Thursday report

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Thursday report

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

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump announced Thursday night he would immediately begin paying Transportation Security Administration workers through an emergency executive order.
    • “The order promised to end long delays at the nation’s airports and allow TSA workers to get paychecks they have been denied during a partial shutdown of the Department of Homeland Security that has persisted for more than 40 days. 
    • “It also offered a partial reprieve for Congress, which has been locked in a bitter partisan standoff over immigration enforcement policies that has kept the department unfunded for weeks. Long lines at airport checkpoints and complaints from TSA workers had become critical pressure points in a search for an end to the shutdown.”
  • Per a White House fact sheet,
    • Today, President Donald J. Trump signed an Executive Order eliminating racially discriminatory “diversity, equity, and inclusion” (DEI) practices by Federal contractors and their subcontractors, ensuring merit-based and efficient contracting and employment.
      • The Order requires that all Federal contracts that are subject to the Federal Property and Administrative Services Act include a clause prohibiting contractors and their subcontractors from engaging in racially discriminatory DEI activities.
      • The Order directs the Office of Management and Budget to issue guidance to contracting agencies to ensure compliance and identify economic sectors that pose a particular risk of engaging in racially discriminatory DEI activities.
      • The Order authorizes contracting agencies to cancel, terminate, or suspend contracts — and to suspend or debar contractors — for failure to comply.
      • The Order directs the Attorney General to prioritize potential claims under the False Claims Act against contractors or subcontractors that are in violation of the contractual terms prohibiting racially discriminatory DEI activities, and ensure the prompt review of related civil actions brought by private persons.
      • The Order directs the Federal Acquisition Regulatory Council to amend Federal Acquisition Regulations to include this clause and remove any conflicting provisions.  
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) announced the members of the Healthcare Advisory Committee, a new federal advisory body comprised of leaders from across the healthcare system to provide expert advice on improving, strengthening and modernizing U.S. healthcare.
    • “The Committee will advise HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz on ways to improve how care is financed and delivered across Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.
    • “This Administration is bringing leaders together to tackle the challenges facing American patients and the health care system, putting prevention front and center,” said HHS Secretary Robert F. Kennedy, Jr. “This committee will help us shift from a sick care system to a true health care system by delivering practical solutions that drive real change.”
    • “We received an overwhelming response from highly qualified candidates across the country,” said CMS Administrator Dr. Mehmet Oz. “These members bring deep expertise across care delivery, financing, innovation, and patient engagement. Their insights will help us advance higher-quality care, reduce administrative burden, and strengthen the sustainability of our programs, while supporting efforts to transform our healthcare system and restore a stronger focus on patients.” * * *
    • “The Committee will convene its first meeting later this year. Additional information, including meeting notices and opportunities for public engagement, will be published in the Federal Register and on the CMS website.
    • “For more information, visit: www.cms.gov/priorities/healthcare-advisory-committee/overview“
  • Federal News Network tells us,
    • “Thrift Savings Plan participation is at an all-time high — and nearly 90% of Federal Employee Retirement System (FERS) participants are contributing enough to receive a full match from the government. The TSP board is also reporting that participant satisfaction with the agency’s customer service center is at nearly 94%. Satisfaction scores have remained at that level, now for more than a year. (Federal Retirement Thrift Investment Board – TSP monthly report, March 2026)”

From the judicial front,

  • Bloomberg Law reports,
    • “The government can lawfully limit federal health carriers from covering certain gender transition procedures, the EEOC said in a new ruling.
    • “The Republican-controlled commission on Thursday rejected claims from a group of transgender current and former federal employees that the Office of Personnel Management’s health coverage policy violated anti-discrimination laws. 
    • “The ruling in Sam T. v. Kupor adds to the Equal Employment Opportunity Commission’s efforts under the Trump administration to chip away at transgender rights in the private and federal sectors.”
  • An OPM news release adds,
    • “The EEOC’s landmark ruling reinforces OPM’s duty to manage the FEHB Program responsibly and protect taxpayer-funded benefits for federal employees and retirees,” Associate Director for Healthcare and Insurance Shane Stevens said. “Federal health benefits must be administered in a way that is fiscally responsible, legally sound, delivers high-quality care, and works toward improved health outcomes.”
  • The next step for this lawsuit is federal district court.
  • The Wall Street Journal relates,
    • “The Justice Department filed an antitrust lawsuit against the prominent hospital system NewYork-Presbyterian, alleging that it used restrictions in its contracts with insurers to limit price competition and block lower-cost healthcare options.
    • “The suit, first reported by The Wall Street Journal, was filed Thursday in the U.S. District Court for the Southern District of New York. It is the latest development in a broader Justice Department effort focused on whether hospital systems use hidden contracts to protect their market position and maintain high prices.”

