Thursday report

SCOTUS

Thursday report

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, NIH, OPM, SCOTUS, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republican senators stopped short of using their political leverage to kill President Trump’s $1.8 billion “anti-weaponization” fund, approving a critical immigration-enforcement bill without adding language reining in the controversial program.
    • “Passage of the $70 billion package funding Immigration and Customs Enforcement and Border Patrol through the end of Trump’s second term came after a more than 19-hour session of amendment votes and intraparty negotiations. The GOP-backed measure passed 52 to 47 shortly before 5 a.m., with Republican Sen. Lisa Murkowski of Alaska voting with Democrats against the bill.
    • “The session’s votes allowed GOP senators in competitive election fights this fall—including Susan Collins of Maine, Dan Sullivan of Alaska, Jon Husted of Ohio and Ashley Moody of Florida—to register their objections to the fund without derailing a bill that is a priority for Trump and the party.
    • “The House is expected to take up the immigration-enforcement measure next week.”
  • The No Surprises Act’s final independent dispute resolution (IDR) rule was published in the Federal Register today. Federal Hearings and Appeals Services, which a certified IDR entity, offers its summary of the rule with helpful charts!
  • Federal News Network reports
    • The Postal Service, on the verge of running out of cash early next year, is pricing out a wide range of possible reforms that, if passed by Congress, could address the agency’s long-term financial problems.
    • Postmaster General David Steiner told House lawmakers in March that USPS is set to run out of cash in early 2027 and that lawmakers need to act soon to keep the agency running.
    • The agency’s wish-list of possible legislative reforms, outlined in a document titled “Accelerating Progress: Elements of Postal Reform,” includes several longstanding proposals supported by postal watchdogs and unions. The document also considers more controversial options, such as closing post offices and reducing delivery days to save USPS billions of dollars each year.
  • Per a House of Representatives Oversight and Government Reform news release,
    • “Subcommittee on Government Operations Chairman Pete Sessions (R-Texas) delivered his opening statement at today’s hearing with the Commissioners of the Postal Regulatory Commission. In his opening remarks, Subcommittee Chairman Sessions highlighted the financial crisis the U.S. Postal Service (USPS) is facing and how actions to reform the agency have fallen short of expectations. He also emphasized that Congress and the American people have to decide what they want out of USPS to help resolve procedural and financial issues in the agency.” 
  • The OPM Director Scott Kupor added to his Secrets of OPM blog (available on LinkedIn and Substack) concerning a Presidential Memorandum approving the use of critical position pay to support investment programs related to national security.
  • Tammy Flangan, writing in Govexec, discusses whether a record number of new retirees this year will slow your retirement claim.
    • “New OPM data offers clues about processing times, potential delays and why retiring employees may need a larger financial cushion than expected.” 
  • Per a National Institutes of Health news release,
    • “National Institutes of Health Director Jay Bhattacharya, M.D., today announced the selection of Steven Schiff, M.D., Ph.D., as the next director of the Fogarty International Center (FIC) and NIH associate director for international research. Schiff began his role on June 4, 2026. 
    • “A pediatric neurosurgeon and global health researcher, Schiff currently serves as the Harvey and Kate Cushing Professor of Neurosurgery, vice chair for global health in the Department of Neurosurgery, and professor of epidemiology and of electrical and computer engineering at Yale University in New Haven, Connecticut.” * * *
    • “As director of FIC, Schiff will lead NIH’s global health research efforts by supporting collaborations between U.S. and international investigators, strengthening partnerships among research institutions worldwide, and training future global health scientists. He will oversee the center’s approximately $95 million annual budget, most of which supports research grants and training programs.” 
  • Beckers Health IT lets us know,
    • “The White House is backing a push for AI to take over more of the duties of physicians, The Washington Post reported.
    • “The Trump administration supports an experiment in Utah where AI is writing prescriptions, plans to offer over $50 million in research awards to developers of conversational AI for cardiovascular care, has created an expedited approval process for digital health products like AI chatbots, and is working on a regulatory pathway for independent AI physicians, according to the June 4 story.
    • “People are seeing the difference the AI is bringing,” Amy Gleason, the administrator of the Department of Government Efficiency who is now a healthcare AI advisor at HHS, told the news outlet. “And it’s like the genie is out of the bottle.”
  • and
    • “HHS, under Secretary Robert F. Kennedy Jr., has sought access to detailed patient records held by state health information exchange systems as part of an effort to research a potential link between vaccines and autism, KFF Health News reported June 4.
    • “Federal officials met with leaders of state-run health information exchanges several times over the past year, asking how the medical records they maintain from hospitals and health systems could be used for vaccine research, according to seven people familiar with the meetings.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Leaders at the Food and Drug Administration on Thursday listened to criticisms and recommendations for how to move forward with a speedy drug review program put in place by former FDA commissioner Marty Makary. 
    • “The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, particularly those whose drugs have already been approved through the program. But most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback.” 
  • Per a corporate news release,
    • “Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis® (Genentech).”
  • Reuters relates,
    • “The U.S. FDA’s Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for ​an artificial intelligence-based drug development tool designed to ‌help predict drug-induced liver injury.
    • ‘Drug-induced liver damage is a major cause of trial failures, and current methods do not reliably ​predict human risk. The U.S. Food and Drug Administration said ​the tool could potentially help improve early safety assessments, reduce reliance ⁠on animal testing and support more informed decisions before human trials ​begin.’

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court raised the bar for branded pharmaceutical companies seeking to sue over a competitor’s generic versions of their drugs that are marketed using what’s called a skinny label.
    • “The justices unanimously concluded that a district court judge was right to dismiss Amarin Pharma Inc.’s infringement suit over claims that Hikma Pharmaceuticals USA Inc. was encouraging doctors to prescribe its generic version of Amarin’s Vascepa heart health drug for a still-patented treatment method.
    • “Drugmakers frequently obtain patents not just on chemical compounds they discover for novel drugs, but separately for methods of using such drugs to treat various medical conditions. When some uses are covered by active patents while others aren’t, generics can get government approval of a “skinny label” that carves out the patented uses.
    • “Thursday’s ruling ramps up the evidence that branded drugmakers need in order to sue when they think the generic label in combination with a generic company’s marketing statements or other communications cross a line into actively inducing patent infringement.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Scientists have made a discovery that may help prevent some people from developing lung cancer, which kills more people worldwide than any other cancer. 
    • “A team of more than 80 researchers working across four continents have identified a set of proteins in the blood that accurately predict lung cancers more than five years before diagnosis. The scientists also found early evidence that an existing anti-inflammatory drug could significantly reduce lung cancer risk in people with elevated concentrations of these proteins, which they linked to inflammation.
    • “More research is needed before a test based on these proteins could be ready for use in patients. And scientists would still need to run a randomized trial to determine whether the drug prevents lung cancers. Still, outside experts said the findings, which were published on Thursday in the journal Cell, offer a promising starting point toward a long-held public health goal.”
  • The Washington Post adds,
    • “The story of GLP-1 drugs keeps getting bigger.
    • “First they transformed the treatment of diabetes. Then they upended the science — and culture — of weight loss. Now a growing body of research is raising another possibility: that these drugs may help protect against cancer.
    • “At this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago, more than 40 studies, abstracts, oral presentations and poster presentations examined the relationship between GLP-1-based drugs and cancer. The results were strikingly consistent. Taken together, they suggest that people taking medications such as Ozempic, Wegovy and Mounjaro may develop certain cancers at lower rates than comparable patients who are not taking the drugs — and that those already diagnosed may experience a slower decline and better outcomes.
    • “For oncologists, the accumulation of evidence is hard to dismiss. The findings are “super promising,” said Mark Orland, a cancer researcher at the Cleveland Clinic. “We’re really excited to be on the forefront of looking at the effects of these drugs.”
  • Health Day relates,
    • “A simple urine test might help identify children who are likely to have autism earlier than the best assessment tools now available, a new study says.
    • “Autistic children appear to have specific gut microbe profiles that can be used to distinguish them from neurotypical (or typically developing) children, researchers reported May 26 in the journal Molecular Psychiatry.
    • “A urine test based on these profiles correctly identified 90% of autistic children and did not misidentify any children without autism, researchers found.
    • “What’s really striking about the bacteria is that they make metabolites that are basically altered versions of serotonin and dopamine,” said researcher James Adams, a professor of engineering at the Biodesign Center for Health Through Microbiomes at Arizona State University (ASU) in Tempe.”
  • and
    • “Mailed fecal immunochemical tests (FITs) can significantly increase colorectal cancer (CRC) screening across racial and ethnic groups, according to a study published in the May/June issue of the Annals of Family Medicine.
    • “Anisha P. Ganguly, M.D., from the University of North Carolina at Chapel Hill, and colleagues compared the effects of a CRC intervention (mailed FIT for screening-eligible patients plus patient navigation for positive results) across race/ethnicity. The analysis included 3,734 patients at federally qualified health centers.” * * *
    • “This analysis showed that mailed colorectal cancer screening tests have the power to improve screening rates for diverse populations,” Ganguly said in a statement. “This is really important, because we want these innovations in screening to improve outcomes among the hardest to reach populations and move the needle on colorectal cancer disparities.”
  • The American Journal of Managed Care tells us,
    • “Sudden death has long been considered an abrupt and unpredictable event in patients with heart failure
       (HF). But a new post hoc analysis of the FINEARTS-HF randomized clinical trial challenges that assumption, finding that most sudden deaths in patients with HF with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) are preceded by measurable clinical deterioration in the months before death.”
  • According to Infectious Diseases Advisor,
    • “Maternal SARS-CoV-2 mRNA vaccination during the third trimester reduces risk for infection and related hospitalization in infants through 6 months of age, highlighting the importance of maternal vaccine timing.”
  • STAT News informs us,
    • “Otsuka’s Voyxact slowed the loss of kidney function after one year in patients with a chronic autoimmune kidney disease, but the benefit was less than expected and left room for competing treatments to perform better. 
    • “In a Phase 3 study, patients with IgA nephropathy, or IgAN, who received injections of Voyxact saw their kidneys lose function at an annualized rate of 3 points over one year compared to an annualized function loss of 7.6 points over one year for patients receiving a placebo, the Japanese drugmaker reported Thursday.” * * *
    • “While the relative improvement in kidney function was positive, the result was also less robust than what was seen in an earlier Otsuka study. The data left open the possibility that competing drugs from Vera Therapeutics and Vertex Pharmaceuticals may be able to show a larger effect on kidney function when their respective studies read out results.” 

