Friday report

Patient safety

Friday report

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

From Washington, DC

  • The Thompson Hine law firm tells us,
    • “The Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) recently released their 2025 Report to Congress on enforcement activity under the Mental Health Parity and Addiction Equity Act (“MHPAEA”).” * * *
    • “Both the DOL and the Centers for Medicare & Medicaid Services (CMS) issued more requests for comparative analyses signaling that enforcement was active in the two year period.” * * *
      • “Employers should continue to pay careful attention to the following specific types of NQTLs that continue to draw the most scrutiny from the Departments:
      • “Provider network admission standards,
      • “Prior authorization requirements,
      • “Concurrent care review requirements, and
      • “Exclusions of key mental health and substance use disorder treatments (such as ABA therapy, methadone maintenance treatment, and nutritional counseling for eating disorders).”
  • Healthcare Dive reports,
    • “A pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare is delaying care for seniors in Washington, according to a report released Wednesday by one of the state’s Democrat senators. 
    • “Under the WISeR program, procedures that were previously approved within about two weeks now take four to eight weeks to be authorized, according to survey data from the Washington State Hospital Association.
    • ‘The pilot is creating increased administrative work for providers in the state, as well as potentially worsening health outcomes for patients whose care is delayed, the report released by Sen. Maria Cantwell, D-Wash., found. “It’s not taking a few days to find out whether you’re going to get covered or not,” Cantwell said during a Senate Finance Committee hearing Wednesday. “It’s basically taking weeks to find out you were denied.”
  • KFF News relates,
    • “More than 12 million people — about 43% of those in traditional Medicare [including the FEHBlog] — buy a Medigap policy. Others rely on some sort of retiree employer coverage or a different backup. About 13% of people in traditional Medicare don’t have supplemental coverage, according to KFF, meaning they could be vulnerable to large costs if they have a serious illness.
    • “In the supplemental market, following big increases last year, rates appear to be rising again. In early 2026 filings with state insurance commissioners from Aetna, Blue Cross Blue Shield, Cigna, Humana, Mutual of Omaha, and UnitedHealthcare, rate increases for Plan G policies — the most commonly purchased supplement type — ranged from just over 12% to more than 26% in the first quarter, according to Nebraska-based consulting firm Telos Actuarial.
    • “While this is a small dataset across a select number of states, it’s an indication that carriers are looking to correct their premium rates in light of upward pressure on their claims experience,” said Brett Mushett, a consulting actuary with Telos.”
  • Contemporary OB/GYN lets us know,
    • “The American Medical Association (AMA) and the Current Procedural Terminology (CPT) Editorial Panel have approved a comprehensive restructuring of maternity care services codes, marking a departure from the long-standing global payment model, according to an announcement from the Association. 
    • “Beginning January 1, 2027, the CPT code set will transition to a granular framework that replaces the traditional bundled payment model with codes that accurately represent 4 distinct phases of care: 
      • “Antepartum 
      • “Labor management 
      • “Delivery 
      • “Postpartum.
    • “This transition follows nearly 2 years of collaborative efforts between the AMA, the American College of Obstetricians and Gynecologists (ACOG), and various national medical specialty societies. By moving away from the legacy global model, which historically reported maternity care as a single service, the new structure is designed to reflect the realities of modern, team-based obstetric practice, a change that ACOG is welcoming.” * * *
    • “To facilitate this transition, the AMA is releasing the 2027 codes ahead of the standard schedule to ensure that physicians, payers, and EHR vendors have sufficient time to prepare. ACOG and the AMA have developed several educational resources to support clinicians through this transition as they move toward a framework that supports improved transparency and risk adjustment.¹
    • “You can view and download these codes via the AMA website, here.”
  • The American Hospital Association News informs us,
    • “The AHA April 24 urged the Sequoia Project to delay implementation of the Trusted Exchange Framework and Common Agreement Individual Access Services Exchange Purpose Standard Operating Procedures version 3.0 until key legal and regulatory issues are resolved. The proposed IAS SOP, slated for implementation by August 2027, includes new patient-matching methodologies that bypass or limit provider verification, which the AHA argues could expose hospitals to unauthorized disclosures, data breaches and misidentification errors. 
    • “The AHA emphasized that hospitals and health systems are already legally bound to verify identity, consent and authority before disclosing protected health information, warning that the proposed IAS SOP does not adequately account for these statutory obligations, creating significant compliance and liability risks for covered entities. To address the risks, the AHA recommended delaying the SOP and pursuing statutory or regulatory solutions, such as a provider safe harbor or clear regulatory guidance confirming compliance with IAS satisfies the Health Insurance Portability and Accountability Act verification and consent requirements.” 

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration today announced it is accelerating regulatory action on a new class of psychedelic-based therapies, following an April 18 executive order calling to speed up access to treatments for serious mental illness. The agency said it will prioritize development and review of serotonin-2A agonists for conditions such as treatment-resistant depression, post-traumatic stress disorder and substance use disorders, including issuing national priority vouchers for studies of the drugs psilocybin and methylone for alcohol use disorder. The FDA also noted it would aim to balance urgency with rigorous science and to expect final guidance for study sponsors soon.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19
      • COVID-19 activity is low in most areas of the country.
    • “Influenza
      • Seasonal influenza activity continues to decrease. Influenza A activity is low across all regions and influenza B activity continues to trend downward.
      • Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The American Hospital Association News reports,
    • “The Utah measles outbreak has increased to 607 cases, the state’s Department of Health and Human Services reported April 24. Nationwide, there have been 1,792 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 93% of cases are outbreak-associated, and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • The Hill relates,
    • “With spring in full force and summer on the way, the Centers for Disease Control and Prevention (CDC) is raising the alarm on tick bites.
    • “The agency says the bites are sending Americans to the emergency room(ER) at the highest rate in nearly 10 years. 
    • “During the second week of April, 71 out of every 100,000 emergency room visits were for tick bites, according to the CDC.
    • “The administration’s data notes that the Northeast region of the country has seen the largest spike in ER visits, followed by the Midwest.
    • “To avoid potential tick bites, the CDC recommends steering clear of wooded and brushy areas with high grass and leaf litter. They also advise checking animals that go outside every day during warm weather.”
  • The University of Minnesota’s CIDRAP tells us,
    • “Transmission of clade 1 mpox virus during commercial air travel appears to be uncommon, according to a study published yesterday [April 23] in Morbidity and Mortality Weekly Report from the US Centers for Disease Control and Prevention (CDC).” 
  • The American Medical Association lets us know what doctors wish patients knew about cervical cancer prevention.
  • MedPage Today points out,
    • “The epidemiology of sudden cardiac deaths (SCDs) was turned on its head Thursday, with research showing that in reality, ischemic cardiac disease is not the leading driver of SCDs, as previously thought.
    • “From a prospective autopsy study of unselected deaths in San Francisco County, California, it was evident that out of 943 presumed SCDs, 62% were autopsy-confirmed, and only 41% of those were due to myocardial infarction (MI) upon comprehensive postmortem and histologic evaluation — “one-half the long-accepted 80% prevalence among SCDs,” according to Zian Tseng, MD, MAS, of University of California San Francisco, and colleagues of the POST SCD study.
    • “For the remaining 59% of autopsy-confirmed SCDs not traced to an MI, they can be explained by a range of causes including hypertensive heart disease, dilated cardiomyopathy, substance-related cardiomyopathy, and normal heart primary electrical disease. When an MI was involved, nine in ten cases were attributed to acute or healed MI with obstructive coronary artery disease, and one in ten related to acute MI with nonobstructive coronary arteries (MINOCA).
    • “The study was presented at the annual meeting of the Heart Rhythm Society (HRS), held in Chicago this year. A full manuscript was published in the Journal of the American College of Cardiology.”
  • Per a National Institutes of Health news release,
    • “A large clinical trial supported by the National Institutes of Health (NIH) compared two commonly used treatments for pediatric patients treated for septic shock and found no difference in meaningful outcomes. The trial, which enrolled over 9,000 participants across five countries, sought to answer a longstanding question about which intravenous crystalloid fluid type was the superior option for children who were in septic shock, a life-threatening condition triggered by severe infection which requires immediate medical treatment.
    • “For decades, pediatricians have debated which is the best intravenous resuscitation treatment for children with severe infections who have suspected septic shock,” said Rohan Hazra, M.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study. “This largest-ever clinical trial for children treated for septic shock has immediate clinical application and allows physicians caring for these vulnerable patients to know they can confidently choose either intervention as a standard of care.”
  • Per Medscape,
    • “New drugs approved in 2025 are poised to significantly improve the management of motion sickness, acute pain, urinary tract infections (UTIs), and chronic spontaneous urticaria.
    • “Gerald W. Smetana, MD, a professor emeritus of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, talked about new treatments in a presentation at the American College of Physicians Internal Medicine (ACP-IM) Meeting 2026 in San Francisco.
    • “This is the first time in my 15-year history of giving this new drugs talk that I’ve given all four drugs a thumbs-up, with the potential to change practice,” Smetana said during his presentation.”
  • Per Health Day,
    • “For adults with type 2 diabetes (T2D), a ketogenic diet (KD) reduces the proportion of proinsulin secreted to a greater extent than a low-fat diet (LFD), according to a study published online April 21 in the Journal of the Endocrine Society.” * * *
    • “We showed that three months of a ketogenic diet was able to improve beta-cell function in patients with T2D, and these improvements were associated with changes in the PICP ratio, a biomarker of pancreas stress,” Yurchishin said in a statement. “Other than bariatric surgery or large-volume intentional weight loss, interventions for improving beta-cell function in T2D do not currently exist.”
  • The Wall Street Journal notes,
    • “A health-tech startup, NewDays, developed an AI chatbot named Sunny to help people with dementia practice communication skills.
    • “NewDays’ service combines telehealth visits with bot practice; a study found seven of nine patients showed cognitive improvement.
    • “A clinical trial, on which NewDays’ therapy is based, found participants had higher cognitive scores than the control group.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “U.S. health insurers are accelerating efforts to streamline prior authorization requirements, with UnitedHealthcare, Aetna and Cigna on Friday detailing progress toward industry commitments aimed at reducing administrative burdens and speeding patient access to care.
    • “UnitedHealthcare said more than half of its prior authorization volume will be incorporated into a standardized electronic submission process, with that share expected to exceed 70% by the end of 2026.
    • “Aetna, a unit of CVS Health CVS -1.59%decrease; red down pointing triangle, said it has already standardized 88% of its prior authorization volume. The company also said it is processing 83% of requests in real time, ahead of a 2027 goal set by insurers, and that more than 95% of eligible requests are approved within 24 hours.
    • “Cigna said it expects to standardize electronic prior authorization submission requirements for more than 70% of volume by the end of the year.
    • “All the companies emphasized the use of automation and digital tools to reduce administrative friction for providers. Aetna said it has eliminated more than 1 million provider calls through automation, while UnitedHealthcare highlighted efforts to reduce documentation requirements and limit the need for follow-up information.”
  • Fierce Healthcare relates,
    • “HCA Healthcare executives worked to reassure investors that lower-than-expected patient volumes during the first quarter are in the past and not expected to diminish the company’s full-year growth targets. 
    • “In quarterly numbers released Friday morning and discussed during an earnings call, the executives focused on two curveballs—a sharp end to the flu season and disruptive winter storms—which said were almost entirely offset by unexpected receipt of Medicaid state supplemental payments. 
    • “Specifically, the quarter’s respiratory-related admissions declined 42% year-over-year while respiratory-related emergency room visits were down 32%, translating to a 70 basis point drag for the former and a 140 basis point dip for the latter. In Texas, Tennessee, North Carolina and Virginia, the inclement weather reduced admissions and ER visits by 30 basis points and 50 basis points, respectively. 
    • “The two factors hit volumes across payer categories and resulted in an estimated $180 million hit to HCA’s adjusted EBITDA, they said. 
    • “On the other hand, an expected $80 million net benefit increase to adjusted EBITDA compared to Q1 2025 related to the supplemental payments was, in reality, about $200 million, thanks to program approvals and reinstatements in Georgia and Texas.” 
  • Kaufmann Hall adds,
    • “Kaufman Hall’s latest National Hospital Flash Report underscores persistent cost pressures that continue to strain hospital and health system finances. Calendar year-to-date margins adjusted for corporate allocations declined at the start of the year. Operational shifts—fewer inpatient days, greater reliance on outpatient revenue, and softer, uneven volumes—reflect an ongoing transition in where and how care is delivered.”
  • MedTech Dive tells us,
    • “Edwards Lifesciences increased its full-year financial forecast as sales of its transcatheter aortic replacement valves grew at a faster-than-expected pace in the first quarter.
    • “Edwards CEO Bernard Zovighian said on a Thursday earnings call that the upturn in first-quarter TAVR sales reflects a move away from watchful waiting in clinical practice for patients with severe heart valve disease.
    • “There has been a shift toward proactive disease management with an increased focus on evaluation and intentional referral of patients with severe aortic stenosis earlier in the disease pathway,” Zovighian told analysts and investors.
    • “He said heart patients are being referred for valve replacement sooner due to the company’s study data that points to better outcomes with earlier treatment and the long-term durability of its Sapien valves. It was Edwards’ third consecutive quarter of double-digit TAVR sales growth.”
  • The Wall Street Journal cautions,
    • “After months of dizziness and arms aching so badly, she could barely walk her dog, Susan Glannan lay stunned in a sunny hospital room as a doctor told her she should have open heart surgery. 
    • “The idea of a surgeon cracking her chest open and stopping her heart terrified her. Glannan, who was 64, lived alone. She didn’t have her affairs in order. And just four years earlier, she had had a procedure that she thought would take care of her heart problem—a diseased aortic valve. “I was disappointed and scared,” she said, “and I started worrying, ‘Do I have a will?’” 
    • “That first procedure was called a transcatheter aortic valve replacement, or TAVR. It’s considered one of the biggest innovations in cardiovascular medicine, offering a way to spare patients the physical and emotional trauma of open heart surgery.
    • “TAVR was approved in 2011 for frail, older patients unlikely to withstand surgery—people with no more than a few years left to live. The Food and Drug Administration later approved it for healthier patients at intermediate and low risk of dying from surgery.
    • “Yet there’s limited research on how long the valves might last. And as TAVR has become more widely used among younger and healthier people, some are finding that their valves don’t work as well or last as long as they hoped. The procedure they thought would spare them a complicated surgery leads some to the operating table anyway.”

