Tuesday report

Medicare

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old and RSV hospitalizations are highest among infants less than 1 year old. COVID-19 activity is low but increasing nationally.
    • “COVID-19
      • “COVID-19 activity is low but increasing nationally.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country, but influenza activity has decreased or remained stable for two consecutive weeks. CDC will continue to monitor closely. A second period of increased influenza activity does often occur after the winter holidays.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old and hospitalizations among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains suboptimal for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • Beckers Hospital Review offers five notes about dipping numbers of hospital admissions for flu.
  • The University of Minnesota’s CIDRAP relates,
    • “Two new analyses, one from France and one from China, suggest that seasonal influenza vaccination provided moderate protection during the early months of the 2025–26 flu season, despite the rapid spread of influenza A(H3N2) subclade K viruses, which differ from the strains anticipated during vaccine development for the current flu season.”
  • STAT News notes,
    • “Reported measles cases in South Carolina surged by almost 30% in the last few days, state health officials said Friday.
    • “The South Carolina health department reported 124 new cases since Tuesday, bringing the state’s total to 558 in a wave of infections centered around an outbreak in Spartanburg County.”
  • The AP informs us,
    • “Wastewater testing can alert public health officials to measles infections days to months before cases are confirmed by doctors, researchers said in two studies published Thursday by the Centers for Disease Control and Prevention.
    • “Colorado health officials were able to get ahead of the highly contagious virus by tracking its presence in sewer systems, researchers wrote. And Oregon researchers found wastewater could have warned them of an outbreak more than two months before the first person tested positive.
    • “The findings add to evidence that wastewater testing is a valuable weapon in tracking disease, including COVID-19, polio, mpox and bird flu.”
  • The American Hospital Association News points out,
    • “The AHA has published a webpage that highlights facts, causes, effects and solutions that hospitals and health systems can use for reducing the risk and severity of postpartum hemorrhage. Resources include how to prepare for, train, measure and support the workforce and patients during maternal care. LEARN MORE“
  • The Washington Post reports,
    • “A sweeping new study of psychiatric and genetic records has the potential to change treatment for millions of psychiatric patients, finding that many conditions involve similar genes and may not need to be treated as distinct illnesses.
    • “In essence, the study suggests that bolstering the traditional emphasis on patient behavior with a deeper understanding of the biology of mental illness could lead to better treatment.
    • “Published in Nature, the paper addresses the boundaries psychiatry uses to separate similar conditions like bipolar disorder and schizophrenia. The research also suggests that linking genes to the brain processes they influence will provide psychiatrists with greater insight into their patients, and guide researchers toward new therapies.”
    • “The findings could also spare patients the burden of carrying multiple different diagnoses that require an assortment of different pills.”
  • Per Healio,
    • “People with hypertension who meet guideline-directed levels of weekly physical activity in just 1 or 2 days may derive similar mortality benefit vs. those who are consistently active, researchers reported.
    • “The 2020 WHO guidelines on physical activity and sedentary behavior, published in the British Journal of Sports Medicine, recommended 150 minutes or more of moderate to vigorous physical activity per week for people with chronic conditions such as hypertension.”
  • Per Fierce Pharma,
    • “Just days after AbbVie unveiled a major new oncology play in the form of its high-dollar RemeGen collab, the Illinois drugmaker closed out the week with some mixed news for its marketed cancer offering Epkinly.
    • “Friday afternoon, the company and its partner Genmab shared word that the phase 3 Epcore DLBCL-1 trial missed on its primary endpoint of overall survival. Specifically, the partners’ Epkinly failed to mount a statistically significant OS benefit among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).” 

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front

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

From the J.P. Morgan Healthcare Conference 2026,

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

From the U.S. healthcare business front,

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

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend update

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

From Washington, DC

  • Congress is out of session again this week. The House of Representatives begins its 2026 session on January 6 while the Senate begins its 2026 session on January 5.
  • The American Bazaar tells us,
    • “Around 25,000 people have expressed interest in joining the “Tech Force,” a cadre of engineers to be hired by the Trump administration as it looks to install staff with artificial intelligence expertise in federal roles.
    • “The Trump administration will use that list to recruit software and data engineers, in addition to other tech roles, said Scott Kupor, director of the U.S. Office of Personnel Management, in a post on X. The 25,000 figure has been provided by a senior Trump administration official, according to a Reuters report.”
  • Beckers Hospital Review informs us,
    • “The Department of Homeland Security will replace the random lottery used to select H-1B visa recipients with a system that gives greater weight to applicants with higher skills.”
    • The article lets us know five things about this change.