From the public health and medical / Rx research front.

  • The American Hospital Association News reports,
    • “An American Heart Association study published March 25 found that children born to mothers with premature placental separation could be at higher risk of heart disease by age 28. They also are nearly three times more likely to be hospitalized for heart-related complications, such as heart failure, ischemic heart disease, heart attack, blocked arteries or general cardiovascular disease. The study examined nearly three million pregnancies and found that approximately 1% were impacted by placental abruption. Although limited in scope and not focused on interventions, the study highlights the importance of postpartum and postnatal monitoring for maternal and infant complications.” 
  • The Washington Post points out “five things you need to know about meningitis.”
    • “Two people died in an outbreak of bacterial meningitis in England. The infection, which is rare, requires prompt medical treatment to avoid severe complications.”
  • MedPage Today tells us,
    • “After peaking at over 185,000 courses in 2015, prescriptions for direct-acting antivirals (DAAs) for hepatitis C virus infections dropped 63% by 2025.
    • “While those older than 61 years accounted for over 40% of DAA-treated patients in 2015, that percentage shrank to roughly 25% by 2025.
    • “Specialists wrote two-thirds of DAA prescriptions in 2015, but their share fell to 28% by 2025.” * * *
    • “These are “sobering numbers” that reflect the need for a national HCV elimination plan such as the Cure Hepatitis C Act of 2025, Debika Bhattacharya, MD, of the University of California Los Angeles, told MedPage Today. “We must expand access to DAAs.”
  • and
    • “Patients with a history of depression or anxiety were less likely to see their mental health decline while on GLP-1 medications.
    • “The link between GLP-1 drug use and lower risk of psychiatric decline was more pronounced for semaglutide than for other agents.
    • “The data may allay prior concerns about suicidality, which prompted an FDA investigation in 2023.”
  • and
    • “Alzheimer’s can be detected early with p-tau blood biomarkers, but some tests can lead to overdiagnosis.
    • “Combining p-tau217 and eMTBR-tau243 may refine diagnostic accuracy and reduce false-positives.
    • “Plasma eMTBR-tau243 also could help identify people with high tau burden.”
  • NPR adds,
    • “Babies under 6 months old still have one of the highest rates of hospitalization from COVID-19 infections compared to other age groups, but no COVID vaccine is available for these infants.
    • “That’s one reason the American College of Obstetricians and Gynecologists, or ACOG, recommends COVID vaccination during pregnancy.
    • “There are a number of studies that show one of the benefits of COVID vaccination during pregnancy is the passage of antibodies to the newborn, and then that protects the newborn against COVID,” says Dr. Kevin Ault, a professor of obstetrics and gynecology at Western Michigan University Homer Stryker M.D. School of Medicine in Kalamazoo, Mich.”

