Midweek update

Telehealth

Midweek update

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The White House May 4 released its National Drug Control Strategy, which, among other efforts, recommends effective primary prevention programs. The initiative increases the implementation of evidence-based prevention strategies; establishes new partnerships with organizations supporting youth health and expanding primary prevention; supports a national media and education campaign against drug use; and supports and enhances the federal drug-free workplace program.”
  • The Centers for Medicare and Medicaid Services announced,
    • “The Centers for Medicare & Medicaid Services (CMS) will provide eligible Medicare beneficiaries access to certain GLP-1 medications for $50 per month beginning July 1, 2026, through December 31, 2027.
    • “Under the Medicare GLP-1 Bridge, a time-limited demonstration, CMS is expanding access to innovative, evidence-based weight-loss treatments. Eligible individuals enrolled in Medicare Part D prescription drug plans will be able to access these medications at a predictable and affordable cost—$50 for a monthly supply. This approach reflects CMS’ continued focus on improving access to high-value treatments that support better long-term health outcomes.
    • * * * “Beginning July 1, Medicare beneficiaries with Part D coverage may be eligible to access certain GLP-1 medications at $50 for a monthly supply. Beneficiaries can talk to their doctor to determine whether a GLP-1 medication is right for them. CMS will share additional information for beneficiaries as the program begins.
    • “In addition, CMS continues to work with stakeholders—including providers, pharmacies, and manufacturers—to support implementation and ensure all partners have the information they need ahead of launch. 
    • “The Medicare GLP-1 Bridge builds on CMS’ broader efforts to improve access to innovative therapies and support healthier outcomes for Medicare beneficiaries. For additional “demonstration details, visit: https://www.cms.gov/medicare/coverage/prescription-drug-coverage/medicare-glp-1-bridge
  • U.S. Office of Personnel Management Director Scott Kupor, writing in his Secrets of OPM blog on Substack, optimistically discusses the state of artificial intelligence.
  • Meanwhile, KFF Health News reviews “Regulation of AI in Prior Authorization and Claims Review: A Look at Federal and State Consumer Protections.”

From the Food and Drug Administation front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.  
    • “The agency also consolidated more than 40 disparate application and submission data sources, systems and portals across all FDA centers into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data).The agency began integrating HALO and Elsa so that FDA staff can query data and build workflows without having to manually upload documents within each chat. The HALO consolidation is expected to enable more penetrating deployment of AI capabilities within agency operations. 
    • “Elsa’s new capabilities once again position FDA as a leader in deploying AI tools that empower staff,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Removing tedious burdens for staff enables them to focus more on science and makes their work streams more efficient and enjoyable. We have some of the best scientists in the world and we need to take good care of them.”
  • and
    • The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient. As part of this pilot, which launched in April, the agency is conducting shorter, focused screening assessments to complement standard FDA inspections. 
    • “One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “For the FDA, the ability to conduct shorter, targeted assessments allows for broader surveillance coverage, enabling the agency to assess more facilities and gather critical insights without compromising regulatory rigor. For industry, these assessments can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments.”
    • One-day inspectional assessments also support the development of more robust risk models across FDA programs. Data gathered through these assessments—such as recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations—can be used to better target future oversight activities.
  • MedTech Dive tells us,
    • “The Food and Drug Administration added neurosurgical supplies to its medical device shortages list on Wednesday.
    • “The regulator sent a letter to healthcare providers warning about disruptions in availability of neurosurgical patties, sponges and strip devices, which are used to absorb fluids and protect tissue during surgery.
    • “The FDA attributed the problem to recent supplier issues, noting that Medline Industries recently recalled its neuro sponge products. The agency expects the shortage to continue through the end of the year.”

From the public health and medical / Rx research front,

  • The New York Times explains,
    • “Hantaviruses have most likely been around as long as rodents, but little was known about these pathogens before the 20th century. This rare family of viruses that rodents carry has been cited as the source of a deadly outbreak aboard a cruise ship in the Atlantic Ocean.
    • “The virus is zoonotic, meaning it can be transmitted to humans from animals. And while outbreaks have been rare, it is one of the most widely distributed zoonotic viruses on Earth.
    • “Some are Old World hantaviruses and others are New World hantaviruses,” said Sabra Klein, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health.
    • “Different species of the virus are carried by different rodents,” Dr. Klein said, adding that European strains cause less severe illnesses than those from Asia.
    • She noted that “there’s no vaccine, there’s no cure, there’s no money” in finding a cure “in part because these are so rare.”
  • The Wall Street Journal adds,
    • “Hantavirus is an unlikely source of contagion on a cruise ship. The virus isn’t as infectious between humans as fast-spreading respiratory illnesses like Covid-19 and the flu. 
    • “It belongs to a family of viruses carried by rodents and spread to humans through contact with infected urine, droppings or saliva. Only one strain—the Andes virus—has shown limited evidence of human-to-human transmission. Researchers in South Africa and Switzerland confirmed this week the virus involved in the suspected outbreak is the Andes strain.
    • “Human-to-human transmission of the Andes strain requires very close contact, like sharing food or living quarters, according Steven Bradfute, an immunologist at the University of New Mexico Health Sciences Center whose lab has sequenced hantaviruses. “It doesn’t spread into huge outbreaks,” Bradfute said.
    • “WHO and other health authorities say the threat to public health is low. 
    • “Yet the ship’s passengers are at risk, as well as perhaps people they came into close and extended contact with after leaving the ship. That is why Oceanwide Expeditions, the Hondius’s operator, plus health authorities around the world and airlines, are mobilizing to trace the paths of the ship’s travelers.”
  • Fierce Healthcare reports,
    • “The Leapfrog Group highlighted broad improvements across several patient safety measures in this year’s spring release of hospital safety grades, the first reflecting changes made after a court-ordered removal of hospitals that declined to voluntarily submit information to the watchdog group. 
    • “Top marks were handed out to 917 hospitals, with Leapfrog outlining a particularly high share of “A” hospitals in the states of Connecticut (where 64% of hospitals received an “A”), Virginia (59%), South Carolina (51%), Utah (50%) and Montana (44%). 
    • “A hospital’s assigned grade is calculated by reviewing recent data on up to 22 patient safety measures, including a 10-part Medicare composite of reported patient safety and adverse events. Among these, Leapfrog said it saw “significant improvement” in 17 measures, including those related to healthcare-associated infections and medication safety plus multiple items related to patient experience. 
    • “The good news is that hospitals across the country are making meaningful strides in patient safety and helping save countless lives,” Leah Binder, president and CEO of The Leapfrog Group, said. “But not all hospitals are the same. That’s why it’s so important for people to consult Safety Grades and do their research when choosing a hospital.”
    • “Of note, the latest release excludes 450 hospitals that did not participate in Leapfrog’s 2024 or 2025 surveys.” 
  • Beckers Hospital Review points out the “eleven U.S. hospitals have earned consecutive “A” safety grades from The Leapfrog Group since 2012.” You can see “the list of Leapfrog’s five “F” hospitals here.
  • Pulmonary Advisor notes,
    • “While vaccinations showed protective trends, prior viral infections were generally linked to an increased likelihood of future respiratory illnesses.”
  • Per MedPage Today,
    • “Updated findings from a European randomized trial continued to show that colonoscopy screening significantly reduced colorectal cancer (CRC) incidence, but its impact on CRC mortality was less clear.”
  • Following up on recent Wall Street Journal articles, Cardiology Business relates
    • “Three of the leading U.S. cardiovascular health societies have joined forces for a new statement about the importance of multidisciplinary, patient-centered decision-making when managing patients with severe aortic stenosis (AS).
    • “The Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC) and Society of Thoracic Surgeons (STS) collaborated on the joint statement, calling it a response to “recent media coverage” about transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). The primary focus of the statement appears to a feature story published by The Wall Street Journal on April 23 that included interviews with patients who experienced significant complications after undergoing TAVR. 
    • “The joint statement highlights the fact that multidisciplinary heart teams are at the center of every treatment decision for patients who present with severe AS and require an aortic valve replacement. This has been the case for many years now, but coverage from The Wall Street Journal and other mainstream news outlets is sure to grab the attention of people unfamiliar with how such treatment decisions are made. 
    • “This statement serves as a fresh reminder for the general public that cardiologists and cardiac surgeons do not take these decisions lightly. The cardiology groups said years of hard work and dedication have gone into developing the framework that is now in place.”
  • Per MedTech Dive,
    • “Neptune Medical’s gastrointestinal robot met both of its primary endpoints in a clinical trial assessing the safety and feasibility of the system to perform colonoscopies.
    • “The study followed 50 adults who underwent screening, surveillance or diagnostic colonoscopy with the robotic endoscopy system at a single center in Poland for 14 days after the procedure.
    • “The results, announced Tuesday, showed no adverse events and a 100% rate of cecal intubation, where the endoscope is guided through the entire colon to the beginning of the large intestine.”
  • and
    • “Johnson & Johnson said Tuesday that a study evaluating the investigational Ottava robotic system in gastric bypass surgery met its safety and efficacy endpoints through 30 days. The average weight loss in that time frame was 30 pounds.
    • “Results from the 30-patient study were among the pre-clinical evidence included in J&J’s submission to the Food and Drug Administration, announced in January, for de novo classification of the robot in multiple procedures in the upper abdomen. 
    • “All procedures in the prospective, multicenter study were completed robotically on Ottava without conversion to a non-robotic approach, the company said. There were no adverse events related to the device.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health exceeded first-quarter earnings expectations and raised its full-year adjusted-earnings guidance.
    • “The company reported first-quarter net income of $2.96 billion, driven by a turnaround at its Aetna insurance unit.
    • “Aetna’s medical-loss ratio was 84.6%, below analysts’ projections, but 2027 Medicare rates still fall short.”
  • Modern Healthcare relates,
    • “Humana plans to cut Medicare Advantage supplemental benefits in 2027 in a strategic shift for the insurer.
    • “Medicare Advantage payments are not keeping pace with medical costs, President and CEO Jim Rechtin said.
    • “Medicare Advantage membership was 22.6% higher in the first quarter.
    • “Humana downgraded its annual earnings guidance.”
  • Beckers Payers Issues tells us,
    • “Oscar Health reported a net income of $679 million in the first quarter of 2026, according to a May 6 earnings release. This marked the highest quarterly profit in the company’s history, nearly 2.5 times greater than profit in the first quarter of 2025.
    • “Membership reached roughly 3.2 million members, a 56% year-over-year increase. The company’s medical loss ratio was 70.5%, compared to 75.4% during the same period last year.
    • “Total revenue reached $4.6 billion, up 53% year over year. Earnings from operations were $704.1 million, more than double from the first quarter of 2025.
    • “The company also reaffirmed its 2026 guidance. The strong quarter follows a $443 million net loss in 2025.”
  • Fierce Healthcare informs us,
    • “Hinge Health boosted its full-year revenue outlook by $64 million as the company reported a stronger-than-expected first quarter and kicked off an expansion of its business beyond muscle and joint pain.
    • “The digital musculoskeletal (MSK) care provider, which went public nearly a year ago, brought in first-quarter revenue of $182 million, up 47% year-over-year from $123.8 million in Q1 2025. The company posted first-quarter adjusted earnings of 45 cents per share, significantly exceeding Wall Street analyst estimates of 12 cents per share. Hinge Health’s non-GAAP income from operations jumped 208% to $46.2 million compared to non-GAAP income from operations of $15 million during the same quarter a year ago.
    • “The company’s results easily topped Wall Street analyst estimates, with a revenue target of $172 million for the quarter and a Street estimate of $31.2 million for operating income.”
  • and
    • “Amwell, the telehealth platform formerly known as American Well, brought in $54.9 million in first-quarter revenue, down approximately 18% the same period a year ago, as executives discussed artificial intelligence and key contract renewals with investors on Tuesday.
    • “The company is shifting towards subscription revenue, and in Q1, subscription software revenue was 53% of total revenue at $24.9 million, which Chief Financial Officer Mark Hirschhorn said was down “approximately 23%” year-over-year in a May 5 call to discuss Q1 results. 
    • “Encouragingly, renewals and retention were higher than budgeted in the first quarter, providing greater confidence in the stability of our subscription base going forward,” Hirschhorn said.
    • “Amwell’s visit volume was down approximately 19% compared to a year ago, according to Hirschhorn, with 1.1 million visits in Q1. Hirschhorn said the figure is “is in line with the portfolio changes” previously disclosed by the company.”
  • The Wall Street Journal lets us know,
    • “BioNTech plans to shrink its workforce and manufacturing network to cut costs after Covid-19 vaccine demand waned.
    • “The company will affect 1,860 roles, about 22% of its 8,400-person workforce, and exit manufacturing plants.
    • “BioNTech will hand Covid shot supply to Pfizer, pivot to cancer therapies, and projects 500 million euros in annual savings by 2029.”
  • and
    • “Bayer agreed to acquire Perfuse Therapeutics, an eye disease drug specialist, for up to $2.45 billion.
    • “The acquisition aims to complement Bayer’s ophthalmology pipeline, following patent expiration issues with its Eylea drug.
    • ‘Perfuse’s lead drug candidate is an experimental treatment for glaucoma and diabetic retinopathy in mid-stage trials. Bayer will pay $300 million upfront.”
  • Per Fierce Pharma,
    • “Since the start of the decade, Eli Lilly has committed to spend more than $50 billion to bolster its United States manufacturing capabilities. But even that’s not enough to meet the needs of the rapidly growing pharma giant.
    • “On Wednesday, Lilly said that it has earmarked another $4.5 billion to further build up two of three planned production facilities in Lebanon, Indiana, some 28 miles northwest of Lilly’s headquarters in Indianapolis. The company revealed the new investment at a ribbon cutting ceremony for its genetic medicine plant in Lebanon, the first of the three new facilities at the site to become operational.
    • “Of the sum Lilly has pledged to spend for its domestic manufacturing in this decade, more than $21 billion has been allocated for the buildup in its home state. Lilly’s “evolving pipeline” and shifts in the anticipated demand for its products dictated the additional funding, the company said.”





Thursday report

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

Scheduling note: Because one of the FEHBlog’s children is getting married on May 1, there will be no Friday report this week.

From Washington, DC,

  • Federal News Network reports,
    • “President Donald Trump swiftly signed a bipartisan legislation Thursday to fund much of the Department of Homeland Security, but not its immigration enforcement operations, shortly after the package won final approval in the House, ending the longest agency shutdown in history.” * * *
    • “The White House had urged Congress this week to act, warning that the money Trump tapped to temporarily pay TSA and other workers through executive actions was drying up.” * *
    • “With the budget resolution now adopted by the House and Senate, lawmakers will next draft the actual $70 billion ICE and Border Patrol funding bill, with voting expected in May. 
    • “Trump has said he wants it on his desk by June 1.”
  • The Wall Street Journal reports,
    • “President Trump is withdrawing his nomination of healthy-food advocate Dr. Casey Means to serve as U.S. Surgeon General, after it became clear that the champion of his administration’s Make America Healthy Again agendawas unable to secure support in the Senate for confirmation.
    • “The president said Thursday that he instead would nominate Dr. Nicole B. Saphier, the director of breast imaging at Memorial Sloan Kettering Cancer Center Monmouth and a former Fox News contributor, for the role. * * *
    • “Trump’s new nominee, Saphier, has supported Kennedy’s efforts to probe the cause of rising autism rates in the U.S., but has expressed some criticism of his approach. “Mr. Kennedy’s commitment to addressing the autism epidemic is a welcome change. But as a physician, mother and medical journalist, I am deeply concerned—not with Mr. Kennedy’s intent, but with his methods,” Saphier wrote last year in a Wall Street Journal opinion column.”
    • “She is also a supporter of the MMR vaccine and has publicly cited studies showing no link between the vaccine and autism. Saphier has praised Trump for delivering Covid-19 vaccines through Operation Warp Speed, but criticized mandates under the Biden administration that she says undermined confidence in the vaccine.”
  • STAT News adds,
    • “The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply. 
    • “A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT. 
    • “She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco. 
    • “Szarama joined the FDA at the end of last year to serve as Prasad’s deputy. She trained as a biophysicist at Johns Hopkins and the Karolinska Institutet. Later, she worked as a research analyst at the Centers for Medicare and Medicaid Services, a director of clinical trials at Arnold Ventures, and a program manager at the Advanced Research Projects Agency for Health, according to her LinkedIn profile.” 
  • Per a CMS news release,
    • “Following overwhelming interest from prescription drug manufacturers, the Centers for Medicare & Medicaid Services (CMS) is extending the application deadline for drug manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model. The deadline extension to June 11, 2026, from April 30, 2026, provides interested drug manufacturers, particularly those that are small to mid-sized, with more time to engage with the CMS Innovation Center, review participation information and prepare their application to join the model.
    • “Additionally, CMS is extending the deadline for drug manufacturers to enter into participation agreements from June 30, 2026, to July 17, 2026. Companies that manufacture at least one drug and that participate in the Medicaid Drug Rebate Program are eligible to apply to participate in the GENEROUS Model, which is intended to offer improved and streamlined access for state Medicaid programs to participating manufacturers’ products. 
    • “Interested drug manufacturers that wish to schedule a meeting with CMS about their potential participation in the model should contact generousmodel@cms.hhs.gov.” 
  • Tammy Flanagan, writing in Govexec, helpfully “sorts through Medicare myths in federal retirement decisions.”
    • “Common assumptions about Part B, IRMAA and FEHB coordination can obscure how coverage and costs actually play out over time.” Check it out.

