Midweek update

HSA

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Electronic health records, FDA, Federal employment benefits, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC

  • Beckers Hospital Review reports,
    • “The U.S. national debt surpassed $40 trillion for the first time Aug. 19, adding another layer of financial uncertainty for hospitals already navigating elevated borrowing costs and significant federal reimbursement pressures, according to The New York Times. 
    • “The news comes as the federal government is on track to borrow more than $2 trillion this year, with rising interest expenses consuming an increasingly large share of federal spending, according to the report. 
    • “The knock-on effects extend far beyond the federal government’s balance sheet. Higher Treasury yields can increase hospitals’ cost of capital, while the deteriorating fiscal outlook could intensify scrutiny of Medicare, Medicaid and other federal healthcare programs already targeted by the Trump administration for spending reductions.”
  • STAT News relates,
    • “Erica Schwartz, the new director of the Centers for Disease Control and Prevention, told agency staff on Wednesday that she was prepared to disagree with administration leaders and sought to empower others to do the same, according to a recording of the meeting obtained by STAT.
    • “During her first all-hands address on Wednesday, Schwartz identified three priorities: preserving trust through radical transparency and scientific rigor; strengthening the CDC’s ability to respond to disease threats; and building up the agency’s relationship with state and local partners.”
    • “She said she was ready to stand up to health secretary Robert F. Kennedy Jr. if needed to accomplish those goals.
    • :Schwartz said she wasn’t blind to what her predecessor, Susan Monarez, went through — being fired because she wouldn’t agree to follow Kennedy’s orders on vaccine policy — and said she was clear with Kennedy she would act and share information as a physician.
    • “I feel very comfortable and very confident, already having like three or four meetings with them since I started this position, of speaking truth to power,” she said. “I do not feel at all challenged with speaking, you know, what the science tells me and what you all are telling me to represent for the CDC.”
  • Per a CMS news release,
    • “The Trump Administration announced a $90 million investment is being delivered to South Dakota through the federal Rural Health Transformation Program (RHTP) to accelerate digital health modernization, strengthen cybersecurity, and enhance interoperability across rural and underserved communities. This investment will strengthen South Dakota’s health workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state.
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
  • Beckers Payer Issues tells us,
    • “The average end-of-year balances for health savings accounts reached $5,532 in 2024, up from $4,747 the year prior.
    • “However, that balance fell far below out-of-pocket maximums. In 2025, out-of-pocket maximums for HSA-eligible health plans were $8,300 for individual coverage and $16,600 for families.
    • “The Employee Benefit Research Institute released an issue brief Aug. 13 detailing HSA trends from 2011 through 2024. The institute formed its HSA database more than a decade ago. As of the end of 2024, the database had 15.2 million accounts with total assets of $53.7 billion.
    • “The report outlined the “triple tax advantage” of HSAs: tax-free contributions, tax-free growth and tax-free qualified withdrawals.”
  • Fierce Healthcare points out,
    • “While many individuals believe they have a firm grasp on their Medicare benefits, the reality is far different, according to a new survey.
    • “Insurance agency eHealth conducted a survey of 1,000 Americans and found that 89% of beneficiaries feel “confident” that they understand their Medicare benefits and coverage options. However, just 13% could identify each of the main facets of Medicare, such as the traditional program, Medicare Advantage, Part D and Medicare supplement plans.
    • “In addition, most (88%) said they did not know there is no annual cap on out-of-pocket spending in traditional Medicare, while 82% of those nearing Medicare eligibility said they were not aware that there is a 20% coinsurance for medical services.
    • “Close to half (42%) of beneficiaries were unaware or underestimated that 20% coinsurance, according to the report.”
  • Beckers Behavioral Health informs us,
    • “The percentage of U.S. adults who report doing any kind of gambling during the past year fell to 45%, down from 64% a decade ago, according to an Aug. 17 report from Gallup. 
    • “The findings are based on telephone interviews conducted by ReconMR June 1 to July 19, 2026, with a random sample of 2,201 adults, aged 18 and older, living in all 50 U.S. states and the District of Columbia. Gallup also conducted a web survey from June 1-15, 2026, with a stratified random sample of 2,043 adults, aged 18 and older, who are members of the Gallup Panel.’ 

From the U.S. Office of Personnel Management front,

  • FedWeek lets us know,
    • “The [Federal Employee Benefits] open season this year will run November 9-December 14. Available plans and their premiums for the upcoming year typically are announced a month or so in advance, with fuller details released just ahead of the enrollment period.”
  • OPM Director Scott Kupor made his latest post to his Secrets of OPM blog available on LinkedIn today. The post concerns a recent OPM employee survey.

From the Food and Drug Administration front,

  • CBS News reports,
    • “The Food and Drug Administration upgraded a recall of frozen blueberries and mixed berries sold at Publix grocery stores across the U.S. to the highest health risk level on Tuesday, according to an enforcement report.” 
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) to reduce daily cornstarch intake as an adjunct to nutritional management in adults and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa), a rare, inherited genetic disorder caused by a deficiency of the enzyme glucose-6-phosphatase, which prevents the body from properly breaking down stored glycogen into glucose. Genglycos is the first approved treatment for this condition.
    • “The accelerated approval pathway allows the FDA to approve certain drugs or biologics intended to treat a serious or life-threatening disease or condition if the agency determines the treatment has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
    • “Patients with GSDIa face possible life-threatening complications and have limited treatment options that include primarily life-long, strict dietary management,” said Karim Mikhail, B. Pharm., M.S., acting director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval is a great milestone in using a gene therapy to treat this disease and improve the quality of life for people with this condition.”
  • and
    • “The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current phlebotomist shortage in the U.S.
    • “This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.”
  • Fierce Pharma tells us,
    • “After more than 10 years in development, Regeneron secured a landmark approval for its monoclonal antibody garetosmab, now commercially known as Pasatru. The drug has become the second cleared by the FDA to treat fibrodysplasia ossificans progressiva (FOP) and the first to reduce clinician-assessed flare-ups in adults with the disease.
    • “Pasatru, given intravenously every four weeks, is designed to block what is believed to be the key protein behind the FOP disease process—activin A—which was pinpointed by Regeneron scientists as a possible target for treating FOP more than a decade ago. 
    • “The approval follows a victory last year in a phase 3 study, which randomized 63 adults with FOP to receive one of two doses of the anti-activin A antibody or placebo every four weeks for 56 weeks. In the trial, both high- and low-dose Pasatru reduced new bone lesions in FOP patients by 90% over 56 weeks. And high dose Pasatru reduced bouts of painful localized inflammation by 89% compared to placebo, too.
    • “By the end of the trial, an independent data monitoring committee recommended all patients on placebo be switched to Pasatru as soon as possible.” 

No Surprises Act News,

  • Modern Healthcare reports,
    • “Providers are triumphing against insurers in bitter out-of-network billing battles at a record pace and by an unprecedented margin.
    • “President Donald Trump enacted the No Surprises Act in 2020. The law succeeded in protecting patients from many surprise medical bills. But its baseball-style arbitration system was quickly overwhelmed.
    • “Independent Dispute Resolution filings represent a tiny percentage of commercial health insurance claims, but cases have increased each year since the process debuted in 2022. Disputes rose almost 75% to more than 2.5 million from 2024 to 2025, according to an analysis of Centers for Medicare and Medicaid Services data the Niskanen Center published in July. CMS originally projected there would be about 17,000 cases a year.
    • “Providers won 83.6% disputes in the fourth quarter of 2025, a share that’s been consistent since 2023, according to the Niskanen Center, a centrist think tank.
    • “Provider groups maintain these wins are warranted and arbitrators have agreed. Publicly held insurers including UnitedHealth Group subsidiary UnitedHealthcare, CVS Health subsidiary Aetna and Elevance Health contend out-of-network providers are abusing the system. Last month, CMS acknowledged arbitration is not working as intended and suggested it would take action.
    • “When we look at other models of arbitration, the win rates tend to be 50-50, and it tends to be a pretty rare option of last resort,” said Christopher Whaley, a health economist at Brown University. ”Obviously, that’s not happening in the No Surprises Act arena.”
  • FEHBlog observation: The NSA IDR rules stack the deck in favor of the providers who have inside information on the provider’s credentials and the patient’s acuity.

From the judicial front,

  • Fierce Pharma reports,
    • “In their attempts to challenge the Medicare drug price negotiation program, introduced by former President Joe Biden under the Inflation Reduction Act (IRA), biopharma companies have been largely shut out in federal courts.
    • “On Tuesday, however, Teva Pharmaceuticals gained a partial win as the U.S. Court of Appeals for Washington, D.C. sent (PDF) a previous ruling back to the District Court for further review. It concerns Teva’s challenge to the requirement by the Centers for Medicare & Medicaid Services (CMS) that a generic drug be genuinely marketed before its brand-name reference product is excluded from negotiation.
    • “The appeals court did not decide on the legality of the CMS’s “bona fide marketing” standard. It only determined that it should be considered by the lower court. 
    • “The district court never addressed whether CMS’s standard comports with the IRA, and we leave that question for it to consider in the first instance,” Circuit Judge J. Michelle Childs wrote.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Packaged-food makers are testing new strategies to appeal to consumers using GLP-1 weight-loss drugs, which suppress hunger and alter taste.
    • “JPMorgan estimates that GLP-1 treatments could drain $30 billion to $55 billion in annual revenue from the food and beverage industry by 2030.
    • “Companies like Conagra and General Mills are developing protein-rich products aimed at GLP-1 users.”
  • Health Day adds,
    • “Are you worried that extra pounds might be harming your health?
    • “Check the notches on your belt, a new study suggests.
    • “Waist size might be one of the simplest and most effective measures to detect health risks associated with obesity, researchers reported recently in JAMA Network Open.
    • “Pay attention to the need to loosen your belt or get bigger pants,” lead researcher Dr. Aayush Visaria said in a news release. He is a faculty member at Rutgers Health-RWJBarnabas Health Center for Climate, Health, and Healthcare in New Jersey. 
    • “Although clothing size isn’t the same as a proper waist circumference measurement, it can be an early sign of unhealthy amounts of body fat,” Visaria said. “Measuring your waist, along with your weight, can help identify health risks earlier and provide an opportunity to reduce your risk of diabetes, heart disease, stroke and some cancers.”
  • Cardiovascular Business relates,
    • “Rates of heart failure (HF) in the United States are stable or even beginning to decline. When it comes to HF with preserved ejection fraction (HFpEF), however, the numbers are on the rise. 
    • “This prompted the American College of Cardiology (ACC) to create an expert consensus decision pathway document focused on the efficient management of HFpEF patients.[1]
    • “The new document represents an update of the ACC’s 2023 recommendations, exploring new data to provide an abbreviated, practical guidance for patient management. The format was revised to associate treatment algorithms and tables to match the evolving clinical evidence.
    • “Despite advances in HF therapy, it remains a major consumer of healthcare resources and death worldwide. HFpEF accounts for more than 50% of new cases of HF each year and has outcomes comparable to heart failure with reduced ejection fraction (HFrEF). However, the consensus authors said HFpEF is often underdiagnosed and results in substantial resource utilization.”
  • and
    • “The use of artificial intelligence (AI) to identify incidental cardiac findings is a growing area of research, and now the identification of aortic stenosis (AS) is being tested on noncardiac chest CT scans. Cedars-Sinai Medical Center researchers are conducting a real-world study of an opportunistic algorithm that looks at all chest scans for the hallmark signs of AS.
    • “Some imaging experts have said this specific use of AI could serve as an early screening system to catch patients with heart disease years before they would become symptomatic, adding diagnostic value beyond why these scans were originally ordered. AS is one of the most common and serious heart valve disease problems, but most patients are unaware they have it at first and go undiagnosed until they become symptomatic. The American Heart Association (AHA), for example, believes there is still a sizable population of patients who remain undiagnosed or untreated.” 
  • Medscape offers physicians “Five Steps to Earlier Heart Failure Detection.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded scientific team has shown that under the right circumstances, 3D cell culture models of human brain tissue, known as organoids, can express features of later stage brain development. This breakthrough could turn previously unattainable, long-term, benchtop studies of neurodevelopmental disorders into a reality.
    • “The unprecedented longevity and lifelike qualities of these tissue models could afford us the opportunity to dig deeper into how conditions such as autism emerge and unfold later in life,” said Andrea Beckel-Mitchener, Ph.D., acting director of NIH’s National Institute of Mental Health (NIMH).”
  • Genetic Engineering and BioTechnology News adds,
    • “The Human Cell Atlas (HCA) was co-founded in 2016 by Aviv Regev, PhD, currently the head, executive vice president of research and early development at Genentech and Sarah Teichmann, FMedSci FRS, professor at the University of Cambridge and vice president translational research at GSK.
    • “This year, the group celebrated its 10-year anniversary, at the annual meeting in June, held in Boston. The first day was focused on the successes of the past decade. The second day looked ahead to the future, and the impact the HCA will make on research and drug discovery. GEN spoke with Holger Heyn, PhD, ICREA professor at the Centro Nacional de Análisis Genómico (CNAG) and co-founder of Omniscope about the meeting and what the next 10 years may bring. Heyn has been with the HCA since (almost) the beginning and currently serves as the co-chair of the Standards and Technologies working group, co-chair of the Industry Partnership Program, an organizing committee member, and a member of the task force to design HCA 2.0.”
    • The interview can be found in the article.
  • In the big research news of the day, the New York Times informs us,
    • “An experimental mRNA vaccine allowed people with high-risk melanoma to live longer, cancer-free, the pharmaceutical companies Moderna and Merck announced Wednesday.
    • “For decades, cancer vaccines have been one of the most tantalizing ideas in cancer treatment — offering the hope of harnessing a person’s own immune system to attack tumors.
    • “It’s a big deal,” said Dr. Elias Sayour, a pediatric oncologist at the University of Florida, who was not involved in the trial. The results, he said, “could help usher a whole new wave of new therapeutic treatments for cancer.” * * *
    • “The study is the most advanced of a number of trials testing the approach against a variety of cancers, including lung, bladder, kidney and pancreatic cancer. While small trials have shown the promise of the approach, the Moderna and Merck trial was seen as a bellwether in demonstrating the technology — and a first step toward transforming cancer care with treatments that are individualized to a person’s tumor and that may ultimately be able to stay ahead of it as it changes.”
  • The Wall Street Journal adds,
    • “Novo Nordisk is studying smaller doses of its Wegovy weight-loss pill to find the lowest dose that still allows patients to lose weight.
    • “The study began last week, has enrolled 450 overweight people and will test two low doses of the pill compared to a placebo.
    • “Novo Nordisk recently disclosed that uptake of the pill has been particularly strong for its lowest doses across self-paying patients.”

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

  • The Association of Healthcare Journalist reports,
    • “Investing more in primary care is linked to lower health care costs, according to a new report.
    • Journalists can cover this story nationally and locally, especially in rural areas where access to primary care can be more challenging, according to the report, “Investing in Primary Care: The Missing Strategy in America’s Fight Against Chronic Disease,” from the Milbank Memorial Fund.
    • “The report matters to reporters because it shows that adults and children with primary care physicians (PCPs) or a regular source of primary care have lower health care costs than those without.
    • “The report comes as Congress and President Trump are implementing changes under the 2025 budget reconciliation bill, cutting billions of dollars in federal Medicaid spending. Such a big decrease means low-income families could lose their Medicaid coverage, and not all physicians will treat the uninsured, the Milbank report notes. 
    • “The Milbank report is also timely because federal efforts since 2021 to increase the number of primary care doctors “have fallen short”, as Dennis Thompson reported for HealthDay. Primary care positions increased by just 2% under laws Congress passed in 2021 and 2023 to increase U.S. medical residencies, while residency positions in interventional radiology and psychiatry increased the most, rising by 16% and 13% respectively, he wrote, citing research JAMA published in June.” 
  • Beckers ASC Review adds,
    • “Physicians who once worked in a physician-owned practice before their current job are significantly more likely than their peers to be heading for the exit, according to the 2026 PAI Employed Physician Survey.
    • “Among physicians with prior experience in a physician-owned setting, 35% cite a lack of clinical autonomy as a reason they’re considering a new job, compared with 21% of physicians who’ve never practiced outside a corporate structure. They’re also more likely to say they plan to leave clinical practice entirely before retiring — 20% versus 12%.
    • “That group also reports operating under tighter terms: 63% are bound by a non-compete agreement, versus 48% of physicians without prior independent-practice experience, and 53% have patient-volume targets built into their compensation, versus 41%.”
  • Beckers Hospital Review relates,
    • “Altamonte Springs, Fla.-based AdventHealth recorded operating income of $916.2 million (13.4% operating margin) during the second quarter of 2026, up from $657.4 million (11.7% margin) during the same period last year.”
  • Beckers Health IT tells us,
    • “A year ago, health system CIOs walking the halls of Epic’s Users Group Meeting were still convincing themselves — and their boards — that generative AI in the EHR was more than a demo. This year, that debate is over. The new one is about speed.
    • “What strikes me overall is just the pace is blistering,” Tom Bentley, BSN, RN, chief information and digital technology officer of Columbus-based Ohio State University Wexner Medical Center, told Becker’s at the EHR giant’s sprawling headquarters in Verona, Wis. “Epic is cranking out new functionality, and I’m thinking what every CIO is thinking about: How do we increase our pace of adoption?”
    • “Epic used its Aug. 18 keynote to detail the scope of that push, including its Agent Factory platform that will soon allow health systems to build their own AI agents, the advancement of Cosmos-powered prediction tools called Curiosity, and the debut of an AI-assisted outpatient visit called Ergo.”
  • Beckers Payer Issues adds,
    • ‘The health systems and health plans that have pushed AI furthest into their operations are among the least equipped to prove what it is returning, according to a survey of 64 U.S. healthcare CFOs and finance leaders published Aug. 12 by Deloitte.
    • ‘Only 18% of organizations Deloitte classified as “AI scalers” said they have mature financial attribution capabilities, meaning they consistently measure AI’s effect on revenue growth or cost savings with defined baselines and clear ownership of key performance indicators. Among “AI starters,” 31% reported that level of maturity.’

