in the U.S. But it’s also an acquiescence to specialty groups, which have long lobbied the powerful medical association that modern obstetric services are more complex than the current coding system is able to reflect.
    • “The move also represents a step back for value-based care, and could incentivize OB-GYNs and other doctors to provide unnecessary medical services at a time of skyrocketing health spending.
    • “But the changes shouldn’t result in OBGYNs, nurse-midwives or other maternity care specialists bringing in more revenue, according to the AMA, which argues the new coding system will benefit the entire healthcare industry.” * * *
    • “Global codes are normally billed when a baby is delivered, which can keep insurers in the dark about their members’ pregnancies. The new codes should give insurers more information, including when a member gets pregnant, that could help them ensure expecting mothers get adequate prenatal care, or know if mothers had complications during delivery that could necessitate follow-up services, according to Dr. Daniel Halevy, an executive at New York nonprofit insurer Healthfirst.”
  • and
    • “Sweeping reforms in the Consolidated Appropriations Act of 2026, signed into law by President Donald Trump earlier this month, included changes that could upend the traditional PBM model, while also turning attention back to drugmakers.” * * *
    • “With PBMs’ bargaining power facing stricter limits under the new reform [which takes effect later this decade to allow for necessary rulemaking], questions surrounding pricing could shift in a new direction.
    • “Be ready for the spotlight to swing back to drug manufacturers,” said Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department and head of its pharmacy practice group.
    • “As PBMs lose traction in the coming years, the pressure on drugmakers to justify their own list prices could intensify.
    • “Now, the argument is going to be that PBMs have been handcuffed, limiting their ability to use some of these abusive tools,” Dresser suggested. “So, it’s going to be up to the drug manufacturers to make sure they’re taking the appropriate steps and not continuing in the old paradigm now that there should be a shift in financial incentives.”
  • Bloomberg Law reports,
    • “A group representing thousands of pharmacies across the US said its members are experiencing financial issues after the rollout of the government’s drug price negotiation program, urging the Centers for Medicare & Medicaid Services to immediately address cash flow concerns.
    • “A letter from the National Community Pharmacists Association is asking CMS Administrator Mehmet Oz to ensure pharmacies receive timely payments under the Medicare Drug Price Negotiation Program, finding in a survey that its members are facing cash flow issues after dispensing certain drugs and waiting for a refund from the manufacturer. 
    • “We need CMS to take all necessary steps to expedite the manufacturers’” refund payments to pharmacies, Ronna Hauser, senior vice president of policy and pharmacy affairs for NCPA, said in the letter to the CMS sent Thursday. “Pharmacies cannot continue to dispense these drugs with delayed payments unless the cash flow issues significantly improve.”
  • Per an Employee Benefits Research Institute news release,
    • “Rising health care costs are affecting household finances for many privately insured adults, with 4 in 10 reporting higher expenses in the past year and many cutting discretionary spending or reducing retirement contributions, according to results from the 2025 EBRI/Greenwald Research Consumer Engagement in Health Care Survey (CEHCS) released today by the Employee Benefit Research Institute (EBRI).
    • “Employment-based coverage remained the dominant source of private insurance, with 6 in 10 covered through their own job. Deductibles also remained widespread across plan types: More than three-quarters of enrollees had a medical deductible, including 70% of traditional plan enrollees. Enrollment in high-deductible health plans dipped slightly in 2025, while enrollment in consumer-directed health plans and health savings accounts (HSAs) appeared relatively stable.
    • “The annual survey also found that most enrollees spent relatively little time selecting coverage during open enrollment, with about half spending less than an hour reviewing options and most spending under two hours. While most adults reported being satisfied with the ease of plan selection and the information available, satisfaction with the availability of affordable plan options and the number of plans to choose from declined in 2025.”
  • Beckers Payer Issues tells us,
    • “CMS is sanctioning Elevance Health and plans to suspend enrollment into the insurer’s Medicare Advantage prescription drug plans, according to a Feb. 27 agency letter.
    • ‘The enrollment and communications pause is set to begin March 31 unless Elevance submits all data corrections and an attestation in advance. CMS said the intermediate sanctions stem from “substantial and persistent noncompliance with Medicare Advantage risk adjustment data submission requirements.” The sanctions will apply until Elevance resolves the issues.”
  • Per a Labor Department news release,
    • “The U.S. Department of Labor’s Wage and Hour Division announced [February 26] a proposed rule designed to help workers and employers better understand how to determine when a worker is an employee and when the worker may be classified as an independent contractor under the Fair Labor Standards Act and related federal laws. 
    • The proposed rule would rescind the department’s 2024 final rule addressing the classification of independent contractors and replace it with an analysis for employee classification similar to the one adopted by the department in 2021. Consistent with Supreme Court and federal circuit court precedent, the proposed rule would make it easier to properly differentiate between employees with the protections under the Fair Labor Standards Act and those workers who work as independent contractors.” * * *
    • “The department encourages all interested parties to submit comments on the proposed rule, which has a 60-day comment period that closes at 11:59 p.m. ET on April 28, 2026.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Ascendis Pharma said Friday the Food and Drug Administration granted accelerated approval to a treatment it’s developed for the most common type of dwarfism, ending what had been a monopoly for rival drugmaker BioMarin Pharmaceutical. 
    • “The new drug, previously known as TransCon CNP and now Yuviwel, is a once-weekly injection cleared for children aged two and older with achondroplasia and open growth plates. The treatment will compete with Voxzogo, a daily shot sold by BioMarin.”
  • MedTech Dive relates,
    • “Abbott has won approval for updated remote heart failure monitoring technology, the company said Friday.
    • “The Food and Drug Administration awarded approval to CardioMEMS Hero, a new version of the device that patients use to take daily pulmonary artery pressure readings.
    • “Abbott has made Hero smaller and 60% lighter than the previous reader, fitting the electronics into a device the size of a laptop case to make it easier to use and take on planes.”
  • and
    • “Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, received a warning letter from the Food and Drug Administration in January.
    • “Inspectors raised concerns with leaking infusion sets, which can pose a risk of insulin under-delivery, potentially leading to life-threatening complications like diabetic ketoacidosis.  “Regulators called for Unomedical to address problems with validating its devices, addressing complaints and providing timely adverse event reports to the FDA.
    • “The warning letter followed a remote regulatory assessment of Unomedical’s facility in Reynosa, Mexico, last summer.”

From the judicial front,

  • Bloomberg Law reports,
    • “The Justice Department said it won’t appeal the decision of a New York federal judge to throw out a murder charge against Luigi Mangione, which means he won’t face the death penalty if he’s convicted of killing UnitedHealth Group Inc. executive Brian Thompson.
    • “US District Judge Margaret Garnett ruled in January that prosecutors can’t pursuethe capital murder charge, but that a jury could determine if Mangione caused Thompson’s death under two federal stalking laws. If convicted of those crimes, he could face life in prison without possibility of parole. 
    • “In a one-page letter Friday to Garnett, a Justice Department lawyer said prosecutors won’t challenge the judge’s decision.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A report published March 2 by the American Cancer Society found that colorectal cancer rates among adults 65 and older continue to decline while rates for younger adults continue to increase. The study found that the increase is being driven by a higher prevalence of rectal cancer, which now makes up 32% of all colorectal cancer diagnoses, up from 27% in the mid-2000s. The study also projects 158,850 new cases of colorectal cancer in the U.S. in 2026, and that 55,230 individuals will die from the disease. Nearly one-third of deaths are estimated to be younger than age 65.” 
  • Cardiovascular Business tells us,
    • “Patients with type 2 diabetes who use GLP-1 receptor agonists (GLP-1 RAs) and make healthy lifestyle choices can significantly lower their risk of experiencing a heart attack or stroke, according to new data published in The Lancet Diabetes & Endocrinology.[1]
    • The study’s authors explored data from more than 98,000 participants from the U.S. Department of Veterans Affairs’ Million Veteran Program. These individuals were enrolled from 2011 to 2023. 
    • “Lifestyle habits explored in this analysis included getting a recommended amount of exercise, not smoking, sleeping well, drinking minimal alcohol, properly managing stress, connecting with others socially and avoiding opioids. Overall, adults on a GLP-1 RA and following six to eight of these healthy habits was associated with a 43% lower risk of experiencing a major adverse cardiovascular event (MACE) than those not taking GLP-1 RA or adhering to these habits. When adults followed all eight habits, meanwhile, the risk was approximately 60% lower.
    • “In addition, those using a GLP-1 RA had a 16% lower MACE risk than those who did not use a GLP-1. 
    • “Our findings underscore that, even in the era of highly effective GLP-1 pharmacotherapy, lifestyle habits remain central to diabetes management and cardiovascular risk reduction and can substantially amplify the benefits of modern medications,” corresponding author Frank Hu, MD, PhD, chair of the department of nutrition at the Harvard T.H. Chan School of Public Health, said in a statement.”
  • Contemporary OB/GYN informs us,
    • “The quadrivalent HPV vaccine is associated with a significantly reduced risk of invasive cervical cancer that persists for at least 18 years after administration.
    • “Vaccination before the age of 17 provides a 79% lower risk of cervical cancer, while those vaccinated at age 17 or older also experience significant long term risk reductions.
    • “Population level data shows that school based vaccination cohorts have significantly lower rates of invasive cervical cancer compared to earlier opportunistic vaccination cohorts.”
  • MedPage Today points out,
    • “The location and amount of brain microbleeds that a person has could be telling of their risk of dementia, according to an observational analysis.
    • “Compared with controls with no cerebral microbleeds detected on MRI, there was an increased dementia risk in older people with:
      • “Mixed subcortical and lobar microbleeds (HR 1.99, 95% CI 1.40-2.83)
      • “Lobar-only microbleeds, with or without cortical superficial siderosis (HR 1.96, 95% CI 1.30-2.97)
      • “Any cortical superficial siderosis (HR 2.57, 95% CI 1.36-4.89)
    • “Participants with three or more cerebral microbleeds of any pattern also had an increased risk of dementia (HR 1.92, 95% CI 1.35-2.72), as did peers with at least two subcortical microbleeds, according to Rebecca Gottesman, MD, PhD, of the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland, and colleagues.
    • “Their report, based on the Atherosclerosis Risk in Communities-Neurocognitive Study, was published in Stroke.
  • and
    • “Chronic migraine patients who used GLP-1 receptor agonists to treat conditions like obesity or diabetes had fewer emergency department (ED) visits than those on topiramate (Topamax), a real-world data analysis showed.
    • “Compared with topiramate users, GLP-1 drug initiators were 10% less likely to visit the ED over the following year (RR 0.90, 95% CI 0.86-0.94), reported Hsiangkuo Yuan, MD, PhD, of Jefferson Headache Center at Thomas Jefferson University in Philadelphia, in an abstract released ahead of the American Academy of Neurologyopens in a new tab or window annual meeting.”
  • The Wall Street Journal asks whether Multi-Cancer Blood Tests Are Ready for Prime Time?
    • Early detection tests are already on the market, but without FDA approval or proof they reduce deaths some doctors urge caution
  • Per BioPharma Dive,
    • “Roche’s experimental pill fenebrutinib hit its main goal in a second Phase 3 trial in the most common form of multiple sclerosis, helping treatment recipients experience significantly fewer relapses than study volunteers who got Sanofi’s Aubagio, the company said Monday.
    • “However, Roche also reported a case of severe liver side effects in one enrollee who got fenebrutinib in the study. It also revealed a higher number of deaths among people who took its therapy in the two Phase 3 trials in relapsing MS, which prompted one analyst, Michael Leuchten of Jefferies, to question the drug’s approval prospects. Analysts have forecasted peak sales of more than 3 billion Swiss francs, or $3.8 billion, for fenebrutinib, Leuchten wrote.
    • “Fenebrutinib is part of a new crop of “BTK inhibitors” that drugmakers are now positioning as potential autoimmune disease treatments. The effort has yielded multiple setbacks in MS, though, as the Food and Drug Administration recently rejected a BTK drug from Sanofi, and other developers like Merck KGaA and Biogen have given up on prospective drugs.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealth Group has named Dennis Stankiewicz as chief accounting officer, effective March 2. 
    • “Tom Roos, who has served as CAO since 2015, has been named CFO at Optum Insight, the company said in regulatory filings.”
  • Healthcare Dive adds,
    • “UnitedHealth executive and former Optum leader Heather Cianfrocco is leaving the company, according to a post on LinkedIn.
    • “Cianfrocco was promoted to executive vice president of governance, compliance and information security at UnitedHealth in May, after serving for a year as CEO of Optum, the company’s health services arm. Patrick Conway, the former CEO of Optum Rx, replaced Cianfrocco.
    • “Cianfrocco is departing UnitedHealth after serving in a number of executive positions, including as CEO of Optum Rx and chief of UnitedHealthcare’s community and state division. “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she said in a post on LinkedIn. “I am leaving with so much pride in what we have accomplished together.”
  • Beckers Hospital Review notes,
    • “According to data gathered by Becker’s, Parkland Health and Hospital System [in Dallas, Texas] saw the highest number of emergency department visits in 2025. 
    • “The figures [shown in the article] represent the number of ED visits at individual hospital facilities, rather than the total visits across entire health systems. These self-reported totals were provided directly by hospitals.
  • Fierce Healthcare relates,
    • “Healthcare technology companies DoseSpot and Arrive Health have merged to combine an electronic prescribing platform with medical and pharmacy benefits data to advance real-time medication price transparency for providers and patients.
    • “The new company, called Interra Health, combines Arrive Health’s coverage and pricing network with DoseSpot’s e-prescribing capabilities to support prescribing decisions and help patients access the right medication at the lowest cost, according to the companies.
    • “Bain Capital Tech Opportunities is backing the deal and will serve as majority owner. PSG, the former majority owner of DoseSpot, will be a minority owner. Additional minority investors include Providence and UPMC Enterprises.
    • “The combined company is profitable, growing at approximately 40% annually and projected to exceed $100 million in revenue in 2026, executives said.”
  • Per BioPharma Dive,
    • “Privately held Candid Therapeutics will merge with Rallybio in a deal to take the inflammatory disease drugmaker public, the companies said Monday.
    • “The new entity will operate under Candid’s name, and trade on Wall Street under the ticker “CDRX.” As part of the deal, Candid raised $505 million from more than a dozen venture capital firms and mutual funds including Venrock, RA Capital Management and Janus Henderson Investors.
    • “Candid is developing bispecific antibodies known as T-cell engagers it acquired in two deals with Chinese biotechnology firms in 2024. One of Candid’s central goals is to show it can advance drugs that are similar to cell therapies targeting B cells, but easier to manufacture and administer. While bispecifics research has largely focused on cancer, startups like Candid — and even some pharmas — are now testing the applicability of these drugs against autoimmune conditions.”

Tuesday report

David Ermer–Congress, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NCQA, Patient safety, SCOTUS, Uncategorized–