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

  • Beckers Payers Issues reports,
    • “UnitedHealth Group and CVS Health, Aetna’s parent company, are among the top 10 companies on the Fortune 500 this year.
    • “Fortune‘s June 3 list ranks the top 500 U.S. companies by revenue. Nine health payers [which are listed in the article] made the cut, with 2025 revenues ranging from $11.7 billion to $447.6 billion.
    • “UnitedHealth Group held its third-place standing from 2025. Amazon topped the list, ending Walmart’s 13-year tenure in the top spot.”
  • Beckers Hospital Review relates,
    • “Brentwood, Tenn.-based Lifepoint Health has completed its acquisition of eight community hospitals from Louisville, Ky.-based ScionHealth.
    • “The hospitals are spread across six states, according to a June 2 news release. Lifepoint acquired:
      • “Bolivar Medical Center in Cleveland, Miss.
      • “Ennis (Texas) Regional Medical Center
      • “Livingston (Tenn.) Regional Hospital
      • “Logan (W.Va.) Regional Medical Center
      • “Palestine (Texas) Regional Medical Center
      • “Parkview Regional Hospital in Mexia, Texas
      • “St. Joseph Regional Medical Center in Lewiston, Idaho
      • “Watertown (Wis.) Regional Medical Center
    • “Lifepoint originally signed an agreement to acquire the hospitals in March.
    • “ScionHealth said the eight hospitals will keep their current employees, providers and services. The company described the divestiture as part of a broader effort to strengthen its capital structure and focus on core operations.”
  • Healthcare Dive adds,
    • “West Virginia University Health System has solidified the next phase in its plan to acquire Greensburg, Pennsylvania-based nonprofit Independence Health System, announcing this week the two parties had signed a definitive agreement to combine.
    • “As part of the deal, which was announced last year, WVU Health System will invest $800 million into Independence’s five hospitals in order to install a new electronic health record and upgrade the facilities.
    • “The health systems now expect the acquisition will close in September or October, pending regulatory approval.”
  • Fierce Healthcare tells us,
    • “Due to advances in cancer treatment and early detection, the population of cancer survivors continues to grow, reaching more than 18 million individuals in the U.S. By 2035, that number is projected to exceed 22 million.
    • “But many cancer survivors have ongoing medical and mental health needs after cancer treatment ends. Faced with long-term side effects, behavioral health challenges and hormone therapies, many survivors are left to manage these healthcare challenges on their own.
    • “Value-based cancer care navigation company Thyme Care has expanded its cancer survivorship program, called Next Chapter Care, to provide a personalized, longitudinal approach to survivorship support. That program provides coordinated oncology support beyond active treatment for the more than 15,000 Thyme Care members who have completed cancer treatment.
    • “Rather than treating survivorship as a disconnected phase of care, the program extends the existing relationship Thyme Care already has with members across diagnosis, treatment and recovery, according to the company.”
  • and
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. 
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. “
  • Beckers Hospital Review points out,
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to the American Society of Health-System Pharmacists — and the FDA’s database continues to reflect new discontinuations weekly. The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also lists eight recent additions to the shortage list.

Monday report

David Ermer–CDC, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “President Donald Trump on Monday announced that about 600 low-cost generic drugs would be available through TrumpRx.gov, a government website aimed at helping Americans purchase medications at discounted prices. 
    • “By incorporating this massive catalog of low-cost generics at TrumpRx.gov, consumers will now have one source to ensure that they’re getting the lowest possible cost on their prescription,” Trump said in a presentation at the Eisenhower Executive Office Building.”
  • Federal News Network relates
    • “HHS sends RIF notices to dozens of staff it missed during office-wide layoffs last year.
    • “Meanwhile, HHS is looking to convert hundreds of senior positions to a rebranded version of the “Schedule F” classification for federal employees.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a reorganization of its Office for Civil Rights (OCR), the Department’s law enforcement agency charged with enforcing laws protecting civil rights, conscience and religious freedom, and health information privacy and security. The reorganization returns OCR to a program-based structure that aligns OCR’s three critical substantive areas with three distinct subject-matter divisions: the Conscience and Religious Freedom Division, the Civil Rights Division, and the Health Information Privacy, Data, and Cybersecurity Division.
    • “This reorganization restores the HHS Civil Rights Division and the Conscience and Religious Freedom Division and strengthens the Office for Civil Rights’ ability to defend religious liberty, enforce conscience protections, and combat unlawful discrimination,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “Under President Trump’s leadership, HHS will defend these rights with clarity, accountability, and resolve.”
    • “This reorganization reinstitutes a structure that rightly prioritizes civil rights and conscience and religious freedom alongside health information privacy and security,” said HHS Office for Civil Rights Director Paula M. Stannard. “All three areas are deserving of subject-matter expertise and distinct senior executive leadership for OCR to best serve the American people.”
  • The American Hospital Association News adds,
    • “Most hospital outreach laboratories must report private payer clinical diagnostic laboratory data for services furnished during the first six months of 2025 to the Centers for Medicare & Medicaid Services by July 31, the agency announced. This includes Healthcare Common Procedure Coding System codes, associated private payer rates and volume data. CMS previously sent letters to hospitals, which the agency believes have outreach laboratories that are likely required to report their data. CMS also has a guide and other resources for hospital outreach laboratories to determine whether and how they must report.” 

From the Food and Drug Administration,

  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it received U.S. approval for a new hypertension treatment, getting the green light to launch a drug the U.K. pharmaceutical company expects to generate multibillion-dollar annual sales at its peak.
    • “The drug, known until now as baxdrostat, will be marketed under the brand name Baxfendy, the company said Monday. The approval expands AstraZeneca’s cardiovascular, renal and metabolism portfolio shortly after diabetes drug Farxiga—its biggest product in that therapeutic area and the bestselling medicine in the company’s history—went off patent in the U.S.
    • “AstraZeneca said that Baxfendy treats hypertension in a new way by targeting aldosterone, a hormone that raises blood pressure.
    • “Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, said the approval brings a new treatment to a disease that has had little therapeutic progress for the past two decades.”
  • Fierce Pharma relates,
    • “Enhertu’s market conquest is continuing apace. Already tracking at $5 billion in annual sales, the star antibody-drug conjugate from Daiichi Sankyo and AstraZeneca has secured FDA approval to treat early breast cancer, further encroaching on Roche’s Kadcyla territory.
    • “The FDA has simultaneously greenlighted Enhertu for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer, the two companies said Friday [July 15, 2026]. The adjuvant nod came nearly two months ahead of schedule, as the FDA had originally targeted a decision by July 7.”
  • The New York Times tells us,
    • “A California dairy company has issued a recall for five ice cream flavors, warning customers that some tubs may be contaminated with metal.
    • “The company, Straus Family Creamery, recalled some of its organic ice cream, which was sold in 17 states since May 4. It said it ordered the recall because of “the potential presence of metal foreign material,” without giving further details.
    • “The warning applies to its vanilla bean, strawberry, cookie dough, Dutch chocolate and mint chip flavors with specific “best-by” dates in late December 2026.
    • “It did not say how many tubs were affected but said the issue was with a “small number of production runs.”
  • Health Day informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved an AI-powered early warning system to detect sepsis, one of the deadliest infections for hospital patients.
    • “The tool, developed at Johns Hopkins University (JHU), detects sepsis hours faster than doctors. It has already reduced deaths by nearly 20% in dozens of hospitals across the United States, JHU reports.
    • “Pre-suspicion screening is what creates lead time, and lead time is what changes outcomes in sepsis,” said Suchi Saria, director of JHU’s AI & Healthcare Lab. “Once a clinician already suspects sepsis, the clock has been running — often for hours or even days.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court turned away appeals from six pharmaceutical companies seeking to topple the Medicare drug price negotiation program that’s led to billions of dollars in discounts on top-selling treatments.
    • “Making no comment, the justices on Monday refused to hear a variety of constitutional arguments against a program created in 2022 by President Joe Biden’s Inflation Reduction Act. The court rejected separate appeals from units of AstraZeneca Plc, Johnson & Johnson, Bristol Myers Squibb Co., Novartis AG, Novo Nordisk A/S and Boehringer Ingelheim Pharmaceuticals Inc.
    • “The rebuffs leave in force a program the US government said in November will produce a 71% discount on Novo Nordisk’s blockbuster Ozempic and Wegovy drugs for Medicare patients starting in 2027. The Trump administration said that round of discounts, covering 15 drugs, will mean $12 billion in savings compared with 2024 list prices.
    • “The cases at the high court involved the previous year’s negotiated discounts, which covered 10 drugs and took effect in January. The Centers for Medicare and Medicaid Services said in 2024 that the deals would reduce out-of-pocket costs by $1.5 billion this year.”
  • Per a Justice Department news release,
    • “A New York man was sentenced today to 37 months in prison for conspiring to launder nearly $1.5 million in illicit health care fraud proceeds through multiple domestic and global banks on behalf of a Transnational Criminal Organization (Organization).
    • “According to court documents, Elnar Zarbailov, 42, of Staten Island, New York, and dual citizen of the United States and Azerbaijan, was a fixer and money launderer for the foreign-based  Organization that spearheaded the largest health care fraud case ever prosecuted by the Department of Justice, as uncovered by Operation Gold Rush. The Organization, based in Russia and elsewhere, orchestrated a multi-billion-dollar health care fraud and money laundering scheme to target, exploit, and steal from Medicare and private health insurance companies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The CDC announced Monday that an American tested positive for Ebola this weekend while working in Congo and is being transported to Germany for treatment along with six other Americans who are high-risk contacts. 
    • “The Centers for Disease Control and Prevention also is enhancing public health screening and traveler monitoring amid a growing Ebola outbreak, and non-U.S. passport holders face entry restrictions if they have been to Uganda, the Democratic Republic of Congo or South Sudan in the previous 21 days.
    • “To the American public, the risk to the United States remains low,” said Satish Pillai, CDC Ebola response incident manager. “Travelers to the region should avoid contact with sick people, report symptoms immediately, and follow our travel guidance.”
  • Health Exec points out,
    • “A healthcare research firm that provides trend analysis to stakeholders released a new report that examined usage of behavioral health services post-COVID, showing that demand and utilization for mental healthcare and addiction mitigation have intensified since the pandemic.
    • “According to the data from Trilliant Health, while the utilization of care related to emotional health, mental health, autism, and alcohol and drug dependency stand at new highs since the COVID lockdowns, outcomes may not be improving.
    • “Using publicly available data on utilization, provider numbers and demand, Trilliant’s data paints a picture of a mental healthcare system that is overburdened. From 2018 to 2024, the group reports that the number of behavioral health visits jumped 62.6%, standing at 1,346 visits per 1,000 people.
    • “People seeking care for anxiety led the trend, accounting for 89.3% of growth. Women aged 18-44 made up the majority of that cohort. However, Trilliant noted that childhood developmental disorders—autism, attention deficit disorder, speech problems and other issues including anxiety—including attempted self-harm, have risen nearly 48% over 20 years, from 2004-2024.”
  • Health Day adds,
    • Many older adults see cannabis as a more effective or nonpharmaceutical option to manage sleep, pain, or mental health, according to a study published online May 8 in JAMA Network Open.
    • Rebecca K. Delaney, Ph.D., from the University of Utah Intermountain Health Department of Population Health Sciences in Salt Lake City, and colleagues explored the motivations of older adults in Colorado interested in purchasing edible cannabis products to improve sleep, pain, or mental health concerns, as well as the perceived benefits and drawbacks of different cannabinoid profiles. The analysis included 169 interview participants aged 60 years and older.
  • The New York Times relates,
    • “A study of insurance claims for 1.8 million children found that the number of families raising mental health issues at visits to general practitioners rose sharply over a decade, with anxiety by far the fastest-growing complaint.
    • “The study, which was published on Monday in the journal JAMA Network Open, found that the number of pediatric visits rose to 9.7 percent in 2023 from 5.7 percent in 2014.
    • “The study included all insurance claims for children from ages 1 to 18 in Massachusetts, for a total of more than 1.8 million children. Visits were counted as mental health visits if a diagnostic code was included in the claim, either because the child or the family raised the issue or because the child screened positive for mental health symptoms during the visit.
    • “Visits for anxiety rose by more than 250 percent during that period, to 6.1 percent in 2023 from 1.7 percent in 2014.”
  • The American Medical Association lets us know “nine things patients should know about taking creatine.”
    • “The ‘Health vs. Hype’ AMA podcast explores what creatine is, its association with bodybuilders, and whether it’s safe for the general public.”
  • Medpage Today tells us,
    • “A course of azithromycin for preschoolers who presented to the emergency department (ED) with wheezing didn’t improve their symptoms, the AZ-SWED trial showed.
    • :Among children, ages 18-59 months, the 5-day sum of scores on the Asthma Flare-up Diary for Young Children (ADYC) did not differ significantly compared with placebo in either those who initially tested positive for pathogenic bacteria (median 9.59 vs 9.72, P=0.70) or those who tested negative (9.30 vs 9.10, P=0.69). ADYC scores range from 5-35 points, with higher scores indicating more severe symptoms.
    • “While the trial was stopped early for futility — reducing the statistical power of the trial — it was sufficient to show that “a moderate or large true effect is implausible,” Richard M. Ruddy, MD, of the University of Cincinnati College of Medicine, reported at the American Thoracic Societyannual meeting in Orlando. The findings were published simultaneously in the New England Journal of Medicine.”
  • and
    • “The 2025/2026 seasonal COVID vaccination was associated with a roughly 50% reduced risk for illness up to 9 weeks post-vaccination, especially in older Canadian adults, according to an interim analysis by the Canadian Sentinel Practitioner Surveillance Network. The seasonal vaccine, which was specifically formulated to target the LP.8.1 variant, also appeared to offer protection from other strains.
    • “An important aspect of the 2025/2026 season was the simultaneous circulation of influenza and other respiratory viruses, which suggested the need to consider the role that respiratory virus co-circulation might play in estimating vaccine effectiveness (VE).
    • “This year, we were especially interested to check the effects of co-circulating respiratory viruses (eg, influenza and respiratory syncytial virus [RSV]) since COVID circulated at only low levels through the current season,” lead author Danuta M. Skowronski, MD, epidemiology lead for influenza and emerging respiratory pathogens at the BC Centre for Disease Control in Vancouver, told Medscape News Canada.”
  • The American Journal of Managed Care points out,
    • “A retrospective VA cohort (2006–2019) compared ≥75-year-olds with adenoma vs no adenoma at ages 65–75 using registry and National Death Index outcomes. 
    • “Ten-year CRC incidence and CRC death were statistically higher with prior adenoma, but absolute differences were small and clinically overshadowed by competing non-CRC mortality. 
    • “Frailty stratification showed progressively lower CRC incidence and sharply higher non-CRC death, with severe frailty demonstrating <1% CRC versus 82% non-CRC death. 
    • “Advanced adenoma status did not significantly alter CRC risk, and follow-up colonoscopy rates after 75 were not higher among patients later developing CRC. 
    • “Generalizability is limited by a 98% male veteran population, reinforcing the need for confirmatory analyses in cohorts with greater female representation.”
  • Per BioPharma Dive
    • “An experimental cancer immunotherapy from Regeneron failed a late-stage study in melanoma in a surprise setback for the big biotechnology company’s oncology business.
    • “A regimen involving the prospect, fianlimab, and Regeneron’s marketed medicine Libtayo didn’t significantly delay cancer progression compared to Merck & Co.’s Keytruda in patients with unresectable metastatic melanoma. A high-dose combination held tumors in check for a median of 11.5 months, compared to 6.4 months for Keytruda recipients, a difference that narrowly missed statistical significance.
    • “Regeneron didn’t provide additional details but will present them at a future medical meeting. Another Phase 3 study testing fianlimab against Opdualag, a similar cancer immunotherapy sold by Bristol Myers Squibb, is ongoing. Company shares fell by double digits early Monday, erasing billions of dollars in market value.”