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The House of Representatives Budget Committee lets us know,
    • “A new report from the Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) finds reforms to Medicaid provider taxes and state-directed payments in The One Big Beautiful Bill will lower health care prices for Americans across the board.
    • “The report projects the reforms will reduce non-Medicaid health care prices by as much as 3.5 percent, generating between $502 billion and $875 billion in savings for taxpayers, families, and businesses over the next decade, with annual savings reaching $100 to $175 billion once the reforms are fully in place.
    • “The savings extend beyond Medicaid: ASPE estimates that every $100 billion in Medicaid savings produces another $29 billion in savings for Medicare and commercial coverage plans, which lowers health care costs and the tax burden for hardworking American families.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced that health systems represented by the past, current, and incoming chair of the American Hospital Association (AHA) have joined the Make Hospital Food Healthier Pledge, strengthening a nationwide effort to improve the quality of food served in America’s hospitals and reinforce the role of nutrition in patient care. Corewell Health in Michigan, Houston Methodist in Texas, and Sanford Health in South Dakota all signed onto the pledge.
    • “Hospitals cannot promote healing while serving food that contributes to chronic disease,” said HHS Secretary Robert F. Kennedy, Jr. “By joining this pledge, these health systems are putting nutrition where it belongs — at the center of patient care. We are working with hospitals across America to serve healthier food, improve patient health, and Make America Healthy Again.”
  • Fierce Healthcare reports,
    • “The Pharmaceutical Care Management Association announced Thursday that its members had reached an agreement with the feds to offer information on cash prices available through TrumpRx.
    • “The commitment encompasses nine of the industry’s leading pharmacy benefit managers, including the “Big Three” in CVS’ Caremark, UnitedHealth Group’s Optum Rx and Cigna’s Express Scripts. Other participants that have signed on include Elevance Health’s CarelonRx, Humana, MedImpact Healthcare Systems, Navitus Health Solutions, Prime Therapeutics, VtylOne and WellDyne.
    • “Members covered by these PBMs will be able to see costs for drugs purchased through TrumpRx when using their plan’s real-time benefit or other pricing tools, PCMA said.”
  • McKnight’s Homecare relates,
    • “In a new memo outlining the National Fraud Enforcement Division’s enforcement priorities in a variety of industries, the Department of Justice called out home health and hospice fraud as an area of focus in the healthcare sector.
    • “National healthcare expenditures are expected to grow from over $3 trillion a year to over $7 trillion, and estimates are that between 3–10% of that amount is lost to fraud,” the Aug. 13 memo from Colin M. McDonald, assistant attorney general, said. “Home health aide and hospice scams directly impact vulnerable elderly Americans and erode patient care.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Aug. 14 released a request for comments through the Office of the National Coordinator for Health IT on a proposed three-year generic clearance to collect routine customer feedback on service delivery and performance related to the Trusted Exchange Framework and Common Agreement. TEFCA is a nationwide network for health information sharing established by ONC to fulfill mandates under the 21st Century Cures Act. HHS said data collection under the clearance would be used to standardize monitoring and performance reports for TEFCA participants. Comments are due 30 days following publication in the Federal Register.”

From the U.S. Office of Personnel Management front,

  • Govexec reports,
    • “Federal wildland firefighters will soon have more opportunities to receive hazard pay in connection with their work fighting and preventing wildfires, thanks to newly finalized regulations from the Office of Personnel Management.
    • “Currently, federal firefighters are eligible for hazard pay—a 25% increase over their normal salary—only when working to extinguish an unplanned wildfire. But they do not receive this increased pay when working on prescribed burns, in which officials intentionally ignite decaying forest material in the hopes of mitigating the risk of an uncontrolled wildfire breaking out in the future.
    • “In a new rule published in the Federal Register Friday, OPM finalized its April proposal to expand firefighters’ access to hazard pay to include prescribed burns, effective Sept. 13. The regulation authorizes hazardous duty pay for prescribed burns for firefighters hired under the “General Schedule pay sale, as well as environmental differential pay for those serving under the Federal Wage System.
    • “But OPM noted that the new hazard pay will not be available for every activity associated with a prescribed burn.
  • Also in today’s Federal Register, OPM issued a new direct final rule. Here is the summary and comment information:
    • SUMMARY: Pursuant to the President’s direction in Executive Order 14410, Implementing Schedule Policy/Career in the Excepted Service, the Office of Personnel Management (OPM) is issuing a direct final rule to update and amend obsolete and outdated provisions of the
    • Civil Service Rules that do not substantively affect agency operations.
    • DATES: This rule is effective October 13, 2026, unless significant adverse comments are received by September 14, 2026. If significant adverse comments are received, OPM will withdraw the relevant provisions of this direct final rule.
  • Federal News Network relates,
    • “Retirement is supposed to be the payoff for decades of saving, planning and serving the federal government. But for some federal employees, the first year of retirement can bring surprises they never saw coming, whether that be a delayed pension, a tax bill that looks very different from what they expected, anxiety about spending the money they’ve saved for decades, and decisions that can affect a spouse’s benefits for years to come.
    • “On this episode of Fed Thread [which the article summarizes], we called back our three financial professionals—James Campbell of Federal Employees Benefit Association, Katelyn Murray of RJFS and Serving Those Who Serve, and Chris Campbell of CJC Wealth Management and the DC Society for Financial Awareness—to talk through the financial and psychological traps feds may encounter before or after their last day. Because retirement isn’t just the day your paycheck stops. It’s the beginning of a completely different financial system.”

From the Food and Drug Administration front,

  • The Washington Post informs us,
    • “About 1.5 million dozen white and brown cage-free eggs recalled for potential salmonella contamination have been upgraded to the U.S. Food and Drug Administration’s highest-risk warning. 
    • “The agency reclassified the recall of Midwest Poultry Services eggs to Class I due to the reasonable possibility that exposure to the product would cause serious health issues or death, it said in a safety alert. 
    • “Salmonella is a bacteria that can cause diarrhea, vomiting, fever and stomach pain.
    • “The eggs were available to consumers in Brookshire Grocery stores in Texas, Louisiana, Oklahoma, Arkansas, New Mexico and Mississippi. Other locations include Kroger stores in Texas and Louisiana, as well as other small retail outlets, the FDA said.”
  • The UPI reports,
    • “U.S. health officials said they have begun inspections at the Mexican processing plant of the U.S. food distributor Taylor Farms as they deal with a continuing cyclosporiasis outbreak that has spread across 17 states.
    • “The Food and Drug Administration and the Centers for Disease Control and Prevention announced Thursday they have “initiated an onsite inspection and sampling” at Taylor Farms de Mexico’s facility in Guanajuato, Mexico, located about 185 miles northwest of Mexico City.”
  • The University of Minnesota’s CIDRA adds,
    • “The best-if-used-by dates of recalled iceberg lettuce associated with the massive Cyclospora outbreak have passed, according to an update from the US Food and Drug Administration (FDA) yesterday. This means that Cyclospora-tainted Taylor Farms lettuce should no longer be available at stores and restaurants.” 
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new brain imaging agent targeted toward Alzheimer’s, drugmaker Lantheus announced Friday. 
    • “Tauklarify, also known as MK-6240, is a radiodiagnostic agent indicated for PET (positron emission tomography) imaging of adults. Ideal candidates have cognitive impairment, with physicians evaluating them for abnormal buildup of tau—twisted, insoluble protein fibers in brain cells—a potential sign of the neurodegenerative disease. 
    • “Bedford, Massachusetts-based Lantheus—which recently reached a deal to be sold to rival Curius for $8 billion—said the drug’s safety was tested in two clinical trials. Across over 1,700 subjects, researchers reported strong results, with only about less than 1% of subjects experiencing adverse reactions.”

No Surprises Act News

  • The Centers for Medicare and Medicaid Service posted a notice today (Dropbox link) about implementation of changes to the Independent Dispute Resolution Gateway required by a recent final rule.
    • “Organizations and individuals thatprocess disputes, represent parties, or submit IDR web forms in the current Federal IDR process must sign up to manage disputes in the IDR Gateway. If a party uses a third-party administrator or another organization to process disputes, the party does notneed to sign up for the IDR Gateway but must ensure the third-party administrator or organization responsible for managing dispute processing activities signs up for an IDR Gateway account.
    • “Details about signing up for the IDR Gateway are coming soon. Until then, continue using the Federal IDR web.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “Luigi Mangione, whose coldblooded killing of an insurance executive on a Manhattan sidewalk rattled the nation and struck fear into Corporate America, pleaded guilty Friday to two federal stalking charges in the death of UnitedHealthcare leader Brian Thompson.
    • “On the morning of Dec. 4, 2024, I shot Mr. Thompson in Manhattan and he died,” Mangione solemnly told the judge during a court hearing.
    • “Mangione, wearing tan jail garb, told the judge that he spent years enduring severe pain, including a broken back, and witnessed others with similar experiences. He said that after learning of an investor conference, he emailed UnitedHealthcare, posing as an investor at a firm managing over $50 million in assets, to request information about it.
    • “Unlike my previous interactions with insurers, I received an immediate response within an hour,” Mangione added. He said he made part of a gun using a 3-D printer and planned the killing.
    • “U.S. District Judge Margaret Garnett said Mangione faces up to life in prison at his sentencing, which she set for December. Jamie McDonald, the U.S. attorney for the Southern District of New York, said after Friday’s hearing that his office intended to seek the maximum penalty, saying Mangione committed the crime in order to “draw public attention to his dislike of certain businesses.” 
    • “No grievance, political belief or ideological cause can ever justify murder,” McDonald said. “There can be no celebrity in assassination.”
  • FEHBlog observation: Well put observation, Mr. McDonald.
  • Healthcare Dive tells us,
    • “A patient advocacy group is going up against the most powerful doctor’s association in the U.S. in a bid to wrest away its ownership of U.S. medical codes and release them into the public domain.
    • “On Thursday, PatientRightsAdvocate.org sued the American Medical Association, challenging its copyright over the current procedural terminology, or CPT, billing code system, which shapes billions of dollars in healthcare payments every year.
    • “The goal of the lawsuit is to get the codes published online and let the public access them for free, the group, which lobbies for better price transparency in healthcare, said. Currently, the AMA charges licensing fees to retrieve and use CPT codes.”
  • FEHBlog observation — It’s no problem looking up CPT Codes on the internet.

From the public healh and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 14, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 101 newly confirmed measles cases nationwide, the US total has now reached 2,566 this year, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
    • “This is the second straight week of about 100 new cases after previous weeks’ totals of about half that. Most this week’s cases are in Pennsylvania, though Ohio also saw a substantial increase. 
    • “The CDC noted 38 outbreaks, the same as last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level several weeks ago. 
    • “All but 16 of this year’s cases have been locally acquired, with the rest tied to international travel.
    • “Of the 2026 cases, 19% involve children age 5 and under, and 67% involve kids and teens. Seven percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status.”
  • and
    • “A pair of new studies confirm that recently developed immunizations against respiratory syncytial virus (RSV) protect infants in their first year of life. 
    • “The research, including one study conducted in France and another in the United Kingdom, confirm that the immunizations are effective in the real world, not just in carefully supervised clinical trials”
  • MedPage Today relates,
    • “By this time of year, both the FDA and CDC normally have weighed in on fall respiratory virus vaccine recommendations. But given ongoing controversies over vaccination spurred by the Trump administration, a wrench has once again been thrown into the gears of that process.
    • “The FDA has done its part, making recommendations about vaccine composition for influenza vaccines in March, followed by recommendations for COVID shots in May. But the CDC’s Advisory Committee on Immunization Practices (ACIP) hasn’t done its part as it hasn’t held its March or June meetings this year.” * * *
    • But clinicians shouldn’t worry, because medical groups have stepped in to fill the gaps. The IDSA, the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians (AAFP) have issued guidance on fall respiratory virus shots and more, as the Trump administration has also tried to make significant changes to the pediatric immunization schedule.
    • At the same time, insurers have pledged to cover all recommended vaccines without cost-sharing through the end of 2027, Richard Hughes IV, MPH, legal counsel for AAP, said in an email in June.
    • “There are some shades of gray, however, as the FDA approved the first mRNA flu shot (mFlusiva) from Moderna earlier this month. While the company has said its shot — approved for adults 50 and up — should be available for the upcoming 2026-2027 season, it’s unclear whether it will be written into recommendations.”
  • and
    • “GLP-1 agonists and bariatric surgery are top obesity treatments, raising questions of their combined efficacy.
    • “A retrospective study found that patients taking GLP-1 drugs before surgery achieved similar 12-month weight loss as non-users (24% vs 25%).
    • “Treatment groups had comparable outcomes on surgical complications and diabetes control.”
  • Health Exec informs us,
    • “Right now U.S. healthcare has almost everything it needs to eliminate one awful affliction—and then to adapt the resulting victory for going after many others.  
    • “All it would take to set the precedent is responsible AI deployment, attuned government leadership, cross-sector partnerships and generational investments.  
    • “That, and an orchestrated targeting of the low-hanging fruit at hand—cervical cancer.  
    • “The cure-in-waiting for this maddeningly preventable cancer represents a “breakthrough with a failure to follow through,” physician-researchers explain in an article published Aug. 13 in JAMA.  
    • “Erstwhile Surgeon General Special Advisor Adam Beckman, MD, MBA, and co-author Dave Chokshi, MD, MSc, believe cervical cancer is a prime candidate for first dibs because of its 90%-plus early-stage survival rate on top of the near-perfect efficacy of vaccines for human papillomavirus (HPV), which causes many if not most cervical cancers. 
    • “All that’s lacking is the will to “bridge the stubborn gap between what we know and what we do in public health and healthcare,” the researchers write.”
  • Health Day points out,
    • “Taking the stairs instead of the elevator may do more for your health than you think.
    • “A large study published in the American Journal of Cardiovascular Drugs found people who regularly climbed the stairs were 39% less likely to die from cardiovascular disease. And 24% less likely to die from any cause. Their odds of heart attack, stroke and heart failure were also lower.
    • “Taking the stairs is a practical and often overlooked way to build physical activity into daily life,” said senior author Dr. Vassilios Vassiliou, a professor of cardiac medicine at Norwich Medical School at the University of East Anglia in the U.K. “We wanted to better understand how this everyday activity could have life-saving potential.”
  • and
    • “Gambling is a powerful temptation for today’s college students, and those hooked have a greater risk of deeper mental health issues, a new study says.
    • “Student gambling frequently occurs alongside depression, anxiety and substance use, researchers reported recently in the International Journal of Mental Health and Addiction.
    • “What’s interesting about this study is even though mental health concerns were very prominent, students who tended to gamble more were more likely to be experiencing greater levels of problems among a sample that was already experiencing plenty,” said lead researcher Nicholas McAfee, director of the William Magee Center for AOD and Wellness Education at the University of Mississippi.
    • “Gambling is a real concern for college students, given the proliferation of online betting and prediction markets in the United States, researchers said in background notes.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “U.S. employers project a median health care cost increase of 10% for 2027, according to Health Care Costs Pulse Survey: 2027 Cost Trend, a new survey from the International Foundation of Employee Benefit Plans. A similar International Foundation survey conducted in 2025 also projected a 10% increase for 2026.” 
  • Healthcare Dive adds,
    • “Nearly 4 in 5 U.S. adults said either high insurance premiums or out-of-pocket spending were the most important problem in the healthcare system, according to a Commonwealth Fund survey released Thursday. 
    • “Affordability concerns crossed party and coverage lines. Premiums were the top problem for 45% of Republicans, 44% of Democrats and 42% of independents, while more than 8 in 10 adults with employer, individual or marketplace coverage — as well as uninsured adults — said either premiums or out-of-pocket costs were the biggest issue.
    • “Still, according to the survey, Americans are split over who’s best to tackle the problem. Most respondents said the federal government is best suited to solve high healthcare prices, while Republicans were more likely to say insurance companies were best to address the issue.”
  • FEHBlog observation — Consumers pay insurance premiums and cost sharing but evidently fail to understand that those costs are driven by hospital, doctors and pharmacy charges.
  • In that regards, The Washington Post relates,
    • Prescription drug prices recorded the biggest year-over-year drop in more than 60 years in July, a startling reduction experts chalked up to an array of factors, including more generics and discount GLP-1 weight-loss drugs. 
    • While overall costs for medical services continued to rise, prices for medicinal drugs fell 2.7 percent over the 12 months ending in July, the largest annual drop on record, according to Bureau of Labor Statistics data released Wednesday. Prescription drugs, part of the medicinal drug category, fell by 3.1 percent, the steepest annual decline since March 1963.
  • EBRI calls to our attention,
    • “Plan sponsors that wish to introduce or continue offering health savings account (HSA)-eligible health plans as part of their workplace benefit program can benefit from a long-term view of HSA accountholder behaviors. As such, the Employee Benefit Research Institute (EBRI) has undertaken a series of longitudinal studies from its HSA Database, examining trends in account balances, individual and employer contributions, distributions, invested assets, and account-owner characteristics from 2011‒2024. Such analysis can help plan sponsors, providers, and policymakers better understand strategies that can help improve employee financial wellness.”
    • “HSAs offer a triple tax advantage to accountholders, enabling them to stretch money they save for health care expenses further than they otherwise could. The tax benefits of HSAs are maximized when accountholders contribute the statutory maximum and minimize withdrawals for current medical expenditures — if they are able — and invest their HSA balances in assets other than cash. However, the majority of accountholders appear to use their HSAs to pay for current expenses and do not take complete advantage of the tax benefits HSAs offer. Average contributions are well below the statutory maximum, most accountholders take a distribution from their HSA, and relatively few accountholders invest. We do find that as time goes on, accountholders tend to take fuller advantage of the benefits HSAs offer. And, despite out-of-pocket spending on health care rising by 5.9 percent in 2024, average balances in HSAs increased, rising from $4,747 in the prior year to $5,532. Further, the share of accountholders who invest their HSAs has crept steadily upward since EBRI began analyzing its HSA Database, reaching 18 percent in 2024.”
  • Beckers Hospital Review tells us,
    • “Providence Health Plan will completely shut down after it was unable to reach a deal with a national insurer to operate its Medicare Advantage business.
    • “We are in discussion with regulators about this development and the broader wind-down of Providence’s health plan operations,” a spokesperson for the system told Becker’s. “We will share more details with our members and the public as we are able under applicable regulations.”
    • “In May, the Renton, Wash.-based health system said it would shutter most of its insurance business beginning in 2027 after operating more than 40 years as a regional payer and serving more than 440,000 members. 
    • “At the time, President and CEO Erik Wexler said state and federal regulations and consolidation among large insurers had left Providence “in an untenable situation” and unable to continue operating the health plan.”
  • and
    • “Cleveland Clinic recorded operating income of $245.6 million (5% operating margin) during the second quarter of 2026, down from operating income of $255.3 million (5.6% margin) during the same period last year, according to its Aug. 14 financial report.”
  • and
    • “New Orleans-based Ochsner Health recorded operating income of $32.5 million (0.8% operating margin) in the first half of 2026, up from an operating loss of $42.7 million (-1.1% margin) during the same period last year, according to its Aug. 13 financial report.” 
  • Beckers Physician Leadership points out,
    • “Hollywood, Fla.-based DermCare Management and Dallas-based U.S. Dermatology Partners have partnered to form one of the largest dermatology groups in the U.S. 
    • “The combined company will expand patient access, preserve physician autonomy, support national dermatology clinical trials, improve practice management support and unify culture, according to an Aug. 13 news release from DermCare Management. 
    • “DermCare Management partners with more than 270 dermatology practices, and U.S. Dermatology Partners supports a network of more than 120 locations across nine states.” 

