Midweek report

Medicare

Midweek report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Senate negotiators said an effort to renew expired healthcare subsidies had effectively collapsed, likely ending the hopes of 20 million Americans that the tax-credit expansion could be revived and lower their monthly insurance premiums.
    • “Talks had centered on a proposal from Sens. Bernie Moreno (R., Ohio) and Susan Collins (R., Maine) to extend a version of the enlarged Affordable Care Act subsidies for at least two years, while cutting off higher-income people from participating and eventually giving enrollees the option of putting money into health savings accounts. It also would eliminate zero-dollar premium plans. But lawmakers from both parties now say the chances of a deal have all but evaporated.
    • “It’s effectively over,” Moreno said Wednesday. Sen. Bill Cassidy (R., La.)—the architect of an adjacent plan—agreed. While Collins declined to be as definitive, she did say that it was “certainly difficult.”
  • Federal News Network tells us,
    • “Following a year of the Trump administration’s overhauls to the civil service, a bicameral group of lawmakers on Wednesday launched a congressional caucus focused on the federal workforce.
    • “Sens. Chris Van Hollen (D-Md.) and Tim Kaine (D-Va.), along with Reps. James Walkinshaw (D-Va.), Steny Hoyer (D-Md.) and Suhas Subramanyam (D-Va.) joined federal unions and good government organizations to announce the newly formed Federal Workforce Caucus. The group aims to more cohesively advocate for federal employees.” * * *
    • “Members of the new Federal Workforce Caucus, which includes at least some bipartisan support, are expected to meet regularly with leaders from federal unions, employee groups and other organizations. The group plans to propose legislation and workforce policies focused on long-term improvements to the career civil service.
    • “The Partnership for Public Service, American Federation of Government Employees, National Federation of Federal Employees and National Active and Retired Federal Employees Association, among several others, are also partners in the new caucus.”
  • OPM Director Scott Kupor has added another post to his Secrets of OPM blog.
  • Per a CMS news release,
    • “CMS continues to bring accountable care to more people with Medicare in 2026, expanding the benefits of high-quality, whole-person health care to achieve better health outcomes for millions of older Americans.
    • “As of January 2026, 14.3 million Medicare beneficiaries are estimated to receive care coordinated by Accountable Care Organizations (ACOs), up from 13.7 million in 2025, representing a 4.4% increase. This includes patients whose health care providers are in Medicare Shared Savings Program (Shared Savings Program) ACOs and entities participating in Center for Medicare and Medicaid Innovation (CMS Innovation Center) accountable care models, as well as other CMS Innovation Center models focused on total cost of care, advanced primary care, and specialty care.
    • “ACOs are groups of doctors, hospitals, and other health care providers who collaborate and provide coordinated, high-quality care to people with Medicare, and they are a critical tool to help Make America Healthy Again by supporting whole person care that addresses prevention, chronic illness and the root causes of disease.
    • “In addition to improving health care, ACOs save billions of dollars for the Medicare program by focusing on delivering the right care at the right time while avoiding unnecessary services and medical errors. ACOs achieve savings because health care providers are held accountable for saving money and improving health care quality, delivering a win for both patients and the Medicare Trust Funds.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of serious injuries.
    • “The Food and Drug Administration, which published an early alertabout the devices on Tuesday, said sensor values in Impella RP heart pumps may drift over time.
    • “Erroneous information on automated Impella controllers has caused users to make inaccurate adjustments to the devices and unnecessary pump exchanges, the FDA said.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors by Abbott Diabetes Care due to incorrect glucose readings that are lower than actual blood glucose levels. The FDA said patients with impacted sensors should immediately discontinue use and dispose of any affected products. Abbott has reported 860 serious injuries and seven deaths associated with the issue since Jan. 7.” 
  • USA Today relates,
    • “A shortage in estrogen patches because of manufacturing issues and some brand discontinuation has been exacerbated by an increase in prescriptions for estrogen since the Food and Drug Administration removed its black-box warning label last fall. The shortage has left women exhausted, frustrated and scrambling each month to call pharmacies for the medicine they need to treat their menopause symptoms.
    • Some women have switched from generic medication to available brand names, which costs them as much as $300 a month and are not covered by insurance. Others have been forced to use a different brand of estrogen each month, leading to inconsistent care. Women have driven 45 miles to pick up a coveted box of the tiny plastic patch they place near their belly button and change twice a week to help with their symptoms, from frozen shoulders to vaginal dryness.”
  • STAT News adds,
    • “Vertex executives warned that Casgevy, its curative treatment for sickle cell disease, would be slow to reach patients. But few expected it to be this slow.
    • “More than two years after its approval, only about 60 patients across the U.S., Middle East, and Europe have been treated with the gene-editing therapy. Specialists at four sickle centers told STAT they’ve been surprised by one of the key stumbling blocks to faster rollout: They can’t collect enough cells to create the treatment.

From the judicial front,

  • Healthcare Dive reports,
    • “The Federal Trade Commission has agreed to what it called a “landmark” settlement with Express Scripts, allowing the company to bow out of the agency’s lawsuit against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “In return, Express Scripts, which is owned by Cigna and is one of the largest PBMs in the country, has agreed to make major changes to its drug benefit designs, including no longer preferring drugs with high list prices on its standard formularies when there are cheaper equivalents and delinking its compensation from the savings it negotiates with drugmakers, the FTC announced Wednesday.
    • “Express Scripts has also agreed to increase transparency, including reporting more data on drug spending and disclosing any kickbacks to brokers that help employers choose PBMs.
    • “Notably, the company also agreed to reshore its group purchasing organization Ascent from Switzerland back to the U.S.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The measles outbreak in South Carolina has increased to 876 cases, the state’s Department of Public Health reported Feb. 3. Last week, the South Carolina outbreak surpassed last year’s outbreak in Texas, which had 762 cases. The agency said the number of public exposure sites indicates community spread is occurring, increasing the risk of exposure and infection for individuals who are not immune due to vaccination or natural infection. “Vaccination continues to be the best way to prevent measles and stop this outbreak,” the department said.” 
  • MedPage Today informs us,
    • “In this self-controlled case series, myocardial infarction rates were nearly 9 times greater in the week after an RSV-related hospitalization compared with a control period prior to infection.
    • “Stroke rates were more than 7 times higher compared with the control period.
    • “Recent research has suggested that RSV vaccination lowers the risk of cardiorespiratory hospitalizations.”
  • and
    • The effectiveness of last season’s COVID vaccines among immunocompetent adults reached 40% against hospitalization and 79% against invasive mechanical ventilation or death.
    • Those levels of protection were similar among seniors and sustained through 6 months post-vaccination.
    • This study is a reminder that “vaccines still have a role, even in the current epidemiological landscape,” an expert said.
  • Per an NIH news release,
    • The National Institutes of Health (NIH) has opened the East Palestine Train Derailment Health Research Program Office to assess and address the long-term health outcomes stemming from the 2023 train derailment in East Palestine, Ohio. The new office is the hub of a five-year, $10 million research initiative funded by NIH.
    • “Federal research experts will engage directly with the community, coordinate studies, and help enroll residents in federally supported health research through the new office.” * * *
    • Three years ago, on Feb. 3, 2023, a Norfolk Southern freight train derailment involving 38 railcars carrying hazardous chemicals — including vinyl chloride, butyl acrylate, ethylene glycol and benzene residue — resulted in prolonged fires and controlled burns in East Palestine. Several railcars burned for more than two days, and emergency responders conducted controlled burns that raised concerns about the potential airborne release of hydrogen chloride and phosgene.
    • “Local residents reported a range of initial health symptoms, including headaches and respiratory, skin and eye irritation. These reports prompted concerns about potential longer-term effects on maternal and child health, as well as psychological, immunological, respiratory and cardiovascular health.”
    • “This research program is designed to bring rigorous, independent science directly to the community,” said NIH Director Jay Bhattacharya. “By establishing a local presence, we can better engage residents, support enrollment in studies, and ensure the research reflects the real experiences and concerns of the people affected.”
  • Genetic Engineering and BioTechnology News observes,
    • “As drug‑resistant hospital infections continue to rise worldwide, a team of Australian researchers has identified a surprising new bacterial vulnerability: a sugar that only microbes make. By designing antibodies that recognize this sugar, the scientists were able to clear lethal infections in mice—offering a potential new strategy for tackling multidrug‑resistant pathogens.
    • “The work, published in Nature Chemical Biology, describes the development of monoclonal antibodies that target pseudaminic acid, a carbohydrate found on the surface of many dangerous bacteria but absent from human cells. The study, titled “Uncovering bacterial pseudaminylation with pan‑specific antibody tools,” demonstrates that this sugar may serve as a highly selective molecular flag for immunotherapy.”
  • Per Healio,
    • “Once-weekly subcutaneous tirzepatide may not raise risk for depression compared with placebo, according to a post hoc analysis of the SURMOUNT trials.
    • “As Healio previously reported, in January the FDA requested that risk for suicidal ideation and behaviors be removed from labels for liraglutide (Saxenda, Novo Nordisk), injectable semaglutide 2.4 mg (Wegovy, Novo Nordisk) and tirzepatide (Zepbound, Eli Lilly). 
    • “In data published in Obesity, researchers found adults receiving tirzepatide in three SURMOUNT trials did not experience worsening of depression throughout the studies.
    • “The low occurrence of these events with tirzepatide is similar to that observed in pooled analyses of semaglutide 2.4 mg and liraglutide 3 mg, both GLP-1 receptor agonists approved for weight management,” Thomas A. Wadden, PhD, professor of psychology in psychiatry at Perelman School of Medicine, University of Pennsylvania in Philadelphia, told Healio. “The present report provides the first detailed analysis of the risk of these psychiatric events with tirzepatide.”