From the Food and Drug Adminstration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.
    • “This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer’s disease,” said FDA Commissioner Marty Makary, M.D., M.P.H. “With today’s action, patients and their families have access to an additional important treatment for complications of this devastating disease.”
    • “Agitation is a common and distressing symptom in patients with Alzheimer’s disease dementia, characterized by excessive motor activity, or verbal or physical aggression. It can significantly impact quality of life for patients and caregivers.”  * * *
    • “The FDA granted breakthrough therapy designation and priority review designation for this action. The approval of Auvelity for agitation associated with dementia due to Alzheimer’s disease was granted to Axsome Therapeutics.”
  • and
    • “The U.S. Food and Drug Administration today announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. 
    • “The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing. 
    • “After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances. 
    • “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”
  • Healio tells us,
    • “The FDA approved Breztri Aerosphere, a single-inhaler triple therapy, as a maintenance treatment for patients aged at least 12 years with asthma, according to a press release from AstraZeneca.” * * *
    • “Notably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.”
  • MedTech Dive informs us,
    • “The Food and Drug Administration has recommended that users of Trividia Health’s True Metrix devices switch to other methods of testing their blood glucose. 
    • “Officials made the recommendation on Tuesday because the devices show the same error code when a patient has very high blood glucose or when there is a problem with the test strip.
    • “Trividia has recalled millions of owners’ booklets and systems instruction documents in response to the problem. The meter, test strips and control solution remain on the market.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports
    • “The CDC sent an alert to state and local health departments April 27, warning that additional measles cases are expected over the next few months.
    • “With continued measles transmission in areas across North America and expected increases in international and domestic travel and large events during spring and summer, additional measles cases are anticipated in the coming months,” the alert said.” 
  • Radiology Business points out,
    • “Nearly half of women eligible for breast cancer screening are confused on when exactly they should begin said screenings, according to new survey data. 
    • “The survey was the result of a collaboration between the Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. It was distributed in early April and included a sample of more than 1,000 women. Responses revealed that 44% of participants still believe they should begin breast cancer screening starting at age 50. While this assumption is in line with prior recommendations, the U.S. Preventive Services Task Force updated its guidelines in 2024 to recommend women at average risk undergo biennial screening starting at age 40.”
  • The Washington Post points out,
    • “Some physicians and researchers have argued for years that emotional dysregulation is not peripheral to ADHD but a central, overlooked part of the condition. Yet this symptom does not appear in the formal diagnostic criteria for ADHD in the manual that doctors use to classify mental disorders. That gap has left clinicians without a clear way to categorize what they’re seeing: Are these children best understood as having severe anxiety, as being on the autism spectrum, or as something else entirely? Or does ADHD itself need to be more broadly defined?
    • “A study published in JAMA Psychiatry this year analyzing 1,154 brain scans of children and adolescents offers fresh evidence for reevaluating the medical establishment’s definition of the disorder.
    • “The researchers grouped three forms of ADHD identified in the imaging into familiar — and one less familiar — categories: predominantly inattentive; predominantly hyperactive/impulsive; and a more severe, combined presentation marked by emotional dysregulation or difficulty managing and responding to emotions in a controlled, appropriate way.
    • “The findings are part of a broader shift: Advances in brain imaging are pushing scientists beyond symptom-based labels toward biologically grounded classifications of neurological conditions — an approach already reshaping autism research, where a study published last year identified four distinct subtypes.”
  • STAT News relates,
    • “Body mass index has its limitations, but for now it’s the metric medicine often defaults to when predicting weight-related health problems. A new tool promises to better define who’s at risk for obesity complications, based on measures that include BMI but also family history, diet, current illness, and socioeconomic factors culled from medical records.” * * *
    • “We really wanted to have an integrated model that enables us to look at not one, but 18 different obesity-relevant complications,” Claudia Langenberg, co-author of a study about the new model published Thursday in Nature Medicine, said in a media briefing Tuesday. She is director and professor of medicine and population health at Precision Healthcare University Research Institute of Queen Mary University of London.
    • “The new tool, called OBSCORE, stratifies 10-year risk for different outcomes at 5.7%, 1.8%, 0.9%, 0.4%, and 0.1% for death from, for example, cardiovascular causes. 
    • “What needs to happen next is to take this very helpful score and to incorporate it, as the team have done, with evidence from trials to show that people are not only at risk, but estimate what their capacity to benefit is — and then the cost-effectiveness of intervention,” co-author Nick Wareham, co-director of the Institute of Metabolic Science at the University of Cambridge, said at the briefing.”
    • “Experts not involved in the study praised its ambition to predict obesity’s serious ramifications, but they differed on how well this step toward early recognition and refined response might play out.”
  • The Washington Post informs us,
    • “A drug taken by thousands of Americans to improve longevity might have an unexpected side effect, a study has found. It may blunt some of the health benefits of exercise.
    • “The drug, rapamycin, is approved by the Food and Drug Administration to prevent organ-transplant rejection in people. But recent studies in yeast, flies and mice showed that relatively low doses of the drug often increase the creatures’ lifespans, prompting many longevity enthusiasts to start using it off-label to extend their lifespans.
    • “The new study, published this month in the Journal of Cachexia, Sarcopenia and Muscle, is among the first to look at interactions between rapamycin and exercise. The researchers anticipated rapamycin would enhance the effects of exercise, while also initiating health improvements of its own.”
    • “But the results surprised them, said Brad Stanfield, a physician and researcher in Auckland, New Zealand, who led the study. The sedentary, older people taking a low dose of rapamycin once a week during the study wound up gaining less strength and physical function from an exercise program than other volunteers of the same age who were taking a placebo. They also developed more aches, fatigue and, in one case, a serious infection.
    • “These findings resonate because, exercise is the most effective way to improve health and longevity as we age. “It is important to understand how potential health span-extending drugs” such as rapamycin “interact with other health span-extending treatments like exercise,” said Benjamin Miller, who studies aging and metabolism at the Oklahoma Medical Research Foundation in Oklahoma City. He was not involved with the new study.
    • “Since exercise is the benchmark,” he continued, “we do not want to inhibit its potential benefits.”
  • Health Day tells us,
    • “Screening for dementia doesn’t appear to stress out seniors’ families
    • “Family members whose seniors received screening were no more anxious than those who didn’t 
    • “However, screening alone did not lead to family members better prepared for caregiving.”

From the healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Cigna Group will exit the Affordable Care Act market next year, the latest sign of turmoil in a business that has been hit hard by the loss of federal subsidies.
    • “Cigna will be the second major health insurer to leave the rapidly shrinking ACA market, after CVS Health’s Aetna stopped offering plans at the start of this year.” 
  • Modern Healthcare adds,
    • [Cigna] reported first-quarter profit ahead of Wall Street estimates and lifted its outlook for the year as healthcare expenses in its medical plans came in lower than forecasts.
    • Adjusted earnings of $7.79 a share topped the average analyst estimate in a Bloomberg survey. Cigna nudged its 2026 profit outlook up by 10 cents a share to at least $30.35, the company said in a statement Thursday. A key gauge of medical costs was more favorable than Wall Street expected. 
    • The results extend a string of favorable reports from US health insurers for the start of 2026. Cigna’s medical plan business drove the company’s earnings, while the company’s Evernorth health services segment, which includes the largest US drug benefits manager, powered revenue growth. Selling, general and administrative expenses declined from a year ago.
  • Fierce Healthcare relates,
    • “Tenet Healthcare topped its earnings expectations for the year’s first quarter, with CEO Saum Sutaria, M.D., crediting the company’s long-term strategy and “old-fashioned discipline” in the face of volume disruptions plaguing providers in the opening months of 2026.
    • “The company’s net income for the quarter was $8.01 per diluted share ($702 million), or a market consensus-beating 10.6% year-over-year increase to $4.82 per share after adjustments (including over $400 million received from the early severance of a revenue cycle contract with CommonSpirit Health). Net operating revenues increased 2.8% year over year to $5.37 billion, falling short of the market’s consensus estimate.
    • “Executives said they were pleased with the performance of both major segments of Tenet’s business, its ambulatory surgery business and its hospitals.” 
  • and
    • “Parsley Health, a functional medicine provider, is now in-network with all major commercial insurers nationwide.
    • “The company’s in-network reach spans plans covering 150 million lives, including Aetna, Cigna, UnitedHealthcare, Blue Cross Blue Shield, Humana and Centene. Eligible services covered include provider visits, diagnostic testing and prescriptions. Parsley members must pay an annual non-covered program fee of $1,500 for wraparound support.
    • “The announcement builds on Parsley’s phased expansion into insurance over the past two years, which began in New York and then California. Today’s nationwide expansion represents a tenfold increase in coverage, per the company. The company offers healthcare via telehealth nationwide or in-person in Los Angeles and New York City.” * * *
    • “Functional medicine aims to look at the whole person and get under the hood of symptoms to identify and address root causes of disease. Parsley takes a multidisciplinary approach, with members getting a care team of board-certified doctors, registered nurses, functional nutritionists, care coordinators, member experience advisors and access to the digital platform to track progress, access data and more. Members also get unlimited messaging with their care team.” 
  • The Wall Street Journal tells us,
    • “Booming sales of weight-loss shots fueled strong revenue and profit growth for Eli Lilly LLY  in the latest quarter, as robust consumer demand helped offset falling prices for the drugs.
    • “The results blew past Wall Street expectations, and Lilly raised its forecast for full-year 2026 sales and profit.” * * *
    • “The results cement the Indianapolis company’s dominance in the anti-obesity drug market as it seeks to extend that to weight-loss pills. Lilly released its new weight-loss pill Foundayo this month, competing with Novo Nordisk’s Wegovy pill, which came out in January.
    • “Early prescription data showed a slower start for Lilly’s pill than for Novo Nordisk’s, but analysts predict Lilly’s pill will eventually be a big seller.
    • “Both companies think there is a large, untapped market for pill versions of weight-loss drugs, because some people don’t like needles or find pills more convenient.”
  • and
    • “Merck reported higher first-quarter sales and raised its full-year earnings guidance as demand for its flagship Keytruda cancer drug continues to grow.
    • “Sales rose 5% to $16.29 billion, boosted by 12% growth for Keytruda. Wall Street had expected $15.85 billion, according to FactSet.
    • “The company has been adding to its portfolio as it braces for Keytruda to lose the protection of its main U.S. patent, which expires in 2028, opening the door for lower-cost versions to compete.
    • “Last year, the FDA approved a form of Keytruda administered by injection rather than intravenously, which could help the company offset the impact of the patent expiration. Merck has said the new form of the drug, called Qlex, provides greater convenience as it can be offered in a wider variety of settings and can be given in one minute every three weeks as opposed to a 30-minute IV infusion.
    • ‘In the first quarter, the company recorded $128 million in Qlex sales.”
  • and
    • “Bristol Myers Squibb BMY posted higher first-quarter revenue boosted by its portfolio of newer treatments for heart and blood conditions.
    • “The biopharmaceutical company on Thursday posted a profit of $2.68 billion, or $1.31 a share, compared with $2.46 billion, or $1.20 a share, a year earlier.
    • “Stripping out certain one-time items, adjusted per-share earnings were $1.58, ahead of the $1.42 anticipated by analysts, according to FactSet.
    • “Revenue rose 3% to $11.49 billion. Analysts surveyed by FactSet forecast revenue of $10.93 billion.
    • “Sales in Bristol Myers Squibb’s growth portfolio rose 12%, driven by Camzyos, Breyanzi and Reblozyl. The drugs are designed to treat heart disease, lymphoma and blood disorders, respectively.”
  • Health Exec notes “six things the hospital-at-home model needs to scale up nationally.”
  • Beckers Payer Issues calls attention to “five ways insurers are betting big on AI.”
    • “Payers have been experimenting with internal and member-facing capabilities, while grappling with health system AI use, as well. As insurers build upon their substantial investments and weigh how humans can stay “in the loop,” here is where that money is actually going.”

Tuesday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “A prominent physician voice in the House of Representatives has introduced a new bill that would compel insurers to apply the cost for drugs purchased from direct-to-consumer platforms to deductibles and out-of-pocket maximums.
    • “North Carolina Republican Greg Murphy, M.D., on Tuesday unveiled the Every Dollar Counts Act, a bill that aims to lower patients’ out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise.
    • “Using these platforms, patients can often find prices that cost far less out-of-pocket, especially for branded drugs, per Murphy’s office.”
  • The American Hospital Association News adds,
    • “The AHA and dozens of other organizations April 14 sent a letter of support to Reps. Suzan DelBene, D-Wash., and Mike Kelly, R-Pa., for their introduction of the Chronic Care Management Improvement Act. The bill would waive beneficiary cost-sharing requirements for Medicare beneficiaries receiving chronic care management services. Beneficiaries are currently required to pay a 20% coinsurance fee to receive such services. “This cost-sharing requirement creates a barrier to care, as beneficiaries are being billed for services that do not always include interfacing with their provider, thus creating confusion for patients,” the organizations wrote. “Also, many of these beneficiaries consider any additional out-of-pocket expense for healthcare services untenable.”
  • CMS has posted MMSEA Section 111 GHP User Guide Version 7.8 – April 13, 2026 (PDF)
    • “The GHP User Guide * * * is your primary source for Section 111 GHP reporting requirements.”
  • OPM Director Scott Kupor has added a new post titled “Merit Matters” to his Secrets of OPM blog.
    • “If we want the best talent in the federal government – which I think we do – we should not refuse to hire college dropouts, unless dropping out of college is somehow representative of their ability to work successfully on behalf of the American people. And, if they are in fact world-class engineers, then we should pay them at the level at which they are performing versus force-fitting them into a lower pay level because they have no prior work experience.
    • “Once again, merit matters.”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Fox News’ Saturday in America with host Kayleigh McEnany to highlight the launch of EarlyCareers.gov, a new initiative to recruit more early career Americans into federal service and strengthen the government’s talent pipeline.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Even as Eli Lilly gets underway with its next major obesity launch in Foundayo, an FDA document related to the oral treatment shows lingering reservations about multiple “unexpected serious” risks potentially related to the drug.
    • “In the FDA’s approval letter (PDF) for GLP-1 pill Foundayo, the agency tasks Eli Lilly with obtaining more information about the med’s potential link to major adverse cardiovascular events and drug-induced liver injury. In addition, the agency wants to gain more info about delayed gastric emptying associated with the drug and its potential effects in lactating women.
    • “In its assessment of the medicine’s data, the FDA “determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events (MACE), drug-induced liver injury (DILI), and exposure to [Foundayo] during lactation,” the letter says.”
  • STAT News adds,
    • “In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
    • “FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
    • “In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, and this inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.”
  • MedTech Dive relates,
    • “Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected.
    • “Medline began the recall in February, and it was posted to the Food and Drug Administration’s website last week. The problem was the subject of a warning letter that Medline received in March, also recently posted to the FDA’s website.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. When finalized, this guidance will provide recommendations for standardized methods for comprehensively assessing the safety of genome editing therapies to bring effective treatments to patients sooner.
    • “Genome editing holds extraordinary promise for treating previously incurable genetic diseases, and today’s announcement represents the FDA’s forward approach to drive innovation and advance the development of genome editing therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance provides sponsors with clear, scientifically-grounded recommendations for evaluating off-target editing risks using state-of-the-art sequencing technologies. We are serious about moving this ball forward.”  
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research, supports the FDA’s framework for accelerating development of individualized therapies for ultra-rare diseases launched in February. The framework revolutionizes how the FDA engages with industry and promotes a path for transformative rare disease treatments.
    • “The “Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing” guidance provides specific recommendations on sequencing strategies, sample selection, analysis parameters, and reporting.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal [magistrate] judge has tossed an Elevance subsidiary’s lawsuit against billing intermediary HaloMD and several California-based providers alleging they’re abusing the out-of-network billing dispute process set up by the No Surprises Act.
    • “[Magistrate] Judge Karen Scott of the Central District of California dismissed the suit on Monday, finding that Anthem Blue Cross, Elevance’s California subsidiary, failed to prove that the companies were gaming the law’s independent dispute resolution, or IDR, in order to inflate their reimbursement.
    • “It’s a major win for HaloMD, which is facing similar lawsuits from Elevance in three other states and has found itself in hot water over its status as the No. 1 submitter of IDR disputes. The Texas-based company cheered the court’s decision, while Elevance said it plans to appeal.”
    • Yesterday, Anthem Blue Cross did appeal the court’s decision to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law reports,
    • “A Delaware judge threw out lawsuits seeking to link the heartburn drug Zantac to cancer, freeing makers of the product from facing trials in the state over the cases.
    • “Superior Court Judge Francis “Pete” Jones concluded Monday lawyers for ex-Zantac users couldn’t produce legitimate evidence backing up claims the over-the-counter product caused cancer. Zantac is currently made by French drugmaker Sanofi.” * * *
    • Because former Zantac owners GSK Plc, Pfizer Inc., Sanofi and Boehringer Ingelheim Pharmaceuticals already have settled thousands of Zantac suits over the last several years, it’s unclear how many Delaware cases will be dismissed by Jones’ order. GSK paid more than $2 billion in 2024 to resolve what it said was more than 90% of its pending cases.

From the public health and medical / Rx research front,

  • Fierce Healthcare reports,
    • “Seven in 10 U.S. adults gamble, according to a survey from the National Council on Problem Gambling (NCPG). Commercial gaming revenue broke records at $78.7 billion in 2025, with over $18 billion in tax revenue going into state and local coffers. All gaming segments, from casinos to sports betting to online games (iGaming), are growing. Throw in prediction markets, which allow users to speculate on the outcome of real-world events but are not legally considered gambling platforms, and the betting buffet becomes basically limitless. 
    • “This menu of options is creating an addiction crisis yet to be widely recognized by the public, policymakers and the healthcare sector, experts caution. Current national problem gambling prevalence is unknown due to a lack of research and funding dedicated to the issue. States that measure and publish their own prevalence rates see anywhere from 1% to 6%. Those most at risk include young adults, men and online gamblers. Gambling-related harms can be dire, from financial stress to co-occurring behavioral health conditions to suicide, which a fifth of individuals with gambling addiction attempt.
    • “To understand problem gambling, what’s driving it and efforts underway to address it, Fierce Healthcare talked to two dozen providers, researchers, advocates and regulators. This story is also based on a review of research, as well as exclusive data from Komodo Health analyzed on Fierce Healthcare’s behalf.
    • “It’s a small but mighty group of us that have been in this field, treating,” said Jody Bechtold, L.C.S.W., president of the International Problem Gambling and Gaming Certification Organization (IPGGC). “We call it the next opioid epidemic.” 
  • Healio tells us,
    • “The risk for subsequent fractures is similar for older adults, regardless of whether they had an initial major osteoporotic fracture or nonmajor osteoporotic fracture, researchers reported.
    • “In findings published in Journal of Bone and Mineral Research, researchers found that sustaining a major or nonmajor osteoporotic fracture raises the risk for subsequent fractures and mortality.”
  • Infectious Disease Advisor informs us,
    • “Rhinovirus and enterovirus are associated with severe clinical outcomes among hospitalized patients, including mechanical ventilation and death, highlighting the need for expanded respiratory virus surveillance among high-risk patient populations.”
  • MedPage Today points out,
    • “A dual deprescribing intervention for proton pump inhibitors (PPIs) targeting patients and their primary care doctors proved effective in reducing potentially inappropriate use, a cluster-randomized trial in France found.
    • “At 1 year, the combined approach — where patients got educational material about reducing PPI use mailed to them and their physicians received a letter detailing a deprescribing algorithm — resulted in twice as many patients cutting their PPI use in half (14.9%) versus usual care (7%) or physician-targeted intervention alone (7.7%, P<0.001 for both).
    • “The results underscore “the value of prioritizing patient-facing deprescribing strategies,” wrote researchers led by Jean-Pascal Fournier, MD, PhD, of Nantes Université in France, in JAMA Internal Medicineopens in a new tab or window. Furthermore, the interventions were not associated with a resurgence in gastroesophageal reflux disease (GERD) symptoms.
    • “PPIs in the U.S. are frequently prescribed for inappropriate indications and sometimes prescribed indefinitely, according to Fournier and colleagues.” * * * Potentially unnecessary PPI spending — reimbursements in 2015 hit $12 billion in the U.S.