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

  • MedCity News reports,
    • “Affordability is top of mind for executives at AHIP as Americans battle skyrocketing healthcare costs.
    • “We are laser-focused on affordability at AHIP,” said Mike Tuffin, president and CEO of AHIP. “That’s, of course, the issue at every kitchen table. … We see the cost of hospital care, certainly the cost of brand prescription drugs, specialty care, imaging, down the line, just continuing to rise faster than wages, faster than inflation. That’s driving up premiums across all markets. Premiums directly reflect the underlying cost of medical care.”
    • “Tuffin made these comments during a press briefing on Tuesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. AHIP is an advocacy organization for health insurers.
    • “As for what’s leading to the rising cost of care, Tuffin pointed the finger at hospital consolidation, as well as actions by drug manufacturers like patent thickets (in which there is a dense web of multiple patents around one medication). 
    • “Tuffin added that AHIP is focused on improving affordability across four zones:
      • “More competition, especially for prescription drugs, and addressing hospital consolidation
      • “Site of service reforms, and increasingly using the home as a site of service. According to Tuffin, too much care is delivered at the costliest sites of care, like the emergency room
      • “Tackling administrative burden, as the healthcare system is still “far too dependent on fax machines”
      • “Aligning incentives around patient care outcomes and driving value across the system.”
  • The Wall Street Journal assesses the “Weight Loss Drug Frenzy: What’s Here and What’s Likely Coming Next.”
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • Beckers Payer Issues relates,
    • “Centene has named Kate Casso senior vice president of finance operations and innovation and Theodore Pienkos corporate controller and chief accounting officer.
    • “Ms. Casso has been with Centene for more than two decades and has served as the company’s corporate controller and chief accounting officer since April 2021, according to a March 24 regulatory filing. 
    • “Ms. Casso will focus in part on enterprise and finance innovation while continuing to lead data analytics, medical economics, payment integrity, finance shared services and financial planning and analysis. 
    • “Mr. Pienkos has been with Centene since 2011 and has served as the company’s deputy corporate controller since August 2024. He previously served as vice president of finance and accounting.
    • “Both appointments were effective March 18.”
  • BioPharma Dive informs us,
    • “Merck’s deal for Terns [mentioned in yesterday’s FEHBlog post] sparks debate over a possible biotech bidding war
    • “Some analysts argue the $6.7 billion offer undervalues biotech’s lead cancer drug, although investors may be happy with one-year returns.”
  • and
    • “Shares of Maze Therapeutics, a San Francisco-area biotechnology company, fell over 30% Wednesday despite positive clinical trial results for a progressive kidney disease drug that could potentially compete with a rival therapy from Vertex Pharmaceuticals.
    • “Maze said that, in a mid-stage trial, treatment with its experimental drug, “MZE829,” led to a “clinically meaningful” reduction of protein levels in urine by an average of almost 36% in people with a kidney disease caused by mutations in a gene called APOL1. Maze said it will continue enrollment for its Phase 2 trial and plans to meet with regulators to advance MZE829 into pivotal testing for AMKD, or APOL1-mediated kidney disease.
    • “Full results from the Phase 2 trial will be presented at a future medical conference, Maze added.”
  • Beckers Payer Issues informs us that “UnitedHealthcare has launched Avery, a generative AI companion that helps members navigate healthcare services.”
  • Health Exec adds,
    • “U.S. patients wait an average 31 days to see a doctor, so it’s no wonder 65% of surveyed consumers have consulted AI specifically because it’s faster and easier.
    • “Meanwhile 77% of clinicians appreciate the technology’s contributions to healthcare—yet 1 in 5 patients have tried to hide their use of AI from their doctors. 
    • “Most who admit to the secrecy chalk it up to a fear of being judged. 
    • “The findings are from a survey report released March 24 by Zocdoc, a digital appointment-booking service that has markedly increased its use of AI.”
  • Fierce Healthcare notes,
    • “OpenEvidence released an artificial intelligence-powered medical coding feature embedded in its clinical AI assistant.
    • “The new feature, called Coding Intelligence, provides automatic Current Procedural Terminology (CPT) code suggestions, evaluation and management (E/M) level recommendations with supporting medical decision-making rationale written directly into the note and ICD-10 diagnoses, according to the company.
    • “The tool, available in OpenEvidence Visits, provides coding derived from the clinical documentation and it automatically applies at the end of every doctor-patient visit, executives said.
    • “Without any extra work, OpenEvidence is able to generate concise rationale for their CPT + E/M suggestions. It truly captures the complexity of the encounter and saves me hours when I’m at the ER,” said Ania Bilski, M.D., vice president of clinical AI at OpenEvidence.”