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

  • BioPharma Dive reports,
    • “Eli Lilly shares jumped early Wednesday after the company reported better-than-expected fourth-quarter revenue and shared higher forecasts for 2026, buoyed by its obesity and diabetes medicines.
    • “Fourth-quarter revenue soared 43% to $19.3 billion, Lilly said Wednesday. That’s 7% above the Wall Street consensus, Leerink Partners analyst David Risinger wrote in a note to clients. Earnings per share beat estimates by 9% and operating income came in 13% higher than analysts expected, he said.
    • “This year, Lilly expects revenue of between $80 billion and $83 billion, with non-GAAP earnings of $33.50 to $35 a share. Analysts had been expecting midpoint forecasts of $78.5 billion for revenue and $33.30 for EPS, according to Risinger.”
  • Fierce Pharma tells us,
    • “Novartis CEO Vas Narasimhan is doubling down on a growth forecast for 2026, even as the Swiss drugmaker’s fourth-quarter results start to show the impact of the “largest patent expiry” in its history. And while a $4 billion revenue hole awaits, Narasimhan insisted that a wave of newer blockbusters will pull the company back into growth by year-end.
    • “The steep patent cliff that Narasimhan was referring to follows the 2025 U.S. entry of generic rivals to heart failure treatment Entresto, blood disorder drug Promacta and cancer therapy Tasigna.”
  • MedTech Dive informs us,
    • “Boston Scientific has been one of the big winners of the pulsed field ablation revolution. Over the past two years, the company has reported strong electrophysiology sales growth — sometimes in the triple digits — and declared itself the clear market leader in PFA.
    • “However, on a Wednesday morning earnings call, analysts questioned executives on the electrophysiology unit’s potential after U.S. sales growth stalled in the fourth quarter compared with the third quarter.
    • “CEO Mike Mahoney told investors that the company remains confident in PFA’s potential, even as the market becomes more penetrated and competition in the space ramps up. Mahoney said that the electrophysiology market should grow about 15% in 2026, and the company expects to grow above that rate.
  • Beckers Clinical Leadership notes,
    • [Nurse] workforce projections from HHS’ Health Resources and Services Administration indicate “the gap between the demand for and supply of RN services is expected to shrink over the next decade from 10% in 2027 to 6% in 2037,” according to a January report from the council. 
    • “This forecast is partly due to an increase in first-time examinees of the National Council Licensure Examination, according to the report. 
    • “By comparison, the U.S. supply of licensed practical nurses and licensed vocational nurses is projected to decrease a whopping 36% by 2037, HRSA data shows. These workforces have declined in labor participation and absolute licensure statistics across most states, the report said. 
    • “Although the projected outlook for the RN workforce is more favorable than it is for LPNs/LVNs, maldistribution of providers remains a critical issue, with nonmetropolitan areas projected to face significantly higher shortages than metropolitan areas in the coming years,” the report said. “These issues exacerbate the broader projected shortfall owing to the dual trends of increasing demand due to an aging population and an aging workforce.”
  • Cardiovascular Business lets us know,
    • “Early adopters have been using robotics to perform cardiac surgeries in the United States for years now, but multiple factors—including high costs and early concerns about patient outcomes—have held back widespread implementation.   
    • “According to a new commentary in The Annals of Thoracic Surgery, however, robotic cardiac surgery has gained considerable momentum in the last year. Is now the time for this trend to truly take off?
    • “A convergence of improved training frameworks, maturing technology and increasingly standardized quality processes have supported a broader and more sustainable growth,” wrote co-authors Andrea Amabile, MD, a cardiothoracic surgery resident with the University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute, and Johannes Bonatti, MD, director of the cardiac robotic surgery at the UPMC Heart and Vascular Institute. “In this context, the past year has brought forward a set of notable global milestones that collectively illustrate the evolving capabilities of robotic cardiac surgery.”
  • Per Beckers Health IT,
    • “KLAS Research released its annual “Best in KLAS” report Feb. 4, ranking healthcare technology vendors and service providers across more than 140 market segments based on feedback from the clinicians and administrators who use them.
    • “The report, now in its 28th year, draws on tens of thousands of provider evaluations to identify the top-performing solutions in categories spanning electronic health records, revenue cycle, cybersecurity, AI and other areas. This year’s edition arrives as AI — particularly ambient speech technology — continues to reshape clinical workflows, and as health systems navigate tightening finances alongside growing vendor competition.
    • “For the 16th consecutive year, Epic was named the top Overall Health System Suite. Epic also won Best in KLAS recognition in 11 market segments.
    • [The article lists] the winners in some of the report’s most closely watched categories. The full report is accessible from KLAS Research here.
  • Per Beckers Payer Issues,
    • “Optum has launched a pair of AI-driven prior authorization products, one designed to speed up submissions on the provider side and another to accelerate clinical reviews for payers.
    • “The provider-facing product, Digital Auth Complete, went live in January in collaboration with digital health company Humata Health. The payer-facing product, InterQual Auth Accelerator, began piloting with two large health plans in late 2025, with the first payer expected to be fully live by April.
    • “It’s a combination of three things,” John Kontor, MD, senior vice president of clinical technology at Optum Insight, told Becker’s, explaining why the products are coming to market now. “It is the policy changes, including CMS-0057, that have accelerated everyone’s urgency to get this figured out. Two, it’s the readiness now of technology to be able to support solving many of these administrative, burdensome problems in healthcare. And third, the policy changes really reflect both industry frustration and impatience and the public’s real desire to get real and better answers to the problems of prior authorization.”
  • Per Fierce Healthcare,
    • “Epic is rapidly building out artificial intelligence tools integrated into its electronic health record solution as health IT companies strive to keep up with the dizzying speed of AI innovation.
    • “This week, the EHR giant released AI Charting, a built-in feature that ambiently listens during patient visits and drafts the clinician’s note. The AI charting feature also queues up orders based on the conversation. 
    • “Epic CEO Judy Faulkner announced the AI Charting technology during the company’s Users Group Meeting (UGM) in August as part of its collaboration with longtime partner Microsoft.
    • “AI models are advancing at a rapid pace; we continue to work with Microsoft on AI Charting and use a variety of different models through the Microsoft Azure platform,” an Epic spokesperson said Wednesday.”

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Medicare, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports.
    • “Speaker Mike Johnson (R., La.) faces a tougher-than-expected vote to end a partial government shutdown this week, after House Democrats pushing for sweeping changes to immigration enforcement signaled they wouldn’t help Republicans pass any funding measures through the narrowly divided chamber.
    • “Johnson, with a 218-213 majority, will need to keep almost all Republicans on board or risk the shutdown that started Saturday stretching deep into the week. The measure, endorsed by President Trump, funds swaths of the government for the rest of the fiscal year, while providing a two-week extension for the Department of Homeland Security—which contains immigration-enforcement agencies. The extension is intended to jump-start talks on reining in enforcement officials’ practices.
    • “I’m very optimistic that we will get everyone back in town,” Johnson said Sunday in an interview, referring to GOP lawmakers. “We will convince them that we need to implement the president’s play call,” giving the White House time to discuss changes to DHS with Democrats.” * * *
    • “Johnson’s tiny vote margin gives any one or two GOP members powerful leverage if they want changes or concessions. Johnson as soon as Monday is expected to swear in Christian Menefee, a Democrat who just won a Texas special election to represent Texas’ 18th Congressional District after former Rep. Sylvester Turner’s death last year. That will bring the majority to 218-214.”
  • Here’s a link to Roll Call’s take on what to expect to occur on Capitol Hill this week.
  • The American Medical Association tells us,
    • “The influential Medicare Payment Advisory Commission (MedPAC) voted in January to address inadequate payment for Medicare physician services under current law, once again underscoring a longstanding policy failure that is widely recognized but remains unresolved.
    • “MedPAC voted to recommend an additional 0.5% update on top of the updates specified in current law—0.25% and 0.75%—and will forward that recommendation to Congress. 
    • “The AMA appreciates that last year’s reconciliation bill provided a temporary 2.5% update for 2026; however, that increase expires in 2027. Absent meaningful reform, physicians again will face payment cuts, and Congress will once more be forced into last-minute efforts to avert further disruption,” AMA Board Chair David H. Aizuss, MD, said in a statement.
    • “The AMA is leading the charge to reform the Medicare payment system. That includes strongly urging MedPAC to recommend to Congress that they update 2027 physician payment rates so that they keep pace with the Medicare Economic Index (MEI).” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.
    • “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”
    • “The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “There’s been a small but “alarming” bump in aortic stenosis (AS) deaths among people ages 45 to 74 in recent years, according to nationwide trends.
    • “In this younger group, age-adjusted AS mortality rates had been relatively stable until 2019, when they started climbing from a rate of 3.33 per 100,000 to 3.57 per 100,000 in 2023 — a statistically nonsignificant change that is notable nonetheless, according to Sameer Hirji, MD, MPH, of Brigham and Women’s Hospital in Boston.
    • “In comparison, those ages 75 and older showed a consistent decline in age-adjusted AS mortality rates from 2012 (112.3 per 100,000) to 2023 (104.1 per 100,000) based on the CDC WONDER database, Hirji reported at the Society of Thoracic Surgeons (STS)opens in a new tab or window annual meeting.
    • “This emerging trend — spanning sex, race, and geography — demands urgent evaluation of existing screening practices, timely diagnosis, and equitable access to both transcatheter and surgical therapies,” he concluded.”
  • The Washington Post relates,
    • “For years, scientists have been working to unravel the mystery of patients with failing kidneys dying from heart-related complications.
    • “Researchers now say they’ve uncovered a clue that explains why people with chronic kidney disease have such a high risk of heart failure — and it could have major implications for the diagnosis and treatment of the two common health conditions.
    • “A new study found that diseased kidneys released tiny particles that were toxic to the heart, according to findings published recently in the peer-reviewed journal Circulation.” * * *
    • “That molecular discovery is helping to shed light on one way the kidney and heart are linked — and, in this case, to dangerous effect, said Susmita Sahoo, the study’s senior author and an associate professor of medicine at the Cardiovascular Research Institute at the Icahn School of Medicine at Mount Sinai.
    • “No one has shown this causal relationship before,” Sahoo said.” * * *
    • “Sahoo said her team’s findings could help identify heart disease in kidney patients earlier, before they show symptoms.
    • “By measuring these cardiotoxic microRNAs, you can actually predict or identify or diagnose the patient who are on the way to developing a failing heart,” she said.
    • “The research can also influence treatment recommendations, said Erdbrügger, the study co-author who is also a practicing kidney doctor. For instance, Erdbrügger said if she knew one of her kidney patients had a higher risk of heart disease, she would consider treating more aggressively by increasing drug dosages or using more combinations of medications.”
  • The Wall Street Journal tells us,
    • “Federal regulators issued a safety warning, telling used-car owners in the U.S. to examine their vehicles’ maintenance histories regarding air-bag safety.
    • “NHTSA said nine people have died and two were injured in otherwise-survivable crashes after DTN inflaters ruptured.
    • “NHTSA urged drivers who find that their vehicles experienced an air-bag deployment to have an inspection.” * * *
    • “If a DTN inflater is found, the vehicle should not be driven until you are able to have it replaced with genuine parts,” NHTSA said.
  • NPR Shots informs us,
    • “Building strength and muscle comes with huge payoffs for health and longevity, but most Americans still don’t lift weights or regularly practice any muscle-strengthening activity.
    • “Why? People often blame a lack of time.
    • “Exercise physiologist David Behm says often when he talks to people about resistance training they seem to think they’d need hours in the gym to get results, working through rows of machines targeting each muscle.
    • “They’re like ‘my God, I’m going to be in there for an hour and a half or longer,” says Behm, a professor at Memorial University of Newfoundland in Canada.” * * *
    • “The evidence shows you can make real gains in strength and muscle with as little as one or two quick workouts a week — depending on the approach, you might be able to get away with as little as a half hour in the gym (or even less).
    • “The key is focusing on what are called multi-joint exercises, or compound lifts.”
  • The New York Times points out,
    • “A study published this week in the journal JAMA Pediatrics found that a close, nurturing relationship with parents during middle and high school was associated with a variety of positive social metrics up to two decades later.
    • “Researchers looked at six outcomes, such as having three or more close friends or socializing at least once a week. They found that high social connection in adulthood was more than twice as common among those who had felt the strongest family ties in youth, compared with those who had felt the weakest.
    • “We tend to think of adult loneliness or low social connectedness as byproducts of individual choice or adult social structures,” said Dr. Andrew Garner, a pediatrician and researcher at Case Western Reserve University, who was not involved in the research. This study, on the other hand, “forces us to think developmentally.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “2026 is an “execution year” for Teladoc Health, CEO Chuck Divita told Healthcare Dive.
    • “The telehealth company has spent the past year focusing on a strategy shift, prioritizing international expansion, improving operating efficiency, better leveraging its mental health assets and enhancing its integrated care business.
    • “The goal is to deliver sustainable long-term growth at Teladoc, which has seen its stock price decline significantly from the heights reached during the COVID-19 pandemic. To that end, the virtual care giant completed multiple acquisitions last year, launched new products and began accepting insurance coverage at its direct-to-consumer mental health arm BetterHelp. 
    • “I believe that we have the right strategy, the right priorities, and it’s really about execution now,” said Divita, who took up the role as Teladoc’s chief executive about a year and half ago.”
    • For the full interview, read the article. 
  • McKinsey & Co. discusses the changing contours of health and wellness.
    • “As 2026 takes shape, long-held notions of health and wellness, both in and out of the workplace, are evolving—expanding beyond disease prevention to focus on longevity, performance, and quality of life.
    • “Advances in healthspan science are driving biomedical innovations that contribute to healthy longevity, while the rapidly evolving wellness economy reflects shifting consumer expectations around fitness, nutrition, and healthy aging. McKinsey Health Institute research from Barbara Jeffery, Jacqueline Brassey, Lucy Pérez, and Darshini Mahadevia also shows that workplace health interventions can deliver measurable gains for both individuals and organizations. 
    • “As you navigate your own wellness journey this year, explore these insights on what it means to live a healthier, more fulfilling life.”
  • Per Fierce Healthcare,
    • “Maven Clinic launched a research institute on Thursday to rally further research and collaboration in digital health.
    • “The Clinical Research Institute is based on what Maven claims is the largest public evidence base measuring the impact of virtual care on women’s and family health. Maven has published over 40 peer-reviewed publications. A clinical research team, including Maven’s chief medical officer, is part of the center and driving its research and collaborations with partners.
    • “The goal is to serve as a platform for partnerships across academia and industry while expanding the scope of women’s and family health research. Current and past research partners include Harvard Medical School, Brown University, Posterity and OURA, with additional studies planned.
    • “The Institute also advances research through Maven’s Visiting Scientist program. Visiting Scientists work part-time with Maven for up to one year, contributing to research that informs care delivery and helps translate evidence into practice.”
  • and
    • “Nourish, a virtual nutrition provider, is launching a program that gives patients access to free cardiometabolic lab testing. 
    • “Nourish Labs will integrate blood testing into personalized nutrition care. The free basic panel will include key cardiometabolic markers like cholesterol, A1C and thyroid-stimulating hormone. An enhanced lab panel for insights into heart and hormone health will be available for a small add-on cost. 
    • “The objective measurement will improve treatment plans and strengthen patient engagement, executives say.
    • “We had just really wanted to, for a long time, bring it in-house and to be able to do this ourselves,” Aidan Dewar, co-founder and CEO of Nourish, told Fierce Healthcare in an exclusive advanced interview.”