Thursday report

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

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

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

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network offers an interview with Tammy Flanagan about how “health‑coverage decisions in retirement can shape when and how federal retirees tap their money.”
  • Govexec reports,
    • “The percentage of federal employees who are classified as “thriving” decreased by 10 points between 2024 and 2025, according to a recent report from Gallup, which sheds light on how civil servants are reacting to cuts and other reforms that President Donald Trump has made to agencies since the start of his second term. 
    • “By taking the average of responses from quarterly surveys conducted respectively in both years, the analytics firm found that the percentage of “thriving” feds dropped from 58% in 2024 to 48% in 2025.” * * *
    • “While the “thriving” rate for federal employees held steady at around 60% from 2022 to 2024, the latest data puts them on par with the average for U.S. workers in general, which also stood at 48% in 2025. That broader group, however, saw a smaller decline, going from 51% in 2024.”
  • OPM has brought the Director’s Secrets of OPM blog posts up to date on the agency’s website, which may be more easily accessible than Substack.
  • Per a CMS email,
  • This reporting requirement applies to FEHB and PSHB plans.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services April 9 held a demonstration showcasing the first series of products intended to push the health care industry toward a more connected ecosystem. The event highlighted tools and applications from more than 50 companies supporting the Medicare App Library that was initially announced in February. Tools intended to promote digital data access and eliminate manual check-in forms were featured, along with personalized health apps providing tailored guidance for nutrition, wellness and chronic disease management.” 
  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services has proposed a 2.4% payment rate bump for inpatient services for fiscal year 2027 as well as the first mandatory, nationwide test of an episode-based payment model. 
    • “The plans were outlined Friday in the annual release of CMS’ Inpatient Prospective Payment Systems (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System proposed rule. 
    • “Other planned changes, according to a fact sheet from the agency and the proposed rule’s summary, include various measure additions or modifications to measures in the Hospital Inpatient Quality Reporting Program; adjustments to the Transforming Episode Accountability Model (TEAM) alternative payment model controversially finalized in last year’s rule; and changes to graduate medical education payments to implement discrimination requirements aligned with the administration’s view of diversity, equity and inclusion practices.” 
  • A CMS news release adds,
    • “Medicare beneficiaries undergoing knee, hip, and ankle replacements, among the most frequent surgeries for people with Medicare, could soon experience more coordinated care and lower costs under a new Centers for Medicare & Medicaid Services (CMS) proposal. CMS is looking to implement these improvements by expanding the Comprehensive Care for Joint Replacement (CJR) Model nationwide through the Fiscal Year (FY) 2027 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule.
    • “Every year, Medicare funds thousands of knee, hip, and ankle replacements that help seniors keep up with their speedy little grandkids,” said CMS Administrator Dr. Mehmet Oz. “This proposed expansion of our successful joint replacement pilot program would better align financial incentives with improved health outcomes—protecting taxpayer dollars while ensuring patients get the care they need before, during, and after surgery.” * * *
    • “To learn more about the CJR-X Model, including independent evaluation reports, visit: https://www.cms.gov/priorities/innovation/innovation-models/cjr-x“
    • “The FY 2027 IPPS and LTCH PPS proposed rule can viewed on the Federal Register at: https://www.federalregister.gov/public-inspection/current. 
    • “For a fact sheet on FY 2027 IPPS and LTCH PPS proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/fy-2027-hospital-inpatient-prospective-payment-system-ipps-long-term-care-hospital-prospective.”
  • Fierce Healthcare relates,
    • “The Trump administration has issued a proposed rule that aims to significantly overhaul prior authorization for pharmaceuticals.
    • “Through the Interoperability Standards and Prior Authorization for Drugs rule, the Centers for Medicare & Medicaid Services said it would establish deadlines for payers in government insurance plans, setting the timeline at 24 hours for urgent requests and 72 hours for standard determinations.
    • “In addition, the rule would require insurers to publicly report certain metrics around prior authorization, including approval and denial rates; outcomes for appeals; and decision timeframes, according to an announcement from the agency.”
    • “The rule also builds on a 2024 regulation that took aim at prior authorization for non-drug services as well as payers’ 2025 pledge to significantly overhaul their approach to prior auth, an agreement brokered in part by CMS officials.” * * *
    • “CMS would also push to adopt Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models, making it easier for real-time electronic workflows to thrive.”
  • and
    • “Despite encountering a legal roadblock last month in his effort to rework the U.S. vaccine infrastructure, HHS secretary Robert F. Kennedy Jr. is continuing to reshape the Centers for Disease Control and Prevention’s vaccine advisory panel in a way that’s setting off alarm bells for some experts.
    • “In the new charter for the Advisory Committee on Immunization Practices (ACIP), the focus of the group—which helps advise the CDC on vaccine schedules and recommendations—seems to be shifting more toward concerns around vaccine safety and side effects. 
    • “In particular, the panel will now work on identifying “gaps in vaccine safety research, including adverse effects following vaccination.” The language is new in the updated charter and will likely appease the vaccine skeptic crowd, which has long used the potential for vaccine injuries and erroneous links to the development of neurological disorders like autism to further their cause.
    • “The group will also now specifically be tasked with reviewing new vaccine platforms such as mRNA shots, which have become a frequent bugbear in anti-vaccine rhetoric following the COVID-19 pandemic.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has, for the second time, turned back a medicine for a tough-to-treat skin cancer in a decision that marks a major setback for the therapy and its developer, biotechnology company Replimune.
    • “The agency on Friday rejected the treatment, vusolimogene oderparepvec or “RP1,” which had been under review for people whose advanced melanoma progresses despite treatment with a widely used cancer immunotherapy. In a letter made public Friday, the agency claimed that the review team, as well as multiple agency leaders and subject matter experts, determined the data are “insufficient to conclude substantial evidence of effectiveness.”
    • “The decision comes eight months after U.S. regulators spurned RP1, arguing that the company’s findings couldn’t be “adequately interpreted.” Replimune claimed to have been blindsided by the rejection and afterwards provided the FDA with additional information and analyses to boost its case. The agency, though, argued in its letter that its feedback to Replimune has remained consistent through years of communications and that its issues weren’t addressed.”
  • The Wall Street Journal relates,
    • “GSK withdrew its application for a drug touted last year by President Trump as a potential treatment for autism symptoms, just months after the company submitted it at the request of health officials.
    • “The U.K. drugmaker asked the Food and Drug Administration to pull its application for the drug leucovorin calcium because it doesn’t market the medicine, according to a regulatory filing posted Thursday. 
    • “The FDA had just approved leucovorin last month. Generic forms of the medicine will still be available. * * *
    • “GSK hadn’t sold the drug since 1999. At the request of the Food and Drug Administration, GSK said in September it would submit its application for patients with cerebral folate transport deficiency—a rare genetic condition with similarities to autism—in a move that allowed the agency to update the label for the drug and its generic counterparts. 
    • “FDA officials last month announced they had approved the drug for that condition based on a review of existing studies, but said in a call with reporters that they hadn’t found enough evidence to merit OK’ing the drug’s use to treat autism more broadly.
    • “Senior FDA officials said they examined scientific studies to see whether they could approve leucovorin to treat autism, but didn’t come up with enough strong scientific evidence to do so.
    • “A spokesman for HHS said GSK’s withdrawal on Thursday doesn’t affect generic versions of the drug, which already have updated labels for the genetic condition.”
  • Cardiovascular Business tells us,
    • :The U.S. Food and Drug Administration (FDA) is warning the public that certain sizing catheters from Indiana-based Cook Medical should no longer be used due to an increased risk of cracking or breaking.
    • “The agency’s warning covers specific lots of Cook Medical’s Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters. These devices are used for a variety of angiographic procedures, aortic interventions, peripheral interventions and vascular interventions. They are made in a variety of sizes and multiple configurations.
    • “Potential adverse events that could result include increased procedural time, harms associated with device fragmentation/separation and vessel injury,” according to the FDA. “In a worst-case scenario, device fragmentation and separation could cause life-threatening harm or death.”
    • “At this time, the FDA noted, no serious injuries or deaths have been linked to this issue. The agency is still reviewing the situation.
    • “The FDA’s early alert can be read in full here. It also includes a full list of all affected product lots.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “Even as the US respiratory illness season continues to ebb, it remains deadly, with the Centers for Disease Control and Prevention (CDC) documenting 12 more pediatric deaths in its FluView update today. 
    • “So far this season, 139 children have died from the virus, and about 85% with a known vaccination status were unvaccinated. While the CDC has classified this flu season as moderate for adults, it’s been high-severity for children.
    • “For comparison, in the previous three flu seasons the CDC logged 187, 210, and 296 flu-related deaths for the complete season. The 289 pediatric deaths in 2024-25 was the most since the 2009-10 H1N1 flu pandemic.
    • “Only four jurisdictions were reporting moderate flu activity last week, and none saw high activity. Flu accounted for 8.2% of viral respiratory diseases, down from 9.8% the previous week. A total of 2,589 people were hospitalized, compared with 3,050 the week before. The proportion of outpatient visits for flu declined to 2.4% from 2.6% the previous week.” * * *
    • “The level of acute respiratory illness causing people to seek medical attention is very low. Rates of respiratory syncytial virus (RSV) remain elevated, but the virus is past peak in many areas of the country, the CDC said in its weekly respiratory virus activity update today.
    • “COVID-19 levels are low in most parts of the country, and viral wastewater concentrations are low for RSV and very low for COVID-19 and influenza A.” 
  • The American Hospital Association adds,
    • “The Utah measles outbreak has increased to 583 cases, the state’s Department of Health and Human Services reported April 7. Of those, 386 cases have been diagnosed this year. Nationwide, there have been 1,714 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 94% of cases are outbreak-associated and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • Harvard Professor of Pediatrics Dr. David S. Ludwig opines in STAT News
    • “Targeting ultra-processed foods would make packaged foods less tasty and appealing, but no less fattening.
    • “Ironically, many products now emblematic of ultra-processed foods were developed in response to calls from nutrition scientists and government to replace dietary fat with carbohydrates, a misguided campaign that did more harm than good. We can’t afford another sweeping restructuring of the food supply based on imprecise interventions and uncertain science.
    • “Instead, focusing on processed carbohydrates offers a more precise and pragmatic solution, one that could invite collaboration with, rather than opposition from, the food industry.
    • “Delicious, calorie-rich food — whether home-prepared or packaged — isn’t the problem. What matters is how long we stay satisfied (satiety) relative to calories consumed. A 100-calorie snack or a sugary beverage isn’t better for our waistline than 200 calories from nuts if the lower-calorie option leaves us hungry and craving more soon after.
    • “By targeting the dietary drivers of weight gain, rather than misleading notions about food palatability and pleasure, we can have our (low-carb) cake and eat it, too.”
  • STAT News also tells us,
    • “With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavoredvapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem. 
    • “Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations. 
    • “The GAO report was focused on actions that involved the DOJ, so those tallies do not take into account enforcement actions like the seizure of more than 6 million illegal products by the Food and Drug Administration and U.S. Customs and Border Protection between 2024 and 2025. To put those seizures in context, a large seizure of $76 million worth of products in 2024 — 3 million vapes — equated to about 4% of China’s e-cigarette exports to the U.S. in a single month, said Steven Xu, an adjunct assistant professor at the University of Waterloo who studies e-cigarettes.
    • “Sen. Dick Durbin (D-Ill.), who requested the report, said it shows that much more work needs to be done to combat the public health threat posed by illegal vapes.”
  • Health Day informs us,
    • “Standard cognitive tests may fail to capture early brain changes in women 
    • “Women’s brains often show a steeper and more widespread decline than men’s when moving from mild impairment to Alzheimer’s
    • “Sex-specific standards may be needed to interpret brain scans and screening results accurately.”
  • and
    • “Cardiovascular health may impact fracture risk in women after menopause, according to a study published online March 27 in The Lancet Regional Health-Americas.” * * *
    • “Many of the same factors that protect your heart — regular physical activity, a balanced diet rich in calcium and vitamin D, not smoking and managing conditions like diabetes and high blood pressure — also help protect your bones,” Hossain said in a statement. “If you’ve been told you have intermediate or high cardiovascular risk, particularly if you are a postmenopausal woman, it may be worthwhile to talk to your doctor about bone health screening, given the many effective treatments available that reduce fracture risk.”