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “It’s been a long time coming: Four years after Omeros came up short in its bid to gain an FDA approval for stem cell transplant drug narsoplimab, the Seattle biotech has finally scored its long-awaited nod.
    • “With a Christmas Eve thumbs-up for narsoplimab, the FDA has delivered Omeros its first U.S. approval in its 31 years. Taking on the commercial name Yartemlea, it also becomes the first treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The first-in-class lectin pathway inhibitor is for patients age 2 and older.
    • By selectively inhibiting MASP-2, which is the effector enzyme of the lectin pathway, Yartemlea blocks activation while preserving complement functions important for host defense.”

From the public health and medical / Rx research front,.

  • The Washington Post reports,
    • “When Marc and Cristina Easton’s son was diagnosed with autism at 20 months, the Baltimore couple left the doctor’s appointment in confusion. Their toddler — who was very social — didn’t resemble the picture of the condition they thought they knew. And the specialists could offer little clarity about why or what lay ahead.
    • “It wasn’t until four years after their child’s diagnosis that the Eastons finally began to get answers that offered them a glimmer of understanding. This summer, a team from Princeton and the Flatiron Institute released a paper showing evidence for four distinct autism phenotypes, each defined by its own constellation of behaviors and genetic traits. The dense, data-heavy paper was published with little fanfare. But to the Eastons, who are among the thousands of families who volunteered their medical information for the study, the findings felt seismic.
    • “This idea that we’re seeing not one but many stories of autism made a lot of sense to me,” Cristina said.”
  • The New York Times relates,
    • “The egg has become a dominant source of anxiety for many women. Human eggs are finite, declining in both quality and quantity with age. In a woman’s 30s, this starts to make it harder to get pregnant, and by menopause, a woman is without functional eggs. Growing awareness of this reproductive reality has led to a surge in egg freezing, as women aim to preserve the vitality of their younger eggs.
    • “But there’s more to infertility than old eggs. Recent research is bringing greater attention to the ovaries.
    • ‘An expanding body of evidence suggests that the age of an ovary, not just the eggs it contains, is important to reproduction and healthy aging. That includes the cells and tissues that make up the environment around a woman’s eggs, such as support cells, nerves and connective tissue.
    • “The tissues surrounding the follicles — fluid-filled sacs that contain an immature egg — can change with age, even becoming fibrotic. Research has shown that this can harm the quality of eggs, reduce the number that mature each month and block ovulation. Fibrosis is common in many aging organs as thick, scarlike tissue builds up. But it occurs decades earlier in the ovaries.”
  • The Wall Street Journal lets us know,
    • “Approved by the Food and Drug Administration decades ago for seizures and nerve pain from shingles, gabapentin is now the seventh-most widely prescribed drug in the U.S., according to the Iqvia Institute for Human Data Science. About 15.5 million people were prescribed gabapentin in 2024, according to an analysis by Centers for Disease Control and Prevention researchers. 
    • “Studies show that most of the prescriptions are written to treat conditions that it wasn’t approved for—a practice that is legal and common, but means the FDA hasn’t vetted its risks and benefits for those purposes.
    • “Some doctors say gabapentin can be helpful for certain types of neuropathic pain, a condition resulting from nerve damage. But doctors also give it to patients with other types of chronic pain, anxiety, migraines, insomnia, distorted sense of smell and hot flashes in menopause. Veterinarians dispense it to calm or treat pain in cats and dogs.
    • “A growing body of research shows it isn’t as safe or effective as doctors have long thought. Gabapentin has been associated in studies with greater risk of dementia, suicidal behavior, severe breathing problems for people who have lung disease, and edema, in addition to well-known side effects like dizziness.
    • “A study published this year found giving gabapentin to surgery patients didn’t reduce complications or get them out of the hospital any faster, and more of them reported pain four months after surgery. Doctors for years had touted gabapentin as a way to use fewer opioids. 
    • ‘While the medical establishment has mostly maintained that gabapentin isn’t habit-forming, some patients have reported debilitating adverse effects when they try to taper off it. They say the withdrawal symptoms make it clear to them they have developed a dependence to the drug taking it as prescribed.”
  • and
    • summarizes “The Future of Everything’s top stories of the year, including a formula for aging, fruit-picking robots and the car of the future.”
      • “This longevity doctor has a formula for aging better. Dr. Eric Topol’s research suggests lifestyle impacts longevity more than genes. The cardiologist believes more people can become “super agers” by embracing regular exercise and digital health technology.”
      • “Inflammaging” leads to cancer, but allergy drugs could help fight it. Dr. Miriam Merad is testing whether allergy drugs and other seemingly unlikely medications can help reduce chronic inflammation—or inflammaging—and thereby slow cancer in older patients.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Mail-order pharmacies filled just 9% of Medicare prescriptions in the three-year period examined by the Journal, but accounted for 37% of the excess dispensing, the analysis showed. Such pharmacies often send 90-day refills automatically when patients near the end of their earlier supplies.” * * *
    • “The Journal’s analysis counted as excess only dispensed prescription drugs that exceeded a month’s supply over up to three years’ worth of prescriptions.” * * *
    • “The Journal analysis is based on Medicare prescription records accessed under a research agreement with the federal government. The records include details of each individual prescription for more than 50 million Medicare recipients between 2021 and 2023, but don’t identify individuals. 
    • “Doctors and patients said such earlier-refilling practices aren’t limited to Medicare patients, and that it also happens with people covered by employer-sponsored plans. The Journal analysis doesn’t cover those private plans.”
  • Beckers Payer Issues identifies six insurer moves in 2025 that signal a heightened PBM focus.
  • Fierce Healthcare offers a 2026 outlook based on parting thoughts from dozens of healthcare CEOs retired in 2025.
  • HR Dive shares its “top 10 learning stories of 2025. Workers sounded off about the need for more training and just how great a role the onboarding experience plays in their retention.”