From Washington, DC,

  • Federal News Network reports,
    • “The House [of Representatives] passed a spending package to end a short-term partial government shutdown and fund most federal agencies through the end of the fiscal year.
    • “The spending deal, which includes a two-week continuing resolution for the Department of Homeland Security, was passed by the Senate last Friday.
    • “President Donald Trump signed the spending package into law on Tuesday afternoon.” * * *
    • “The spending package includes language guaranteeing back pay to federal employees who were briefly furloughed during the partial shutdown.” * * *
    • “After Trump signed the spending plan into law, OPM directed furloughed employees to return to work.”
  • The Wall Street Journal notes,
    • Twenty-one Republicans voted against the package [on the final vote [217-214] for passage], largely hard-liners who wanted to use the spending package as a vehicle to tighten election procedures. Twenty-one Democrats—mostly a collection of appropriations-committee members and centrists—voted for it.
  • Fierce Healthcare adds,
    • “The legislation finalizes several key healthcare extenders including provisions of the Medicare telehealth program and Acute Hospital Care at Home waiver as well as major supplementary funding programs for rural hospitals and those with high proportions of government-covered patients. The bill provides a five-year extension of the Acute Hospital Care at Home program and a two-year extension for Medicare telehealth flexibilities. The telehealth provisions in the bill include removing Medicare’s geographic requirements for telehealth and expanding the types of practitioners able to furnish telehealth services for the government health program.
    • “The bill also introduces reforms to pharmacy benefit manager (PBM) practices, including elements that would prevent PBMs from tying compensation in Part D to the list price of drugs, and boost price transparency for employers in their PBM contracts.
    • “Other provisions in the bill require that Medicare Advantage plans provide accurate provider lists, addressing so-called “ghost networks” that have come under fire in recent years. It would also require that health systems establish unique identification numbers for outpatient services, allowing the Centers for Medicare & Medicaid Services to track pricing in these facilities.”
  • Rep. Jodey Arrington (R TX), the chairman of the House Budget Committes, writing in Real Clear Health, shares his vision of a second reconciliation bill that would focus on healthcare.
  • The HHS Office of Inspector General posted “Medicare Advantage Industry Segment-Specific Compliance Program Guidance.”
  • Per an AHIP news release,
    • “Public and private payers are delivering greater value to Americans and the health care system by advancing value-based care (VBC). AHIP, in collaboration with the Centers for Medicare & Medicaid Services (CMS), today released the results of the 2025 Alternative Payment Model (APM) Adoption Survey. The findings reaffirm the commitment of the federal government and private health plans to advance VBC and APM models that shift away from fee-for-service (FFS) models toward payment arrangements that reward quality, efficiency and improved patient outcomes.
    • “This year’s survey highlights how health plans continue to work hand-in-hand with providers to advance value-based care and drive meaningful improvement for patients. These innovative payment models reward outcomes, resulting in patient-centered, high-quality, coordinated care that is more affordable for Americans,” said Danielle Lloyd, MPH, AHIP’s senior vice president of private market innovations and quality initiatives for Clinical Affairs.” * * *
    • To view the full 2025 survey findings, click here.
  • NCQA announced today,
    • “Every year, NCQA seeks public comment about proposed changes to HEDIS Volume 2.
    • “Public comment is your opportunity to weigh in on the relevance, scientific soundness and feasibility of new and revised measures for HEDIS. Your feedback helps us determine changes to our programs, procedures and processes.
    • “This year’s public comment is open February 13–March 13.
    • We’d like input on:
      • Seven new HEDIS measures.
      • Revising three HEDIS measures.
    • “This year’s public comment will go live Friday, February 13, at 9:00a.m. ET.
    • “We’ll post the link and more details here, so check back on February 13.”
  • The Washington Post relates,
    • “The American Society of Plastic Surgeons has issued a broad recommendation against gender transition surgeries for youths, becoming the first major medical association in the United States to narrow its guidance on pediatric gender care amid a crackdown by the Trump administration.
    • “A statement sent Tuesday to the group’s 11,000 members and obtained by The Washington Post recommends surgeons delay gender-related chest, genital and facial surgery until a patient is at least 19 years old. Fewer than 1,000 minors in the United States receive such surgeries every year, according to research published in JAMA, the American Medical Association’s journal, and the vast majority of the procedures are mastectomies, not genital surgeries.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices could display inaccurate information due to a malfunction of the differential pressure sensors. The company reported 22 injuries associated with the issue since Jan. 15.” 
  • MedTech Dive relates,
    • “Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose monitors.
    • “The warning letter, dated Jan. 23 and posted to the FDA’s website on Tuesday, concerns performance specifications and testing for the glucose sensors’ accuracy. An Abbott spokesperson wrote in an email that the company is implementing corrective actions and providing ongoing updates to the FDA.
    • “The warning letter does not affect Abbott’s ability to manufacture, market or distribute Libre products, wrote Leerink Partners analyst Mike Kratky and J.P. Morgan analyst Robbie Marcus.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN said the U.S. Food and Drug Administration rejected an initial submission for its Saphnelo lupus drug in injection form, and vowed to work with the regulator to move forward with an updated application.
    • “The U.K. pharmaceutical company said Tuesday that the FDA issued a complete response letter, which indicates that a new drug application can’t be approved in its present form, regarding Saphnelo for subcutaneous administration. The company said it subsequently provided information requested in the letter and that it was committed to working with the FDA to progress the application as quickly as possible.
    • “A decision on the updated application is expected in the first half of 2026, AstraZeneca said.
    • “The drug, a treatment for the autoimmune disease systemic lupus erythematosus, is already approved as an intravenous infusion and that form of administration remains commercially available, AstraZeneca said.”
  • Fierce Biotech tells us,
    • “As the first CAR-T treatment for an autoimmune disease draws ever closer, officials at the FDA have signaled a willingness to support the development of these novel cell therapies with a flexible regulatory approach.
    • “While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the FDA is equally wary of their “unpredictable long-term toxicity,” according to an article published Monday in the Annals of Internal Medicine.
    • “In the article, Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research, and two other regulators said that, recognizing the complexity of autoimmune conditions in terms of seriousness and type, the agency will work with CAR-T makers “on a case-by-case basis to encourage appropriate study populations in rheumatologic autoimmune disease.”
    • “Simultaneously, citing a need to monitor a drug’s effect on fertility, the FDA officials recommended that industry conduct long-term follow-up studies for CAR-T products in the autoimmune setting, “as is standard for genetic therapies and CAR T-cells for oncologic indications.”
    • “While the FDA “shares enthusiasm for this class of products,” it will “carefully shepherd” the advancement of clinical studies “focused on the development, durability, and long-term safety of CAR T-cell therapies,” the regulators wrote.”
  • STAT News lets us know, “AI could soon renew prescriptions without clinician help. Should the FDA make sure it’s safe? Doctronic claims its AI doctor doesn’t need FDA approval. Experts aren’t so sure.”

From the public health and medical / Rx research front,

  • Nature reports,
    • “Nearly 40% of new cancer cases worldwide are potentially preventable, according to one of the first investigations1 of its kind, which analysed dozens of cancer types in almost 200 countries.
    • “The study found that in 2022, roughly seven million cancer diagnoses were linked to modifiable risk factors — those that can be changed, controlled or managed to reduce the likelihood of developing the disease. Overall, tobacco smoking was the leading contributor to worldwide cancer cases, followed by infections and drinking alcohol. The findings suggest that avoiding such risk factors is “one of the most powerful ways that we can potentially reduce the future cancer burden”, says study co-author Hanna Fink, a cancer epidemiologist at the World Health Organization’s International Agency for Research on Cancer in Lyon, France.
    • “The study was published today in Nature Medicine.”
  • The American Journal of Managed Care relates,
    • “The majority (57.5%) of commercially insured patients had at least 1 chronic condition in 2024. The average allowed amount1 for a patient with no chronic conditions was $1590, whereas the average allowed amount for a patient with 1 chronic condition was nearly double ($3039). Of 44 common chronic conditions studied, hyperlipidemia, or high cholesterol, was the most common, with a crude prevalence2 of 21.2%. These and other findings are reported in a new FAIR Health white paper: Chronic Conditions in the United States: A Study of Commercial Claims.” * * *
    • “Many patients had more than 1 chronic condition. For example, 11.5% of patients had 2 conditions, and 9.1% had 3.
    • “Some chronic conditions frequently co-occur. In the commercially insured population, 33.4% of patients had hyperlipidemia, hypertension, obesity, or some combination of these, and 4.3% had all 3.3 Half the patients with any one of these conditions had more than 1.” * * *
    • “For the complete white paper, click here“
  • CNN tells us,
    • “Men develop a greater risk of cardiovascular disease years earlier than women — starting at around age 35, according to a new long-term study.
    • “The report, published Wednesday in the Journal of the American Heart Association, followed more than 5,000 adults from young adulthood and found that men reached clinically significant levels of cardiovascular disease about seven years earlier than women.
    • “Experts advise both men and women to monitor their heart health in early adulthood and to see their doctor regularly.
    • “Heart disease doesn’t happen overnight; it develops over years. One of the things I think oftentimes people aren’t aware of is that it can start really early in your 30s or 40s,” said study coauthor Dr. Sadiya Khan, professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine in Chicago.
    • “Even if you don’t have heart disease at that time, your risk can start at that time.”
  • MedPage Today adds,
    • “National data showed 79% of adults with hypertension didn’t have their blood pressure within the blood pressure goal recommended by guidelines.
    • “Most of those uncontrolled hypertension cases went untreated by blood pressure medication.
    • “These findings highlight a large gap in hypertension control that treating hypertension earlier and more intensively could address.”
  • The New York Times observes,
    • “For much of the 20th century and beyond, social scientists attributed a range of chronic mental health problems to dysfunction between infants and their mothers, who were categorized as overbearing, rejecting, domineering or ambivalent.
    • “But a team of researchers from Pennsylvania State University has found that at times the early parenting behavior of fathers may have a greater impact on children’s health.
    • “For a study published recently in the journal Health Psychology, the scientists observed three-way interactions between 10-month-old infants, their fathers and their mothers, and then checked in on the families when the children were 2 and 7.
    • “They found that fathers who were less attentive to their 10-month-olds were likely to have trouble co-parenting, instead withdrawing or competing with mothers for the children’s attention. And at age 7, the children of those fathers were more likely to have markers of poor heart or metabolic health, such as inflammation and high blood sugar.
    • “Mothers’ behavior did not have the same effect, said Alp Aytuglu, a postdoctoral scholar at Penn State’s College of Health and Human Development and an author of the paper.
    • “We of course expected that family dynamics, everybody in the family, fathers and mothers, would impact child development — but it was only fathers, in this case,” Dr. Aytuglu said.”
  • Per Health Day,
    • “More than one-quarter of young children experience persisting symptoms after concussion (PSaC), according to a study published online Jan. 26 in Pediatrics.
    • “Sean C. Rose, M.D., from The Ohio State University in Columbus, and colleagues assessed the frequency of PSaC after early childhood concussion and identified potential predictors of PSaC. The analysis included 235 young children (ages 6 months to <6 years) with concussion, 108 with orthopedic injury, and 75 community controls.
    • “The researchers found that at one month postinjury, PSaC were documented in 28 percent of children with concussion, higher than in the orthopedic injury group (10 percent) and the community control group (2 percent). PSaC were documented in just under one-quarter of children at three months postconcussion (24 percent) and 16 percent at 12 months. PSaC at one month postconcussion was predicted by total symptom burden in the emergency department (odds ratio, 1.108). There were no associations for age, loss of consciousness, receiving brain imaging in the emergency department, attending daycare or school, or parent education with PSaC.”
  • and
    • “The symptoms women experience on the verge of menopause could be vastly different from what they might expect, a new study says.
    • “Women in perimenopause – the time leading up to their final period, as well as the year after – expect to be plagued with hot flashes and night sweats.
    • “However, these women reported symptoms like exhaustion and fatigue far more frequently than those typically associated with menopause, researchers reported Jan. 28 in the journal Menopause.
    • “This study shines a light on how little we still understand about perimenopause and how much it affects people’s daily lives,” lead researcher Dr. Mary Hedges said in a news release. She’s a community internal medicine physician at the Mayo Clinic in Jacksonville, Florida.”
  • Per BioPharma Dive,
    • “An experimental obesity shot Pfizer got through a buyout of Metsera helped enrollees in a mid-stage trial lose significantly more weight than a placebo, spurring up to an 11% reduction over 28 weeks using a regimen that switched from a weekly to monthly dose after 12 weeks.
    • “When including only participants who completed the trial, the shot helped people lose up to 12 percentage points more of their body weight than those who received a placebo. Though cross-trial comparisons can be misleading, the results “look slightly inferior” to what was seen in testing of Eli Lilly’s blockbuster Zepbound at a similar timepoint, wrote Leerink Partners analyst David Risinger.
    • “Pfizer executives noted on a conference call that, going forward, they intend to test a far higher dose than they did in Phase 2 testing. Phase 3 trials starting later this year will involve a dose that’s double the highest one used in the Phase 2.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente and Renown Health have wrapped the paperwork on a deal forming an insurance and outpatient care joint venture in northern Nevada. 
    • “The arrangement announced last September (see below) represents an entry into the geographic market for Kaiser, the country’s largest nonprofit health system. It brings Hometown Health—an existing health plan run by Renown Health, a Reno-based, two-hospital nonprofit system—plus an existing primary care medical office under joint ownership. The partners have plans to open two more facilities in 2026, plus retail pharmacies in 2027. 
    • “This joint venture with Renown Health allows us to extend our value-based care model and nation-leading health outcomes to northern Nevada, in collaboration with Renown Health’s trusted local teams,” Greg Adams, chair and CEO of Kaiser, said in a Tuesday announcement. “Together, we will improve health outcomes; expand access to affordable, high-quality care; and serve the needs of this growing community.”
    • “Financial terms of the transaction were not disclosed.” 
  • and
    • “Primary care company Carbon Health filed for Chapter 11 bankruptcy relief in Texas. 
    • “The company, which offers both in-person care at nearly 100 clinics and virtual care services, said Monday it reached a restructuring agreement with its existing lenders that establishes a “clear path to recapitalization and new ownership.”
    • “Carbon Health intends to pursue a dual-track, court-supervised process that allows it to enter a Chapter 11 plan premised on a debt-for-equity exchange, and a post-petition marketing and sale process for all or a portion of its assets, the company said in a press release issued Monday.
    • “This structure is intended to maximize value while preserving flexibility as the process moves forward,” Carbon Health executives said.
    • “To implement the restructuring, Carbon Health and certain affiliates have filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas.”
  • Healthcare Dive relates,
    • “Humana is launching an artificial intelligence tool that aims to help its call center workers answer beneficiaries’ questions about their coverage, the insurer said Tuesday. 
    • “Agent Assist, developed in partnership with Google Cloud, can summarize conversations between workers and enrollees in real time while highlighting relevant information, like the member’s benefit and eligibility details and important context from the call, Chris Sakalosky, vice president of strategic industries at Google Cloud, said via email.
    • “The insurer began rolling out Agent Assist in October, and plans to implement the tool across Humana’s service centers this year.”
  • Per MedCity News,
    • “About 50 million people in the U.S. are affected by autoimmune disease, and about 80% of them are women. When women give birth, they often experience significant hormonal changes that can trigger new diagnoses or symptoms of autoimmune disease.
    • “That’s why WellTheory, a platform focused on autoimmune disease, launched a new program last week aimed at supporting women in the postpartum period.
    • ‘Atherton, California-based WellTheory treats autoimmune conditions such as Addison’s disease, celiac disease, multiple sclerosis and lupus. Using a collaborative care model, it partners with patients’ physicians to deliver personalized plans focused on nutrition, stress, sleep and movement. The company offers video sessions, unlimited expert messaging and diagnostics. It serves both employers and health plans.
    • “The new postpartum program includes personalized care plans and one-on-one support with autoimmune and hormonal health experts. WellTheory also provides advanced hormonal testing if appropriate, including assessment of sex hormones, cortisol levels and metabolites. This helps identify root causes of conditions like postpartum depression.”
  • Adam Fein writing in his Drug Channels blog lets us know,
    • “The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which track all U.S. spending on healthcare. (Links below.)
    • “We spent an astounding $5,278,588,000,000 on healthcare in 2024. Yes, that’s $5.3 trillion!
    • “Retail outpatient prescription drugs accounted for less than 9% of that total. More than half of net outpatient drug spending was paid by federal, state, and local government programs. Below, we delve into the spending trends, which reveal the impact of the Inflation Reduction Act (IRA) on Medicare spending, the boom in healthcare marketplaces, and the post-pandemic bust in Medicaid. 
    • “Contrary to what you might read, the government’s data show that drug spending growth was not driven by purportedly “skyrocketing” drug prices. In reality, nearly all of the increase in drug spending reflected higher utilization—more people treated, more prescriptions dispensed, and shifts among drugs dispensed—rather than higher net prices.”
  • Per Fierce Pharma,
    • “Armed with what CEO Robert Davis called the “broadest and widest pipeline we’ve had in years,” Merck is preparing for its post-Keytruda future with what it foresees as a host of major sales opportunities over the next decade.
    • “Thanks in part to its recent acquisitions of Verona Pharma and Cidara Therapeutics, the company sees new growth drivers delivering potential annual revenue of more than $70 billion by the “mid-2030s,” Merck said in its fourth-quarter and full-year earnings presentation (PDF).
    • “To put the $70 billion number into context, Davis pointed to the figure as being more than double the $35 billion Keytruda is expected to pick up during its peak sales year in 2028. The oncology superstar is slated for a loss of exclusivity (LOE) in 2028, and a growing pipeline of Keytruda biosimilars is already lining up to take a shot at the drug’s massive market.
    • “Our belief in our ability to have substantial growth once we get closer to the LOE is as high as it’s ever been,” Davis emphasized on a conference call. “And we’re not done.”
  • and
    • “During the first six months of Maziar Mike Doustdar’s tenure as Novo Nordisk’s CEO, the company enjoyed a run of positive momentum highlighted by the launch of its Wegovy pill and a recent stock-price runup. But investor optimism came to a sudden halt Tuesday as the company warned of significant sales and earnings declines in 2026.
    • “Tuesday, Novo put out word that it’s expecting sales and earnings to slide between 5% and 13% this year. In 2025, Novo generated sales growth of 10% and operating profit growth of 6%, the company said.
    • “A few factors are playing into the 2026 guidance. For one, the company said it’s expecting sales to decline in the U.S. amid “intensifying competition” and lower prices in some areas of its business. Novo is also warning of a sales hit from the recent “Most Favored Nation” pricing deal it struck with the Trump administration.
    • “The company is also forecasting a currency hit as the U.S. dollar has lost value against the Danish krone, Novo’s local currency.”
  • Per MedTech Dive,
    • “Medtronic plans to acquire CathWorks, which makes tools to help detect coronary artery disease, the companies announced on Tuesday. Medtronic will pay up to $585 million, with the potential for undisclosed earn-out payments after the acquisition closes.
    • “The companies have worked together since 2022, when Medtronic agreed to co-promote CathWorks’ FFRangio System in the U.S., Europe and Japan.
    • “The FFRangio System uses artificial intelligence and computational science to provide an assessment of the entire coronary tree using routine angiograms, a type of X-ray for imaging blood vessels. The system can provide fractional flow reserve, or FFR, values that help detect what lesions are causing a reduction in blood flow. The system can also help physicians measure the dimensions of a lesion during an operation.”
  • Per Radiology Business,
    • “RadNet Inc. is entering the Midwest by acquiring a 60-year-old private practice’s outpatient imaging assets. 
    • “The Los Angeles company has reached a deal to acquire six freestanding centers, all operated by Indianapolis-based Northwest Radiology, for an undisclosed sum. 
    • “Founded in 1967, NWR is one of Indiana’s largest independent imaging groups, employing 18 physicians. They will continue to provide contracted services across the practice’s former locations. 
    • “The centers are primarily located in Carmel, a growing northern suburb of Indianapolis recently recognized by Travel & Leisure magazine for its livability. RadNet—which, as a publicly traded company, will eventually disclose the purchase price in a future regulatory filing—expects to net $18 million in annual revenue from the sale. 
    • “Steve Forthuber, president and CEO of Eastern Operations for RadNet, said the practice has built “remarkable trust and confidence” among the local physician community. The company plans to work closely with NWR radiologists to further expand their “clinical reach and capabilities.” 