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

  • Modern Healthcare reports,
    • “The Purchaser Business Group on Health, which represents large companies, launched a project to combine federally required data with claims data culled from its biggest members to provide insight into costs and quality in employer-sponsored health plans.
    • “This has the potential to supply employers with unprecedented access to healthcare pricing data that could help curb escalating employee health benefit costs, said Purchaser Business Group on Health President and CEO Elizabeth Mitchell.
    • “There is employer demand for this information that is unmet in the market,” Mitchell said during a Purchaser Business Group on Health webinar on healthcare transparency in February.
    • “The Purchaser Business Group on Health has found that normal market forces that should be expected to link prices to quality don’t function in healthcare. Prices often fluctuate wildly based more on the size and market power of health systems or insurers than on the quality of services rendered.
    • “For instance, its data reveal prices at hospitals in the same markets do not correlate with scores from the Leapfrog Group, which assesses hospital quality and safety. Often, low-rated hospitals charge more. Or the same hospital charges vastly different prices for the same procedures depending on the insurance plans, not any differences in the service.” 
  • and
    • “Health systems are increasing their investments in concierge medicine to meet patient demand and keep burned-out doctors practicing.
    • “Though typically a small percentage of a health system’s operations, concierge medicine — where patients pay thousands of dollars in membership fees for increased access to primary care physicians — helps diversify revenue and creates growth opportunities in new and existing markets.
    • “Still, it’s a controversial model that raises questions about equal access to care because it historically has appealed to wealthier, often older individuals looking for more personalized primary care. Health systems say patient demand has expanded beyond that demographic.”
  • Fierce Healthcare relates,
    • “Anthem and Mount Sinai have reached a new multi-year contract agreement, restoring coverage for thousands after the system went out-of-network last month.
    • “Anthem Blue Cross and Blue Shield of New York said in a statement Monday that the three-year deal returns Mount Sinai’s hospitals, physicians and other providers to its network. The health plan said that the contract “reflects both organizations’ commitment to delivering quality care while helping control healthcare costs for New York workers, families, employers and taxpayers.”
    • “The contract also includes updated reimbursement models that aim to reward quality and outcomes, while continuing to support accurate billing and payment.”
  • The Wall Street Journal lets us know ,
    • Healthcare giant Johnson & Johnson JNJ reported nearly 10% revenue growth for the latest quarter on strong cancer drug sales that offset a steep decline from one of its bestselling drugs, Stelara.
    • J&J said its first-quarter sales rose to $24.06 billion, topping the mean estimate of $23.62 billion from analysts surveyed by FactSet. Adjusted quarterly earnings also beat Wall Street expectations.
    • On the back of those results, the drug and medical-device maker boosted its full-year financial forecast. So far, disruptions from the war in Iran haven’t materially hurt J&J.
    • “There’s a lot of macro uncertainty out there,” J&J Chief Financial Officer Joseph Wolk said in an interview. “We think the fact that we’re not only maintaining but raising” the forecast is a sign of the company’s strength, he added.
    • J&J has been working to ensure consistent growth after losing patent protection for Stelara, a treatment for skin and digestive conditions. Competitors introduced lower-cost alternatives last year, leading to a 60% drop in first-quarter sales of the brand-name version of the drug.
    • Strong sales of J&J cancer medications like multiple-myeloma treatment Darzalex helped make up for those declines. The company’s cancer-drug sales rose more than 22% for the quarter. J&J is in a stronger position than some of its peers, which face even bigger patent cliffs in coming years.
  • BioPharma Dive tells us,
    • “Eli Lilly is again turning to dealmaking to boost its oncology portfolio, reaching a deal Tuesday to acquire a biotechnology company, CrossBridge Bio, that’s developing newer types of targeted cancer medicines.
    • “Lilly will pay up to $300 million in cash for CrossBridge, a Houston-based startup making antibody-drug conjugates for cancer. That total includes an unspecified upfront payout and subsequent payment tied to a development milestone, CrossBridge said in a statement.
    • “The deal hands Lilly technological capabilities that have become increasingly desirable to major pharmaceutical firms. Antibody-drug conjugates, or ADCs, are now a pillar of cancer care, a method of precisely delivering a toxic blow to malignant cells. Over 20 ADCs are currently available to treat tumors of the breast, lung, bladder and more. Many are working their way into earlier treatment lines, in some cases supplanting decades-old chemotherapy approaches.”
  • MobiHealth informs us,
    • “New York-based virtual women’s health provider Maven Clinic announced a strategic collaboration with care concierge company Wellthy to combine clinical care and caregiving support for employees.
    • “Maven Clinic is a digital reproductive health and family platform that offers fertility and family planning services, pregnancy and postpartum care, parenting and pediatric support, and menopause-related care.
    • ‘Wellthy offers a care concierge service that connects employees with care teams to help them navigate the healthcare system, including finding in-home support, understanding benefits, accessing legal resources and obtaining financial assistance.
    • “The company also offers Backup Care services to help employees find emergency care for family members, including daycares, on-site childcare facilities and other community-based programs.    
    • “The aim of Maven and Wellthy’s partnership is to help employees in the “sandwich generation, – those in the period of starting a family and caring for an older loved one – navigate the process from fertility, growing a family and overseeing eldercare.
    • “This partnership is about building a system that reflects how people live, with clinical care and caregiving support together in one place. When technology makes that support intuitive, you don’t just improve outcomes – you make it possible for people to ask for help in the first place,” Kate Ryder, founder and CEO of Maven Clinic, said in a statement.”
  • The Wall Street Journal informs us,
    • “Novo Nordisk NOVO.B said it would work with ChatGPT maker OpenAI on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as healthcare companies seek to harness the technology to get ahead of the competition.
    • “The Danish drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients.
    • “The group said the partnership would boost efficiency across manufacturing, distribution, the supply chain and corporate, with pilot programs initially launching in research and development, manufacturing and commercial operations ahead of a full AI integration by the end of the year.” * * *
    • “Drugmakers are turning to AI companies and their increasingly powerful models to improve operations and cut repetitive tasks for employees, giving them more time to focus on R&D in a bet that advancements in the technology will help them identify promising new drugs and treatments.”
  • Modern Healthcare adds,
    • “Health systems and payers are making big investments in artificial intelligence to improve their operations by reducing administrative burden, beefing up clinical prediction capabilities and increasing access to care. 
    • “A case in point: This year alone, UnitedHealth Group is investing $1.6 billion into its AI efforts. Companies also are realigning executive roles by adding chief AI officers or adding AI responsibilities to C-suite executives overseeing data and innovation.” * * *
    • “Mike Baker, chief operating officer, UnitedHealthcare
    • “UnitedHealth Group, our parent, has embedded the use of AI across our business to simplify healthcare and improve how people access care, information and support. UnitedHealth Group is investing $1.6 billion this year with the aim of making experiences more personalized, reducing administrative friction for clinicians, increasing transparency around cost and coverage, and supporting better care decisions.” 

Tuesday report

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

From Washington, DC

  • Avalere Health breaks down yesterday’s CMS Medicare Advantage premium announcement.
  • Per an HHS news release,
    • “The Health Resources and Services Administration (HRSA) today announced more than $135 million in new funding opportunities to expand nutrition services and strengthen the rural health workforce. Secretary of Health and Human Services Robert F. Kennedy, Jr., alongside HRSA Administrator Tom Engels and Representative Juan Ciscomani (AZ-06), announced this important investment during a Preventative Care Roundtable with key stakeholders.
    • “Preventative care cuts costs, improves outcomes, and drives our mission to Make America Healthy Again,” said Secretary Kennedy. “These investments expand access to high-quality, affordable care—especially in rural communities that need it most.”
    • “HRSA is committed to strengthening the health workforce, advancing preventative care, and expanding access to essential nutrition services,” said HRSA Administrator Engels. “By supporting new rural residency programs to deliver evidence-based nutrition services, we are creating a stronger, more sustainable system of care that helps prevent chronic disease, improves health outcomes, and advances HHS and Make America Healthy Again priorities for communities across the country.”
  • Beckers Hospital Review tells us,
    • AbbVie and Genentech are the latest drugmakers to sell prescription medications on TrumpRx, CBS News reported April 6.
    • “They are the 10th and 11th drugmakers to offer discounted medications on the website. 
    • TrumpRx now lists AbbVie’s best-selling anti-inflammatory drug Humira — in syringe or pen form — for $950, representing an 86% discount off the list price. Genentech’s antiviral medication Xofluza is also available for $50, down from a list price of $168.” * * *
    • “Since launching in February, TrumpRx’s list has expanded from 43 medications to 69. Amgen also recently added its arthritis treatment Enbrel and plaque psoriasis drug Otezla to the platform.”
  • Bloomberg Law reports,
    • “President Donald Trump is in no hurry to tap a permanent attorney general to replace Pam Bondi following her ouster, according to people familiar with the matter, allowing Todd Blanche time to settle into his role as the US Justice Department’s acting chief.”
  • NewsNation relates,
    •  “Acting Attorney General Todd Blanche revealed key details Tuesday about the Department of Justice’s newly created National Fraud Enforcement Division.
    • “Our vision is to build a robust fraud-fighting squad capable of investigating and prosecuting the full spectrum of fraud against taxpayer dollars,” Blanche explained. 
    • “Blanche said the division will be staffed with some of the DOJ’s “best prosecutors,” including experts in health care, tax, benefits and corporate fraud.
    • “There will be an additional 93 prosecutors in every district across the country devoted to the mission of combating fraud,” Blanche added.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “One year into his tumultuous tenure as the FDA’s commissioner, Marty Makary, M.D., has laid out ambitious internal goals and perhaps a more ambitious legislative wish list in his fiscal year 2027 budget proposal (PDF) to Congress.
    • “Alongside the justification of a $7.2 billion budget request, including $3.3 billion from congressional appropriations and $3.9 billion in industry-paid user fees, Makary is asking for a broad set of legislative actions. 
    • “The proposed changes would, among other things, create a new clinical trial initiation pathway as an alternative to the existing Investigational New Drug (IND) pathway, allow the FDA to disclose more information to the public in complete response letters, remove the interchangeability determination for biosimilars, give domestic generic manufacturers an upper hand and permanently authorize the rare pediatric disease priority review voucher program.”
  • The Wall Street Journal relates,
    • “Novo Nordisk NOVO.B launched its higher-dose Wegovy weight-loss shot in the U.S. after the new treatment gained regulatory approval there last month.
    • ‘The Danish drugmaker said Tuesday that Wegovy HD is now available nationwide through more than 70,000 pharmacies, its online pharmacy, certain telehealth providers and other outlets.
    • “Wegovy HD is a once-weekly injection that contains 7.2 milligrams of active ingredient semaglutide, offering the highest weight-loss of any Wegovy injection so far, the company said.” * * *
    • “In a trial of adults with obesity but without diabetes, patients taking a 7.2 milligram dose of Wegovy over about a year and a half lost 21% of their body weight on average, while around one in three people lost 25% or more of their body weight.
    • “Prior to the launch of Wegovy HD, the highest available injectable dose was 2.4 milligrams of semaglutide, which has shown to help patients lose around 18% of their body weight on average.
    • “The higher dose of Wegovy was approved by the Food and Drug Administration nearly three weeks ago under an accelerated approval process based on the results of the trial.”
  • Beckers Hospital Review tells us,
    • “Pfizer and BioNTech have halted a U.S. study of their updated COVID-19 vaccine in adults ages 50-64 due to slow enrollment, a Pfizer spokesperson confirmed to Becker’s.
    • “We can confirm our communication to the FDA about the status of the Pfizer-BioNTech COVID-19 vaccine postmarketing activities, including our intent to stop study C4591081,” the spokesperson said. “Notably, this study is not ending as a result of any safety or benefit-risk concerns.”
    • “The spokesperson added that the companies “intend to stop the study due to slow enrollment and therefore the inability to generate relevant postmarketing data.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A Centers for Disease Control and Prevention report published April 7 found that 47.2% of all U.S. adults met federal guidelines for aerobic physical activity in 2024. The report found that 52.3% of men and 42.4% of women met the standards. The CDC found that the prevalence of meeting the guidelines increased with education level. Aerobic physical activity was higher among adults without disabilities (49.8%), those with a healthy weight (54.8%), and those with excellent or very good health (57.8%). The analysis was based on data from the 2024 National Health Interview Survey.” 
  • Healio adds,
    • “Modest real-world weight loss may significantly reduce a person’s risk for cancer, according to results of a retrospective observational study.
    • “The risk reduction conferred by nonsurgical weight loss appeared consistent over multiple time intervals.
    • “The benefits became apparent quickly, with each 1% reduction in BMI equating to an approximately 1% reduction in cancer risk after as little as 3 years of follow-up.
    • “I definitely was surprised by the results, especially that we saw them as early as we did,” Daniel M. Rotroff, PhD, chairman of the department of quantitative health sciences and Eddie J. Brandon Endowed Chair for Diabetes Research at Cleveland Clinic, told Healio. “A 1% BMI reduction for a 1% reduction in risk may not sound like a lot but, when you think about some interventions achieving 5% weight loss pretty rapidly — and [some GLP-1 or dual GLP-1/GIP receptor agonists] achieving 10% or greater — that is a really meaningful reduction in cancer risk.”
  • Infectious Disease Advisor points out,
    • “The significant burden of respiratory syncytial virus-associated hospitalization in older adults, particularly those with underlying conditions, underscores the need for targeted vaccination strategies.”
  • MedPage Today adds,
    • “Influenza vaccines were effective in preventing related hospitalizations and outpatient visits among U.S. kids in recent years, but vaccine uptake remained low.
    • “Vaccine effectiveness against hospitalization ranged from 28% during the 2021-2022 flu season to 67% in the 2023-2024 season, and against outpatient visits ranged from 28% during the 2021-2022 season to 56% in the 2023-2024 season.
    • “Experts pointed to a need to properly communicate the benefits of influenza vaccines, especially as “distrust in vaccines grows.”
  • Health Day tells us,
    • “Cancer risk is higher for people battling autoimmune diseases, but the danger declines after they start taking anti-inflammatory medications, a new report finds.
    • “Italian researchers reporting in the journal Cancers found a 32% increase in the odds for cancer in the first year after a diagnosis for an autoimmune disease such as lupus, rheumatoid arthritis or psoriasis.
    • “However, after patients start taking drugs to ease the runaway inflammation that characterizes these illnesses, their cancer risk declines.
    • “The peak risk observed in the early stages suggests that chronic inflammation, rather than treatments, is a key factor in cancer development,” said Daniela Marotto, co-senior author of the study. She is head of rheumatology at the Local Health Authority of Gallura, in Italy.”
  • Health Day adds,
    • “Catching tumors early is crucial to lung cancer survival
    • “New robotic technologies, along with other innovations, is making early detection safer and easier on patients
    • “Often, detection, staging and treatment are done during the same procedure.”
  • Per STAT News,
    • “For some advanced cancers, sequencing the tumor genome should be one of the first steps patients and physicians take. But a new study finds that many patients never receive genomic testing and so never get the chance to know if they might have benefitted from newer, more targeted therapies.
    • “The study, published on Tuesday in JAMA Network Open, examined how many patients diagnosed with one of five different metastatic cancers received genetic sequencing for the cancers. For most cancers in the study, roughly half of patients in the cohort received genetic sequencing. Patients with low income, Medicare or Medicaid coverage, and Black or Hispanic race or ethnicity were also less likely to receive sequencing.”
  • MedPage informs us,
    • “Under physician supervision, 26% of older adults successfully stopped levothyroxine while maintaining stable thyrotropin and free thyroxine levels for a year.
    • “Discontinuation was more common in patients taking lower levothyroxine doses at baseline.
    • “Researchers urged clinicians to reassess thyroid therapy in older adults to avoid overtreatment and its associated risks.”

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

  • Fierce Healthcare reports,
    • “Last summer, the insurance industry broadly agreed to reform a major healthcare pain point: prior authorization.
    • “Now, two of the industry’s leading organizations are offering a look at progress toward those goals. AHIP and the Blue Cross Blue Shield Association released a report on Tuesday that found leading health plans reduced prior authorizations for an array of services by 11% since the pledge was made.
    • “This equates to 6.5 million fewer prior auth requests for patients, according to the report. Reductions in Medicare Advantage specifically were 15%, it reads.
    • “Health plans have taken important initial steps to support patients and are working toward the shared goal of delivering answers at the point of care whenever possible—a goal that will require both plans and providers to eliminate manual processes and adopt real-time electronic data sharing,” said Mike Tuffin, AHIP President and CEO, in the announcement.”
  • Physicians’ Practice adds,
    • “Access to affordable health care has displaced administrative burden as the single biggest policy concern among U.S. physicians, according to athenahealth’s fifth annual Physician Sentiment Survey. The shift signals the industry’s growing concern over systemic cost and coverage pressures, stretching well beyond the exam room.
    • “The survey, conducted online by The Harris Poll in October 2025 among 1,045 primary care physicians and specialists nationwide, found that 52% of physicians now consider access to affordable health care to be the most pressing issue they want policymakers to address. That figure was 44% in the 2025 survey and 38% in 2024, a 14-point climb in just two years. For the first time in the survey’s five-year history, the issue overtook minimizing excessive documentation requirements, which fell to 46% from 49% in 2024.”
  • The Wall Street Journal charts the weight loss drug frenzy ongoing in our country.
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • The Journal also relates,
    • “Gilead Sciences GILD agreed to buy German biotechnology company Tubulis for $3.15 billion to expand its portfolio of a cancer technology that aims to better guide chemotherapies to tumors.
    • “Tubulis’s lead drug is a targeted cancer therapy known as an antibody-drug conjugate. It is in mid-stage trials for ovarian and lung cancers. The German company has another antibody-drug conjugate in earlier stages of development that is being tested across several tumor types.”
    • “The deal, announced Tuesday, is expected to close by the end of June and includes up to $1.85 billion in potential milestone payments. Gilead already had a two-year research partnership, signed in 2024, with Tubulis.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi) for the protection against Covid-19, including both the short- and long-term effects of the infection. 
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
  • Per Fierce Healthcare,
    • “Alloy Health, a virtual platform serving women in midlife, is expanding its weight care program with two new offerings: micro-dosing and the Wegovy pill.
    • “Micro-dosing will allow for more personalized dosing for women who, for whatever reason, do not tolerate the manufacturer-made doses. The Wegovy pill introduces a daily oral GLP-1 option for women who prefer an alternative to injections. The company hopes to keep adding more brand-name products, including the Zepbound KwikPen, as they become available. 
    • “The products build on Alloy’s existing weight care program, launched last year, which aims to offer menopause-specialized weight care. The program offers physician-led hormonal expertise with personalized care plans designed for midlife women. Alloy is an entirely asynchronous, text-based provider.” 
  • and
    • “Artificial intelligence-enabled virtual care company Counsel Health is building out its clinical offerings to include lifestyle and chronic condition services. 
    • “The expansion will first focus on lifestyle conditions, including hair loss and sexual health, with plans to broaden its scope to chronic conditions later in 2026, including services to address high cholesterol and obesity. 
    • “If its chatbot recommends consultation with a physician, users can pay $29 to schedule follow-up care. Counsel Signature members, the company’s annual membership plan, will be able to use the expanded capabilities at no extra cost, according to a company announcement.”
  • Beckers Payer Issues lets us know,
    • “Cigna Healthcare offers the best digital experience to commercial members, while UPMC Health Plan provides the best experience to Medicare Advantage enrollees, according to J.D. Power’s 2026 U.S. Healthcare Digital Experience Study. Both plans topped their respective segments in last year’s ranking as well.
    • “Overall, the segment average for commercial plan digital experience is 658 on a 1,000-point scale. For MA, the segment average is 645. Both figures represent an improvement over the 2025 study, which recorded averages of 653 for commercial plans and 597 for Medicare Advantage.
    • “The study measured satisfaction across visual appeal; navigation; information/content; speed; and telehealth. The 2026 study included evaluations from 7,687 members of the 17 largest MA plans and 16 largest commercial plans, fielded from August through December 2025.”
    • More results are available in the article.
  • Modern Healthcare reports,
    • “Health systems and health plans are embracing performance-based contracts with digital health vendors. 
    • “In 2025, 75% of health plans and 61% of health systems implemented performance-based contracts with digital health vendors, according to a 2025 survey conducted by Peterson Health Technology Institute. In addition, the majority of the organizations that didn’t use performance-based contracts last year expressed interest in doing them.
    • “The contracts can ensure that payment is tied to return on investment and measurable outcomes. That makes formulating them tricky.”