Tuesday report

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

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

FEHBlog response to public comment

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

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase across the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • Beckers Clinical Leadership tells us,
    • “Flu hospitalization cases are evenly split between children and older adults, Northwell said, and its Cohen Children’s Medical Center in New York City is at capacity. 
    • “Flu is rising a lot faster than it did last year,” Dwayne Breining, MD, senior vice president of lab services at Northwell, said during a Dec. 18 news conference. 
    • “The other two [COVID-19 and RSV] are rising but not as fast as they did last year,” Dr. Breining said. “That’s driven by a couple of things. What’s very concerning for us is the cases of flu are rising at like 35% per week; the hospitalizations are rising at 75% per week. So we’re keeping a close eye on that trend. It could mean the flu is more severe.”
    • “Experts have said a mutated version of H3N2, “subclade K,” could be fueling the current uptick in flu activity amid earlier and more intense outbreaks abroad. The strain is a version of the influenza A virus, which is generally known to cause more severe illness, particularly in older adults and young children.
    • “At Northwell, more than one-third of flu tests for the week ending Dec. 14 were positive for influenza A’s H3 subtype. The same week period in 2024 saw a 10% flu positivity rate.”
  • Per a National Institutes of Health news release from its Director Dr. Jay Bhattacharya,
    • “At the National Institutes of Health (NIH), engendering trust and confidence in the research we support is one of our top priorities. Three things guide these efforts: engaging in open, honest dialogue, acting in transparency, and delivering on our commitment to advancing science and improving health.
    • “To help guide this work, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) recently undertook a multi-year effort to provide the NIH with a roadmap for incorporating public voices in clinical research (see NExTRAC report).  Deliberations were informed by a team of multi-disciplinary experts and community conversations across the country, specifically asked to think about strategies for incorporating public voices at every stage of the clinical research process.
    • “I am pleased to endorse these recommendations, which focus on:
      • “providing a clear vision and framework for maximally involving patients and communities in clinical research;
      • “ensuring that people and communities have meaningful input into the agenda and direction of research that is relevant and impactful for them; and
      • “increasing transparency for how research participant data are utilized in moving the scientific enterprise forward.
    • “NIH is eager to begin implementing this roadmap, starting in 2026.”
  • The University of Minnesota’s CIDRAP adds,
    • Today [December 17] the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and NEJM Evidencelaunched their new Public Health Alerts initiative with reports on potential local transmission of clade 1b mpox virus (MPXV) in California and on influenza viruses circulating during the 2024-25 flu season.
    • Public Health Alerts is designed to deliver information and early warnings about emerging health threats, enabling swift, informed responses across the United States and globally.
    • “The new collaboration between NEJM Evidence and CIDRAP fills a gap in reliable data, offering expert-reviewed reports that translate frontline observations into actionable public health evidence. An NEJM Evidence editorial today explains the initiative further.
    • “Access to emerging public health data saves lives,” said infectious disease doctor Eric J. Rubin, MD, Editor-in-Chief of the New England Journal of Medicine and NEJM Group, publisher of NEJM Evidence, in a news release. “By providing this new, rigorous pathway for public health information, NEJM Group is delivering on its commitment to equip physicians with reliable information to support evidence-based care.”
    • “Rapid, credible communication has always been essential to an effective public health response,” added CIDRAP Director Michael Osterholm, PhD, MPH. “With this new collaboration, we hope to restore and strengthen that early-warning function, providing timely, evidence-based alerts that can help local and state health leaders act quickly to protect the health of people in their communities.” 
  • Health Day informs us,
    • “It’s beside the point to debate whether vaping or nicotine pouches can be more healthy than smoking a cigarette, a major new report argues.