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Patient safety, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “The Senate inched closer to triggering a partial government shutdown Monday as GOP leaders pushed forward with a $1.33 trillion funding package that includes a Homeland Security bill Democrats vowed to oppose.
    • “With only four days left before current funding for most federal agencies runs out, both parties sought to find an exit ramp from the road to a shutdown that neither side wants.”
  • The Wall Street Journal reports,
    • “The Trump administration is proposing a .09% average payment increase for Medicare Advantage plans in 2027, significantly below Wall Street’s roughly 4% to 6% expectations.
    • “The proposal also includes eliminating payments tied to diagnoses from insurer medical chart reviews not linked to specific medical visits, reducing the 2027 payment rate by 1.53 percentage points.
    • “Overall payments are projected to increase by 2.54% for 2027, combining the proposed rate changes with an additional 2.45% from underlying billing trends.”
  • Per another CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) today issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking public feedback on potential approaches to strengthen the American-made supply chain for personal protective equipment (PPE) and essential medicines. Building on lessons learned during the COVID-19 public health emergency, the agency is exploring ways to reduce reliance on foreign-made medical supplies and enhance the nation’s readiness for future emergencies while supporting American workers and manufacturers.” * * *
    • “Information on how to submit comments is available via the Federal Register at: https://www.federalregister.gov/public-inspection/current. There is a 60-day comment period.”
  • The American Hospital Association (AHA) News notes,
    • The AHA Jan. 26 urged the Health Resources and Services Administration to take immediate action to stop a new Eli Lilly and Company policy from taking effect on Feb. 1, including by “assessing civil monetary penalties for intentionally overcharging 340B hospitals.”  
    • On Jan. 15, Lilly issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. The policy would require 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting.  
    • “All told, Lilly’s draconian new policy is a case of ‘déjà vu all over again,’” the AHA wrote. “Once more, we have a drug company taking unilateral action against 340B hospitals based on flawed legal and policy reasoning, testing the limits of the law and challenging HRSA’s authority over the 340B Program. Much like its 2021 contract pharmacy restrictions and its 2024 unilateral rebate policy, Lilly seeks to boost its bottom line at the expense of 340B hospitals and the vulnerable patients they serve.” 
  • Healthcare Dive reports,
    • “Providers and health insurers submitted almost 1.2 million cases to a federal portal meant to resolve disputes over surprise medical bills in the first half of 2025 — almost 40% more than in the last six months of 2024, according to new data from the CMS.
    • “Arbiters are handling the rising volume while cutting into the existing backlog, processing more than 1.3 million disputes in the first half of the year, the CMS said. That’s up almost 50% from the prior six months.
    • “Still, despite faster closures, the independent dispute resolution process remains dogged by problems. Many submitted disputes are actually ineligible for IDR, and parsing through those is the primary cause of delays, the CMS said. And, the lion’s share of disputes continue to be submitted by a handful of mostly private equity backed-provider groups, raising concerns IDR is being exploited for profit.”
  • The AHA News adds,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Dane Street, LLC as a new independent dispute resolution entity, bringing the total number to 16. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.” 
  • OPM Director Scott Kupor writes in his Secrets of OPM blog about “the performance management priorities and actions the Trump Administration is taking on behalf of the American people.”

From the Food and Drug Administration front,

  • Fierce Healthcare relates,
    • “Aidoc has secured 11 new indications from the Food and Drug Administration (FDA), bringing a comprehensive body CT triage solution to emergency departments and ambulatory settings to reduce patient backlogs. 
    • “Aidoc, a clinical artificial intelligence company, is trying to solve the root issue of overcrowding in emergency departments and provider offices. The company argues that providers’ operational workflows, which mostly prioritize patients on a “first come, first serve” basis, don’t work well.
    • “Instead of first-in, first-out, Aidoc’s AI triage solution can prioritize scans based on its initial review of the images. Those scans are then moved up in the queue for radiologists to review, allowing acutely ill patients to receive care more quickly.”
  • MedTech Dive points out,
    • “Intuitive Surgical on Monday provided more details about its new cardiac surgery initiative for the da Vinci 5 robot, including specifying nine procedures that received U.S. clearance.
    • “Among those are mitral and tricuspid valve repair, mitral valve replacement, and left atrial appendage closure — procedures that comprise key businesses for heart device companies such as Boston Scientific, Abbott and Edwards Lifesciences.
    • “Intuitive said cardiac procedures with da Vinci 5 can enable surgeons to operate through small incisions without splitting the breastbone, which is typically required in open heart surgery.” * * *
    • “The update comes after Intuitive executives told analysts on an earnings call last week that the Food and Drug Administration had cleared the robot for cardiac surgery.”
    • “Intuitive said it plans to begin working with a limited number of U.S. sites through 2026 to establish da Vinci 5 cardiac programs.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The American Academy of Pediatrics recommends children be vaccinated against 18 diseases, more than the U.S. government directs after it overhauled its schedule.
    • “The doctors group, which released its recommendations Monday, kept its guidance largely unchanged from its previous version from last year. The group said it doesn’t endorse the Centers for Disease Control and Prevention’s childhood-vaccine schedule. The agency now recommends all children get vaccinated against 11 diseases.”
  • A commentator, writing in STAT News, observes,
    • “The recent overhaul of the U.S. pediatric vaccine schedule under Health and Human Services Secretary Robert F. Kennedy Jr. touched off a firestorm of criticism — most of it for demoting six vaccines from routinely recommended to “shared clinical decision-making” (SCDM). The implication was that these six vaccines are optional, less safe, or less useful than the routinely recommended ones.
    • “Like nearly everyone in public health, I agree that the evidence for the safety and efficacy of the six vaccines is robust and hasn’t changed.
    • “But in its urge to say what Kennedy gets wrong, the public health and medical community is actively resisting something he gets right: Vaccination decisions belong to patients and their parents, guided by candid advice from health care professionals.”
  • The American Medical Association lets us know what doctors wish their patients knew about polio.
  • The New York Times relates,
    • “For years, the nonprofit groups that coordinate transplants in the United States regularly ignored federal rules — skipping patients at the top of waiting lists and sending organs to those who weren’t as sick and hadn’t waited as long.
    • “But new federal data shows that the rate of skipped patients has dropped by more than half in recent months, a change that reflects a far-reaching effort to make the transplant system fairer and safer.
    • “This is truly great news for patients and the system,” said Dr. Jesse Roach of the National Kidney Foundation. “We need to continue to monitor it, to ensure the system is fair, efficient and transparent. But this is a win.”
  • Beckers Clinical Leadership informs us,
    • “The Joint Commission and the National Quality Forum are aligning their serious safety event reporting frameworks in an effort to reduce redundancy and ease the administrative burden on healthcare providers.
    • “Effective Jan. 1, 2027, The Joint Commission will adopt the NQF’s Serious Reportable Events, or SRE List, across all accredited domestic and international organizations, according to a Jan. 26 news release from the organizations. Three workplace safety events — homicide, sexual abuse or assault, and physical assault of staff — will be retained as part of the revised SRE list.
    • “Leaders of both organizations said consolidating around the NQF list will simplify reporting for clinicians and hospitals while providing a more consistent, standardized framework for measuring and tracking patient safety events across states and health systems.”
  • Genetic Engineering and BioTechnology News notes,
    • “It is known that inflammatory bowel disease (IBD) increases the risk of colorectal cancer (CRC). But the underlying mechanism—and the genetic drivers—between this link remain yet to be determined. Genetic variants in TNFSF15, encoding tumor necrosis factor (TNF)-like cytokine 1A (TL1A), are associated with both severe IBD and advanced CRC.
    • “Now, a new study points to immune reactions in the gut—driven by a key signaling protein and a surge of white blood cells from the bone marrow—to help explain why people with inflammatory bowel disease have a higher risk of colorectal cancer.
    • “This work is published in Immunity in the paper, “Innate lymphoid cells activated by the cytokine TL1A link colitis to emergency granulopoiesis and the recruitment of tumor-promoting neutrophils.”
  • Per Healio,
    • “Researchers compared the outcomes of more than 40,000 infants who were immunized through nirsevimab or maternal RSV vaccination.
    • “Nirsevimab was associated with fewer severe outcomes than the maternal vaccine.” * * *
    • “Our results should not be interpreted as evidence against maternal RSV vaccination,” Marie Joelle Jabagi, PharmD, PhD, MPH, said. “Instead, they underscore that clinicians should individualize prevention strategies based on clinical context, access to care and timing within the RSV season. Both approaches remain valuable and may be complementary, particularly in efforts to maximize population-level protection against RSV.”
  • Per Health Day,
    • “Childhood ADHD can set a person up to have poor health in middle age, a new study says.
    • “People with ADHD traits at age 10 are likely to have chronic illness and disability at age 46, researchers reported Jan. 21 in JAMA Network Open.
    • ‘The study said these health problems can include asthma, migraines, back problems, cancer, epilepsy, hearing problems, GI disorders, kidney disease and diabetes.
    • “We have added to the concerning evidence base that people with ADHD are more likely to experience worse health than average across their lifespan,” said lead researcher Joshua Stott, a professor of aging and clinical psychology at University College London in the U.K.
    • “People with ADHD can thrive with the right support, but this is often lacking, both due to a shortage of tailored support services but also because ADHD remains underdiagnosed, particularly in people in midlife and older, with needs unaddressed,” Stott said in a news release.”

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

  • The Street reports
    • “The Centers for Medicare & Medicaid Services (CMS) recently published some in-the-weeds datasets on the use of, and spending for, drugs prescribed to Medicare beneficiaries. 
    • “There’s the Medicare Quarterly Part B and Part D Drug Spending Datasets and the annual version of the Medicare Part B and Part D Drug Spending datasets.”
    • The Street feature a 13 minute webinar with a consultant who has used the data sets (plus a transcript of that webinar).
  • Beckers Hospital Review tells us,
    • “More than 500,000 providers prescribed GLP-1s in 2025, with wide variation between specialties, according to a Jan. 22 article from IQVIA, a clinical research firm. 
    • “GLP-1 medications are approved for several conditions, including Type 2 diabetes, obesity, cardiovascular disease, chronic kidney disease, liver disease and sleep apnea. Among GLP-1 drugs approved for weight loss — Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound — adoption and prescribing trends differed across provider specialties.
    • “Endocrinologists stand out as both quick adopters of Wegovy and subsequent high writers for Zepbound, leveraging their expertise in managing complex metabolic conditions to integrate new treatments earlier,” according to IQVIA. “Their readiness to prescribe is shaped by familiarity with the mechanisms of GLP-1 therapies and a patient base that often presents with comorbidities where these drugs deliver added value.”
    • “Primary care providers account for the largest share of GLP-1 prescriptions due their broad patient base. However, in contrast to endocrinologists, they have been slower to adopt GLP-1s, which IQVIA defines as prescribing a GLP-1 within the first 1.75 years of the drug entering the market.”
  • Per BioPharma Dive,
    • “Children with Duchenne muscular dystrophy who received Sarepta Therapeutics’ gene therapy Elevidys in a clinical trial continued to perform better on tests of motor function than historical data suggests they should, and the benefits appear to compound with time, the company said Monday.
    • “According to Sarepta, patients in the study, Embark, had greater reductions on three measures of function than a matched historical control group, with the gap “significantly widening” between two and three years after treatment. Doug Ingram, Sarepta’s CEO, said the data is an opportunity to “rebalance the discussion” surrounding Elevidys, sales of which have slowed amid safety concerns and newly restrictive labeling. 
    • “In research notes published Monday, multiple Wall Street analysts viewed the data as a positive development for the company. They also noted, though, that investors will be more focused on whether the results translate to sales growth. Sarepta shares, which have lost much of their value over the last year, rose by double digits in morning trading.” 
  • MedCity News considers “what does OpenAI and Anthropic’s healthcare push mean for the industry?”
    • “As OpenAI and Anthropic move deeper into healthcare, experts say AI chatbots are becoming the new front door to medicine. This shift is shaking things up for some health tech startups, redefining the patient-provider relationship, and intensifying debates over safety, privacy and accountability.:

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • MedCity News offers four takeaways from yesterday’s House of Representatives hearings with health insurance CEOs.
    • Everyone agrees healthcare affordability is a problem.
    • Everyone has different ideas for addressing the affordability problem.
    • Vertical integration [bad per a bipartisan group of members of Congress]
    • Prior authorization and denials [bad per a bipartisan group of members of Congress]
  • Roll Call adds,
    • “The House left Thursday night after barely shooting down another war powers resolution and passing a last slate of funding bills, leaving it up to the Senate to avert a partial government shutdown by next week’s deadline.
    • “But with a major winter storm predicted to blanket Washington and other swaths of the country in double digits of snow this weekend, senators are already facing delays that make for tight timing. A spokesman for Senate Majority Leader John Thune, R-S.D., announced Friday that Senate votes originally slated for Monday would be postponed until 5:30 p.m. on Tuesday [due to the impending winter storm].”
  • The Wall Street Journal offers the Medicare-eligible community helpful information about Medicare Part B and D’s income adjustment premiums, which are known as IRRMA.
  • OPM Director Scott Kupor added to his Secrets of OPM blog with a post about improving claims administration for the complex federal employee retirement systems.
    • “Here’s the reality: OPM does not receive a fully completed application and cannot begin its work – on average – for about 120 days from when the applicant starts the application process.
    • “So, where are those 107,000 total [online retirement] applications [(ORA)} sitting today? 
    • Roughly half are at OPM (more on that later), but 30% are sitting with the payroll providers; 12% are sitting with agency HR teams, and 8% are sitting with the applicant.
    • That matters, because when cases do reach OPM, we move quickly. We are issuing interim pay immediately in about 75% of cases, and on average within seven days in 100% of cases. That means, on average,  within seven days of receiving the application, annuitants will be getting 80% of their expected final post-adjudication payout. Making sure retirees have money in their bank accounts as fast as possible is our first priority, and our performance there is strong.
    • And we are also seeing huge dividends from ORA in the time it takes for us to complete the final review of an annuitant’s case and deliver them 100% of their earned pension. As of today, we are completing ORA applications in less than 40 days from when we receive them in OPM. To give you a reference point, it takes at least twice as long for us to adjudicate paper-based cases. So, we are moving in the right direction.
    • But we are not complacent with the status quo and will continue to do even better.
  • FedWeek reports,
    • “The Postal Service has launched a new bid solicitation platform allowing businesses to submit proposals to access its last-mile delivery network, something Postmaster General David Steiner has touted as a key to turning around the service’s finances.
    • “Competitive bidding is now open for its 18,000 delivery destination units (DDUs) for same day or next day service, something that had become increasingly likely as contract renewal talks with Amazon stalled late last year – and with Amazon reportedly threatening to directly compete with it own, expanded, fleet.
    • “USPS officials said the move responds to growing demand for speed and convenience in the shipping market and to better leverage agency’s last-mile capabilities. Accepted bids are expected to be formalized through negotiated service agreements, with winning bidders notified in the second quarter of 2026 and service beginning in the third quarter.
    • ‘The news is bitter sweet for some postal carriers that have been wrestling Amazon packages to their final destinations for years, as any relief could be short lived and potentially result in the same volume but dealing with multiple carriers instead of one.”
  • The American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration has released a guide to improve coordination between 988 lifeline and 911 emergency services. It outlines strategies to reduce legal risk, clarify roles and strengthen partnerships to ensure appropriate care in crisis situations. The guide also includes resources to help achieve interoperability between the services.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Sanofi said Friday it will ask regulators around the world to review its new eczema drug amlitelimab following mixed study results that could lead to a clearance in the U.S. but spell trouble in Europe.  
    • “A combination of amlitelimab and topical steroids helped between one-quarter and one-third of people with eczema completely or almost completely clear their skin lesions, depending on the dose frequency received and trial they’d participated in. Amlitelimab met all its objectives in one late-stage study. too. But in a second trial, amlitelimab missed a statistical threshold sought by European regulators. A safety study also uncovered one case of a type of skin cancer in a drug recipient.
    • ‘The results show amlitelimab is “a U.S. file-able drug that can differentiate on convenience,” Jefferies analyst Michael Leuchten wrote in a note to clients. Sanofi said it intends to move forward with global submissions based on the “totality of the data.”
  • MedTech Dive informs us,
    • “Integra LifeSciences has recalled wound and burn treatments over issues linked to 14 serious injuries, the Food and Drug Administration said Thursday.
    • “The FDA published an early alert after Integra wrote to customers about packaging failures that affected the sterile barrier and could lead to patient infection.
    • “Integra wrote to customers last week, around five months after recalling other wound and burn devices because of inadequate sealing of sterile barrier packaging.”

From the judicial front,

  • Beckers Payer Issues reports,
    • “Jury selection in the federal murder trial of Luigi Mangione is scheduled to begin Sept. 8, U.S. District Judge Margaret Garnett said Jan. 23.
    • “The 27-year-old is accused of fatally shooting UnitedHealthcare CEO Brian Thompson outside the New York Hilton Midtown in late 2024. Mangione has pleaded not guilty to four federal charges, including murder through use of a firearm, as well as state murder charges.
    • “The next milestone in the federal case will depend on Judge Garnett’s decision on whether Mangione will face the death penalty, which Attorney General Pamela Bondi directed federal prosecutors to pursue in April. If Judge Garnett removes capital punishment as an option, the trial would begin Oct. 13; if she allows the case to proceed as a capital case, the trial would start in early 2027, according to reporting from The Guardian.“
  • MedPage Today points out,
    • “The American Psychiatric Association (APA) is suing a New York State health plan over its alleged use of “ghost networks” that list mental health providers that are not in their network or aren’t taking new patients.
    • “The class action lawsuit, filed on Dec. 30 in federal court against EmblemHealth, alleges that the ghost network directory “constitutes unlawful deceptive acts and practices, false advertising, and violations of statutory and regulatory requirements,” according to an APA press releaseopens in a new tab or window. “It also alleges that their provider directory violates federal trademark law by falsely advertising and misusing the names, identities and reputations of mental health clinicians.”