From the U.S. healthcare business front,

  • Beckers Payer Issues shares a boatload of Blue Cross Blue Shield updates.
  • Healthcare Dive reports,
    • “Menopause has come out of the shadows and into the public spotlight in recent years. Celebrities have become more eager to dish about hot flashes and night sweats, and a flurry of telehealth start-ups promising relief from a broad constellation of symptoms have given rise to a $17 billion menopause market.
    • “But demand for treatments still far outpaces the science, as persistent structural barriers confound the women’s health space. 
    • “People have taken up the charge and are trying to make an impact in a specific area,” said Kim Dalla Torre, an EY Global and Americas Health leader.” * * *
    • “More also needs to be done to raise women’s awareness that menopausal symptoms shouldn’t be something they need to tolerate in silence, Dalla Torre said. Some 80% of women experiencing these symptoms don’t reach out to their doctors for help, according to the Mayo Clinic. Drugmakers also need to play a role.” 
       
  • Cigna, writing in LinkedIn, tells us,
    • “Mental fitness is essential for stress management, resilience, and workplace productivity, helping employees achieve work/life harmony.
    • “When organizations truly care about mental fitness, employees feel more supported and valued—which leads to higher engagement, fewer days missed from work, and meaningful reductions in healthcare costs for everyone.
    • “By thoughtfully weaving together mental and physical wellness programs, organizations can nurture a more vibrant and supportive workforce—leading to lasting success, greater employee retention, and the ability to attract exceptional talent.”
  • Healthcare Innovation points out,
    • “Sentara Health’s navigators are trained professionals with expertise in behavioral health, community resources, and motivational interviewing, working closely with ED teams and patients.
    • “The program started with pilot phases at select hospitals, expanding to 10 sites over a year, with ongoing data collection to measure impact and guide future improvements.
    • “Early results indicate significant reductions in readmission rates, demonstrating the program’s effectiveness in connecting patients to appropriate community-based care.”
  • Radiology Business informs us,
    • “In a bid to offer more services outside of Manhattan, Weill Cornell Medicine is planning to build a $57 million new radiology clinic in Brooklyn.
    • “The New York City academic system officially applied for the necessary state Department of Health approvals on Monday. Located in South Brooklyn’s Bay Ridge neighborhood on 86th Street, the clinic is expected to include three MRI machines, a CT scanner and ultrasound and mammography offerings, Crain’s New York Business reported. 
    • “The outpatient radiology clinic will be housed inside the NewYork-Presbyterian Bay Ridge Primary Multispecialty center and marks a significant expansion for the hospital system outside of Manhattan.
    • “While it’s premature to talk about the services of this location, we are always striving to meet the healthcare needs of New Yorkers in their own neighborhood,” Robert J. Min, MD, radiology chair and president and CEO of the Weill Cornell Physician Organization, told Radiology Business by email April 9. “We are still in the planning stages and will share details in the coming months.”
    • “Weill Cornell hopes the new center will help alleviate demand for radiology services in Brooklyn and the surrounding communities, according to the state application. The project is part of a bigger push by Weill Cornell and NewYork Presbyterian to expand their outpatient footprint across the city, local news outlet Hoodline reported Thursday.” 

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump on Wednesday endorsed a two-part plan to quickly fund most of the Department of Homeland Security and then use a special procedure to pay for immigration enforcement with only GOP votes, stepping in to resolve a standoff between Republican congressional leaders.” * * *
    • “Congress could now pass a bill funding most of DHS that the Senate approved last week, and Trump set a goal of June 1 for funding the rest of the department using a process called budget reconciliation. The maneuver requires a simple majority for budget-focused bills, rather than the 60 votes typically required in the Senate, which Republicans control 53-47.
    • [Senate Majority Leader John] Thune [(R., SD)] and House Speaker Mike Johnson (R., La.), who had publicly disagreed over the best way to end the DHS shutdown, issued a joint statement backing Trump’s directive and saying they agreed on the two-step path to fully fund the department in “coming days.”
  • Healthcare Dive reports,
    • “Elevance avoided steep sanctions against its Medicare Advantage plans that were set to kick in on Wednesday, after the CMS granted the insurer an extension to make up for incorrect risk adjustment data reporting stretching back years.
    • “Earlier this year, the CMS notified Elevance that it planned to prevent the insurer’s MA plans from enrolling new members, along with other sanctions, starting on March 31 after finding that Elevance failed to comply with federal data submission requirements. Elevance asked regulators for more time to comply, and the CMS granted the company’s request in mid-March, according to a disclosure from Elevance.
    • “Elevance now has until May 30 to correct its data reporting before sanctions kick in. The CMS also exempted several of Elevance’s MA plans that weren’t impacted by the noncompliance from the potential penalties.”
  • The Labor Department issued a “Frequently Asked Question (FAQ) regarding implementation of certain provisions of Title I (the No Surprises Act)(1) of division BB of the Consolidated Appropriations Act, 2021. This FAQ has been prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM).”
    • The FAQ 73 concerns an ongoing Qualifying Payment Amount dispute long pending before the U.S. Court of Appeals for the Fifth Circuit.
    • “Q1: Are the Departments and OPM extending the enforcement relief regarding the use of QPAs announced in FAQs Part 71?
      • “Yes. The Departments and OPM extend the exercise of enforcement discretion, originally provided in FAQs Part 62 and extended in FAQs Parts 67, 69, and 71, under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026, the first day of the calendar month that begins after 6 months from the issuance of these FAQs. This exercise of enforcement discretion applies to QPAs for purposes of calculating patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment,(14) and providing required disclosures and submissions under the Federal IDR process.
      • “HHS similarly extends its exercise of enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026.”
  • Per an OPM March 31, 2026, news release,
    • “Today, the Office of Personnel Management (OPM) announced the President’s Commission on White House Fellowships is now accepting applications for the 2026-27 class of White House Fellows.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS), through the CMS Innovation Center, announced that organizations participating in certain Innovation Center models may begin offering a new Substance Access Beneficiary Engagement Incentive (BEI) starting April 1, 2026. Through this optional incentive, eligible hemp-derived products can be incorporated into patient care plans under clinician guidance, consistent with model requirements and applicable law.
    • “This milestone reflects the Administration’s broader efforts to expand access to innovative, patient-centered care. It also aligns with President Trump’s Executive Order supporting research and innovation related to hemp-derived products. It marks a meaningful step as CMS begins testing how emerging care tools can be integrated into coordinated care to improve outcomes and quality of life. 
    • “CMS is committed to innovation that meets patients where they are while maintaining strong safeguards and clinical oversight,” said CMS Administrator Dr. Mehmet Oz. “Under the President’s leadership, we’re expanding the tools available to improve patients’ health while generating important insights into how providers can use these tools safely and effectively in real-world care settings.” * * *
    • “More information about the Substance Access Beneficiary Engagement Incentive, including eligibility criteria and program requirements, is available at: https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services March 30 announced that C2C Innovative Solutions will replace Maximus in reviewing and processing appeals of adverse organization determinations and reconsiderations made by Medicare Advantage plans as of May 1. Maximum will continue to process appeals requests received on or before April 30. CMS said there will be a short period when both Maximus and C2C are issuing decisions. Updates on procedures for submitting appeal case files and other communications will become available on C2C’s website beginning April 1.” 
  • The Wall Street Journal informs us,
    • “The latest Census Bureau data show the broad effects of a big immigration slowdown in the U.S., and a lot more.
    • “The numbers for the year through June 2025 also show fewer people bailing on America’s tech epicenter, a modest Midwest rebound and rising appeal for small southern metros.” 

From the Food and Drug Administration front,

  • In the biggest healthcare news of the day, the Wall Street Journal reports,
    • “The weight-loss pill wars start now. 
    • “Eli Lilly’s once-daily pill for weight loss got approval from U.S. drug regulators Wednesday. The all-clear sets up a battle with rival Novo Nordisk, which has been selling a pill version of its Wegovy since the start of this year.
    • “The Wegovy pill has had one of the best drug launches in history. Now that the Food and Drug Administration has approved its pill, Lilly will seek to overtake the rival, and further its dominance of the booming $70 billion-plus market for weight-loss and diabetes drugs known as GLP-1s.
    • “It will be a battle royal for GLP-1 pill leadership between Novo and Lilly,” Leerink Partners analyst David Risinger said.
    • “Lilly has won a weight-loss fight before: While Novo Nordisk pioneered the use of GLP-1 drugs for weight loss with its Wegovy and Ozempic weekly injections, Lilly’s Zepbound and Mounjaro injections now outsell them.
    • “Yet Novo Nordisk plans to avoid the mistakes that hurt it during the last round, and will seek to hold on to its early lead by emphasizing the effectiveness of its pill.
    • “Analysts are betting on Lilly, expecting its pill, named Foundayo, to generate about $21 billion in global sales by 2030, compared with $4 billion for the Wegovy pill, according to pharmaceutical commercial intelligence firm Evaluate.”
  • Fierce Pharma relates,
    • “The FDA has delayed its target decision date for Orca Bio’s blood cancer cell therapy candidate Orca-T by three months to July 6.
    • “The review extension comes after the company submitted additional data related to chemistry, manufacturing and controls (CMC) a couple of weeks ago upon request by the agency, Orca Bio’s CEO Nate Fernhoff, Ph.D., told Fierce.
    • “Fernhoff wouldn’t specify the exact nature of the FDA’s questions but said the company doesn’t believe “any of these to be fundamental or unaddressable.”
  • MedTech Dive tells us,
    • “Distalmotion has submitted a 510(k) application to expand the label of its Dexter robotic surgery system in the U.S., the company said Wednesday.
    • “The company aims to expand use of Dexter in gynecological indications, strengthening its push to support ambulatory surgical centers that want to perform more outpatient procedures.  
    • “Distalmotion has identified ASCs, which may have less space, resources and infrastructure than hospitals, as sites of care where Dexter could have an advantage over existing surgical robots.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) has confirmed a new recall of the purge cassettes sold with certain Johnson & Johnson MedTech Impella heart pumps. The alert covers individually packaged Generation 1 Purge Cassettes as well as the ones sold with certain Impella RP, Impella 2.5, Impella CP, Impella CP with Smart Assist, Impella 5.0 and Impella 5.5 with Smart Assist heart pumps. 
    • “The FDA issued this recall due to a risk of the purge cassettes leaking. Purge cassettes play a critical role in patient care, delivering a rinsing fluid to the catheter that prevents blood from flowing back into the motor.
    • “A purge leak may lead to low purge pressure if it goes unaddressed,” according to Johnson & Johnson MedTech. “This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.”
    • “The leaks have been linked to four serious injuries and no deaths.”

From the judicial front,

  • ABHW reports,
    • “The Association for Behavioral Health and Wellness (ABHW), the national voice for payers that manage behavioral health insurance benefits for 200 million people, issued the following statement in response to the Trump Administration’s announcement that they will issue a new proposed rule on the Mental Health Parity and Addiction Equity Act (MHPAEA), including anticipated significant revisions to the provisions of the Rule, as ABHW had requested. The Administration has indicated through court documents that it intends to include this rulemaking on the 2026 Spring Regulatory Agenda, and to issue a notice of proposed rulemaking no later than December 31, 2026.”