Midweek report

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats demand an overhaul of immigration enforcement, tying it to passing a $1.3 trillion spending package to avert a government shutdown.
    • “Democrats propose changes including: ending roving patrols, tightening warrant rules and requiring ICE coordination with local law enforcement.
    • “The standoff follows two fatal shootings by federal immigration agents in Minneapolis, with Democrats refusing to fund DHS without revisions.”
  • The Hill adds,
    • “House Republicans are warning the Senate against making any changes to a government funding package that includes funds for the Department of Homeland Security (DHS), saying any reforms sought by Democrats would not clear the House and would lead to a government shutdown at the end of the week.
    • “Conservatives also say they would seek significant concessions from Democrats if they were to split up the six-bill funding package and tinker with the DHS spending bill — threatening to seek avenues to fund the department without needing support from Democrats.
  • The House Budget Committee identified highlights from last week’s hearing on how to reverse the healthcare cost curve. One of the experts that the FEHBlog admires, Avik Roy, observed,
    • “Mr. Avik Roy, Foundation for Research on Equal Opportunity: I’d encourage you to look at the World Index of Health Care Innovation that my organization puts out every year. FREOP, which looks at a lot of these metrics of how we measure the quality of the health care system, what we can learn from other countries, what they can learn from us. On the point about options other than health insurance, first of all, we have to make health insurance more affordable. You can do a lot to have alternatives to health insurance, and I will talk about that, but we, the people, still need affordable options for health insurance. The fact that the Affordable Care Act made health insurance massively more expensive for people who buy it on their own is a huge problem, because the foundation of free market health insurance is you buying that health insurance for yourself, not depending on your employer to buy it for you, not depending on the government to buy it for you. You buy it for yourself, and maybe the government helps you pay for that premium.“
  • FEHBlog note — The FEHB Program would be a good model for choice but for the fact that the U.S. Office of Personnel Management has been benefit mandate crazy in recent years. OPM needs to revoke those mandates.
  • The Wall Street Journal tells us,
    • “The Census Bureau’s first snapshot of population data for 2025 confirms some big trends, like a major shift in immigration as the U.S. cracks down on border crossings and steps up deportations. 
    • “The estimates, which cover the 12-month period ended in mid-2025, also uncovered some surprises regarding the comings and goings between states. Some places in the Midwest, for example, are seeing a net influx of people from within the U.S. for the first time in years.” ***
    • “The U.S. added slightly more babies, but not enough to move the needle significantly on population growth. Births ticked up about 12,200 on the year to 3.6 million. That is better than the decline of 40,700 in the prior year, but it didn’t shift a still-falling birthrate that has become a concern among some Republicans.”
  • The American Hospital Association New informs us,
    • “The Centers for Medicare & Medicaid Services Jan. 28 released a proposed rule that would update conditions for coverage for organ procurement organizations. The proposal would eliminate regulatory requirements that limited the Secretary of Health and Human Services in certifying new OPOs, clarify the OPO designation process, modify the appeals process for OPOs, and update and add certain key definitions, among other changes. CMS also seeks comments on various topics, including a new process to certify OPOs; conflicts of interest in organ and tissue procurement; automated electronic referrals, from donor hospitals to OPOs; and alternative approaches to OPO designation and non-renewal of OPO agreements.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of 21 new members to the Interagency Autism Coordinating Committee (IACC). These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to support breakthrough innovations in autism research, diagnosis, treatment, and prevention by bringing the nation’s understanding of and policies concerning autism into alignment with gold-standard science.”
  • MedCity News points out,
    • “While the 15 medications selected for the latest round of the federal government’s drug price negotiation program will face steep cuts in what Medicare will pay, the financial impact to pharmaceutical companies is expected to be minimal.
    • “Leerink Partners analyst David Risinger said in a Wednesday research note that Gilead Sciences HIV drug Biktarvy is the only one of the selected products with Medicare exposure that is material to its manufacturer’s sales, accounting for about 8% of Gilead’s 2027 estimated global revenue. Rexulti, a drug approved for schizophrenia among other neurological indications, has the second-largest exposure, with revenue from Medicare estimated to be about 3% of Lundbeck’s global sales. But Risinger said this exposure for Lundbeck is overstated because the company shares in commercialization of the drug with partner Otsuka Pharmaceutical.”
  • Avalere Health explains how this week’s “2027 Advance Notice Materially Alters Part D Risk Adjustment.”
  • Tammy Flanagan, writing in Govexec, discusses “how federal employees can protect a spouse in retirement”
    • “To better understand their potential benefits and financial risks in retirement, both spouses should be aware of some benefits planning realities.”

From the Food and Drug Administration,

  • Fierce Pharma reports,
    • “Even as Johnson & Johnson’s oncology superstar Darzalex Faspro racks up megablockbuster sales and reshapes the multiple myeloma treatment paradigm, the drug is still finding ways to consolidate its position. This week, the drug is doing just that with an FDA nod for a more powerful regimen in newly diagnosed patients who are ineligible for autologous stem cell transplant.
    • “The Jan. 27 approval enables Darzalex Faspro’s use within a quadruplet combination that includes Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), which is altogether referred to as D-VRd. Before that, the triplet regimen of D-Rd has been allowed to treat first-line, transplant-ineligible patients since 2019. 
    • D-VRd is now the only anti-CD38 antibody-based regimen that can treat newly diagnosed patients regardless of transplant eligibility, J&J said in a Jan. 27 press release.”
  • BioPharma Dive adds,
    • “Regenxbio lost almost a fifth of its value Wednesday after the Food and Drug Administration placed a clinical hold on two of the company’s experimental gene therapies.
    • “Regulators acted after researchers found a case of brain cancer in a 5-year-old child who had received one of the treatments, RGX-111, four years earlier. The agency decided to extend the hold to the second therapy, RGX-121, because of similarities between the two and “shared risk between the clinical studies,” Regenxbio said Wednesday.
    • “The company said there has been no causal link between RGX-111 and the child’s condition and emphasized that RGX-121 is a separate therapy with years of safety data. “We are surprised by FDA’s decision to place our RGX-121 program on hold while the investigation of this single, inconclusive incident in RGX-111 continues,” CEO Curran Simpson said in the statement.”

