Tuesday report

CMS

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.:

Thursday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

From the artificial intelligence front,

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

Midweek update

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

From Washington, DC

  • The American Hospital Association News reports,
    • “The House Budget Committee hosted a hearing Jan. 21 on health care affordability titled, “Reverse the Curse: Skyrocketing Health Care Costs and America’s Fiscal Future.”
  • The health subcommittee of the House Energy and Commerce Committee has posted the prepared testimony of the health insurance executives who will be testifying at tomorrow morning’s hearing.
  • The Health Care Cost Institute released a one pager explaining why healthcare has become unaffordable.
  • Healthcare Dive reports,
    • “Healthcare fraud settlements under the False Claims Act totaled over $5.7 billion for the 2025 fiscal year ended Sept. 30, the highest amount ever and more than triple last year’s total, the Department of Justice said Friday.
    • “The FCA settlements fueled $6.8 billion in total judgments across industries, the highest amount in a single year.
    • “In healthcare, settlements involved federal programs like Medicare, Medicaid and Tricare, the program for active and retired service members and their families. The Justice Department said it also expanded its enforcement in cases involving managed care, prescription drugs and medically unnecessary care.”
  • The AHA News informs us,
    • “The Centers for Medicare & Medicaid Services will host a webinar Feb. 11 at 2 p.m. ET on updated hospital price transparency requirements that were finalized in the hospital outpatient prospective payment system final rule for calendar year 2026. CMS will begin enforcement of the new and revised requirements April 1. During the webinar, the agency will review changes to the requirements, provide information on resources available to hospitals, and offer tips for ensuring that hospital machine-readable files conform to requirements finalized in the rule. Attendees with questions are advised to contact CMS at PriceTransparencyHospitalCharges@cms.hhs.gov.”
  • Healthexec observes,
    • “A study looking at healthcare pricing at Texas hospitals found that paying cash for services is typically a lot cheaper than the typical negotiated rate charged to insurance companies, calling into question the practicality of transparency regulations. 
    • “The research was conducted by market intelligence firm Trilliant Health, which based its analysis on reported rates coming from 327 hospitals in the state. Zooming in on 79 common procedures, the data revealed that four times out of five, the patients who paid cash received a discount larger than insurance companies were able to negotiate for reimbursement. 
    • “The federal government has pushed for transparency on service pricing. For example, a 2021 rule from the Centers for Medicare & Medicaid Services (CMS) that required the prices of “shoppable” services be prominently displayed. A machine-readable file containing all prices for common services—including cash and negotiated prices—also must be available. 
    • “However, the law does not standardize prices. Trilliant noted that healthcare is at odds with all other industries, because prices are locked into brackets determined by a person’s ability to pay, not the services themselves. So for those who are insured by their employer, costs will always be fundamentally different when compared to those paying strictly out of pocket.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.”
  • STAT News reports,
    • “Bundling isn’t just for your streaming plans anymore. In radiology, new artificial intelligence tools are getting cleared by the Food and Drug Administration to check for multiple findings at once — sometimes more than a dozen in one go.
    • “On Wednesday, radiology AI company Aidoc announced the FDA has cleared a tool that can triage 14 critical findings in a single abdominal CT scan: liver injury, spleen injury, bowel obstruction, appendicitis, and more.” 

From the judicial front,

  • Modern Healthcare reports,
    • “Cigna may be on the verge of striking a deal with the Federal Trade Commission over allegations it artificially raised insulin prices.
    • “The FTC has suspended its administrative case against the Evernorth Health Services, Express Scripts and Ascent Health Services parent company while it considers a settlement, the FTC disclosed in a legal filing Tuesday.
    • “Attorneys for the agency and the company have “submitted a proposed consent agreement containing a proposed decision and order … that, if accepted by the commission, would resolve the claims against the [Cigna] respondents in their entirety,” FTC Secretary April Tabor wrote in the document.”