From the public health and medical / Rx research front,

  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a novel, highly potent opioid that shows potential as a therapy for both pain and opioid use disorder. In a study published in Nature, the team observed the new drug’s effect in laboratory animals. They showed that it has high pain-relieving effects without causing respiratory depression, tolerance or other indicators of potential for addiction in humans.
    • “Opioid pain medications are essential for medical purposes, but can lead to addiction and overdose,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “Developing a highly effective pain medication without these drawbacks would have enormous public health benefits.”
    • “The team investigated formulations of an understudied class of synthetic opioid compounds, known as nitazenes. Nitazenes selectively engage mu-opioid receptors, primary targets for opioid drugs in the brain and peripheral nervous system. However, nitazenes had been shelved in the 1950s due to their excessive potency. The scientific team revisited this class of compounds with a focus on harnessing their selectivity for the mu opioid receptor and engineering new nitazenes with a safer pharmacological profile.
    • “Our goal was to study the profile, or pharmacology, of these drugs,” said Michael Michaelides, Ph.D., senior author and NIDA investigator. “We wanted to decrease the potency and create a potential therapeutic. What we discovered exceeded our expectations.”
  • STAT News reports,
    • “Few things will give a man as much of an insight into the female body as growing up with sisters. Painful, irregular periods, body hair, skin trouble: Al Barrus, a 43-year-old veteran and communications specialist from New Mexico, heard all about it growing up, the only male of three siblings. He’s also known for a while that one of his sisters had been diagnosed with polycystic ovary syndrome, an endocrinological disorder and leading cause of infertility associated with a range of issues including high androgen levels, insulin resistance, and enlarged ovaries. His other sister, too, had some PCOS symptoms. 
    • “Recently, he’s begun to wonder: Could he have it, too? 
    • “Not exactly PCOS but a “male form.” Where women with PCOS’ levels of androgen are too high, his are too low; rather than hirsutism (excess body hair), he has sparse body and facial hair and began going bald as a teenager. He has other issues similar to the ones that can appear in women with PCOS: high levels of the hormone prolactin, suspected insulin resistance, obesity, mental health struggles.” * * *
    • “It took more than a decade, but at last, there is a name, though it is still tightly under wraps “pending submission to a journal for publication,” said Robert Norman, a professor emeritus of reproductive and periconceptual medicine at Adelaide University and one of the experts who worked on selecting a new name. He declined an interview request: “I think you would find it frustrating talking with us when we are not going to reveal the new name yet!” 
  • The American Hospital Association News relates,
    • “The Centers for Disease Control and Prevention has temporarily paused rabies and pox virus testing, according to an update on its website March 30. The pox virus family consists of several viruses, including smallpox and mpox. The CDC typically confirms infections for rabies and pox viruses, among several other infectious diseases.”
  • MedPage Today tells us,
    • “Significant incidental findings detected on low-dose CT lung cancer screening were associated with an increased risk of an extrapulmonary cancer diagnosis over the following year.
    • “Risk differences were significantly higher for urinary cancers, as well as lymphoma and leukemia.
    • “Certain significant incidental findings should be assessed as potential indicators of undiagnosed cancers, researchers said.”
  • Healio informs us,
    • “Incidence of fractures among women begins to rise at age 35 years and increases dramatically starting at age 45 years, whereas men have their highest rates of fracture at age 35 to 45 years, according to data from the UK Biobank.
    • “Our findings reveal a previously underrecognized trajectory of increasing fracture risk in women beginning as early as age 35 years old, with a marked acceleration from the mid-40s,” Catherine Rolls, MSc, research associate in the musculoskeletal research unit and translational and applied research group at University of Bristol in the U.K., and colleagues wrote in a study published in Journal of Bone and Mineral Research. “This female-specific pattern resembles the postmenopausal risk profiles traditionally seen in older populations and suggests that skeletal vulnerability begins earlier than often assumed.”
  • Health Day points out,
    • “Teenagers might be known for being night owls, but they’ll be healthier if they can get to bed earlier, a new study says.
    • “Teens who stay up late and sleep the morning away are more likely to eat more and be less physically active, especially when school is in session, researchers report in the April issue of the journal Sleep Health.
    • “Sleep timing — when teens go to bed and wake up — had the biggest influence on sedentary and eating behavior in teens,” senior researcher Julio Fernandez-Mendoza, a professor of psychiatry and behavioral health at Penn State College of Medicine, said in a news release.
    • “It’s something parents need to pay attention to — and protect — during critical developmental years like adolescence,” he said.”
  • Per MedTech Dive,
    • “Medtronic said it will support a new study of its Symplicity Spyral procedure in patients with uncontrolled high blood pressure and multivessel artery disease who are undergoing percutaneous coronary intervention. Global guidelines indicate patients with both conditions need more aggressive hypertension management, the device maker said this weekend at the American College of Cardiology’s annual meeting.
    • “Medtronic’s Symplicity Spyral renal denervation device won Food and Drug Administration approval in late 2023 to treat patients whose high blood pressure cannot be controlled by drugs. The new study, called EMBRACE, will evaluate renal denervation performed in the same procedure as PCI, a treatment to remove plaque buildup and open blocked coronary arteries.
    • “Separately, Medtronic released results from a pooled analysis of the SPYRAL HTN ON and OFF MED trials showing that patients who underwent a renal denervation procedure to improve their blood pressure had a significantly lower rate of hypertensive emergencies (40%) at three years than those who received a sham treatment.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The combination of technology and alternative care options is slowing the growth rate of healthcare spending.
    • “In January, the Centers for Medicare and Medicaid Services said healthcare expenditures rose 7.2%, to $5.3 trillion, in 2024. Healthcare spending accounted for 18% of gross domestic product in 2024, less than the 21.2% the agency projected.
    • “Advances in care delivery, reduced pricing on some treatments and payer restrictions on care utilization drove down spending, according to a recent study by public policy organization Brookings Institute. 
    • “The healthcare spending growth rate relative to GDP from 2010 to 2024 is the lowest in a 14-year period since 1960, the study said. 
    • “While we’re documenting that the healthcare cost curve has bent and we think that there are reasons that it will continue to be bent, it could still bend more,” said Lev Klarnet, one of the study’s authors and a doctoral student in business economics at Harvard University.
    • “Here are three takeaways from the research.
      • Cost sharing, prior authorizations reduce demand
      • Outpatient procedures are saving money, and
      • “Technology is lowering costs by improving health.”
  • and
    • “The Leapfrog Group will expand its rating system for ambulatory surgery centers.
    • “Starting in July, Leapfrog plans to use publicly reported Centers for Medicare and Medicaid Services data to compare safety and quality measures across nearly 4,000 ASCs, similar to how the independent watchdog group rates hospitals, according to a Tuesday news release. 
  • Beckers Payer Issues reminds us,
    • “For the first time, payers must publicly post data on how often they deny prior authorization requests, how quickly they process them and how often denials are overturned on appeal. The first reports are due March 31 under a rule CMS finalized in 2024.” 
  • Fierce Healthcare tells us,
    • “It’s been seven years since the American Medical Association (AMA) launched its Joy in Medicine program to address physician burnout. 
    • “The issue is far from resolved, with burnout peaking during the COVID-19 pandemic. Recent estimates have found that more than half of surgeons are still burned out. Amid pressing financial challenges and as organizations struggle to recruit clinicians, the need for joy in medicine has never been more pressing.
    • “The AMA’s voluntary program is meant to serve as a guide to health systems looking to assess and address their institutions’ levels of burnout. Organizations must apply and it is free to participate. About 1,800 organizations have participated to date.”
  • BioPharma Dive informs us,
    • “Merck and Co. has signed an agreement with California-based Infinimmune to develop multiple antibodies for various disease targets, the companies announced Tuesday.
    • “Per deal terms, Merck could load Infinimmune with up to $838 million in upfront and milestone payments if any of the drug candidates make it into clinical testing and onto the market. Neither company disclosed how much was offered as an upfront payment. Merck will hold exclusive rights to develop and commercialize drugs that are discovered through the collaboration.”
  • Beckers Hospital Review shares “the big bets 20 pharmacy leaders are making right now.”
  • The Wall Street Journal points out,
    • “The nation’s costliest autism therapy provider will shut down by mid-May, the company’s human resources chief said in an email to employees one week after the state of Indiana said it would bar the firm from billing Medicaid.
    • “The autism-therapy provider, Piece by Piece Autism Centers, received $340,000 in Medicaid payments per patient in 2023, the highest level in the country, The Wall Street Journal reported last month in an article examining how some providers had outpaced regulators in their fast-growing businesses.
    • “Once Piece by Piece—which state officials have said abused the taxpayer-funded program for low-income people—closes, its centers will be operated by a rival autism-therapy provider, Applied Behavior Center for Autism, emails show. Applied Behavior Center settled federal civil fraud allegations over billing issues just three years ago without admitting wrongdoing, the Justice Department announced at the time.”

Weekend Update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The FEHBlog noticed the following noteworthy hearing scheduled for Wednesday, March 25:
    • House Appropriations Subcommittee on Financial Services and General Government
    • 10:00 AM Local Time | 2359 Rayburn House Office Building, Washington, D.C.
    • Hearing: Oversight Hearing – U.S. Office of Personnel Management
    • Witnesses: The Honorable Scott Kupor.
    • Meeting Details
  • Per a Federal Trade Commission news release,
    • “Today, Federal Trade Commission Chairman Andrew N. Ferguson directed FTC staff to form a Healthcare Task Force that will engage in a coordinated, integrated approach to healthcare enforcement and advocacy to protect American patients, healthcare workers, and taxpayers.
    • “In a memorandum, Chairman Ferguson directed the FTC’s Bureaus of Competition, Consumer Protection and Economics, as well as the Office of Policy Planning and Office of Technology to form the Healthcare Task Force.
    • “The Healthcare Task Force will:
      • “Lead targeted enforcement and advocacy initiatives focused on key priorities;
      • “Devise coordinated agencywide strategies on investigations;
      • “Take a proactive and strategic approach to identifying amicus and statement of interest opportunities; and
      • “Identify emerging issues and new priority areas for enforcement and advocacy.”
  • The American Hospital Association News tells us,
    • “The White House today [March 20] released its national policy framework on artificial intelligence. The framework includes several recommendations for Congress, including establishing regulatory sandboxes to foster AI application development, providing resources to make federal data accessible to industry, and a proposal to not create new federal rulemaking bodies to regulate AI. It urges Congress to support the development and deployment of sector-specific AI applications through existing regulatory mechanisms.  
    • “Additionally, the framework includes workforce-specific recommendations for Congress, such as expanding federal efforts to study trends in task realignment driven by AI to inform future workforce policies. Finally, the framework also calls for Congress to establish policies to preempt state laws that impose undue burden but not preempt otherwise lawful state regulations related to child safety, zoning for data centers and state government procurement of AI.”

From the Food and Drug Administration front,

  • MSN informs us,
    • “Organic spinach, both bulk and cut, has been recalled nationwide after testing found listeria.
    • “Sno Pac Foods recalled Sno Pac Organic Frozen Cut Spinach in 10-ounce bags and Del Mar Bulk Organic Frozen Spinach in 35-pound boxes the day after Sno Pac spinach in HelloFresh meals triggered a public health alert.”
  • Health Day reports,
    • “A long-debated plan to block teens from using tanning beds nationwide will not move forward.
    • ‘The U.S. Food and Drug Administration (FDA) said earlier this week it is withdrawing a proposed rule that would have banned anyone under age 18 from using tanning beds.
    • “The rule, first proposed in 2015, would have also required adults to sign a waiver acknowledging risks like skin cancer and severe burns before using tanning devices.
    • “Without a federal rule, regulations will continue to vary by state. Some states, including California, Delaware, Illinois, Kansas and Minnesota as well as Washington, D.C., already bar minors from using tanning beds.
    • “Other states allow teens to use them with the consent of a parent.
    • “The FDA stressed that the “withdrawal of the proposed restrictions does not mean that exposure to UV radiation does not cause skin cancer.”