From the public health and medical / Rx research front,

  • Infectious Disease Advisor reports,
    • “Millions of COVID-19-associated illnesses and outpatient visits as well as thousands of hospitalizations and deaths continued to occur annually in the United States from late 2022 through 2024, despite the formal end of the public health emergency, according to a cross-sectional analysis published in JAMA Internal Medicine.
    • “To provide updated national estimates during a period marked by evolving SARS-CoV-2 variants, changes in testing practices, and increasing population immunity, investigators analyzed data from the COVID-19 Hospitalization Surveillance Network. Using hierarchical Bayesian modeling and probabilistic multiplier methods, the investigators estimated the national burden of symptomatic illnesses, outpatient visits, hospitalizations, and deaths across 2 surveillance periods aligned with influenza seasons: October 2022 to September 2023 and October 2023 to September 2024.”
  • The Wall Street Journal informs us,
    • “A recent email ad from a telehealth company selling weight-loss medications features tennis-superstar Serena Williams.  
    • “If you’re carrying 15-20 extra pounds,” it says, “medications like Wegovy can help jumpstart your progress.”
    • “For obesity doctors and researchers, this kind of messaging is problematic. The blockbuster drugs—known as GLP-1s—are increasingly marketed as lifestyle fixes to help take off some weight. But they are actually designed as lifelong treatments for chronic diseases, namely obesity and Type 2 diabetes. 
    • “That distinction matters.
    • “While nearly 18% of U.S. adults have taken a GLP-1 drug for weight loss or to treat a chronic condition, about half of people will stop taking it within a year. Often, they don’t understand what is likely to come next. 
    • “Studies show that after stopping the drugs, people typically regain lost weight within about 1.5 years. And any improvements in blood sugar, blood pressure or cholesterol are reversed.
    • “People who take GLP-1s regain weight four times faster than those who lose weight through lifestyle interventions, according to a recent analysis published in the British Medical Journal.
    • “The depressing results raise the question: Are the drugs worth starting if you can’t stay on them long-term? Doctors largely say yes but caution the need for proper counseling and lifestyle changes.
    • “The medications, which include Ozempic, Mounjaro and Zepbound, mimic naturally occurring gut hormones such as GLP-1, suppressing appetite and making people feel full faster.”
  • Cardiovascular Business calls attention to five takeaways from new stroke guideline.
    • “The American Stroke Association (ASA), a division of the American Heart Association, has developed an updated ischemic stroke guideline that highlights the importance of coordinated care and expands patient access to critical treatments. The new document, published in full in Stroke, also includes the first detailed recommendations for treating stroke in pediatric patients.
    • “This update brings the most important advances in stroke care from the last decade directly into practice,” Shyam Prabhakaran, MD, MS, chair of the writing group behind the guideline and chair of the department of neurology at the University of Chicago Medicine, said in a statement. “New recommendations in the guideline expand access to cutting-edge treatments, such as clot-removal procedures and medications, simplify imaging requirements so more hospitals can act quickly, and introduce guidance for pediatric stroke for the first time.”
  • MedPage Today lets us know,
    • “Unhealthy alcohol use ranks among the top three causes of preventable deaths in the U.S., yet less than one-third of patients who visit a primary care clinician ever discuss alcohol use.
    • “A tailored practice facilitation strategy was linked to increased adoption of evidence-based screening and counseling for unhealthy alcohol use among adults at small and medium-sized primary care practices.
    • “Studies in two other states documented similarly positive findings.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance became the second major insurer to predict declining revenue in 2026 on Wednesday, as for-profit payers continue to shave off members to try and recover margins.
    • “The Indianapolis-based insurer estimated its operating revenue will drop by a low-single digit percentage next year. The guidance comes one day after UnitedHealth forecast an annual revenue decline for the first time in more than three decades, sparking a selloff of managed care stocks that continued into Wednesday.
    • “Elevance also projected adjusted diluted earnings per share of at least $25.50, compared to the $30.29 it posted in 2025. Analysts said the insurers are setting attainable guidance to rebuild investor confidence after a difficult few years for the sector.”
  • Cigna released on LinkedIn a white paper about the healthcare landscape facing employers this year.
  • Bio Pharma Dive notes,
    • “Eli Lilly is expanding its footprint in genetic medicine, announcing Wednesday an agreement with Germany-based startup Seamless Therapeutics to develop treatments for hearing loss. 
    • “The alliance gives Lilly access to a type of next-generation gene editing technology. Seamless engineers and programs “recombinases,” or enzymes that rearrange DNA, in such a way that they can precisely pinpoint and modify specific areas of the genome. Through the deal, Seamless will design certain recombinases to correct mutations in unspecified “genes of interest” in hearing loss, the companies said.
    • “Lilly didn’t specify how much guaranteed cash Seamless will receive initially. But the startup is eligible for over $1.12 billion in total payouts, which includes an upfront payment and a variety of unspecified milestones.
    • “The deal adds to a concerted push by Lilly, which recently flirted with a $1 trillion market value thanks to its diabetes and obesity medicines, into the field of genetic medicine.”  
  • Per Fierce Healthcare,
    • “Premise Health and Crossover Health plan to merge, creating a large employer-focused advanced primary care company serving more than 400 organizations and operating 900 clinics across the country.
    • “Both companies offer primary care and occupational health services for employers, unions, tribes and health plans with worksite or near-worksite clinics. The companies also offer virtual care services.
    • “Financial details of the agreement were not disclosed. The deal is subject to customary closing conditions, including regulatory approval.
    • “After closing, the combined company will approach $2 billion in annual revenue, according to a Premise Health spokesperson.”
  • and
    • “Reperio Health, a provider of at-home health screenings with instant results, is teaming up with Amazon One Medical to expand access to primary care. 
    • “This marks Amazon’s first partnership in the at-home preventive screening space. 
    • “Reperio was founded in 2020, working with employers to offer at-home health screenings with instant results. Now, it is launching ReperioCare, which adds an on-demand virtual visit with a contracted clinician to interpret those results. Employees using the service can then take advantage of an included One Medical membership for ongoing primary care. 
    • The partnership’s goal is to streamline the path from early detection to ongoing primary care, particularly in rural areas.” 
  • Per Beckers Hospital Review,
    • “Fort Wayne, Ind.-based Parkview Health has signed a letter of intent with Goshen (Ind.) Health to explore a partnership.
    • “The partnership would make Goshen Health Parkview’s largest hospital outside of Fort Wayne and establish it as a regional hub for care, access and growth, according to a Jan. 27 Goshen Health news release.
    • “Goshen and Parkview plan to collaborate to strengthen clinical services, expand care access and build a sustainable healthcare system. The process begins with a 90-day due diligence period, followed by regulatory review and final board approval.”
  • and
    • “Walmart has moved 3,000 of its pharmacy technicians into pharmacy operations team lead roles and expanded pay ranges for the workforce.
    • “Pharmacy technician hourly rates average $22, which can increase to $40.50 depending on location and certification, according to a Jan. 28 news release from Walmart. The 3,000 recently promoted pharmacy operations team leads receive an average hourly pay of $28 with the potential to earn up to $42 per hour. Walmart operates about 4,600 locations in the U.S.
    • “The two largest U.S. pharmacy chains by prescription dispensing revenue, Walgreens and CVS, have made similar investments in their pharmacy technicians. In April, Walgreens said it would pay for pharmacy employee’s prerequisite coursework for a PharmD degree. A few months later, CVS opened a workforce development center in Texas for pharmacy technicians, customer service representatives and other pharmacy employees.” 

Notable Obituary

  • The New York Times reports
    • “Thomas Fogarty, 91, Who Helped Revolutionize Vascular Surgery, Dies
    • “Drawing on his love of fly-fishing, he developed a balloon catheter that removes blood clots from patients’ limbs in a minimally invasive way. It has saved millions of lives.”
  • RIP

Tuesday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Republicans and the White House were trying to broker a last-minute deal Tuesday with Democrats who are demanding changes to immigration enforcement in a sprawling funding package, with an agreement seen as critical to averting a partial government shutdown.
    • “The Senate is set to consider a $1.3 trillion package of six spending bills, including one that would fund the Department of Homeland Security. Lawmakers need to send the measures to President Trump’s desk by the end of this week to avoid a funding lapse. Democrats have said they would pass five of the bills, but insisted on separating or reworking the DHS funding legislation, arguing that any changes to immigration enforcement must be written into law. 
    • “An administration official said the White House is offering to change its immigration-enforcement operations to get the final appropriations bills passed, pointing to steps already taken such as removing Border Patrol commander Gregory Bovino from Minneapolis. But the White House doesn’t want to alter the funding bills, the official said, seeing such a move by the Senate as effectively guaranteeing a shutdown this weekend by requiring the House—currently on recess until Monday—to take action.”
  • Fierce Pharma relates,
    • “Even as the Trump administration works to implement its “most favored nation” pricing system, the U.S. government continues to advance efforts to negotiate Medicare drug prices as enabled by the Inflation Reduction Act. 
    • “On Tuesday, the Centers for Medicare & Medicaid Services unveiled the next 15 high-spend medicines up for price negotiations under the program. 
    • “Meds up for first-time Medicare price negotiations this year include GSK’s inhaler Anoro Ellipta, Gilead’s HIV blockbuster Bitkarvy, AbbVie’s Botox and Botox Cosmetic brands, Takeda’s inflammatory bowel disease drug Entyvio and Johnson & Johnson prostate cancer medicine Erleada, according to a Jan. 27 release from the CMS.
    • “In addition, Novartis’ breast cancer medicine Kisqali, Eisai’s cancer therapy Lenvima, Lundbeck and Otsuka’s atypical antipsychotic Rexulti, Eli Lilly’s diabetes drug Trulicity and its breast cancer treatment Verzenio are also due up for first-time negotiations, according to the government.
    • “Rounding out the list are Roche and Novartis’ Xolair for food allergies, chronic hives and other uses, plus immunology biologics Cosentyx, Cimzia, Orencia and Xeljanz from Novartis, UCB, Bristol Myers Squibb and Pfizer, respectively.
    • “Also for the first time, the government will renegotiate a drug’s price under the IRA system, tagging Boehringer Ingelheim’s diabetes med Tradjenta for renegotiations. The drug was previously included in last year’s batch of pricing talks.”
    • “After the negotiation process for the drugs kicks off this year, their new Medicare prices will become effective in early 2028, according to the CMS. Drugmakers have until the end of February to decide whether to participate in the process.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients — including Medicare and Medicaid enrollees — in a manner that’s low risk under the federal anti-kickback statute, so long as key safeguards are met. * * *
    • “The guidance, issued as a bulletin [PDF] by the HHS Office of Inspector General (OIG), supports efforts to make medically necessary drugs more affordable while protecting patients and federal health care programs from fraud and abuse. It also aligns with the Trump Administration’s broader effort to lower drug prices, increase transparency across the prescription drug market, and expand the availability of affordable direct-to-consumer pharmaceuticals as part of the TrumpRx program. * * *
    • “The guidance issued today provides pharmaceutical manufacturers with assurance that they may sell prescription drugs directly to patients who choose to pay cash — including patients enrolled in federal health care programs — when the arrangement meets specific conditions. These include ensuring the drug is not billed to Medicare, Medicaid, or other federal programs, is not used to market other federally reimbursable products, and is not tied to future purchases or referrals.
    • “Importantly, the guidance does not change the federal anti-kickback statute itself, which remains a criminal law enforced on a case-by-case basis. It also does not address financial relationships between manufacturers and other parties such as physicians, pharmacies, pharmacy benefit managers, or marketers. HHS OIG has indicated it will seek additional public input on those arrangements separately.”
  • Healthcare Dive tells us,
    • “The Trump administration’s top Medicare official is coming to the defense of the 2027 Medicare Advantage rate notice, after the rule sparked a wave of backlash from the health insurance sector.
    • “The CMS proposed a flat rate update for next year, which won’t adequately cover higher spending on seniors in the privatized Medicare program, insurers say. Regulators also proposed reforms to MA risk adjustment that would restrict insurers’ ability to inflate members’ risk scores and, correspondingly, their reimbursement from the federal government.
    • “The rule sent a shockwave down Wall Street, which had expected a much higher update from the historically pro-business Trump administration.”
  • Yesterday, CMS released proposed Medicare Part D payment policies for 2027. The American Hospital Association News notes,
    • “CMS plans updates to the Part D risk adjustment model. Out-of-pocket prescription drug costs for individuals with Medicare Part D are proposed to be capped at $2,400 in 2027, up from $2,100 in 2026. Comments on the [two] CY 2027 proposals are due Feb. 25. The agency expects to publish a final rate announcement on or before April 6.” 