From the U.S. healthcare and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. Among children 5–17 years, hospitalizations are stable and emergency department visits are increasing. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old.
    • “COVID-19
      • COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. Among children 5–17 years, hospitalizations are stable and emergency department visits are increasing. Activity is increasing or stable in the Midwest, Central, and West Coast regions.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations among infants less than 1 year old are elevated.”
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains suboptimal for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds,
    • “The South Carolina Department of Public Health (DPH) today confirmed 54 new measles cases in just three days, raising the size of its outbreak, which DPH first reported in October, to 700 cases.
    • “The news comes as the Centers for Disease Control and Prevention (CDC) confirmed 416 total US cases so far this month—an increase of 245 infections in the past week—and as US health officials downplay the burgeoning outbreak and the key role that vaccines play in preventing illness.”
  • and
    • “Routine childhood vaccinations, nor the aluminum used as vaccine adjuvants, are not associated with an increased risk of epilepsy in young children, according to a new case-control study published this week in The Journal of Pediatrics. 
    • “The study, led by a team from the Marshfield Clinic Research Institute in Marshfield, Wisconsin, examined whether being up to date on recommended vaccines or having higher cumulative exposure to vaccine-related aluminum was linked to the development of epilepsy in children under age four. 
    • “Analyzing a decade of pediatric health data from the Vaccine Safety Datalink, which is a collaboration between the Centers for Disease Control and Prevention and several health care sites that monitor vaccine safety, the team identified 2,089 children diagnosed as having epilepsy from age 1 year to less than 4 years and matched them with 20,139 children without epilepsy based on age, sex, and health care site. 
    • “Most participants were boys (54%) and between the ages of 1 year and 23 months (69%). White non-Hispanics composed the largest ethnicity group in the study (40%).”
  • STAT News tells us,
    • “The number of ongoing prescription drug shortages rose slightly in the last quarter of 2025, but remained significantly lower than the all-time high reached in the beginning of 2024. Moreover, the number of new shortages identified last year marked the lowest level in nearly 20 years, according to a new report from the American Society of Health-System Pharmacists.
    • “As last year drew to a close, there were 216 prescription medicines in short supply in the U.S., which was slightly more than earlier in the year, but this was significantly less than the 323 prescription drug shortages recorded in the beginning of 2024, the report found.
    • “The number of new shortages identified last year was just 89, the lowest figure since 2006, and considerably less than 130 medicines that were in shortly supply in 2024. And notably, long-standing shortages are beginning to resolve; 75% of all the active shortages started in 2022 or later.”
  • Per MedPage Today,
    • “People with the lowest serum vitamin D levels were 33% more likely than those with the highest levels to be hospitalized for respiratory tract infections.
    • “Researchers found no evidence that the association between vitamin D status and respiratory tract infection risk differed by race or ethnicity.
    • “Obesity, being male, older age, statin use, and lower income were all linked to a greater risk of hospitalization for respiratory infections.”
  • and
    • “Arthritis can be disabling enough to prevent people from working, but the factors influencing employability in this population have not been well studied.
    • “This study used data from the long-running Health and Retirement Study to estimate “healthy working life expectancy” (HWLE) for people with arthritis, including major subgroups.
    • “HWLE was found to be markedly diminished for people with arthritis, and especially so for arthritis patients not finishing high school, those with obesity, and Black individuals.”

From the U.S. healthcare business front,

  • Fierce Pharma reports,
    • “With just a few months to go before Eli Lilly expects to launch its own oral GLP-1 obesity drug, Novo Nordisk is making the most of its head start with the Wegovy pill.
    • “In the second week of oral Wegovy’s launch, which ended Jan. 16, the pill logged roughly 18,400 total prescriptions, according to IMS data cited in a Friday note from analysts at Jefferies. Other tracking data put the second week of Wegovy pill prescriptions closer to 20,000, the analyst team pointed out.
    • “The quick uptake of Novo’s new oral obesity offering is impressive and appears “numerically higher” than both injectable Wegovy (roughly 1,600 prescriptions) and its Lilly counterpart Zepbound (around 7,300 prescriptions) in the first two weeks of their respective launches, the Jefferies team said.”
  • The FEHBlog ran across this Health Care Cost Institute website which “shows average price data for bundles of health services to help you better understand the cost of care in your area.” Check it out.
  • Fierce Healthcare informs us,
    • “CommonSpirit Health and Altru Health System are considering a deal to transfer three North Dakota hospitals to the latter, the organizations announced Thursday.
    • “The pair’s signed letter of intent outlines plans to evaluate a potential deal for the facilities, a process they said would run “the next several months” before a potential definitive agreement might be struck.
    • “In the balance are CHI St. Alexius Health Bismarck, a multispecialty acute care medical center in the state’s capital, and two smaller critical access hospitals, CHI St. Alexius Health Turtle Lake and CHI St. Alexius Health Garrison. All three are Catholic facilities within CommonSpirit’s regional healthcare system CHI St. Alexius Health.”
  • Beckers Hospital Review notes,
    • “Newly released data from KFF show there were an average of 422 emergency room visits per 1,000 population nationally in 2024, the most recent year for which data are available. KFF used  data from the American Hospital Association’s annual survey of community hospitals  — which accounts for 85% of all U.S. hospitals — and population estimates from the Census Bureau to compile ED visits per 100,000 population for every state.
    • “ED utilization rose in many states compared to data from 2023. The latest figures offer a preview of where added strain from rising coverage losses and reduced access to preventive care may hit hardest. 
    • “[The article includes] a state-by-state breakdown of total emergency department visits per 1,000 population in 2024, including the District of Columbia, starting with states where rates are highest.” 
  • Beckers Health IT lets us know,
    • “Walmart is set to open four clinical research sites in spring 2026, including at its former healthcare centers.
    • “The Walmart Healthcare Research Institute is launching the facilities in collaboration with clinical research company Care Access at three ex-Walmart Health locations and a rural Walmart store. The sites will offer health screenings and explore study opportunities with patients.
    • “Clinical research should feel practical and approachable, not distant or intimidating, especially for communities that have had difficulty participating in opportunities for innovative treatments,” Walmart Chief Medical Officer Emily Aaronson, MD, said in a Jan. 22 news release.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Healthcare Dive reports,
    • “Republicans and Democrats in the House Budget Committee spent Wednesday blaming each other for the steep cost of healthcare, and arguing for diametrically opposed ideas to lower it. However, a few areas of bipartisan agreement emerged, including targeting healthcare consolidation — once an unheard-of view for members of the GOP.
    • “We got problems in Peoria with consolidation, with too much power and too many assets in too few market participants,” said Chairman Jodey Arrington, R-Texas, referring to a small community in Hill County. “You know how we feel about big government … but the most important thing here is, I think there’s common ground here.”
    • “We ought to huddle up at some point, probably not during a hearing, and figure out where we can deal with big medicine monopolies in pharma, hospital, insurance — the whole gambit. And I just want you to know I’m down with that,” Arrington continued.”
  • AHIP released two more healthcare cost articles today.
  • The Hill reports,
    • “Some of the nation’s top health insurance executives sought to deflect blame for the soaring cost of health care in the U.S., arguing that rising hospital and prescription drug prices were driving premiums higher and making health care less affordable for Americans.
    • “The CEOs of five major health insurers testified before a House Energy and Commerce subcommittee on Thursday, the first in a series of back-to-back hearings focused on finding the root causes driving unaffordability in the health care system, including skyrocketing premiums.”
  • and
    • “The House passed its final four appropriations bills Thursday afternoon, bringing Congress one step closer to avoiding a partial shutdown at the end of the month.
    • “A minibus package passed with a convincing 341-88 vote, funding the departments of Defense, Transportation, Housing and Urban Development, Health and Human Services, Labor, Education and other related agencies. The House separately passed legislation to fund the Department of Homeland Security with a 220-207 vote.”
  • The House of Representatives will be on recess next week while the Senate returns to Capitol Hill to tackle these appropriations bills.
  • Beckers Payer Issues raises three big questions about Trump’s healthcare policy plan.
  • On the bright side, Modern Healthcare relates,
    • “More than 40 hospitals have converted to rural emergency hospitals since 2023 [under a new federal program]. 
    • “The program has stabilized rural hospital finances but fewer hospitals converted last year.
    • “Hospitals have expanded services to their communities since joining the program.”
  • Federal News Network tells us,
    • “Agencies are getting more information on how to implement the recently finalized “rule of many.” The federal hiring strategy, several years in the making, aims to create broader pools of qualified job candidates while adding flexibility for federal hiring managers.
    • “A series of guidance documents the Office of Personnel Management published earlier this month outlined the steps agencies should take to begin using the “rule of many” when hiring. OPM’s new resources also detail how the “rule of many” intersects with other aspects of the federal hiring process, such as shared certificates, skills-based assessments and veterans’ preference.
    • “Under the “rule of many,” federal hiring managers score job candidates on their relevant job skills, then rank the candidates based on those scores. From there, hiring managers can choose one of several options — a cut-off number, score or percentage — to pare down the applicant pool and reach a list of qualified finalists to select from.”
  • Tammy Flanagan, writing in Govexec, answers “a litany of new questions on how to receive retirement benefits” coming from “an influx of federal retirees due to the Deferred Resignation Program and other separation programs.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Drugmakers developing experimental multiple myeloma drugs may have a quicker path to market under new guidance the Food and Drug Administration published this week.
    • “According to the new framework, the regulator may grant accelerated approvals in some settings based on a therapy’s ability to induce “minimal residual disease” or “complete responses,” both of which are achieved when drugs drastically reduce levels of dysfunctional blood cells in people with the disease.  
    • “The FDA has recently handed accelerated approvals to multiple myeloma drugs like Johnson & Johnson’s Tecvayli and Talvey based on the “objective response rate” — a measure of remissions determined by the presence of disease on a scan — observed in clinical testing.” 

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Despite gains in treatment, cardiovascular disease remains the leading cause of death in the United States, accounting for nearly three in 10 fatalities — 916,000 — in 2023, according to a report published Wednesday by the American Heart Association.
    • “It outnumbers deaths from the second and third leading causes — cancer and accidental injuries — combined.
    • “The statistics are a sobering reminder that there is “a lot of work to do” when it comes to prevention and treatment of heart disease and stroke, said Dr. Donald Lloyd-Jones, a professor of cardiology at Boston University and former president of the association, who was not involved in the new report.”
  • Cardiovascular Business adds,
    • “Cardiology has been shifting away from reactionary treatment strategies to a greater emphasis on prevention. With a shortage of heart failure specialists in the United States and hospitalization rates on the rise, reducing the number of advanced heart failure cases is a major target of such prevention efforts.
    • “A joint scientific statement from the Heart Failure Society of America (HFSA) and the American Society for Preventive Cardiology (ASPC) about prevention in heart failure was released online in 2025 and then published in the Journal of Cardiac Failure (JCF) to kick off 2026.[1] The goal of the statement is to raise awareness that prevention efforts to stop the advance of heart failure symptoms should start with primary care and general cardiologists before the symptoms of these patients becomes critical. This is part of a wider effort across cardiology and medicine to try and reduce heart failure hospitalizations.”
  • and
    • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
    • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
    • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
    • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.”
  • The Wall Street Journal relates,
    • “Colorectal cancer is on the rise among young people. Now it is the leading cause of cancer death in the U.S. for those under 50, according to a new analysis. 
    • “More than 1.2 million people under age 50 died of cancer in the U.S. from 1990 through 2023, American Cancer Society researchers reported Thursday.
    • “Some 3,905 people ages 20 to 49 died of colorectal cancer in 2023, according to Cancer Society statistics, compared with 3,809 for breast cancer and 2,086 for brain and other nervous system cancers.
    • “This is absolutely disconcerting,” said Dr. Madappa Kundranda, division chief of cancer medicine at Banner MD Anderson Cancer Center in Phoenix, who wasn’t involved in the research.” * * *
    • “As colorectal cancer among younger people has emerged as a bigger threat, medical groups have lowered the recommended age for colonoscopies that can detect the disease while there are good odds for effective treatment.
    • “Yet not enough people under 50 are getting the screenings, doctors said, prompting calls for a redoubling of efforts to educate doctors and nurses about the need to talk with patients.”
  • The New York Times points out,
    • “Is there a way to use the body’s way of fighting cancers to make a new drug?
    • “Perhaps, according to preliminary research studies.
    • “The idea is to exploit what is known about the growth of cancers. While many grow and spread and are deadly without treatment, some go away on their own or simply do not progress. They remain in the body, harmless and causing no symptoms. It’s contrary to conventional wisdom.
    • “But Dr. Edward Patz, who spent much of his career researching cancer at Duke, has long been intrigued by cancers that are harmless and has thought they might hold important clues for drug development.
    • “The result, after years of research, is an experimental drug, tested so far only in small numbers of lung cancer patients. The results are encouraging, but most promising experimental drugs fail after larger, more rigorous studies.
    • “That hasn’t stopped Dr. Patz from recently starting a company, Grid Therapeutics, hoping that the experimental drug will turn out to be a new type of cancer treatment.”
  • The Washington Post cautions,
    • Obesity in midlife may cause vascular dementia later in life by raising blood pressure over decades and quietly damaging brain vessels, according to new research released Thursday.
    • The danger could be significant. Having a higher body mass index increases the risk of vascular dementia by roughly 50 to 60 percent, according to the study, published in the Journal of Clinical Endocrinology & Metabolism. An association between obesity and dementia has long been the subject of study, and the new research strongly indicates there is indeed a link.
    • “We add a layer of evidence that suggests causality,” said Ruth Frikke-Schmidt, who was the study’s lead author and is a professor and chief physician at Copenhagen University Hospital Rigshospitalet and the University of Copenhagen. “For public health, this is an important message.”
  • Beckers Clinical Leadership informs us,
    • “Even as patient acuity climbed over the last several years, hospitals posted notable gains in mortality and reductions in two major hospital-acquired infections, a new Vizient report found.
    • “The Jan. 22 report is based on an analysis of the Vizient Clinical Data Base, which includes data from more than 1,000 hospitals nationwide. It compares trends from the fourth quarter of 2019 to the second quarter of 2025 across measures of acuity, mortality performance and select hospital-acquired infections.
    • “These improvements occurred during a period marked by workforce shortages, supply chain instability and rising case complexity, signaling that the system’s quality infrastructure is stronger, more adaptive and more scalable than often recognized,” the report said.”
  • Per MedPage Today,
    • “Ten-year follow-up results showed that 37.8% of patients who received antibiotics versus appendectomy had a true recurrence of appendicitis.
    • “Overall, cumulative complication rates at 10 years were significantly higher in the appendectomy group versus the antibiotic group.
    • “The analysis “reaffirms antibiotics as a safe and feasible alternative to appendectomy,” researchers said.”
  • Per Health Day,
    • “Even brief treatment with Ozempic can improve knee replacement outcomes among people with type 2 diabetes.
    • “Taking semaglutide for as little as two to three months improved a person’s odds of avoiding major surgery complications.
    • “Less than a month’s treatment lowered odds of minor complications.”
  • and
    • “Super agers are likely to have genetic advantages that protect their brain health.
    • “They are less likely to carry a gene linked to increased risk of Alzheimer’s.
    • “They also are more likely to have a gene that appears to protect against Alzheimer’s. * * *
    • “Super agers” are people whose brain power at 80 or older compares to that of people 20 to 30 years younger, researchers said.”
  • Truveta adds,
    • “As of December 2025, GLP-1 RA prescriptions account for more than 7% of all prescriptions.
    • “Tirzepatide continues to be the most prescribed anti-diabetic (ADM) and anti-obesity (AOM) medication (sold as Mounjaro and Zepbound, respectively) and showed the largest increase in total prescribing from September to December 2025.
    • “Overall prescribing rates (GLP-1 RA prescriptions per total prescriptions) increased slightly from September to December 2025 (+5.0%); however, first-time prescribing rates declined over the same period (-6.6%). These trends are consistent with first-time prescribing rates seen around the holidays in previous years.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Insurance technology company Sidecar Health is offering health plans to employers in Texas.
    • “The company, which launched in 2018, covers employees in 48 states who work for businesses headquartered in Ohio, Georgia, Florida and Texas.
    • “Insurance technology company Sidecar Health is offering health plans to employers in Texas.
    • The company, which launched in 2018, covers employees in 48 states who work for businesses headquartered in Ohio, Georgia, Florida and Texas. 
    • “Sidecar touts an alternative model promising no prior authorizations, referrals or specific networks. For covered services, the plan will pay for up to a maximum allowable amount based on local market prices, according to the company. If a service is below the benefit amount, members can keep half the savings, Sidecar said in the release. If they receive care that costs more than the benefit amount, members are required to pay the difference.”
  • and
    • “A unique marketing campaign from Blue Cross and Blue Shield of Vermont lays out price variations between specific providers for certain services. 
    • “Blue Cross and Blue Shield of Vermont unfavorably compares costs at the University of Vermont Medical Center to other hospitals.
    • “Industry watchers say it could represent a new era in contract negotiations between health insurance companies and providers.”
  • Beckers Health IT tells us,
    • Amazon’s One Medical and Cleveland Clinic have opened their second collaborative primary care office. 
    • The new office, located in Shaker Heights, Ohio, offers preventive care, chronic disease management and treatment for common illnesses such as colds and flu. Patients also have access to on-site lab services and same- or next-day appointments.
    • The office follows the October opening of the organizations’ first joint primary care site in Northeast Ohio, according to a Jan. 22 news release One Medical shared with Becker’s.
  • Fierce Pharma relates,
    • “As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade, the generic and biosim specialist sees a multibillion-dollar opportunity up for grabs. 
    • “The company detailed its outlook on the upcoming “‘golden decade’ of affordable medicines” at the J.P. Morgan Healthcare Conference last week. Tallying up expected losses of exclusivity across the industry over that period, the Swiss drugmaker sees a generic drug opportunity of up to $340 billion and a biosim opportunity totaling $322 billion.
    • “More than 50 biologic drugs are set to go off patent in the next seven years and have no biosimilars lined up to launch. This situation has created what’s been coined the “biosimilar void” among industry watchers.
    • “While fully dissipating the void will require participation from many biosim players, Sandoz is committed to the cause: The company boasts a plan to target some 60% of the total biosimilar opportunity in sight.
    • “Still, “we want to do more,” the company’s North American president, Keren Haruvi, told Fierce Pharma in an interview on the sidelines of JPM.”
  • MedTech Dive notes,
    • “Abbott’s fourth quarter sales came in below expectations, as the company navigated challenges in its nutrition and diagnostics businesses. Abbott also reported less growth than expected in its medical devices segment. 
    • “The company’s revenue of $11.46 billion for the quarter fell short of analysts’ consensus of $11.8 billion, Leerink Partners analyst Mike Kratky wrote in a research note on Thursday.”