From the public health and medical / Rx research front,

  • Health Day reports,
    • “High blood pressure is taking a growing toll on younger women, a new study warns.
    • “Researchers say deaths from heart disease linked to hypertension are rising among women ages 25 to 44.
    • ‘The rate has more than quadrupled over the past two decades — from about one to nearly five per 100-thousand women – according to their analysis.
    • “What’s behind the increase? One author points to an  underestimated cardiovascular risk, delayed diagnosis and missed chances for early treatment.
    • ‘She says, “Even though hypertension is more prevalent in older populations, it’s something that we need to be vigilant about in younger populations, as well.”
  • MedPage Today suggests, “To Limit Antibiotic Overprescribing, Take a Page from the Opioid Epidemic — Both drugs are dangerous when misused.
    • “The following strategies may help reduce inappropriate prescribing:
      • “Prescription drug monitoring programs. Statewide programs to monitor opioid prescriptions are credited with curbing prescribing rates. While these programs are intended to provide clinicians with patients’ medication histories, they can also be used to identify outlier over-prescribers, and artificial intelligence can be used to quickly analyze large prescribing datasets and recognize patterns of overuse.
      • “Prescriber education and feedback. Institutional programs focused on individual prescriber education and feedback can reduce both opioid and antibiotic prescribing. Since 2019, the Centers for Medicare & Medicaid Services has required hospitals to implement inpatient antimicrobial stewardship programs, which monitor antibiotic prescription and promote appropriate use. Similar requirements do not yet exist for outpatient settings, where most antibiotic prescribing occurs, and expanding outpatient stewardship efforts could substantially reduce overuse.
      • “Published treatment guidelines. In 2016, the CDC released evidence-based guidelines for the use of opioids for chronic pain, which helped reduce opioid use by encouraging lower doses, shorter durations, and non-opioid alternatives. While guidelines for antibiotic prescribing do exist, more definitive recommendations for avoiding antibiotics in patients with a low likelihood of bacterial infection could help promote more judicious prescribing.
      • “Public education campaigns. Campaigns to educate the public on the harms of antibiotic misuse would reduce the demand for these medicines, just as growing awareness of the dangers of opioids has prompted some patients to ask for alternative options for pain relief.”
  • The New York Times lets us know four things opthamologists wish you knew about your eyes.
    • “Your eyes can get sunburned.”
    • “Contacts should not be worn while swimming or sleeping.”
    • “Staring at your screen can cause dry eyes.”
    • “An eye exam can reveal a wide range of diseases.”
  • Health Day notes,
    • “Got something important you don’t dare forget — like taking your heart medication, turning off the stove or a big date? 
    • “Here’s some friendly advice from Carrie Cuttler, a researcher at Washington State University in Pullman.
      • “You probably don’t want to be high at the time you need to remember to do it,” said Cuttler, an associate professor of psychology and co-author of a new study looking at what cannabis does to your memory.
      • “In a study of 120 regular cannabis users, she and her colleague Ryan McLaughlin found that smoking weed disrupted multiple memory systems at the same time. 
      • “In fact, they reported, THC, the chemical in cannabis that makes you high, may do even more than make you a tad forgetful. It can even create new memories — of things that never happened.”
    • “The findings were recently published in the Journal of Psychopharmacology.
    • “The research suggests that cannabis affects not only simple recall — like remembering a list of words — but kinds of memories people rely on to get through the day.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Providence is exploring a potential sale of its health plan, citing the higher spending that’s swamping insurers.
    • “The news disclosed on Thursday [March 19] comes as the Catholic nonprofit system continues to pursue a financial turnaround plan that’s included layoffs and hospital sales.
    • “Providence declined to comment on potential acquirers or timing of a deal, and said it will provide updates as decisions are made.”
    • “Providence said its decision to consider a sale of Providence Health Plan isn’t due to the plan’s quality, but its struggle as a smaller regional insurer to overcome challenges like rising costs and technology investments that are easier for its larger peers.
    • “PHP covers hundreds of thousands of members, mostly in the Pacific Northwest, across employer, commercial Medicare, Medicare Advantage, managed Medicaid and Affordable Care Act plans.”
  • BioPharma Dive relates
    • “Earendil Labs, a high-powered startup with a presence in China and the U.S., has secured $787 million to advance a sprawling pipeline of biologic medicines for autoimmune conditions and cancer. 
    • “The hefty funding announced by the biotechnology company on Friday included more than half a dozen investors, among them venture firms Dimension and Luminous Ventures and the French pharmaceutical giant Sanofi. That bankroll “allows us to operate at a fundamentally different scale,” enabling the company to advance several programs towards clinical testing while building an “R&D organization designed for long-term impact,” founder and CEO Jian Peng said in a statement.”
    • “The company is using artificial intelligence to develop next-generation biologics for several different diseases, from asthma and eczema to colorectal cancer. Earendil claims its technology has produced more than 40 programs overall, and on its website lists 19 in its pipeline. One, for inflammatory bowel disease, is ready for Phase 2 development, the company said Friday.”

Notable Death

  • The Washington Post reports,
    • “J. Michael Bishop, a microbiologist who shared a Nobel Prize in 1989 for research that illuminated the genetic roots of cancer, and who later served as chancellor of the University of California at San Francisco, died March 20 at a hospital in San Francisco. He was 90.
    • ‘The cause was pneumonia, said his son Eliot Bishop.”
  • RIP

Midweek report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Healthcare Dive reports,
    • “Overpayments to Medicare Advantage plans are causing seniors’ Medicare premiums to spike by billions of dollars, according to new report from congressional investigators.
    • “Medicare Part B premiums rose by $212 per enrollee in 2025, totaling $13.4 billion in higher premiums, due to health insurer practices like recording extra member diagnoses to inflate government reimbursement, the report from the Joint Economic Committee published Tuesday found. [FEHBlog note — CMS tells us that the Medicare premium rose $10.30 monthly from 2024 to 2025 or $123.60 annually]
    • “Health insurance groups argued that the report is based on flawed data and that MA saves money and drives better health outcomes for enrollees.”
  • Beckers Payer Issues relates,
    • “Elevance said it was “surprised and disappointed” by a recent CMS sanction threat, which would suspend enrollment in Medicare Advantage prescription drug plans, CFO Mark Kaye said March 10 at the Barclays 28th Annual Global Healthcare Conference in Miami.
    • “The executive claimed Elevance flagged provider-submitted diagnosis codes and shared information with CMS “in good faith.”
    • “The issues CMS raised relate to historical risk-adjustment processes. They do not reflect our current operating processes or practices,” he said.
    • “Mr. Kaye said he views the issue as a misalignment with policy interpretation.
    • “This is not simply a data submission issue. We view this as a broader policy and payments dispute about how retroactive corrections should be treated under the risk-adjustment framework that was in place during that period,” Mr. Kaye said. “This is a disagreement over the interpretation of policy. It’s not an unwillingness to correct inaccurate data.” He said the rules at the time were in line with Elevance’s conduct.” 
  • The Hill brings us up to date on the Department of Homeland Security shutdown.
  • Per CMS news releases,
    • “The Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS) is committed to improving health care and outcomes, and strengthening accountability, across the nation’s health- and long-term care systems.
    • “Over the next several years, CCSQ will focus on five strategic goals—Prevention, Quality and Safety, Coverage Innovation, Data and Technology, and Burden Reduction. These priorities build on CCSQ’s core mission to establish national health and safety standards; implement quality measurement, reporting and improvement; and support Medicare’s coverage determinations. Together, they represent a roadmap for health- and long-term care systems that are safer, stronger, and more transparent.”
  • and
    • The Centers for Medicare & Medicaid Services (CMS) today issued new guidance to strengthen public trust and ensure patients and their families are treated with dignity and care throughout the organ donation process. The guidance clarifies and reinforces the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals, both in providing patients full medical care regardless of potential donor status and allowing families the time to make decisions regarding organ donation without coercion. This action follows reports that some OPOs have rushed aspects of the organ donation and procurement process, pressuring families to make decisions during moments of grief. 
  • Govexec tells us,
    • “The No. 1 thing to know entering retirement: How much are you really spending?
    • “Many new retirees may overestimate how far their savings will go towards their budget. Having an idea of your cost of living can make them go further.”

From the Food and Drug Administration,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.  
    • “The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re fixing the problem through a major modernization initiative. Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”
  • Health Exec informs us,
    • “The U.S. Food and Drug Administration has released an early alert pertaining to patient safety, after the agency said it became aware of an issue with flexible cryoprobes—used to deliver extreme cold to a site on the body for a variety of medical purposes, including removing tissue tumors—manufactured by Erbe USA.
    • “According to the FDA, the company reported incidents of its cryoprobes “rupturing or bursting during activation,” leading to excessive pressure at sites of foreign bodies, mucus plugs, blood clots, necrotic tissue, or biopsies—essentially anything a provider is trying to remove.”

From the public health, medical and Rx research front,

  • The New York Times reports,
    • “In a survey by the health research group KFF and The Washington Post, released in September, 16 percent of parents said they had skipped or delayed at least one childhood vaccine other than for flu or Covid-19. And doubts about vaccines are increasingly spilling into refusal of other mainstays of pediatric medicine, including antibiotics, medications like Tylenol and diagnostic procedures like spinal taps.
    • “At a hospital in Boise, Idaho, for example, three infants died last year after their parents declined a shot of vitamin K, administered to newborns to prevent bleeding, said Dr. Amanda Lee, a pediatrician there.
    • “Parents have always had questions about vaccines, but Dr. Lee and other pediatricians say they are now finding their expertise to be sometimes powerless against the flood of misinformation.” * * *
    • “Conferences of pediatricians now routinely hold workshops on earning parents’ trust. They are training clinicians to be less authoritarian, less judgmental and more patient, said Dr. Brandan Kennedy, a pediatric hospitalist in Kansas.”
  • Medpage Today tells us,
    • “Semaglutide for weight loss (Wegovy) was associated with a significantly higher risk of ischemic optic neuropathy (ION) compared with the diabetes formulation (Ozempic) and other GLP-1 agonists.
    • “Added to the existing evidence base, the study suggests a dose-dependent risk of ION.
    • “Men treated with Wegovy had a threefold higher risk of ION versus women.”
  • and
    • “The COBRRA trial directly tested apixaban and rivaroxaban, the oral anticoagulants most frequently used to treat acute venous thromboembolism.
    • “The risk of clinically relevant bleeding came out significantly lower with apixaban than with rivaroxaban during the 3-month treatment period.
    • “The study-specific dosing regimen may have played a role in the results, however.”
  • and
    • “Over 40% of smokers who received one psilocybin dose quit by month 6 versus 10% of nicotine patch users in a pilot randomized trial.
    • “No serious adverse events were reported, and the most common side effects with psilocybin were temporary increases in blood pressure and nausea.
    • ‘Psilocybin works by increasing “mental flexibility,” allowing patients to reframe their relationship with addiction, researcher said.”
  • Health Day lets us know,
    •  “Women who have pregnancy complications might face a higher risk of heart disease, a new study has concluded.
    • “The stress of these complications increase a woman’s risk of high blood pressure for years after they deliver, researchers reported March 9 in the journal Hypertension.
    • “For women who were having babies for the first time and had complications, referred to as adverse pregnancy outcomes, we found that higher stress levels over time were associated with higher blood pressure levels two to seven years after delivery,” lead researcher Virginia Nuckols, a postdoctoral fellow at the University of Delaware, said in a news release.”
  • and
    • “An already-approved IV drug significantly reduces the symptoms of lupus, a new clinical trial showed.
    • “More than three-quarters of lupus patients taking obinutuzumab (Gazvya) had a significant improvement in their symptoms after a year on the drug, researchers reported March 6 in The New England Journal of Medicine.
    • “The drug also improved time between lupus flares, and had a more than doubled remission rate compared to placebo, researchers said.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Researchers headed by a team at the University of California San Diego have found that a novel blood-based biomarker can predict a woman’s risk of developing dementia as many as 25 years before symptoms appear. The study, involving more than 2500 women, showed that higher levels of phosphorylated tau 217 (ptau217)—a form of tau protein that reflects early brain changes associated with Alzheimer’s disease—were strongly associated with future mild cognitive impairment (MCI) and dementia among older women who were cognitively healthy at the start of the study, before any memory or thinking problems were detected.
    • “Our study suggests we may be able to identify women at elevated risk for dementia decades before symptoms emerge,” said Aladdin H. Shadyab, PhD, MPH, UC San Diego associate professor of public health and medicine at the Herbert Wertheim School of Public Health and Human Longevity Science and the School of Medicine. “That kind of long lead time opens the door to earlier prevention strategies and more targeted monitoring, rather than waiting until memory problems are already affecting daily life.”
  • MedPage points out,
    • “The nation’s safest hospitals, according to annual rankingsopens in a new tab or window from Healthgrades, represent the top 10% of hospitals nationwide for patient safety, with the lowest incidences of 13 preventable patient safety events.
    • “Patients treated at these 438 hospitals, located across 40 states, were significantly less likely to experience the four most common patient safety indicators, characterized as serious, preventable complications, which account for 78% of all safety events, including:
      • “In-hospital falls resulting in fracture: 52.4% less likely
      • “Collapsed lungs due to a procedure or surgery in or around the chest: 57.5% less likely
      • “Catheter-related bloodstream infections acquired in the hospital: 67.8% less likely
      • “Pressure sores or bed sores acquired in the hospital: 71.9% less likely
    • “The data behind this year’s Patient Safety Excellence Award highlights how measurable improvements in safety can prevent thousands of complications,” said Alana Biggers, MPH, medical advisor at Healthgrades, in a press release.
  • Per BioPharma Dive,
    • “Biogen on Wednesday unveiled updated data showing its spinal muscular atrophy drug salanersen slowed neurodegeneration and improved motor function in an early-stage study.
    • “The trial enrolled patients who had already been treated with the Novartis’ gene therapy Zolgensma, and found a reduction of 75% in neurofilament light chain levels, a measure used to evaluate neurodegeneration. Half of those patients also achieved a motor function milestone according to World Health Organization standards.
    • “As part of the update, Biogen also revealed the design for a late-stage study that includes three separate trials of salanersen in newborns, infants already treated with Zolgensma, and teens and older adults who have either not been treated or previously took another SMA drug, Roche’s Evrysdi.”
  • Per Fierce Pharma,
    • “After strutting its stuff against blockbusters in three head-to-head psoriasis trials, UCB’s Bimzelx has conquered another powerhouse product—AbbVie’s Skyrizi—in psoriatic arthritis (PsA).
    • “A phase 3b study of 553 adults with active psoriatic arthritis has achieved its primary objective, showing the “statistically significant superiority” of Bimzelx over Skyrizi in reducing disease activity as measured by the ACR50 endpoint at Week 16, the Belgian company said.”
    • “ACR50 is a composite efficacy measurement, specified by the American College of Rheumatology, which indicates 50% or greater improvement from baseline in tender or swollen joint counts in addition to 50% improvement in three of five other disease markers.”  