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, HSA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Benefits Link calls to our attention:
    • “Text of IRS Rev. Proc. 2026-24: 2027 Inflation Adjusted Amounts for Health Savings Accounts (HSAs) and Maximum Amount for Excepted Benefit Health Reimbursement Arrangements (HRAs) (PDF)
    • “For calendar year 2027, the annual limitation on deductions under section 223(b)(2)(A) for an individual with self-only coverage under a high deductible health plan [which thereby entitles the enrollee to contribute to a health savings account] is $4,500. For calendar year 2027, the annual limitation on deductions under Section 223(b)(2)(B)for an individual with family coverage under a high deductible health plan is $9,000.
    • “For calendar year 2027, a DPCSA [Direct Primary Care Service Arrangement] is not treated as a health plan with respect to an otherwise eligible individual if the aggregate monthly fees for all DPCSAs with respect to the individual do not exceed $150 or, if the individual is covered by a DPCSA that covers more than one individual, $300.
    • “For calendar year 2027, a ‘high deductible health plan’ is defined under section 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,750 for self-only coverage or $3,500 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,700 for self-only coverage or $17,400 for family coverage.
    • “For plan years beginning in 2027, the maximum amount that may be made newly available for the plan year for an excepted benefit HRA under Section 54.9831-1(c)(3)(viii) is $2,250.” 
  • Healthcare Dive shares industry reactions to yesterday’s final rule on the No Surprises Act Independent Dispute Resolution process.
    • “No Surprises has largely been successful in that goal, preventing millions of Americans from being hit with unexpected out-of-network charges. But the law came with an unintended consequence, creating a multi-billion dollar industry enabling doctors to get paid significantly more than they normally would for providing care.
    • “This rule is a missed opportunity to restore the balance that Congress intended — a balance that has been badly warped by activist courts and predatory provider interests,” James Gelfand, the CEO of the ERISA Industry Committee, which lobbies on benefits issues for large employers, said in a statement.
    • “Payers and providers have been at odds over independent dispute resolution, or IDR. Each side has long complained that the process unfairly benefits the other.
    • “But over the past few years, data has emerged suggesting that doctors and medical groups are raking in the dough from IDR — filing snowballing disputes, winning an exceptional share of awards and garnering massive payouts.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced a series of major initiatives to strengthen the nation’s response to Lyme disease and other tick-borne illnesses. HHS actions include a multi-million-dollar pilot program focused on tick control, up to $2.5 million in innovation challenges, funding for NIH researchers to combat Alpha-gal syndrome, and a public-private collaboration to help patients connect with experienced providers.
    • “Secretary Kennedy delivered these announcements during a press conference in New Hampshire — one of the states hardest hit by Lyme disease — after convening a roundtable with state lawmakers and Lyme disease advocates as part of his “Take Back Your Health” tour.”
  • The American Hospital Association reports,
    • The Centers for Medicare & Medicaid Services May 28 issued a final rule making changes to the Increasing Organ Transplant Access Model beginning July 1. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1, 2025. CMS finalized its proposal to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. The agency also finalized its proposal to include Medicare Advantage beneficiaries in the calculation of upside and downside risk payments. Although CMS considered lowering the maximum upside risk payment to $10,000 per transplant, it will remain $15,000 due to comments in opposition submitted by the AHA and other stakeholders. In addition, CMS adopted requirements for notifying patients of changes in waitlist status; however, in response to many concerns raised by the AHA and other commenters, it did not finalize its proposals regarding notifications of declined organ offers. Finally, in a modification of its original proposal, CMS adopted an updated risk adjustment methodology for performance on the model’s one quality measure that is consistent with the widely used Scientific Registry of Transplant Recipients framework.
  • Fierce Healthcare relates,
    • “Elevance Health has earned a reprieve from potential federal sanctions on its Medicare Advantage plans.
    • “The Centers for Medicare & Medicaid Services sent a letter (PDF) to the company Friday, saying that it has completed key steps to remedy the agency’s concerns. CMS was set to suspend enrollment in Elevance’s MA plans on March 31 if the insurer did not comply.” * * *
    • In Friday’s letter, CMS said the Elevance has completed initial data submissions through the designated channels, and sent a wire transfer for overpayments based on “all auditable estimates” in the case. How much money that amounts to was not disclosed.
    • But despite the good news, the company is not out of the water yet. CMS said it must complete further steps by June 30 to avoid sanctions, as well as tie up any loose ends from previous steps in the process by July 31.
    • Sanctions would be implemented on July 1 if new steps are not met, or on Aug. 1 if these incomplete processes are not resolved, CMS said.

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • The U.S. Food and Drug Administration (FDA) is once again warning the public about a safety concern with Johnson & Johnson MedTech’s line of Impella heart pumps. 
    • This latest alert was put in place after the company learned that certain Impella CP sets with SmartAssist “do not meet design specifications” and could experience a low purge pressure event. 
    • “Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support,” according to the FDA’s advisory. “Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.”
    • One patient died as a result of this issue.
  • Fierce Pharma relates,
    • “With a pediatric approval in hand for Afrezza, MannKind believes that it finally has the boost it needs to make an impact in the market after struggling for more than a decade with the inhaled insulin powder.
    • “On Friday, the FDA signed off on an expansion for Afrezza to treat adolescents and children ages 6 and older with Type 1 or Type 2 diabetes. The drug must be used alongside basal insulin in patients with Type 1 disease, according to a May 29 press release. 
    • “The nod comes 12 years after the U.S. regulator cleared Afrezza as a fast-acting, before-meal option for adults with diabetes.”
  • and
    • “Johnson & Johnson has bolstered the psoriatic arthritis (PsA) nod for its IL-23 inhibitor Tremfya in the U.S., picking up an FDA expansion that covers the med’s ability to thwart the progression of structural joint damage in adults with active disease. 
    • “Patients with active PsA can start to suffer joint damage as early as 6 months after the onset of their condition, reinforcing the need for a treatment like Tremfya that can provide daily symptom relief and protection from structural joint damage over the long term, Philip Mease, M.D., of the Swedish Medical Center and University of Washington School of Medicine in Seattle, said in a J&J press release.” 
  • The Wall Street Journal tells us,
    • “Replimune Group REPL said Friday it has reached an agreement with the Food and Drug Administration on a path to resubmit its application for its experimental treatment for advanced melanoma.
    • “It wasn’t immediately clear whether Replimune would submit new clinical data or additional analyses of existing trial results to help secure approval.
    • “The company plans to resubmit the application in the coming days, the company said.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 29, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 31 new measles cases in a nationwide outbreak that has now reached 1,983 infections, as experts describe sometimes-serious symptoms that can warrant hospital stays, including brain inflammation and pneumonia. 
    • “All but nine of the US infections are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.” * * *
    • “According to the CDC measles map, South Carolina has recorded the most cases so far this year, at 669, but its outbreak is now over. Utah is next, with 484 cases—although the Utah health department lists 476,just two more than last week. The state recorded eight new cases the previous week and 10 the week before, for a three-week total of 20.
    • “Texas has 182 cases, and Florida 139, four of them new, according to the CDC map.
    • “Fortunately, the outbreak in our region does appear to be slowing,” said Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah. He was part of a media briefing this week sponsored by the Infectious Diseases Society of America (IDSA).”
  • The Wall Street Journal relates,
    • “Trump administration officials are asking states to ensure 24/7 monitoring for [over a dozen] Americans exposed to hantavirus to allow home isolation.
    • “Federal officials require states to issue quarantine orders if people fail to comply, with health officials checking symptoms twice daily.
    • “The World Health Organization recommended a 42-day quarantine for high-risk exposure to the Andes strain of hantavirus.”
  • MedPage Today tells us,
    • “Alzheimer’s pathology appeared as early as midlife and correlated with poorer cognitive performance in a cohort study.
    • “Blood biomarkers identified Alzheimer’s pathology in 6% of middle-age adults.
    • “Baseline pathology predicted steeper 5-year declines in verbal memory and processing speed.”
  • and
    • “Strong preclinical evidence suggested PCSK9 inhibitors may overcome immunotherapy resistance by preventing tumor cells from evading the immune system.
    • “In patients with lung cancer, melanoma, or kidney cancer, use of PCSK9 inhibitors, in addition to immunotherapy, was associated with better survival in this matched-cohort study.
    • “The survival benefit was independent of cardiovascular outcomes, suggesting an alternative biological pathway.”
  • and
    • “Enhanced, abbreviated MRI (AMRI) outperformed ultrasonography (US) as a screen for early liver cancer in high-risk patients with cirrhosis, according to a single-center, randomized clinical trial.
    • “Overall, AMRI yielded significantly more early-to-advanced stage cancer among 759 patients: the per-patient detection rate in Barcelona-Clinic Liver Cancer (BCLC) stage 0, A, B, or C hepatocellular carcinoma (HCC) was significantly greater in those randomized to screening with hepatobiliary-phase image AMRI (HBP-AMRI) using gadoxetic acid than in those screened with US, at 8.5% versus 3.1% (P=0.002).”
  • tctMd informs us
    • “The likelihood that patients with hypertension will stop taking their prescribed blood pressure-lowering medications varies by drug regimen, a meta-analysis of short-term clinical trials suggests.
    • “Combination therapies—particularly angiotensin II receptor blockers (ARBs) paired with calcium channel blockers (CCBs)—generally were better tolerated than monotherapies, researchers reported today in JAMA, and some meds even had discontinuation rates lower than seen with placebo.
    • ‘High blood pressure is notoriously undertreated, something that’s often attributed to the  perceived tolerability, or lack thereof, of antihypertensive drugs. 
    • “Fear of adverse events remains a major reason for undertreatment of high blood pressure, the leading modifiable risk factor for death and cardiovascular disease worldwide. For years, we have assumed that more blood pressure-lowering treatment equates to worse tolerability, and hence most patients are started and remain on single drug monotherapy,” Nelson Wang, MD, PhD (University of New South Wales, Sydney, Australia), told TCTMD in an email.”
  • The Journal of American Managed Care informs us that “Endometriosis Surgery Becomes More Complex With Older Age Despite Plateauing Severity, Study Finds.”

From the American Society of Clinical Oncology conference front,

  • BioPharma Dive reports,
    • “A regimen combining Bristol Myers Squibb’s experimental mutliple myeloma drug mezigdomide with standard therapies delayed disease progression or death about 10 months longer than typical care alone, according to Phase 3 data unveiled Friday at the American Society of Clinical Oncology meeting.
    • “Trial enrollees who got mezigdomide along with Amgen’s Kyprolis and a steroid were 52% less likely to have progressed or died during the trial period compared with people receiving only those two other therapies. Study recruits in the “SUCCESSOR-2” trial had already seen their disease advance after at least one treatment line. Many had previously received two or more therapies.
    • “Mezigdomide is one of two protein-degrading drugs Bristol Myers has already submitted to U.S. regulators and hopes to position as successors to its popular multiple myeloma therapies Revlimid and Pomalyst. The treatment lanscape has become more competitive, though, with the emergence in recent years of cell therapies and bispecific antibodies that are becoming part of early-stage treatment.”
  • and
    • “Merck & Co. has said many new products will be needed to absorb the coming financial impact when its blockbuster cancer medicine Keytruda loses patent protection. One, discovered by China-based Kelun-Biotech and licensed to Merck a few years ago, has now come to the forefront.
    • “Dubbed sacituzumab tirumotecan, or sac-TMT, the therapy is part of a class of “antibody-drug conjugates” drugmakers see as potentially supplanting traditional chemotherapy in many cancers. Merck has been so encouraged by the clinical results it’s seen so far that it’s put the drug into a sprawling Phase 3 program consisting of 17 studies in a range of tumor types.
    • “Sac-TMT “could be one of our cornerstone ADCs, and that’s why you see our conviction in all of these trials,” said Shweta Jain, who oversees Merck’s oncology assets, in an interview with BioPharma Dive.”
  • STAT News adds,
    • “Investors have never really been excited about Pfizer’s Lorbrena, a targeted drug that is the successor to the company’s earlier targeted drug, Xalkori, to treat non-small cell lung cancer that is caused by any of a number of genetic alterations to the gene including ALK and ROS1. For patients, it has been a breakthrough.”
    • “Lorbrena was approved as second- or third-line treatment in 2018, and then as first-line treatment in 2021. Its main benefit over Xalkori is that Lorbrena can penetrate the brain. Non-small cell lung cancer often metastasizes there, but the large size of the earlier molecule meant that patients would have their disease controlled throughout their body, except inside their heads.
    • “Two years ago at ASCO, Pfizer presented data showing that five years out, Lorbrena reduced disease progression by 81% in patients with altered versions of the ALK gene. Today, researchers presented data that are even more remarkable. At seven years, patients had a 55% likelihood of being alive without disease progression, compared to 3% for those who were taking Xalkori. In an interview, Jeff Legos, Pfizer’s chief oncology officer, said that this appeared to be the longest progression-free survival ever reported in metastatic or advanced non-small cell lung cancer.
    • ‘ALK+ non-small cell lung cancer accounts for less than 5% of cases of disease. But in those patients, about a third will develop brain metastases within two years. Lorbrena reduced those metastases by 91% compared to Xalkori.” 