From the U.S. healthcare business front

  • Kauffman Hall reports,
    • Key Takeaways
      • March was the best month for hospitals in 2026 so far, despite mixed volumes. Month-over month discharges rose while patient days fell, indicating increased focus on improving average length of stay and a continued shift to outpatient care.
      • Operating margins improved month-over-month but remain below 2025. While bad debt and charity care declined month-over-month, gross revenue continues to outpace net, highlighting eroding payor mix.
      • Expenses declined in March, yet remain elevated year-over-year. Favorable improvements across the board are likely correlated to the decrease in average length of stay. However, drug expenses remain a primary driver of expense growth year-to-date.
      • Two notable outliers emerged in otherwise steady regional trends. The Northeast saw margin improvement, despite historical underperformance, while the West experienced the most dramatic increase in drug expense.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Massachusetts reported a net income of $59.6 million in the first quarter of 2026, a return to profitability after back-to-back annual losses in 2024 and 2025.
    • “The insurer posted revenue of $2.6 billion in the first quarter, reflecting a 2% net margin. Operating and other income came in at $17.4 million (0.6% operating margin), with investment income contributing $42.2 million.
    • “The company attributed the improved results to disciplined cost management, a milder-than-expected flu season and changes to its coverage of GLP-1 medications.
    • “Our first-quarter results reflect the challenging but necessary actions we’ve taken over the past year, including pricing our benefit plans to their true cost, identifying medical and pharmacy spending that doesn’t add value for our members, and keeping rate increases to our provider network at or below the state benchmark,” CFO Ruby Kam said May 15.”
  • Fierce Healthcare relates,
    • “Now three quarters into its fiscal year, Ascension has chopped down its operating losses by more than half and more than tripled its bottom-line gain. 
    • “The nonprofit system reported Friday a $203 million operating loss (-1.1% operating margin) for the nine months ended March 31, 2026, improving on the $466 million operating loss (-2.3%) for the prior fiscal year. 
    • “Both its total operating revenue and operating expenses dipped from the prior year due to a slew of divestitures. The former declined by 7.2% to $18.1 billion while the latter fell by 8.1% to $18.3 billion; on a same-facility basis, total operating revenue grew 9.3% while expenses increased 5.7%.” 
  • Healthcare IT News explains “How one practice combines in-clinic, telehealth and in-home care.”
    • “Dr. Payam Zamani is a practicing family medicine physician and founder and CEO of My Dr Now, one of the largest primary care providers in the Southwest. It’s designed as a hybrid in-person/telehealth/in-home health system.”
    • “When patients engage earlier and follow through consistently, the health system operates more efficiently, My Dr Now’s physician CEO reports: “This is not about technology for its own sake, it’s about designing care delivery around real life.”
  • Modern Healthcare tells us,
    • “Oregon gave the green light for Compassus to acquire a 50% stake in Providence’s home health and hospice operations across the state.
    • “After more than a year of review, Oregon Health Authority’s Health Care Market Oversight program said in a Friday news release it approved the joint venture with conditions.
    • “The Oregon deal is expected to close in the fall, Providence said in an email.”
  • and
    • “RWJBarnabas Health has opened a $7 million food-is-medicine hub to take on chronic disease, making it a potential standard bearer in the Make America Healthy Again movement.
    • “Last week, the New Jersey academic health system opened Harvest — an 8,000-square-foot facility in Newark that is a combination food bank, commercial kitchen and classroom. The center is designed to teach people living in nearby food deserts how to eat healthier and provide them with the food to do it.”
  • Health System CIO informs us,
    • “Epic added 77 acute care hospitals in 2025 while Oracle Health shed 56, according to the new KLAS report, “US Acute Care EHR Market Share 2026.” The five-year picture is even starker. Epic has gained a net 568 hospitals since 2021 while Oracle Health has lost 173. In total, the report covers EHR contracts executed from January through December 2025. Epic now holds 43.7% of acute care hospital market share and 56.9% of beds. Oracle Health, meanwhile, sits second at 21.9% of hospitals and 20.4% of beds, followed by Meditech at 14.7% and 12.5%.” * * *
    • “Hospitals impacted by EHR decisions fell about 40% from 2024 as buyers shifted investment toward AI and operational efficiency tools.”
  • Per MedTech Dive,
    • “Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.
    • “The agreement gives Boston Scientific an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain clinical and regulatory milestones. Boston Scientific said it may opt to acquire the rest of the TAVR business for additional cash payments totaling $3 billion.
    • “The deal comes about a year after Boston Scientific stopped selling its Acurate Neo2 and Acurate Prime TAVR devices, which were CE-marked in Europe, and ended plans to pursue approvals in the U.S. and other locations.”

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medicare, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Roll Call offers an overview of this week’s anticipated activities on Capitol Hill.
  • STAT News reports,
    • “Bill Cassidy, a key Republican health care leader in the Senate, will lose his seat, as Louisiana’s Senate primary heads for a runoff between state treasurer John Fleming and Rep. Julia Letlow, who won President Trump’s endorsement.” * * *
    • “Cassidy’s defeat is a win for President Trump and his allies, who have criticized the senator for voting in 2021 to convict the president for inciting the January 6 insurrection.” * * *
    • “Cassidy will likely remain chair of his committee until his term ends at the start of next year, potentially setting up roadblocks for Kennedy as he attempts to fill several vacancies across his department. That includes a new Food and Drug Administration commissioner, and nominees for surgeon general and Centers for Disease Control and Prevention director.”
  • Federal News Network points out four benefits bills in Congress for federal employees, retirees to watch. “Potential adjustments to short-term disability insurance and credit protection for feds during government shutdowns are on the table through new legislation.
  • Per a May 15, 2026, Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) issued a sweeping rule to strengthen oversight of the Affordable Care Act (ACA) Exchanges for plan year 2027 by lowering user fees, tightening eligibility verification, and giving states greater authority over plan oversight.
    • The final rule, “Notice of Benefit and Payment Parameters for 2027; Basic Health Program” (the 2027 Payment Notice final rule) reduces federal Exchange user fees to help lower premiums, establishes new safeguards to prevent improper enrollments, ensures subsidies go only to eligible individuals, increases consumer choice, affordability, access and protections, and expands state flexibility to manage Exchange operations.
    • “The rule strengthens program integrity, expands consumer protections, promotes plan innovation and consumer choice, and restores greater authority to states. 
    • “American taxpayers deserve to know their dollars are going only to people who truly qualify,” said CMS Administrator Dr. Mehmet Oz. “This rule strengthens eligibility checks, cracks down on abuse, and gives insurers more flexibility to offer affordable, consumer-focused coverage options.”
  • Here is a link to the CMS fact sheet on this final rule.
  • Kevin Moss writes in Govexec,
    • “CMS is launching the Medicare GLP-1 Bridge program, which will extend coverage of certain GLP-1 medications for weight loss to eligible Medicare beneficiaries, regardless of whether they have an underlying medical condition” effective July 1, 2026. 
    • “For [FEHB and PSHB} annuitants enrolled in Part D, this program could expand your options. Here’s [in the article] what it covers, who qualifies, and what it means for you.”
  • The U.S. Supreme Court will be releasing opinions at 10 am every Thursday morning until the end of next month.

From the public health and medical / Rx research front

  • The Wall Street Journal considers whether “the Weight-Loss Drug Revolution Causing a Frailty Epidemic? As millions flock to GLP-1s, doctors warn the drugs can cause rapid and significant muscle loss” and assesses “What Science Tells Us About the Risks of Hantavirus. Rare virus has high fatality rate and can spread through the air, research shows, though it is easier to contain than Covid-19.”
  • Health Day reports,
    • “A major women’s health condition is getting a new name—and experts say it could change how millions are diagnosed and treated worldwide.
    • “Polycystic ovary syndrome, or PCOS, will now be known as polyendocrine metabolic ovarian syndrome, or PMOS.
    • “The condition affects more than 170 million women worldwide and is linked to hormone imbalances, weight and metabolic issues, mental health symptoms, skin changes and fertility challenges.
    • “Experts said the old name was misleading because the condition is not actually defined by ovarian cysts.
    • “What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” said Helena Teede, director of the Monash Center for Health Research & Implementation in Australia and an endocrinologist at Monash Health.”
  • BioPharma Dive relates,
    • “A year after Vertex’s big launch, pain drug research faces a pivotal moment.
    • “Journavx started to revive area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?”