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Amid a deregulatory push by the Trump administration, the Food and Drug Administration is scrutinizing its digital health policies. The agency suddenly issued a pair of guidances earlier this month, intended to clarify its approach to wellness devices and medical software. 
    • “The updates reflect changes to the agency’s thinking about what counts as a wellness device, but also raise new questions and pose challenges to consumers, experts said. 
    • “FDA Commissioner Marty Makary announced the pair of guidances — issued without any prior notice or public comment period — at the Consumer Electronics Show in early January. Makary said the agency has 27 different guidances that deal with software and digital health, and he aims to cut that number by at least half, while updating them to be more clear, modern and consistent.
    • “Despite Makary’s framing, attorneys viewed the updates as less of a major change to regulations, and more as tweaks and examples. 
    • “He was talking about cutting red tape and deregulating, and that’s not really what these are,” said Amanda Johnston, a partner at Gardner Law. “The law itself has not changed.” 
  • BioPharma Dive informs us,
    • “Shares for Intellia Therapeutics climbed by about 10% early Tuesday after the company said the Food and Drug Administration cleared it to resume one of two Phase 3 trials evaluating its experimental CRISPR-based treatment against the rare genetic disease transthyretin amyloidosis.   
    • “U.S. regulators halted two studies of Intellia’s nexiguran ziclumeran, or nex-z, last October following the occurrence of serious liver toxicity that resulted in the death of a trial participant. Intellia said Tuesday that the FDA has allowed it to restart “MAGNITUDE-2,” a trial testing nex-z in people with a form of the disease that affects the nerves, by incorporating new risk mitigation measures. It’s also enrolling about 10 more patients in that study. Intellia aims to begin testing again “as quickly as possible.” 
    • “Intellia also revealed, however, that a pause in the “MAGNITUDE” trial in patients with the “cardiomyopathy” form of the disease is ongoing. The company will provide an update once aligned with regulators on the program’s path forward there.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “The South Carolina measles outbreak has surpassed the recorded case count in Texas’ 2025 outbreak, as health officials have logged almost 600 new cases in just over a month.
    • “The outbreak centered in northwestern Spartanburg County is showing little sign of slowing down, with health officials saying Tuesday that 789 cases have been confirmed since September. Last year in Texas, 762 cases were reported, although experts believe that was likely an undercount.
    • “A large outbreak on the Utah-Arizona border is also ongoing, and the United States’ measles elimination status is at risk.”
  • ABC News informs us,
    • “Long-term alcohol use has been linked to higher risks of colorectal cancer, according to a study published Monday in the journal Cancer.
    • “Researchers found that those with heavy lifetime alcohol consumption have up to a 91% higher risk of developing colorectal cancer compared with those who drank very little. That risk significantly increased with consistent heavy consumption, whereas those who quit drinking may have demonstrated decreased risk of precancerous tissue.
    • “The longer someone drinks, the longer their colon and rectum are exposed damage and impaired repair, both major mechanisms of cancer,” Dr. Lynn M O’Connor, section chief of colon and rectal surgery at Mercy Medical Center and St. Joseph Hospital in New York, told ABC News.
    • “The study followed more than 88,000 adults with no prior history of cancer. Participants reported their alcohol use beginning in early adulthood and were followed for nearly a decade to track cancer outcomes.
    • “Compared with those who averaged one drink or less per week over their lifetime, those who consumed over 14 drinks a week had a 25% higher risk of developing colorectal cancer. The link was even stronger for rectal cancer, where one’s risk nearly doubled.”
  • and
    • “Reducing the sodium in pre-packaged and prepared foods may prevent thousands of cases of heart disease, stroke and death, according to two new studies.
    • “The studies, published early Monday in the journal Hypertension, took place in France and the United Kingdom, countries where food giants have subtly reduced salt levels in store-bought foods.
    • “Using national diet and health data, researchers in France estimated that modest decreases in bread salt content could cut adults’ daily salt intake by 0.35 grams, lower their blood pressure and prevent more than 1,100 deaths.
    • “Researchers from the U.K. estimated that similar salt reductions in packaged foods and takeout meals could lower daily British sodium intake by 17.5%, preventing more than 100,000 cases of heart disease and 25,000 cases of stroke over 20 years.
    • “Sodium plays important health roles, like helping blood vessels hold water. However, about 90% of Americans consume too much of it, according to the American Heart Association. Excessive sodium raises the risk of high blood pressure, a risk factor for issues such as cardiovascular disease, long-term kidney disease and cognitive decline.”
  • The New York Times considers whether “Intermittent Fasting Live Up to the Hype? The diet has been linked to weight loss, longer life span and even a lower risk of cancer — in mice. What about humans?” For example.
    • “The most common claim about intermittent fasting is that it’s a better way to lose weight than other diets. Early mouse and rat experiments suggested that something interesting was going on beyond simple calorie restriction. The animals lost weight and stayed healthier than mice that ate normally, no matter how many calories they binged between fasts.
    • “But in humans, the idea that intermittent fasts offer special weight loss benefits “really hasn’t been borne out by the data,” said James Betts, a professor of metabolic physiology at the University of Bath in the United Kingdom.”
  • Per an NIH news release,
    • “A study funded by the National Institutes of Health (NIH) provides the clearest evidence to date to link severe chronic traumatic encephalopathy (CTE) to dementia risk. CTE is a degenerative brain disorder in some people who have had repeated head impacts over time. It can only be diagnosed after death by examining brain tissue. While researchers were able to link severe CTE (stages III and IV) to dementia risk, they did not find any measurable link between less severe CTE (stages I and II) and changes in thinking, mood, or daily functioning.
    • “The research, led by scientists at Boston University CTE Center and the U.S. Department of Veterans Affairs Boston Healthcare System, analyzed 614 donated brains from people with known exposure to repetitive head impacts. None of the donors had Alzheimer’s disease, Lewy body disease, or frontotemporal lobar degeneration, three of the most common neurodegenerative diseases that cause dementia.”
  • NIH released its latest edition of Research Matters which covers the following topics:
    • “Testing risk-based breast cancer screening
      • “In a large clinical trial, risk-based breast cancer screening was as safe and effective as annual mammograms.
      • “This approach could help reduce anxiety, costs, and unnecessary follow-up testing.”
    • “ADHD medications stimulate alertness, motivation”
      •  “Researchers found that prescription stimulants for ADHD act on brain networks that control wakefulness and reward, but not attention as previously thought.
      • “The study suggests that stimulants and additional sleep affect the brain in similar ways, and that getting enough sleep could help in managing ADHD.”
    • “Cellular mitochondria transfer prevents pain”
      • “Studies in mice and human cells revealed that power-hungry sensory neurons get mitochondria for energy production from nearby supporting cells.
      • “The results point to potential new treatments for nerve pain caused by drugs or health conditions that harm mitochondria.”
  • Per MedPage Today,
    • “Postmenopausal women on the GLP-1 medication tirzepatide (Zepbound) for obesity lost more weight if they were also using menopause hormone therapy, a retrospective cohort study indicated.
    • “Among 120 women with overweight or obesity on tirzepatide, hormone therapy users lost 19.2% of their body weight, while those not using hormone therapy treatment lost 14% (P=0.0023), reported Maria Daniela Hurtado Andrade, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and colleagues.
    • “Women in the hormone therapy group lost 35% more body weight than those in the no hormone therapy group and showed notable improvements in key cardiometabolic parameters, supporting a potential enhancing effect of hormone therapy on tirzepatide’s therapeutic effect,” the researchers wrote in Lancet Obstetrics, Gynaecology, & Women’s Health.”
  • The Wall Street Journal points out,
    • “Roche ROG Holding said an experimental injection achieved positive results in a midstage clinical trial by helping patients shed weight, paving the way for the start of the company’s first late-stage obesity study.
    • “Eli Lilly and Novo Nordisk’s GLP-1 drugs currently dominate the obesity-drug market, but big drugmakers including Roche, Pfizer and Amgen, as well as smaller players, are trying to come up with new treatments to challenge them.” * * *
    • “The Swiss pharmaceutical company said Tuesday that a once-weekly injection of a drug candidate known as CT-388—one of its experimental drugs bought from Carmot—resulted in a weight loss of 22.5% when adjusting for placebo at 48 weeks.
    • “The reduction was achieved at the highest dose tested, 24 milligrams, without reaching a weight-loss plateau, the company said. Roche said 54% of trial participants on the 24 mg dose achieved resolution of obesity.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Wall Street believed the Trump administration was going to take a friendly approach to Medicare insurers. Now, investors think the industry might be in for a rough ride.
    • “Shares of big insurers plunged after The Wall Street Journal first reported that the Medicare agency was proposing 2027 Medicare insurer rates well below analysts’ expectations.
    • “UnitedHealth Group’s shares were down nearly 20% on Tuesday, while Humana’s dropped 21%. CVS Health and Elevance Health both fell 14%.”
    • “Among those large companies, $96 billion in market capitalization was wiped out Tuesday.” 
  • Beckers Payer Issues informs us,
    • “UnitedHealth Group reported fourth-quarter and full-year 2025 earnings Jan. 27. Profits took a hit, with the company attributing drops to Medicare funding reductions, the Inflation Reduction Act, steeper medical costs and remaining Change Healthcare cyberattack costs.”
  • Modern Healthcare adds,
    • “United Health Group plans to reduce Optum Health’s footprint by 20%.
    • “Optum Health will focus on its profitable segments as UnitedHealth Group navigates a multiyear recovery.
    • “Optum Health lost $278 million from operations in 2025. 
    • “Optum Financial Services will be incorporated into Optum Insight.”
  • Beckers Hospital Review lets us know,
    • “Nashville, Tenn.-based HCA Healthcare reported a net income of $6.8 billion in 2025, a 17.8% increase year over year, according to its Jan. 27 financial report.” 
  • and
    • “Healthgrades published its annual “America’s Best Hospitals Awards” Jan. 27, recognizing 250 hospitals across the country for strong quality performance.
    • “The list recognizes the top 50, 100 and 250 best hospitals, representing the top 1%, 2% and 5% of hospitals in the country for clinical excellence, respectively, the consumer platform said in a news release. For the ranking, Healthgrades analyzed clinical performance for 4,500 hospitals across 30 common procedures and conditions. It covers Medicare data from 2022 through 2024. Full details on the methodology can be found here.”
    • The article lists the top 50 hospitals organized by State.
  • Fierce Pharma informs us,
    • “Pfizer again heads up a physician ranking of vaccine manufacturers, beating Merck & Co. and Moderna to complete an unchanged top three from the last edition of the survey. But, while the rankings held steady, the operating environment has changed quickly to reinforce the value of being in good standing with physicians.
    • “ZoomRx generated the league table by asking 58 U.S.-based healthcare professionals (HCPs) about 14 vaccine manufacturers. Respondents graded the companies’ innovation, patient centricity, reputation, HCP centricity and promotions, generating data that ZoomRx used to give each manufacturer a score out of 100. 
    • “As happened when ZoomRx ran a similar survey in 2024, Pfizer took the top spot after achieving strong scores across all five dimensions. The Big Pharma scored 83 out of 100 after HCPs praised its innovation, reliability and sales execution in particular.”
  • Per MedCity News,
    • “Purchasers are increasingly seeking performance-based contracts — in which payment is tied to outcomes — with digital health solutions. However, implementing these contracts is difficult, especially for employers who have limited resources.
    • “That’s why the Peterson Health Technology Institute (PHTI) released a playbook last week for purchasers on how to effectively execute performance-based contracts. The playbook was created in collaboration with health plans, vendors, brokers, consultants, data warehouses and other stakeholders.
    • “We have consistently heard from both health plans and employers that the process of negotiating performance-based contracts remains very arduous. … We would really like to see purchasers coming to the table as a customer with high standards, we want to raise the bar on purchasing,” said Caroline Pearson, executive director of PHTI, in an interview. “Every payer should be holding their partners accountable for outcomes that really matter.” 

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.:

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, OPM, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Beckers Payer Issues offers three takeways from the President’s healthcare plan that was announced yesterday.
    • “President Donald Trump released a sparsely detailed healthcare policy framework Jan. 15 that calls on Congress to codify voluntary drug pricing agreements with major pharmaceutical companies, direct payments to Americans over extending enhanced ACA subsidies, and expand price transparency requirements for insurers and providers. The proposal does not identify how most of its provisions would be implemented or enforced.”
  • Rick Pollack, the American Hospital Association’s President, points the healthcare cost increase finger at health insurers.
  • Healthcare Dive adds,
    • “The federal government will pay an estimated $76 billion more to cover Medicare Advantage seniors this year than it would if those same seniors were in traditional Medicare, according to new estimates from an influential advisory group.
    • “It’s a smaller sum than last year thanks to the continued phase-in of a new risk adjustment model. Overpayments were estimated to reach $84 billion in 2025.
    • “Still, the report released Friday by the Medicare Payment Advisory Commission is likely to add more fuel to concerns about overpayments in the privatized Medicare program, which has grown to cover more than half of all Medicare enrollees.”
  • The American Hospital Association News tells us,
    • “The Medicare Payment Advisory Commission Jan. 15 voted to recommend that Congress update Medicare payment rates for hospital inpatient and outpatient services by the current law amount for 2027 and reiterated its recommendation to distribute an additional $1 billion to safety-net hospitals by transitioning to a Medicare safety-net index policy. The AHA Jan. 9 urged the commission for higher updates.
    • In other action, MedPAC recommended that Congress update 2027 Medicare payments for physicians and other health professional services by current law plus 0.5%. The commission also recommended reducing the 2027 payment rates for home health agencies by 7%, skilled nursing facilities by 4% and inpatient rehabilitation facilities by 7%.
  • and
    • The White House hosted a roundtable on rural health Jan. 16 that included health care leaders, legislators and administration officials. The event included discussion on the Rural Health Transformation Fund and the “The Great Healthcare Plan,”with a focus on “most favored nation” prescription drug pricing and other topicsimpacting rural health. Speakers included President Trump, CMS Administrator Mehmet Oz, M.D., Andrew McCue, M.D., a cardiologist at AdventHealth, Senator Dan Sullivan, R-Alaska, Gov. Jim Pillen, R-Neb., Reps. Rob Bresnahan, R-Pa., Mike Lawler, R-N.Y., and Secretary of Agriculture Brooke Rollins.”
  • Per Medical Economics,
    • “Telehealth adoption did not increase overall office visit volumes among traditional Medicare patients, with visit volumes remaining stable or declining through mid-2024.
    • “Researchers categorized specialists into low, medium and high telehealth usage groups, finding declines in outpatient office visits across all groups.
    • “The study suggests telehealth serves as a substitute for in-person visits, not increasing total utilization among Medicare fee-for-service beneficiaries.
    • “Congress must decide on extending Medicare’s telehealth coverage standards, impacting patient access to virtual care.”
  • Per a Senate news release,
    • “U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Maggie Hassan (D-NH) support the Trump administration taking action to implement the No Surprises Act, which protects patients from surprise medical bills and ensures they know the cost of care before receiving it.
    • “Since the bipartisan legislation, led by Cassidy and Hassan, was signed into law by President Trump in 2020, the No Surprises Act has protected American patients from more than 25 million surprise medical bills. This would not be possible without the work of the Departments of Health and Human Services, Labor, and the Treasury.
    • “We are writing to express our support of the Department’s efforts to improve the implementation of the No Surprises Act and encourage the pursuit of additional solutions to ensure that the process established under the law to resolve payment disputes between providers, facilities, and health plans is effective,” wrote the senators. “We look forward to continuing to work with the Department and stand ready to assist to ensure that the implementation of the No Surprises Act continues to be successful.”
  • An HHS news release informs us,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today [January 13] a $231M funding opportunity to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is comprised of a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded 988 network administrator. In 2025, 988 received more than 8 million contacts from help seekers via call, text, chat and ASL videophone.”
  • NCQA calls our attention to its 2026 trends.
    • “Re-Thinking Our Approach to Population Health”
    • “Understanding Health Differences Within Populations and Communities”
    • “Shaping the Future of Primary Care”
    • “Integrating Primary Care and Behavioral Healthcare”
    • “Advancing the Transition to Digital Quality Measurement”
    • “Expanding Use of Clinical Data in HEDIS®”
    • “Improving Quality of Care for Patients with Cardiovascular-Kidney-Metabolic Syndrome”
    • “Defining High Quality Diabetes Care”
    • “Reducing the Administrative Burden of Utilization Management”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court agreed to hear Bayer AG’s appeal taking aim at thousands of lawsuits targeting its top-selling Roundup weedkiller for causing cancer. 
    • “The high court agreed Friday to hear Bayer’s challenge to a $1.25 million Missouri jury verdict against the company’s Monsanto unit over Roundup on the grounds some of the claims in the 2023 case were preempted by federal law. Bayer officials hope the justices’ ruling will help knock out thousands of Roundup cases that include failure-to-warn claims.”
  • and
    • “The US Supreme Court will hear generic drug maker Hikma Pharmaceuticals USA Inc.’s challenge of an appeals court holding that it induced doctors and pharmacists to prescribe its heart medicine for off-label treatments that would infringe a rival’s patents. (Case no.
      24-1068)
    • “The government urged the high court to reverse the US Court of Appeals for the Federal Circuit’s ruling reviving a lawsuit from Amarin Pharma Inc. Amarin claimed that Hikma infringed its patents despite the generic company’s use of a “skinny label” instructing users only to take the drug to treat severe hypertriglyceridemia, a method-of-use no longer covered by any Amarin patent.” (Case No. 24-889).

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. 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 and RSV hospitalizations are highest among infants less than 1 year old. COVID-19 activity is low but increasing nationally.
    • “COVID-19
      • “COVID-19 activity is low but increasing nationally.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country, but influenza activity has decreased or remained stable for two consecutive weeks. CDC will continue to monitor closely. A second period of increased influenza activity does often occur after the winter holidays.
      • “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 and hospitalizations among infants less than 1 year old.
    • “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. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • Beckers Hospital Review offers five notes about dipping numbers of hospital admissions for flu.
  • The University of Minnesota’s CIDRAP relates,
    • “Two new analyses, one from France and one from China, suggest that seasonal influenza vaccination provided moderate protection during the early months of the 2025–26 flu season, despite the rapid spread of influenza A(H3N2) subclade K viruses, which differ from the strains anticipated during vaccine development for the current flu season.”
  • STAT News notes,
    • “Reported measles cases in South Carolina surged by almost 30% in the last few days, state health officials said Friday.
    • “The South Carolina health department reported 124 new cases since Tuesday, bringing the state’s total to 558 in a wave of infections centered around an outbreak in Spartanburg County.”
  • The AP informs us,
    • “Wastewater testing can alert public health officials to measles infections days to months before cases are confirmed by doctors, researchers said in two studies published Thursday by the Centers for Disease Control and Prevention.
    • “Colorado health officials were able to get ahead of the highly contagious virus by tracking its presence in sewer systems, researchers wrote. And Oregon researchers found wastewater could have warned them of an outbreak more than two months before the first person tested positive.
    • “The findings add to evidence that wastewater testing is a valuable weapon in tracking disease, including COVID-19, polio, mpox and bird flu.”
  • The American Hospital Association News points out,
    • “The AHA has published a webpage that highlights facts, causes, effects and solutions that hospitals and health systems can use for reducing the risk and severity of postpartum hemorrhage. Resources include how to prepare for, train, measure and support the workforce and patients during maternal care. LEARN MORE“
  • The Washington Post reports,
    • “A sweeping new study of psychiatric and genetic records has the potential to change treatment for millions of psychiatric patients, finding that many conditions involve similar genes and may not need to be treated as distinct illnesses.
    • “In essence, the study suggests that bolstering the traditional emphasis on patient behavior with a deeper understanding of the biology of mental illness could lead to better treatment.
    • “Published in Nature, the paper addresses the boundaries psychiatry uses to separate similar conditions like bipolar disorder and schizophrenia. The research also suggests that linking genes to the brain processes they influence will provide psychiatrists with greater insight into their patients, and guide researchers toward new therapies.”
    • “The findings could also spare patients the burden of carrying multiple different diagnoses that require an assortment of different pills.”
  • Per Healio,
    • “People with hypertension who meet guideline-directed levels of weekly physical activity in just 1 or 2 days may derive similar mortality benefit vs. those who are consistently active, researchers reported.
    • “The 2020 WHO guidelines on physical activity and sedentary behavior, published in the British Journal of Sports Medicine, recommended 150 minutes or more of moderate to vigorous physical activity per week for people with chronic conditions such as hypertension.”
  • Per Fierce Pharma,
    • “Just days after AbbVie unveiled a major new oncology play in the form of its high-dollar RemeGen collab, the Illinois drugmaker closed out the week with some mixed news for its marketed cancer offering Epkinly.
    • “Friday afternoon, the company and its partner Genmab shared word that the phase 3 Epcore DLBCL-1 trial missed on its primary endpoint of overall survival. Specifically, the partners’ Epkinly failed to mount a statistically significant OS benefit among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Despite ongoing pushback, the University of Nebraska Board of Regents on Jan. 15 unanimously approved a proposed deal to bring jointly operated Nebraska Medicine under its full ownership and governance.
    • The deal would see co-owner Clarkson Regional Health Services offload its 50% share of the independently run system for $500 million plus another $300 million for owned land and buildings. Nebraska Medicine’s board is staunchly opposing the plan, and launched a public messaging campaign warning that sole governance, among other possibilities, would allow the university to redirect healthcare funds to cover its own budget gaps.
  • Beckers Hospital Review tells us,
    • “Nashville, Tenn.-based Vanderbilt Transplant Center completed 960 solid organ transplants in 2025 — the most ever performed by a single center in one year — making it the largest transplant center by volume in the U.S. 
    • “In addition to the record number of solid organ transplants, the center set a world record for the performing 210 adult and pediatric heart transplants in 2025, according to a Jan. 14 news release from Nashville-based Vanderbilt University Medical Center.” 
  • MedTech Dive informs us,
    • “Intuitive Surgical executives said this week that general surgery, particularly in after-hours care, drove procedure growth for the da Vinci robotic platform. U.S. procedures increased 15% in the fourth quarter compared with a year ago.
    • “After-hours procedures such as gallbladder removal and appendectomy using a da Vinci robot grew 35% in the fourth quarter, CFO Jamie Samath said in a presentation at the J.P. Morgan Healthcare Conference.
    • “Intuitive has been ramping up the launch of its latest system, da Vinci 5, making it broadly available in the U.S. in the third quarter of 2025. Da Vinci 5 is also cleared in Korea, Japan and Europe. 
    • “The strong launch has exceeded the company’s expectations, with about 1,200 da Vinci 5 systems installed and 270,000 procedures performed globally, CEO Dave Rosa said at the conference.”

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC,

  • Federal News Network reports,
    • “Congressional appropriators are seeking less aggressive budget cuts for the IRS than what the Trump administration has proposed.
    • ‘Members of the House and Senate appropriations committees, in the latest package of spending bills for fiscal 2026, are also renewing efforts to shrink federal office space.
    • “Funding for the State Department remains relatively unchanged, despite a massive reorganization carried out last year.
    • “Meanwhile, lawmakers want agencies to use artificial intelligence tools to speed up the delivery of public-facing benefits and services.
  • Govexec adds,
    • “Lawmakers in Congress appear to have abandoned a plan to bar insurers participating in the federal government’s employer-sponsored health care program from covering gender affirming care for federal workers and their family members, though the development changes little, practically speaking.
    • ‘When the House first unveiled its draft of the fiscal 2026 Financial Services and General Government appropriations package last September, it included language barring federal funds being used to cover the cost of “surgical procedures or puberty blockers or hormone therapy” as part of gender affirming care under the Federal Employees Health Benefits Program.
    • “But a new version of the bill unveiled Sunday, negotiated with Senate appropriators and containing three of the 12 traditional appropriations packages, strikes that language, issuing no prohibition on gender-affirming care for FEHBP participants.
    • “Despite the recent reversal, the measure, if passed, on its own would not restore access to gender affirming care for federal workers and their families. That’s because the Office of Personnel Management last year instructed insurance carriers who participate in FEHBP to cease covering those treatments.”
  • Here is a link to the House Appropriations Committee’s January 11 news releases on these new appropriations bills.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services has released a request for information seeking input on replacing its Medicare claims processing system with a real-time, cloud-based platform. Under the program, called ClaimsCore, CMS is seeking vendors already capable of supporting more than 2 million active members on a single production instance and processing more than 100,000 claims per day. CMS said the program would provide faster, more transparent claims, strengthen fraud protection and provide near real-time explanations of benefits, among other improvements.” 

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.” * * *  
    • “Menkes disease is a neurodegenerative disorder caused by a genetic defect that impairs a child’s ability to absorb copper. The disease is characterized by seizures, failure to gain weight and grow, developmental delays, and intellectual disability. It leads to abnormalities of the vascular system, bladder, bowel, bones, muscles, and nervous system. Children with classical Menkes (90% of those with the disease) begin to develop symptoms in infancy and typically do not live past three years. It affects approximately one in every 100,000-250,000 live births worldwide and is more common in boys.”
  • and
    • “The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective treatments to patients sooner. 
    • “Bayesian methodologies help address two of the biggest problems of drug development: high costs and long timelines,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Providing clarity around modern statistical methods will help sponsors bring more cures and meaningful treatments to patients faster and more affordably.”
    • “Bayesian approaches use a different framework from traditional statistical approaches. In a Bayesian analysis, data from a study are combined with relevant prior information to form a new distribution that can be used for inference and to draw conclusions about safety and efficacy.” 