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

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group plans to stop requiring doctors to get approvals for an array of pediatric procedures, tests and services, further cutting back on a process that has long been detested by physicians and patients.
    • “UnitedHealth, parent of the biggest U.S. health insurer, on Friday said that the changes will eliminate roughly two-thirds of prior-authorization requirements for members under the age of 18 by the end of the year.
    • “UnitedHealthcare said it will stop requiring signoffs for many diagnostic services, routine surgical procedures and specialty care services across pediatric subspecialties such as cardiology, neurology, pulmonology and orthopedics.
    • “The insurer will additionally introduce authorization waivers for certain procedures performed at pediatric hospitals.
    • “UnitedHealthcare said it is conducting a rigorous and data-driven review of all pediatric prior authorization requirements in order to determine which services can be safely removed.”
  • Beckers Payer Issues informs us,
    • “The forces reshaping health plans over the next several years are converging fast. Across the industry, executives and clinical leaders point to three trends that will define which organizations will thrive: the rapid maturation of AI from pilot projects into core operational workflows, the intensifying pressure to make healthcare genuinely affordable, and the rising tide of consumer expectations for transparency, simplicity and personalized care. 
    • “Becker’s asked 16 health plan executives which trend they think will most influence health plans over the next few years.”
    • You can read the exec’s thoughts in the article.
  • Beckers Hospital Review ranks 66 health systems by long term debt.
    • “Long-term debt continues to weigh on health system balance sheets, even as many reported improved operating margins in 2025. Some systems have been actively deleveraging through hospital divestitures, debt refinancings and operational improvements, while others have taken “on new debt to fund capital projects, acquisitions and EHR investments.
    • Highly leveraged systems are looking to sell hospitals, facilities or business lines to reduce leverage and secure long-term sustainability, while systems with stronger balance sheets are using the dislocation to pursue growth through M&A.”
  • Healthcare Dive points out,
    • “The Coalition for Health AI released a series of governance resources this week that aim to help health systems safely roll out artificial intelligence tools. 
    • “The playbooks, developed through community workshops and work groups that included more than 150 clinicians and health AI leaders, provide examples and guidance on implenting AI, including resources on setting up AI policies, managing third party developers and assessing risks. 
    • “The goal is to provide a standardized, but flexible framework that health systems can use to deploy AI tools, regardless of their size or available resources, CHAI said.”

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, HSA, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Washington Post lets us know,
    • “The White House will make the case Monday to Congress — and to voters — that it has developed a strategy to address frequent frustrations involving U.S. medical care, such as too few physicians and too much paperwork.
    • “The Trump administration casts its physician-focused agenda as a fix for a strained health care system — pointing to a $50 billion funding program for rural health it contends will boost the number of doctors in remote areas, efforts to reduce payment distortions that favor hospitals rather than doctors, and regulatory changes intended to speed insurance approvals for tests and follow-up care.
    • “Together, these reforms will enable faster, more affordable, and higher-quality physician services for Americans,” the White House writes in the Economic Report of the President [WhiteHouse.gov link], an annual document previewed with The Washington Post and set to be transmitted to Congress on Monday.
    • “The economic report, which does not offer new proposals, is best understood as a distillation of White House economists’ thinking ahead of this year’s midterm elections, in which voters’ frustrations regarding health care costs and access are set to play a central role. Past administrations have often used the report, which is written by the president’s Council of Economic Advisers, as a messaging document to rally support for their initiatives. This year’s report addresses health care affordability, a key focus for President Donald Trump and his advisers, and says it is working to “unleash” more competition in health care markets to lower costs and improve quality.”
  • Bloomberg Law informs us,
    • “Senate Republicans aren’t planning to include Medicare and Medicaid changes in the next partisan spending package—instead focusing it largely on ending the partial government shutdown.
    • “Top Republicans plan to use a bill that advances through the simple-majority budget reconciliation process to fund immigration enforcement and US Border Patrol and would not require Democrats’ support.
    • “Though some Republicans have been pushing for including Medicare and Medicaid policies in the package, the narrow focus does not leave room for other priorities, Senate Majority Leader John Thune (R-S.D.) said Monday. He said budget instructions will not be sent to the Senate Finance Committee.” * * *
    • “But he didn’t rule out returning to other health care policies. For instance, he mentioned a provision blocking federal Medicaid payments from going to Planned Parenthood, which was included in the 2025 tax-and-spending law and sunsets in July, as a possible candidate for inclusion.”
  • Beckers Hospital Review reports,
    • “CMS on April 10 proposed a 2.4% pay increase for hospitals under the fiscal 2027 Inpatient Prospective Payment System, but hospitals are concerned that the update does not keep pace with the mounting financial challenges.
    • “CMS has proposed another inadequate update to inpatient payment rates, another extremely high productivity cut, and reductions to disproportionate share payments — in the face of rising need for care and higher uninsured rates,” Ashley Thompson, the American Hospital Association’s vice president of public policy analysis and development, said in an April 10 statement. 
    • “Beth Feldpush, America’s Essential Hospitals’ senior vice president of policy and advocacy told Becker’s in an April 11 statement that the proposed DSH payment cuts “fails to acknowledge the growing number of uninsured individuals due to recent Congressional actions.” 
    • ‘Charlene McDonald, president and CEO of the Federation of American Hospitals, said in an April 10 statement that CMS’ proposal is a step in the right direction, but added it “does not negate the compounding effects of rising inflation, record levels of uncompensated care and a growing uninsured population.”
    • “National hospital group leaders also raised concerns about another aspect of the proposal: the introduction of the first mandatory nationwide episode-based payment model.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services picked 150 digital health companies and healthcare providers to participate in the launch of its tech-enabled chronic care model.
    • “The Center for Medicare and Medicaid Innovation (CMMI) announced in December the Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model as a 10-year payment program to encourage the use of technology to treat chronic diseases. CMS aims for the ACCESS Model to provide stable, recurring payments for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety. The model will help pay for telehealth software, wearables and wellness apps that address the conditions.
    • “The CMMI plans to use outcome-aligned payments to cover the cost of technology for Medicare providers if a patient with a qualifying chronic condition achieves clinically significant outcomes, such as lowering their blood pressure.” 
  • Citeline points out,
    • An April 1, 2026, proposal [Federal Register link] from the US Treasury Department would allow whistleblowers who alert the government to certain financial crimes to collect 10%-30% of any monetary penalties collected, creating a new risk for healthcare firms – especially those with overseas business partners. The public comment period ends on June 1, 2026.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For the first time, the FDA has approved generics for AstraZeneca’s Type 2 diabetes blockbuster Farxiga. The U.S. regulator has given thumbs up to 14 companies, including Teva, Sandoz and a host of Indian drugmakers including Aurobindo, Biocon, Cipla, Lupin and Zydus to produce 5 mg and 10 mg tablets of dapagliflozin.
    • “The treatment is indicated for glycemic control and to reduce the risk of hospitalization for heart failure for those with Type 2 diabetes who also have established cardiovascular disease or multiple cardiovascular risk factors.Farxiga generated sales of $8.5 billion last year, including $1.7 billion in the U.S.
    • “The FDA originally approved the SGLT2 inhibitor in 2014. Generic versions of Farxiga became available (PDF) in the U.K. and Japan in the second half of last year.”
  • and
    • “From a negative phase 3 readout and a seemingly tightening regulatory climate to a grueling three-month review extension, the path for Travere Therapeutics in its first-in-disease bid was anything but certain. Yet, the company has defied the odds, securing Filspari a landmark FDA approval in focal segmental glomerulosclerosis (FSGS) and delivering the first treatment for the rare kidney disease.
    • “Monday’s FDA approval makes Filspari the first therapy specifically indicated for FSGS, a condition that represents a $1 billion-plus sales opportunity, according to Leerink Partners analysts. The drug was originally approved in 2023 for the treatment of IgA nephropathy, another kidney disease.
    • “FSGS is estimated to affect more than 40,000 patients in the U.S. The disorder is characterized by scarring in the kidney’s filtering units as protein keeps leaking into the urine, often leading to further disease progression and kidney failure, sometimes quite rapidly.” 
  • Cardiovascular Business relates,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has received U.S. Food and Drug Administration (FDA) clearance for a new algorithm designed to detect signs of cardiac amyloidosis (CA). This represents Anumana’s second FDA clearance in just two weeks, highlighting the company’s growing impact in the world of cardiovascular care. 
    • “CA is a life-threatening condition that often leads to heart failure complications, but it remains critically underdiagnosed. Anumana sees this clearance as a way to help care teams identify CA early so patients can receive timely treatment.
    • “The newly cleared algorithm, which previously received the FDA’s breakthrough device designation, was designed to evaluate standard 12-lead electrocardiograms (ECGs) and flag patients at increased risk of CA. 
    • “Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” Maulik Nanavaty, CEO of Anumana, said in a prepared statement. “The more conditions we can identify from a single ECG, the more valuable the test becomes in clinical practice. That’s what Anumana is working toward with each new clearance as we continue to advance our rigorous clinical evidence approach.”

From the census front,

  • The Wall Street Journal reports,
    • “The first of the youth-obsessed baby boomers turn 80 this year, including President Trump, and they want to shake up old age.
    • “Having reached octogenarian levels, a generation that shaped much of our past is shaping the future of aging for themselves and those who follow. They want better healthcare and housing, cures for dementia and a say in when to die. New professions and products will appear. Their massive spending will shift and innovators will follow.
    • “They are reinventing old age,” says Joseph Coughlin, director of the Massachusetts Institute of Technology AgeLab. Unlike the patient Silent Generation, boomers had high expectations and used their sheer numbers as well as financial and political clout to make them happen, which isn’t necessarily a bad thing.
    • “If you don’t have expectations of getting better, then you simply become satisfied with what is,” says Coughlin.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Protein-hungry shoppers are buying more meat with their health top of mind. Health experts, however, wish they’d think beyond the butcher counter.” * * *
    • “Meat is indeed packed with protein, but it comes with some well-established health drawbacks.
    • “Saturated fat we’ve known about for decades,” said Dr. Sarah C. Hull, a cardiologist at Yale Medicine. It’s common in red meat and contributes to increasing LDL cholesterol levels, hardening the blood vessels and, in turn, raising the risk of heart attack or stroke.” * * *
    • “Hull said that many common plant-based proteins are particularly high in fiber, which 95% of Americans don’t get enough of, and they’re generally associated with better overall health outcomes than animal proteins. Her research suggests that increased consumption of certain plant-derived nutrients may help counter some negative effects of red meat and ultra-processed foods.”
  • Health Day relates,
    • “Influenza vaccination may offer cardiovascular protection even when it does not prevent infection, according to a study published online April 2 in Eurosurveillance.” * * *
    • “Hospital admissions for heart attack and stroke were more frequent in the first week after testing positive for influenza than during any other period in the year before and after their test,” the authors write. “This increased risk was about half as high among people who tested positive for influenza but had received the influenza vaccine that season.”
  • and
    • “Children with ADHD are more apt to have a bright future if they’re diagnosed in their early elementary years rather than as high schoolers, a new study says.
    • “Kids diagnosed with ADHD at an earlier age are more likely to have better grades and go on to college, researchers reported April 8 in JAMA Psychiatry. They’re also less likely to drop out of school.
    • “ADHD diagnosis during the first years of school was associated with better school performance, more academic track choices and lower probability of school dropout,” concluded the research team led by Lotta Volotinen, a doctoral researcher at the University of Helsinki in Finland.
    • “The findings support the recommendations for earlier diagnosis, and screening for ADHD before age 12 years should be considered,” the team wrote.”
  • The American Medical Association lets us know “what doctors wish patients knew about managing food allergies.”
    • Once a food allergy is diagnosed, learning how to avoid triggers, recognize warning signs and when to seek medical care are key. Two physicians share more.
  • Per Cardiology Advisor,
    • “Maternal stroke is associated with significantly higher rates of maternal mortality and severe delivery complications, including cardiac arrest and acute renal failure.”
  • Per Pulmonology Advisor,
    • “The increased risk for asthma attacks among those using marijuana was consistent regardless of whether individuals vaped or smoked cannabis or did both.”
  • Per an Oregon State University news release,
    • “Researchers at Oregon Health & Science University have uncovered a key reason why immunotherapy has largely failed in pancreatic cancer — and identified a promising strategy to overcome that resistance. 
    • “The study, published in the journal Immunity, shows that pancreatic tumors actively reshape their immune environment by co‑opting regulatory immune cells that normally shut down tumor-killing cells. By reprogramming those cells, the research reveals a potential pathway to make immunotherapy effective against one of the deadliest and most treatment‑resistant cancers. 
    • “Pancreatic cancer is incredibly resistant to most therapies,” said the study’s senior author, Katelyn Byrne, Ph.D., assistant professor of cell, developmental and cancer biology in the OHSU School of Medicine and member of the OHSU Brenden‑Colson Center for Pancreatic Care. “Even when we know the immune system is capable of long‑lasting protection, it’s been very difficult to get that response to work in this disease.” 
    • “In the new study, Byrne and team tested an experimental immunotherapy in mouse models known as agonistic CD40, which works differently from standard checkpoint inhibitors. Rather than targeting a single immune signal, the therapy broadly activates the immune response upstream. 
    • “Byrne said the researchers were surprised to find out that activating the immune system this way didn’t just stimulate tumor‑killing cells — it also reprogrammed regulatory T cells, converting them from immune suppressors into cells that support anti‑tumor activity. 
    • “We didn’t expect this,” Byrne said. “The therapy doesn’t directly target Tregs, but as a secondary effect of turning on the immune response, those Tregs changed their behavior. Cells that were shutting down the immune reaction suddenly started supporting tumor killing.” 
    • “The team’s findings help explain one reason why many immunotherapies haven’t worked in pancreatic cancer and point to a possible solution: Treatments may need to both turn on the immune system and overcome the tumor’s own ability to shut it down.” 
  • Per an NIH news release,
    • “A National Institutes of Health (NIH)-funded research team has discovered an enhanced CRISPR gene-editing system that could enable targeted delivery inside the human body — a key step toward broader clinical use. Researchers identified a naturally occurring enzyme, Al3Cas12f, that is small enough to fit into adeno-associated virus vectors, a leading targeted delivery method for gene therapies. They then engineered an enhanced version that dramatically improved gene-editing performance in human cells. 
    • “The advance addresses a major limitation in CRISPR technology. Commonly used gene-editing proteins are too large for targeted delivery systems, restricting clinical applications to cells modified outside the body, such as blood and bone marrow. 
    • “Smart delivery of gene editing systems is a powerful notion with broad clinical implications, and this basic science finding takes us a significant step toward that future,” said Erica Brown, Ph.D., acting director of NIH’s National Institute of General Medical Sciences (NIGMS).” 
  • BioPharma Dive adds,
    • “Revolution Medicines said Monday its experimental pancreatic cancer drug hit every goal at an early checkpoint in a Phase 3 trial, helping people who got it live nearly twice as long as those who got standard chemotherapy.
    • “Enrollees who got daraxonrasib lived a median of 13.2 months after treatment, compared with 6.7 months for those who got chemo, a finding that equates to a 60% reduction in the risk of death among those who got the experimental drug. Daraxonrasib achieved its other objectives at an interim look at the results, findings so striking that the company ended the trial early. Revolution enrolled people whose metastatic pancreatic cancer had returned after an earlier treatment.
    • “The Food and Drug Administration has already awarded daraxonrasib a “national priority” voucher that could help Revolution gain an approval within weeks of an official submission. Revolution shares rose nearly 40% in early trading, adding $7 billion to the company’s already hefty valuation.”
  • BioPharma Dive also informs us,
    • “An experimental therapy from Allogene helped eliminate signs of cancer better than standard treatment in a Phase 3 trial in first-line large B-cell lymphoma, results suggesting the biotechnology company may have found a role to use donor-derived cell therapy against the deadly blood cancer.  
    • “After 45 days of treatment, seven of the 12 patients given Allogene’s therapy in the study were negative for “minimal residual disease,” meaning that diagnostic tests could no longer detect signs of cancer. By comparison, only 2 of 12 placebo recipients hit that mark, a roughly 42-percentage-point difference that clears an important bar published literature has suggested is crucial for delaying a relapse. 
    • “The results come from an early “futility” analysis. Allogene is enrolling 220 people in the study and expects to report in 2027 results showing whether treatment staved off cancer’s return.
  • and
    • “In experimental drug from Spyre Therapeutics helped lower signs of disease activity and improve remission rates in a Phase 2 study of people with ulcerative colitis. 
    • After 12 weeks of treatment, patients who received “SPY001” in the trial had a statistically significant, 9.2-point reduction on a scoring system that assesses the severity of their disease, meeting the study’s primary objective. Notably, treatment was also associated with a 40% remission rate and a 51% improvement on endoscopic imaging. One severe adverse event was reported — chest pain in a 68-year-old male with a history of cardiovascular disease — but was deemed unrelated to treatment.
    • Spyre said the findings were “clinically meaningful” and support SPY001’s “best-in-class profile.” The drug is one of multiple therapies the company is evaluating in Phase 2 trials in inflammatory bowel disease. Proof-of-concept data for two other therapies in the trial are expected later this year. Data from a placebo-controlled portion of the study are on track for 2027.” 
  • Per Fierce Pharma,
    • “Eli Lilly has chalked up another victory in the chronic lymphocytic leukemia (CLL) space, as its BTK inhibitor Jaypirca delivered its fourth positive phase 3 readout in the blood cancer. 
    • “Monday, Lilly said its phase 3 Bruin CLL-322 trial in patients with previously treated CLL or small lymphocytic lymphoma (SLL) has met its primary endpoint. In an industry first, the study showed that adding Jaypirca to a fixed-duration regimen of venetoclax and rituximab significantly extended progression-free survival (PFS) compared with the standard combo alone. 
    • “As Lilly pointed out, Bruin CLL-322 is the first phase 3 in CLL to utilize and outperform a venetoclax-based regimen. Roche and AbbVie sell venetoclax, an oral BCL-2 inhibitor, under the brand name Venclexta.” 