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

  • The Wall Street Journal reports,
    • “Nurse practitioners and physician assistants are increasingly filling healthcare gaps, with NP ranks growing 60% to 461,000 between 2019 and 2025.
    • “Doctors’ groups express concern that non-MD providers practicing without physician oversight may pose risks to patients.
    • “A 2023 study found that allowing nurse practitioners to work without physician supervision reduced deaths that could have been prevented through healthcare by 2%”
  • Fierce Healthcare relates,
    • “Even without counting the multi-billion hit tied to the early termination of a major joint venture and outsourcing arrangement, CommonSpirit Health’s operations took a bruising during the three months ended March 31.
    • “The major Catholic nonprofit system reported Friday a $578 million operating loss (-5.8% operating margin) during the third quarter of its fiscal year. That’s after two key adjustments: normalization for delayed income received through California’s provider fee program; and removing the nearly $2.5 billion of “special charges” the system recorded on paper for the quarter that include contract termination and intangible asset impairment stemming from its breakup with Tenet Healthcare’s revenue cycle services business. 
    • “For comparison, CommonSpirit had logged an $85 million operating loss (-0.9% operating margin) a year prior with the California provider fee program adjustment. Across the first nine months of the fiscal year, the system is looking at a $743 million operating loss (-2.4% operating margin) for 2026 and a $282 million operating loss (-1.0% operating margin) in 2025, with the same adjustments.” 
  • Health Exec tells us,
    • “The days when most doctors worked in independent practice settings are fading from memory like old photoprints in a musty scrapbook.
    • “Taking their place is an era dominated by physician employment. And the employers are not only hospitals but also a “vast array of corporate entities with various financial incentives for employing physicians.”
    • “The quote is from the authors of a new report compiled by Avalere Health for the Physicians Advocacy Institute, also known as PAI.
    • “The shift towards corporatization of physician practice, the PAI analysts add, has “significant implications for costs, patient care and the future practice of medicine.”
    • “The report looks at trends in practice acquisitions as well as physician employment over the eight-year stretch from January 2018 to January 2026.”
  • MedCity News informs us,
    • “Anomaly Insights, an AI-powered payer intelligence company, announcedWednesday that it raised $17 million in funding.
    • “The company’s platform analyzes healthcare transactions to identify payer behavior patterns, policy changes and adjudication deviations. It helps predict at-risk payments so providers can proactively ensure claims are paid accurately. It also detects new denial patterns and identifies revenue opportunities. Currently, Anomaly is being used across more than 20 health systems.
    • “Specifically, the company seeks to solve the issue of “not knowing whether a healthcare encounter will be paid for or not before it happens,” said Mike Desjadon, CEO of Anomaly.”

Tuesday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Oklahoma Republican Gov. Kevin Stitt on Tuesday selected Alan Armstrong, an energy executive, to fill the seat being vacated by Sen. Markwayne Mullinuntil a new election takes place in November.
    • “The announcement came a day after Mullin was confirmed Monday by the Senate as secretary of the Department of Homeland Security. The appointment of Armstrong as a temporary seat holder keeps the Senate’s GOP majority at 53-47.
    • “Armstrong, the chairman of Williams Companies, focused in remarks Tuesday morning on permitting reform, the cost of energy and infrastructure.” * * *
    • “President Trump has endorsed Oklahoma Rep. Kevin Hern for the Senate seat in the coming election, calling him a “true friend of MAGA.” The Republican primary in the deep-red state is scheduled for June 16.
    • “Armstrong said he had a positive meeting with Trump before his selection. Oklahoma state law prohibits Senate appointees from running for the seat in a subsequent election.” 
  • and
    • “Senate Republicans offered Tuesday to fund all of the Department of Homeland Security except for the unit that carries out immigrant arrests and deportations, moving to end a nearly six-week funding standoff that has caused security snarls at airports nationwide. 
    • “Democrats reacted coolly to the proposal, which didn’t include the new restrictions on immigration enforcement practices they have demanded, but said that they were engaged in negotiations. President Trump indicated he wasn’t pleased with the direction of the talks, muddying the prospects of a quick resolution.”
  • The Hill adds,
    • “House Republicans are pushing back stiffly against the idea of splitting up legislation to fund the Department of Homeland Security (DHS), despite the White House and Senate Republicans saying President Trump is open to doing just that.”
  • Roll Call notes,
    • “As a deadline arrives this week to nominate a Centers for Disease Control and Prevention director, some Republicans are skeptical the administration will find someone who can check all the boxes necessary for confirmation.
    • “The candidate will need the “Make America Healthy Again” mindset of Secretary Robert F. Kennedy Jr.’s Health and Human Services Department, while also appeasing a set of stick-to-science senators increasingly unhappy with Kennedy’s direction.” * * *
    • “HHS senior adviser Chris Klomp, in an interview last week with Stat News, said the agency has interviewed “dozens” of potential candidates. Though there is a structured process to name top candidates, Kennedy will ultimately make the final decision.
    • “Klomp also said that if the White House hasn’t named a nominee Wednesday, HHS would shift to delegate responsibilities, but getting a qualified nominee “is a top priority.”
  • The Washington Post points out,
    • “The nascent Make America Healthy Again movement got one of its biggest wins last spring: Casey Means was selected to be the nation’s top doctor.
    • :But more than 10 months later, the controversial surgeon general pickhas yet to assume the position advising Americans on how to improve their health. Her nomination has stalled as some Republicans question her stance on vaccines, her medical credentials and her pushes against the medical establishment.
    • “Means probably cannot afford to lose the support of a single Republican on the Senate health committee, which has yet to schedule a vote to advance her nomination to the full Senate. The panel’s chairman, Sen. Bill Cassidy (R-Louisiana), repeatedly pressed Means on her views on immunizations during a late February hearing — questions she largely dodged — and Sens. Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska) afterward publicly said they still have questions.”
  • The New York Times relates,
    • “Dr. Robert Malone, vice chair of the federal committee that recommends vaccines to Americans, angrily resigned his position on Tuesday.
    • “The panel, called the Advisory Committee on Immunization Practices, or ACIP, is currently in judicial limbo. A federal judge ruled last week that the advisers, appointed by Health Secretary “Robert F. Kennedy Jr., did not have the expertise needed to make vaccine recommendations and prevented them from meeting as planned this month.
    • “The judge also blocked all of the committee’s actions to date, including decisions to rescind recommendations for some childhood vaccines.
    • “The Department of Health and Human Services has indicated that it will appeal the ruling but has not said when. Dr. Malone indicated that he would not rejoin the committee even if the ruling were to be overturned or if Mr. Kennedy announced a new slate of advisers.”
  • FedManager observes,
    • “With the cancellation of the Federal Employee Viewpoint Survey (FEVS) for 2025, the Partnership for Public Service conducted its own version of FEVS. The goal: check the pulse of the workforce in a year of major workforce changes, including deferred resignations, returns to office, the cancellation of union contracts, and other changes. 
    • “The revamped survey was modeled after FEVS but was developed and deployed by the Partnership. While it’s not directly comparable, it contained similar questions. The survey was conducted on a smaller scale with 11,000 feds responding, compared to the 500,000 or so who respond to the official FEVS. Responses were collected in November and December 2025.
    • As for the results, employee engagement and satisfaction governmentwide was measured at a score of 32 out of 100, with 58 percent of respondents saying engagement has gotten worse since 2024. 
    • “We have every red light blinking across the federal government,” said Partnership President and CEO Max Stier. “Morale is as low as imaginable.”
  • Govexec informs us,
    • “As the U.S. Postal Service contemplates service cuts due to the prospect of running out of money as soon as fall 2026, President Donald Trump recently nominated three additional individuals to the postal agency’s Board of Governors. Several unions and other stakeholders, however, reported that they are largely unfamiliar with his picks. 
    • “[The National Association of Letter Carriers] is closely monitoring these unknown nominees and will actively work to ensure they have the best interests of the employees and the network before they are confirmed,” the union said in a press release responding to the nominations announcement. 
    • “The postal board nominees are: Robert Steffens of Texas, Jeffrey Brodsky and William Gallo, both of Florida.” * * *
    • “There are currently four governors on the USPS board — two Democrats, one Republican, one independent — leaving five vacancies. No more than five of them can be from the same political party. 
    • “NALC noted that the Senate has traditionally advanced postal nominees in bipartisan pairs, but all of Trump’s picks, so far, have been Republicans. The president has attempted to remove Democratic members of several bipartisan agency boards, prompting legal challenges that have reached the Supreme Court.” 
  • Modern Healthcare lets us know,
    • “The Accelerating State Pediatric Innovation Readiness and Effectiveness, or ASPIRE, Model is designed for children and young adults with complex physical and behavioral health needs.
    • “The demonstration will test wraparound Medicaid and Children’s Health Insurance Program payments to promote care coordination.
    • “CMS will distribute $125 million to up to five states over 10 years.”
  • KFF analyzes the BALANCE Model for GLP-1s in Medicare and Medicaid.
    • “GLP-1s, a class of drugs used to treat type 2 diabetes, obesity, cardiovascular disease, and other conditions, have exploded in popularity in recent years due to their demonstrated effectiveness, but are often not covered by insurance, particularly for the treatment of obesity. According to KFF polling, about half (56%) of GLP-1 users say these drugs were difficult to afford, including one in four who say they were “very difficult” to afford.
    • “The Trump administration is pursuing various approaches to lowering the cost and expanding coverage of these medications. These approaches include striking “most-favored nation” deals with GLP-1 manufacturers Novo Nordisk and Eli Lilly, providing access to discounted prices for GLP-1s through TrumpRx, and implementing a new demonstration program called the BALANCE (Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth) Model to expand Medicare and Medicaid coverage of GLPs for obesity, which is currently subject to statutory limitations (prohibited in Medicare, permissible but not required in Medicaid). In addition, the GLP-1 drug semaglutide (branded as Ozempic, Wegovy, and Rybelsus) was selected for Medicare drug price negotiation in 2025, with a negotiated price set to take effect in 2027.
    • “This brief describes current coverage of GLP-1s in Medicare and Medicaid, the Centers for Medicare & Medicaid Services’ (CMS) efforts to expand access and lower costs for GLP-1s through temporary demonstration programs including the BALANCE Model, and potential impacts on beneficiaries and program budgets.”
  • The American Hospital Association tells us,
    • “The Administration for Strategic Preparedness and Response March 24 announced an investment to expand the domestic manufacturing of propofol and metoprolol. Propofol is a sedative used for anesthesia and intensive care unit sedation, while metoprolol is a medication used to treat cardiovascular conditions such as arrhythmias and hypertension, and can also reduce lung inflammation in ICU settings. ASPR said the API Innovation Center, based in St. Louis, was awarded $8.3 million to produce both ingredients. The investment is the latest in a series of projects by ASPR and the Department of Health and Human Services to reduce reliance on foreign resources and increase the domestic production of essential medications and their active pharmaceutical ingredients.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “GE HealthCare has received 510(k) clearance for its spectral photon-counting CT technology, the company said Monday.
    • “The Food and Drug Administration clearance positions GE HealthCare to compete with Siemens Healthineers’ Naeotom Alpha, the first photon-counting CT machine to reach the U.S. market.
    • “Citi Research analysts said in a note to investors that GE HealthCare’s Photonova Spectra is differentiated by its use of a detector designed to produce high-contrast spectral images with detailed visualization.”
  • Cardiovascular Business adds,
    • “Medtronic has received an expanded U.S. Food and Drug Administration (FDA) approval for its OmniaSecure defibrillation lead. 
    • “The lead was originally approved for placement in the right ventricle in April 2025. This expanded indication covers the left bundle branch (LBB) area, meaning it can now be used for conduction system pacing and even LBB optimized cardiac resynchronization therapy (LOT-CRT). This is the first time the FDA has approved a defibrillation lead for placement in the LBB area.
    • “Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker,” Trevor Cook, vice president and general manager of Medtronic’s defibrillation solutions business, said in a statement. “Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy and activate the heart’s natural electrical system to enable a more synchronous, physiologic pattern. This approval underscores the versatility of the OmniaSecure defibrillation lead and supports its use across a variety of implant approaches to best serve a broad range of patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “CVS Health has reached a proposed settlement with the Federal Trade Commission in the agency’s sweeping case against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “The proposed consent agreement was disclosed Monday in a joint motion from the FTC and CVS for the company’s subsidiaries, PBM Caremark and group purchasing organization Zinc, to withdraw from the case while antitrust regulators consider the deal.
    • “The filing did not include the terms of the potential settlement, but analysts expect it would be similar to the deal the FTC secured with Cigna’s PBM Express Scripts earlier this year. If CVS reaches a settlement, that would leave UnitedHealth as the lone holdout in the high-profile suit.”