From the HIMSS conference front,

  • Fierce Healthcare reports,
    • “Epic is ramping up more artificial intelligence capabilities and features as it also touts how its AI tools drive measurable outcomes beyond just faster documentation time. 
    • “Health systems are reporting earlier diagnoses, fewer denials and improved patient experiences, the company said.
    • “At the 2026 Healthcare Information and Management Systems Society (HIMSS) Global Health Conference & Exhibition, which kicked off Monday, Epic teased its future AI road map with new features across clinical, patient-facing and operational workflows.”
  • and
    • “Samsung Electronics and digital health company b.well Connected Health are working together to toss out the traditional patient clipboard and replace it with smartphones.
    • “Samsung Galaxy smartphone users, through the Samsung Health app, will now have digital access to their complete health history and can share their medical record with participating providers via a QR code. That eliminates the intake paperwork patients fill out at nearly every healthcare visit, according to the two companies. 
    • “Despite advances with technology, patients typically still fill out the same paperwork at the doctor’s office and often have to repeat pertinent medical information from memory and log into multiple portals.”
  • Health Tech Magazine adds,
    • “Documentation overload, clinical burnout and rising operational costs are just some of the challenges healthcare organizations face today. This can have a major impact on clinician satisfaction and retention.
    • “Microsoft Dragon Copilot is one way health systems can address these concerns. The artificial intelligence-powered tool streamlines clinical documentation, giving clinicians more time in their day for seeing additional patients or other important tasks. In addition to improving clinical workflows, Dragon Copilot improves documentation, creates more accurate coding and improves the patient experience.
    • “At HIMSS26 in Las Vegas, HealthTech spoke with two Microsoft Dragon Copilot experts about what problems it solves, how it integrates with the electronic health record, how it can be used across departments and clinical specialties, and tips for implementation success.”
  • Healthcare Dive notes,
    • “Amazon is expanding access to its health-focused artificial intelligence chatbot, the technology giant said Tuesday. 
    • “The Health AI assistant first launched for members of Amazon’s primary care chain One Medical in January. The tool allows users to connect their health information and ask questions about their health, symptoms and potential treatments. 
    • “Now, the tool is rolling out to all U.S. consumers. “The desire to ask questions of an AI agent is enormous,” Dr. Andrew Diamond, chief medical officer at Amazon One Medical, told Healthcare Dive at the HIMSS conference Tuesday. “It is clearly the fastest way for people to get their basic health questions answered. And even basic is almost putting it too simply. They’re getting pretty in-depth questions answered.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “American hospitals saw expenses grow 7.5% in 2025, more than twice the rate of growth in hospital prices that year, according to the American Hospital Association’s annual “Costs of Caring” report.
    • “The findings, which were drawn from industry benchmark data compiled by Strata Decision Technology, point to a system under mounting strain: Hospitals are treating more patients, those patients are getting sicker and the cost of supplies from drugs to disposable gloves is increasing quicker than reimbursements can keep up with.
    • “Rising costs for labor, supplies, drugs, and administrative burdens caused by corporate insurers, combined with caring for sicker patients, have created challenges for hospitals and health systems,” AHA President and CEO Rick Pollack said in a March 11 news release shared with Becker’s. “These strains are jeopardizing hospitals’ ability to provide around-the-clock care and services that patients and communities need.”
  • and calls attention to ten hospital M&As finalized in 2026.
  • Fierce Healthcare relates,
    • “It’s not a secret that commercial payers are navigating an earnings slump.
    • “Weighed down by elevated member utilization and staring down stagnant proposed Medicare Advantage (MA) rates for 2027, insurers are looking to lessen the pain by securing more favorable network contracts with providers and increasing scrutiny of reimbursement claims.
    • “The former has recently led to some high-profile dustups in which MA contracts with health systems are permitted to expire, while the latter has forced hospitals to devote more resources toward combating denials. 
    • “However, for-profit hospital and ambulatory surgery center chain Tenet Healthcare isn’t viewing payer pushback as a major headwind. In last month’s earnings call, executives told analysts that its commercial rate updates are so far landing in a healthy range of 3% to 5%. The company is also almost entirely contracted for 2026, and about 80% contracted for 2027, they said.”
  • and
    • “Carrum Health, which offers value-based specialty care for employers, is teaming up with Virta Health on weight management.
    • “Virta offers virtual counseling, nutrition coaching and medication management with GLP-1s. Employers can customize Virta’s offering depending on their benefits. Meanwhile, Carrum has already provided bariatric surgeries for weight management. 
    • “Now, members can be referred and coordinated between the two as needed.”
  • Fierce Pharma tells us,
    • “Twelve months ago, drugmakers came roaring into 2025, fueled by a massive year of growth that peaked in the fourth quarter of 2024. Now, the momentum has dissipated, and most companies are bracing for a slowdown in sales heading into 2026. 
    • “In fact, over the last few weeks of earnings reports, drugmakers’ financial results were less noteworthy than their guidances. Of 25 companies with quarterly revenue of at least $2 billion that had reported through March 5, just five projected that their sales would grow at a higher rate in 2026 than in 2025, with each of those increases slight.
    • “The pharmas offered a variety of reasons—macro and micro—for their pessimistic 2026 projections. Several mentioned pricing effects related to the Inflation Reduction Act (IRA), as well as U.S. President Donald Trump’s most-favored-nation plan and his threats of tariffs on pharmaceutical products. An anticipated decline in vaccine sales, linked to a demand shortfall in the U.S., also plays into the computation for several companies, while many others are dealing with the loss of exclusivity (LOE) of blockbuster products.”

Monday report

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

From Washington, DC

  • Federal News Network reports,
    • “Federal employees’ retirement applications are continuing to flood the Office of Personnel Management. In February, another 31,000 retirement claims entered the agency’s systems. That puts OPM’s Retirement Services center at yet another record high of pending applications — now reaching above 65,000 cases with pensions that are yet-to-be finalized. That’s an 88% increase since OPM’s inventory last October, when retirements from the deferred resignation program first began trickling in.” 
  • The Government Accountability Office posted a report titled “Private Dental and Vision Insurance: Market Concentration Varied Among States.”
    • “As in health insurance markets, people looking for dental or vision insurance may face a concentrated market—i.e., only a few companies to choose from. Consumer choice may also be affected by “vertical integration”—e.g., when a vision insurance company owns the ophthalmologist’s practice and the company that makes glasses frames and lenses.
    • “Dental and vision insurance market concentration varied across states. Little research is available that shows the effects of concentration and vertical integration in these markets. Groups representing dental and vision care insurers, providers, and consumers shared varying opinions on potential effects.”
  • The American Hospital Association New tells us,
    • “March 8-14 marks Patient Safety Awareness Week. The AHA has several resources including podcasts, videos and reports that show how AHA members are advancing patient safety through innovative programs and technologies. LEARN MORE” 
  • Beckers Clinical Leadership adds,
    • “The use of artificial intelligence in diagnosis, rural healthcare access and federal funding cuts are among the most pressing patient safety concerns facing healthcare organizations in 2026, according to a new report from the Emergency Care Research Institute and the Institute for Safe Medication Practices.” * * *
    • “Here are the 10 most pressing patient safety challenges in 2026, per the report:
      • “Navigating the AI diagnostic dilemma
      • “Reduced access to rural healthcare increases health risks and disparities
      • “Increasing rates of preventable acute diseases in communities and healthcare settings 
      • “Effects of federal funding cuts on healthcare operations and patient safety 
      • “Lack of recognition and reporting of harm events
      • “Structural and systemic barriers inhibit equitable pain management for women
      • “Persistent workforce shortages continue to burden staff and restrict access to care 
      • “The impact on system improvement when a culture of blame hinders learning
      • “Emergency department boarding contributes to worse patient outcomes 
      • “Persistent gaps in manufacturer packaging and labeling design continue to undermine medication safety efforts.   

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies. 
    • “The newly proposed guidance (PDF) focuses on clinical pharmacokinetic (PK) testing, a core aspect of biosimilar drug testing that serves as a key comparative test to weigh a proposed biosimilar against the approved product it references.
    • “In its draft guidance, the FDA offers recommendations for streamlining unnecessary PK testing when “scientifically justified,” a change that could save biosimilar drugmakers up to 50% of their PK study costs, which equates to about $20 million, the agency said in a press release.
  • and
    • “In a dizzying span of seven months in 2022, Bristol Myers Squibb gained FDA approval for three new products, touting each with the potential to achieve $4 billion in peak sales. 
    • “While multiple myeloma drug Opdualag and cardiomyopathy treatment Camzyos became blockbusters last year, psoriasis med Sotyktu wasn’t close.
    • “With a new FDA nod in hand for Sotyktu, however, BMS can reach more patients with the oral med, which was acquired in the drugmaker’s 2019 buyout of Celgene for $74 billion.
    • “The U.S. regulator has endorsed Sotyktu as a treatment for adults with active psoriatic arthritis. It becomes the first drug in its class as a selective allosteric tyrosine kinase 2 (TYK2) inhibitor to be approved in the indication. The thumbs up comes on top of Sotyktu’s original FDA approval for moderate-to-severe plaque psoriasis.”

From the judicial front,

  • The AHA News reports,
    • “The U.S. District Court for the Southern District of Florida March 6 ruled in favor of five Florida hospitals in a case challenging the methodology used by the Leapfrog Group regarding hospital safety ratings. In particular, the court determined that Leapfrog’s methodology violated Florida’s unfair and deceptive business practices law. “Leapfrog’s change in methodology has no scientific basis, unfairly penalizes non-participating hospitals, and misrepresents hospital safety,” Judge Donald M. Middlebrooks wrote. The court’s injunction requires Leapfrog to cease assigning safety grades to hospitals, remove grades assigned to the plaintiff hospitals in 2024 and 2025, and issue corrective disclosures, along with other actions.”
  • Per a Justice Department news release,
    • “A Texas man was sentenced Friday to 90 months in prison for his role in a $59.9 million conspiracy to pay kickbacks and submit claims for medically unnecessary durable medical equipment (DME) to Medicare.
    • “According to court documents, Patrick Cassells, 65, of Fulshear, Texas, owned and operated three DME companies and concealed his role in one of those companies by falsely identifying another individual as the sole owner and manager in a Medicare enrollment application. Cassells paid illegal kickbacks to co-conspirators who sent him signed doctors’ orders and other paperwork necessary to bill Medicare for orthotic braces such as knee, back, shoulder and wrist braces. The kickbacks were disguised by referring to the doctors’ orders as “leads” and the services provided as “marketing.” Based on these orders, which were issued without doctors examining or treating the patients, Cassells submitted claims to Medicare that falsely represented that the braces were medically necessary. In total, through the three companies, Cassells caused over $59.9 million in false and fraudulent claims to Medicare, for which Medicare paid over $27 million. Cassells used proceeds of the fraud to purchase personal vehicles and vehicles that he intended to export to Nigeria.
    • “In June 2024, Cassells pleaded guilty in the Southern District of Texas to one count of conspiracy to commit health care fraud.
    • “In addition to the prison sentence, Cassells was ordered to pay $25,402,614.97 in restitution and forfeiture, and to forfeit four vehicles and three properties in the Houston area.”