Thursday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers boarded planes Thursday and headed home for the weekend, passing through security checkpoints manned by agents working without pay, as Democrats and Republicans blamed each other for the monthlong impasse over funding the Department of Homeland Security.
    • “Funding for DHS lapsed on Feb. 14, held up over demands from Democrats that new restrictions be placed on Immigration and Customs Enforcement operations as a condition for funding its parent agency. Since then, lawmakers have made no progress in resolving the standoff.
    • “The shutdown has forced a swath of federal workers—including Transportation Security Administration officers at airports—to continue working without pay, contributing to staffing shortages and long security lines at some airports across the country. TSA employees received partial paychecks earlier this month and are due to miss a full paycheck in coming days, just as spring break travel is kicking off. 
    • “Democrats again blocked a measure to fund DHS on Thursday afternoon. Earlier in the day, Republicans blocked a proposal by Democrats to fund individual parts of DHS, including the TSA and Coast Guard but not ICE.”
  • Bloomberg Law relates,
    • “Senate Health, Education, Labor and Pensions Chair Bill Cassidy has a wide range of health care affordability priorities he wants to pursue in 2026, including addressing drug costs and price transparency. 
    • “In terms of the [health care] affordability, it is a campaign issue,” the Louisiana Republican said in an interview at an exclusive Bloomberg Government event on Tuesday.
    • “You can tell Tony Fabrizio is in Donald Trump’s ear, right?” referring to the president’s longtime pollster who has released a survey that shows high drug prices top voter concerns, and many have unfavorable views of pharmaceutical companies. 
    • “Some policies Cassidy thinks could help with affordability are price transparency, site-neutrality in Medicare, which equalizes payments between hospitals and off-site physician offices, and pre-funding health savings accounts to help lower-income people buy insurance. 
    • “There are ways in which the cost of health care is affecting the average American that sometimes flies below the radar,” Cassidy continued.”
  • Beckers Hospital Review tells us,
    • “Sen. Ron Johnson, R-Wis., said he is opening an investigation into the FDA’s rejection of treatments for rare diseases, including ataluren, a drug used by some patients with Duchenne muscular dystrophy.
    • “Mr. Johnson, who chairs the Senate Permanent Subcommittee on Investigations, announced the inquiry at a news conference March 11. He said the FDA should allow patients access to high-risk treatments with clear disclosures rather than remove those options altogether, according to a report from Spectrum News 1.”
  • Federal News Network reports,
    • “Federal annuitants who have been waiting for weeks on a key tax document from the Office of Personnel Management should keep an eye on their mailboxes in the coming days.
    • “In an email sent Wednesday, OPM informed federal retirees who requested physical copies of their 1099-R forms that the remaining paper documents were being sent out this week, and should be delivered in the next three to five days.
    • “If retirees who requested a physical copy of their 1099-R form do not receive it by March 18, they should email OPM, “so that we can look into it and help get you your form,” OPM wrote Wednesday in its message to annuitants, viewed by Federal News Network.
    • “OPM Director Scott Kupor further confirmed on social media that the remaining paper tax documents would be delivered shortly. He said about 93% of annuitants have either downloaded digital copies of their documents, or already received a copy of the tax form in the mail.”
  • Tammy Flanagan, writing in Govexec, tells us,
    • “Women in federal service still face retirement gaps.
    • “Lifetime earnings, career interruptions and caregiving responsibilities continue to shape retirement outcomes for women in federal service.” * * *
    • “While challenges exist, federal employment offers tools that women can leverage so they can prepare for retirement.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration is cracking down on telehealth companies’ marketing of compounded versions of weight loss drugs. In recent months, the agency has warned them against implying that their products are FDA approved, or that they themselves manufacture the products.
    • “But those companies may not be the only ones under the microscope. 
    • “The telehealth companies that have been warned — with names like Lovely Meds, Hello Cake, and MEDVi — don’t directly prescribe the medications, which are not approved by the FDA or evaluated for safety and efficacy. That falls to the clinicians in medical groups affiliated with the companies. And a STAT analysis shows that cited companies can share clinical DNA.
    • “Among more than 70 telehealth companies warned by the FDA in the last six months, at least 30% have publicly stated affiliations with just four nationwide medical groups: Beluga Health, OpenLoop, MD Integrations, and Telegra. 
    • “These “white label” telehealth practices, which allow brands to quickly plug into a stable of clinicians often licensed to practice medicine across the country, have helped telemedicine companies grow rapidly. But in doing so, they are now closely tied to an industry attracting government regulators’ scrutiny.” 
  • Fierce Pharma adds,
    • “Though it’s hard to say exactly what the future holds for mass GLP-1 compounding, the pressure is mounting from multiple angles in the U.S. as drugmakers and the FDA alike seek to crack down on the practice. 
    • “Now, Eli Lilly—which has already staged multiple efforts in court to protect sales of its diabetes and obesity meds Mounjaro and Zepbound from compounders, medical spas and telehealth firms—is launching a new salvo focused on the potential safety risks behind a common compounding tactic. 
    • Lilly cautioned Thursday that through its own testing, it has “uncovered significant levels of an impurity” in certain compounded products marketed in the U.S., which seem to stem from a chemical reaction between vitamin B12 and tirzepatide, the active ingredient in Mounjaro and Zepbound. 
    • “Lilly called the impurity “concerning” given what little is known about its short- or long-term effects in humans, as well as its potential to interact with the GLP-1 itself or how it is absorbed, distributed, metabolized and eliminated from the body. 
    • “The Indianapolis pharma stressed that tirzepatide has never been studied in combination with B12 and warned that the compounders making these products, who are beholden to different regulations than branded drugmakers are, aren’t required to monitor and report potential negative reactions to their medicines.” 
  • Cardiovascular Business lets us know,
    • “Toro Neurovascular, a California-based medtech company focused on developing new treatments for stroke and other neurovascular conditions, has secured U.S. Food and Drug Administration (FDA) clearance for its new Toro 88 Superbore Catheter.
    • “The large-bore device was built to provide support, trackability and stability during the treatment of time-sensitive stroke patients. According to Toro Neurovascular, the company worked closely with physicians to ensure it can deliver value to care teams treating even the most challenging cases. 
    • “Satoshi Tateshima, MD, PhD, a professor of interventional neuroradiology at UCLA, performed the first clinical use case with the Toro 88 device in the United States.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “The U.S. cardiovascular mortality rate decreased dramatically from 2000 to 2011. Since then, however, it has remained relatively unchanged, according to new findings published in JACC.
    • “Cardiovascular mortality in the United States declined steadily for more than five decades; yet, progress slowed beginning around 2010,” wrote first author Adith S. Arun, BS, a research fellow with Yale New Haven Hospital and Yale School of Medicine, and colleagues. “Recent work has described this pattern as a ‘disquieting plateau,’ a period in which gains in cardiovascular outcomes have stalled despite major advances in therapies and an expanding clinical armamentarium. At the same time, national healthcare spending has reached historic levels.” * * *
    • “The researchers did note that the growth in spending is somewhat expected due to an aging patient population and the high costs associated with emerging technologies. At the same time, they wrote, “the value of these technologies depends on both their clinical effectiveness and their pricing.”
    • “The group also highlighted the importance of prevention efforts and lifestyle interventions as health systems look to keep healthcare costs down and potentially get cardiovascular mortality to start dropping again. 
    • “Click here to read the full study in JACC, the flagship journal of the American College of Cardiology.”
  • Beckers Hospital Review relates,
    • “West Virginia had the highest rate of fatal opioid overdoses of any state in 2024, according to a new analysis from KFF. 
    • “The analysis is based on finalized 2024 opioid overdose death totals from the CDC’s WONDER database, which uses ICD-10 codes to identify deaths where synthetic and prescription opioids are listed as a contributing cause. Rates are age-adjusted per 100,000 population using the 2000 U.S. standard population distribution. The data includes both deaths involving illegally manufactured and pharmaceutical fentanyl.
    • “The national opioid overdose death rate was 16 per 100,000 residents in 2024. More broadly, the U.S. recorded its largest-ever annual decline in overall drug overdose deaths, with the national rate falling from 31.3 per 100,000 in 2023 to 23.1 per 100,000 in 2024.”
  • MedPage Today tells us,
    • “This season’s influenza vaccine effectiveness rates against outpatient visits and hospitalizations may be lower than last season’s, according to an interim CDC analysis.
    • “During the current flu season, 88% of subtyped influenza A-positive specimens have been H3N2, 93% of which have been an antigenically drifted subclade K version that’s different from the 2025-2026 flu vaccine virus.
    • “These national trends were mirrored in the nation’s most populous state, California.”
  • and
    • “In cancer patients with brain metastases and type 2 diabetes, those using GLP-1 drugs had a 37% lower risk of death over 3 years.
    • “Significant mortality benefits were linked to semaglutide and dulaglutide, but not with liraglutide.
    • “The risk of all-cause mortality was consistently lower with GLP-1 drugs among patients with primary cancers of the lung, breast, and melanoma.”
  • Infectious Disease Advisor informs us,
    • “Human papillomavirus (HPV) vaccination may provide strong protection among men, highlighting its role in comprehensive disease prevention and gender-neutral control of HPV-related morbidity and mortality.”
  • Health Day notes,
    • “Providing support to stressed-out parents might help their children avoid obesity, a new study says.
    • “Children were more likely to eat healthy and not gain weight if their parents participated in training to help manage stress, researchers reported March 6 in the journal Pediatrics.
    • “We already knew that stress can be a big contributor in the development of childhood obesity,” senior researcher Rajita Sinha, director of the Yale Interdisciplinary Stress Center in New Haven, Connecticut, said in a news release.
    • “The surprise was that when parents handled stress better, their parenting improved, and their young child’s obesity risk went down,” Sinha said.”
  • Science points out,
    • “Scientists have plenty of ideas about why aging impairs memory. Reductions in blood flow in the brain, shrinking brain volume, and malfunctioning neural repair systems have all been blamed. Now, new research in mice points to another possible culprit: microbes in the gut.
    • “In a study published today in Nature, scientists show how a bacterium that is particularly common in older animals can drive memory loss. This microbe makes compounds that impair signaling along neurons connecting the gut with the brain, dampening activity in brain regions associated with learning and memory, the team found.
    • “This is a tour de force,” says Haijiang Cai, a neuroscientist at the University of Arizona who studies gut-brain communication and was not involved in the work. “They define the pathway all the way from aging and bacteria … to cognitive function—it’s really impressive.” However, he and others emphasize it remains to be seen whether a similar mechanism exists in humans—and if so, how important it is compared with other drivers of cognitive decline.”
  • STAT News relates,
    • “Jim Wells, a biologist at the University of California San Francisco, was studying proteins on the surface of cancer cells when he noticed one that wasn’t supposed to be there. This protein, called Src, should only be tucked inside cells.
    • “An accident,” he said, and a serendipitous one. Wells and his team report in Science that they have found Src on the surface of malignant cells, not healthy donor tissue.  This discovery may bring scientists closer to a long-sought goal: finding an ideal immunotherapy target for solid tumors.
    • “It was certainly provocative and exciting to see this cancer-associated Src kinase now presented on the cell surface,” said Kathleen Yates, a biologist at the Broad Institute of MIT and Harvard University who did not work on the study. But, she added, it’s still too early to know how much clinical benefit there will be from targeting Src on the cell surface. “They’ve accomplished a great deal. It is an outstanding question as to whether this will be translationally impactful,” she said.”
  • Genetic Engineering and Biotechnology News adds,
    • “After becoming the world’s first patient treated with a bespoke base editing therapy, baby KJ Muldoon is now healthy and free from the toxic ammonia buildup caused by his rare genetic metabolic disorder that initially presented a 50% mortality rate in infancy. While his story highlights the life-changing potential of gene editing, it also underscores a major challenge for the field: expanding these therapies to benefit broader patient populations.  
    • “KJ’s urea cycle disorder stemmed from a single disease-causing mutation that could be precisely targeted. However, many genetic disorders arise from numerous mutations scattered across a gene, making individualized corrections far too resource-intensive to scale.
    • “Ben Kleinstiver, PhD, associate investigator at Massachusetts General Hospital (MGH) and co-author of the NEJM study describing KJ’s case, told GEN that insertion of large DNA sequences at programmable locations in the genome holds tremendous promise as a generalizable medicine that could treat patients regardless of their underlying disease-causing mutations. His team has recently taken one step closer to making large gene insertions safer for therapeutic applications. 
    • ‘In the new study published in Nature titled, “Immune evasive DNA donors and recombinase license kilobase-scale writing,” Kleinstiver and colleagues, in collaboration with Full Circles Therapeutics, have developed a circular single stranded DNA donor (ssDNA) that enables kilobase-scale integration while remaining non-toxic to cells.”

From the HIMSS Conference 2026,

  • Fierce Healthcare reports,
    • “The Department of Health and Human Services (HHS) is ramping up major federal interoperability initiatives on several fronts.
    • “As part of this interoperability work, the Trump administration unveiled in July a sweeping health tech initiative that aims to modernize Medicare and advance next-generation digital health for patients, including conversational artificial intelligence, digital IDs and easier ways to access health data.
    • “The Centers for Medicare & Medicaid Services (CMS) is spearheading an API-focused data exchange framework to enable sharing of patient medical records through a new initiative called the CMS Aligned Network. This work is meant to accelerate data sharing at a faster pace than can be achieved through regulations alone, according to Amy Gleason, acting administrator, U.S. DOGE Service, and strategic advisor to the CMS.”
  • The Wall Street Journal adds.
    • “Microsoft MSFT is betting on healthcare as a path to become more competitive in artificial intelligence. The company’s biggest push yet: a new tool it describes as an AI concierge doctor—one that can access your medical records and health data, with your consent. 
    • “The company on Thursday unveiled Copilot Health, a feature within the Copilot app that lets the chatbot dispense personalized healthcare advice informed by the user’s disease history, test results, medications, doctors’ visit notes and biometric data as recorded by wearable devices. 
    • “Health data imported into the feature will be encrypted and firewalled from the rest of the app to address the privacy concerns of handing over one’s medical records to a generative AI platform, Microsoft AI Chief Executive Mustafa Suleyman said in an interview.
    • “It’s something that Microsoft is uniquely placed to do with our scale, with our regulatory experience, with the kind of trust and confidence that people have in our security and the history that we have as a mature, stable player,” Suleyman said.”

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

  • Modern Healthcare reports,
    • “North Dakota rural hospitals are showing they don’t need the help of a large health system to provide more primary care while driving down costs.
    • “In 2023, more than 20 critical access hospitals formed the Rough Rider High-Value Network, seeking to share data and collective resources to standardize care and improve financial performance.
    • “It’s been less than three years, but the network’s early results are a good sign for the concept given the pressure on margins at all hospitals, and especially those in far-flung communities. Rural providers in five other states have since banded together in similar coalitions of independent hospitals while many of their peers join larger health systems.” 
  • Beckers Health IT relates,
    • “More than 80% of physicians use artificial intelligence in their professional practice — more than double the share in 2023, according to a March 12 survey from the American Medical Association.
    • “AMA polled 1,692 U.S. physicians across various specialties, practice settings and career stages about their use and perception of AI. Responses were collected between Jan. 15 and Feb. 2. About 38% of participants practiced in group settings and 24% in hospitals.” 
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (Takeda Pharmaceutical Co., Ltd.) for narcolepsy type 1.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “Register for ICER’s Early Insights Webinar
    • “On March 24, as part of ICER’s Early Insights Webinar Series, ICER’s Senior Vice President of Research, Foluso Agboola, MBBS, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “Submit a Public Comment
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on April 7, 2026. * * *
    • “ICER’s Patient Portal and Manufacturer Engagement Guide  provide additional detail on what types of information may be most informative to the report.”