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

  • The AP reports,
    • “Whether they’re using weekly shots or daily pills, more Americans than ever are turning to anti-obesity drugs to lose weight and boost health.
    • “About 1 in 8 U.S. adults say they are taking a GLP-1 drug, according to a recent surveyby the health research group KFF.
    • “Just since January, more than 600,000 prescriptions have been written for Novo Nordisk’s new Wegovy pill, the company said. Early analysis suggests that more than a third of users are new to the drugs, according to Truveta, a health care data company. 
    • “But medication alone isn’t the answer, experts caution. It also takes lifestyle changes — healthy diet, exercise, adequate sleep and stress management — to reap the biggest benefits from the drugs known as GLP-1s.
    • “The biggest mistake people make with GLP-1 medications is thinking the prescription is the treatment,” said Dr. Katherine Saunders, an obesity medicine expert at Weill Cornell Medicine and co-founder of FlyteHealth, a weight-loss treatment company.
    • “GLP-1s can spur weight loss and health benefits on their own, but the effects are larger and last longer when the drugs are combined with lifestyle changes, a recent review of nearly three dozen studies found.”
  • Beckers Clinical Leadership relates,
    • “The CDC is tracking a new SARS-CoV-2 variant — BA.3.2 — that has been identified in 23 countries, including the U.S.
    • “Here are [four] things to know:
      • “1. The variant was first identified in South Africa in November 2024. Detections began increasing in September 2025, with the highest number reported during the week of Dec. 7, 2025.
      • “2. BA.3.2 was first detected in the U.S. in June 2025 at San Francisco International Airport through traveler-based surveillance. As of mid-February, it had been found in clinical samples from five patients across four states and 132 wastewater samples from 25 states. Prevalence among sequenced specimens remains low at 0.19%. Two of the five patients were hospitalized older adults with comorbidities, and all five survived.
      • “3. BA.3.2 carries about 70 to 75 mutations in its spike protein compared to JN.1 and its descendant LP.8.1, the antigens used in the most current COVID-19 vaccine. Lab studies show BA.3.2 evades antibodies more effectively than other circulating variants. The 2025–26 COVID-19 vaccine demonstrated the lowest antibody neutralization against BA.3.2 among seven variants tested. The CDC said real-world vaccine effectiveness data is still needed and that current vaccines continue to protect against the predominant circulating strains.
      • “4. Data from several European countries show BA.3.2 has not rapidly overtaken other strains. Instead, the strain has cocirculated with other JN.1 descendent lineages at 10% to 40% prevalence. Two lab studies also found BA.3.2 had reduced lung cell entry compared with other variants, potentially limiting its ability to become dominant. However, further evolution or seasonal transmission increases could enable broader circulation, the CDC noted.”
  • The American Journal of Managed Care tells us,
    • “AMD [Age related macular degeneration] affected more men than women and was higher in White vs Black individuals; Rhode Island reached ~7214 per 100,000. 
    • “Diabetic retinopathy clustered in Black and Hispanic populations and in southern states, with Mississippi ~3607 per 100,000 and marked male predominance. 
    • “DME [diabetic macular edema] prevalence remained low overall yet disproportionately higher in Black individuals (712 per 100,000) than Hispanic (578) and White (155), supporting targeted screening within diabetes care. 
    • “RVO [retinal vein occlusion] was least prevalent but showed higher rates in White individuals and in Rhode Island; analyses assumed age-related increases, potentially influencing estimates. 
    • “Specialist access and costs were substantial: California had 918 retina specialists vs 3 in Wyoming; annual payer costs were ~$13.4B AMD, $6.2B DR, $4.4B DME, $6.4B RVO.”
  • Cardiovascular Business informs us,
    • “Exercise and using medications to reduce a patient’s cardiovascular risk factors are not associated with significant improvements in cognitive function, according to new findings published in JAMA Neurology. The study’s authors focused on older patients with a family history of dementia and/or self-reported signs of possible cognitive decline. 
    • “Exercise combined with pharmacological management of cardiovascular risk factors is the evidence-based strategy for maintaining cardiovascular health,” wrote first author Rong Zhang, PhD, a researcher with the University of Texas Southwestern Medical Center and Texas Health Presbyterian Hospital Dallas, and colleagues. “However, its effects on cognitive function remain unknown.”
  • “Today’s issue of Research Matters from the National Institutes of Health discusses Treating addiction.”
    • “Alcohol and drug addiction can cause many harms. This Research in Context feature looks at research into the causes of addiction and new ways to treat it.”
  • Per Health Day,
    • “Higher combined consumption of fruits, vegetables, legumes, and potatoes may reduce the risk for Crohn disease (CD), according to a study published in the March issue of the American Journal of Gastroenterology.
    • “Antoine Meyer, M.D., Ph.D., from Université Paris-Saclay in France, and colleagues assessed the risk for developing CD and ulcerative colitis (UC) based on intake of individual fruits, vegetables, legumes, and potatoes. The analysis included 341,519 individuals completing food frequency questionnaires who were followed for a median 13.4 years.”

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

  • Plan Advisor reports,
    • “Rising health care costs are reshaping how employees choose workplace benefits, even when those selections expose workers to significant future financial risk.
    • “Nearly two-thirds of employees reported cost as their top priority during open enrollment, according to Securian Financial’s annual workplace benefits study, “The Affordability Trap: Why Cheaper Choices Cost Employees More.” The focus on cost leads many employees to choose lower-premium plans with higher deductibles; skip supplemental coverage; or scale back voluntary benefits, a pattern identified by the report as an “affordability trap.”
    • “While these decisions may reduce payroll deductions in the short term, the study found they often leave employees vulnerable to sizable out-of-pocket expenses when medical events occur.”
  • Per Healthcare Dive,
    • “Cencora has agreed to acquire EyeSouth Partners’ retina business for $1.1 billion as the drug distributor continues to expand its specialty medical arm.
    • “Once the transaction closes, EyeSouth’s physicians will join Cencora’s management services organization Retina Consultants of America, according to the Monday announcement.
    • “Cencora expects the deal to close after the company’s fiscal year ends on Sept. 30 and be slightly accretive to Cencora’s earnings.”
  • Fierce Healthcare relates,
    • “Highmark posted a $175 million net loss in 2025 as its insurance arm weathered cost pressures that strained the industry nationwide.
    • “The company said Tuesday morning that full-year revenue $32.4 billion, up 11%. Revenues were up across business units, with Highmark Health Plans posting a 12% increase, Allegheny Health Network reporting an 11% increase in revenue and the diversified business unit—which includes United Concordia Dental and its stop-loss business, HM Insurance Group—seeing revenue up 7%.
    • “The insurance division posted a $609 million operating loss in 2025, and executives told reporters during a briefing that the performance of other businesses helped to offset some of that downturn. Allegheny Health Network, the company’s provider arm, posted $90 million in operating income, up from $237 million in 2024.”
    • “We are not immune to the strong headwinds experienced across the entire insurance industry,” Carl Daley, Highmark’s chief financial officer, said during the briefing. “About half of the industry has had credit ratings or outlooks downgraded, including some of the largest players.”
  • BioPharma Dive tells us,
    • “Gilead Sciences will acquire autoimmune drugmaker Ouro Medicines, the companies said Monday afternoon, spending nearly $1.7 billion on the young startup and a T cell engager it licensed from a Chinese biotechnology firm.
    • “Ouro launched in early 2025, backed by GSK and Monograph Capital. Its bispecific antibody, called OM336 or gamgertamig, is designed to bind to a pair of immune cell proteins, BCMA and CD3, that have been popular targets for drugmakers.
    • “Many bispecific antibodies have been approved for cancers, but over the past decade, a flurry of research has shown these treatments hold promise in autoimmune diseases as well. The multipronged drugs eliminate B cells much like cell therapies, but cost less to manufacture, don’t require harsh chemotherapy conditioning and can be dosed multiple times.”
  • Fierce Pharma informs us,
    • “UCB plans to build a $2 billion manufacturing facility near its U.S. headquarters in Atlanta, Georgia. It will become the first plant in the U.S. for the Belgium-based company and will produce biologics.  
    • “The 460,000-square-foot factory will sit on a 79-acre plot of land in the Rowen innovation district, a mixed-use development designed to attract corporate investment. The project is modeled after North Carolina’s Research Triangle Park (RTP). 
    • “Officials from Gwinnett County signed off on UCB’s application on Tuesday afternoon. It becomes the largest investment a company has made in county history, according to the Atlanta Journal-Constitution. The site is near Dacula, Georgia, which is 35 miles northeast of downtown Atlanta. UCB’s U.S. headquarters is in Smyrna, which is in Atlanta’s northwest suburbs, about 45 minutes away.”
  • The Wall Street Journal lets us know,
    • “Finance chiefs once questioned the returns on investing in artificial intelligence. Those days are gone.
    • “Speaking at The Wall Street Journal’s CFO Council Summit in Palo Alto, Calif., finance chiefs from the tech, retail and financial services sectors said their companies are seeing big gains in efficiency and productivity—in some cases worth millions of dollars—from their investments in generative AI. Nudging employees to embrace AI also has yielded new ideas about how to accomplish time-consuming tasks, CFOs said.
    • “Finance chiefs say they are playing a leading role in their company’s AI transformation efforts, evaluating performance, pushing for productivity gains and clearly articulating the value to reluctant employees.”

Holiday Weekend Update

David Ermer–Congress, Medical / Rx research, Medicare, Obesity, SCOTUS, U.S. Healthcare–

Happy Presidents’s Day!

  • Congress is on recess this week unless a bipartisan settlement over the issues causing the Department of Homeland Security shutdown is reached midweek.
  • On Friday February 20, 2026, the U.S. Supreme Court may announce opinions, which are posted on the homepage after announcement from the Bench.
  • STAT News reports,
    • “The Medicare Advantage program continues to bring in more older adults and people with disabilities, but not nearly at the same rates from just a few years ago.
    • “Almost 35.5 million people were enrolled in a Medicare Advantage plan as of Feb. 1, up roughly 3% from 34.4 million at the same time in 2025, according to new federal data analyzed by STAT. The growth during Medicare’s annual enrollment window, which runs from Oct. 15 through Dec. 7, stagnated — with enrollment increasing just 1%.
    • “By comparison, annual enrollment growth in Medicare Advantage ranged between 7% and 10% between 2017 and 2024, according to historical data analysis by STAT.”
  • Federal News Network interviews Jonathan Smith, the new President of the American Postal Workers Union. “Smith started his leadership role last November. He’s been a member of APWU since 1988, and previously served as president of APWU’s largest local, the New York Metro Area Postal Union.”