From the artificial intelligence front,

  • Healthcare Dive shares a mixed bag of reports,
    • “Amazon is launching a health-focused artificial intelligence chatbot for members of its One Medical primary care chain, the tech giant said Wednesday. 
    • “The Health AI assistant uses One Medical members’ medical record information to answer health questions and provide guidance on symptoms and potential treatments. Users can also chat with the assistant to book appointments, decide between care settings and renew prescriptions.
    • “The chatbot is built with “multiple patient safety guardrails,” including protocols that connect patients with a provider through messages or an in-person appointment when their clinical judgment is needed, an Amazon spokesperson said.”
  • and
    • “Healthcare workers are using artificial intelligence tools that haven’t been approved by their organizations — a potential patient safety and data privacy risk, according to a survey published Thursday by Wolters Kluwer Health. 
    • “More than 40% of medical workers and administrators said they were aware of colleagues using “shadow AI” products, while nearly 20% reported they have used an unauthorized AI tool themselves, according to the survey by the information services and software firm.
    • “Those unapproved tools might be useful to individual workers, but their health systems haven’t vetted the products’ risks or considered governance processes, according to Dr. Peter Bonis, chief medical officer at Wolters Kluwer. “The issue is, what is their safety? What is their efficacy, and what are the risks associated with that?” he said. “And are those adequately recognized by the users themselves?”
  • and
    • “Misuse of artificial intelligence-powered chatbots in healthcare has topped ECRI’s annual list of the top health technology hazards.
    • “The nonprofit ECRI, which shared its list Wednesday, said chatbots built on ChatGPT and other large language models can provide false or misleading information that could result in significant patient harm.
    • “ECRI put chatbot misuse ahead of sudden loss of access to electronic systems and the availability of substandard and falsified medical products on its list of the biggest hazards for this year.”

Tuesday report

David Ermer–CMS, FDA, HSA, Medical / Rx research, Medicare, OPM, Patient safety, Rx coverage, U.S. Healthcare–

The FEHBlog will be on hiatus following today until next December 27 Cybersecurity Saturday. Merry Christmas and Jingle Bells to all.

From Washington, DC,

  • Federal News Network reports,
    • “There’s an old adage that tells someone to “put your money where your mouth is.” Well, Don Bauer is going all in at the Office of Personnel Management.
    • “Bauer wrote a column for Federal News Network criticizing OPM’s plans to consolidate and modernize human resources systems across the government. In his Oct. 30 column, Bauer wrote that OPM’s initial plan was “not modernization; it’s madness.”
    • “Now Bauer is in charge of that madness. Federal News Network has learned Bauer will join OPM on Jan. 12 as its new deputy associate director for workforce standards and data center (WSDC) in the HR Solutions (HRS) office. He will be leading the HR Line of Business, the quality service management office (QSMO) and human capital management core modernization effort.”
  • Good luck, Mr. Bauer.
  • Mercer tells us,
    • “In Notice 2026-5, IRS and the Treasury Department provide key details about health savings account (HSA) enhancements passed as part of the One Big Beautiful Bill Act (OBBBA) (Pub. L. No. 119-21), clearing the way for employers to continue offering telehealth and to begin offering direct primary care service arrangements (DPCSAs) to otherwise HSA-eligible employees.
    • “Effective for the 2025 plan year, OBBBA reinstated and made permanent COVID-19-era telehealth relief allowing HSA-compatible high-deductible health plans (HDHPs) to cover telehealth and other remote care services before the statutory minimum deductible is satisfied.
    • “Beginning Jan. 1, 2026, OBBBA also allows individuals enrolled in DPCSAs to remain eligible to make or receive HSA contributions and treats certain bronze and catastrophic plans as HDHPs.
    • “This article summarizes the Notice 2026-5 question-and-answer guidance, addressing significant topics such as which services the IRS will treat as “telehealth and other remote care services;” whether a DPCSA can separately bill for primary care services or offer services beyond primary care; and whether a bronze or catastrophic plan can be an HDHP if purchased using an employer-sponsored individual coverage health reimbursement account (ICHRA).
    • ‘Comments about the guidance are due March 6, 2026.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today a new voluntary test of a model that is designed to enable Medicare Part D plans and state Medicaid agencies to cover GLP-1 medications used for weight management and metabolic health improvement, while helping control costs for patients and taxpayers.
    • “The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model builds on emerging evidence that combines access to GLP-1 medications with access to evidence-based lifestyle supports to achieve better long-term health outcomes. The model represents a major step toward potential expanded access and affordability for millions of Americans. 
    • “Today’s announcement builds upon our historic Most Favored Nations drug pricing deals’ goal of democratizing access to weight-loss medication, which has been out of reach for so many in need,” said CMS Administrator Dr. Mehmet Oz. “These actions further the administration’s bold plan to reform our country’s health systems and Make America Healthy Again. With the BALANCE Model, we’re pairing breakthrough science with healthy living to cut costs while empowering Americans to take control of their health.”
    • “Under the model, CMS negotiates directly with pharmaceutical manufacturers of GLP-1 drugs for lower net prices and standardized coverage terms. Negotiation areas include: 
      • “Guaranteed net pricing and potential out-of-pocket limits for beneficiaries;
      • “Standardized coverage criteria; and
      • “Evidence-based lifestyle support offerings.”
    • “To learn more about the BALANCE Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/balance.” * * * 
    • “Prior to the launch of the BALANCE model, CMS also plans to implement a new Medicare GLP-1 payment demonstration beginning in July 2026, which will serve as a short-term bridge to the model. This additional payment demonstration means that Medicare beneficiaries can start accessing these important medications at prices negotiated by the Administration as soon as possible.
    • “The GLP-1 payment demonstration will operate outside of the Medicare Part D benefit’s coverage and payment flow, which means that Part D Plan Sponsors will not carry risk for eligible GLP-1 products furnished under the demonstration. Beneficiaries enrolled in Medicare Part D who meet the negotiated access criteria will have access to these drugs. Under the demonstration eligible Medicare beneficiaries will pay $50 for a month of GLP-1 medications.
    • “CMS will provide additional information on the design and implementation of the GLP-1 payment demonstration in early 2026.
  • The Wall Street Journal points out,
    • “About half of 20 million Americans with FSA [healthcare flexible spending] accounts let some of their money expire each year.
    • “The average forfeited amount per individual is over $400, and unused FSA money generally returns to employers.
    • “FSAs offer tax savings; a worker in the 22% tax bracket contributing $1,500 could save as much as around $500 in taxes.”
  • Per an AHIP news release from December 18,
    • “AHIP’s Board of Directors has elected Jim Rechtin, President and CEO of Humana, as Board Chair effective January 1, 2026. Rechtin succeeds Pat Geraghty, who announced his retirement after 14 years leading GuideWell and Florida Blue effective December 31, 2025.
    • “I was proud to be part of AHIP’s work this year to unite our industry around voluntary commitments to simplify prior authorization – an important ongoing effort that shows what’s possible when health plans work together to deliver for patients. As Board Chair, I look forward to taking the same cooperative approach to helping health consumers navigate the system and access high-quality, affordable care,” Rechtin said.

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • “The FDA has expanded the indication of ferric maltol (Accrufer) capsules for the treatment of iron deficiency to include adolescents.
    • “The approval makes the drug the first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older. It was first approved in 2019 for adults with iron deficiency.
    • “The expanded indication was supported by the phase III FORTIS trialopens in a new tab or window in which 24 patients ages 10-17 received age-based dosing of ferric maltol twice daily, and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at 12 weeks. This would be the expected average increase in hemoglobin with one blood transfusion, the agency noted.”
  • MedTech Dive reports,
    • “Edwards has received Food and Drug Administration approval for its Sapien M3 mitral valve replacement system, the company said Tuesday.
    • “The device is intended for people with moderate to severe mitral regurgitation, a heart condition where the valve between the left heart chambers doesn’t fully close, allowing blood to leak back through. Sapien M3 is indicated for people who are deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy, a minimally invasive procedure to fix a valve by clipping its leaflets together.”
  • and
    • “The Food and Drug Administration said Monday it has issued a Class I recall notice regarding Medtronic’s removal of heart vent catheters.
    • “Medtronic previously asked customers to quarantine lots of its DLP Left Heart Vent Catheters in response to an issue linked to three serious injuries. The FDA published an early alert about the recall in August.
    • “The agency updated its notice this week to inform the public that it has classified the issue as a Class I recall.” 

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Infants given the monoclonal antibody nirsevimab, which provides temporary immunity to respiratory syncytial virus (RSV), had lower risks of related hospitalizations and severe outcomes than those whose mothers got the RSVpreF vaccine, according to a population-based study.
    • “The study may be the first to compare the two interventions in a real-world setting in a national population.
    • “The study and two others reported alongside it join a growing body of real-world evidence demonstrating the effectiveness of RSV products in protecting against severe outcomes related to RSV in the youngest kids.”
  • Health Day informs us,
    • “People on the verge of type 2 diabetescan cut their risk of death from heart disease by more than 50% if they bring their blood sugar levels back to normal, a new study says.
    • “Patients with prediabetes reduced their heart risk by up to 58% when they successfully lowered their blood sugar, researchers reported in The Lancet Diabetes & Endocrinology.
    • “This is an important finding, given that recent studies have concluded people with prediabetes can’t lower heart disease risk through lifestyle changes like exercise, weight loss and a healthy diet, researchers said.
    • “Essentially, reversing prediabetes by lowering blood sugar matters more to your heart than any healthy habits you adopt, researchers said.
    • “This study challenges one of the biggest assumptions in modern preventative medicine,” said lead researcher Dr. Andreas Birkenfeld, a reader in diabetes at King’s College London.
  • Medscape points out,
    • “A trio of large observational studies reported at the San Antonio Breast Cancer Symposium (SABCS) 2025 suggest that GLP-1 receptor agonists may improve outcomes in some women with breast cancer.
    • “Two studies reported an overall survival benefit of GLP-1 use in certain patients with breast cancer, including those with ductal carcinoma in situ (DCIS) and invasive hormone receptor (HR)-positive nonmetastatic disease, and a third found improvements in a range of toxicities among patients receiving chemotherapy.
    • “These studies, presented during a poster session, add to other emerging research indicating that GLP-1 drugs could have implications across the breast cancer trajectory, including prevention, active therapy, and posttreatment survivorship, explained study discussant Jasmine S. Sukumar, MD, with University of Texas MD Anderson Cancer Center in Houston.”
  • Fierce Pharma relates,
    • “Just days after an upbeat R&D event, Neurocrine Biosciences has found itself having to report a phase 3 failure.
    • “The company’s Ingrezza (valbenazine), approved to treat certain uncontrolled movement conditions, failed to make a significant difference in a phase 3 trial for patients with dyskinesia due to cerebral palsy (CP), Neurocrine announced Monday.
    • “Ingrezza didn’t outperform placebo on improving involuntary, jerky movements of the body after 14 weeks of treatment, causing the phase 3 trial to miss its primary endpoint. The study, dubbed Kinect-DCP, also did not meet key secondary endpoints, according to Neurocrine.”
  • and
    • “A patient in an open label extension study of Pfizer’s hemophilia treatment Hympavzi has died, the company and several hemophilia advocacy groups confirmed this week.
    • “Pfizer is now working with its trial investigator and independent data monitoring committee to accrue more information and better understand the circumstances behind the incident, the New York drugmaker wrote in a letter to the hemophilia community, which was posted online (PDF) by the World Federation of Hemophilia (WFH) on Dec. 22.”
  • STAT News reports,
    • “Oncologists have been moving away from the notoriously unpopular neutropenic diet. It requires nearly all food to be cooked to high temperatures — or, as some have described it, “boiled to death” — to reduce the risk of food-borne illnesses. But since evidence in recent years suggested the diet didn’t actually help ward off infections, doctors started leaning away from a strict neutropenic diet.
    • “Now, a new study published last week in the Journal of Clinical Oncology is giving some physicians pause about fresh fruits and vegetables for patients whose treatment involves heavy suppression of the immune system, particularly neutrophils, white blood cells that are key to preventing infection. Contrary to research in the past, the trial found that certain blood cancer patients who were allowed a less restrictive or liberalized diet had 11% more infections than patients who were prescribed the neutropenic diet.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Analysts expect health insurance companies to be better positioned for 2026 after adjusting their offerings.
    • “Medicare Advantage offers the sector the largest potential for improvement because companies will receive a significant increase in federal pay. 
    • “Federal changes to Medicaid and the exchanges will pressure health insurance companies’ finances.”
  • Ernst & Young informs us,
    • “A changing healthcare landscape is shifting economic returns, leading organizations to rethink their value chain position.
    • “Expansion in lower-acuity care and opportunistic mergers and acquisitions can accelerate long-term growth.
    • “Implementing new benefit cost containment strategies and investing in innovative AI solutions can elevate efficiency and performance.”
  • Per a Harvard Business Review article,
    • “U.S. employers are grappling with surging healthcare costs as healthcare prices and service volumes rise. Provider consolidation, high drug prices, labor shortages, and growing chronic disease are fueling the cost increases. Employer have largely responded by shifting expenses to workers. Their track record in pursuing aggressive options—including collective purchasing, tiered plans, value-based care, and advocating for changes in government policies—is poor. The big question is whether they have the will to become more aggressive in pursuing remedies. The outlook is not promising. The reasons include the complexity of the problem, employee resistance to some solutions, and the fact that most employers just don’t have sufficient “skin in the game” to take on the disruption and risk that would be required to bend the healthcare cost curve significantly or sustainably.”
  • The FEHBlog has more confidence in employers.

FEHBlog response to public comment

  • A commenter called into question the statistices upon which AHIP relied in this recent news release which the FEHBlog quoted. In response the FEHBlog notes that the AHIP news release was generated in response to the Affordable Care Act marketplace subsidy controversy and 2020 was an outlier year for all health insurers as it was the first year of the Covid pandemic. Health plans did make MLR rebates in that year according to CMS.

Monday report

David Ermer–CDC, FDA, Generative AI, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • OPM’s leadership posted an end of the year letter to OPM employees.
  • STAT News reports,
    • “Drug manufacturers and pharmacy benefit managers received a holiday gift from President Trump on Friday: They still will not have to publicly post the actual prices of prescription drugs, more than five years after federal law required them to do so.
    • “Net drug prices — the amounts that health insurance companies and PBMs pay to drugmakers, after factoring in rebates — are highly valuable data that undergird the entire economic foundation of the U.S. pharmaceutical industry. But the decision from the Trump administration, rolled out in a new proposed rule, means that drug pricing data will likely remain locked out of public view for the foreseeable future.”
  • Avalere Health shares its perspective about December 2025 Advisory Committee on Immunization Practices Insights and 2026 Emerging Priorities.
    • “The ACIP’s December meeting resulted in a key change to the pediatric immunization schedule and signaled several potential changes to US vaccine coverage and access in 2026.”
  • Per an HHS news release,
    • “Executing on President Trump’s Executive Order (EO) 14192 titled “Unleashing Prosperity through Deregulation” and the President’s mandate to ensure the United States’ continued leadership in artificial intelligence (AI), the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), today released the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule.
    • “Today’s HTI-5 Proposed Rule has three core goals: (1) reducing burden on health IT developers by streamlining ASTP/ONC’s voluntary Health IT Certification Program by removing redundant requirements; (2) updating the information blocking regulations to better promote electronic health information access, exchange, and use so that patients’ access to their data is not blocked; and (3) advancing a new foundation of Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces (APIs) that promote AI-enabled interoperability solutions through modernized standards and certification. The HTI-5 proposed rule is expected to save $1.53 billion in total, including $650 million over the next five years for health IT developers, providers, and other stakeholders.
    • “The HTI-5 proposed rule delivers on President Trump’s directive to reduce regulatory burden and to enable American innovation through artificial intelligence,” said Tom Keane, MD, Assistant Secretary for Technology Policy and National Coordinator for Health IT. “These proposals reflect a commonsense approach that removes redundant requirements on health IT developers, that better ensures seamless patient access to their information and that sets a foundation for AI-based data exchange.” * * *
    • “More information can be found at healthit.gov/hti5 and via ASTP/ONC’s X account, @HHS_TechPolicy
    • “ASTP/ONC is also withdrawing certain proposals not yet finalized from the HTI-2 proposed rule.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “U.S. regulators approved the first GLP-1 weight-loss pill—a tablet formulation of Novo Nordisk’s NOVO.B  Ozempic and Wegovy—ushering in a new era of the obesity-drugs revolution that is expected to broaden their use.
    • “Novo Nordisk said it plans to start selling the new pill in the U.S. soon after the new year, with a cash price of $149 a month for the starting dose.
    • “The Food and Drug Administration approval is a milestone because weekly shots such as Wegovy and Eli Lilly’s LLY Zepbound have dominated the anti-obesity market to date. Yet many people with excess weight don’t take the shots due to cost, spotty insurance coverage and fear of needles.
    • “Drug companies and analysts say pills will tap in to demand from people who don’t want an injection or would prefer the cadence of a daily dose. Pills also offer the prospect of lower prices and better health-insurance coverage than injections, because pills cost less to make.
    • “Eli Lilly also plans to introduce a new weight-loss pill, potentially within weeks or months.” 
  • Fierce Pharma tells us,
    • “Just two months after reviving its prowess in the idiopathic pulmonary fibrosis (IPF) treatment area with rare lung disease med Jascayd, Boehringer Ingelheim is already unlocking another patient population with a new FDA nod.
    • “The new approval for Jascayd in progressive pulmonary fibrosis (PPF) makes the drug the only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication, according to a Dec. 19 company press release.
    • “Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The U.S. approval of Jascayd is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option,” Boehringer’s head of human pharma, Shashank Deshpande, said in a release.”
  • MedTech Dive notes,
    • “Abbott said Monday that it has received Food and Drug Administration approval for its Volt pulsed field ablation system.
    • “The catheter-based device uses targeted, high-energy electrical pulses to treat a common heart arrhythmia called atrial fibrillation. Abbott’s Volt device is indicated for both paroxysmal AFib, where episodes come and go, and persistent AFib, or episodes that last longer than seven days, according to the FDA.
    • “Medtronic, Boston Scientific and Johnson & Johnson have all debuted their own PFA devices in the last two years. The approval allows Abbott to join the fast-growing, competitive market in the U.S.”