    • “Nicotine is toxic to the heart and blood vessels regardless of how it’s consumed, according to an expert consensus report published today in the European Heart Journal.
    • “Nicotine is not a harmless stimulant; it is a direct cardiovascular toxin,” said lead researcher Dr. Thomas Münzel, a senior professor of cardiology at University Medical Center at Johannes Gutenberg University in Mainz, Germany.
    • “Across cigarettes, vapes, heated tobacco and nicotine pouches, we consistently see increased blood pressure, damage to blood vessels and a higher risk of heart disease,” Münzel said in a news release. “No product that delivers nicotine is safe for the heart.”
  • and
    • “Young adults are inheriting a world filled with turmoil and unrest, and this instability is leaving its mark on their mental and emotional health.
    • “A single half-hour course, however, could help them feel less anxious and depressed, by helping them increase their tolerance of uncertainty, a new study says.
    • “Young adults who took the course titled “Uncertainty-Mindset Training” continued to feel better a month after taking it, researchers reported Dec. 15 in the journal Psychological Medicine.
    • “Young people today are coming of age amid great climate, economic, social and health uncertainty,” senior researcher Susanne Schweizer, an associate professor with the University of New South Wales in Sydney, said in a news release.”
  • The Washington Post points out that “feeling wonder every day improves our health and explains how to do it.
  • Health Day calls attention to
    • “A new rapid test [that] could improve treatment of urinary tract infections (UTIs), by identifying the most effective antibiotic for each individual patient.
    • “The test applies different antibiotics to bacteria found in urine samples, to see which one best suppresses bacterial growth, researchers recently reported in the journal Microbiology Spectrum.
    • “This new method could cut a full day off the time between testing and prescription, researchers said, and arm a patient with the best means of clearing their infection.
    • “The sooner we know which antibiotic is effective, the more targeted our treatment can be,” senior researcher Oliver Hayden, a professor of biomedical electronics at the Technical University of Munich in Germany, said in a news release.”
  • Beckers Hospital Review lets us know about GLP-1 drugs that are poised to enter the U.S. market.
  • Per BioPharma Dive,
    • “An experimental anti-inflammatory drug being developed by Belgium-based Galapagos met its main goal in one Phase 2 clinical trial but missed in another, the company said Thursday.
    • “The drug, which blocks an inflammation-signaling enzyme called TYK2, helped significantly improve disease signs and symptoms in people with a muscle and skin condition called dermatomyositis. But it didn’t help people with lupus, missing statistical significance on a broad measure of clinical response.
    • “Called GLPG3667, the drug is Galapagos’ biggest remaining asset following a decision to wind down the company’s cancer cell-therapy business after an unsuccessful attempt to sell it. Galapagos may seek a partner to help further develop GLPG3667, which has some competition in the form of a Roivant medicine that could be under Food and Drug Administration review for dermatomyositis early next year.”
  • Per the Genetic Engineering and Biotechnology News,
    • “As the number of antibiotic-resistant infections continues to rise, scientists are looking to bacteriophages (“phages”), viruses that infect bacteria, as an approach to tackling antibiotic resistance. A new study by researchers at the Hebrew University of Jerusalem has revealed how bacteriophages use a tiny piece of genetic material to hijack bacterial cells and make more copies of themselves.
    • “Focusing on infection of Escherichia coli by phage lambda, a bacteriophage that scientists have been studying for decades, research lead Sahar Melamed, PhD, and colleagues identified a virus-encoded small RNA molecule (sRNA) called phage replication enhancer sRNA (PreS) that acts like a hidden genetic “switch.” The team’s research indicated that this switch rewires bacterial genes to help the virus copy its DNA more efficiently and boost viral replication.
    • “The team said that understanding how phages control bacterial cells is important both for basic science and to help inform future medical applications. By uncovering how phages use tools such as PreS to take control of bacterial cells, the newly reported study provides important basic knowledge that could help scientists design new phage-based therapies targeting drug-resistant bacteria.”

From the U.S. healthcare business front,

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