From the public health and medical / Rx research front,

  • Insurance News Net reports,
    • “According to MetLife research, less than half of America’s workforce is holistically healthy, as employees battle rising costs and employers balance investing in benefits with broader cost-cutting measures. These early findings from MetLife’s 2026 U.S. Employee Benefit Trends Study (EBTS) underscore the challenge of sustaining workforce well-being and engagement in an environment in which employees and employers are financially strained, the report said.
    • “MetLife’s EBTS defines holistic health as a combination of physical, mental, financial and social health.
    • “Highlights of the study include:
      • “83% of employees said that rising living expenses and medical costs are their top stressors and 77% said that economic uncertainty is a major concern.
      • “On average, employees miss 6.1 days of work because of health-related issues and 50% of key employees often avoid seeking medical care because of out-of-pocket costs.
      • “Employers cited “controlling health care costs” as the #1 benefits objective. This surpasses productivity, loyalty, and attracts new talent for the first time since 2022.
      • “60% of employers increased their investment in benefits and 62% expanded their non-medical offerings.
      • ‘As overall workforce well-being has stalled, with just 44% of employees report feeling holistic healthy and engagement, loyalty and productivity remain flat.”
  • NBC News relates,
    • “The recent death of the 48-year-old actor James Van Der Beek is again highlighting how colorectal cancer is increasingly killing younger people.”
    • “Overall, cancer death rates in people younger than 50 have dropped by 44% since 1990. But after increasing for decades, colorectal cancer is now the leading cause of cancer death in people under 50. Colorectal cancer starts either in the colon or rectum. 
    • “Overall, cancer death rates in people younger than 50 have dropped by 44% since 1990. But after increasing for decades, colorectal cancer is now the leading cause of cancer death in people under 50. Colorectal cancer starts either in the colon or rectum. 
    • “Federal cancer screening guidelines and the American Cancer Society recommend that people who have an average risk for colorectal cancer should begin screening at age 45 with a colonoscopy every 10 years, or a stool test every one to three years. Insurance companies use the guidelines to determine whether the screening is covered.” * * *
    • “It’s clear that colorectal cancer rates are rising among young people, but the cause is still poorly understood.
    • “Research suggests that rising rates of obesity and declining physical activity, changes in the gut microbiome and diets high in ultraprocessed foods, which have become more common since the 1980s, are largely to blame. Some early research has also suggested that antibiotic use and having certain bacteria in the gut could also play a role. 
    • Dr. Andrew Chan, a gastroenterologist and chief of the clinical and translational epidemiology unit at Mass General Brigham in Boston “said that while screening is important, people should also focus on improving their diet and getting enough exercise, two lifestyle factors that have been shown to significantly reduce a person’s risk of colorectal cancer. 
    • “Those types of interventions will hopefully have benefits that extend beyond screening,” he said. “Screening is important, but I don’t want us to ignore those other factors.”
  • The American Medical Association lets us know “what doctors wish patients knew about stress management.”
    • “Whether it is using a stress ball or practicing yoga, stress relief is key. Brian Chaney, MD, of Baptist Health, offers tips for relief from stress.”
  • Per MedPage Today,
    • “Lifelong intellectual activity, such as reading or museum visits, was tied to lower Alzheimer’s dementia risk in older adults.
    • “Adults with the highest level of cognitive enrichment developed mild cognitive impairment about 7 years later than others.
    • “Results persisted even after adjusting for Alzheimer’s pathology, suggesting strong cognitive resilience.”
  • and
    • “Adherence to one of five healthy diets was tied to lower mortality risk and added up to 3 years to lifespan.
    • “Associations remained robust regardless of genetic predisposition for longevity.
    • “Diet focused on reducing diabetes risk showed the strongest link with lower death risk.”
  • Cardiovascular Business tells us,
    • “Childhood obesity is associated with a significant risk of vascular damage, according to a new study of children between the ages of six and 11 years old. Researchers hope these findings make it clear just how important it is to prevent childhood obesity and encourage young children—with help from their families—to make healthy eating choices.
    • ‘The new analysis, published in the International Journal of Obesity, focused on 113 children who were categorized as either having a healthy weight or being overweight/obese. Each child was assessed using peripheral arterial tonometry. Overall, overweight and obese children performed worse on the reactive hyperemia index, a measurement of endothelial function. These children also had higher TNF-alpha gene expression and elevated levels of endothelial microparticles, which are both signs of vascular inflammation. Such inflammation has a long-term impact on the body, causing immune cells to age prematurely and doing permanent damage.
    • “The results of the study reinforce the seriousness of childhood obesity, showing that it needs to be reversed early on. We also warn about the need for public policies to reduce obesity in childhood, especially in socioeconomically vulnerable populations,” senior author Maria do Carmo Pinho Franco, a professor at the Federal University of São Paulo in Brazil, said in a statement.”

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

  • Modern Healthcare reports,
    • “Humana completed its acquisition of the primary care clinic operator MaxHealth from private equity firm Arsenal Capital Partners.
    • “The deal adds 54 primary care clinics, four specialty sites and 24 affiliated facilities to Humana’s CenterWell healthcare services arm.
    • “The companies did not disclose financial details of the acquisition, and Humana declined to comment.
    • “Related: Humana is said to be near $1B deal for MaxHealth
    • “Tampa, Florida-headquartered MaxHealth counts more than 120,000 Medicare and Medicaid patients as customers, according to a Friday news release.”
  • Cardiovasular Business informs us,
    • “Boston Scientific has agreed to acquire Penumbra, a California-based medtech company focused on vascular technologies, for approximately $14.5 billion. This is a cash and stock transaction that values Penumbra at $374 per share.
    • “Penumbra is known for its mechanical thrombectomy devices, including those used to perform peripheral vascular disease treatments, and a variety of offerings in the neurovascular space. The company, founded in 2004, currently has more than 4,500 employees and expects its 2025 revenue to total approximately $1.4 billion. That figure represents growth of more than 17% compared to the previous year. 
    • “Penumbra is a well-established company with an experienced, high-performing team and this acquisition offers Boston Scientific an opportunity to enter new, fast-growing segments within the vascular space,” Mike Mahoney, chairman and CEO of Boston Scientific, said in a prepared statement. “I’m thrilled to combine the talents and shared values of our teams—including welcoming Penumbra’s chairman and chief executive officer, Adam Elsesser, to our board of directors upon close. The addition of Penumbra can expand access for these novel technologies to more patients and customers around the world, further enhancing our revenue and margins over time with proven offerings that have a history of growth and innovation.”
  • The Wall Street Journal discusses the signficance of the movement towards direct to consumer sales of GLP-1 drugs.
    • “Ro, a competitor to Hims, points to a different path. Rather than leaning on legally murky, high-margin compounded drugs, Ro acts as a telehealth gateway for branded medications. Ro also sold compounded GLP-1s during the shortages, but both Eli Lillyand Novo Nordisk now sell their drugs on the platform. As CEO Zach Reitano explains: “Too many problems in our healthcare system exist because the patient does not control the flow of money at the point of purchase,” he says. “When they do, the system rewires itself.”
  • Beckers Hospital Review ranks physicians assistants’ pay by State.
    • “Compensation for physician assistants varies widely by state, with California reporting the highest mean PA income in 2024 at $151,351, according to the National Commission on Certification of Physician Assistants’ 2024 Statistical Profile of Board Certified PAs by State.
    • “Nationally, the mean PA income was $129,291.
    • ‘The data, released Feb. 12, reflect responses from PAs who were board certified as of Dec. 31, 2024. Income figures are based on PAs’ state of residence and reflect total income from all PA positions combined for the most recent calendar year reported by respondents. Midpoints of income ranges were used to calculate mean and median values.”
  • MedCity News observes,
    • “Health informatics leaders at NYU Langone Health think fully autonomous clinical AI is coming in the next five years or so, with algorithms soon able to manage routine tasks like blood pressure medication titration and diabetic retinopathy screening without human oversight. They argue automation is not just about efficiency, but also a practical and necessary solution to workforce shortages and system inefficiencies.”

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

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.”

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.” 

Monday Report

David Ermer–CMS, Medical / Rx research, No Surprises Act, OPM, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Dec. 29 announced $50 billion in funds awarded to all 50 states through the Rural Health Transformation Program. Beginning in 2026, states will receive first-year awards averaging $200 million to expand access to care, bolster the rural workforce, modernize facilities and technology, and support innovative payment and care delivery models. 
    • “Funds will be allocated over the next five years, with $10 billion available each year through 2030. Fifty percent of the funding is distributed equally among all approved states, while the additional 50% is allocated based on rural health needs and proposed impact.” 
  • Federal News Network informs us,
    • “Probationary federal employees are on track to see more restrictions when appealing any future terminations, according to a new proposal from the Trump administration.
    • “Under new proposed regulations from the Office of Personnel Management, fired probationary employees would only be able to appeal their termination if they believe it was due to discrimination based on “partisan political reasons” or “marital status” — or if their agency diverged from standard termination procedures.
    • “These limited grounds of appeal for probationary terminations reflect the historical principle that probationary periods serve as a critical evaluation phase for new federal employees, and thus that agencies should enjoy great flexibility in separating employees serving probationary or trial periods,” OPM wrote in its proposal, which is scheduled to be published Tuesday on the Federal Register.
    • “Generally, OPM’s regulations seek to alter both the latitude and method for probationary federal employees to appeal an agency’s decision to fire them. Along with limiting options for appeal, the proposal would put OPM in charge of adjudicating employees’ cases, rather than the Merit Systems Protection Board.”

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge issued a preliminary injunction against a new government pilot set to significantly shift how certain health-care providers access steeply discounted medicines from drugmakers, halting the program from going into effect Jan. 1, 2026.
    • “Judge Lance E. Walker of the US District Court for the District of Maine ruled Monday that hospital groups suing the US Department of Health and Human Services over its new 340B Rebate Model Pilot Program demonstrated they’ll suffer irreparable harm in order for the court to grant a temporary block on the plan.
    • “The order hands a win to the American Hospital Association, the Maine Hospital Association, and other safety-net health systems that sued the government Dec. 1, alleging violations of the Administrative Procedure Act because the health department ignored comments about shifting the program to a rebate model.”
  • and
    • “A series of class actions over the exclusion of coverage for GLP-1 weight loss drugs is testing several legal strategies against how health insurance plans decide which drugs to cover and why.
    • “The cases target health insurance giants CareFirst BlueCross BlueShield, CVS Caremark, the Cigna Group, and Elevance Health Inc., alleging they and their pharmacy benefit managers breached their fiduciary duties under the Employee Retirement Income Security Act by discriminating against people with obesity and illegally denying coverage for Eli Lilly & Co.’s Zepbound, the only drug approved for sleep apnea.
    • “The lawsuits highlight the broadening dilemma that insurers and employers face in deciding whether to cover the blockbuster shots, as their popularity surges and lower cash prices come available to consumers outside of health plans. But pressure for coverage is likely to increase as the list of conditions the drugs are approved for continues to grow and as a newly approved pill is poised to increase demand.
    • “There’s more policy momentum to scrutinize exactly these kinds of PBM practices on the whole,” said Elizabeth McCuskey, a health law professor at Boston University. “So I think this adds a little fuel to that fire.”
  • The Proskauer law firm adds,
    • “In another development in the ongoing litigation over the enforceability of Independent Dispute Resolution (“IDR”) awards issued under the No Surprises Act (“NSA”), two air ambulance providers, Guardian Flight LLC and Med‑Trans Corporation, have filed a petition for writ of certiorari with the U.S. Supreme Court, seeking review of the Fifth Circuit’s decision holding that the NSA provides no private right of action to enforce IDR awards.  The petition asks the Court to decide a key question that has divided federal courts across the country: whether the NSA permits providers to bring private causes of action to enforce IDR awards in court.  Should the Supreme Court grant cert, the outcome of the case could have broad implications for the enforceability of NSA arbitration awards, a key feature of the NSA’s regulatory framework.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “An NBC News/Stanford University investigation has found widespread declines in kindergarten vaccination against tetanus. In states that provided data back to 2019, more than 75% of counties and jurisdictions across the U.S. have seen downward trends in young children getting the diphtheria-tetanus-pertussis (DTaP) series of shots. The vaccine is first given to babies at 2 months.
    • “Because tetanus isn’t spread from person to person, there isn’t a herd immunity threshold, but reductions in vaccination rates leave more people vulnerable to the disease.”
  • The American Medical Association lets us know what doctors wish their patients knew about Wilson disease.
    • “Wilson disease is a rare genetic condition that causes copper to build up in the body, often damaging the liver, brain and other organs before symptoms are recognized. Early signs of the condition—also called Wilson’s disease and named for the British neurologist who described it in 1912—can be subtle or mistaken for more common conditions. Because of that, many people live with the disorder for years before receiving the diagnosis that can change the course of their health.”
  • The Washington Post relates,
    • “University of Pennsylvania researcher Ran Barzilay is a father of three. His first two children received cellphones before they turned 12. But this summer, as early results from his own study on screens and teen health rolled in, he changed course. His youngest? Not getting one anytime soon.
    • “Barzilay’s analysis of more than 10,500 children across 21 U.S. sites found that those who received phones at age 12, compared with age 13, had a more than 60 percent higher risk of poor sleep and a more than 40 percent higher risk of obesity.
    • “This is not something you can ignore for sure,” said Barzilay, a professor of psychiatry and a child-adolescent psychiatrist at the Children’s Hospital of Philadelphia.”
  • Medscape considers whether “Relative Fat Can Replace Mass BMI in Assessing Obesity?”
    • “Developed and validated in 2018 using data from the National Health and Nutrition Examination Survey (NHANES), RFM is a sex-specific anthropometric measure of obesity that estimates body fat percentage based on height and waist circumference using the following formula:
      • “RFM = 64 − (20 × height/waist circumference) + (12 x sex [0 for males and 1 for females])
    • “This simple calculation incorporates waist circumference as a proxy of visceral body fat while accounting for sex-based differences in fat mass. Multiple studies have shown RFM to be a superior and more consistent predictor of cardiometabolic risk and mortality. 
    • “Obesity cutoffs were derived from NHANES (1999-2014) data linking RFM with all-cause mortality. After adjusting for age, BMI category, ethnicity, education, and smoking status, this analysis suggested that higher RFM was associated with substantially increased mortality risk. Women with an RFM of ≥ 40% (40% body fat) and men with an RFM of ≥ 30% (30% body fat) had a 50% higher risk of death compared with women with an RFM of ≤ 35% and men with an RFM of ≤ 25%. Additionally, women with an RFM of ≥ 45% had nearly double the risk of death, whereas men with an RFM of ≥ 35% had more than 2.5 times the risk of death.”
  • The Wall Street Journal tells us,
    • “It’s the leading cause of disability and one of the most costly health challenges of our time: chronic lower back pain.
    • “Yet effective and safe treatments are few and far between, leading patients to try everything from supplements to acupuncture to cannabis for relief.
    • “Now, two new studies provide some of the most comprehensive evidence yet that THC—the psychoactive compound in cannabis that creates the high—in combination with other parts of the cannabis plant may provide safe and effective relief. The two large, Phase 3 clinical trials demonstrated that the THC product is safe and more effective at reducing chronic lower back pain than placebo or opioids.
    • “Unfortunately, the news, while promising, won’t provide immediate relief for the more than 70 million U.S. adults who suffer from chronic lower back pain. The product tested is expected to be available in parts of Europe next year, while the path to approval in the U.S. will require another clinical trial.”
  • Beckers Hospital Review identifies “eight recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