From the public health and medical / Rx research front,

  • The American Medical Association lets us know “What doctors wish patients knew about family immunizations.”
    • “Vaccines save millions of lives each year. Two infectious diseases physicians discuss the key role they should play for the loved ones in your family.”
  • Health Day informs us,
    • “Psychiatric conditions as varied as schizophrenia and bipolar disorder might be driven by very similar genetic underpinnings, a new study says. 
    • “Mental health problems can be sorted into five general genetic categories, each with a shared “genetic architecture” driving people’s illness, according to results published in the journal Nature.
    • “Right now, we diagnose psychiatric disorders based on what we see in the room, and many people will be diagnosed with multiple disorders. That can be hard to treat and disheartening for patients,” lead researcher Andrew Grotzinger, an assistant professor of psychology and neuroscience at the University of Colorado-Boulder, said in a news release.
    • “This work provides the best evidence yet that there may be things that we are currently giving different names to that are actually driven by the same biological processes,” he said.”
  • and
    • “A new risk score can help predict which pancreatic cancer survivors are more likely to suffer a recurrence of their cancer, researchers said.
    • “The score could help better manage the follow-up care for patients who’ve had pancreatic tumors surgically removed, and whose cancers have not spread to their lymph nodes, researchers wrote Dec. 17 in JAMA Surgery.
    • “We now have a way to identify patients whose higher risk of recurrence may have been previously overlooked,” senior researcher Dr. Cristina Ferrone, chair of surgery at Cedars-Sinai Medical Center in Los Angeles, said in a news release. “This gives us the opportunity to change the way we care for this patient population in a meaningful way.”
    • “The score helps people with pancreatic neuroendocrine tumors, which are a less common and typically less aggressive form of pancreatic cancer.
    • “Patients whose cancer has not spread outside the pancreas, to either the lymph nodes or surrounding organs, have a 91% five-year survival rate following surgery, researchers said in background notes.”
  • The Wall Street Journal relates
    • “For years, Barbara Schmidt’s family feared an illness was behind a pattern of terrifying falls that repeatedly landed the 83-year-old great-grandmother in surgery with broken bones. Instead, Schmidt’s frequent tumbles might have been tied to something else: medications intended to make her better.
    • “Schmidt, who lives with her husband of 65 years in Lewes, Del., filled prescriptions for more than a dozen different drugs in the past year, according to pharmacy and medical records.
    • “That isn’t unusual for America’s seniors, according to a Wall Street Journal analysis of Medicare data. One in six of the 46 million seniors enrolled in Medicare’s drug benefit, which pays for most drugs taken by older Americans, were prescribed eight or more medications.”
    • * * * “Schmidt’s recent prescriptions came from at least five different healthcare providers. Most were affiliated with the nearby hospital system Beebe Healthcare, including a nurse practitioner whom she sees for primary care and a gastroenterology office. An orthopedic surgeon who has treated her back problems and prescribed medications to help with her pain works for an independent practice, First State Orthopaedics. 
    • “A Beebe spokesman said it has reviewed its prescribing patterns and, this November, added a new electronic medical record that will allow doctors to “view consolidated medical and medication histories” for patients and deliver “safer, more informed care.” First State Orthopaedics said it doesn’t comment on matters of patient care unless it is legally required to do so.
    • “Pharmacists who work with seniors say doctors might not be aware of their patients’ full medication list. Patients don’t always mention what their other doctors have prescribed when a history is taken, and specialists might not have access to a shared medical record.
    • “The Journal analysis found that, among seniors taking eight or more drugs, it was common for the prescriptions to come from a large number of doctors.”

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

  • Per Beckers Hospital Review,
    • “Houston-based Nutex Health has opened its 26th micro-hospital, Archview ER & Hospital, in St. Louis.
    • “The 16,000-square-foot facility includes 15 emergency room beds, three inpatient suites, a full-service laboratory and advanced imaging technology, according to a Dec. 22 Nutex Health news release.
    • “It replaces Homer G. Phillips Memorial Hospital, which surrendered its license and closed in March. The hospital had been temporarily closed since December 2024, when its license was suspended due to a blood supply shortage.”
  • and
    • “Mark Cuban Cost Plus Drug Co. has added Vegzelma, a biosimilar indicated for six cancer types, to its marketplace for hospitals and other healthcare providers. 
    • “The company plans to expand its biosimilar offerings amid growing demand for biologics among health systems, according to a news release shared with Becker’s. Cost Plus Drugs also offers Starjemza, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab), at a price about $3,000 lower than retail at other pharmacies.
    • “Vegzelma is a biosimilar to Roche’s Avastin (bevacizumab), which is approved for treatment of metastatic colorectal cancer; non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.”  

Midweek update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, Medicare, OPM, Patient safety, SDOH, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Senate plans two healthcare votes Thursday: one on a GOP bill that would put as much as $1,500 a year into health savings accounts in lieu of providing subsidies to cover premiums, and the second on a Democratic plan that extends ACA subsidies for three years. Neither is expected to reach the 60 votes needed to advance, but the willingness of some Republicans to consider any form of ACA extensions has opened the door to possible talks if the partisan measures fail.
    • “In the House, Speaker Mike Johnson (R., La.) said Republicans plan to put on the floor next week a package of healthcare proposals that doesn’t include extending subsidies. But other lawmakers see an ACA extension as the only way to prevent widespread pain ahead of the 2026 midterms and get a GOP-led Congress in position to make more sweeping changes.
    • “Rep. Jim Jordan (R., Ohio)—a onetime leader of the hard-line House Freedom Caucus—argued in a closed-door House Republican meeting that the party needed its own plan to temporarily extend the subsidies in tandem with more sweeping changes. If they didn’t, he warned, conservatives could be sidelined by centrists’ push to bring their own ACA extension to the floor.
    • “There’s a whole list of good things that we need to put in the legislation,” Jordan said in an interview. “But we also need to recognize reality, which is the cliff is coming in 21 days, and we have members who are very concerned about that. I think we all are.”
  • The Hill adds,
    • “The House on Wednesday easily passed the annual defense policy bill, sending the mammoth, $900 billion measure to the Senate ahead of the year-end deadline.
    • “The measure, known as the National Defense Authorization Act (NDAA), passed the lower chamber by a vote of 312-112. Ninety-four Democrats and 18 Republicans opposed the bill.
    • “The NDAA, a traditionally bipartisan bill that lays out defense priorities for the next year, would increase pay for service members, provide some military aid to Ukraine, restrict U.S. investment in China and fully repeal sanctions on Syria, among other things.”
  • Axios points out,
    • “Lab testing companies including giants Quest Diagnostics and LabCorp are pressing Congress to stop hundreds of millions of dollars of Medicare cuts for diagnostic tests that are due to take effect at the end of January.” * * *
    • “A 15% reduction to Medicare payments for nearly 800 lab tests is set to take effect Jan. 31, followed by additional cuts in following years.
    • “The change stems from 2014 legislation that aimed to align Medicare reimbursements for lab tests more closely with commercial payments.
    • “Medicare cuts that previously went into effect from the legislation cost labs nearly $4 billion over three years. Since then, the diagnostics industry has successfully argued the cuts are based on incomplete and outdated pricing information.” * * *
    • “Federal budget analysts previously used the Consumer Price Index as a proxy for lab payments. That measurement showed that delaying the changes appeared to save Medicare money. 
    • But the analysts have changed their model and now estimate that delaying the payment cuts will add to Medicare costs.”
  • Govexec tells us,
    • “The heads of the Office of Management and Budget and the Office of Personnel Management unveiled plans Wednesday to build a single information technology platform to manage all human capital data across the federal government. 
    • “In a joint memo, OMB Director Russ Vought and OPM Director Scott Kupor described a two-year plan to transition the federal government’s collection of disparate human resources networks onto a single system dubbed Federal HR 2.0.
    • “For too long, the Federal Government has lacked what is taken for granted at any other organization — a single system of record for personnel management. Instead, the Federal Government spends an inordinate amount each year on numerous costly, duplicative, and outdated core human capital management (“Core HCM”) systems,” the memo said. 
    • “As part of the plan, the memo said OMB and OPM officials will lead efforts “to procure a modern, best-in-class commercial Core HCM system” for governmentwide adoption by fiscal 2028.”
  • The Journal of Accountancy informs us,
    • “The IRS provided guidance Tuesday on new tax benefits for health savings accounts (HSAs) that include allowing bronze and catastrophic plans to be considered HSA-compatible under Sec. 223.
    • “The changes, which were part of H.R. 1, P.L. 119-21, commonly known as the One Big Beautiful Bill Act, generally expand the availability of HSAs under Sec. 223 and were outlined in Notice 2026-05.” * * *
    • “The IRS guidance also covered:
      • “Telehealth and remote care services: H.R. 1 made permanent the ability to receive telehealth and other remote care services before meeting the HDHP deductible while remaining eligible to contribute to an HSA, effective for plan years beginning on or after Jan. 1, 2025.
      • “Direct primary care (DPC) service arrangements: Beginning Jan. 1, 2026, an otherwise eligible individual enrolled in certain DPC service arrangements may contribute to an HSA. In addition, they may use their HSA funds tax-free to pay periodic DPC fees.”
    • “The IRS is seeking comments on Notice 2026-05 by March 6, 2026.”
  • Per Fierce Pharma,
    • “For more than two years, the U.S. Federal Trade Commission has been taking certain drugmakers to task over their alleged listing of “improper” patents in an FDA registry, a practice the agency says thwarts generic competition. 
    • “Now, after several prior wins with the effort, the agency is celebrating once again as Teva has agreed to remove more than 200 patents from FDA records, according to a Dec. 10 announcement.
    • “Following pressure from the FTC, Teva has asked the FDA to delist patents on certain products for asthma, diabetes, chronic obstructive pulmonary disease and for epinephrine autoinjectors, the FTC said. The removals from the FDA’s Orange Book registry will “pave the way for greater competition for generic alternatives” to more than 30 products, the agency explained.” * * *
    • “The AHA Board of Trustees has engaged WittKieffer to conduct a national search for Pollack’s successor as part of a planned transition. Pollack will remain fully engaged until the transition is complete.
    • “Recognizing Pollack’s commitment to the association, the AHA Board last month voted to bestow on him the title of AHA President and CEO Emeritus for when the transition is complete.”
  • The American Medical Association announced,
    • “AHA President and CEO Rick Pollack today announced his plans to retire by the end of 2026. A 43-year veteran of the association, Pollack has served as its chief executive for the past decade.
    • “Under Pollack’s leadership, the AHA steered hospitals through the COVID-19 pandemic, securing critical resources and regulatory flexibility to keep hospitals and health systems open and caring for patients during the most challenging public health crisis of recent time. Pollack launched bold initiatives to strengthen the health care workforce, advance quality and patient safety, and fortify cybersecurity defenses through partnerships with the FBI and other government agencies.
  • Per a Department of Justice news release,
    • “United States Attorney David Metcalf announced today that Recovery Centers of America (RCA) has agreed to pay $1,000,000 to resolve allegations that it failed to comply with provisions of the Controlled Substances Act (CSA) that are designed to prevent the diversion of controlled substances for illegal uses, and an additional $1,000,000 to resolve allegations that it violated the False Claims Act (FCA) by billing the government for drug and alcohol treatment services that it failed to adequately provide.
    • “The United States’ allegations under the CSA arise from audits and investigations the Drug Enforcement Administration (DEA) conducted at RCA facilities in Pennsylvania and Maryland between 2019 and 2024. Based on those audits and investigations, the United States contends that RCA dispensed controlled substances in an unlawful manner, that certain controlled substances were missing from the company’s records, and that the company failed to comply with additional recordkeeping requirements of the CSA.
    • “In addition, the United States alleges that, at certain facilities during a period from 2017 through 2019, RCA violated the FCA by billing the Federal Employees Health Benefits Program and Medicaid for the care of beneficiaries to whom it failed to provide and document the requisite treatment services.” * * *
    • “The resolution obtained in this matter was the result of a coordinated effort among the United States Attorney’s Office for the Eastern District of Pennsylvania, the DEA, the Office of Personnel Management Office of Inspector General, and the Department of Health and Human Services Office of Inspector General.
    • “The matter was handled in the U.S. Attorney’s Office for the Eastern District of Pennsylvania by Assistant U.S. Attorneys Peter Carr and Charlene Keller Fullmer and former auditor Dawn Wiggins.
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
    • “GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
    • “FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a statement Tuesday.”
  • Fierce Pharma adds
    • “The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione Telethon the first nonprofit to usher a gene therapy across the regulatory finish line in the U.S.
    • “Branded as Waskyra, the drug is specifically indicated for children 6 months and older, as well as adults who have a mutation in the WAS gene. To be eligible for the ex vivo gene therapy, patients must have no available human leukocyte antigen-matched related stem cell donor and be cleared for hematopoietic stem cell transplantation, the FDA said in its Dec. 9 announcement.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad, M.D., said in a release.”
  • and
    • “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.”
  • Per Beckers Health IT,
    • “The FDA has qualified the first AI-based drug development tool to support metabolic dysfunction-associated steatohepatitis clinical trials.
    • “The cloud-based tool, AI-Based Histologic Measurement of NASH (AIM-NASH), is designed to assist pathologists in assessing liver biopsy images, according to a Dec. 8 news release. It evaluates disease activity by scoring steatosis, hepatocellular ballooning, lobular inflammation and fibrosis according to the NASH Clinical Research Network scoring system.
    • “AIM-NASH uses AI to analyze digital images of liver tissue, but human pathologists remain responsible for interpreting the results. They review the entire slide and AIM-NASH output before accepting or rejecting the scores.”
  • BioPharma Dive notes,
    • “Vinay Prasad and two other officials within the Food and Drug Administration office regulating many genetic medicines have outlined a stricter approval framework for the next CAR-T cell therapies developed for cancer. In an article published Monday in the Journal of the American Medical Association, the trio wrote that newer CAR-T treatments need to extend survival, or the time before a type of event occurs, in randomized, controlled trials. The control groups in those studies must also take into account the existing standard treatments, including other approved CAR-T therapies, and prove superior unless “adequately justified and discussed” with the FDA. The new protocol represents a higher approval bar for CAR-T therapies, which, historically, have been cleared based on their ability to induce responses in single-arm studies.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today said the United States has 1,912 confirmed measles cases so far in 2025, an increase of 84 cases since last week and a bad sign as holiday gatherings, travel, and indoor activities is set to pick up in the final weeks of the year. 
    • “In January 2026, the United States is at risk of losing its measles elimination status because of ongoing transmission chains from a West Texas outbreak that began early last year and sickened roughly 800 people. The country first gained elimination status in 2000. 
    • “Eighty-eight percent of cases in the United States this year are outbreak-associated, and there have been 47 outbreaks recorded. Last year, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.
    • “Currently Utah, Arizona, and South Carolina are seeing large outbreaks that since Thanksgiving have pushed state totals well past 100 cases. Those outbreaks have been marked by exposures at schools and churches in communities with low vaccination levels.”
  • STAT News relates,
    • “Federal health officials on Wednesday [December 10] expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
    • “The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
    • ‘The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
    • “No deaths have been reported in the outbreak, which was announced Nov. 8.
    • “Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.”
  • and
    • “While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or myocarditis. Scientists on Wednesday reported that they have identified a pair of immune signals they believe drive these cases — and offered early evidence that these signals can be blocked.
    • Researchers sifted through previous Covid vaccine studies and identified a pair of immune signaling molecules, or cytokines, present at higher levels in the blood of vaccine recipients with myocarditis: CXCL10 and interferon-gamma (IFN-γ). The authors found that these signals could also be triggered in the lab when immune cells were exposed to the Pfizer and Moderna Covid vaccines, or when mice were inoculated.
    • “Scientists found that using antibodies to block CXCL10 and IFN-γ reduced signs of cardiac stress in vaccinated mice and in cardiac spheroids, three-dimensional growths of human cells meant to mimic some aspects of the heart’s structure and function. The authors also found they could block the cytokines’ effects with genistein, a compound found in soybeans and other legumes that has been linkedto reduced inflammation.
    • “The findings, published in the journal Science Translational Medicine, come as messenger RNA vaccines face scrutiny from the Trump administration and some lawmakers. That has forced researchers studying these shots to strike a tricky balancing act between reporting new insights on adverse events while making clear that the shots are safe overall.
    • “I want to emphasize this is very, very rare. This study is purely to understand why. In those rare cases, what’s going on? People talk about it, and here we provide a mechanism,” said Joe Wu, director of Stanford Cardiovascular Institute and the study’s senior author.”
  • Medscape tells us,
    • “As women age, they face several health risks related to the menopause transition. Treating these risk factors, which include obesity and high blood pressure, can reduce the risks for diabetes, cardiovascular disease (CVD), and other health problems.
    • “These risks also can be driven by age-related changes that occur around the time of menopause, said Marie K. Christakis, MD, MPH, assistant professor of obstetrics and gynecology and menopause and mature women’s health at the University of Toronto in Toronto, during a presentation at the Diabetes Canada and Canadian Society of Endocrinology and Metabolism (CSEM) Professional Conference 2025.
    • “Women at midlife are in what I term a cardiovascular storm,” she said. “More than 42% of American women between ages 40 and 59 years have a BMI over 30, and the prevalence of obesity is higher among women between ages 40 and 59 years. Generally, menopause occurs naturally between ages 46 to 54 years, and central adiposity is a particular issue.” 
  • MedPage Today notes,
    • “In a large phase III trial of adjuvant treatment for early-stage breast cancer, the investigational oral drug giredestrant reduced the risk of invasive disease recurrence by 30% versus standard endocrine therapy.
    • “Among more than 4,000 patients with hormone receptor (HR)-positive disease, 3-year invasive disease-free survival (IDFS) rates reached 92.4% with the next-generation oral selective estrogen receptor antagonist and degrader (SERD), as compared with 89.6% with standard of care (HR 0.70, 95% CI 0.57-0.87, P=0.0014).”
    • “The findings of the lidERA Breast Cancer trial mark the first benefit with a novel endocrine agent in early breast cancer in 20 years, not since the approval of aromatase inhibitors (AIs) in the 2000s, said Aditya Bardia, MBBS, MPH, of the University of California Los Angeles.
    • “Overall, the results support giredestrant as a potential standard endocrine option for patients with hormone receptor-positive breast cancer,” said Bardia, who presented the findings here at the San Antonio Breast Cancer Symposium.”
  • Fierce Pharma adds,
    • “Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.
    • “The current standard of care for the disease includes induction chemotherapy in combination with Roche’s Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes.
    • “Specifically, addition of Tukysa to first-line maintenance therapy significantly reduced the risk of progression or death by 35.9%, according to investigator-assessed results from the phase 3 HER2CLIMB-05 trial, which were presented at the San Antonio Breast Cancer Symposium. Patients who received the Pfizer small molecule went 8.6 months longer without tumor progression, reaching 24.9 months at the median.
  • and
    • “A year after a clutch of major pharmas threw their weight behind a new campaign devoted to addressing the serious health disparities facing Black breast cancer patients, “Care for HER” has been shown to have a tangible positive impact on patients’ lives.
    • “Touch, The Black Breast Cancer Alliance and Unite for HER—the two nonprofit organizations behind the program—presented a study about that impact at the San Antonio Breast Cancer Symposium on Wednesday.
    • “The research centers ran a survey of 57 participants in the Care of HER program, all Black women who have been diagnosed with breast cancer, 93% of whom said they’d used the program’s resources.”
  • Per Cardiovascular Business,
    • “Intravascular lithotripsy (IVL) is a viable treatment option for patients with diabetes undergoing percutaneous coronary intervention (PCI), according to new findings published in The American Journal of Cardiology.[1]
    • “While IVL has demonstrated favorable procedural and clinical outcomes in general populations with calcified lesions, its performance in patients with diabetes mellitus remains insufficiently characterized,” wrote senior author Jose M. Montero-Cabezas, MD, PhD, a cardiologist with Leiden University Medical Center in The Netherlands, and colleagues. “Given the unique anatomical and pathophysiological features of coronary artery disease in diabetic patients, such as medial calcification, longer lesion length, and more frequent multivessel disease, there is a clear need to specifically evaluate the efficacy and safety of IVL in this higher-risk population.”
    • “Montero-Cabezas et al. tracked data from nearly 600 patients who underwent PCI with IVL from May 2019 to September 2024. All data came from the BENELUX-IVL registry, an international database open to all IVL patients. Patients with missing data were excluded.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS plans to launch a first-of-its-kind healthcare engagement platform, banking that perennial gripes about poor access and navigation will incentivize both consumers and rival companies to sign on.
    • “The platform will include data and services offered by CVS’ different health businesses — and those of participating industry partners. The goal is to create an integrated healthcare experience for consumers, hopefully enhancing their experience with the industry, lowering costs and improving outcomes, CVS executives said Tuesday during the healthcare giant’s investor day in Hartford, Connecticut. 
    • “CVS is also banking that the platform will also be a source of revenue by driving consumers to CVS products and services they might not know about otherwise.”
  • Kaufman Hall announced,
    • “Hospital volumes remained strong in October, while average length of stay declined, translating to a dip in net revenue per discharge. Bad debt and charity care continue to rise, and staffing levels are tightening.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • The American Journal of Managed Care lets us know,
    • “As states and federal programs accelerate the shift to value-based care, a new national survey suggests clinicians face a widening gap between policy expectations and the tools available to meet them.
    • “Tracking patient progress emerged as the biggest barrier—more than insurance—for mental health and primary care clinicians adapting to outcome-based payment models, according to October 2025 survey findings released by Twofold Health, an artificial intelligence (AI) clinical notetaking platform.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) targeting abnormal complexes of immunoglobulin for IgA nephropathy.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On December 17, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on January 14, 2026.”
  • Per MedTech Dive,
    • “Teleflex has struck deals to sell its acute care, interventional urology and OEM businesses for a combined $2.03 billion, the company said Tuesday.
    • “Montagu and Kohlberg, two private equity firms, are buying the OEM business for $1.5 billion. Intersurgical, an anesthesia and respiratory care medtech company, is buying the acute care and interventional urology businesses for $530 million.
    • “Needham analysts said in a note to investors that the total sale price is at the low end of their estimates. Yet RBC Capital Markets analysts told investors they view the update positively.”
    • * * * “Selling the units will leave Teleflex focused on its vascular access, interventional and surgical businesses. The company picked the businesses as the focus of its ongoing operations because they serve attractive, primarily hospital-focused end markets. Teleflex framed the split as a way to simplify its operating model and manufacturing footprint.”