From the public health, medical and Rx research front,

  • Per a Centers for Disease Control and Prevention news release,
    • “Diabetes continues to affect millions of Americans and is among the major health threats facing the nation. New CDC data in the updated National Diabetes Statistics Report show:
      • “40.1 million people in the United States (12% of the population) have diabetes.
      • “11 million adults (more than 27% of adults with diabetes) are undiagnosed. 
      • “115.2 million adults (more than 43%) have prediabetes, and most don’t know they have it.
    • “The National Diabetes Statistics Report uses the latest technologies and methods to provide up-to-date data on the impact of diabetes and prediabetes. 
    • “It’s important that all people can take steps to prevent or delay type 2 diabetes and manage diabetes if they already have it.” 
  • Beckers Clinical Leadership points out,
    • “About a year after West Texas reported a large measles outbreak, South Carolina has the most measles cases of any U.S. state so far in 2026. 
    • “The state’s health department is counting 646 cases as of Jan. 20. Most cases are in Spartanburg County, a county in northwest South Carolina that is about 70 miles from Charlotte, N.C.
    • “This figure far surpasses the 145 cases reported in South Carolina by the CDC as of Jan. 13. Some jurisdictions report probable measles cases; however, the CDC only reports confirmed cases that jurisdictions have notified to CDC.” * * *
    • “South Carolina far exceeds other states, according to CDC data on confirmed measles cases. In 2026, eight other states have reported confirmed measles cases to the CDC: Utah with 14, Ohio (three), Florida (two), North Carolina (two), Oregon (two), Arizona (one), Georgia (one) and Virginia (one).” 
  • The AHA News notes,
    • “The American Red Cross Jan. 20 declared a severe blood shortage as the national blood supply fell approximately 35% within the last month. The organization is urging Americans to donate blood to alleviate the shortage. The current flu season and winter weather were cited as reasons for the decline.” 
  • Senior Living News relates,
    • “New research from Case Western Reserve University was recently heralded as a big step forward in the fight to not only slow but reverse the effects of Alzheimer’s Disease. Senior living memory care experts are encouraged by the results, but that there is still much left to be done to further that goal. 
    • “The study, published in December 2025 in Cell Reports Medicine, links Alzheimer’s progression to the brain’s inability to maintain healthy levels of NAD+, a molecule critical to cellular energy and resilience. In two studies, researchers restored NAD+ balances with an experimental compound that not only prevented further damage, but reversed disease characteristics.”
  • ‘The Washington Post offers “six daily habits to slow aging, from a Harvard brain expert. Harvard scientist Rudolph Tanzi shares his plan for brain health and aging well, including habits for sleep, stress and social interaction.” Check it out.
  • NBC News points out,
    • “Pregnant women’s exposure to wildfire smoke — particularly in the third trimester — may increase the risk of autism in their children, according to new research, which looked at hundreds of thousands of births in Southern California.
    • “The study, published Tuesday in the journal Environmental Science & Technology, is the first to examine a potential link between prenatal wildfire smoke exposure and autism. Earlier research has suggested that pregnant women’s exposure to air pollution more broadly, including smog spewed by vehicles, smoke stacks and lead, may be linked to the developmental disorder.”
  • Per Healio,
    • “Home-based self-sampling for squamous cell carcinoma of the anus could be a cost-effective way to increase screening among high-risk individuals.
    • “An evaluation of the randomized phase 2 Prevent Anal Cancer (PAC) Self-Swab Study showed higher screening rates for participants who sampled at home compared with those who went to a clinic. Each additional screen had a societal cost of approximately $25 and health care cost of about $130.
    • “Home-based screening promises to be a cost-effective option to enhance anal cancer screening participation,” Haluk Damgacioglu, PhD, assistant professor in the department of public health sciences in the College of Medicine at Medical University of South Carolina, and colleagues wrote.
    • “In addition, the lower [incremental cost-effectiveness ratio] from the societal perspective underscores the economic value of home-based screening by capturing time, travel and productivity costs associated with clinic-based screening.”
  • Per MedPage Today,
    • “Among kids with obstructive sleep-disordered breathing in a randomized trial, 29.5% had resolution of symptoms with an initial 6-week course of intranasal saline.
    • “For those with persistent symptoms, another 6 weeks of intranasal saline was as effective as switching to intranasal steroids.
    • “The researchers proposed that intranasal saline be used for 3 months before assessing the need for specialist referral for polysomnography and potential surgery.”
  • and
    • “A Finnish cohort study probed the long-term mortality, morbidity, recovery, and recurrence of stroke after maternal ischemic stroke.
    • “There was a greater risk of mortality after pregnancy-related stroke, particularly in the first year.
    • “Affected patients were also more prone to subsequent morbidities, though functional outcomes seemed good in the short and long term.”
  • Per BioPharma Dive,
    • “A regimen involving Moderna’s personalized cancer vaccine intismeran autogene and Merck & Co.’s immunotherapy Keytruda cut the risk of relapse or death in half over five years in study participants with melanoma when compared with Keytruda alone, the companies said Tuesday. Moderna and Merck reported three years ago that the Phase 2 study, which evaluated the vaccine-immunotherapy regimen after surgery, had met its primary endpoint. The partners have continued following trial enrollees to assess its impact on long-term health outcomes, though, and at the latest data check found that the shot maintained the survival benefit seen in 2023. The result is a “signal of durable tumor control,” wrote William Blair analyst Myles Minter. Moderna and Merck, which first partnered on cancer vaccines nearly 10 years ago, could announce Phase 3 results later this year. Merck paid Moderna $250 million to license intismeran autogene in 2022.”