From the U.S. healthcare business front,

  • The American Medical Association reports,
    • “Physicians continue to use telehealth at far higher levels than they did before the COVID-19 public health emergency, but an AMA report shows that the practice setting in which a physician delivers care can influence how often they use the technology.
    • “Overall, 71.4% of physicians reported using telehealth in 2024. That figure is far higher than the 25.1% of physicians who used it prior to the COVID-19 public health emergency in 2018, though it is down from the 79% of doctors using telehealth in 2020, according to the AMA Policy Research Perspectives report, “Patient-Facing Telehealth: Use Is Higher Than Pre-Pandemic But With Great Variation Across Physician Specialties” (PDF).
    • “Among the physicians surveyed in 2024, here is how many said their practices used telehealth for these services:
      • “52.5%—managed patients with chronic disease.
      • “48.5%—diagnosed or treated patients.
      • “40.3%—provided care to patients with acute disease.
      • “25%—provided preventive care.
    • “However, the ownership of the practice a physician was a part of appeared to have an impact on those numbers. Physicians in hospital-owned practices were more likely to report using telehealth than physicians who were part of a private practice.”  
  • Beckers Hospital Review informs us,
    • “Chesterfield, Mo.-based Mercy Health recorded an operating income of $70.2 million (2.6% operating margin) in the first quarter of fiscal 2026, up from an operating loss of $7.5 million (-0.3% margin) during the same period last year. 
    • “Mercy reported total operating revenue of $2.7 billion for the three months ended Sept. 30, up from $2.5 billion during the same period last year. Patient service revenue totaled $2.4 billion, up from $2.2 billion. Capitation revenue was $150.5 million, up from $141.3 million.”
  • and
    • “Seven hundred fifty-six rural U.S. hospitals are at risk of closure due to financial problems, with more than 40% of those hospitals at immediate risk of closure.
    • “The counts are drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through December 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure.” 
  • Fierce Pharma points out,
    • “Following a feud with activist investor Deep Track Capital in the first half of 2025, vaccine developer Dynavax Technologies has rounded out the year by agreeing to sell itself to France’s Sanofi.
    • “To get its hands on the Emeryville, California-based company and its approved adult hepatitis B vaccine Heplisav-B, Sanofi will pay $15.50 per Dynavax share in cash, which works out to a total deal value of roughly $2.2 billion, the French pharma said in a Dec. 24 press release.
    • “The acquisition, which is expected to close in 2026’s first quarter, also grants Sanofi access to Dynavax’s promising shingles prophylactic Z-1018, which is currently in phase 1/2 testing and could eventually challenge GSK’s incumbent shot Shingrix, if approved.”

In notable death news,

  • The Wall Street Journal reports,
    • “Joel F. Habener, a Harvard University academic whose research paved the way for revolutionary weight-loss drugs Ozempic, Mounjaro and others, which analysts forecast will be the biggest blockbusters in pharmaceutical history, died Sunday in Newton, Mass. He was 88.
    • “Eileen Martin, a friend of Habener’s, said he died peacefully at home. She didn’t give a cause.
    • “Habener led research that discovered a hormone dubbed GLP-1. The hormone regulates blood sugar levels and would later become the key ingredient in Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro—drugs that proved a major advance in diabetes treatment and so effective at regulating appetite that people who take them have called them miracle cures for obesity. Others taking the drugs say they cure addictions to nicotine, alcohol and gambling.”
  • RIP 

Monday report

David Ermer–ACA, Congress, FDA, Medical / Rx research, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Per a Senate news release,
    • “U.S. Senators Mike Crapo (R-Idaho), chair of the Senate Finance Committee, and Bill Cassidy, M.D. (R-Louisiana), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, unveiled the Health Care Freedom for Patients Act, historic Republican legislation to lower health care costs and give money directly to families to control their own care. This bill is an alternative to Democrats’ temporary COVID bonuses, which send billions of tax dollars to giant insurance companies without lowering insurance premiums.
    • “Giving billions of taxpayer dollars to insurers is not working to reduce health insurance premiums for patients,” said Senator Crapo. “We need to give Americans more control over their own health care decisions. This bill builds on the work we did in the Working Families Tax Cuts Act and will help Americans manage the rising cost of health care without driving costs even higher.”
    • “Instead of 100 percent of this money going to insurance companies, let’s give it to patients. By giving them an account that they control, we give them the power. We make health care affordable again,” said Dr. Cassidy.
    • “This legislation:
      • “Sends money to patients, not giant insurance companies;
        • “Americans on affordable bronze and catastrophic plans would access these dollars in a Health Savings Account (HSA).
        • “These funds cannot be used for abortion or dangerous gender transitions.
      • “Lowers insurance premiums by funding cost-sharing reduction (CSR) payments [beginning in 2027};
      • “Empowers Americans to choose the insurance plan that fits their needs by increasing access to low-cost catastrophic plans;
      • “Prevents illegal immigrants from accessing Medicaid by requiring states to verify citizenship and immigration status before coverage; and
      • “Stops taxpayer dollars from funding gender transition services under Medicaid and excludes them as an essential health benefit for plans sold on the Obamacare exchanges.” * * *
    • Click here for a one-pager.
    • Click here for bill text.
  • MedPage Today reports,
    • “Members of the Medicare Payment Advisory Commission (MedPAC) generally responded favorably Thursday to a draft recommendation to increase reimbursement in 2027 for physicians who treat Medicare patients — with one exception.
    • “The MedPAC chairman’s draft recommendation was to “increase payment rates for physician and other health professional services by 0.5 percentage points more than current law.” However, commission member Brian Miller, MD, MPH, of Johns Hopkins University in Baltimore, pointed out that last year, “[MedPAC’s recommended] physician fee schedule update … was a net update of 3%.”
  • Govexec tells us,
    • “The Trump administration laid out its plans to “end weaponized government” in its new management agenda released Monday. 
    • “The latest President’s Management Agenda includes goals to eliminate “woke” programs, downsize the government workforce and real estate portfolio, implement workforce reforms and modernize government technology, as well as targets to “annihilate government censorship of speech” and centralize government contracting.
    • “The agenda reflects much of the Trump administration’s longstanding priority to drastically reshape the government, an objective the White House focused on immediately after the inauguration through its Department of Government Efficiency.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  [The manufacturer is Gamida Cell Ltd.]
    • “This approval is revolutionary in the therapeutic landscape and fundamentally changes how we approach treatment for SAA, where earlier treatment has potential to alter one’s life course,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “Severe aplastic anemia is a rare blood disorder that can be fatal, and the FDA remains committed to expanding treatment options for patients with this disease.”  
  • CNN adds,
    • “Medical technology company MED-EL announced Thursday [December 4] that the US Food and Drug Administration has approved expanding the use of its Synchrony cochlear implants to children as young as 7 months who have bilateral profound sensorineural hearing loss. The implants were previously indicated for 9 months and older.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court seemed poised Monday to expand the president’s power to fire the heads of many regulatory agencies, even as one pivotal justice expressed a desire to insulate the Federal Reserve from political pressure.
    • “During 2½ hours of oral arguments, the justices probed the limits of President Trump’s assertion of virtually unfettered authority to remove agency leaders, despite federal laws that protect them from being fired over policy disagreements.
    • “Justice Brett Kavanaugh pointedly asked Solicitor General D. John Sauer about concerns from economists that a broad victory for Trump in the case would jeopardize the independence of the Fed’s board of governors.
    • “I share those concerns,” said Kavanaugh, a Trump appointee.
    • “Still, Kavanaugh and the other five conservative justices were, as expected, mostly receptive to the administration’s argument that the president is entitled to more control over dozens of regulatory bodies in the executive branch, such as the Federal Trade Commission and the National Labor Relations Board.”
  • The Supreme Court is expected to announce its decision toward the end of the current term in June 2026.