Midweek update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC

  • The Hill reports,
    • “The House on Wednesday advanced a GOP-backed Department of Homeland Security (DHS) funding bill, an effort by Republicans to pressure Democrats to end the partial government shutdown in the wake of the U.S. launching strikes against Iran.
    • “The panel voted 211-209 to pass the rule, which tees up debate and a vote on the final passage of the measure. The bill is expected to pass the lower chamber on Thursday.”
  • Roll Call relates,
    • “The White House tentatively aims to release President Donald Trump’s fiscal 2027 budget proposal the week of March 30, according to multiple sources with knowledge of the plan.
    • “That timing would put budget delivery some eight weeks after the statutory due date of the first Monday in February, though presidential budgets often miss that deadline.
    • “Office of Management and Budget staff couldn’t immediately be reached for comment.”
  • Federal News Network tells us,
    • “Agencies would make layoff decisions based more highly on federal employees’ performance, rather than how long they have been working in government, according to a new proposal from the Trump administration.
    • “If finalized, proposed regulations that the Office of Personnel Management (OPM) is expected to publish Thursday morning would reorder the factors that agencies consider when determining which employees to retain or remove during a reduction in force (RIF).
    • “When it comes to personnel decisions during RIFs, current federal regulations tell agencies to first look at employees’ tenure and length of service, before considering their performance ratings. The new proposed regulations seek to reverse that order, making employee performance the top priority.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) and the National Aeronautics and Space Administration (NASA) today announced the launch of NASA Force, a dedicated talent track within the US Tech Force initiative designed to recruit and deploy the nation’s top engineers and technologists to support America’s space program.
    • “NASA Force will identify and place high-impact technical talent into mission-critical roles supporting NASA’s exploration, research, and advanced technology priorities, ensuring the agency has the cutting-edge expertise needed to maintain US leadership in space.”
  • Healthcare Dive informs us,
    • “Federal regulators received a record number of comments on their proposal to keep Medicare Advantage rates flat next year, Trump administration officials said Tuesday during an industry event, as insurers continue to lobby heavily for higher reimbursement.
    • “We appreciate all the input. I mean, obviously there’s been a little bit more input this year than we typically get,” John Brooks, the CMS’ chief policy and regulatory officer, said during the Better Medicare Alliance’s summit in Washington, D.C.
    • “In January, the Trump administration proposed an average rate bump of less than 0.1% for MA plans in 2027, along with tighter guardrails around how plans adjust for the health risks of their members.” * * *
    • “Regulators received almost 47,000 comments on the rule during the input period ended Feb. 25 — an all-time high, according to Brooks.
    • “In their comments, major MA carriers like UnitedHealth along with industry associations like the BMA and AHIP argued that the CMS ignored rising costs, resulting in a payment proposal underfunding MA.”
  • and
    • “The CMS innovation center is exploring more mandatory payment models as the Trump administration brainstorms how to get more providers to participate in value-based care, health officials said Tuesday.
    • “Mandatory models are going to have to be part of the equation,” CMMI Director Abe Sutton said at a conference hosted by value-based care advocacy group Accountable for Health.
    • “The CMMI tests ways of injecting more value-based care into federal programs through its models, which can be mandatory or voluntary. Mandatory models require all eligible participants — usually providers — to take part. Participants generally can’t exit the model before the testing period is up.
    • “That’s opposed to voluntary models, in which accountable care organizations or other actors can opt into participation.” * * *
    • “The CMMI started trialing more mandatory models during the first Trump administration, a direction that continued under President Joe Biden. Now, the second Trump administration is once again reiterating its support of expanded mandatory tests.”
  • Cardiovascular Business points out,
    • “The U.S. Centers for Medicare and Medicaid Services (CMS) has released a list 2,600 cardiologists who will be required to participate in a new Ambulatory Specialty Model (ASM) payment model for heart failure starting on Jan. 1, 2027.
    • “CMS said the new program aims to improve prevention and upstream management of high-cost chronic diseases with an initial push in heart failure and lower back pain. The new payment model is an attempt to reduce avoidable hospitalizations and unnecessary procedures. Heart failure is a major driver of Medicare expenses, and currently costs the U.S. health system about $179.5 billion annually.[1]
    • “Participation in the ASM will be mandatory for certain specialists who commonly treat these conditions in Medicare patients in an outpatient setting. The ASM will begin on Jan. 1, 2027, and run for five performance years through Dec. 31, 2031.”
  • Beckers Hospital Review notes,
    • “For the third time since March 2025, HHS has postponed a planned meeting for the U.S. Preventive Services Task Force, which provides clinical preventive health recommendations to Congress every year. 
    • “The USPSTF, which is a volunteer panel of national experts that was launched in 1984, usually meets three times a year. The group did not meet in July or in November of 2025, with the latter tied to a government shutdown. * * *
    • “An HHS spokesperson confirmed the March 2026 meeting’s postponement to Becker’s, adding that the meeting “will be rescheduled in the coming months.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Food and Drug Administration officials are giving Prime Medicine new hope for a gene-editing treatment the company was forced to shelve last year.
    • “The therapy, PM359, is designed to treat chronic granulomatous disease, or CGD, a potentially deadly condition that leaves patients highly susceptible to bacterial and fungal infections. A study of two patients released last year suggested PM359 could correct the genetic anomaly that causes the disease, offering the possibility of a cure.
    • “But the condition is so rare that Prime opted not to continue development of the therapy amid a cash crunch. Even as it announced the promising early results, Prime said it would deprioritize PM359 and focus on other programs after cutting a quarter of its staff. On Tuesday, Prime said it now sees the possibility of approval based on the two-patient study alone.”

From the judicial front,

  • STAT News reports,
    • “For the fourth time, federal auditors have turned up improper or potentially improper Medicaid payments in every sample of autism therapy records they audited. This report, focused on Colorado, yielded the highest improper payment amount yet. 
    • “The Department of Health and Human Services’ Office of Inspector General uncovered $285.2 million in improper and potentially improper payments in 2022 and 2023 to clinicians who provide a popular form of autism therapy called applied behavior analysis, or ABA. The payments, administered under Colorado’s Medicaid program, come from the state and federal governments. 
    • “HHS OIG announced in 2022 it would conduct reviews of Medicaid payments to ABA providers in seven states. The first was Indiana, then Wisconsin, and Maine. ABA is a commonly used therapy for managing autism symptoms, but a 2022 STAT investigation found that a rapid influx of private equity investment in the industry has contributed to a crisis of providers routinely overbilling insurers while providing substandard treatment to vulnerable children and families.” 

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • Heard about a lot of people getting flu this winter but not much about covid?
    • It’s not just you. For the second winter in a row, the United States has faced a punishing flu season, with covid as a more muted threat.
    • Early in the covid pandemic, coronavirus proved far more transmissibleand deadly as it ripped through the world than the flu typically was. Flu was almost nonexistent that first pandemic winter in 2020-2021.
    • Now that SARS-CoV-2 is no longer a novel virus sweeping through a population with little immunity, covid and influenza illnesses are becoming more similar, with a key difference: Coronavirus circulates year-round and ticks up in the summer, when flu is gone.
    • “Does that mean flu is now the woe of the winter, and covid is the scourge of the summer? It’s complicated and too soon to say.”
  • The American Hospital Association relates,
    • “The U.S. maternal mortality rate fell to 17.9 deaths per 100,000 live births in 2024, statistically similar to the 2023 rate of 18.6 per 100,000, according to data from the Centers for Disease Control and Prevention. The CDC reported that the maternal mortality rate for Black women in 2024 was 44.8 deaths per 100,000 live births, significantly higher than rates for white (14.2), Hispanic (12.1) and Asian (18.1) women. 
    • “The AHA is committed to safeguarding mothers and babies by eliminating maternal mortality and reducing maternal morbidity. For more on members’ efforts, including case studies, podcasts, webinars and other resources, visit the AHA’s Better Health for Mothers and Babies Initiative webpage.” 
  • The New York Times tells us,
    • “The doctor kept hearing the same story from his patients. After taking GLP-1 weight-loss drugs and finally shedding those excess pounds, some had gone a bit rogue. They began spacing out the shots instead of injecting themselves every week.
    • “And it seemed to be working, said Dr. Mitch Biermann, an obesity and internal medicine specialist at Scripps Clinic in San Diego.
    • “By the time the third person told me they were taking it every second or third week and still maintaining their weight, I started recommending it to other patients,” he said.
    • “Dr. Biermann also conceived a study to test the strategy. Now the results of that research are in: After 36 weeks of follow-up, most of the patients who spaced out their GLP-1 injections kept the weight off and also maintained health benefits like reduced blood pressure and better blood sugar control.
    • “Only four patients gained weight after making the switch, and they quickly reverted back to weekly injections, the report said.
    • “The study was small, only 34 patients in a relatively homogeneous group — mostly white and privately uninsured. And it was done by analyzing their existing medical charts.
    • “Still, the research, published in February in the journal Obesity, provides a potentially appealing new option for patients who are loath to commit to lifelong weekly injections of a costly medication that may not be covered by insurance and that some fear could have unknown side effects.”
  • Medscape informs us,
    • “Viral and bacterial infections’ overlapping symptoms and signs can complicate RSV diagnosis and lead to unnecessary antibiotic prescriptions.
    • “In this study, children who had RSV detected via a rapid antigen test had a 48% lower likelihood of receiving antibiotics within 14 days of diagnosis.
    • ‘Overall, 20% of the kids who tested positive for RSV received at least one antibiotic prescription compared with 40% of those testing negative.”
  • and
    • “Alzheimer’s brain changes progressed up to 20 times faster in women with Alzheimer’s and alpha-synuclein co-pathology compared with men, a cohort study showed.” * * *
    • “The findings suggest that when alpha-synuclein — a protein associated with Parkinson’s and other Lewy body diseases — accumulates alongside Alzheimer’s pathology, it may drive faster Alzheimer’s progression in women.”
  • Health Day points out,
    • “A frequently prescribed atrial fibrillation drug might interact with blood thinners
    • “Diltiazem had a higher rate of serious bleeding events when taken with blood thinners like apixaban or rivaroxaban
    • “Diltiazem interacts with enzymes that play a role in the metabolism of the blood thinners.”
  • Per an NIH news release,
    • “A research team funded by the National Institutes of Health (NIH) has developed a versatile machine learning model that could one day greatly expand what medical scans can tell us about disease. Scientists used their tool, named Merlin, to assess 3D abdominal computed tomography (CT) scans, accomplishing tasks as simple as identifying anatomical features to as complex as predicting disease onset years in advance. Despite being developed as a general-purpose CT model, Merlin surpassed a gauntlet of similar automated tools in tasks they were specifically built to handle.
    • “The team trained their model on a unique set of patient CT scans linked to radiology reports and medical diagnosis codes collected from the Stanford University School of Medicine. The researchers note that it is the largest collection of abdominal CT data to date.  
    • “Rich datasets like this are necessary to push the limits of what artificial intelligence models can accomplish in medicine,” said Bruce Tromberg, Ph.D., director of NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). “This work exemplifies how meticulously crafted training data can enable remarkable insights that significantly streamline workflows and assist in clinical decision-making.” 
  • Genetic Engineering and BioTechnology News adds,
    • “Life is governed by tiers of gene regulation, driven by modulation of RNA polymerase (RNAP) by transcription factors. The second tier is composed of cell signaling cascades and feedback loops. Dissecting gene regulation requires distinguishing transcription factor targets from indirect network effects. 
    • “A new study by The Rockefeller University published in Molecular Cell titled, “Cell-free genomics reveals fundamental regulatory principles of the Mycobacterium tuberculosis transcription cycle,” has revealed fundamental features of the transcription cycle in the bacteria that causes tuberculosis. The study informs the development of new drugs.
    • “Gaining a deep understanding of how transcription works reveals central principles in biology that have huge significance for human health,” said Elizabeth Campbell, PhD, head of the Laboratory of Molecular Pathogenesis at The Rockefeller and corresponding author of the paper. “We can more precisely design therapeutics to target a process if we truly understand it.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “In recent months, payers across the country have tried tightening policies to get a better grip on evaluation/management coding.
    • “While payers often say the policies aim to control costs or combat fraud, these more restrictive policies are often met with provider backlash. [You will find in the article] three insurer policies from the past few months — and where they stand.
  • Fierce Healthcare relates,
    • “Even as its inpatient occupancy surged near the end of 2025, the nation’s largest for-profit hospital system said it has generally managed to avoid revenue-limiting capacity constraints and should continue to do so through 2026 even as its volumes grow. 
    • “HCA Healthcare, with its stock sitting at an all-time pricing high, pleased investors earlier this year when announcing a better-than-expected fourth-quarter performance and bullish 2026 guidance despite hundreds of millions in expected headwinds due to changes in Medicaid policy. 
    • “But, while that quarter’s same-facility equivalent admissions rose 2.5% over the prior year, in line with expectations, its inpatient surgeries remained flat while its outpatient surgical volume dipped by about 1.5%. At the same time, its hospitals were filled to about 73% to 74% capacity, a historical high point that could place strains on the operating efficiency of hospitals pulling the average upward.”
  • Beckers Hospital Review tells us,
    • “Grand Forks, N.D.-based Altru has acquired CHI St. Alexius Health Devils Lake (N.D.) — a 25-bed critical access hospital — from Chicago-based CommonSpirit. The hospital is now known as Altru Hospital Devils Lake, according to a March 2 Altru news release. 
    • “This transition represents an opportunity to make a meaningful difference in the lives of those we serve,” Altru CEO Todd Forkel said in the release. “Over the next several months, we will be expanding services and enhancing care offerings to better meet the needs of this important community.” 
    • “Altru is also in the process of acquiring three more hospitals from CommonSpirit. In January, Altru signed a nonbinding agreement to acquire CHI St. Alexius Health in Bismarck, CHI St. Alexius Health Turtle Lake and CHI St. Alexius Health Garrison (N.D.). If finalized, the move would expand Altru’s footprint further west in North Dakota.
    • “CommonSpirit is also in talks with Pittsburgh-based UPMC to sell Trinity Health System — a three-hospital network based in Steubenville, Ohio. CommonSpirit CFO Michael Browning said on the system’s March 2 investor call that both deals, if approved, could close in 2026.”
  • and
    • “Academic health systems posted a wide range of operating performance in 2025 and early fiscal 2026, with margins spanning from negative territory to double digits. While strong investment returns buoyed bottom lines at many organizations, core operations remain under strain from rising labor, supply and drug costs.
    • “Across these systems, operating margins spanned from -2.6% to 10.7%, highlighting the uneven financial recovery taking shape in academic healthcare. Many organizations saw stronger net income driven by investment returns and nonoperating gains, even as core operating performance remained thin. Expense growth — particularly labor, supplies and drug costs — continues to pressure margins, while scale, integration and restructuring efforts are increasingly shaping financial trajectories across academic healthcare.
    • “{The article shows] how 12 major academic and nonprofit systems stack up based on their most recent financial reports. 
  • Health Day informs us,
    • “Telemedicine appointments aren’t only more convenient, but actually save money for both patients and health care systems, a new study says.
    • “Telemedicine visits are five times less costly than in-person appointments for the most common conditions, researchers recently reported in JAMA Network Open.
    • “On average, telemedicine patients are billed $400 less, researchers found, and are less likely to need follow-up visits after their first appointment.
    • “Before we did this study, there was a common concern that telemedicine might serve only as an easy source of ‘first aid,’ just delaying in-person care and increasing costs overall,” said co-senior researcher Dr. David Asch, senior vice president for strategic initiatives at the University of Pennsylvania.
    • “But we found that wasn’t true, and our work suggests that for many patients, telemedicine can be a complete solution, not just a temporary band-aid,” he said in a news release.”
  • Per Fierce Pharma,
    • “The primary growth drivers in Bayer’s pharma sector—Nubeqa and Kerendia—are performing even better than the company anticipated and their momentum is expected to continue in 2026. But that won’t lead to growth of Bayer’s pharma business overall this year as two contraction drivers—Xarelto and Eylea—are working in the opposite direction. 
    • “This will be the last year of the sector’s “resilience phase,” Bayer’s pharma president Stefan Oelrich said during a quarterly conference call, which will set it up for growth in 2027.”
    • “In a way, Bayer’s pharma business is the company in a microcosm. As the German conglomerate absorbs massive litigation charges related to its disastrous acquisition of Monsanto a decade ago and eyes a potential $7.25 billion settlement of Roundup lawsuits, a rebound is finally in sight.”
  • Per Fierce Healthcare,
    • “Eldercare company Papa is rolling out a new program that leans on its existing companion care services to support quality improvements for health plans.
    • “Called Papa Plus, the company’s network of vetted “Pals” will be able to provide key services that insurers need in addition to their work in addressing social needs of members. These tasks could include assisting a member in scheduling a key wellness visit and then accompanying them to the appointment, providing support after hospital discharge or helping an individual use a telehealth visit.
    • “This builds a direct engagement channel to some of the most vulnerable—and least reachable—patients, Papa said in the announcement, which was shared exclusively with Fierce Healthcare.”

Friday report

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, Telehealth, U.S. Healthcare–

From Washington, DC

  • Fierce Healthcare reports,
    • “The Trump administration has proposed flat rates in Medicare Advantage (MA) for 2027, and insurers argue in new commentary that those levels do not reflect the realities of the program.
    • “In late January, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed advance notice governing MA and Part D. 
    • “The proposal includes a net payment rate increase of 0.09% in MA, meaning levels will be essentially flat if the plan becomes final.
    • “The proposed rule drew immediate ire from the industry, which is already navigating significant financial challenges in this market. Multiple leading players have elected to exit certain MA markets. 
    • “In official comments (PDF) submitted Wednesday to the CMS, the AHIP said the proposed rule “risks undermining CMS’ goal of providing beneficiaries with stable, affordable choices during the annual enrollment period.”
    • “At a time of sharply rising medical costs and high utilization of medical services, the combined effect of the proposed policy changes and growth rates will not keep pace with the cost of caring for seniors in 2027,” the organization, which is the largest lobbying group representing insurers, said in its comment letter.”
  • MedPage Today relates,
    • A top health official at the Centers for Medicare & Medicaid Services (CMS) [Chris Klomp] hedged on payment reform, but committed to helping physicians address prior authorization challenges, during the American Medical Association’s (AMA) National Advocacy Conference.”
  • Per Beckers Health IT,
    • “CMS has rolled out an app directory for Medicare recipients as part of the agency’s push to digitize healthcare.
    • “The Medicare App Library seeks solutions that fall under one of three use cases: “kill the clipboard,” conversational AI assistants, or diabetes and obesity prevention and management.
    • “We are calling on health app developers, tech-enabled organizations, and innovators to voluntarily align around a shared framework for data and access that empowers people, improves care, and accelerates progress,” CMS stated Feb. 23. “This is a movement, not a mandate. It is a call to action, not a regulation. Let’s show what’s possible when we work together — and finally bring healthcare into the modern era.”
  • Federal News Network tells us
    • “Tens of thousands of federal employees at U.S. Customs and Border Protection are expected to continue receiving pay during the Department of Homeland Security’s current funding lapse, according to an email viewed by Federal News Network.
    • “CBP, a component of DHS, plans to use discretionary funding from the One Big Beautiful Bill Act to exempt and continue paying more than 57,600 agency employees who have been working throughout the partial shutdown this month. Details of the agency’s decision come from an email sent this week by the National Treasury Employees Union, obtained by Federal News Network.
    • “Under the current shutdown, CBP will “exempt” and provide pay to a large portion of its workforce, including law enforcement personnel and certain civilian agency employees. Some other CBP employees, however, are still considered “excepted” and will not receive pay until after the shutdown ends.”
  • MedTech Dive informs us,
    • “The Trump administration is imposing a six-month moratorium on Medicare enrollment for certain suppliers of durable medical equipment, prosthetics and orthotics, or DMEPOS, as part of a broader plan to combat fraud in healthcare.
    • “The administration said Wednesday that the nationwide halt on enrollment would give the government time to consider more actions “to further mitigate longstanding instances of fraud, waste, and abuse perpetrated by certain DMEPOS companies.”
    • “The temporary freeze applies to all applications for initial enrollment and changes in majority ownership for medical supply companies.
    • “Durable medical equipment includes items such as walkers, wheelchairs, oxygen equipment, hospital beds, continuous positive airway pressure machines and blood sugar monitors.”
  • NCQA, writing in LinkedIn, announced its “Advanced Primary Care Pilot Program” and invited readers to “Meet Our Primary Care Partners!”
  • The Labor Department’s Employee Benefits Security Administration let us know about extending the public comment period on its proposed Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure rule to April 15, 2026.