From the judicial front,

  • Bloomberg Law lets us know,
    • “The US Supreme Court rejected a case seeking to force health insurers to pay arbitration awards that medical providers win in disputes over surprise medical bills, ending a long-running fight for a pair of air ambulance companies.” * * *
    • “Courts have so far mostly ruled for insurers in determining that oversight of the process resides with the Department of Health and Human Services, though providers have notched a couple of victories in district court.
    • The petition sought the high court’s input on whether the law grants parties the private right to sue, as well as whether breaching the relevant plan terms constitutes an injury to an enrollee under the Employee Retirement Income Security Act.” * * *
    • “The case is Guardian Flight LLC v. Health Care Serv. Corp. , U.S., No. 25-441, decision issued 1/12/26.”
  • STAT News reports,
    • “The Trump administration has signaled plans to drop its appeal of a court order that blocked a pilot program from changing payment terms for a controversial federal drug discount program.
    • “In a Monday court document, the Department of Justice indicated talks are underway with the American Hospital Association and several hospital systems, which filed a lawsuit challenging a plan that allowed drug companies to pay rebates — instead of discounts — for some medicines purchased under the 340B Drug Pricing Program.
    • “The parties are engaged in discussions about returning the [rebate] approvals challenged in this litigation to the agency for reconsideration. The agency intends to resolve such proceedings promptly. Therefore, the parties do not believe that expediting this appeal is warranted at this time and plan to dismiss the appeal in short order,” the DOJ wrote.”
  • MedTech Dive informs us,
    • “Edwards Lifesciences said Friday it has dropped plans to acquire JenaValve Technology after a U.S. district court granted the Federal Trade Commission’s motion for an injunction blocking the transaction.
    • “Edwards said it disagrees with the ruling, in the U.S. District Court for the District of Columbia, and believes the acquisition would have been in the best interest of a large underserved group of patients.”

From the public health and medical / Rx research front

  • The Wall Street Journal reports,
    • “If everyone you know seems to have the flu, there is a reason for that: Influenza climbed to unusually high levels across the country, thanks to a flu strain that caught us off guard.
    • “There have already been an estimated 15 million cases of the flu, according to the Centers for Disease Control and Prevention, along with 180,000 hospitalizations and 7,400 deaths.
    • It is the worst flu season in recent years though numbers are starting to decline yet remain high. But there are two things making things easier for some folks.
    • One, we all became familiar with at-home rapid tests for Covid-19 during the pandemic so more people are comfortable taking such tests at home for influenza. This results in more timely diagnoses.
    • That makes it easier to take antivirals, which make people feel better sooner, provided they are started within two days of getting sick. While most people are familiar with Tamiflu (oseltamivir phosphate), there is another antiviral, Xofluza (baloxavir marboxil) making the rounds on social media.
  • The AP related last Friday,
    • “South Carolina’s measles outbreak exploded into one of the worst in the U.S., with state health officials confirming 99 new cases in the past three days. 
    • “The outbreak centered in Spartanburg County grew to 310 cases over the holidays, and spawned cases in North Carolina and Ohio among families who traveled to the outbreak area in the northwestern part of the state.
    • “State health officials acknowledged the spike in cases had been expected following holiday travel and family gatherings during the school break. A growing number of public exposures and low vaccination rates in the area are driving the surge, they said. As of Friday, 200 people were in quarantine and nine in isolation, state health department data shows.
    • “The number of those in quarantine does not reflect the number actually exposed,” said Dr. Linda Bell, who leads the state health department’s outbreak response. “An increasing number of public exposure sites are being identified with likely hundreds more people exposed who are not aware they should be in quarantine if they are not immune to measles.”
  • The American Medical Association lets us know what doctors wish their patients knew about donating blood.
    • “When caring for patients, physicians and other health professionals rely on blood donation to support care ranging from trauma response to cancer treatment. But ongoing blood shortages mean many hospitals and health systems struggle to keep an adequate supply on hand. With the need for donating blood rising during seasonal shortages or public health crises, a single donation of blood can help up to three people. Donating blood when you can is vital because maintaining an adequate blood supply is a shared responsibility that strengthens patient care across the country.”
  • The Washington Post informs us,
    • “An estimated quarter of traditional Medicare beneficiaries with dementia are prescribed risky, brain-altering drugs despite years of clinical guidelines cautioning against the practice, a new study shows.
    • “The drugs fall into five broad categories — including antidepressants, antipsychotics, antidepressants and barbiturates — that may leave older adults in a drowsy, confused fog that can make them less steady on their feet and more prone to falls. And while the study published Monday in JAMA found that overall prescriptions for these types of drugs for traditional Medicare beneficiaries fell from 2013 to 2021, their “potentially inappropriate” use was significantly higher for people who are cognitively impaired or have dementia compared to people whose cognition was normal.
  • Per Genetic Engineering and Biotechnology News,
    • “Many of us will recognize being in a situation where it’s really hard to get started on a task—whether it’s making a difficult phone call or preparing a presentation that’s stressful just to think about. We understand what needs to be done, yet taking that very first step feels surprisingly hard.
    • “When this difficulty becomes severe, it is known medically as avolition. People with avolition are not lazy or unaware. They know what they need to do, but their brains seem unable to push the “go” button. Avolition is commonly seen in conditions such as depression, schizophrenia, and Parkinson’s disease, and it can seriously disrupt a person’s ability to manage daily life and maintain social functions.
    • “Working with macaque monkeys trained to perform certain tasks, scientists at Kyoto University applied chemogenetics techniques to identify a pathway between the ventral striatum (VS) and ventral pallidum (VP) in the brain that functions as a “motivation brake,” suppressing this internal “go” button, particularly when facing stressful or unpleasant tasks. The results showed that chemogenetic suppression of this VS–VP pathway restored motivation in the animals under aversive conditions.
    • “The team, headed by Ken-ichi Amemori, PhD, an associate professor at the Institute for the Advanced Study of Human Biology (WPI-ASHBi), and colleagues, suggests that the discovery of this VS–VP motivation brake may shed light on conditions such as depression and schizophrenia, where severe loss of motivation is common, and point to interventional strategies.”

From the J.P. Morgan Healthcare Conference 2026,

  • Per BioPharma Dive,
    • “JPM26: US biotech’s ‘Sputnik moment,’ Pfizer’s obesity ambitions and Bristol Myers’ big year.
    • “Four recent deals fueled more angst about China’s biotech progress, while Pfizer, Bristol Myers and Sarepta all worked to appease jittery investors.”
  • Fierce Healthcare reports,
    • “Abridge is partnering with real-time health information network Availity to fire up AI-powered prior authorization, expanding the reach of real-time coverage approval to more providers.
    • “The two companies announced a partnership, timed to the annual J.P. Morgan Healthcare Conference, to scale up real-time prior authorization. The integration of the two companies’ technologies could significantly speed up prior auth, from months to minutes. The use of Abridge’s ambient AI and Availity’s data exchange tech can compress a weekslong process that occurs post-visit to one that happens in real-time during the patient exam.
    • “Rather than create disparate AI systems, Abridge and Availity decided to team up to share information between providers and health plans at the point of care, making the process of medical necessity review more efficient, the companies said in a press release.”
  • and
    • “Teladoc is improving its 24/7 virtual urgent care for health plans by upskilling providers through real-time specialist consultations and offering care for a broader set of conditions, the company announced at the 2026 J.P. Morgan Healthcare Conference.
    • “The company hopes to save health plans money by reducing the number of follow-up appointments a patient may need to have after a virtual urgent care visit. 
    • “Teladoc’s virtual urgent care, which has been operational for over 20 years, will now be treating back and joint pain, hair loss and sleep issues, in addition to acute conditions like colds, coughs and ear infections.” 
  • Fierce Pharma offers a potpourri of stories from day one of the conference.

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Boston Scientific said Monday it has agreed to acquire Valencia Technologies, a developer of treatments for bladder dysfunction, for an undisclosed sum.
    • “Valencia makes the eCoin tibial nerve stimulator, which received Food and Drug Administration approval in 2022 to treat urinary urge incontinence. The leadless device is implanted near the ankle.
    • “The deal will allow Boston Scientific to expand into a high-growth area that complements the company’s existing pelvic health product line, Meghan Scanlon, Boston Scientific’s president of urology, said in a statement.” 
  • Beckers Payers Issues points out,
    • Administration and automation are not the only AI use cases payers should be focused on this year, according to McKinsey Senior Partner Adi Kumar, who broke down his 2026 predictions for insurers in a Jan. 12 report.
      • “1. Payers are at a place to look beyond AI administrative use cases. Care management is one opportunity where payers can assert more control.
      • “2. Mr. Kumar said healthcare has been slow to reach a technological revolution, but payers can harness technology to better engage with consumers.
      • “3. The One Big Beautiful Bill Act will raise the bar for payer performance, affecting how much money insurers get from the federal level. Payer financials could either take a hit — hurting risk pools — or payers could play the “productivity game” to get ahead.
      • “4. Mr. Kumar encourages payer CEOs to consider what types of business they want to focus on as the line between payers, providers and services get more blurred.
      • “5. CEOs also need to think about productivity and “how to do more with less.”
  • BioPharma Dive calls attention to five questions facing biopharma this year.
    • “The biopharmaceutical sector finally regained its footing in 2025. Here are five issues that could determine whether the renewed optimism will carry over into the new year.”
  • Beckers Hospital Review relates,
    • “In recent years, a swell of states has adopted laws to lessen the requirements for foreign-trained physicians to join the U.S. workforce.  
    • “The laws aim to combat the nation’s growing physician shortage, which is becoming more urgent as patient acuity rises, more physicians approach retirement age and a plethora of other factors. One tactic to staunch the shortage is reducing or eliminating residency requirements for internationally trained medical school graduates to gain employment in the U.S.
    • “Eighteen states have laws allowing internationally trained physicians to gain full licensure, three states grant limited licensure, three other states have pending bills related to limited licensure and another six state legislatures are considering pathway bills in 2026.
    • “International medical graduates account for about one-fourth of physicians practicing in the U.S., according to the American Medical Association, which supports these pathway laws.” 