Monday report

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Mental health care, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Beckers Hospital Review reports,
    • “President Donald Trump has postponed a planned announcement of a proposal to extend enhanced ACA subsidies, CNN reported Nov. 24.
    • “Trump was expected to unveil a proposal as early as Nov. 24 that would extend the subsidies for two years while introducing new eligibility restrictions, according to earlier reports from Politico and MS Now. 
    • “The proposal, dubbed the “Healthcare Price Cuts Act,” would also establish an income cap limiting subsidies to individuals earning up to 700% of the federal poverty line, three people familiar with the plan told Politico. All enrollees would be required to make minimum premium payments, two White House officials told MS Now. 
    • “The plan also includes a health savings account component. Enrollees who switch to lower-premium marketplace plans could direct the difference in premium costs into tax-advantaged savings accounts funded with their subsidy dollars, according to both reports.
    • “Additionally, the White House intends to ask Congress to appropriate funding for cost-sharing reductions, which lower out-of-pocket expenses for ACA enrollees, Politico reported.”
  • MedCity News considers whether President Trump can do for branded expensive drugs what he just did for GLP-1s?
    • “While many are applauding the Trump administration for taking this step to expand access to GLP-1s, some believe that specifically targeting weight loss drugs actually does very little to bring down overall prescription drug costs.
    • “I think that focusing on market solutions on GLP-1s alone misses the mark, because it’s a market problem,” said Chris Deacon, principal and founder of VerSan Consulting. “[Whether it’s] GLP-1s or other medications, we have a problem of a complete lack of transparency for the purchaser.”
    • “Another expert echoed these comments, stating that while this is a positive move, there needs to be a broader effort in order to effectively bring down drug costs entirely.
    • “This is a step in the right direction,” said Edgar Asebey, an FDA regulatory attorney at Frier Levitt. “A policy initiative that is more of a blanket policy with branded drugs would be much better for the American patients.”
  • Modern Healthcare tells us,
    • “Juan Carlos “JC” Scott, president and CEO of the Pharmaceutical Care Management Association since 2018, stepped down Friday. 
    • “PCMA Chief Government Affairs Officer Lucia Lebens is serving in the president and CEO roles on an interim basis, a spokesperson for the pharmacy benefit manager trade group said Monday. The spokesperson did not respond to questions about whether Lebens also still holds the chief government affairs officer position. 
    • “A search is underway for Scott’s permanent replacement. 
    • “Scott announced in October he would be leaving the organization by the end of the year.
    • “The trade group declined to respond to a request for comment on why Scott decided to depart from the organization. 
    • “An October news release, however, said 2025 was the last year of Scott’s contract.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced five new agency leaders who will serve our nation’s families and advance goals to Make America Healthy Again. Four of these five presidential appointees required and recently received Senate confirmation.”
      • Brian Christine, MD, Assistant Secretary for Health
      • Alex J. Adams, PharmD, MPH, Assistant Secretary for Family Support, Administration for Children and Families
      • Gustav Chiarello, Assistant Secretary Financial Resources
      • Michael Stuart, General Counsel
      • Alicia Jackson, Ph.D., Director, Advanced Research Projects Agency for Health (ARPA-H)
  • The American Hospital Association News adds,
    • “The Advanced Research Projects Agency for Health announced Nov. 21 that it will fund up to $100 million in projects for quantitative measures of mental and behavioral health through its new Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health initiative. The program will focus on data regarding individual clinical outcomes and patient response to novel treatments. ARPA-H said it is seeking multimodal, longitudinal data collected in clinical trials testing the effects of rapid behavioral health interventions. The agency said the awards will be actively managed contracts, where continuation would be contingent upon satisfactory performance reviews.”
  • The National Bureau of Economic Research points out,
    • “We use comprehensive tax data to study how saving behavior responds to the Health Savings Account (HSA) “catch-up” contribution provision, which raises HSA contribution limits for individuals aged 55 and older. Using a regression discontinuity design, we find a sharp increase in contributions among those previously near the limit and smaller increases among unconstrained savers. Induced contributions are not immediately withdrawn and do not appear to crowd out retirement savings. Responses are strongest among payroll contributors and long-term savers. However, married couples do not appear to coordinate their HSA behavior to take advantage of the complex spousal rules governing catch-up contributions. Our findings highlight how tax incentives shape HSA saving and suggest that tax-advantaged account design meaningfully affects household financial behavior.”
  • Bloomberg Law informs us,
    • “Employers hope a forthcoming [federal] rule to improve surprise medical bill arbitration will strengthen their hand against doctors and improve transparency into insurers’ processes.
    • “Doctors win a high percentage of disputes, and industry groups are lobbying lawmakers and regulators to make changes, with employers arguing that doctors are abusing the process by refusing to negotiate and submitting ineligible claims for arbitration.
    • “The forthcoming rule is expected to address many of employers’ complaints, but it could also face legal fights similar to those that overturned a series of previous rules and guidance.”
  • Federal News Network interviews OPM Director Scott Kupor about the next executive development programs that OPM announced last week.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Abbott has issued a medical device correction for about 3 million Freestyle Libre 3 and 3 Plus sensors in the U.S. after determining that some sensors may provide incorrect low glucose readings, the company announced Monday.
    • “Abbott has received reports of 736 severe adverse events and seven deaths overall associated with the problem. In the U.S., 57 severe adverse events and no deaths were reported.
    • “The problem could lead to incorrect treatment decisions, such as people skipping or delaying insulin doses and excessive carbohydrate intake. Abbott said it has resolved the cause of the problem, which was related to one production line, and will replace any potentially affected sensors at no charge.”
  • Reuters notes,
    • “The U.S. Food and Drug Administration has approved Novartis’ (NOVN.S) new gene therapy for patients with a rare muscle disorder, the drugmaker said on Monday.
    • “The therapy, branded as Itvisma, was approved for the treatment of spinal muscular atrophy patients of age two years and older who have a confirmed mutation in the survival motor neuron 1 gene.
    • “Itvisma contains the same active ingredient as the Swiss drugmaker’s older therapy, Zolgensma, which is approved in the U.S. to treat SMA patients less than 2 years of age.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Unlike much of Europe and East Asia, America hasn’t reached the point at which we have more people dying than we do being born.
    • “At least not in the long run. We briefly blew past that point in a few winter months at the height of the covid-19 pandemic, according to our analysis of birth- and death-certificate data collected by the National Vital Statistics System.”
    • The article digs into the details.
  • The AP relates,
    • “The U.S. flu season is starting slowly, and it’s unclear if it will be as bad as last winter’s, but some health experts are worried as U.S. Centers for Disease Control and Prevention data posted Friday shows a new version of the virus has emerged.
    • “An early analysis suggests current vaccines may still be somewhat effective against the new version of the flu, which has been the main driver of recent infections, CDC data shows.
    • “Some scientists and medical professionals are more worried about disappointing vaccination rates, a main reason why flu hospitalizations and deaths were unusually bad during last year’s flu season — one of the deadliest this century.” * * *
    • “Some sources have suggested flu vaccinations are down. Over two million fewer flu shots were given at U.S. pharmacies through the end of October compared to last year, according to data from IQVIA, a health information and research company.
    • “But the latest CDC data indicates that for children, the vaccination rate this year is about the same as it was at this point last fall, at 34%. And the vaccination rate for adults is up a few percentage points to about 37%, according to the CDC data, which relies on survey information.
    • “It is early in the season and too early to know if the increase will be sustained or what is causing it, CDC officials said.”
  • Per Health Day,
    • “Many people don’t know they have a genetic risk factor for high cholesterol
    • “Nearly 90% of people carrying variants for familial hypercholesterolemia didn’t know it
    • “Researchers say 1 in 5 had already developed heart disease”
    • “Our findings expose a blind spot in current national guidelines, which rely on cholesterol levels and family history to determine who should receive genetic testing,” lead researcher Dr. Niloy Jewel Samadder, a cancer geneticist at the Mayo Clinic Comprehensive Cancer Center in Phoenix, said in a news release.”
  • Per MedPage Today,
    • “Girls ages 16 years or younger who received HPV vaccines were 80% less likely than their unvaccinated counterparts to develop cervical cancer.
    • “Evidence from 23 studies showed with moderate certainty that HPV vaccination lowered the incidence of high-grade cervical precancers.
    • “Vaccinated persons had 25 fewer cases of anogenital warts per 1,000 participants at 48 months, regardless of HPV type.”
  • Per the Washington Post,
    • “People who stopped taking weight-loss drugs before or during pregnancy were associated with greater gestational weight gain and had a higher risk of preterm delivery and gestational diabetes compared with those who had not been prescribed the drugs before, according to a study published Monday in JAMA.
    • “Researchers from Mass General Brigham in Boston reviewed medical records from nearly 150,000 pregnancies between June 2016 and March 2025. They found that people who had been prescribed GLP-1 drugs, a class of medications used to treat Type 2 diabetes and obesity, were more likely to gain more weight than recommended during pregnancy.
    • “Sixty-five percent of 448 pregnancies among people previously prescribed GLP-1 medications included excess gestational weight gain, compared with 49 percent of 1,344 pregnancies among those who did not receive the medication but had similar characteristics to those who received a GLP-1.
    • “If we can find those at risk of cardiovascular disease early, we can treat it early and change its course and likely save lives,” Samadder said.”
  • Per BioPharma Dive,
    • “The theory that GLP-1 medicines, which have profound benefits on metabolism and heart health, can also help combat Alzheimer’s disease suffered a major blow Monday with the failure of two large, closely watched clinical trials.
    • “The studies, titled Evoke and Evoke+, together enrolled more than 3,800 people with early-stage Alzheimer’s to evaluate whether Novo Nordisk’s semaglutide can help preserve brain function. According to Novo, its drug was not significantly better than a placebo on that measure after two years of follow-up. And though semaglutide treatment did improve some biological markers tied to Alzheimer’s, it didn’t delay the progression of the disease.”
  • STAT News adds,
    • “A promising Alzheimer’s disease treatment from Johnson & Johnson failed to slow the progress of the disease in a closely watched study, news that could dampen enthusiasm for a new class of potential medicines.
    • “J&J terminated its mid-stage study of the injectable medicine posdinemab, the company said Friday, after an early look at results determined the treatment would not prove more effective than placebo. J&J said it would present full data from the trial at a later date.
    • “Posdinemab’s failure could cast a shadow over a cadre of in-development Alzheimer’s treatments meant to improve on the standard of care. Biogen, UCB, and Voyager Therapeutics are developing similar treatments of their own.”
  • The New York Times discusses how certain hospitals lowered their C-section rates,
  • and tells us,
    • “Dialing down the use of social media for a week reduced symptoms of anxiety, depression and insomnia in young adults, according to a study published on Monday in the journal JAMA Network Open.
    • “Researchers followed 295 volunteers, ages 18 to 24, who opted to take a break from social media. Instructed to stay off social media as much as possible, the group on average reduced it to a half-hour per day from just under two hours. Before and after, the participants answered surveys measuring depression, anxiety, insomnia, loneliness and a number of problematic social media behaviors.
    • “Overall, they reported positive changes: On average, symptoms of anxiety dropped by 16.1 percent; symptoms of depression by 24.8 percent; and symptoms of insomnia by 14.5 percent. The improvement was most pronounced in subjects with more severe depression. At the same time, there was no change in reported loneliness — perhaps, the authors wrote, because the platforms play a constructive social role.”
  • The American Medical Association lets us know what doctors wish their patients knew about cutting down on screen time.
    • “Too much time with smartphones or TVs can do harm. Three physicians share tips on how to reduce screen time before it turns toxic.”
  • Per BioPharma Dive,
    • “Bayer’s experimental blood thinner asundexian met its main goal in a closely watched Phase 3 stroke prevention trial, reducing the recurrence of a stroke in people who took the therapy along with standard treatments. The trial compared treatment with a combination of asundexian and an antiplatelet therapy against a placebo and the same antiplatelet treatment. 
    • “The German-based company didn’t release detailed data, stating that researchers will disclose them at an upcoming medical meeting while company executives discuss them with regulators ahead of possible approval applications.
    • “Results of the trial lifted optimism for asundexian’s drug class, called Factor XIa inhibitors, following a series of clinical setbacks. Most recently, a rival drug missed its main goal in a trial of people who’d had a recent heart attack.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Optum Rx will reduce reauthorizations on 40 additional medications Jan. 1, surpassing initial goals set out earlier this year.
    • “The pharmacy benefit management arm of UnitedHealth Group first revealed earlier this year that it was aiming to reduce reauthorizations, a specific model for prior authorization, by up to 25%. The new additions bring the total number of drugs in the initiative up to 180, surpassing that 25% goal.
    • “The new group of 40 medications includes therapies for chronic conditions and two new classes of drugs: hormone therapy and injectables for knee osteoarthritis.
    • “In addition, Optum announced that it will expand the PreCheck Prior Authorization program, covering more than 45 medications beginning Jan. 1. The tool will reach 20 health systems, Optum said.”
  • and
    • “Three former Amazon employees launched a new online healthcare marketplace earlier this year aiming to make healthcare a better experience for patients. The vision, executives said, was to make healthcare as easy as shopping online.
    • “General Medicine, started by the founding team that built PillPack and Amazon Pharmacy, connects consumers to providers to either address specific medical needs or to chat about the symptoms they’re having. Consumers can use General Medicine for a wide variety of medical issues, and the platform provides both insurance and cash pricing. There’s no subscription or access fee. 
    • “General Medicine executives refer to it as a “one-stop-shop” for telemedicine, prescriptions, imaging, labs and specialists. PillPack co-founders TJ Parker and Elliot Cohen teamed up with Ashwin Muralidharan, who most recently served as technical advisor and chief of staff to Amazon’s top health executive Neil Lindsay, to launch General Medicine.”
  • Cardiovascular Business tells us,
    • “Medtronic had a strong second quarter, reporting a worldwide revenue of $8.96 billion, and earnings per share (EPS) of $1.36. Both figures exceeded the company’s expectations. 
    • “Medtronic’s cardiovascular portfolio helped lead the way with a worldwide revenue of $3.44 billion, an increase of 9.3%. 
    • “This was our strongest growth in over a decade, excluding the easy comparisons we had after the pandemic,” Thierry Piéton, Medtronic’s chief financial officer, explained during an earnings call.
    • “Ablation devices—particularly those built for pulsed field ablation (PFA)—played a critical role in Medtronic’s triumphant quarter. In fact, worldwide revenue was up 71% for cardiac ablation solutions, including a 128% increase in the United States.”  
  • MedTech Dive informs us,
    • “Insulet laid out plans for new diabetes devices at an investor event last week, including a fully automated insulin delivery system for people with Type 2 diabetes. 
    • “The company is working on updates to its current Omnipod 5 device, plans to debut its Omnipod 6 device in 2027 and expects to launch a separate, fully-closed loop system for people with Type 2 diabetes in 2028, CEO Ashley McEvoy said.  
    • “Insulet, which leads the market for insulin patch-pumps, is also working on bringing its devices to more people with Type 2 diabetes, after receiving an expanded label from the Food and Drug Administration last year.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A bipartisan group of House lawmakers released text of legislation Friday aimed at avoiding the health care subsidy cliff by extending Affordable Care Act tax credits for two years while installing income caps and anti-fraud measures.
    • “Reps. Tom Suozzi, D-N.Y., Don Bacon, R-Neb., Josh Gottheimer, D-N.J., and Jeff Hurd, R-Colo., see the measure as a viable compromise that includes Democrats’ demand for a subsidy extension alongside protections sought by many Republicans. It would also significantly lengthen the open enrollment window, which would allow more people into plans, thus strengthening risk pools and lowering premiums.
    • “The text arrives as much of Congress is divided on how to approach the possible end to enhanced premium tax credits under the 2010 health care law, which expire Dec. 31. Many Republicans see any extension as propping up the ACA and won’t support such a move. Without a solution, prices for insurance through state exchanges or healthcare.gov could force people to quit the coverage.” * * *
    • “A bill from Reps. Sam Liccardo, D-Calif., and Kevin Kiley, R-Calif., that also features a two-year extension largely follows a similar framework.
    • “Unlike the Liccardo-Kiley bill, however, this legislation does not include language that would limit excessive payments to Medicare Advantage, a practice known as upcoding. The Liccardo-Kiley bill incorporated the Medicare Advantage language as an offset to pay for the tax credit extension.”
  • and
    • “At least one of the Senate’s yet-to-be-unveiled fiscal 2026 appropriations bills could be released next week, even though lawmakers will be in their districts for the Thanksgiving recess.
    • “There is a good chance the Senate will post its version of the Energy-Water bill, one of the four the Senate has not yet released, House Appropriations Chair Tom Cole, R-Okla., said Friday.
    • “The issue was discussed when the top four House and Senate appropriators met Thursday, Cole said. “I don’t know about the other three, but we raised a lot of questions about Energy and Water, since we’ve actually passed that one across the [House] floor,” he said.
    • “Senate appropriators are aiming to release that bill and potentially more of the outstanding bills — Financial Services, Homeland Security and State-Foreign Operations — next week, a source familiar with the plan said. But that plan is not final, the source said.
    • “House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday that the lawmakers discussed the outstanding Senate bills and that Senate Appropriations Chair Susan Collins, R-Maine, said the text could be posted early next week.”
  • Mercer consulting offers an overview of the current healthcare care policy debate in Congress.
  • OPM Director Scott Kupor posted a new Secrets of OPM blog entry, this time about ongoing Administration efforts to right size the federal workforce.
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is improving the quality of care for Medicare beneficiaries while significantly reducing unnecessary spending and improving choices and hospital price transparency for Medicare beneficiaries. The calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule (CMS-1834-FC) advances a series of patient-focused reforms that will modernize payments, expand access to care, enhance hospital accountability, and safeguard the Medicare Trust Funds from fraud, waste, and abuse.
    • “This final rule from CMS closes the loopholes hospitals exploit to hide real prices and advances President Trump’s demand for radical hospital price transparency,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are also confronting addiction head-on by expanding access to non-opioid treatments and implementing common-sense payment policies that make care more affordable and accessible for seniors.”
    • “We are strengthening Medicare’s foundation by protecting beneficiaries, eliminating fraud, and advancing medical innovation —all while maintaining strict provider accountability and responsible use of taxpayer funds,” said CMS Administrator Dr. Mehmet Oz. “These comprehensive reforms expand patient choice and establish the price transparency Americans need for confident healthcare decisions.” * * *
    • “The final rule can be viewed at the Federal Register at: www.federalregister.gov/public-inspection/.
    • “View the fact sheet on the final rule at: www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-ambulatory-surgical-center.
    • “For a fact sheet on the hospital price transparency policy changes in the final rule, visit: www.cms.gov/newsroom/fact-sheets/cy-2026-opps-ambulatory-surgical-center-final-rule-hospital-price-transparency-policy-changes.”
  • The American Hospital Association adds,
    • “The Centers for Medicare & Medicaid Services released an updated notice Nov. 20 on the processing of Medicare provider claims impacted by the government shutdown. The agency said it instructed Medicare Administrative Contractors to conduct mass adjustments to any paid claims that are inconsistent with the government funding legislation, which retroactively restored many payment provisions through Jan. 30. This includes a payment adjustment for low-volume inpatient hospitals and one for the Medicare-dependent Hospital program. In addition, CMS said that hospitals can resubmit returned claims for telehealth services and the Acute Hospital Care at Home program dated Oct. 1 or later.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “Hexoskin, a Canadian medtech company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new “smart shirt” capable of long-term heart and respiratory monitoring. 
    • “The Hexoskin Medical System was designed to deliver continuous evaluations of a person’s real-time electrocardiogram (ECG) and respiratory health. Signals are then evaluated through the company’s data management platform.
    • “According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as medical researchers. The device is now approved for use during clinical trials performed in the United States, for example, delivering ECG, heart rate, respiratory rate and other activity data that can research teams can track for extended periods of time.
    • “Hexoskin has also made it a priority to use advanced artificial intelligence algorithms to seek out new digital biomarkers that work “beyond traditional cardiopulmonary monitoring.” 
  • Fierce Pharma adds,
    • “As the researchers behind Pfizer and Astellas’ Padcev and Merck’s Keytruda have taken victory laps on the heels of the positive readout of Keynote-905 study—also known as EV-303—terms like “transformational,” “practice-changing” and “new standard of care” have been put to use.
    • “With an FDA approval on Friday, the combination now has its official go-ahead as a perioperative treatment regimen for people with muscle-invasive bladder cancer (MIBC) who can’t receive chemotherapy.
    • ‘Padcev and Keytruda is the first and only approved perioperative treatment regimen for cisplatin-ineligible patients with MIBC, Pfizer said in a media statement Friday, meaning the pairing can be used before and after surgery.
  • and
    • “The FDA has opened an investigation into Takeda’s recombinant protein med Adzynma following the reported death of a pediatric patient who received the drug.
    • “The probe comes as the regulator says it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13, the enzyme-creating gene that underpins Takeda’s drug. The single reported patient death “appears to be related to Adzynma,” the FDA said in a Nov. 21 safety communication.
    • “Takeda’s medicine was approved in November of 2023 as the first recombinant protein product for use as a preventive or on-demand enzyme replacement therapy in adults and children with the rare genetic blood-clotting disorder, congenital thrombotic thrombocytopenic purpura (cTTP). The condition is believed to be caused by a disease-triggering mutation in the ADAMTS13 gene, which produces an enzyme responsible for regulating clotting.
    • “The Tokyo-based pharma did not respond to Fierce Pharma’s request for comment on the situation by publishing time.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced Friday,
    • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old. Seasonal influenza activity remains low nationally but is increasing. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits 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.’ * * *
    • “Season Outlook
      • “CDC expects the upcoming fall and winter respiratory disease season in the United States will likely have a similar number of combined peak hospitalizations due to COVID-19, influenza, and RSV compared to last season. CDC will update this outlook every two months throughout the season and as warranted by changes in the trajectories of any of the three diseases. Read more: 2025-2026 Respiratory Disease Season Outlook“
  • Beckers Clinical Leadership adds,
    • “Some hospitals are reporting an uptick in respiratory syncytial virus hospitalizations in recent days, though national data — delayed by the federal shutdown — has yet to offer a clear picture.
    • “Cincinnati Children’s Hospital reported an early uptick in admissions this fall, according to Hamilton County Public Health Medical Director Steve Feagins, MD.
    • “Last year, we saw it early. This year, we saw it even earlier, resulting in, like, September beginning to get some admissions and hospitalizations at Cincinnati Children’s,” he told CBS affiliate WKRC.
    • “The county reported 32 admissions in the week ending Nov. 15, up from 28 a week prior, state data shows.” 
  • The University of Minnesota CIDRAP relates,
    • “Over 40% of nearly 8,600 US adults who had advanced hepatitis B–related liver disease appear to have received no treatment for their infection, a gap especially apparent in women and Black or White patients, according to findings published yesterday in JAMA Network Open.
    • “A team led by a Stanford University researcher and including scientists from hepatitis B virus (HBV) drug maker and study funder Gilead Sciences evaluated the HBV treatment status of 8,594 infected patients included in an electronic health record data network from April 2016 to December 2022. The study focused on patients who met American Association for the Study of Liver Diseases 2016 and 2018 qualification criteria for HBV treatment.
    • “Treatment of hepatitis B virus (HBV) infection reduces the risk of disease progression and negative outcomes such as hepatic decompensation and hepatocellular carcinoma (HCC),” the researchers wrote. “Studies from select populations in the US suggest that treatment levels are low; whether this pattern occurs nationally remains unclear.” * * *
    • In a commentary in the same journal, Amir Mohareb, MD, of Massachusetts General Hospital, and Arthur Kim, MD, of Harvard Medical School, noted that the risk of perinatal HBV transmission from mother to child is very low in the United States due to the availability of HBV immunoglobulin and the HBV vaccine birth dose. 
    • “But “there is cause for concern that this policy may change, as newly appointed members of the Advisory Committee on Immunization Practices in 2025 debate removing the recommendation for birth-dose HBV vaccination in the US,” they wrote.
    • “Removing the recommendation for universal birth-dose vaccination would be a major step backward for elimination of HBV and would be potentially in direct contradiction to the Department of Health and Human Services Viral Hepatitis National Strategic Plan for the US,” they added”
  • Beckers Hospital Review tells us,
    • “The overall U.S. healthcare system received a “C” grade from a broad survey of U.S. adults, according to the West Health-Gallup Center for Healthcare in America, which released its inaugural report, “State of the States 2025: Insights on Healthcare in America.”
    • “Nationwide, the healthcare system received a “D+” for cost, a “C+” for quality and a “C+” for access. 
    • “The rankings are based on an online survey of 19,535 U.S. adults conducted June 9 to Aug. 25 across all 50 states and the District of Columbia. Respondents graded the healthcare system in their state, with letter grades converted to a 4.0 GPA scale for analysis.”
  • A medical specialist interviewed in MedPage Today identifies “13 Visible Signs of Heart Disease. What skin, nails, eyes, and more can reveal about cardiovascular disease.”
  • Health Day informs us,
    • “Even occasional or low-intensity smoking significantly increases cardiovascular and mortality risks, according to a study published online Nov. 18 in PLOS Medicine.
    • “Erfan Tasdighi, M.D., from the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease in Baltimore, and colleagues examined the relationships among smoking burden, intensity, and cessation duration across multiple cardiovascular outcomes. The analysis included data from 323,826 adult participants in 22 prospective cohort studies with median follow-up varying from 14.4 to 19.9 years.” * * *
    • “It is remarkable how harmful smoking is — even low doses of smoking confer large cardiovascular risks,” the authors said in a statement. “As far as behavior change, it is imperative to quit smoking as early in life as possible, as the [amount] of time passed since complete cessation from cigarettes is more important [than] prolonged exposure to a lower quantity of cigarettes each day.”
    • “Abstract/Full Text“
  • and
    • “The risk for motor vehicle crashes is increased after a concussion, according to a study published online Nov. 5 in BMJ Open.” * * *
    • “The risk of a motor vehicle crash after a concussion suggests current mitigating efforts are insufficient; however, driving cessation may be unreasonable since the risk also extends to patients as pedestrians,” the authors write. “Instead, clinicians might warn concussion patients to be cautious about prevailing motor vehicle crash risks along with standard anticoncussion campaigns.”
    • “Abstract/Full Text“
  • Healio points out,
    • “Child abuse is linked to long-term risk for negative health outcomes. 
    • “Boys and girls experienced decreases in confirmed maltreatment cases, but girls were subject to greater maltreatment.” * * *
    • “As a preventive measure, we need to address the drivers of maltreatment,” Richard T. Liu, PhD, director of suicide research in the division of child and adolescent psychiatry in the Depression Clinical and Research Program at Massachusetts General Hospital, told Healio. “One prominent driver of maltreatment risk is poverty. Reducing poverty would therefore be important for reducing risk for child maltreatment.”