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “The Food and Drug Administration on Tuesday posted a warning letter sent to Beta Bionics in late January.
    • “The letter raised concerns with how the diabetes tech company handled complaints of severe low and high blood sugar associated with its automated insulin delivery system. The FDA also flagged problems with the company making modifications to its device without notifying regulators.
    • “In an annual report filed Tuesday, the company said it has already taken several corrective actions, including improvements to the processes identified in the warning letter. The company is also preparing a written response to the letter.”
  • Cadiovascular Business informs us,
    • “Cara Medical, a medtech company focused on advanced imaging technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its new platform that noninvasively visualizes a patient’s cardiac conduction system.
    • “The CARA System, which previously earned the FDA’s breakthrough device designation, was designed to help interventional cardiologists and electrophysiologists plan ahead before procedures and then guide them during treatment. It can be used for structural heart interventions such as transcatheter aortic valve replacement (TAVR) as well as pacing procedures.
    • “The newly cleared system includes two primary components. The CARA Metis Simulator is a preprocedural planning software that identifies the cardiac conduction axis on CT angiography results and generates a 3D map of the patient’s conduction system. The CARA Atlas Navigator, meanwhile, overlays that map onto live fluoroscopic images to assist with intraprocedural guidance. 
    • “Artificial intelligence (AI) algorithms play a role in both components, extracting metadata and detecting the user’s catheter for visualization, but all AI calculations can still be confirmed by a physician.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country.
      • “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 and hospitalizations among infants and children 4 years and younger.
    • Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) has ended its investigation into the recent multistate infant botulism outbreak traced to ByHeart powdered formula and lowered the total case number by three. In a Public Health Alert issued earlier this week, California, CDC, and Food and Drug Administration scientists reported 51 infections, but yesterday the CDC said it has excluded three suspected cases, for a total of 48 (28 confirmed, 20 probable) in November and December 2025. While the outbreak is over, investigators continue to probe how Clostridium botulinum bacteria got into the formula, the CDC said.
    • “A report published yesterday in the CDC’s Morbidity and Mortality Weekly Report describes how officials used artificial intelligence (AI) to identify contaminated ice in a beer cooler as the source of a 2024 Salmonella enterica outbreak at a county fair. Ice is an uncommon vehicle for Salmonella spread at public events, noted author Katherine Houser, RN, of the Brown County Health Department in Mount Sterling, Illinois. The outbreak sickened 13 people (seven confirmed, six probable cases). AI tools helped synthesize background information to support and contextualize the environmental health team’s assessment, Houser said.”
  • The CDC also announced today,
    • “As of February 26, 2026, 1,136 confirmed* measles cases were reported in the United States in 2026. Among these, 1,130 measles cases were reported by 28 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 10 new outbreaks** reported in 2026, and 90% of confirmed cases (1,023 of 1,136) are outbreak-associated (152 from outbreaks starting in 2026 and 871 from outbreaks that started in 2025).”
  • MedPage Today informs us,
    • “Identical stool samples sent to seven direct-to-consumer microbiome testing companies produced substantially different bacterial profiles and health assessments.
    • “Across 18 commonly reported microbial genera, no company’s results matched the consensus; and only three genera of 1,208 identified taxa appeared in every report.
    • “Researchers attributed the discrepancies to differences in laboratory methods and analysis pipelines, and say the results underscore the need for standardized testing and quality controls.”
  • The Wall Street Journal considers
    • “Why All The Fuss About Bone Density?
    • “Like most of my peers, I’m being bombarded daily with hectoring advice about my bones. What’s a 40-something woman to do?” * * *
    • “For guidance, [the journalist] consult[s] with Dr. Karen Tang, the author of “It’s Not Hysteria: Everything You Need to Know About Your Reproductive Health (but Were Never Told),” who offers a more measured take.” 
  • Medscape adds,
    • “A low-dose, single pill that combines three antihypertensive treatments is as effective as standard-dose monotherapy — in some cases even better — for treating mild-to-moderate hypertension, according to the first phase 3 double-blind trials comparing the medications.
    • “Investigators for the HM-APOLLO-301 and HM-APOLLO-302 phase 3 clinical trials, which were published in the Journal of the American College of Cardiology, contend there is now concrete evidence to support the efficacy of the single-pill therapy.
    • “They argue that starting with the traditional single-agent therapy and then titrating up can delay blood pressure control, increase the possibility of adverse effects, and affect patient adherence.”
  • The University of Minnesota’s CIDRAP relates,
    • “The results of a randomized controlled trial (RCT) indicate that meningococcal B vaccine is not effective at preventing gonorrhea infection in high-risk groups.
    • “The results, presented this week at the Conference on Retroviruses and Infections by a team of Australian researchers, show that among gay and bisexual men with a history of gonorrhea infection who received either the 4CMenB vaccine or placebo, gonorrhea incidence was essentially the same—roughly 48% in both arms.
    • “The 4CMenB vaccine is designed to protect against four serogroups of Neisseria meningitidis, which can cause invasive meningococcal disease. But in recent years, observational studies have suggested 4CMenB might also provide moderate cross-protection against Neisseria gonorrhoeae, the bacterium that causes gonorrhea—one of the most common sexually transmitted infections (STIs) worldwide.” 
  • Genetic Engineering and Biotechnology News reports,
    • “CAR T cell therapy has revolutionized the treatment of many blood cancers, but has shown little success against solid tumors, which account for more than 85% of all cancers.
    • “Columbia University researchers have now developed a new form of highly sensitive CAR T cells, known as HIT T cells, that aims to overcome one of the biggest barriers in solid tumor immunotherapies, which is the way that solid tumors lack a single, widely shared surface target.
    • “Headed by Michel Sadelain, MD, PhD, director Columbia Initiative in Cell Engineering and Therapy (CICET), the researchers engineered an ultra-sensitive and highly selective chimeric antigen receptor called an HLA-independent T cell (HIT) receptor, which is capable of detecting even the smallest amounts of the protein CD70 on tumor cells.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance is consolidating control of its health insurance businesses under Felicia Norwood, its head of government benefits, as the company looks to improve coordination across its Medicaid, Medicare and commercial plans and — hopefully — bolster waning profits.
    • “Mark Kaye, Elevance’s CFO, will also take on leadership of health services division Carelon as current president Peter Haytaian leaves to spend more time with his family, according to a press release Thursday announcing the executive changes.
    • “Haytaian will leave the role effective May 4 and stay on as an advisor through the end of the year. The executive first joined Elevance in 2012 through its acquisition of Amerigroup before becoming president of Carelon in 2021.”
  • Beckers Payer Issues adds,
    • “Longtime UnitedHealth Group executive Heather Cianfrocco is leaving the company.
    • Ms. Cianfrocco has served as executive vice president of governance, compliance and information security at UnitedHealth since April 2025. She briefly served as CEO of Optum from 2024 to 2025 before being succeeded by Patrick Conway, MD, who previously led Optum Rx. 
    • “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she wrote on LinkedIn Feb. 27. “I am leaving with so much pride in what we have accomplished together. I’ve had the privilege of working alongside some of the most talented, mission-driven people who show up every day determined to make health care easier to navigate, more affordable and more human.”
  • Beckers Hospital Review notes,
    • “CVS Caremark is expanding its use of Surescripts’ Touchless Prior Authorization platform to accelerate approvals for select specialty medications.
    • “The prior authorization technology connects directly to patients’ EHRs to gather required clinical data and match it with prior authorization criteria, according to a Feb. 25 news release. When requirements are met, CVS Caremark can approve medications automatically in as little as 22 seconds.
    • “The platform is currently used for select specialty drugs, including Vivitrol and Epidiolex, which treat substance use disorder and epilepsy. These medications typically require complex approvals because of their high impact and specialized clinical use cases.”
  • Healthcare Dive tells us,
    • “Teladoc Health projects membership in its business-to-business integrated care unit will decline this year, in part due to the expiration of enhanced Affordable Care Act subsidies, management said during a fourth-quarter earnings call Wednesday.
    • “The company expects 97 million to 100 million members in U.S. integrated care in 2026, down from 101.8 million at the end of last year. 
    • ‘Teladoc expects the decline will be driven by enrollment reductions at some client health plans in government programs, which were impacted by the lapse of more generous financial assistance for ACA coverage, CEO Chuck Divita said on the call.”
  • Fierce Healthcare adds,
    • “Walgreens is wading into the self-pay GLP-1 space, going head-to-head with telehealth subscription offerings.
    • “The retail pharmacy giant launched a digital weight management service to offer access to personalized, clinician-guided support for weight loss. The service expands Walgreens’ virtual healthcare platform and provides patients with access to licensed doctors and nurse practitioners, FDA-approved medication options and ongoing virtual support, according to the company in a press release.
    • “Virtual visits through the weight management service cost $49 with no requirement for a monthly subscription. The program, currently available in 28 states, is intended for eligible overweight and obese adults ages 18-64 who plan to self-pay for their GLP-1 medication.”
  • Healthexec summarizes news from “the 2026 ViVE conference, part of HLTH, [which] just wrapped up in California. On the show floor, people from across the healthcare and health IT space gathered for four days of events, thought leader insights and product showcases on the floors of the Los Angeles Convention Center. 

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec.com reports,
    • “While the Homeland Security Department is shut down, the vast majority of employees—about 92%—are still reporting to work. In some cases, however, workers are finding creative solutions to get out of their regular duties and save money while their paychecks hang in the balance. 
    • “My unit is rotating voluntary furlough days,” said one DHS staffer.  “Workers in that office are taking turns to take time off work, which, during a shutdown, entails being placed in an unpaid furlough status. 
    • “[We] conserve finances by not commuting, since we’re only allowed to telework in emergency situations,” the employee said, noting some employees in the unit commute 80 miles per day and are therefore seeing significant savings on gas when they do not go to work. The employees who accept the furloughs have used the time to schedule medical appointments, handle errands or tackle home projects.” * * *
    • “Most DHS employees will not miss a full paycheck until the beginning of March. Craig Carter, president of the Federal Managers Association, said the impacts are already being felt across the DHS workforce.” 
  • The OPM Office of Inspector General has posted its semi-annual report to Congress for the period ended September 30, 2025. Here is a link to the OPM management’s response to this report.
  • Legistorm tells us about GAO report number GAO-26-107169 which was issued yesterday.
    • “What GAO Found
      • “The No Surprises Act, among its provisions, generally prohibits providers from balance billing in certain circumstances—such as emergency services—for individuals with private health insurance. Balance billing is when insured patients receive a bill from an out-of-network health care provider for the amount above any applicable cost-sharing that exceeds the health plan or issuer’s payment. An unexpected balance bill is referred to as a surprise bill.
      • “GAO analyzed the percentage of claims that were in-network for selected specialties to examine potential changes in network participation after the act’s implementation. Increases in the percentage of in-network claims may indicate increases in provider participation, while decreases may indicate reduced participation.
      • “Among specialties likely to be affected by the No Suprises Act protections—emergency medicine, radiology, anesthesiology, and air ambulance—the percentage of in-network claims increased for three of the four specialties after the act took effect. For example, GAO found the percentage of in-network facility claims (typically submitted by hospitals) and professional claims (typically submitted by physicians) for emergency medicine declined before the No Surprises Act took effect, then increased afterward.
      • “Payment changes for the selected services largely reflected continuations of trends prior to the No Surprises Act taking effect. For example, the inflation-adjusted payment for in-network emergency medicine services billed by facilities increased in 2022 and 2023, continuing the trend since 2019. Meanwhile, the inflation-adjusted payment for in-network emergency services billed by physicians or their practices decreased in 2022 and 2023, continuing previous trends.”
    • FEHBlog note: This is encouraging news.
  • NCQA writes in LinkedIn
    • “NCQA has updated its State of Health Care Quality Report to include data for HEDIS® Measurement Year (MY) 2024. This free resource, available on the NCQA website, offers valuable insight into healthcare quality performance nationwide.
    • “You can use this report to:
      • “Learn more about each quality measure, how it is defined and why it matters.
      • “Access national averages and historical trends for over 90 measures of clinical quality and patient satisfaction.
      • “Compare performance across different products, like Commercial, Medicare and Medicaid.
      • “We will add data for MY 2025 in February 2027, or you can get it sooner through NCQA’s Quality Compass®.
    • “The report is available through this link. You can also find a link to the report on the HEDIS Measures and Technical Resources web page.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV.
    • “Høeg told employees on Thursday that her top priorities include two issues she’s focused on in the recent past: evaluating the safety of antidepressants taken by pregnant women and of monoclonal antibodies that protect infants against RSV.
    • “I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job,” Høeg said. “I actually think that there’s agreement about that, and among the CDER staff that I’ve been working with on this issue, so I’m excited to see that.”
    • “Høeg also discussed her interest in vaccine policy, and mentioned she’d like to “bring that interest” into the drug center.”
  • Radiology Business relates,
    • “GE HealthCare has secured three notable new MRI clearances from the U.S. Food and Drug Administration. 
    • “On Thursday, the company announced the clearance of two MRI systems, Signa Sprint with Freelium and Signa Bolt, and one artificial intelligence-enabled workflow platform. Each of the three cleared produts were designed with the rising demand for MR imaging in mind, according to the company’s president and CEO of MR, Kelly Londy. 
    • “Achieving FDA clearance of our next-generation Signa MRI technology underscores our commitment to expanding access to high-quality imaging and elevating the standard of care for patients everywhere,” Londy said in an announcement. “As MRI demand continues to rise across clinical areas, providers need solutions that deliver greater efficiency without compromising diagnostic precision.”
  • BioPharma Dive informs us,
    • “Roche said Friday that the Food and Drug Administration will decide by Dec. 18 whether to approve its experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications.  
    • “Roche’s submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the “adjuvant” setting after surgery. 
    • “If approved, giredestrant would become the third new oral “SERD” on the market, following clearances for Menarini Group’s Orserdu and Eli Lilly’s Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class’ commercial outlook.”

From the judicial front,

  • The American Hospital Association News reports,
    • The Supreme Court Feb. 20 ruled [in a 6-3 opinion written by the Chief Justice] that the International Emergency Economic Powers Act [of 1977] does not authorize the imposition of global tariffs. The court held that IEEPA does not provide the president with “the independent power to impose tariffs on imports from any country, of any product, at any rate, for any amount of time.” The court did not address whether the government will have to refund the tariff revenue or what other legal authorities the president may have to impose similar tariffs. [The Court remanded those decisions to the lower courts.]
  • Bloomberg Law reports,
    • “The FTC has asked a federal appeals court to revive requirements for companies to divulge more information to US antitrust regulators ahead of potential mergers.
    • “The Federal Trade Commission Wednesday appealed a Feb. 12 decision from a US district court judge in Texas blocking a 2024 Biden-era rule. The case is pending in the US Court of Appeals for the Fifth Circuit.
    • “The regulation updated a decades-old US pre-merger notification program to require companies share more about overlapping business lines and ownership structures, among other details. Companies seeking combinations valued at $133.9 million or more must undergo an initial 30-day review by the FTC and Justice Department under the notice system.”
  • and
    • “The [U.S. Court of Appeals for the] First Circuit rejected a lawsuit accusing Cigna Health & Life Insurance Co. of obesity discrimination, shutting down an attempt to broaden coverage of blockbuster GLP-1 weight-loss drugs.
    • “Pressure to cover the drugs is growing for insurers and employers as their uptake among the general public increases. One in five adults has taken a GLP-1 drug at some point, according to a November 2025 poll from health-care think tank KFF.
    • “The US District Court for the District of Maine previously dismissed Jamie Whittemore’s case, along with a similar case against Elevance Health Inc. The district judges determined that Whittemore didn’t prove that obesity qualified her as disabled.” * * *
    • “Here, even if Whittemore plausibly alleged that obesity is a physical impairment, she failed to allege sufficient facts to support an inference that her obesity substantially limits her major life activities,” Judges Lara E. Montecalvo, Sandra L. Lynch, and Ojetta Rogeriee Thompson wrote in their opinion Thursday.”
  • Per a Justice Department news release,
    • “The Justice Department’s Antitrust Division, together with the Attorney General of Ohio, filed a civil antitrust lawsuit today challenging OhioHealth Corporation’s (OhioHealth) anticompetitive contract restrictions that force Ohio patients to pay higher prices for healthcare.
    • “The complaint, filed in the U.S. District Court for the Southern District of Ohio, seeks to enjoin OhioHealth, the largest healthcare system in central Ohio, from enforcing its anticompetitive contractual terms and continuing to suppress healthcare competition.”
  • Per Beckers Payer Issues,
    • “An insurance brokerage president and the CEO of a marketing company were each sentenced to 20 years in prison for their roles in a scheme to fraudulently enroll individuals in subsidized ACA plans to obtain commission payments from insurers.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits for RSV are highest among infants and children less than 4 years old. RSV hospitalizations are highest among infants and children less than 4 years old. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country; however, trends vary by region.
      • “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 and children 4 years and younger. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Feb. 19 released a report on the low use of COVID-19 antiviral drugs among individuals age 65 and older, a population at high risk of severe illness from the disease. The report found that from June 2023 through September 2025, 16%-23% of COVID-19 patients older than 65 received an antiviral prescription during low occurrences of COVID-19, compared to 37%-38% during higher occurrences. Adults ages 75-84 and 85 and older were more likely to receive an antiviral prescription than those ages 65-74. “COVID-19 vaccination and treatment can prevent severe COVID-19 among older adults,” the CDC wrote. “Efforts to improve health care provider and patient knowledge regarding the benefits of COVID-19 vaccination and antivirals, especially for older adults, are needed to reduce the risk for severe illness and death.”
  • The University of Minnesota’s CIDRAP adds,
    • “Two studies examined the effects of COVID-19 vaccination in pregnancy, with one estimating that full vaccination and a booster dose reduce the risk of preeclampsia (PE) by 15% and 33%, respectively, and the other finding no elevated risk of miscarriage before 20 weeks’ gestation among pregnant or soon-to-be-pregnant recipients of the Pfizer/BioNTech or Moderna vaccines.”
  • The CDC also announced,
    • “As of February 19, 2026, 982 confirmed* measles cases were reported in the United States in 2026. Among these, 976 measles cases were reported by 26 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New York City, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 7 new outbreaks** reported in 2026, and 89% of confirmed cases (870 of 982) are outbreak-associated (73 from outbreaks starting in 2026 and 797 from outbreaks that started in 2025).”
  • The University of Minnesota’s CIDRAP adds,
    • “Utah has confirmed 300 measles cases in an ongoing outbreak, with the virus now spreading in Salt Lake County and new exposures at high schools in that county, according to an update yesterday from the Salt Lake County Health Department (SLCoHD).
    • “The first measles symptoms are often cold- or flu-like, with cough, runny nose, red/watery eyes, and fever, so you may think you have a common respiratory illness and can continue engaging in normal activities,” said Dorothy Adams, executive director of SLCoHD. “But please stay home if you have any signs of illness, especially now that we know measles is actively circulating in our community.”
  • Per the AHA News,
    • “The ongoing measles outbreak in South Carolina has reached 973 cases, the state’s Department of Public Health reported Feb. 20. Of those, 906 cases are unvaccinated, 26 are fully vaccinated, 20 are partially vaccinated and the vaccination status of 21 cases is unknown. Nationally, 982 confirmed measles cases across 26 jurisdictions have been reported to the Centers for Disease Control and Prevention since Jan. 1. The CDC said there have been seven outbreaks reported in 2026 and that 89% of confirmed cases are outbreak-associated.” 
  • Cardiovascular Business informs us,
    • “The American College of Cardiology (ACC) and American Heart Association (AHA) have developed their first clinical practice guidelines focused on the treatment and management of acute pulmonary embolism (PE). The new document, published in full in JACC and Circulation, highlights the importance of diagnosing patients as quickly as possible and determining the best course of action.
    • “A PE is a potentially fatal blood clot that travels through the heart and then becomes lodged in an artery in the lungs. Treating PEs quickly—and effectively—can help minimize the patient’s risk of death and cardiac arrest. Anticoagulants are the most common PE treatment, but catheter-based interventions and surgery may be necessary for more severe cases.
    • “There have been significant advances in the understanding of PE and treatments to effectively manage this condition,” Mark A. Creager, MD, chair of the document’s writing committee and director emeritus of the Heart and Vascular Center at Dartmouth Health, said in a statement. “This guideline is a road map to help clinicians navigate these advances for the safest and most effective approaches to care for people with this condition.”
  • Per Radiology Business,
    • “New research highlights the potential for a PET- and MRI-based imaging approach for differentiating a new type of dementia from Alzheimer’s disease. 
    • “Limbic-predominant age-related TDP-43 encephalopathy, also known as LATE, was recently recognized as a type of dementia that occurs in older adults, typically presenting as memory-related cognitive decline. Due to its impact on memory, it is often mistaken for AD. 
    • “However, both LATE and Alzheimer’s present differently on imaging. While AD is identified due to the accumulation of amyloid and tau proteins on the brain, LATE involves clumps of the protein TDP-43 in the limbic system. It is important to differentiate between the two due to the differing treatment methods for each. 
    • ‘A new paper in the Journal of Nuclear Medicine describes how combining PET and MRI imaging data can help distinguish between the two in living patients. 
    • “The distinction in the causes of these types of dementia is critical, especially in the era of anti-amyloid therapies,” Satoshi Minoshima, MD, PhD, professor of radiology and imaging sciences at the University of Utah, Salt Lake City, said in a news release. “Because LATE has a different underlying pathology and a seemingly different prognosis, it cannot be diagnosed or treated in the same way as Alzheimer’s disease.” 
  • The University of Connecticut, the FEHBlog’s alma mater, writes in LinkedIn about research on Parkinson’s Disease treatments.
  • Per BioPharma Dive,
    • “Grail’s multi-cancer early detection test failed to meet its primary endpoint in a key study, sending the company’s shares tumbling about 50% in Friday trading.
    • “The NHS-Galleri trial evaluated annual screening with the Galleri MCED test in England’s National Health Service over three years in 142,000 asymptomatic participants aged 50 to 77.
    • “Grail said the study aimed to show testing could help reduce late-stage cancer diagnoses and increase detection rates to support national screening in England. A U.S. premarket approval application for Galleri, submitted earlier this month, includes data from the trial on test performance, clinical validation and benefit of detection at stages I through III, including reduction in stage IV cancer diagnoses, the company said.”
  • Per Health Day,
    • “An ancient Chinese mind-body practice can lower a person’s blood pressure as well as medication or a program of brisk walking, a new study says.
    • “Baduanjin is a widely practiced eight-movement sequence that combines slow, structured movement, deep breathing and meditation.
    • “The practice lowered people’s blood pressure by about 3 to 5 points, similar to benefits sustained by people asked to take up walking, according to clinical trial results published Feb. 18 in the Journal of the American College of Cardiology.”
  • Per Genetic Engineering and Biotechnology News,
    • “Stanford Medicine researchers and collaborators have developed a universal vaccine candidate that studies in mice suggest protects against a wide range of respiratory viruses, bacteria, and even allergens. Unlike any vaccine used today, the new vaccine, delivered intranasally, was found to provide broad protection in the lungs for several months. The novel vaccination strategy integrates the two branches of immunity—innate and adaptive—creating a feedback loop that sustains a broad immune response.
    • “The research team, headed by Bali Pulendran, PhD, the Violetta L. Horton Professor II, director of the Institute for Immunity, Transplantation and Infection, and a professor of pathology, microbiology and immunology at Stanford University, demonstrated that vaccinated mice were protected against SARS-CoV-2 and other coronaviruses,  Staphylococcus aureus and Acinetobacter baumannii (common hospital-acquired infections), and house dust mite allergen. Pulendran said the new vaccine has worked for a remarkably wide spectrum of respiratory threats that the researchers tested. Speaking to GEN, Pulendran emphasized that the reported work is preclinical, and the team’s goal is to translate their research carefully and responsibly. “If it ultimately proves safe and effective in humans, the potential impact could be transformative: simplifying seasonal vaccination and improving readiness for emerging respiratory threats,” Pulendran said.”