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

  • The Wall Street Journal reports,
    • “Higher sales of drugs for cancer and autoimmune conditions more than offset the sales hit from a key drug patent loss and helped Johnson & Johnson JNJ -0.09%decrease; red down pointing trianglereport increased revenue and profit for the latest quarter.
    • “The New Brunswick, N.J., drug and medical-device maker also issued a forecast for the coming year that topped Wall Street expectations, despite the impact of tariffs and a recent deal with the Trump administration to cut some drug prices.
    • “J&J said Wednesday that net earnings rose 20.8% in the fourth quarter to $5.12 billion, or $2.10 a share, from $3.43 billion, or $1.41 a share, a year earlier. Adjusted to exclude certain items such as litigation costs, J&J earned $2.46 a share in the quarter, matching the mean estimate of analysts surveyed by Factset. 
    • “The company last year lost patent protection for one of its biggest-selling drugs, Stelara, a treatment for skin and gut conditions. Competitors introduced lower-cost versions of the drug, leading to sales declines for J&J’s. Stelara sales plunged nearly 48% for the fourth quarter.
    • “Yet strong sales growth for newer J&J drugs helped cushion the impact. Sales of Darzalex, a treatment for multiple myeloma, rose nearly 27% in the fourth quarter and sales of autoimmune drug Tremfya were up nearly 68%.”
  • Fierce Healthcare relates,
    • “In the past year, OpenEvidence, an AI-powered medical search engine, has seen breakneck growth, rapidly expanding its reach with doctors.
    • “OpenEvidence developed an AI-powered medical search engine and a generative AI chatbot exclusively for doctors that summarizes and simplifies evidence-based medical information.
    • “In December alone, the company claims it supported about 18 million clinical consultations from verified physicians in the U.S., up from about 3 million consultations per month a year ago. OpenEvidence is now actively used daily, on average, by more than 40% of physicians in the U.S., spanning more than 10,000 hospitals and medical centers nationwide, according to the company.” * * *
    • “The health tech company banked $250 million in series D funding to invest heavily in the R&D and compute costs associated with its multi-AI agentic architecture. OpenEvidence will also use the funding to continue to build out its content licensing partnerships.
    • “The lion’s share is training new models, training the next generation of digital intelligence, and compute costs,” Daniel Nadler, founder and CEO of OpenEvidence, told Fierce Healthcare.
    • “The series D round doubled its valuation to $12 billion, the company said.”
  • Kaufmann Hall offers five key takeaways from recent financial rating reports of hospitals.
    • “Hospital rating downgrades declined in 2025 while the number of upgrades increased, resulting in a lower ratio of downgrades to upgrades and tempering higher downgrade activity in recent years. Growing volumes, increased supplemental funding and better labor and expense management contributed to improved financial performance for many borrowers. Upgrades and downgrades included a wide swath of hospitals including academic medical centers, children’s hospitals and regional and national systems, as well as stand-alone hospitals. The overwhelming majority of ratings were affirmed, providing support for the rating agencies’ stable (Moody’s and S&P) and neutral (Fitch) outlooks for 2026.”
  • Healthcare Dive notes,
    • “Community Health Systems has agreed to sell an Alabama hospital for $450 million, the latest in a string of divestitures from the for-profit hospital operator as it looks to reduce its debt. 
    • “CHS said on Tuesday that a subsidiary has signed a definitive agreement to sell substantially all of the assets of its 180-bed Crestwood Medical Center in Huntsville, Alabama to Huntsville Hospital Health System. The deal includes Crestwood’s network of outpatient centers and medical practices, according to CHS’ release.
    • “The companies expects the deal to close in the second quarter this year.”
  • Per MedTech Dive,
    • “Medtronic has agreed to buy up to $90 million worth of shares in Anteris Technologies Global, developer of a transcatheter aortic valve replacement device for patients with severe aortic stenosis.
    • “The purchase, in a private placement, is contingent on Anteris completing a proposed $200 million public stock offering, the company said Tuesday.
    • “Anteris said it will sell the shares to Medtronic at a price per share equal to the public offering price, subject to a minimum purchase of 16% of the number of common shares outstanding after the offering and a maximum purchase of 19.99%.”

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.”

Midweek report

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

From Washington DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the. J.P. Morgan healthcare conference,

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

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

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

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.”

Thursday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health, medical / Rx research front,

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

From the U.S. healthcare business front,

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