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

  • Beckers Payer Issues reports,
    • “Houston-based Memorial Hermann Health System and BCBS Texas agreed on a contract April 11, bringing the health system back in network.
    • “The agreement ensures “access to quality care at cost-effective prices,” BCBS Texas said in an April 13 statement shared with Becker’s. It covers both commercial and Medicare Advantage members. The previous contract expired April 1, affecting commercial members. The health system had beenout of network for Medicare Advantage plans since Jan. 1.”
  • Fierce Healthcare offers a look at how Evernorth’s new Delaware specialty pharmacy facility highlights a broader care coordination approach.
  • Beckers Hospital Reports ranks 83 health systems by their most recent revenue.
    • “Revenue growth continued across the hospital industry in 2025, with many of the nation’s largest health systems posting mid- to high-single-digit gains fueled by stronger patient volumes, improved payment rates and the expansion of ambulatory and pharmacy operations. 
    • “But the gains were far from uniform. Some systems grew revenue by double digits through mergers, acquisitions and new payer arrangements, while others saw declines as they shed hospitals and restructured their portfolios.”
  • and tells us,
    • “The world’s two main GLP-1 drug manufacturers, Eli Lilly and Novo Nordisk, are taking different approaches with rolling out their recently approved GLP-1 pills for weight loss. 
    • “Two oral GLP-1s, two very different commercial strategies. Health systems operating metabolic programs or making formulary decisions need to understand both.
    • “While both companies offer their recently approved GLP-1 pills through pharmacies and direct-to-consumer platforms that circumvent pharmacy benefit managers, they are diverging in other routes. 
    • “Eli Lilly is betting on retail and digital access, as it’s offering its weight loss GLP-1 pill through GoodRx, telehealth firm Ro and same-day delivery with Amazon Pharmacy. 
    • “By contrast, Novo Nordisk launched a Wegovy subscription program through WeightWatchers, LifeMD, Ro and Hims & Hers — with which the drugmaker previously had a strained relationship. With the 12-month subscription plan, Novo Nordisk said patients can save up to $600 per year on the Wegovy pill.” 
  • and informs us,
    • “Large language models may help identify drug safety signals in clinical notes, though their performance remains below thresholds required for clinical decision support.
    • “Researchers evaluated three models — GPT-3.5, GPT-4 and GPT-4o — using clinical notes from 100 patients at Nashville, Tenn.-based Vanderbilt Health, 70 patients at the University of California—San Francisco and 272 patients from seven Roche-sponsored trials, according to an April 6 Vanderbilt news release.
    • “For detecting immune-related adverse events at the patient level, GPT-4o achieved F1 scores of 56%, 66% and 62% across the respective datasets. The F1 score reflects how well a model balances correctly identifying real safety issues while avoiding false alarms. At the individual note level, the model reached an average F1 score of 57% across 667 notes.
    • “An F1 score of 90% or more is considered excellent, while 80% or higher may support clinical decision-making.”
  • STAT News points out,
    • “Every day, more than 40 million people ask ChatGPT about health care, according to OpenAI. They’re asking questions about diet, exercise, insurance — and in some cases, serious symptoms that would typically get discussed on a 911 call or in a doctor’s office.
    • “For some health systems, that’s creating an imperative. A small number of hospitals are trying to recapture some of those clinical conversations from commercial large language models like ChatGPT, Claude, and Gemini. They’re implementing their own patient-facing chatbots, ones that draw directly from their existing medical records and can funnel patients toward care in their own system. 
    • “Hartford HealthCare this week will launch PatientGPT, a chatbot engineered by clinical AI company K Health, to its patients in Connecticut. Two health systems — California-based Sutter Health and Reid Health, serving Indiana and Ohio — have announced pilot versions of Emmie, the chatbot built by medical record mammoth Epic. The list is likely to grow rapidly.
    • “Health systems need to do this, either through a vendor or building it themselves,” said Mount Sinai chief AI officer Girish Nadkarni, the senior author of a recent study that found ChatGPT Health missed high-risk emergencies when used to triage patients.”
  • The Wall Street Journal cautions,
    • “The artificial intelligence gold rush is rapidly drying up the supply of computing power, leading to product issues and reliability problems.
    • “Anthropic experiences frequent outages and limits user token usage, while OpenAI scrapped its Sora app to free up compute.
    • “CoreWeave raised prices over 20% and extended contracts, as spot-market Nvidia GPU rental costs rose 48% in two months.” * * *
    • “All of it points to a classic problem that has popped up in technology booms throughout history, from the 19th-century railroad expansion to the telecom and internet explosion of the early 2000s. Demand is growing far faster than companies are able to access resources and build out infrastructure. Historically, price increases have been among the only ways to address a supply crunch, but such a move could be perilous for frontier AI companies, which are in a ferocious competition to gain users.”
  • Per MedTech Dive,
    • “Stryker said Monday that it has agreed to buy intravascular lithotripsy firm Amplitude Vascular Systems. The companies did not disclose the terms of the acquisition. 
    • “Intravascular lithotripsy is a procedure to treat artery disease. Boston-based Amplitude Vascular Systems, or AVS, uses pressure waves generated by carbon dioxide through a balloon catheter to break up calcified plaque.
    • “The acquisition is expected to bolster Stryker’s peripheral vascular portfolio once AVS’ device is cleared in key markets.”
  • and
    • “GE HealthCare has provided an update on the integration of its bkActiv intraoperative ultrasound technology with Medtronic’s Stealth AXiS surgical navigation system.
    • “The integrated product is now available commercially, GE HealthCare said Thursday. Medtronic said it had integrated bkActiv into Stealth AXiS when the surgical system received regulatory clearance last month.
    • “Integrating the technologies gives surgeons real-time ultrasound images, helping them to assess mid-procedure anatomy changes that could affect the preoperative plan.”

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, HSA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “President Trump directed federal officials to pay Transportation Security Administration workers, bypassing a gridlocked Congress after the latest proposal to fund the broader Department of Homeland Security ran aground Friday.
    • “The move, which Trump had previewed a day earlier, came as House Republican leaders rejected a Senate-passed bill that would fund most of DHS, including the TSA. A standoff in Congress over immigration enforcement and funding has led to missed paychecks for airport-security workers and long lines for travelers.
    • “The executive action instructs the Homeland Security secretary and the White House budget director to use federal funds that have a “reasonable and logical nexus to TSA operations” to pay the TSA workers. The memo, signed Friday afternoon by Trump, described the situation at the airports as an “unprecedented emergency.”
    • “TSA officers should begin getting paychecks as early as Monday, DHS said.”
  • STAT News tells us,
    • “The White House has drafted legislative text for its drug pricing policy, and officials are in the process of sharing it with more than a dozen major pharmaceutical companies, according to people familiar with the meetings.
    • “The legislative text, according to a White House official, closely follows the outlines of the voluntary deals the administration made with pharma companies. The draft includes a policy that would allow drugs purchased in cash to count toward a patient’s deductible.
    • “The Trump administration’s push for drug price legislation is part of a larger effortto get health reforms signed into law. The president’s focus on his affordability agenda in an election year has heightened the profile of the effort.
    • “Still, despite the White House digging in to get Congress to pass its plan, lawmakers have little appetite for major changes — and there’s no clear path to passage.”
  • The AP relates,
    • “Vice President JD Vance on Friday held the inaugural meeting of a new anti-fraud task force he’s leading as the Trump administration seeks to show it’s cracking down on potential misuse of social programs.
    • “Vance, speaking Friday before the task force held a closed-door meeting, said that the federal government, for decades, had not taken the issue of fraud seriously and that it needed to be tackled with “a whole-government approach.”
    • “This is not just the theft of the American people’s money,” Vance said. “It is also the theft of critical services that the American people rely on.” * * *
    • “Joining the task force was Colin McDonald, a top aide to the Justice Department’s second in command. He was recently confirmed as the assistant attorney general overseeing the department’s new division focused on prosecuting fraud.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration has released an advisory examining innovative solutions to close gaps in behavioral health care deserts. It highlights how more than 60% of rural Americans live in designated behavioral health shortage areas. The advisory details how integrating additional community health workers and peer support specialists can enhance care. It also explains the strengths of both and includes strategies for recruitment and retention.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “Food and Drug Administration officials briefed senators on the agency’s plans for food policy for 2026, according to a person familiar with the meeting.
    • “The agency plans to focus on infant formula safety, updating food labels, defining ultra-processed foods, expanding inspections of food processing plants, and bolstering seafood safety programs, according to a document shared with lawmakers, obtained by STAT.
    • “The meeting comes amid a shift in the administration’s health agenda toward food issues and away from vaccine policy. In recent polls, food reforms have been more popular than the vaccine agenda, catching the attention of administration officials looking to sharpen their message for the midterms.”
  • Fierce Pharma relates,
    • “The FDA signed off on a new insulin from Novo Nordisk, marking the U.S.’s first once-weekly basil insulin for adults with Type 2 diabetes. 
    • “Novo’s Awiqli offers a new long-acting option compared to standard daily basil insulin injections, representing an “important advancement that meets a real need,” the company’s VP of clinical development, medical and regulatory affairs, Anna Windle, Ph.D., commented in a release. 
    • “The FDA based its decision on Novo’s Onwards Type 2 diabetes phase 3a clinical trial program, which consisted of four randomized, active-controlled, treat-to-target trials that enrolled 2,680 adults with uncontrolled Type 2 diabetes. The studies showed that once-weekly Awiqli achieved efficacy in reducing A1C over daily basal insulin, with a safety profile consistent with the daily basal insulin class. 
    • “Awiqli is administered using Novo’s FlexTouch pen and will be available across the country in “the coming months,” the company said.”
  • MedTech Dive tells us,
    • “Philips said Thursday it has received 510(k) clearance for a heart procedure visualization tool it developed with Edwards Lifesciences.
    • “The system, called EchoNavigator R5.0 with DeviceGuide, uses artificial intelligence to enable surgeons to track and visualize mitral valve repair devices during minimally invasive heart procedures. 
    • “Philips said the system is intended for use with Edwards’ Pascal Ace mitral valve repair system, which competes with Abbott’s MitraClip for the transcatheter edge-to-edge repair market.”
  • MedPage Today informs us,
    • “The FDA on Thursday granted accelerated approval to marnetegragene autotemcel (Kresladi) as the first gene therapy for treating kids with severe leukocyte adhesion deficiency type I (LAD-I), an ultra-rare inherited immune deficiency.
    • “Approval stipulates use in LAD-I cases caused by biallelic variants in the ITGB2 gene and in which no human leukocyte antigen (HLA)-matched sibling donor is available for allogeneic hematopoietic stem cell transplant.
    • “LAD-I has an estimated incidence of 1 per 100,000-200,000 live births, and the disorder brings substantial morbidity and mortality in a child’s first decade of life. Roughly two-thirds of patients have the severe form of the disease, which is characterized by recurrent, life-threatening infections that don’t respond well to antimicrobials and time spent in and out of hospitals.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “After a tough flu season, today’s respiratory virus update from the Centers for Disease Control and Prevention (CDC) offers a bit of good news: Doctors are seeing fewer people with influenza.
    • “Cases of flu are declining in most of the country. While influenza A is on its way out, rates of influenza B—which tends to peak later in flu season—vary by region. Levels of influenza A in wastewater are low. Influenza B is not monitored in wastewater.
    • “Most flu viruses reported this week were influenza A(H3N2) and influenza B. Nearly 93% of influenza A(H3N2) viruses since late September belong to subclade K, a new strain that was not included in this year’s flu shots.
    • “About 5,640 people were admitted to the hospital for flu in the past week, nearly 2,000 fewer than the previous week, according to the CDC’s FluView report. Eight additional flu deaths were reported in children, bringing the total number for this season to 123. Among children who were eligible for a flu shot and whose vaccination status is known, 85% of children who died from flu were not fully vaccinated.
    • “The CDC estimates that there have been at least 29 million illnesses, 360,000 hospitalizations, and 23,000 deaths from flu so far this season.
    • “Although respiratory syncytial virus (RSV) levels remain high, the country seems to have gotten past the worst of RSV season, which has peaked in many regions of the nation. Levels of RSV in wastewater are low.
    • “The number of COVID-19 infections is low, with low levels in wastewater. Although COVID-related emergency room visits remain low across the country, they are likely increasing in Florida and Massachusetts. According to the CDC, 2.3% of tests for COVID-19 were positive, along with 7.5% for RSV and 11.5% for the flu.”
  • The American Hospital Association News relates,
    • “A measles outbreak in Utah is now at 486 cases, with 107 reported in the last three weeks, according to datafrom the state’s Department of Health and Human Services. The outbreak began in June 2025. Nationally, 1,575 measles cases have been reported so far this year to the Centers for Disease Control and Prevention. A South Carolina measles outbreak, which began in October 2025, remains at 997 cases, the state’s Department of Public Health reported today. No new cases have been reported by the state since March 17.” 
  • and
    • “The Centers for Disease Control and Prevention March 26 released a report on U.S. child vaccination coverage by age 2. The report found that coverage among children born from 2021-2022 was similar to those born in 2019-2020 but noted decreases for five vaccines. The CDC found declines in vaccinations for the flu (7.4 percentage points), the birth dose of the hepatitis B vaccine (1.8 percentage points), rotavirus (1.7 percentage points), the pneumococcal conjugate vaccine (1.5 percentage points) and the primary series of the Haemophilus influenzae type b conjugate vaccine (1 percentage point). The report also found that coverage varied by race and ethnicity, poverty status, urbanicity and jurisdiction. 
    • “Vaccines have substantially reduced severe illness, hospitalization, and death and have saved approximately $2.7 trillion in societal costs,” the CDC wrote. “Although national vaccination coverage remained stable for most vaccines, lower coverage among certain population subgroups and in some jurisdictions is creating an increased risk for outbreaks of vaccine-preventable diseases.” 
  • The Washington Post identifies “13 surprising ways GLP-1s may benefit the body, according to science.”
  • Beckers Hospital Review points out four ways GLP-1s are changing care patterns, patient behavior
  • Medscape adds,
    • “When individuals with overweight or obesity discontinue GLP-1 receptor agonists (RAs), they regain approximately 60% of their weight within 1 year following GLP-1 RA discontinuation.
    • “Approximately 25% of the weight loss achieved with these medications appears to persist with long-term findings, with significant implications for how clinicians counsel patients at the point of discontinuation.
    • “These are the two central findings of a meta-analysis of 48 studies, including 36 randomized controlled trials, conducted by British researchers led by medical students Brajan Budini and Steven Luo from the School of Clinical Medicine, University of Cambridge, Cambridge, England. The results were published in eClinical Medicine, which is a part of The Lancet Discovery Science.
  • MedPage Today tells us,
    • “While mammography use did not significantly decline overall from 2002 to 2022, there was a significant drop in certain subgroups.
    • “Declines were significant among young women without health insurance, current smokers, unmarried women, and white women.
    • “The prevalence of mammography use among women ages 40-49 fell by almost 10 percentage points from 2010 to 2022 following guideline changes.”
  • Helio informs us,
    • “Global early-onset cancer incidence has risen slightly since 1990, but mortality has decreased significantly.
    • “Deaths related to obesity have gone up substantially in the past 3 decades.”
  • Per BioPharma Dive,
    • “AstraZeneca said Friday its experimental antibody drug tozorakimab met its main goal in two Phase 3 trials in chronic obstructive pulmonary disease, helping reduce flare-ups in a broad range of people with the condition.
    • “The data could help AstraZeneca’s drug reach more patients than the currently available biologics for COPD, Dupixent and Nucala, both of which are limited to those with high levels of white blood cells called eosinophils. The U.K.-based drugmaker said the trials “included former and current smokers, and patients across all blood eosinophil counts and all stages of lung function severity.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “One or two health systems controlled the entire inpatient hospital care market in 47% of metropolitan areas in 2024, a March 27 KFF Health News report found.”
  • Fierce Healthcare relates,
    • “A new oral GLP-1 therapy and the first preventive option for COVID-19 are among the pipeline drugs that payers and plan sponsors should be watching this spring, according to a new report.
    • “The pipeline surveillance team at Optum Rx has released its latest report on notable drugs that are set for an imminent Food and Drug Administration review. The spring edition includes:
    • Icotyde, or icotrokinra, an oral therapy for moderate-to-severe plaque psoriasis that secured FDA approval in March.
      • “Orforglipron, the second oral GLP-1 treatment, which is set for an April review.
      • “Ensitrelvir, or Xocova, a preventative therapy for COVID-19 exposure, with an FDA decision expected in June.
    • “Icotyde and orforglipron both fit within high-priority areas for many insurers: psoriasis and obesity. In the latter case, it would follow an oral Wegovy to market, but orflorglipron is the first oral GLP-1 that does not have meal-time restrictions.”
  • Lively shares its 2026 healthcare savings account spend report.
    • Healthcare is changing — and HSA spending tells the story.
    • In 2025, where and how people use their health savings accounts (HSAs) reveals a clear shift.
    • Consumers are no longer relying solely on hospitals and traditional providers. They are increasingly turning to retail brands, digital platforms, direct-to-consumer healthcare companies, and connected health technology.
    • HSAs are evolving from long-term savings tools into active, everyday healthcare wallets.
  • Fierce Pharma tells us,
    • “New drug manufacturer Neion Bio has emerged from stealth after incubating a novel way to cook up biologic drugs. After its founding two years ago, the company is cracking open a multi-product commercial biosimilar partnership with an unnamed drugmaker.
    • “Using its Raptor platform to produce recombinant biologics in eggs, the company is teaming up with an unnamed pharma company to co-develop and supply up to three monoclonal antibodies in a deal that includes upfront and milestone payments, plus profit sharing upon potential commercialization. 
    • “Neion Bio’s platform removes the capital intensity and process constraints of traditional biomanufacturing, enabling highly scalable and resilient production while materially lowering the cost of development and supply,” CEO and co-founder Dimi Kellari said in a company release.”
  • BioPharma Dive informs us,
    • “One of the largest drug companies in Japan is looking to, through a $700 million buyout, take control of an experimental medicine that could be useful for treating post-traumatic stress disorder and other psychiatric conditions.
    • “On Friday, Otsuka Pharmaceutical announced that its American subsidiary plans to acquire privately held, New York-based Transcend Therapeutics. In addition to the upfront payment, Otsuka offered up to $525 million more if Transcend’s assets ultimately hit certain sales milestones. The companies expect to complete their deal sometime between April and the end of June.
    • “If finalized, the acquisition would hand Otsuka a drug meant to rapidly restore and improve “neuroplasticity,” or the brain’s ability to rewire and adjust the connections between neurons. Neuroplasticity impairment is a fundamental component of many psychiatric conditions — including PTSD, where chronic stress and trauma can keep brain cell networks stuck in a fear-based survival mode.
    • “The active ingredient in Transcend’s “TSND-201” is methylone, an analog of MDMA that was first synthesized three decades ago and widely used as a “designer drug.”  TSND-201 engages with certain transporter proteins that regulate neurotransmitters like serotonin, norepinephrine and dopamine, which, according to Transcend, results in “rapid and sustained enhancement of neuroplasticity.”
  • and
    • “Novartis will acquire Excellergy, a young allergy drugmaker, to gain access to an experimental therapy that could improve upon the widely used medication Xolair. 
    • “The deal announced Friday could be worth as much as $2 billion overall when including the unspecified upfront payment as well as future payouts. It’s expected to close in the second half of the year, the companies said in a statement.
    • “At the heart of the acquisition is a drug called Exl-111, which targets the antibody immunoglobulin E, or IgE. In certain cases, IgE can mistakenly react to substances — like food, pollen or pet dander — that wouldn’t otherwise be harmful. The antibody then binds to cells, triggering the release of histamines and in turn, an allergic reaction.” * * *
    • “It’s the holy grail of what people are trying to accomplish,” Geoff Harris, Excellergy’s chief scientific officer, told BioPharma Dive in October. “If you can turn off this access to the immune system, you can completely control a wide swath of different allergy-driven diseases.”