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

  • Beckers Payer Issues reports,
    • “Medicare Advantage now covers about 55% of eligible beneficiaries nationwide — more than 35 million people — but health systems are confronting a question that until recently felt almost taboo: What happens when participation in the country’s fastest-growing Medicare program no longer makes financial sense?
    • “Over the past three years, Becker’s has reported on roughly 90 hospitals and health systems that have terminated some or all of their commercial Medicare Advantage contracts. In 2026 alone, at least 15 systems have gone out of network with one or more Medicare Advantage plans, and the trend is showing no signs of slowing down. 
    • ‘This year, 1 in 10 Medicare Advantage enrollees — about 2.9 million people — will be forced to disenroll from their plan following a spike in plans exiting the market, according to a Feb. 18 study published in JAMA.
    • “Behind many of those decisions lies what Scripps Health CFO Brett Tande describes as a classic “sunk-cost” dilemma: after years of building infrastructure, staffing and strategy around Medicare Advantage, can systems realistically walk away — even when contracts are losing money?
    • “For a growing number of health systems, the answer is becoming clearer.
    • “Becker’s connected with executives from Providence, Scripps Health, Ascension, MemorialCare and Mayo Clinic to understand how they are reassessing their participation in Medicare Advantage and what that shift could mean for providers, payers and patients.”
  • Kaufmann Hall notes,
    • “Partnerships, like all relationships, are de facto collaborative. Certain success factors are well known, including the importance of cultural alignment, constant communication and effective post-closing integration. Based on our collective experience assisting health systems with the negotiation of strategic partnerships, we share other lessons learned that are important considerations. These are tangible steps that require intentional focus and may require hard choices during the partnership development process but are important for ensuring long-term success. We hope these “inside baseball” lessons and case studies are useful for organizations when negotiating their next strategic partnership.”
  • and
    • “Amazon last week announced it would expand its same-day pharmacy delivery service to 4,500 cities nationwide. The move expands Amazon’s market share against other drug delivery providers like Walmart and CVS Caremark. It adds same-day delivery services to 2,000 communities, including remote areas in Alaska, the Navajo Nation and islands only accessible by ferry and only navigable by horse-drawn carriage. The expansion demonstrates the retail giant’s ability to scale its logistics network in healthcare, offering faster access to medications compared with traditional mail-order pharmacies, which can take up to 10 days to deliver drugs.”
  • Behavioral Health Business relates,
    • “Madison Health Group (MHG) has announced its plans to purchase managed behavioral health provider Magellan Health.
    • “This comes roughly five years after payer giant Centene Corporation (NYSE: CNC) bought Magellan Health at a valuation of $2.2 billion.
    • ​”Magellan Health manages behavioral health services for health plans, employers and government agencies.
    • ​”Following the deal, Magellan will become an independent organization, with MHG’s backing to support innovation. Specifically, the new funds will be used to expand its clinical programs into new markets, leveraging “enhanced technology, AI, data and analytical solutions” for its clients, according to social media posts.”
  • Fierce Healthcare tells us,
    • “Carrot is expanding its parenting benefits with on-demand virtual pediatric care through Blueberry Pediatrics. 
    • “Carrot, a fertility and family-building benefits platform working with payers and employers, will offer Blueberry as an add-on. The new offering will be available to families with kids under 12. It is expected to roll out in the next few months. The offering will be covered by the plan sponsor, and members are not expected to incur out-of-pocket costs.
    • ‘Parents will have 24/7 access to on-demand virtual visits with board-certified pediatricians from Blueberry for common issues like ear infections, rashes, colds and the flu. Families can connect with pediatricians around the clock via secure messaging, video or audio. Members will also get a home medical kit with a wireless digital ear scope, pediatric pulse oximeter and thermometer. This will help Blueberry clinicians remotely assess children.”
  • Per Modern Healthcare,
    • “Early lessons are emerging as the digital health sector’s ambient AI focus shifts from clinical documentation to prior authorization.
    • “Companies such as Abridge, Suki and Cohere say their solutions can do for prior authorization what ambient AI has done for documentation and clinician burnout. The importance of partnerships become an integral part of their efforts in this area.
    • “In August, Abridge announced a partnership with Pittsburgh-based insurer Highmark Health and its integrated health system Alleghany Health Network to develop a tool that would approve prior authorization requests at the point of care. Prior authorization was the logical next step for Abridge after clinical documentation, said Clinical Strategy Principal Matt Troup.
    • “Six months in, the collaboration has shown the importance of building connections with providers and payers when developing ambient AI for prior authorization.
    • “[Our partnership] just gave us access to bring everyone to the table, to figure out, what we can possibly do in this space,” Troup said. “Is it actually possible to get these approvals in real-time, upstream in the conversation, if both the payer and provider are aligned on the impact that this can have in healthcare.” 

Tuesday Report

David Ermer–Congress, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, HSA, Medical / Rx research, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports.
    • “The Congressional Budget Office last week put out an “are you sitting down?” report that projected the U.S. government will spend $1 trillion on interest payments for its debt this year. One. Trillion. Dollars. To finance its gigantic and growing debt. And it will only get worse from there.
    • “It also projected that the U.S. government will spend $1.853 trillion more than it brings in through revenue this year (that’s the budget deficit) and have an even wider gap in 2027. Talks of slashing spending and making difficult choices last year have given way to election-year spending-increase promises in 2026. Perhaps complicating matters more, DOGE never really caught on in 2025, and Republicans seem reluctant to repeat that experiment any time soon.
    • “Budget angst tends to come in waves, but the debt never stops growing. I wrote about the $13.7 trillion debt here in 2010. That was $25 trillion ago.”
  • and
    • “The [Homeland Security Department] shutdown enters Day 4, with little chance of an end in sight after Congress failed to reach a deal on immigration-enforcement policies.”
  • Federal News Network reminds us about the bipartisan federal employment bills brewing in Congress.
  • Last Friday, the HHS Office for Civil Rights posted model HIPAA notices of privacy practices that were update for the Part 2 changes.
  • Navia Benefits lets us know,
    • “Health Savings Accounts (HSAs) have traditionally been viewed as a tax-advantaged way to pay for out-of-pocket medical expenses. But today’s data tells a much bigger story: they can function as a powerful financial wellness tool.
    • “HSAs are increasingly operating like powerful long-term investment vehicles rather than just spending accounts. Yet misconceptions persist across the workforce, and employee education continues to lag. With rising healthcare costs and growing financial pressures, it is a good time to elevate the HSA conversation.
    • [Navia’s article] examines the triple tax advantages, workforce perception trends, and evidence-based insights to guide employers in maximizing HSA participation and value.

From the Food and Drug Administration front,

  • Per a Senate news release,
    • :U.S. Senator Bill Cassidy, M.D. (R-LA), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a landmark report detailing legislative and regulatory reforms to modernize the Food and Drug Administration (FDA). These proposals aim to maintain American biomedical dominance and ensure patients have timely access to the latest lifesaving treatments. The HELP Committee’s recommendations are directly in line with President Trump’s mission to improve the health of American children and families.
  • Fierce Pharma tells us,
    • “Harmony Biosciences is rounding out the U.S. patient pool eligible for its sleep disorder pill Wakix after notching a pediatric nod from the FDA that positions the drug as a treatment for cataplexy in people ages 6 and older with narcolepsy.
    • “The new addition to Wakix’s label makes it the only non-scheduled treatment for both adult and pediatric narcolepsy patients in the U.S. with or without cataplexy. That non-scheduled classification represents an “important distinction that supports its clinical utility,” Harmony’s CEO, Jeffrey Dayno, M.D., commented in a press release. Cataplexy is a common symptom of narcolepsy that involves a sudden weakening of muscles, often when triggered by a strong emotion.”
  • and
    • “Two months after Johnson & Johnson’s Rybrevant Faspro picked up its first FDA approval, the subcutaneous lung cancer drug has scored a label expansion to be given monthly.
    • “On Tuesday, J&J touted a “simplified” monthly dosing regimen for the drug’s combination with lazertinib for the first-line treatment of epidermal growth factor receptor EGFR-mutated advanced non-small cell lung cancer. Previously, the combo was approvedas an every-two-week regimen.
    • “For weeks 1 through 4, patients must still receive weekly doses of Rybrevant Faspro. Beginning week 5, the doses can shift to monthly administration.”

From the judicial front,

  • The Wall Street Journal reports,
    • “Bayer BAYN is making a new multibillion-dollar push to resolve a years long legal nightmare over Roundup weedkiller.
    • “The German pharmaceutical and agriculture conglomerate on Tuesday said it proposed to settle a nationwide class-action lawsuit to resolve claims that its flagship herbicide causes cancer. The settlement plan includes setting aside more than $7 billion to fund payments over 21 years. 
    • “Law firms representing tens of thousands of plaintiffs filed a motion Tuesday seeking approval of the settlement. The proposal requires court approval in Missouri, where the bulk of Roundup cases are outstanding.” 

From the public health and medical / Rx research front,

  • Patient Care reports,
    • “New data from the 2026 Primary Care Scorecard highlight measurable associations between regular primary care access and improved outcomes for patients with chronic disease.
    • “In the interview, Morgan McDonald, MD, National Director for Population Health at the Milbank Memorial Fund and practicing primary care internist and pediatrician, outlined key findings relevant to frontline clinicians.
    • “Among adults with chronic disease, having a usual source of care was associated with:
      • 20% lower hospitalization rates
      • 54% lower total cost of care
    • “For children with chronic disease, reductions in emergency department visits and hospitalizations for ambulatory care–sensitive conditions—such as pneumonia and otitis media—were “cut roughly in half.”
    • “The report also reinforces primary care’s role in prevention. Nearly all adults with a usual source of care received preventive services for conditions such as cardiovascular disease and common cancers, compared with approximately two-thirds of adults without a regular source of care. Similar trends were observed in pediatric populations, including higher receipt of counseling related to nutrition, exercise, injury prevention, and obesity prevention.”
  • Infectious Disease Advisor tells us,
    • “Low rates of diagnostic testing for respiratory syncytial virus in adult outpatient settings may result in an underestimated disease burden, potentially impeding the effective use of novel vaccines and therapeutic interventions.” 
  • MedPage Today informs us,
    • “Health systems where most pregnant patients have a high or moderate risk for preeclampsia may benefit from universal dispensation of aspirin, results from a large cohort study suggested.
    • “The rate of preeclampsia with severe features at a Texas health system was a relative 29% lower after it implemented universal aspirin dispensation in prenatal care compared with the period when aspirin was not recommended, regardless of risk factors (5.2% vs 7.1%; OR 0.71, 0.66-0.78, P<0.001), Elaine Duryea, MD, of University of Texas Southwestern Medical Center in Dallas, reported here.”
  • Medscape points out the top ten triggers for pancreatic cancer which is “an often silent disease.”
  • STAT News reports,
    • “Compass Pathways on Tuesday disclosed results from two Phase 3 studies that support a potential approval of its psilocybin treatment for severe depression, but more detailed data are needed to determine how beneficial the drug would be for patients.
    • “In both trials, patients who received the company’s psychedelic medicine saw greater improvements on a measure of depression than the control group, Compass said in a press release. Its drug, called COMP360, could be the first psilocybin product on the market and the second psychedelic approved after Johnson & Johnson’s Spravato, a ketamine derivative.
    • “Taken together, the data “probably meets the bar for approval. It doesn’t shout out to you that this is miraculous,” said Jerry Rosenbaum, director of Massachusetts General Hospital’s Center for Neuroscience of Psychedelics, who was not involved with the study.”
  • and
    • Ocular Therapeutix said Tuesday that its experimental treatment, called Axpaxli, maintained vision with less frequent injections compared to a standard treatment for patients with a common cause of age-related blindness — achieving the primary goal of a late-stage clinical trial. 
    • “However, the difference in the durability of treatment between Axpaxli and the active control in the study was narrower than investors expected — a finding that may spark debate about Axpaxli’s commercial potential in wet age-related macular degeneration, where effective drugs are already approved.”
  • Fierce Pharma adds,
    • “Continuing the reinvention of its cancer drug Gazyva as a treatment for immune-mediated diseases of the kidney—which resulted in a lupus nephritis nod last fall—Roche is touting new data that could tee up the antibody for a world-first approval.
    • “In an early look at results from the late-stage Majesty study in adults with primary membranous nephropathy, Gazyva (obinutuzumab) helped significantly more patients achieve complete remission at the two-year mark compared with the immunosuppressant tacrolimus, Roche said in a Feb. 16 press release. 
    • “Gazyva’s performance enabled the trial to hit its primary endpoint, and key secondary endpoints further pointed to statistically significant and clinically meaningful outcomes on overall remission at Week 104 and complete remission at Week 76 of the study, the company said.” 
  • Genetic Engineering and BioTechnology News relates,
    • “Researchers headed by a team at the University of California, Irvine, Joe C. Wen School of Population & Public Health have built what they suggest is the first cell type-specific gene regulatory network (GRN) map for Alzheimer’s disease (AD), which shows how genes causally regulate one another across different types of brain cells affected by AD.
    • “The researchers developed a machine learning framework, SIGNET (Statistical Inference on Gene Regulatory Networks), which reveals cause-and-effect relationships rather than simple genetic correlations, and applied this to uncover key biological pathways that may drive memory loss and brain degeneration. Their results pointed to numerous influential “hub genes” that offer promising potential new targets for early detection and therapeutic intervention. The investigators say their methodology is also applicable to other complex diseases, including cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ongoing headwinds caused by elevated utilization and medical costs continued to drag major health plans in the fourth quarter, completing the story of a complex 2025 for the industry.
    • “The most profitable company for the full-year was UnitedHealth Group, with $12.05 billion in earnings for 2025. The healthcare giant had a sizable lead on the next-highest payer in terms of profitability, which was Cigna at just below $6 billion.
    • “However, the company posted just $10 million in profit for Q4, the lowest tally among payers that turned a profit in the quarter. In Q4, the company saw a medical loss ratio of 92.4%, which settled to 89.1% for the full year.”
  • Fierce Healthcare adds,
    • “CommonSpirit Health’s adjusted operating margin inched into the black during the three months ended Dec. 31 as the organization’s leadership touted “noticeable” quarter-to-quarter performance gains stemming from strong volumes and efficiency. 
    • “The 138-hospital Catholic nonprofit posted a $78 million operating loss (-0.8% operating margin) for the second quarter of its 2026 fiscal year; however, after normalizing for delayed income received through California’s provider fee program, the system reached a narrow operating income of $2 million (0.0% operating margin). 
    • “CommonSpirit also reported $456 million excess revenues over expenses after normalizing. A year prior and after adjustment, the organization had an operating income of $135 million (1.3% operating margin) and a $356 million bottom line, which it noted was bolstered by around $352 million of Federal Emergency Management Agency grant revenue.”
  • Per Beckers Hospital Review,
    • “Ontario, Calif.-based Prime Healthcare’s nonprofit public charity, Prime Healthcare Foundation, acquired Lewiston-based Central Maine Healthcare on Feb. 16.
    • “The foundation received Maine’s approval to acquire Central Maine Healthcare in late November after sharing plans to acquire it in January 2025. 
    • “The transaction comprises Lewiston-based Central Maine Medical Center, Bridgton (Maine) Hospital, Rumford Hospital, Rumford (Maine) Community Home, Auburn, Maine-based Bolster Heights Residential Care, Lewiston-based Maine College of Health Professions, Lewiston-based CMH Cancer Care Center, and more than 40 physician practices, according to a Feb. 16 news release.
    • “The Prime Healthcare Foundation comprises 21 hospitals across the U.S. following the acquisition, with more than $4 billion provided in charity care.” 
  • and
    • “Marshfield Medical Center-Wisconsin Rapids Campus will open to patients March 1.
    • “The campus includes the soon-to-open hospital and Marshfield Clinic Wisconsin Rapids Center, according to a Feb. 16 health system news release.
    • “The hospital will include inpatient beds, an emergency department, exam and procedure rooms, radiological services that include general x-ray, computed tomography and ultrasound, and on-site laboratory testing.”
  • and
    • “Telehealth company eMed has partnered with CVS Caremark to offer a GLP-1 benefit model that lets employers subsidize weight loss medications without covering the full cost, Axios reported Feb. 16. 
    • “The arrangement allows eligible employees to purchase GLP-1s online through eMed and receive weight management services including side effect management, weekly check-ins and blood testing. Employers can decide how much of the cost to subsidize, the report said.” 
  • Per Healthcare Dive,
    • “Amwell is projecting lower revenue in 2026 after the health technology firm divested assets, executives said during an earnings call Thursday. 
    • “The firm expects revenue from $195 million to $205 million this year. In comparison, the telehealth vendor and health tech firm brought in revenue of $249.3 million in 2025.
    • “The top line for 2026 is smaller, but it’s “primarily high-quality, high-upside, sticky revenue,” CEO Ido Schoenberg said on the call.”
  • Per MedTech Dive,
    • “Danaher said Tuesday it has agreed to acquire patient monitoring company Masimo for $9.9 billion to bolster its diagnostics franchise.
    • “Masimo will become a standalone business unit and brand within Danaher’s diagnostics portfolio, operating autonomously while strengthening Danaher’s offering in acute care settings, the companies said.
    • “Masimo’s advanced sensor technology and AI-enabled monitoring bring powerful new capabilities to our diagnostics portfolio,” Julie Sawyer Montgomery, Danaher’s executive vice president for diagnostics, said in a statement.
    • “The $180-per-share cash deal has been unanimously approved by both Masimo’s and Danaher’s boards, according to Masimo.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–