From the U.S. healthcare business front,

  • This factoid along with more importantly this Brookings Institute report on PBM profitability support the FEHBlog’s view that cracking down on PBMs will not lower healthcare costs. The President’s efforts to lower drug costs could pay dividends.
  • Modern Healthcare adds,
    • “Eli Lilly & Co. and Novo Nordisk A/S plan to start selling their popular obesity shots to employers through a new approach that would bypass traditional drug sales channels in an effort to expand access to the costly weight-loss medicines.
    • “The drugmakers will offer Zepbound and Wegovy to companies starting Jan. 1 through Waltz Health, a firm that helps employers purchase cheaper medications. The shots will be available to employers at upfront, fixed prices, avoiding the rebates and fees that accompany traditional sales through middlemen who manage pharmacy benefits for many companies.” * * *
    • “The offering is aimed at employers that don’t cover obesity drugs right now. About 43% of companies with more than 5,000 workers cover weight-loss drugs, according to a recent survey from KFF. Thierer said four employer clients are signed up to launch the offering in January. Waltz is targeting a goal of making it available to 100,000 people by the end of the first quarter.
    • “The arrangements will only apply to the companies’ weight-loss drugs, not to similar medications intended for diabetes. Waltz will handle screening patients to see if they’re eligible for the drugs, sending prescriptions to pharmacies and supporting patients taking the drugs.
    • “Waltz was recently purchased by a larger firm, Eversana, that works with drug companies to commercialize and distribute their medications. Thierer, a former PBM executive, has said he aims to build an alternative to the “oligopoly” of PBMs and force the industry to change.”
  • Per Yahoo Finance,
    • “CVS Health® (NYSE: CVS) today announced that its Board of Directors has elected President and Chief Executive Officer David Joyner as Chair of the Board, effective January 1, 2026. Following the effective date of this appointment, Michael Mahoney will continue to serve as the Board’s Lead Independent Director, and Roger Farah, who is currently serving as Executive Chair of the Board, will continue to serve on the Board.
    • “Joyner was named President and CEO of CVS Health in October 2024, and has led significant operational, financial and cultural improvements in the Company’s performance over the past year. In recognition of his leadership, nearly 40 years of experience in the health care industry, and the Company’s future growth opportunities, the Board determined Joyner should also serve as Chair of the Board.”
  • Healthcare Dive lets us know,
    • “Western Pennsylvania-based Independence Health System plans to join West Virginia University Health System in the fall of next year, the systems announced Wednesday.
    • ‘Under the proposed merger, which is subject to regulatory reviews and approvals, Independence Health’s five hospitals as well as its affiliated physician groups will operate under WVU Medicine’s brand. 
    • “The systems say the deal will offer operational and financial efficiencies through resource sharing and allow the providers to expand clinical services and access to specialty care.”
  • Per MedTech Dive
    • “Solventum said Thursday it has struck a deal to buy wound care company Acera Surgical for $725 million in cash.
    • “The deal, which features up to $125 million in milestones, will give Solventum control of a portfolio of synthetic soft tissue repair products. Stifel analysts said in a note to investors that they believe the synthetic market “is growing at a double-digit pace.”
    • “Acera is Solventum’s first acquisition since it spun out of 3M. Solventum executives made M&A part of their focus after selling the company’s purification and filtration business to Thermo Fisher Scientific for $4.1 billion.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Heartflow’s Plaque Analysis software is an effective tool for the diagnosis and management of coronary artery disease (CAD), according to a new retrospective analysis of more than three years of data. The findings were presented at the American Heart Association’s Scientific Sessions 2025 conference.
    • “The FDA-cleared Plaque Analysis software was designed to evaluate coronary CT angiography (CCTA) results and provide cardiologists with an artificial intelligence (AI)-powered assessment of the patient’s coronary plaques. It delivers an interactive 3D model of the coronaries and identifies high-risk CAD patients who may benefit from immediate care. 
    • “This latest analysis included nearly 8,000 symptomatic CAD patients who participated in the FISH&CHIP study. All patients were treated with Plaque Analysis as well as Heartflow’s new Plaque Staging framework. Plaque Staging separates patients into one of four categories—mild, moderate, severe or extensive—based on AI-powered total plaque volume (TPV) measurements. According to Heartflow, this study represents the largest validation to date of the Plaque Staging framework.”
  • McKinsey & Co. explores “the coming evolution of healthcare AI toward a modular architecture.”
  • The Advanced Research Projects Agency for Health (ARPA-H) announced
    • “The AIR program [which’ aims to solve these problems by developing robots that can do parts of or entire surgical interventions on their own. The program’s focus is twofold: first, to develop autonomous robotic systems that can perform thrombectomies, making curative stroke care available to all Americans. Second, to create very small, mechanical, electronic, or hybrid devices (microbots) that can perform medical procedures independently, revolutionizing healthcare delivery.
    • “Notice ID: ARPA-H-SOL-26-146
      • ARPA-H invites interested parties to review the solicitation, which is posted and maintained on SAM.gov. The solicitation outlines the opportunity and its requirements, key dates and deadlines, submission documents and templates, evaluation criteria for submissions, and information on how to apply.
    • “Key Dates:
      • Proposers’ Day: December 16, 2025, Bethesda, MD (Hybrid)
      • Solution Summaries due: January 26, 2026
      • Proposals due: March 30, 2026
    • “Reminder: Dates are estimates and are subject to change. Please reference the solicitation for the most up-to-date information.”