Midweek report

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

From Washington, DC,

  • Healthcare Dive reports,
    • “America has entered its “golden age,” President Donald Trump argued in a lengthy State of the Union address Tuesday night that glossed over the biggest achievements of the president’s second term so far but was notably light on healthcare.
    • “The economy is improving, prices are coming down, illegal immigration is under control and crime is plummeting, the president said, while lauding guests in attendance like Erika Kirk and the Olympic gold medal-winning U.S. men’s hockey team. Trump’s remarks — the longest State of the Union speech in recorded history, at an hour and 47 minutes — were often met with chants of “U.S.A! U.S.A!” from Republicans in the gallery, and come as the president seeks to reverse plummeting approval ratings.
    • “However, Trump didn’t use the State of the Union to introduce many new policy ideas. He also didn’t devote much time to healthcare, spending only about five minutes of his speech on the sector.”
  • Per an HHS news release,
    • “Today at the White House, Vice President J.D. Vance, Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr., and Administrator of the Centers for Medicare & Medicaid Services (CMS) Dr. Mehmet Oz announced new steps to crack down on fraud in Medicare and Medicaid to protect patients and taxpayers and improve affordability. The actions include deferring $259.5 million of quarterly federal Medicaid funding in Minnesota to prevent payment of questionable claims while further investigation is completed; a nationwide moratorium on Medicare enrollment for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; and a nationwide call to action for Americans to support fraud prevention, including stakeholder input on how CMS can continue to expand and strengthen its efforts. Together, these steps reflect a coordinated, data-driven strategy to prevent fraud before it occurs, hold bad actors accountable, and protect taxpayer dollars.”
    • * * * “CMS is looking to stakeholders to provide input, based on their experience and knowledge, on additional ways the agency can tackle fraud prevention to help inform the development of a possible future rule under CMS’ Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative. The CRUSH request for information (RFI) seeks input from a broad range of stakeholders – including states, providers, suppliers, payers, technology companies, patient advocates, beneficiaries, and others – on ways to strengthen CMS’ ability to prevent, detect, and respond to fraud, waste, and abuse, and program inefficiencies in Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.” * * * 
    • “Comments on the CRUSH Request for Information must be submitted by March 20, 2026, via the Federal Register at: https://www.federalregister.gov/public-inspection/2026-03968/request-for-information-comprehensive-regulations-to-uncover-suspicious-healthcare (refer to CMS-6098-NC).
    • “More information on CMS’ fraud prevention efforts is available at: www.cms.gov/fraud.”
  • Govexec offers five things to watch concerning the Department of Homeland Security shutdown.
  • The Wall Street Journal relates,
    • “President Trump’s nominee for surgeon general aligned herself with the administration’s moves on vaccines so far, including shrinking the number of recommended vaccines for children, as she told lawmakers in her confirmation hearing that her focus is fighting chronic disease. 
    • “Dr. Casey Means told the Senate health committee on Wednesday that she believes vaccines save lives but declined to promise recommending measles and flu shots for children. 
    • “I’m not an individual’s doctor, and every individual needs to talk to their doctor before putting medication in their body,” Means said, in response to a question about whether she would recommend other mothers get measles vaccines for their children.” 
  • Per an OPM news release,
    • “The US Office of Personnel Management today issued a memorandum to federal agencies providing updated guidance ending use of the Administrative Careers with America (ACWA) assessment. This step reinforces the administration’s ongoing efforts to streamline hiring and ensure agencies recruit the most qualified applicants based on merit.
    • “From the beginning, ACWA (which was developed in response to the Luevano consent decree) was criticized by hiring managers and applicants alike as ineffective in identifying quality candidates for federal service. In light of OPM’s development of validated, state-of-the-art assessment tools (particularly the USA Hire platform), there is no longer a need for ACWA.”
    • * * * “Read the memo here and Director Kupor’s blog on this here.”
  • Govexec also explains why “Why your federal benefits may not protect your family the way you think.”
    • “While federal employee benefits can assist beneficiaries in the event of a loved one’s death, it’s important to understand the rules of those plans and how to best seamlessly apply them to your survivors.”
  • The American Hospital Association (AHA) News tells us,
    • “The Health Resources and Services Administration Feb. 25 said it will extend the deadline to April 20 to receive comments on its request for information on whether to implement a 340B rebate model program. Comments on the RFI were originally due March 19. The AHA, joined by several other national groups representing 340B hospitals, last week urged HRSA to extend the original deadline to allow stakeholders to provide feedback to HRSA’s detailed questions in the RFI.  
    • “HRSA also indicated that it may expand the 340B rebate model pilot program to all drugs included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program through 2027.”   
  • Per a Federal Register notice,
    • The Centers for Disease Control announced a meeting of its Advisory Committee on Immunization Practices.
    • “The meeting will be held on March 18, 2026, from 8 a.m. to 5 p.m., EST, and March 19, 2025, from 8 a.m. to 5 p.m., EST, (times subject to change; see the ACIP website for updates: https://www.cdc.gov/vaccines/acip/index.html). The meeting is expected to be held at the Centers for Disease Control and Prevention, with virtual option. Written comments must be received between March 2 – 12, 2026.”
  • Mercer lets us know,
    • “Mercer projects the 2027 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs), and excepted-benefit health reimbursement arrangements (HRAs) will increase from 2026 levels. These unofficial 2027 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2026, and Mercer’s projected C-CPI-U values for February and March.
    • ‘The table [in the article] shows the projected HSA, HDHP, and excepted-benefit HRA amounts for 2027, along with the 2026 and 2025 values for comparison. The HSA catch-up contribution limit is set by statute and hasn’t changed since 2009.
  • The Government Accountability Office notes,
    • “Mental health, suicide, and substance misuse issues have increased in the U.S. The federal agency that oversees such issues saw its budget more than double in FY21 due to increased COVID-19 and 988 Lifeline funding. This Q&A examines the use of that funding.
    • “The agency received $8.5 billion for COVID-19. It awarded about $8.3 billion in grants for activities such as community mental health. Recipients spent about $6.9 billion as of July 2025.
    • “The agency got $1.6 billion in FY21-24 for the 988 Lifeline, a call, text, and chat hotline supporting those in crisis. It awarded $1.2 billion to funding recipients, who had spent about $906.3 million.”

From the Food and Drug Administration front,

  • MedPage Today informs us,
    • “Assorted flavors of cream cheese were recalled by Made Fresh Salads due to possible Listeriacontamination, according to an FDA notice.”
  • The FDA issued today an “Early Alert: Heart Pump Purge Cassette Issue from Abiomed.”

From the judicial front,

  • Healthcare Dive reports,
    • “Frustrated by a recent, dramatic overhaul of the U.S. childhood immunization schedule, 15 Democrat-led states have sued the Trump administration in a bid to undo those changes as well as what they alleged to be an “unlawful replacement” of a key vaccine panel. 
    • “The lawsuit, filed by 14 attorneys general and the governor of Pennsylvania [in the U.S. District Court for the Northern District of California], seeks to rescind the new schedule adopted by the Department of Health and Human Services and vacate the committee, known as ACIP, reformed last year by Secretary Robert F. Kennedy Jr. Kennedy, the Centers for Disease Control and Prevention and the agency’s acting director, Jay Bhattacharya, are named as defendants in the suit.” 

From the public health, medical and Rx research front,

  • The AHA News reports,
    • “An American Heart Association study published Feb. 25 found that 6 in 10 U.S. women are projected to develop a form of cardiovascular disease by 2050. The report found a growing prevalence of heart disease, heart failure, atrial fibrillation and stroke and projected increases of conditions leading to cardiovascular disease, such as high blood pressure, obesity and diabetes. Additionally, the study found that nearly 32% of girls age 2-19 may be obese by 2050.”
  • Cardiovascular Business adds,
    • “Metabolic and bariatric surgery (MBS) is associated with better long-term cardiovascular protection than glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes and obesity, according to a new meta-analysis. The findings were published in full in Obesity Surgery.”
  • Healio tells us,
    • “Cervical cancer incidence has declined close to 30% among women aged 20 to 31 years since the start of the millennium, but certain states have achieved significantly greater reductions.
    • “Washington, D.C., Rhode Island, Michigan and Hawaii all achieved decreases of more than 50%, but incidence in Vermont, West Virginia, Idaho, Arkansas and Alabama remained unchanged.
    • “Researchers observed an association between increased HPV vaccination rates and faster decline in incidence, as well.
    • “A decline of more than 50% observed in several states within such a relatively short period is rarely seen in cancer epidemiology, making these findings particularly striking,” Chenxi Jiang, MPH, associate scientist in surveillance, prevention and health services research at American Cancer Society, told Healio. “At the same time, they are highly encouraging, demonstrating what is achievable when prevention efforts are effectively implemented.”
  • Cigna Healthcare, writing in LinkedIn, points out
    • “Proactive mental health care helps lower overall medical costs.
    • “Untreated mental illness leads to higher health expenses and lost productivity.
    • “Investing in treatment for depression and anxiety yields a fourfold return.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies five forces reshaping pharmacy economics this year.
  • Fierce Healthcare reports,
    • “There’s been a flurry of recent activity in the direct-to-consumer space as drug costs and spending continue to rise.
    • “It’s with that backdrop that GoodRx announced Tuesday it would launch Employer Direct, a new program that allows employers to offer workers lower costs on branded products, which often carry the highest prices. Through the program, these firms can select branded drugs and subsidize the cost for the cash-pay price available through GoodRx.
    • “Employers in the program can also tap into GoodRx’s telemedicine solutions, which bring together the clinical care with the prescription fulfillment to ensure patients get the drugs they need.”
  • Modern Healthcare adds,
    • “Employers tired of dealing with health insurers now have another option at their disposal: Go through a different intermediary instead.
    • “Third-party vendors such as Lantern, Nomi Health and Transcarent are making a play for the employer market as businesses wage a perpetual struggle to manage rising health benefit costs. These platforms tout savings, flexibility and a seamless experience to enable direct contracting with providers at scale.
    • “Their reach, once limited, is now national and includes all types of medical services. Transcarent has more than 20 million members after it acquired care navigation company Accolade last year. Nomi Health serves 19 million members. Lantern’s specialty care platform has grown from 100,000 members to more than 12 million in the last decade.”
  • Fierce Healthcare notes,
    • “Uber Health is rolling out a new feature that allows patients who are comfortable with its platform to book their own rides.
    • “Uber’s healthcare platform has traditionally been a back-end option for providers and other partners to book rides to and from appointments on the behalf of the patient. Through this approach, Uber supported processes like transportation benefits and discharge planning for its partners.
    • “However, the company heard feedback from clients that the administrative time to do this was not insignificant, and that there were many patients who were familiar enough with Uber to book trips themselves, Cory Warner, global head of growth and operations for Uber Health, told Fierce Healthcare in an interview at ViVE on Tuesday.
    • “We’re really excited, because we’ve been able to advance the technology to meet the needs of some of our customers who’ve been sharing with us that, while we have a lot of folks that may not have a smartphone, we do have a number of patients and members who have the Uber app in their everyday life,” she said.”
  • Fierce Pharma informs us,
    • “Novartis is wasting little time sketching out the radiopharmaceutical details of its $23 billion U.S. investment push. Shortly after announcing a new manufacturing facility for the class of cancer meds in Florida, the pharma giant is revealing its intention to build another site in Texas. 
    • “The forthcoming 46,000-square-foot radioligand therapy (RLT) production plant will be set upin Denton, Texas—part of the greater Dallas-Fort Worth area—and becomes the fifth existing or planned radiopharmaceutical manufacturing site in Novartis’ U.S. network, the company said in a Feb. 25 release. 
    • “Construction is slated to kick off this year, with the site expected to come online in 2028, Novartis said. 
    • “The plant will generate jobs in fields like bioengineering, advanced manufacturing, quality and operations, although Novartis did not specify how many new hires it has planned.” 
  • Per BioPharma Dive,
    • “Novo Nordisk announced Wednesday a collaboration with startup Vivtex that’ll give it access to technologies that could yield new oral biologics for obesity and other metabolic diseases.
    • “The companies did not disclose the amount of guaranteed cash going from Novo to Vivtex in the deal. But the Boston biotechnology startup stands to gain as much as $2.1 billion, as well as sales royalties, if drugs emerging from the alliance progress and are eventually commercialized.”
  • and
    • “GSK is scooping up a promising experimental medicine for a dangerous type of high blood pressure through a $950 million acquisition of private Canadian drugmaker 35Pharma.
    • “The drug, HS235, has already completed Phase 1 testing in healthy volunteers and, according to GSK, should soon enter studies focused on either pulmonary arterial hypertension or a different pulmonary hypertension caused by a certain kind of heart failure. The company added that this medicine has potential to fight cardiovascular disease, deliver metabolic benefits and offer a lower risk of bleeding — a key limitation of current PH treatments.
    • “HS235 is a so-called activin signaling inhibitor, designed to fight the over-proliferation of cells that can thicken blood vessel walls. This drug class has already seen success; Merck & Co. won approval for one member, Winrevair, in 2024, and chalked up sales of more than $1.4 billion from it last year. Merck is looking to expand its usage as well.”
  • Per MedTech Dive,
    • “Quantum Surgical, which specializes in medical robotics for cancer treatment, said Tuesday that it has acquired NeuWave Medical from Johnson & Johnson.
    • “Quantum, based in Montpellier, France, with an office in Miami, said the deal supports its strategy of expanding robot-assisted tumor ablation treatment to reduce cancer mortality.
    • “Last year, J&J informed customers that it planned to discontinue the NeuWave business, before announcing in September that it had received a binding offer from Quantum to buy NeuWave.”