From the public health and medical / Rx research front,

  • The Hill reports
    • “New data showed childhood obesity has hit a record high in recent years, while federal changes such as cuts to food assistance programs and a revamped food pyramid reignite debates over how to handle the issue.  
    • “A Centers for Disease Control and Prevention (CDC) report late last month showed more than 1 in 5 U.S. children and teenagers were obese between 2021 to 2023, compared to only 5.2 percent between 1971-1974. The number of children with severe obesity in recent years has hit 7 percent.
    • “School meals, physical activity and weight loss drugs have all become talking points in the problem, which is a major issue in the “Make America Healthy Again” movement associated with Health and Human Services Secretary Robert F. Kennedy Jr.
    • “Experts point to school meals and increased activity as key ways to address childhood obesity, with research showing school meals are the healthiest eating options some students have all day.  
    • “They’re noting that this increase in obesity occurred during COVID-19 and that jump in childhood obesity happened during the years when millions of kids lost access to reliable school meals. So, when schools closed for virtual learning, children lost a critical source of daily nutrition,” said Erin Hysom, senior child nutrition policy analyst on the Child Nutrition Programs and Policy team for the Food Research & Action Center.” 
  • The American Medical Association lets us know what doctors wish their patients knew about multiple sclerosis.
  • Brown & Brown released a guide for employers on how to support women’s heart health.
  • MedPage Today tells us,
    • “Infection with Kaposi sarcoma-associated herpesvirus (KSHV) is the cause of Kaposi sarcoma, a type of cancer where lesions grow on the skin and other parts of the body.
    • “This CDC report detailed 46 cases of suspected donor-derived KSHV-related complications among 153 transplant recipients from 2021-2025, roughly five times the number of cases reported from 2016-2020.
    • “Of the 74 transplant recipients identified as having a KSHV infection, 61% developed Kaposi sarcoma.” * * *
    • “A key challenge is the lack of an FDA-approved serology assay to screen for KSHV in donors and recipients. The existing assay for clinical testing is operator-dependent and not easy to scale, Durand noted. A molecular PCR-based assay could theoretically monitor transplant recipients for infection, she added, “but we don’t know who to monitor, how often to monitor, nor what to do with a positive test.”
    • “Despite the challenges, Durand recommended that clinicians keep the KSHV diagnosis in mind, particularly in lung and liver recipients who present with signs and symptoms that might be explained by the virus.”
  • and in better news,
    • “Along with the use of AI, routine screening mammograms could identify women at higher risk of cardiovascular disease, a retrospective cohort study suggested.
    • “A greater amount of AI-calculated breast arterial calcification on imaging was associated with an increased risk of major adverse cardiovascular events.
    • “These findings indicate an opportunity to use routine mammograms for early cardiovascular risk stratification without additional radiation exposure.”
  • Health Day tells us,
    • “Telemedicine has not led to a significant rise in new mental health patients from rural or underserved communities
    • ‘High use of virtual visits led to a 3.6% decrease in the total number of new patients seen by therapists
    • “State licensing laws are likely the barrier to reaching patients across state lines.”
  • Genetic Engineering and BioTechnology News informs us,
    • “Researchers at Washington University School of Medicine in St. Louis have developed genetically altered astrocytes that express chimeric antigen receptors (CARs) as a promising immunotherapy system capable of clearing accumulations of amyloid-β (Aβ)—a hallmark pathological feature of Alzheimer’s disease (AD)—in the brains of mice.
    • “Recently approved anti-Aβ antibody therapies have shown moderate success in slowing AD progression. However, these treatments require large doses, repeated administration, and are associated with potentially serious side effects.
    • “To reduce the frequency of treatment and potentially improve the efficacy of anti-amyloid therapy, scientists headed by Marco Colonna, MD, the Robert Rock Belliveau, MD, professor of pathology at WashU Medicine engineered CAR-expressing astrocytes—CAR-As, as a new type of cellular immunotherapy. Their tests in mice showed that a single injection of the CAR-A treatment prevented amyloid plaques from developing when given before plaques start to form. A single treatment in animals that had already developed plaques also cut the amount of amyloid plaques in half.
    • “This study marks the first successful attempt at engineering astrocytes to specifically target and remove amyloid beta plaques in the brains of mice with Alzheimer’s disease,” said Colonna. “Although more work needs to be done to optimize the approach and address potential side effects, these results open up an exciting new opportunity to develop CAR-astrocytes into an immunotherapy for neurodegenerative diseases and even brain tumors.”
  • STAT News points out,
    • “Xenon Pharmaceuticals said Monday that its treatment for a common type of seizure disorder significantly reduced the frequency of those seizures compared to a placebo — achieving the main goal of a Phase 3 clinical trial. 
    • “The new study results also exceeded the treatment effect reported in the company’s previous mid-stage study. 
    • Xenon said it expects to seek the approval of its drug, called azetukalner, with the Food and Drug Administration in the third quarter. 
    • “In the Phase 3 study, a 25 mg dose of azetukalner reduced the frequency of seizures over a month by 53% compared to 10% in the placebo arm. The difference, just under 43 percentage points, was statistically significant. Participants were treated for 12 weeks.
    • “A 15 mg dose of azetukalner also reduced seizure frequency more than placebo with statistical significance.” 
  • Per BioPharma Dive,
    • “Bristol Myers Squibb said Monday that a regimen including its experimental protein-degrading drug mezigdomide produced positive results in a late-stage trial of patients with relapsed or refractory multiple myeloma.
    • “Investigators found that a combination of mezigdomide and two other standard myeloma therapies was associated with a “statistically significant and clinically meaningful improvement” in progression-free survival when compared to treatment with those two other drugs. Bristol didn’t provide specifics, but said that safety findings were “consistent” with the known profile of mezigdomide and the other components of the regimen.
    • “Mezigdomide is one of several protein-degrading therapies that Bristol Myers acquired in 2019 buyout of Celgene and sees as successors to blood cancer drugs Revlimid and Pomalyst. Another, iberdomide, hit one of its primary goals in a Phase 3 study late last year and is now under review by the Food and Drug Administration.”
  • and
    • “Roche’s experimental drug giredestrant missed the main goal of a Phase 3 trial testing it as an initial treatment for breast cancer, the company said Monday. A combination of the therapy and Pfizer’s Ibrance failed to delay progression or death compared to Ibrance and hormone treatment.
    • “The data is a blow to the Swiss drugmaker’s ambitions for giredestrant, which is already under Food and Drug Administration review in people whose breast cancer has progressed and succeeded in staving off relapses after surgery.
    • “The trial’s failure will also likely reinforce doubts about the commercial potential of drugs in giredestrant’s class, called oral SERDs. The two approved drugs in the class, Menarini’s Orserdu and Eli Lilly’s Inluriyo, have so far only been approved for people whose breast cancer carries a certain mutation.”

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

  • Modern Healthcare announced its Leading Women 2026. Congrats to them.
  • Fierce Healthcare announced its Fierce 15 healthcare companies.
  • BioPharma Dive reports,
    • “Novo Nordisk will begin offering its popular obesity drugs on Hims & Hers’ telehealth platform, ending a messy dispute that resulted in a lawsuit and a crackdown by U.S. drug regulators. 
    • “Under a deal announced Monday, Hims will provide access to Novo’s GLP-1 medicines — the diabetes drug Ozempic and the injectable and pill forms of the weight loss therapy Wegovy — to U.S. consumers at the same prices as other telehealth firms. Hims will no longer promote “compounded” versions of GLP-1 drugs on its website or in advertisements, and will give existing patients the chance to switch to “FDA-approved alternatives,” according to a statement from Novo. 
    • “Novo will, as a result, dismiss its patent infringement lawsuit against Hims while “reserving the right to refile in the future.” News of the deal was first reported by Bloomberg.”
  • Beckers Hospital Review adds,
    • “Amazon Pharmacy has added Eli Lilly’s Zepbound KwikPen in the 2.5-mg starter dose for $299 per month through its cash-pay model.
    • “Zepbound is a multidose injectable medication approved for chronic weight management and, more recently, moderate-to-severe obstructive sleep apnea. With a valid prescription, Amazon customers can order the KwikPen online for home delivery, including same-day delivery in nearly 3,000 cities and towns, according to a March 9 news release. That reach is expected to grow to 4,500 locations by the end of 2026.
    • “Amazon Pharmacy has supplied GLP-1 medications since 2021 and works with partners including LillyDirect, WeightWatchers, UpScriptHealth and Noom. To date, the company said, its platform has saved customers “more than $200 million,” with GLP-1s representing the largest share of savings, according to the release.”
  • and
    • “New York City-based NewYork-Presbyterian is beginning to see early signals from its hospital-at-home program, which launched in November 2025 as health systems across the country continue testing whether acute-level hospital care can be delivered safely in patients’ homes.
    • “The model allows certain patients who would otherwise require inpatient admission to receive hospital-level treatment at home through a combination of in-person nursing visits, remote patient monitoring and virtual physician oversight. Programs like these expanded rapidly during the COVID-19 pandemic under a federal waiver that allowed hospitals to bill Medicare for hospital-at-home services.
    • “Although the waiver was extended until 2030, many health systems are still evaluating whether the care model can deliver consistent outcomes and operational reliability outside traditional hospital walls.
    • “At NewYork-Presbyterian, early data has been encouraging.”
  • Per a Blue Cross news release,
    •  “New research from the Blue Cross Blue Shield Association (BCBSA) and its data analytics partner Blue Health Intelligence® (BHI®) suggests that the growing use of AI in hospital billing is driving higher health care costs by increasing the number and severity of diagnoses billed without any record of the expected treatment.
    • “Analyzing de-identified claims data from tens of thousands of maternity admissions nationwide, researchers found a sharp increase in cases coded for acute posthemorrhagic anemia, a serious condition that typically requires interventions such as blood transfusions. However, many patients coded with the diagnosis never received those treatments.
    • “Something is disconnected,” said Dr. Razia Hashmi, BCBSA’s vice president of Clinical Affairs. “Among hospitals showing the fastest rise in diagnoses of post-partum anemia, the rise in patients coded with this condition wasn’t paired with the level of care we would have expected, and the patterns we’re seeing point to AI‑enabled coding.”
    • “The cost impact is significant, reaching approximately $2.3 billion in spending:
      • “Researchers estimate that roughly $663 million in inpatient spending and at least $1.67 billion in outpatient spending may be tied to more aggressive, AI-enabled coding practices nationwide.”
  • Healthexec shares “four points about healthcare AI that notable experts are emphasizing in the public square.”
  • Per MedTech Dive,
    • “Agilent Technologies said Monday it agreed to acquire Biocare Medical for $950 million in cash to expand its pathology portfolio.
    • “Biocare’s antibody, reagent and instrument business complements Agilent’s offerings in clinical and research pathology and includes immunohistochemistry and in situ hybridization, Agilent said. 
    • “Since 2021, Biocare has generated annual double-digit revenue and profit growth. Revenue exceeded $90 million in 2025. The laboratory instruments and services provider is buying Biocare from an investor group led by Excellere Partners and GHO Capital Partners.”
  • and
    • “Zimmer Biomet shared data on its smart knee implant at the American Academy of Orthopaedic Surgeons conference on Wednesday.
    • “The company found that patients who used its Persona IQ implant with a care management platform had better outcomes a year after surgery than people with a traditional knee implant. 
    • “Mike Anderson, Zimmer’s clinical strategy associate director, said the results of the analysis showed that the company’s technology was associated with lower rates of revision surgery and periprosthetic joint infection, less use of opioids, and fewer visits to urgent care and physical therapy.” 