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Beckers Payer Issues tells us,
    • “CMS has become more aggressive with its rollout of new payment and care delivery models.
    • To provide healthcare leaders with an outlook for 2026, research firm ATI Advisory compiled observations from 2025 to gain a sense of CMS’ plans for its Innovation Center.” 
  • Modern Healthcare reports,
    • “Safety-net providers got a reprieve from a controversial plan to replace discounts with rebates under the 340B Drug Pricing Program, but they aren’t in the clear.
    • “The Health Resources and Services Administration intended to launch a pilot program this month that would allow nine pharmaceutical companies to give 340B providers rebates on 10 prescription drugs, rather than upfront discounts, for at least a year.”
    • “340B providers cried foul, and the American Hospital Association sued to block the initiative, which it contends would enrich drugmakers at its members’ expense. Last month, the U.S. District Court for the District of Maine directed HRSA to suspend the program while it considers the case. The U.S. Court of Appeals for the 1st Circuit upheld that preliminary injunction Wednesday.” * * *
    • “Yet even if the AHA wins the case, the rebates plan could resurface. 
    • “Separate court rulings last year affirmed that HRSA has the authority to institute rebates under 340B, so the agency could simply try another approach. “Congress clearly gave defendants that option,” Walker wrote.
    • “HRSA remains committed to the rebates pilot and other actions on 340B, and the pharmaceutical industry aims to do its part to fight back against the lawsuit and against what it views as a bloated program that has grown beyond its original scope. The Health and Human Services Department declined to comment on ongoing litigation.”
  • Per an NCQA news release,
    • “The National Committee for Quality Assurance (NCQA) today announced the appointment of Sarah E. Saxton, MBA, as Senior Vice President of Quality Services. Saxton brings more than 20 years of experience advancing quality, performance measurement, and large-scale transformation across public and private health systems.
    • “In this role, Saxton will lead NCQA’s Quality Solutions Group, driving research and implementation efforts that underpin NCQA’s evidence-based standards and performance measures. She will also deepen collaboration with federal agencies to advance initiatives that deliver measurable improvements in healthcare systems and patient outcomes.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “A biotechnology firm hatched by two prominent researchers publicly debuted on Friday, aiming to use a new regulatory framework to quickly develop many gene editing treatments for rare diseases.
    • “Called Aurora Therapeutics, the startup was co-founded by Nobel laureate Jennifer Doudna and genetic medicine expert Fyodor Urnov and seeded by Menlo Ventures. It intends to simultaneously work on multiple therapies for the same condition, each of which target different genetic mutations, and quickly advance them with the help of the Food and Drug Administration’s recently unveiled “plausible mechanism” pathway.“
  • Cardiovascular Business relates,
    • “AccurKardia, a New York-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for the latest version of its AccurECG Analysis Software, a fully automated platform that delivers rapid electrocardiogram (ECG) interpretations.
    • “AccurECG 2.0 was designed to interpret a total of 13 different rhythm classifications, including atrial fibrillation, atrial flutter and ventricular tachycardia. According to AccurKardia, it was developed to be used by cardiac monitoring companies, device makers, hospitals and independent diagnostic testing facilities alike. 
    • “AccurECG 2.0 was designed to be device agnostic, meaning these artificial intelligence (AI) algorithms can be utilized by a wide range of stakeholders. The software can interpret test results originating from patches or any other traditional ECG devices.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. RSV activity is elevated in many areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. COVID-19 activity is low but increasing nationally.
    • “COVID-19
      • “COVID-19 activity is low but increasing nationally.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country.
      • “Although some indicators have decreased or remained stable this week compared to last, this could be due to changes in the number of people seeking healthcare, testing or reporting during the holidays rather than an indication that influenza activity has peaked. The country is still experiencing elevated influenza activity and elevated influenza activity is expected to continue for several more weeks.
      • “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 with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “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. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • Beckers Clinical Leadership offers “four things to know from the CDC’s latest FluView report.”
    • Flu positivity dipped but remains high.
    • Pediatric deaths increased.
    • A(H3N2) continues to dominate.
    • Hospitalizations continue to climb.
  • and
    • “The annual number of deaths in the U.S. is projected to exceed the annual number of births beginning in 2030, according to a January report from the Congressional Budget Office.
    • “The projections are based on existing laws and policies as of Sept. 30, as well as recent demographic trends, and serve as a benchmark for assessing how potential legislation could affect the size and structure of the U.S. population.” * * *
    • “The population is expected to become older on average between 2026 and 2056. The cohort of Americans 65 and older is expected to grow through 2036 at an annual average rate of 1.6% — faster than the average growth rates projected for younger cohorts. The group ages 24 and younger is expected to decrease in each of the next 30 years.
    • “An older population presents a dual challenge for hospitals and health systems: increasing demand for more complex care and exacerbating workforce shortages as more Americans retire.
    • “The aging trend is driven by longer life expectancies and baby boomers reaching age 65 or older by 2030, according to Maria Ansari, MD, co-CEO of The Permanente Federation and CEO of three of Oakland, Calif.-based Kaiser Permanente’s medical groups.”
  • The American Hospital Association News lets us know,
    • “A study published Jan. 7 by the University of Minnesota Rural Health Research Center examined the availability of hospital-based obstetric services in the U.S. by county from 2010-2023. It found 293 counties (8.6%) nationwide lost all hospital-based obstetric services during that period. Among those, 26 counties experienced a recent loss between 2022 and 2023, 21 of which are rural counties. Among the 148 rural counties with a town population of 10,000 or fewer people, 11% lost all hospital-based obstetric services from 2010-2023. Overall, 60% of rural counties and 38% of urban counties did not have any hospital-based obstetric services by 2023.” 
  • The University of Minnesota’s CIDRAP tells us,
    • “The influenza and tetanus, diphtheria, and pertussis (whooping cough; Tdap) vaccines are an estimated 69.7% and 88.6% effective against flu- or pertussis-related hospitalizations or emergency department (ED) visits, respectively, among the infants of vaccinated mothers, although with considerable uncertainty, per an observational study published yesterday in JAMA Network Open.”
  • Per HCPLive,
    • “Exercise is as effective as psychological therapy in alleviating depressive symptoms, with no significant difference in outcomes.
    • “Moderate-intensity exercise, especially between 13 and 36 sessions, provides the greatest benefit for reducing depressive symptoms.
    • “Many trials exhibited biases, emphasizing the need for more high-quality, large-scale studies with clinically diagnosed participants.
    • “The study suggests exercise could complement or serve as an alternative to traditional depression treatments, though further research is necessary.”
  • Per the Genetic Engineering and BioTechnology News,
    • “Some parts of the body can recover from injury fairly rapidly. The cornea, for example, can heal from minor scratches within a single day. The human brain, however, is not one of these fast-healing tissues or organs. Adult brain cells are stable and last for a lifetime— barring trauma or disease—while some cells lining the gut last only five days and must be continually replaced.
    • “Scientists would like to use stem cell therapy to boost the brain’s ability to regenerate following damage resulting from concussion or stroke. To date, such treatments have been stymied due to injury-related changes in the brain, as well as with difficulties integrating regenerated cells into existing brain circuits to restore functions such as memory retention or motor skills.
    • “Scientists headed by a team at Sanford Burnham Prebys Medical Discovery Institute and Duke-National University of Singapore (NUS) Medical School now report the results of testing a regenerative therapy derived from human stem cells. Their studies showed that when transplanted into mice, the cells matured, integrated into existing circuits and restored function. By tracing the cells and sequencing their gene expression patterns, the researchers also revealed how transplanted cells find where they need to go and form connections with the nervous system. The studies showed that the cells contain their own intrinsic codes for navigation, and once they become neurons, this code instructs the cell to send its axons to a specific area of the brain.
    • “Headed by Su-Chun Zhang, MD, PhD, the Jeanne and Gary Herberger Leadership chair in neuroscience and the director of and professor in the Center for Neurologic Diseases at Sanford Burnham, the researchers reported their findings in Cell Stem Cell, in a paper titled “Transcriptional code for circuit integration in the injured brain by transplanted human neurons.” In their paper the team concluded, “Our finding opens a promising strategy for treating neurological diseases through promoting regeneration and neural transplantation.”

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

  • The Wall Street Journal reports,
    • “Merck MRK is in talks to acquire Revolution Medicines in a deal that could value it at around $30 billion, according to people familiar with the matter. 
    • “A deal for the cancer-drug biotech could come as soon as later this month, the people said, cautioning the talks could still fall apart or another suitor could prevail. 
    • “Merck has been discussing a deal valued between $28 billion and $32 billion, the people added.” * * * 
    • “Revolution is developing drugs that target a molecular driver of cancers known as RAS. Revolution’s experimental drugs seek to block the driver, thereby thwarting cancers including lung, pancreatic and colon. 
    • “If it proves to work safely, the pancreatic-cancer drug candidate could generate $10 billion in 2035 worldwide sales, Mizuho Securities analysts estimate.” 
  • Digital Commerce 360 informs us,
    • “CVS Health has outlined a broad digital and artificial intelligence (AI) strategy aimed at simplifying health care delivery.
    • “The strategy deepens consumer engagement and supports multiyear earnings growth. It positions technology as a core driver of the company’s next phase rather than a back-office function.
    • “At its 2025 investor day in December, the health care and pharmacy company introduced what it described as an AI-native consumer engagement platform. It designed the platform to connect interactions across CVS Pharmacy, CVS Caremark, Aetna and its health care delivery businesses into a single digital interface. Executives said the company intends for the platform to reduce friction for consumers by navigating prescriptions, benefits, and care, while also improving operational efficiency across the enterprise.”
  • Per a LinkedIn post by a Memorial Sloan Kettering Cancer Center executive,
    • “Memorial Sloan Kettering Cancer Center has entered into a one-year trial partnership with OpenAI on its new HIPAA-compliant version of hashtag#ChatGPT, “ChatGPT Healthcare”. This collaboration is designed to accelerate responsible AI adoption at MSK by providing new a range of tools and access to expertise in support of our clinical, research, and operational workflows. As an early launch partner, we’re also looking forward to shared learning alongside peer institutions across the country. Importantly, this partnership reflects a strong, shared commitment to rigorous governance, privacy, and security. We see this as a meaningful opportunity not only to advance our own work, but also to help shape the broader conversation on how AI can thoughtfully and responsibly enhance cancer care and research.”
  • Fierce Healthcare points out,
    • “Pittsburgh-based insurer Highmark is further expanding its drug offerings through CivicaScript and leaning on biosimilars as pharmaceutical costs continue to rise for many.
    • “Highmark is a founding member of the drug company, which manufactures lower-cost alternatives to high-cost generic products. CivicaScript is a sister to Civica Rx, a drugmaker cofounded by health systems that makes key products for care facilities, which are often in short supply.
    • “The insurer first made abiraterone acetate, a drug for treating prostate cancer, available through CivicaScript in 2023, and found that members are saving $90 each month on average thanks to this partnership and its relationship with specialty pharmacies.
    • “Highmark said that more than 300 members are benefiting from the savings—across both individual and group customers, the plan has collectively saved $8 million.
    • “And as of September 2025, Highmark is now offering four additional CivicaScript products: dimethyl fumarate and dalfampridine, which are both used to treat multiple sclerosis; droxidopa, which is used for neurogenic orthostatic hypotension; and capecitabine, a cancer drug.”
  • Per MedTech Dive,
    • “Haemonetics will acquire Vivasure Medical, an Ireland-based firm that makes a patch device for percutaneous vessel closure, the companies announced Friday.
    • “Haemonetics will pay 100 million euros upfront ($116.3 million), or about 52 million euros when including the value of certain previous investments and loans. Vivasure will be able to get an additional 85 million euros if it meets certain sales growth and other milestones.
    • “The acquisition is expected to bolster Haemonetics’ presence in the large-bore closure market, giving the company a bigger impact in fast-growing structural heart and endovascular procedures, Ken Crowley, general manager of interventional technologies at Haemonetics, said in a statement.”
  • Per MedCity News,
    • “Health tech may be getting a new heavyweight — though the deal is still in its early stages.
    • “Last month, reports emerged that Matt Holt, former managing director and president of private equity at New Mountain Capital, had left the New York City firm to start a new venture combining five of its health tech portfolio companies in a deal valued at more than $30 billion. 
    • “The creation of the new company — apparently to be named Thoreau after essayist and naturalist Henry David Thoreau — is not yet finalized, but steps are underway to move the process forward, an anonymous source familiar with the transaction told MedCity News. The source said significant diligence, analysis and capital-raising efforts are still underway.
    • “The five New Mountain-backed startups that Holt is in discussion to acquire are Datavant, Machinify, Office Ally, Smarter Technologies and Swoop. Anonymous sources close to the deal told media outlets that the new entity, called Thoreau, is being backed by London-based alternative asset manager ICG Strategic Equity.” * * *
    • “Though Thoreau is not yet a done deal, experts think the move represents a major bet on scale and integration in the health tech sector.”