Tuesday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

FEHBlog response to public comment

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

Monday report

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Mental health care, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Beckers Hospital Review reports,
    • “President Donald Trump has postponed a planned announcement of a proposal to extend enhanced ACA subsidies, CNN reported Nov. 24.
    • “Trump was expected to unveil a proposal as early as Nov. 24 that would extend the subsidies for two years while introducing new eligibility restrictions, according to earlier reports from Politico and MS Now. 
    • “The proposal, dubbed the “Healthcare Price Cuts Act,” would also establish an income cap limiting subsidies to individuals earning up to 700% of the federal poverty line, three people familiar with the plan told Politico. All enrollees would be required to make minimum premium payments, two White House officials told MS Now. 
    • “The plan also includes a health savings account component. Enrollees who switch to lower-premium marketplace plans could direct the difference in premium costs into tax-advantaged savings accounts funded with their subsidy dollars, according to both reports.
    • “Additionally, the White House intends to ask Congress to appropriate funding for cost-sharing reductions, which lower out-of-pocket expenses for ACA enrollees, Politico reported.”
  • MedCity News considers whether President Trump can do for branded expensive drugs what he just did for GLP-1s?
    • “While many are applauding the Trump administration for taking this step to expand access to GLP-1s, some believe that specifically targeting weight loss drugs actually does very little to bring down overall prescription drug costs.
    • “I think that focusing on market solutions on GLP-1s alone misses the mark, because it’s a market problem,” said Chris Deacon, principal and founder of VerSan Consulting. “[Whether it’s] GLP-1s or other medications, we have a problem of a complete lack of transparency for the purchaser.”
    • “Another expert echoed these comments, stating that while this is a positive move, there needs to be a broader effort in order to effectively bring down drug costs entirely.
    • “This is a step in the right direction,” said Edgar Asebey, an FDA regulatory attorney at Frier Levitt. “A policy initiative that is more of a blanket policy with branded drugs would be much better for the American patients.”
  • Modern Healthcare tells us,
    • “Juan Carlos “JC” Scott, president and CEO of the Pharmaceutical Care Management Association since 2018, stepped down Friday. 
    • “PCMA Chief Government Affairs Officer Lucia Lebens is serving in the president and CEO roles on an interim basis, a spokesperson for the pharmacy benefit manager trade group said Monday. The spokesperson did not respond to questions about whether Lebens also still holds the chief government affairs officer position. 
    • “A search is underway for Scott’s permanent replacement. 
    • “Scott announced in October he would be leaving the organization by the end of the year.
    • “The trade group declined to respond to a request for comment on why Scott decided to depart from the organization. 
    • “An October news release, however, said 2025 was the last year of Scott’s contract.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced five new agency leaders who will serve our nation’s families and advance goals to Make America Healthy Again. Four of these five presidential appointees required and recently received Senate confirmation.”
      • Brian Christine, MD, Assistant Secretary for Health
      • Alex J. Adams, PharmD, MPH, Assistant Secretary for Family Support, Administration for Children and Families
      • Gustav Chiarello, Assistant Secretary Financial Resources
      • Michael Stuart, General Counsel
      • Alicia Jackson, Ph.D., Director, Advanced Research Projects Agency for Health (ARPA-H)
  • The American Hospital Association News adds,
    • “The Advanced Research Projects Agency for Health announced Nov. 21 that it will fund up to $100 million in projects for quantitative measures of mental and behavioral health through its new Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health initiative. The program will focus on data regarding individual clinical outcomes and patient response to novel treatments. ARPA-H said it is seeking multimodal, longitudinal data collected in clinical trials testing the effects of rapid behavioral health interventions. The agency said the awards will be actively managed contracts, where continuation would be contingent upon satisfactory performance reviews.”
  • The National Bureau of Economic Research points out,
    • “We use comprehensive tax data to study how saving behavior responds to the Health Savings Account (HSA) “catch-up” contribution provision, which raises HSA contribution limits for individuals aged 55 and older. Using a regression discontinuity design, we find a sharp increase in contributions among those previously near the limit and smaller increases among unconstrained savers. Induced contributions are not immediately withdrawn and do not appear to crowd out retirement savings. Responses are strongest among payroll contributors and long-term savers. However, married couples do not appear to coordinate their HSA behavior to take advantage of the complex spousal rules governing catch-up contributions. Our findings highlight how tax incentives shape HSA saving and suggest that tax-advantaged account design meaningfully affects household financial behavior.”
  • Bloomberg Law informs us,
    • “Employers hope a forthcoming [federal] rule to improve surprise medical bill arbitration will strengthen their hand against doctors and improve transparency into insurers’ processes.
    • “Doctors win a high percentage of disputes, and industry groups are lobbying lawmakers and regulators to make changes, with employers arguing that doctors are abusing the process by refusing to negotiate and submitting ineligible claims for arbitration.
    • “The forthcoming rule is expected to address many of employers’ complaints, but it could also face legal fights similar to those that overturned a series of previous rules and guidance.”
  • Federal News Network interviews OPM Director Scott Kupor about the next executive development programs that OPM announced last week.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Abbott has issued a medical device correction for about 3 million Freestyle Libre 3 and 3 Plus sensors in the U.S. after determining that some sensors may provide incorrect low glucose readings, the company announced Monday.
    • “Abbott has received reports of 736 severe adverse events and seven deaths overall associated with the problem. In the U.S., 57 severe adverse events and no deaths were reported.
    • “The problem could lead to incorrect treatment decisions, such as people skipping or delaying insulin doses and excessive carbohydrate intake. Abbott said it has resolved the cause of the problem, which was related to one production line, and will replace any potentially affected sensors at no charge.”
  • Reuters notes,
    • “The U.S. Food and Drug Administration has approved Novartis’ (NOVN.S) new gene therapy for patients with a rare muscle disorder, the drugmaker said on Monday.
    • “The therapy, branded as Itvisma, was approved for the treatment of spinal muscular atrophy patients of age two years and older who have a confirmed mutation in the survival motor neuron 1 gene.
    • “Itvisma contains the same active ingredient as the Swiss drugmaker’s older therapy, Zolgensma, which is approved in the U.S. to treat SMA patients less than 2 years of age.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Unlike much of Europe and East Asia, America hasn’t reached the point at which we have more people dying than we do being born.
    • “At least not in the long run. We briefly blew past that point in a few winter months at the height of the covid-19 pandemic, according to our analysis of birth- and death-certificate data collected by the National Vital Statistics System.”
    • The article digs into the details.
  • The AP relates,
    • “The U.S. flu season is starting slowly, and it’s unclear if it will be as bad as last winter’s, but some health experts are worried as U.S. Centers for Disease Control and Prevention data posted Friday shows a new version of the virus has emerged.
    • “An early analysis suggests current vaccines may still be somewhat effective against the new version of the flu, which has been the main driver of recent infections, CDC data shows.
    • “Some scientists and medical professionals are more worried about disappointing vaccination rates, a main reason why flu hospitalizations and deaths were unusually bad during last year’s flu season — one of the deadliest this century.” * * *
    • “Some sources have suggested flu vaccinations are down. Over two million fewer flu shots were given at U.S. pharmacies through the end of October compared to last year, according to data from IQVIA, a health information and research company.
    • “But the latest CDC data indicates that for children, the vaccination rate this year is about the same as it was at this point last fall, at 34%. And the vaccination rate for adults is up a few percentage points to about 37%, according to the CDC data, which relies on survey information.
    • “It is early in the season and too early to know if the increase will be sustained or what is causing it, CDC officials said.”
  • Per Health Day,
    • “Many people don’t know they have a genetic risk factor for high cholesterol
    • “Nearly 90% of people carrying variants for familial hypercholesterolemia didn’t know it
    • “Researchers say 1 in 5 had already developed heart disease”
    • “Our findings expose a blind spot in current national guidelines, which rely on cholesterol levels and family history to determine who should receive genetic testing,” lead researcher Dr. Niloy Jewel Samadder, a cancer geneticist at the Mayo Clinic Comprehensive Cancer Center in Phoenix, said in a news release.”
  • Per MedPage Today,
    • “Girls ages 16 years or younger who received HPV vaccines were 80% less likely than their unvaccinated counterparts to develop cervical cancer.
    • “Evidence from 23 studies showed with moderate certainty that HPV vaccination lowered the incidence of high-grade cervical precancers.
    • “Vaccinated persons had 25 fewer cases of anogenital warts per 1,000 participants at 48 months, regardless of HPV type.”
  • Per the Washington Post,
    • “People who stopped taking weight-loss drugs before or during pregnancy were associated with greater gestational weight gain and had a higher risk of preterm delivery and gestational diabetes compared with those who had not been prescribed the drugs before, according to a study published Monday in JAMA.
    • “Researchers from Mass General Brigham in Boston reviewed medical records from nearly 150,000 pregnancies between June 2016 and March 2025. They found that people who had been prescribed GLP-1 drugs, a class of medications used to treat Type 2 diabetes and obesity, were more likely to gain more weight than recommended during pregnancy.
    • “Sixty-five percent of 448 pregnancies among people previously prescribed GLP-1 medications included excess gestational weight gain, compared with 49 percent of 1,344 pregnancies among those who did not receive the medication but had similar characteristics to those who received a GLP-1.
    • “If we can find those at risk of cardiovascular disease early, we can treat it early and change its course and likely save lives,” Samadder said.”
  • Per BioPharma Dive,
    • “The theory that GLP-1 medicines, which have profound benefits on metabolism and heart health, can also help combat Alzheimer’s disease suffered a major blow Monday with the failure of two large, closely watched clinical trials.
    • “The studies, titled Evoke and Evoke+, together enrolled more than 3,800 people with early-stage Alzheimer’s to evaluate whether Novo Nordisk’s semaglutide can help preserve brain function. According to Novo, its drug was not significantly better than a placebo on that measure after two years of follow-up. And though semaglutide treatment did improve some biological markers tied to Alzheimer’s, it didn’t delay the progression of the disease.”
  • STAT News adds,
    • “A promising Alzheimer’s disease treatment from Johnson & Johnson failed to slow the progress of the disease in a closely watched study, news that could dampen enthusiasm for a new class of potential medicines.
    • “J&J terminated its mid-stage study of the injectable medicine posdinemab, the company said Friday, after an early look at results determined the treatment would not prove more effective than placebo. J&J said it would present full data from the trial at a later date.
    • “Posdinemab’s failure could cast a shadow over a cadre of in-development Alzheimer’s treatments meant to improve on the standard of care. Biogen, UCB, and Voyager Therapeutics are developing similar treatments of their own.”
  • The New York Times discusses how certain hospitals lowered their C-section rates,
  • and tells us,
    • “Dialing down the use of social media for a week reduced symptoms of anxiety, depression and insomnia in young adults, according to a study published on Monday in the journal JAMA Network Open.
    • “Researchers followed 295 volunteers, ages 18 to 24, who opted to take a break from social media. Instructed to stay off social media as much as possible, the group on average reduced it to a half-hour per day from just under two hours. Before and after, the participants answered surveys measuring depression, anxiety, insomnia, loneliness and a number of problematic social media behaviors.
    • “Overall, they reported positive changes: On average, symptoms of anxiety dropped by 16.1 percent; symptoms of depression by 24.8 percent; and symptoms of insomnia by 14.5 percent. The improvement was most pronounced in subjects with more severe depression. At the same time, there was no change in reported loneliness — perhaps, the authors wrote, because the platforms play a constructive social role.”
  • The American Medical Association lets us know what doctors wish their patients knew about cutting down on screen time.
    • “Too much time with smartphones or TVs can do harm. Three physicians share tips on how to reduce screen time before it turns toxic.”
  • Per BioPharma Dive,
    • “Bayer’s experimental blood thinner asundexian met its main goal in a closely watched Phase 3 stroke prevention trial, reducing the recurrence of a stroke in people who took the therapy along with standard treatments. The trial compared treatment with a combination of asundexian and an antiplatelet therapy against a placebo and the same antiplatelet treatment. 
    • “The German-based company didn’t release detailed data, stating that researchers will disclose them at an upcoming medical meeting while company executives discuss them with regulators ahead of possible approval applications.
    • “Results of the trial lifted optimism for asundexian’s drug class, called Factor XIa inhibitors, following a series of clinical setbacks. Most recently, a rival drug missed its main goal in a trial of people who’d had a recent heart attack.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Optum Rx will reduce reauthorizations on 40 additional medications Jan. 1, surpassing initial goals set out earlier this year.
    • “The pharmacy benefit management arm of UnitedHealth Group first revealed earlier this year that it was aiming to reduce reauthorizations, a specific model for prior authorization, by up to 25%. The new additions bring the total number of drugs in the initiative up to 180, surpassing that 25% goal.
    • “The new group of 40 medications includes therapies for chronic conditions and two new classes of drugs: hormone therapy and injectables for knee osteoarthritis.
    • “In addition, Optum announced that it will expand the PreCheck Prior Authorization program, covering more than 45 medications beginning Jan. 1. The tool will reach 20 health systems, Optum said.”
  • and
    • “Three former Amazon employees launched a new online healthcare marketplace earlier this year aiming to make healthcare a better experience for patients. The vision, executives said, was to make healthcare as easy as shopping online.
    • “General Medicine, started by the founding team that built PillPack and Amazon Pharmacy, connects consumers to providers to either address specific medical needs or to chat about the symptoms they’re having. Consumers can use General Medicine for a wide variety of medical issues, and the platform provides both insurance and cash pricing. There’s no subscription or access fee. 
    • “General Medicine executives refer to it as a “one-stop-shop” for telemedicine, prescriptions, imaging, labs and specialists. PillPack co-founders TJ Parker and Elliot Cohen teamed up with Ashwin Muralidharan, who most recently served as technical advisor and chief of staff to Amazon’s top health executive Neil Lindsay, to launch General Medicine.”
  • Cardiovascular Business tells us,
    • “Medtronic had a strong second quarter, reporting a worldwide revenue of $8.96 billion, and earnings per share (EPS) of $1.36. Both figures exceeded the company’s expectations. 
    • “Medtronic’s cardiovascular portfolio helped lead the way with a worldwide revenue of $3.44 billion, an increase of 9.3%. 
    • “This was our strongest growth in over a decade, excluding the easy comparisons we had after the pandemic,” Thierry Piéton, Medtronic’s chief financial officer, explained during an earnings call.
    • “Ablation devices—particularly those built for pulsed field ablation (PFA)—played a critical role in Medtronic’s triumphant quarter. In fact, worldwide revenue was up 71% for cardiac ablation solutions, including a 128% increase in the United States.”  
  • MedTech Dive informs us,
    • “Insulet laid out plans for new diabetes devices at an investor event last week, including a fully automated insulin delivery system for people with Type 2 diabetes. 
    • “The company is working on updates to its current Omnipod 5 device, plans to debut its Omnipod 6 device in 2027 and expects to launch a separate, fully-closed loop system for people with Type 2 diabetes in 2028, CEO Ashley McEvoy said.  
    • “Insulet, which leads the market for insulin patch-pumps, is also working on bringing its devices to more people with Type 2 diabetes, after receiving an expanded label from the Food and Drug Administration last year.”