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Brayan Garcia was driving along a highway in his red Toyota Corolla when he slammed into the back of a Ram pickup truck that was stopping at an intersection in West Texas.
    • “Garcia, 22, died at the scene of the early morning crash. His Corolla sustained heavy damage, its hood ripped off entirely. Debris was scattered across several lanes. But despite hitting the truck directly, the Corolla’s air bags never went off.
    • “Toyota had recalled Garcia’s car in 2020 over a dangerous defect that could stop its air bags from deploying. But Garcia’s vehicle hadn’t gotten the fix, like millions of others currently on the road. 
    • “From 2015 to 2024, about 12 million vehicles were recalled for safety defects that could result in air bags not deploying. These recalls—37 in total—included models made by General Motors and Ford as well as luxury brands such as Mercedes-Benz and Audi. 
    • “About 2.6 million, or around 22%, of affected vehicles remain unfixed, according to an analysis of the latest National Highway Traffic Safety Administration data by The Wall Street Journal.
    • “The Journal found 12 people, including Garcia, who died after crashes in Toyotas and other vehicles where the air bag was under recall, hadn’t been repaired and didn’t deploy. 
    • “The NHTSA data reveal a broader problem: Roughly one in three cars recalled for all reasons goes unfixed. The rate is roughly the same even for serious flaws such as failing brakes, engine fires or the air bag defects reviewed by the Journal.”
  • The New York Times relates,
    • “The statistics are incontrovertible: Since 1992, the diagnoses of eight cancers has doubled in the United States in patients under age 50, including cancers in the thyroid, anus, kidney, small intestine, colorectum, endometrium and pancreas, as well as the blood cancer myeloma. Other types, including breast cancer, also are on the rise.
    • “The magnitude and speed at which early onset cancer incidence has increased is unlike most cancer trends ever observed (the possible exception being cigarette smoking and lung cancer),” the American Association for Cancer Research said in its announcement of a special conference being held this week that will explore the rise in cancers among younger people.
    • “The sharp uptick has been agonizing for these younger patients and many of their doctors.
    • ‘The patients wonder: Why did I develop cancer? And how will my life be transformed by potentially excruciating treatments?
    • “Their doctors share these questions, and some have additional concerns: What if these cancers had never been detected? Are doctors offering treatments to younger patients with early-stage diseases that may do as much harm as good?”
  • The Washington Post tells us,
    • “Children who returned to in-person schooling during the coronavirus pandemic saw improvements in their mental health, according to a new study that found school reopenings were associated with significant declines in diagnoses of anxiety, depression and other conditions.
    • “The findings, the study authors say, underscore that the social structure and support schools provide protected children’s mental well-being during the pandemic.
    • “Researchers from the Harvard T.H. Chan School of Public Health and Elevance Health, which is a private health insurer in California, analyzed medical claims for more than 185,000 California children ages 5 to 18 between March 2020 to June 2021. Before schools reopened about 5,200 children had a mental health diagnosis and that numbers rose to 6,500 over the course of the pandemic.
    • “But the researchers said after schools reopened, trends in mental health diagnoses, medications and spending dropped relative to trends in schools that stayed closed.”
  • Health Day informs us,
    • “The U.S. stillbirth rate dropped slightly last year, offering some hope after several years of uncertainty, according to new data from the U.S. Centers for Disease Control and Prevention (CDC).
    • “The report, released Dec. 3, found a 2% decline in stillbirths in 2024. Even with that improvement, nearly 20,000 pregnancies ended in fetal death. That’s equal to about 5.4 stillbirths for every 1,000 pregnancies lasting 20 weeks or longer.
    • “This is the lowest national rate seen in decades, although the CDC said that it does not necessarily break previous records.”
  • The American Medical Association lets us know “What doctors wish patients knew about strep throat.
    • “What is causing that sore throat? It could be strep, and it needs to be treated the right way. Two Ochsner Health physicians share more about strep throat.”
  • Per Healio,
    • “In an analysis adjusted for tobacco cigarette use, the likelihood for asthma and COPD significantly rose with daily cannabis inhalation over a 30-day period, according to results published in Journal of General Internal Medicine.
    • “I hope these results give clinicians more confidence in stating that there are serious concerns about negative health impacts of inhaling cannabis on the lungs,” Alison S. Rustagi, MD, PhD, adjunct assistant professor at University of California, San Francisco, told Healio.
    • “We don’t have enough information now to say there’s a causal link, but we also have reason to think that there may be harm to the lungs from cannabis,” she continued. “This is important for patients to know as they make health decisions.”
  • From the American Society of Hematology conference, now underway in Orlando, Florida,
    • Per BioPharma Dive,
      • “An experimental drug from Terns Pharmaceuticals is showing it may emerge as a threat to multiple established medicines for a slow-growing blood malignancy known as chronic myeloid leukemia. 
      • “According to results presented at the American Society of Hematology meeting on Monday, Terns’ drug, codenamed TERN-701, helped a majority of study participants with CML who had received previous treatments significantly reduce the number of diseased white blood cells in their bloodstream. The findings suggest the drug, a type of targeted, oral treatment, may eventually be competitive with widely used medicines like Novartis’ Scemblix, which is expected to generate more than $4 billion in peak yearly sales.”
    •  and
      • Eli Lilly was the last company to bring to market a so-called BTK inhibitor for leukemia and lymphoma. But study results revealed Sunday show Lilly’s medicine may be more effective — and potentially safer — than the oldest drug in its class. 
      • The data come from a study testing Lilly’s Jaypirca directly against AbbVie and Johnson & Johnson’s Imbruvica. Early results presented at the American Society of Hematology meeting suggest Jaypirca helped induce responses in more people with chronic lymphocytic leukemia or small lymphocytic lymphoma than Imbruvica. More definitive measures of impact — such as effects on disease progression and survival — are pointing in Jaypirca’s favor as well, though additional follow-up testing is needed to confirm those benefits.
      • “The results could be crucial in helping Lilly boost sales of Jaypirca as Imbruvica, which was launched in 2013 and has since been a regular blockbuster, approaches the end of its patent life.”
    • Per STAT News,
      • “With so-called menin inhibitors now approved for patients with certain types of advanced acute myeloid leukemia, research efforts are shifting to find uses for the genetically targeted drugs in newly diagnosed patients.
      • “Kura Oncology presented preliminary results today from a study that combines Komzifti, its menin-blocker, with two standard AML treatments. In an analysis that encompassed 40 patients with newly diagnosed, menin-susceptible AML, the triplet regimen showed a complete remission rate of 86% with a manageable safety profile.
      • “Syndax Pharma reported results from its own menin-inhibitor combination study in newly diagnosed AML patients on Saturday at the ASH meeting.”
  • Per Fierce Pharma,
    • “UCB plans to file for regulatory approval of Fintepla to treat a third epileptic condition “as soon as possible,” the company said, as it reported results of a phase 3 trial in patients with the ultra-rare cyclin-dependent kinase-like-5 (CDKL5) deficiency disorder.
    • “The study of 87 patients aged 1 to 35 with CDKL5 achieved its primary endpoint, as Fintepla demonstrated a statistically significant reduction in seizures compared with placebo. The trial also achieved two of its three secondary objectives, the Brussels-based company said at the American Epilepsy Society (AES) conference in Atlanta.
    • “Fintepla was first approved in 2020 to treat seizures associated with Dravet syndrome (DS), a rare, severe form of epilepsy that affects roughly 20,000 in the U.S. Two years later, Fintepla gained expansion into a larger epilepsy indication, Lennox-Gastaut syndrome (LGS), which affects approximately 48,000 in the U.S. In both indications, the cherry-flavored oral solution is cleared for patients age 2 and older.”
  • Per a National Institutes of Health news release,
    • “A study funded in part by the National Institutes of Health (NIH) has revealed important insights into the genetics of deposits in the eye, known as reticular pseudodrusen (RPD), that are linked to greater risk of vision loss among people with age-related macular degeneration (AMD). The study underscores that AMD is not one disease and highlights the need for novel treatment approaches.
    • “This study could help explain why drugs that target just the complement pathway have shown a minimal effect in slowing geographic atrophy,” said Anand Swaroop, Ph.D., chief of the Neurobiology Neurodegeneration and Repair Laboratory at NIH’s National Eye Institute (NEI) and a coauthor of the study report. “It’s clear that AMD involves multiple pathways that differentially synergize to generate distinct phenotypes.”
  • Per the Genetic Engineering and Biotechnology News,
    • “Terray Therapeutics has achieved its first discovery milestone in the company’s multi-target collaboration with Bristol Myers Squibb (BMS). Under the terms of the agreement, which began in 2023, Terray will discover and develop small molecule compounds against a set of targets nominated by BMS. BMS will subsequently assume responsibility for development and commercialization. 
    • “While therapeutic details of the milestone have not been disclosed, Terray describes the target as “novel and difficult to drug,” and representative of the company’s Experimentation Meets Machine Intelligence (EMMI) platform.”  
  • Beckers Hospital Review calls attention to “23 recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

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

  • Modern Healthcare unveiled its 2025 list of the top 100 most influential people in healthcare. Here are the top five:
    • 1. Sam Altman, co-founder and CEO, OpenAI
    • 2. Greg Adams, Chair and CEO, Kaiser Permanente
    • 3. Judy Faulkner, founder and CEO, EPIC Systems
    • 4. Stephen Hemsley, Chair and CEO, UnitedHealth Group
    • 5. Eugene Woods, CEO, Advocate Health
  • STAT News reports,
    • “Health insurance companies have lamented fast-rising medical expenses for more than two years. This year is no different as Americans continue to get more carethan insurers expected. 
    • “One of the main culprits of that higher spending: prescription drugs, and GLP-1s in particular.
    • “Some insurers spent more on drugs in the first nine months of this year than they did in all of 2024, financial documents analyzed by STAT show. For many, drug expenses are up more than 20% in 2025. The proliferation of GLP-1s — the injectable drug blockbusters that lead to substantial weight loss — has played a leading role and has led insurers and employers to consider whether they should stop covering them completely.” * * *
    • “Cynthia Cox, a vice president at health policy and research organization KFF who has studied health care spending across all types of health insurance markets, said GLP-1s are pressuring pretty much every insurer. “It’s not all GLP-1s, but I think a lot of the growth is,” she said.” 
  • The Wall Street Journal adds,
    • “Drugmakers are moving to sell their medicines directly to patients, abandoning the middlemen they have long relied on.
    • “The shift is a huge departure from how pharmaceutical companies including Eli Lilly, Novo Nordisk and Pfizer have sold drugs for decades and threatens the multibillion-dollar business of firms that have traditionally filled prescriptions. 
    • “It is saving some patients hundreds of dollars off the cost of prescriptions because companies have been lowering the prices for drugs sold directly. 
    • ‘Meantime, drugmakers who have been rolling out the services in recent months see a big opportunity to boost sales, though they risk losing revenue if they don’t offset lower prices by selling to more patients. 
    • “For the first time, pharma is actually looking end-to-end at the full patient journey,” said Pratap Khedkar, chief executive of pharmaceutical consulting firm ZS. “That is a very different mindset than has been the case for the last 50 years.”  
  • Brown & Brown has made available the 2026 edition of its Employer Health and Benefits Strategy Survey.
  • Fierce Healthcare tells us how “CommonSpirit Health is working to accelerate its recently launched turnaround plan.”
  • Cardiovascular Business points out,
    • “Edwards Lifesciences held its annual investor conference, predicting considerable sales growth in 2026 and highlighting the company’s continued momentum in the area of structural heart disease. Transcatheter aortic valve replacement (TAVR) and transcatheter tricuspid valve replacement (TTVR) are two areas expected to experience significant growth in the year ahead. 
    • “For 2026, Edwards Lifesciences is currently projecting overall sales growth of 8% to 10%  in addition to an adjusted earnings per share of $2.80 to $2.95. TAVR sales are expected to play a major role thanks to the continued success of its Sapien 3 platform and the planned JenaValve acquisition first announced in July 2024. In fact, the company projects TAVR sales to hit anywhere between $4.6 billion and $4.9 billion in 2026, good for a growth rate of 6% to 8%, respectively. Edwards Lifesciences also pointed to progress in the use of TAVR for patients with aortic regurgitation as a crucial step forward for patient care. 
    • “In addition, transcatheter tricuspid and mitral valve technologies are expected to hit sales of $740 million to $780 million, up 35% to 45% compared to 2025. On the tricuspid side of things, the company’s Evoque device for TTVR represents a particularly important piece of the puzzle, with two-year data on the valve expected by the second quarter of 2026.”
  • Beckers Payer Issues informs us,
    • “Elevance Health has rolled out its virtual assistant to 22 million commercial members, with a Medicare expansion planned for 2026.
    • “The tool, accessible through the Sydney Health app and affiliated plan websites, allows members to ask plain-language questions about coverage, costs, and providers. For example, members can inquire whether a surgery is covered and receive personalized cost estimates, a coverage breakdown, and a list of in-network providers, according to a Dec. 5 news release.
    • “The rollout is part of Elevance’s broader AI push across its operations. The company has deployed AI tools for internal workflows, call center automation, and clinical decision-making. The company has said it plans to invest several hundred million dollars in AI and digital initiatives.”