Happy Lincoln’s Birthday

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Department of Homeland Security is on the verge of a shutdown after Senate Democrats voted to block a bill to fund the agency, saying negotiations with Republicans to put new restrictions on immigration enforcement hadn’t made enough progress.
    • “A bill to fund DHS through September failed to advance with 52 in favor and 47 opposed, short of the 60 votes required. Republicans control the Senate 53-47 but need Democratic support to pass most bills due to the longstanding filibuster rule.
    • “Democratic Sen. John Fetterman of Pennsylvania voted with Republicans to advance the bill, while Senate Majority Leader John Thune (R., S.D.) switched his vote from yes to no to preserve his ability to bring the bill up again. Sen. Mitch McConnell (R., Ky.) was absent.
    • “DHS oversees Immigration and Customs Enforcement and Customs and Border Protection as well as the Federal Emergency Management Agency, the Transportation Security Administration and the U.S. Coast Guard. While the failed vote sets the stage for funding to lapse at DHS for at least a week, there isn’t expected to be any significant impact on border enforcement from the shutdown.”
  • The Washington Post adds,
    • “The Senate is not expected to hold any more votes before a shutdown starts at 12:01 a.m. Eastern time on Saturday, and many senators were set to leave town Thursday to travel to the Munich Security Conference. Schumer and Thune have said they are prepared to bring senators back early if a deal comes together.” * * *
    • “This shutdown would affect only DHS — but it would not shutter U.S. Immigration and Customs Enforcement or Customs and Border Protection, because Republicans sent those agencies tens of billions of dollars in additional funding last year that would allow them to continue to operate.
    • “Instead, the brunt of a shutdown would fall on the Transportation Security Administration, the Federal Emergency Management Agency, the Coast Guard and other agencies within DHS. It would affect about 13 percent of the federal civilian workforce, most of whom would be forced to work without pay, according to data from DHS and the Office of Personnel Management.”
  • The Wall Street Journal tells us
    • “The White House and Health Secretary Robert F. Kennedy Jr. have shaken up the top ranks at his department, a move meant to install more disciplined messengers and smoother operations ahead of the midterm elections.
    • “Kennedy and White House officials tapped Chris Klomp, the head of Medicare and a former healthcare executive, to lead the department as its No. 2 under Kennedy, administration officials said. Klomp will have responsibility for operations and messaging, and he will be aided by at least three other agency lieutenants to take senior counselor roles under him, the officials said.
    • “We’re structuring in such a way that we can move faster and we can make sure the quality is uniform,” Klomp said in an interview.” * * *
    • “The three other senior advisers tapped to help Klomp include John Brooks, who currently heads policy at the Centers for Medicare and Medicaid Services; Grace Graham, who leads the Food and Drug Administration’s policy office; and Kyle Diamantas, who heads FDA’s food division. Brooks will oversee CMS matters, while Graham and Diamantas will have roles managing the FDA.”
  • Beckers Payer Issues informs us,
    • “Fourteen health insurers have voluntarily committed to CMS’ “Advancing Chronic Care with Effective, Scalable Solutions” model, according to a Feb. 12 CMS news release shared with Becker’s.
    • “The insurers that are on board will work toward achieving alignment with the model by 2028. The plans represent 165 million Americans.
    • “With a decade-long evaluation period beginning in July, ACCESS will explore whether linking payments to clinical outcomes can facilitate technology in chronic disease management, focusing on Medicare beneficiaries. Targeted conditions include high blood pressure, diabetes, chronic musculoskeletal pain and depression. The agency began accepting applications, which are due in April, on Jan. 12.
    • “The FDA’s “Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot” will operate in conjunction with ACCESS, allowing expanded availability of relevant devices.”
  • The Internal Revenue Service issued a draft of Publication 969 Health Savings Accounts and Other Tax-Favored Health Plans For use in preparing 2025 Returns.
  • The American Hospital Association News lets us know,
    • “A bipartisan letter supported by the AHA was sent by members of Congress Feb. 11 to the Department of Homeland Security, urging the agency to grant health care workers an exemption from the $100,000 filing fee for H-1B visas. The letter, led by Reps. Yvette D. Clarke, D-N.Y., and Michael Lawler, R-N.Y., was signed by 100 lawmakers. “Imposing a $100,000 fee for new H-1B visa petitions will exacerbate hospitals’ existing staffing challenges and could push chronically underfunded hospitals to their financial brink,” the legislators wrote. “If these hospitals cannot petition for new H-1B visas to address their staffing needs without also having to pay this fee, it will further damage their financial viability. Critically needed open positions will simply go unfilled, leaving rural and high-poverty urban areas without adequate access to care.”
  • and
    • “The Administration for Strategic Preparedness and Response has launched a $100 million competition to support the development of antiviral drug therapies targeting viruses in the Togaviridae and Flaviviridae families, such as dengue, Zika, West Nile and Chikungunya. The initiative, called the Small Molecule Approaches for Rapid and Robust Treatment Prize, will be coordinated by ASPR’s Biomedical Advanced Research and Development Authority. BARDA plans to include input from experts in drug development, virology, artificial intelligence, medicinal chemistry and public health for the program. A series of virtual information sessions will be held in the coming weeks on the initiative, which has a May 11 application deadline.” 
  • Federal News Radio interviews Tammy Flanagan about federal employee retirement benefits.
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC), together with the Office of Personnel Management (OPM), today provided federal agencies with a joint technical assistance document addressing telework as a reasonable accommodation for federal employees with disabilities.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “In an hour-long meeting in January, Food and Drug Administration career staff laid out their objections to a plan to block a new flu shot from vaccine maker Moderna. They argued that refusing to even consider the vaccine was the wrong approach to address any concerns about the product.
    • “Vinay Prasad, the head of the FDA vaccine and biologics division, overruled them—despite the agency earlier signing off on Moderna’s approach to studying the shot. Prasad told Moderna earlier this month he wouldn’t review its flu application, arguing that its clinical trial was inadequate.
    • “The Moderna decision is part of a pattern of regulatory U-turns and overruling of FDA staff by Prasad, a Covid-vaccine critic elevated by FDA Commissioner Marty Makaryand Health Secretary Robert F. Kennedy Jr. At least nine companies, many of them focused on rare or hard-to-treat diseases, have said Prasad’s team has surprised them in recent months with rapid shifts in its decisions, in some cases rejecting their products after previously blessing their approaches.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue.”
  • and
    • “The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning.”

From the judicial front,

  • Fierce Pharma reports,
    • “In response to last month’s list of the 15 drugs chosen by the Centers for Medicare & Medicaid Services (CMS) for upcoming price cuts under the Inflation Reduction Act (IRA), AbbVie is the latest to join the flood of industry litigation over the law.
    • “While AbbVie’s lawsuit contends that the CMS pricing negotiations mandated for Botox step on the company’s constitutional rights—a common thread woven into much of the industry’s legal complaints about the program—the Illinois-based drugmaker also takes a unique position that specifically relates to the formulation of its offering.”
    • “When the IRA was signed into law by former President Joseph Biden in 2022, the law made clear that only certain products are eligible to make the list of drugs that will go through negotiations to determine maximum fair prices paid under Medicare. The IRA specifically excludes “low-spend drugs,” or those with Medicare spending of less than $200 million, certain orphan rare disease drugs and plasma-derived products. 
    • “AbbVie is hedging its argument around the IRA’s “express statutory exclusions” for plasma-derived products, it said in its complaint, which was filed in a Washington D.C. District Court on Feb. 11 and names the Department of Health and Human Services (HHS), CMS and their respective leaders, Robert F. Kennedy Jr. and Mehmet Oz, M.D.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “Interest in lipoprotein(a), or Lp(a), is on the rise thanks to mounting evidence that the genetically inherited lipid particle may be a key missing link in unexplained heart attacks and strokes. While current treatments are limited, experts say that will likely change in the near future when new drugs begin to enter the market.
    • :Nathaniel Lebowitz, MD, who leads preventive cardiology at Hackensack University Medical Center and serves as an assistant professor of internal medicine at Hackensack Meridian School of Medicine, has spent two decades studying this biomarker. He is now part of the American Heart Association (AHA) Lp(a) Discovery Project, a national initiative aimed at expanding physician and patient awareness as new therapies move closer to market. Lebowitz spoke with Cardiovascular Business at length about this important topic.
    • “Lp(a) is a major, major killer. And most of the population, and even most doctors, don’t know the exact degree of how dangerous it really is,” he explained.
    • “Lebowitz noted that Lp(a) is often responsible when patients suffer cardiovascular events despite not showing any of the normal warning signs.
    • “When somebody who you wouldn’t expect to have a stroke or a heart attack has one and does not have traditional risk factors to speak of, check Lp(a), because it will be positive,” he said.
    • “Lp(a) is genetic and present in about 20% of the general population. Guidelines from the AHA, American College of Cardiology and National Lipid Association now emphasize screening in individuals with a family history of premature heart disease, as well as cascade screening of first-degree relatives when Lp(a) is identified. Levels typically do not fluctuate significantly, so testing once is believed to be generally sufficient.
    • “I consider it a risk elevator. It’s a risk multiplier,” Lebowitz said. “So if somebody is considered low risk for cardiovascular disease, but they have Lp(a) now, I would consider them intermediate risk. If they’re intermediate risk, but they have Lp(a), I would now consider them high risk and treatment should ensue accordingly.”
    • “Currently, there are no approved therapies specifically targeting Lp(a), but that may soon change. Several investigational agents are in late-stage clinical trials, including small interfering RNA (siRNA) therapies designed to silence the gene responsible for producing Lp(a).”
  • The New York Times provides a look at what alchohol does to your body.
    • “Dry January has come and gone, but Americans’ relationship with drinking is undergoing a more lasting change. According to one recent poll, just 54 percent of U.S. adults said they consume alcohol, the smallest percentage in nearly 90 years of data collection. That may be because more people are taking alcohol’s negative health consequences seriously.
    • “Drinking alcohol can have profound effects on the brain and body. In the moment, some of those effects can be pleasurable. But in the long term, especially when it’s consumed in large quantities, alcohol can cause serious health harms.”
  • and tells us,
    • “Fertility experts know that the more eggs retrieved from a woman, the better the chances that one of them will lead to a viable embryo that will result in the birth of a baby.
    • “Now, a new study suggests something startling, even to many in the field: the conventional method of searching for eggs often fails to find all of them, and a new technology that automates the process may significantly increase the number recovered.
    • Using the conventional method, embryologists use high-powered microscopes to search the follicular fluid extracted from women in fertility clinics. The fluid is then discarded. The study, published in Nature Medicine on Thursday, reported that a device that uses microfluidic technology to sift through follicular fluid found additional eggs for more than half of the patients.
    • “It’s very, very surprising,” said Dr. Mitchell Rosen, who directs the reproductive laboratories at the University of California, San Francisco and was not involved in the study. “They were finding eggs that we wouldn’t otherwise have had the potential to use.”
  • MedPage Today informs us,
    • “Receiving an mRNA SARS-CoV-2 vaccine during or shortly before pregnancy had no impact on kids’ neurodevelopmental outcomes, a multicenter prospective observational study found.
    • “Kids between ages 18 and 30 months scored similarly on the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) (adjusted median difference -3.4, 95% CI -9.7 to 3.0) as well as in each of the five specific ASQ-3 domains, reported George Saade, MD, of Eastern Virginia Medical School in Norfolk, Virginia, during a presentation at the Society for Maternal-Fetal Medicine (SMFM) annual meeting.
    • “Scores on other neurodevelopment assessments that evaluated emotional and behavioral problems, risk for autism spectrum disorder, and temperament were also similar between groups.
    • “We conclude that the primary neurodevelopmental outcome was equivalent between children of mothers who received and did not receive mRNA SARS-CoV-2 vaccination during or immediately prior to pregnancy, and there was no association with secondary neurodevelopmental outcomes,” Saade said during his presentation.
    • “Our results provide reassurance regarding the safety of mRNA SARS-CoV-2 vaccination and pregnancy,” he added.
    • “Indeed, much research has found no link between COVID vaccination in pregnancy and adverse outcomes for children, including at least two studies showing no increase in birth defects.”
  • BioPharma Dive observes,
    • “An experimental medicine from BridgeBio Pharma, the San Francisco-area biotechnology company, has succeeded in a late-stage clinical trialas a treatment for the most common type of dwarfism, results which could tee up an approval and greater competition for two other closely watched therapies.
    • “The trial enrolled around 110 children with achondroplasia, who, over a main treatment period of a year, were given either a placebo or BridgeBio’s drug, called infigratinib. On Thursday, BridgeBio announced that those in the drug arm were growing taller faster. Depending on the measure, this “annualized height velocity” was, on average, between 1.74 and 2.1 centimeters greater per year than what researchers observed in the control group.
    • “Not only did infigratinib meet the trial’s central goal, it also scored so well on a couple other height and growth tests that BridgeBio said it set records for a randomized study of achondroplasia patients. The drug was well tolerated, too, as no serious adverse events were tied to it. No one dropped out of the trial because of side effects either. BridgeBio did disclose three cases of patients having abnormally high levels of phosphate in their blood, but all were mild, transient, asymptomatic, and didn’t require the dose given to be changed or stopped.”
  • Beckers Hospital Review notes,
    • “The number of active drug shortages has declined sharply since June, according to the FDA’s drug shortage database.
    • “Eighty drugs were in shortage as of Feb. 12, down from 194 in mid-June.
    • “The decline reflects updates to the FDA’s database, which is modified 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 points out “12 recent drug shortages, according to the FDA database.”

From the U.S. healthcare business front,

  • Per an Institute of Clinical and Economic Review news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Medication for Smoking Cessation
    • “Independent appraisal committee votes reflect a net health benefit for cytisinicline alone, but uncertainty when compared to varenicline; Manufacturer setting a price for cytisinicline to align with value would help ensure public health goals for smoking cessation are met.”
    • Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • Beckers Payer Issues reports,
    • “Most of the country’s largest insurers reported year-over-year increases in medical cost ratios in 2025.
    • “Centene reported the highest medical loss ratio at 91.9%, driven by higher marketplace medical costs, Medicaid cost pressures in behavioral health and home health, and program changes in the Medicare prescription drug plan business.”
    • The article provides the largest insurers MLRs for 2023, 2025 and 2025.
  • Healthcare Dive relates,
    • “Hospital operator Tenet Healthcare expects the expiration of more generous Affordable Care Act subsidies to lower its earnings growth this year by about $250 million.
    • “Still, Tenet’s expected loss is smaller than those of some of its peers, including HCA Healthcare, which last month said it expects to lose up to $900 million from the lapse of the enhanced tax credits in 2026.
    • “Excluding the ACA headwind and the impact of some Medicaid state supplemental payments, Tenet anticipates it will grow adjusted earnings before taxes and other non-operating expenses by about 10% this year compared to 2025, executives said on a Wednesday call with investors.”
  • BioPharma Dive tells us,
    • “Sanofi on Thursday announced the ouster of CEO Paul Hudson after a six-year tenure that included a major transformation of the French drugmaker and the rise of Dupixent into one of the world’s best-selling medicines.
    • “Hudson will be replaced by current Merck KGaA CEO Belén Garijo, who is leaving her post at the German company at the end of April as part of a planned transition. Olivier Charmeil, executive vice president for general medicines, will serve as interim CEO after Hudson’s departure at the close of business on Feb. 17, Sanofi said.
    • “Belén Garijo will bring an increased rigor to the implementation of Sanofi’s strategy and accelerate the preparation of the group’s future,” Sanofi said. “Her priority will be to strengthen the productivity, governance and innovation capacity of research & development.”
  • Fierce Healthcare informs us,
    • “Maven Clinic, a virtual women’s and family health provider, is teaming up with health tech company Color Health to support family building after a cancer diagnosis. 
    • “The partnership’s goal is to expand access to oncofertility care, helping patients of childbearing age going through the cancer journey to understand and preserve their fertility options. Members will receive access to oncologists, dietitians, mental health providers, fertility preservation specialists and care advocates. The services will be available to cancer patients through employers and payers to start. 
    • “Both of us have seen the attention being paid by employers to what it really looks like for their team members going through a cancer diagnosis, because it’s happening at such a rapid clip now,” Caroline Savello, president at Color, told Fierce Healthcare. A quarter of Color patients are between the ages of 18 and 45.”
  • and
    • “Specialty care company Lantern revealed it will expand its cancer care navigation platform through a new partnership with AccessHope.
    • “Through the partnership, Lantern’s platform will now include expert review at each point in a patient’s care journey, preventing misdiagnoses and ensuring treatments meet clinical guidelines. Reviews will be conducted by experts at National Cancer Institute (NCI)-designated cancer centers, according to the announcement.
    • “Lantern said the reviews will be available for both adult and pediatric cancers as well as solid tumors and blood-based disease.
    • “Dickon Waterfield, president of Lantern, told Fierce Healthcare that the “beauty of this partnership” lies in the ability to allow people to seek care in their local communities while also providing them supports at the standard of an NCI-designated facility.”