Thursday report

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

From Washington, DC,

  • Roll Call reports,
    • “The top four House and Senate appropriators met Thursday for the first time since the partial government shutdown but emerged with no breakthroughs that could pave the way for a new spending package.
    • “The meeting marked a small, positive step toward bipartisan negotiations that would be needed for an eventual deal. But so far, the two chambers and the two parties remain on different paths when it comes to fiscal 2026 spending bills.
    • “Senate Appropriations Chair Susan Collins, R-Maine, favors moving a massive package of up to five bills, featuring the two largest — Defense and Labor-HHS-Education. But there is no sign of any bipartisan agreement on overall spending limits, a major impediment to moving a package that would well exceed $1 trillion and make up the bulk of the year’s discretionary spending.
    • “By contrast, House Appropriations Chairman Tom Cole, R-Okla., wants to move a smaller batch of bills that could conceivably be enacted before Christmas.
    • “House Appropriations ranking member Rosa DeLauro, D-Conn., said no decisions about the contents of the next package were made during the meeting, though it was discussed. Senate Appropriations ranking member Patty Murray, D-Wash., also attended.”
  • Healthcare Dive tells us,
    • “Republicans and Democrats in Congress remain largely stuck in partisan gridlock over how to lower healthcare costs. But one area of potential compromise emerged during a contentious Senate Finance Committee hearing on Wednesday — resuscitating pharmacy benefit manager reform.
    • “Senate Finance Chair Mike Crapo, R-Idaho, and Ranking Member Ron Wyden, D-Ore., plan to reintroduce a bipartisan package cracking down on PBMs, middlemen in the drug supply chain, Crapo said during the hearing. 
    • “The legislation almost made it out of Congress late last year as part of a larger appropriations bill but eventually failed after public opposition from billionaire Elon Musk, a key ally of President Donald Trump at the time. Crapo said the PBM legislation would be reintroduced “shortly” and hopefully moved to the president’s desk soon after.”
  • The FEHBlog strongly doubts that “cracking down” on PBMs will lead to lower healthcare costs.
  • Genetic Engineering and Biotechnology News informs us,
    • “A bipartisan group of senators and representatives introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence (COE), inspired by recommendations from the National Security Commission on Emerging Biotechnology (NSCEB) April 2025 Action Plan for Congress.
    • “In the Senate, the legislation was introduced by Sen. Coons (D-DE) and Sen. Budd (R-NC), and in the House, the bill was introduced by Rep. Houlahan (D-PA, 06), Rep. Baird (R-IN, 04), Rep. Rouzer (R-NC, 07), and Rep. Ross (D-NC, 02).
    • “The bill would create a public-private partnership focused on advancing innovation in biopharmaceutical manufacturing methods, especially for products important to U.S. national security, health security, and economic security. It would also improve regulatory understanding of innovative manufacturing methods and provide workforce training opportunities in this fast-growing field.”
  • Bloomberg lets us know,
    • The Health and Human Services Department is proposing new initiatives for the Centers for Disease Control and Prevention, including a program to increase hepatitis B screening for pregnant women, as part of a broader push to restructure the agency, according to an internal document viewed by Bloomberg News.
    • Leading five of the 16 initiatives is Sam Beyda — a carryover from the Department of Government Efficiency — who was recently named deputy chief of staff at the CDC, according to people familiar with the matter who were not authorized to speak on the subject. 
    • The new programs are not yet formalized, with details to be settled before they are rolled out to the CDC in January, the document said. The list was developed over the last several months in collaboration with HHS senior advisers and CDC leadership. It includes strategic reviews on existing initiatives.
  • Per a CMS news release,
    • “On November 20, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after Jan. 1, 2026. This final rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2026 and updates requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2026, CMS will increase the ESRD PPS base rate to $281.71, which CMS expects to increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%. The CY 2026 ESRD PPS final rule also includes a new payment adjustment for certain non-labor costs for ESRD facilities located in Alaska, Hawaii, and the United States (U.S.) Pacific Territories.
    • “CMS is shortening the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey to 39 questions, removing 23 questions. CMS is also eliminating three health equity reporting measures from the ESRD QIP. CMS also is finalizing the early termination of the ESRD Treatment Choices Model.”
  • The American Hospital News adds,
    • “The Centers for Medicare & Medicaid Services will retroactively pay claims for telehealth services provided during the government shutdown through Jan. 30, the agency said in an updated FAQ Nov. 20. Telehealth flexibilities will expire at the end of January if government funding is not extended. CMS added that some telehealth practitioners could list their physical practice location instead of their personal address on Medicare enrollment and billing forms when they provide telehealth services from their home. Virtual-only telehealth practitioners will need to enroll their home address as a practice location, but they will have the option to suppress their street address details.” 
  • The Government Accountability Office (GAO) released a report about “Health Savings Accounts: Information on Features and Use, and Characteristics of Account Holders” and a WatchBlog post about “Who Benefits from Health Savings Accounts?”

From the Food and Drug Administration front,

  • The New York Time reports,
    • “ByHeart, the company linked to an outbreak of botulism from infant formula, said late Wednesday that a private lab had found the bacteria that causes the illness in samples of its product.
    • “So far, 31 babies in 15 states have been hospitalized, many in intensive care units, after becoming weak and unable to swallow. No deaths have been reported.
    • “ByHeart said in a statement that it sent its formula to an independent testing lab on Nov. 7, as soon that the Food and Drug Administration notified the company about the outbreak.”
  • STAT News points out,
    • “Paradromics announced Thursday that the Food and Drug Administration approved a clinical study to evaluate whether the company’s brain-computer interface for speech restoration is safe and capable of providing the ability to communicate via text or synthesized speech to someone with paralysis. 
    • “The Austin-based company is one of a handful of startups — including Elon Musk’s Neuralink, Synchron, and Precision Neuroscience, among others — that have transformed brain-computer interfaces from an obscure academic niche to a promising neurotechnology that Morgan Stanley recently valued at $400 billion.” 
  • Fierce Pharma notes,
    • “After months of back-and-and forth with the FDA and a third-party manufacturer, Regeneron has secured two long-awaited approvals for Eylea HD, gaining a new indication and a more flexible dosing option for the eye disease drug.
    • “The FDA has signed off on Eylea HD for patients with macular edema following retinal vein occlusion (RVO), making it the first treatment available in the indication with dosing up to every eight weeks. The agency also endorsed a monthly dosing option for Eylea HD across each of its approved indications, which include wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and now RVO.
    • “The nods allow Regeneron to better compete with Roche, which stormed the market in 2022 with Vabysmo. The Swiss drugmaker’s long-acting treatment can be administered up to every four months, as opposed to Regeneron’s original 2 mg version of Eylea, which has a maximum dosing interval of every two months.” 
  • Per Radiology Business,
    • “Siemens Healthineers has issued a correction for its 3T MRI systems that were recently the subject of a Class 1 recall. 
    • “Siemens first alerted customers about safety issues with nine different scanners from its Magnetom series of MRI offerings in August. Authorities said there have been problems with the systems’ ventilation, which could be subject to pressure buildup of helium in the event of a quench—rapid loss of superconductivity in the machine’s magnet. Such a buildup could cause the helium containment system to rupture and leak helium into the scanning room or potentially trigger an explosion. The issue was categorized as a Class 1 recall due to its potential to cause serious bodily harm or death. 
    • “The U.S. Food and Drug Administration announced the recall in early October. Now, Siemens is issuing an official device correction with more detailed information to assist operators in the event of a system error that could trigger the issue.” 

From the judicial front,

  • Bloomberg Law reports,
    • “The 11th Circuit denied an air ambulance company’s attempt to overturn a surprise billing arbitration award, delivering another blow to medical providers trying to challenge the decisions in court.
    • “Wednesday’s ruling confirms the U.S. District Court for the Middle District of Florida’s decision that REACH Air Medical Services LLC lacked a right to sue Kaiser Health Plan Inc. after losing arbitration under the No Surprises Act, which REACH alleged was based on fraud. 
    • “Lower courts have split on whether doctors and insurers can sue to enforce or overturn the awards outside of a limited set of circumstances outlined in the law.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19 infections are also growing or likely growing in 20 states. The agency said it would begin tracking respiratory syncytial virus trends soon.” 
  • The Wall Street Journal relates,
    • “Tens of thousands of kids who take prescription ADHD medication also wind up on other powerful psychotropic drugs—including antipsychotics and antidepressants, studies show. For some of them, the ADHD drugs themselves can be a trigger, according to doctors, patients and psychologists, who say additional medications are often prescribed to manage side effects such as insomnia, despite limited scientific evidence supporting these combinations in young, developing brains. 
    • About 7.1 million American children ages 3 to 17 have an ADHD diagnosis, according to an analysis of 2022 federal data. About half took ADHD medication for it that year, and prescriptions are growing. 
    • “The decision to treat ADHD with medication is often made by desperate parents trying to keep their kids from falling behind or being kicked out of school or daycare, parents and mental health clinicians say. For preschool-age kids, the drugs are often dispensed against pediatric guidelines, which call first for behavioral therapy, a treatment that can be hard to get. And mental health providers say the drugs are frequently prescribed to treat childhood trauma that has been misdiagnosed as ADHD.
    • “For one in five kids who take them, ADHD drugs are just the beginning. A Wall Street Journal analysis of Medicaid data from 2019 through 2023 shows that children who were prescribed a medication for ADHD were far more likely to take additional psychiatric drugs over the ensuing four years.”
  • Per Health Day,
    • “Long COVID can follow one of eight different symptom paths, as patients suffer for months past their initial infection, a new study reports.
    • “The eight identified “trajectories” show how long COVID can differ between patients based on its severity and duration, as well as whether their symptoms improve or worsen over time, researchers reported Nov. 17 in the journal Nature Communications.
    • “The variability we identified will enable future studies to evaluate risk factors and biomarkers that could explain why patients vary in time of recovery, and help identify potential therapeutic targets,” lead researcher Tanayott Thaweethai, an assistant professor at Harvard Medical School and associate director of Massachusetts General Hospital Biostatistics in Boston, said in a news release.”
  • Per MedPage Today,
    • “Higher physical activity in midlife was associated with a 40% lower dementia risk over 26 years.
    • “Late-life physical activity also was linked with less dementia risk.
    • “Exercise and activity can increase cerebral blood flow, reduce inflammation, and boost neuroplasticity.’
  • Per Genetic Engineering and Biotechnology News,
    • “A new paper from the laboratory of David Liu, PhD, at the Broad Institute describes a genome-editing strategy that could result in a one-time treatment for multiple unrelated genetic diseases. The new technique dubbed prime editing-mediated readthrough of premature termination codons or PERT is detailed in Nature in a new paper titled “Prime editing-installed suppressor tRNAs for disease-agnostic genome editing.” The work is spearheaded by co-first authors Sarah Pierce, PhD, and Steven Erwood, PhD, both of whom are postdoctoral associates in the Liu lab.  
    • “According to its developers, PERT is designed to maximize the potential of gene editing by using a single agent to target multiple disorders. Specifically, it uses prime editing, also developed by the Liu lab, to rescue nonsense mutations, which, when they appear, cause cells to stop protein synthesis early, resulting in malfunctional forms of proteins that are linked to various rare diseases.
    • “Importantly, PERT does not directly edit nonsense mutations, which account for 24 percent of pathogenic alleles in the ClinVar database. It works by “permanently converting a dispensable endogenous tRNA into an optimized [suppressor]-RNA.” This conversion equips edited cells to produce functional forms of the necessary protein, regardless of which gene has the mutation.” 

From the U.S. public health business front,

  • Fierce Healthcare reports,
    • “The average amounts of a hospital’s denied inpatient and outpatient claims have increased by 12% and 14%, respectively, with greater denial volumes also accompanying an uptick in payer’s audits, according to a vendor report released this week. 
    • “The analysis, which looked at real-world data from the first three quarters of 2025 among MDaudit’s network of more than 1.2 million providers and 4,500 facilities, echoes reports from health system executives and management teams describing heightened payer denial activity as a drag on their revenues.
    • “Specifically, for external payer audits, the billing compliance and revenue integrity tech platform said it spotted a 30% year-over-year increase per customer in total at-risk amount.
    • “The average amount per claim also rose by 18%, according to the report. Among these, 45% of the at-risk amount came from commercial payers with Medicare and Medicaid accounting for 28%.”
  • Beckers Payer Issues informs us,
    • “More and more payers and employers have been getting on board with surgical alternatives to GLP-1s for weight loss.
    • “A 2024 survey found most employer-sponsored plans covered these procedures, and covering GLP-1s for diabetes and obesity was much less likely. KFF reported that the majority of organizations with at least 5,000 employees said covering GLP-1 agonists had a “significant” impact on prescription drug spending.
    • “One doctor told Becker’s that insurers see “more reliable outcomes and savings” when they pay for bariatric surgery. During a panel on GLP-1s at Becker’s Fall 2025 Payer Issues Roundtable this month, Select Health Senior Medical Director Kenny Bramwell, MD, echoed that sentiment.
    • “A handful of years ago, I never would have said this, but some people may need to consider — or we need to at least consider — the costs of surgical options,” Dr. Bramwell said. “Bariatric surgery suddenly seems inexpensive compared to $1,000 a month in perpetuity.”
    • The article considers whether recent GLP-1 drug price reductions may change perspectives.
  • Per MedTech Dive,
    • “Abbott has agreed to acquire cancer test-maker Exact Sciences for about $21 billion.
    • “Exact Sciences makes the Cologuard noninvasive screening test for colorectal cancer. The company also makes tests to detect multiple types of cancer early and identify molecular residual disease to assess the risk of recurrence. 
    • ‘The deal is expected to close in the second quarter of 2026, subject to shareholder and regulatory approvals. Abbott expects Exact Sciences to generate more than $3 billion in revenue this year and grow Abbott’s total diagnostics sales to more than $12 billion annually after the acquisition closes.”
  • Per Biopharma Dive,
    • “Biotechnology company Moderna said Thursday it has secured a loan of $1.5 billion as it reevaluates its pipeline in an effort to break even by 2028.
    • ‘The vaccine maker signed a five-year loan facility with Ares Management Credit Funds, a move Chief Financial Officer Jamey Mock said, in a statement, will enable “increased flexibility over the coming years.” The influx of capital provides an additional lifeline as the drugmaker navigates a post-pandemic market.
    • ‘Moderna also announced a three-year business strategy, targeting up to 10% revenue growth in 2026. Company shares subsequently rose over 2%.”
  • Chief Health Executive reports,
    • “Bob Farrell says health plans and providers have plenty of data on their patients, but they’re not always getting the most of it.
    • “Farrell is the CEO of mPulse, a company working with health systems and health plans to get more insights on their patients. The company has been growing significantly in recent years, completing the acquisition of Clarity Software Solutions over the summer. Clarity is the fifth company mPulse has acquired since December 2021.
    • “With the addition of Clarity, Farrell says the goal is to use AI technology to “provide a plan or a provider with a 360-degree view of their members or their patients.”
    • “With that information, he says, “They can do the things that allow that member or patient to really take charge of their health care, and ultimately to improve outcomes, while simultaneously driving efficiencies for the plan or the provider themselves.”
    • “The company works with 450 healthcare organizations and 50 of the nation’s 60 largest health plans.”