Monday report

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

From Washington, DC,

  • Govexec reports,
    • “Republicans are renewing their push to fully fund and reopen the Homeland Security Department, suggesting the war the United States launched against Iran over the weekend has heightened the need to end the single-agency shutdown that entered its third week on Monday. 
    • “House Republicans will bring up another vote on a DHS appropriations bill this week, Majority Leader Steve Scalise, R-La., announced, saying it was dangerous for Democrats to continue holding up the funding due to concerns over the Trump administration’s immigration enforcement crackdown. 
    • “The legislation would “end the DHS shutdown so we can ensure agencies can protect America during this dangerous time,” Scalise said, noting the FBI has warned of an elevated threat of terrorist activity domestically.” * * *
    • “Most of the department’s employees have continued to work during the shutdown, with only about 8% of the workforce home on furlough. Many employees, such as law enforcement and other personnel at Immigration and Customs Enforcement and Customs and Border Protection, are receiving their normal paychecks thanks to funding Congress provided in the One Big Beautiful Bill Act. Others, such as Transportation Security Administration and Federal Emergency Management Agency workers, have started to receive partial paychecks or will do so this week. The U.S. Coast Guard is paying its uniformed personnel on time, but civilians will face delayed pay.” 
  • Healthcare Dive relates,
    • “The American Medical Association is overhauling how U.S. doctors report and bill for pregnancy services, bulldozing the current system of bundled payments and replacing it with more granular, itemized codes next year.
    • “The changes, shared exclusively with Healthcare Dive, could help improve poor maternity health outcomes in the U.S. But it’s also an acquiescence to specialty groups, which have long lobbied the powerful medical association that modern obstetric services are more complex than the current coding system is able to reflect.
    • “The move also represents a step back for value-based care, and could incentivize OB-GYNs and other doctors to provide unnecessary medical services at a time of skyrocketing health spending.
    • “But the changes shouldn’t result in OBGYNs, nurse-midwives or other maternity care specialists bringing in more revenue, according to the AMA, which argues the new coding system will benefit the entire healthcare industry.” * * *
    • “Global codes are normally billed when a baby is delivered, which can keep insurers in the dark about their members’ pregnancies. The new codes should give insurers more information, including when a member gets pregnant, that could help them ensure expecting mothers get adequate prenatal care, or know if mothers had complications during delivery that could necessitate follow-up services, according to Dr. Daniel Halevy, an executive at New York nonprofit insurer Healthfirst.”
  • and
    • “Sweeping reforms in the Consolidated Appropriations Act of 2026, signed into law by President Donald Trump earlier this month, included changes that could upend the traditional PBM model, while also turning attention back to drugmakers.” * * *
    • “With PBMs’ bargaining power facing stricter limits under the new reform [which takes effect later this decade to allow for necessary rulemaking], questions surrounding pricing could shift in a new direction.
    • “Be ready for the spotlight to swing back to drug manufacturers,” said Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department and head of its pharmacy practice group.
    • “As PBMs lose traction in the coming years, the pressure on drugmakers to justify their own list prices could intensify.
    • “Now, the argument is going to be that PBMs have been handcuffed, limiting their ability to use some of these abusive tools,” Dresser suggested. “So, it’s going to be up to the drug manufacturers to make sure they’re taking the appropriate steps and not continuing in the old paradigm now that there should be a shift in financial incentives.”
  • Bloomberg Law reports,
    • “A group representing thousands of pharmacies across the US said its members are experiencing financial issues after the rollout of the government’s drug price negotiation program, urging the Centers for Medicare & Medicaid Services to immediately address cash flow concerns.
    • “A letter from the National Community Pharmacists Association is asking CMS Administrator Mehmet Oz to ensure pharmacies receive timely payments under the Medicare Drug Price Negotiation Program, finding in a survey that its members are facing cash flow issues after dispensing certain drugs and waiting for a refund from the manufacturer. 
    • “We need CMS to take all necessary steps to expedite the manufacturers’” refund payments to pharmacies, Ronna Hauser, senior vice president of policy and pharmacy affairs for NCPA, said in the letter to the CMS sent Thursday. “Pharmacies cannot continue to dispense these drugs with delayed payments unless the cash flow issues significantly improve.”
  • Per an Employee Benefits Research Institute news release,
    • “Rising health care costs are affecting household finances for many privately insured adults, with 4 in 10 reporting higher expenses in the past year and many cutting discretionary spending or reducing retirement contributions, according to results from the 2025 EBRI/Greenwald Research Consumer Engagement in Health Care Survey (CEHCS) released today by the Employee Benefit Research Institute (EBRI).
    • “Employment-based coverage remained the dominant source of private insurance, with 6 in 10 covered through their own job. Deductibles also remained widespread across plan types: More than three-quarters of enrollees had a medical deductible, including 70% of traditional plan enrollees. Enrollment in high-deductible health plans dipped slightly in 2025, while enrollment in consumer-directed health plans and health savings accounts (HSAs) appeared relatively stable.
    • “The annual survey also found that most enrollees spent relatively little time selecting coverage during open enrollment, with about half spending less than an hour reviewing options and most spending under two hours. While most adults reported being satisfied with the ease of plan selection and the information available, satisfaction with the availability of affordable plan options and the number of plans to choose from declined in 2025.”
  • Beckers Payer Issues tells us,
    • “CMS is sanctioning Elevance Health and plans to suspend enrollment into the insurer’s Medicare Advantage prescription drug plans, according to a Feb. 27 agency letter.
    • ‘The enrollment and communications pause is set to begin March 31 unless Elevance submits all data corrections and an attestation in advance. CMS said the intermediate sanctions stem from “substantial and persistent noncompliance with Medicare Advantage risk adjustment data submission requirements.” The sanctions will apply until Elevance resolves the issues.”
  • Per a Labor Department news release,
    • “The U.S. Department of Labor’s Wage and Hour Division announced [February 26] a proposed rule designed to help workers and employers better understand how to determine when a worker is an employee and when the worker may be classified as an independent contractor under the Fair Labor Standards Act and related federal laws. 
    • The proposed rule would rescind the department’s 2024 final rule addressing the classification of independent contractors and replace it with an analysis for employee classification similar to the one adopted by the department in 2021. Consistent with Supreme Court and federal circuit court precedent, the proposed rule would make it easier to properly differentiate between employees with the protections under the Fair Labor Standards Act and those workers who work as independent contractors.” * * *
    • “The department encourages all interested parties to submit comments on the proposed rule, which has a 60-day comment period that closes at 11:59 p.m. ET on April 28, 2026.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Ascendis Pharma said Friday the Food and Drug Administration granted accelerated approval to a treatment it’s developed for the most common type of dwarfism, ending what had been a monopoly for rival drugmaker BioMarin Pharmaceutical. 
    • “The new drug, previously known as TransCon CNP and now Yuviwel, is a once-weekly injection cleared for children aged two and older with achondroplasia and open growth plates. The treatment will compete with Voxzogo, a daily shot sold by BioMarin.”
  • MedTech Dive relates,
    • “Abbott has won approval for updated remote heart failure monitoring technology, the company said Friday.
    • “The Food and Drug Administration awarded approval to CardioMEMS Hero, a new version of the device that patients use to take daily pulmonary artery pressure readings.
    • “Abbott has made Hero smaller and 60% lighter than the previous reader, fitting the electronics into a device the size of a laptop case to make it easier to use and take on planes.”
  • and
    • “Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, received a warning letter from the Food and Drug Administration in January.
    • “Inspectors raised concerns with leaking infusion sets, which can pose a risk of insulin under-delivery, potentially leading to life-threatening complications like diabetic ketoacidosis.  “Regulators called for Unomedical to address problems with validating its devices, addressing complaints and providing timely adverse event reports to the FDA.
    • “The warning letter followed a remote regulatory assessment of Unomedical’s facility in Reynosa, Mexico, last summer.”

From the judicial front,

  • Bloomberg Law reports,
    • “The Justice Department said it won’t appeal the decision of a New York federal judge to throw out a murder charge against Luigi Mangione, which means he won’t face the death penalty if he’s convicted of killing UnitedHealth Group Inc. executive Brian Thompson.
    • “US District Judge Margaret Garnett ruled in January that prosecutors can’t pursuethe capital murder charge, but that a jury could determine if Mangione caused Thompson’s death under two federal stalking laws. If convicted of those crimes, he could face life in prison without possibility of parole. 
    • “In a one-page letter Friday to Garnett, a Justice Department lawyer said prosecutors won’t challenge the judge’s decision.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A report published March 2 by the American Cancer Society found that colorectal cancer rates among adults 65 and older continue to decline while rates for younger adults continue to increase. The study found that the increase is being driven by a higher prevalence of rectal cancer, which now makes up 32% of all colorectal cancer diagnoses, up from 27% in the mid-2000s. The study also projects 158,850 new cases of colorectal cancer in the U.S. in 2026, and that 55,230 individuals will die from the disease. Nearly one-third of deaths are estimated to be younger than age 65.” 
  • Cardiovascular Business tells us,
    • “Patients with type 2 diabetes who use GLP-1 receptor agonists (GLP-1 RAs) and make healthy lifestyle choices can significantly lower their risk of experiencing a heart attack or stroke, according to new data published in The Lancet Diabetes & Endocrinology.[1]
    • The study’s authors explored data from more than 98,000 participants from the U.S. Department of Veterans Affairs’ Million Veteran Program. These individuals were enrolled from 2011 to 2023. 
    • “Lifestyle habits explored in this analysis included getting a recommended amount of exercise, not smoking, sleeping well, drinking minimal alcohol, properly managing stress, connecting with others socially and avoiding opioids. Overall, adults on a GLP-1 RA and following six to eight of these healthy habits was associated with a 43% lower risk of experiencing a major adverse cardiovascular event (MACE) than those not taking GLP-1 RA or adhering to these habits. When adults followed all eight habits, meanwhile, the risk was approximately 60% lower.
    • “In addition, those using a GLP-1 RA had a 16% lower MACE risk than those who did not use a GLP-1. 
    • “Our findings underscore that, even in the era of highly effective GLP-1 pharmacotherapy, lifestyle habits remain central to diabetes management and cardiovascular risk reduction and can substantially amplify the benefits of modern medications,” corresponding author Frank Hu, MD, PhD, chair of the department of nutrition at the Harvard T.H. Chan School of Public Health, said in a statement.”
  • Contemporary OB/GYN informs us,
    • “The quadrivalent HPV vaccine is associated with a significantly reduced risk of invasive cervical cancer that persists for at least 18 years after administration.
    • “Vaccination before the age of 17 provides a 79% lower risk of cervical cancer, while those vaccinated at age 17 or older also experience significant long term risk reductions.
    • “Population level data shows that school based vaccination cohorts have significantly lower rates of invasive cervical cancer compared to earlier opportunistic vaccination cohorts.”
  • MedPage Today points out,
    • “The location and amount of brain microbleeds that a person has could be telling of their risk of dementia, according to an observational analysis.
    • “Compared with controls with no cerebral microbleeds detected on MRI, there was an increased dementia risk in older people with:
      • “Mixed subcortical and lobar microbleeds (HR 1.99, 95% CI 1.40-2.83)
      • “Lobar-only microbleeds, with or without cortical superficial siderosis (HR 1.96, 95% CI 1.30-2.97)
      • “Any cortical superficial siderosis (HR 2.57, 95% CI 1.36-4.89)
    • “Participants with three or more cerebral microbleeds of any pattern also had an increased risk of dementia (HR 1.92, 95% CI 1.35-2.72), as did peers with at least two subcortical microbleeds, according to Rebecca Gottesman, MD, PhD, of the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland, and colleagues.
    • “Their report, based on the Atherosclerosis Risk in Communities-Neurocognitive Study, was published in Stroke.
  • and
    • “Chronic migraine patients who used GLP-1 receptor agonists to treat conditions like obesity or diabetes had fewer emergency department (ED) visits than those on topiramate (Topamax), a real-world data analysis showed.
    • “Compared with topiramate users, GLP-1 drug initiators were 10% less likely to visit the ED over the following year (RR 0.90, 95% CI 0.86-0.94), reported Hsiangkuo Yuan, MD, PhD, of Jefferson Headache Center at Thomas Jefferson University in Philadelphia, in an abstract released ahead of the American Academy of Neurologyopens in a new tab or window annual meeting.”
  • The Wall Street Journal asks whether Multi-Cancer Blood Tests Are Ready for Prime Time?
    • Early detection tests are already on the market, but without FDA approval or proof they reduce deaths some doctors urge caution
  • Per BioPharma Dive,
    • “Roche’s experimental pill fenebrutinib hit its main goal in a second Phase 3 trial in the most common form of multiple sclerosis, helping treatment recipients experience significantly fewer relapses than study volunteers who got Sanofi’s Aubagio, the company said Monday.
    • “However, Roche also reported a case of severe liver side effects in one enrollee who got fenebrutinib in the study. It also revealed a higher number of deaths among people who took its therapy in the two Phase 3 trials in relapsing MS, which prompted one analyst, Michael Leuchten of Jefferies, to question the drug’s approval prospects. Analysts have forecasted peak sales of more than 3 billion Swiss francs, or $3.8 billion, for fenebrutinib, Leuchten wrote.
    • “Fenebrutinib is part of a new crop of “BTK inhibitors” that drugmakers are now positioning as potential autoimmune disease treatments. The effort has yielded multiple setbacks in MS, though, as the Food and Drug Administration recently rejected a BTK drug from Sanofi, and other developers like Merck KGaA and Biogen have given up on prospective drugs.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealth Group has named Dennis Stankiewicz as chief accounting officer, effective March 2. 
    • “Tom Roos, who has served as CAO since 2015, has been named CFO at Optum Insight, the company said in regulatory filings.”
  • Healthcare Dive adds,
    • “UnitedHealth executive and former Optum leader Heather Cianfrocco is leaving the company, according to a post on LinkedIn.
    • “Cianfrocco was promoted to executive vice president of governance, compliance and information security at UnitedHealth in May, after serving for a year as CEO of Optum, the company’s health services arm. Patrick Conway, the former CEO of Optum Rx, replaced Cianfrocco.
    • “Cianfrocco is departing UnitedHealth after serving in a number of executive positions, including as CEO of Optum Rx and chief of UnitedHealthcare’s community and state division. “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she said in a post on LinkedIn. “I am leaving with so much pride in what we have accomplished together.”
  • Beckers Hospital Review notes,
    • “According to data gathered by Becker’s, Parkland Health and Hospital System [in Dallas, Texas] saw the highest number of emergency department visits in 2025. 
    • “The figures [shown in the article] represent the number of ED visits at individual hospital facilities, rather than the total visits across entire health systems. These self-reported totals were provided directly by hospitals.
  • Fierce Healthcare relates,
    • “Healthcare technology companies DoseSpot and Arrive Health have merged to combine an electronic prescribing platform with medical and pharmacy benefits data to advance real-time medication price transparency for providers and patients.
    • “The new company, called Interra Health, combines Arrive Health’s coverage and pricing network with DoseSpot’s e-prescribing capabilities to support prescribing decisions and help patients access the right medication at the lowest cost, according to the companies.
    • “Bain Capital Tech Opportunities is backing the deal and will serve as majority owner. PSG, the former majority owner of DoseSpot, will be a minority owner. Additional minority investors include Providence and UPMC Enterprises.
    • “The combined company is profitable, growing at approximately 40% annually and projected to exceed $100 million in revenue in 2026, executives said.”
  • Per BioPharma Dive,
    • “Privately held Candid Therapeutics will merge with Rallybio in a deal to take the inflammatory disease drugmaker public, the companies said Monday.
    • “The new entity will operate under Candid’s name, and trade on Wall Street under the ticker “CDRX.” As part of the deal, Candid raised $505 million from more than a dozen venture capital firms and mutual funds including Venrock, RA Capital Management and Janus Henderson Investors.
    • “Candid is developing bispecific antibodies known as T-cell engagers it acquired in two deals with Chinese biotechnology firms in 2024. One of Candid’s central goals is to show it can advance drugs that are similar to cell therapies targeting B cells, but easier to manufacture and administer. While bispecifics research has largely focused on cancer, startups like Candid — and even some pharmas — are now testing the applicability of these drugs against autoimmune conditions.”

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Monday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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