Midweek report

David Ermer–CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
  • Federal News Network reports,
    • “Following more than a year of sweeping reductions across the federal workforce, Office of Personnel Management Director Scott Kupor told House lawmakers on Wednesday that he would be open to hiring more federal employees — with one crucial caveat.
    • “Kupor said he would be “perfectly happy” to see an increase in federal workforce staffing if it meant that the number of federal contractors went down. The OPM director described contractors as a “shadow” workforce and argued that creating that type of shift would save taxpayer costs and improve government services.
    • “Contractors, I think, can be very valuable where you have temporary assignments, or you have skill gaps where potentially the government can’t recruit those,” Kupor told the House Appropriations Committee’s subcommittee on financial services and general government. “Instead, we have people who are contractors for five, 10, 15, 20 years. They are basically full-time employees in disguise, and they get paid anywhere from 25% to 100% higher than what a federal employee would.”
  • Payment accuracy.gov commends OPM for being one of the three highest performing agencies. OPM’s annual agency financial report for FY 2025 (p. 112) adds the following detail
    • “In FY 2025, FEHB ERC [experience rated carriers, which includes all nationwide plans] activity is reporting a statistically valid improper and unknown payment estimated amount and rate. The ERC activity reports one year in arrears, based on the time necessary to collect, test, report and aggregate the data. Because the ERC activity reports in arrears, PSHB data is not included in the IP estimate being reported in 2025.
    • “Independent public accountants (IPAs) provide the data by conducting sampling, testing and reporting of transactions performed by carriers as required in the Financial Reporting and Audit Guide’s Agreed Upon Procedures.” * * *
    • Based on the results of the sampling and testing for 2024, the FEHB ERCs properly paid 99.86 percent of payments. The FEHB ERCs had an improper and unknown payment rate of 0.14 percent.
  • That information shows that carriers have strong controls over benefit payments.
  • The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20. 
  • The Wall Street Journal points out,
    • “Indiana is barring Piece by Piece Autism Centers from billing its Medicaid program after a Journal article detailed the company’s practices.
    • “Piece by Piece received the highest per-patient payments in 2023, averaging $340,000, in part by raising list prices up to $640 an hour.
    • “Indiana’s Medicaid director, Mitch Roob, issued an ultimatum to providers to self-report abuses by April 3 or face federal scrutiny.”
  • Modern Healthcare relates,
    • “The Republican congressional majority is weighing further cuts to health programs a year after taking $1 trillion out of the system.
    • “The GOP would use an expedited process called budget reconciliation to prevent Senate Democratic filibusters.
    • ‘The measure could be a vehicle for cuts that didn’t make it into last year’s tax law and for President Donald Trump’s health proposals.
    • “Trump’s demands for Iran war funding and voting restrictions provide the GOP with an opportunity to advance more spending cuts.”
  • Federal News Network further notes,
    • “The U.S. Postal Service is adding a temporary surcharge to most of its standard package shipping options, citing higher fuel and transportation costs.
    • “USPS told its regulatory agency on Wednesday that it plans to implement an 8% across-the-board increase in prices for its core package and shipping services on April 26, and would remain in place until Jan. 17, 2027.
    • “At that time, the Postal Service can determine if a different long-term approach is needed,” USPS said in a press release.
    • “Previously, USPS has only sought limited-time price increases on its package services during its busy holiday peak season, which runs from October through December. But agency officials told the Postal Regulatory Commission that this surcharge is now necessary to account for the higher cost of fuel and contracted transportation services.”
  • Beckers Hospital Review tells us,
    • “The White House has delayed nominating a new CDC director, allowing Jay Bhattacharya, MD, director of the National Institutes of Health, to continue leading the agency past the March 26 deadline, The Washington Post reported March 25.
    • “Dr. Bhattacharya has served as acting CDC director since Feb. 18. Although he will no longer hold that title due to federal rules, he will retain authority over the agency’s delegable duties, an HHS spokesperson told the Post.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20.” 
  • Fierce Pharma relates,
    • “The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates.
    • “In approving Denali’s tividenofusp alfa, now known as Avlayah, the FDA has greenlit the first treatment for Hunter syndrome that can address the condition’s pernicious cognitive symptoms. 
    • “Avlayah is the first product approved to address neurologic complications of Hunter syndrome,” Tracy Beth Høeg, M.D., Ph.D., acting director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a March 25 release. “This accelerated approval was based on a surrogate endpoint: reduction of cerebrospinal fluid heparan sulfate, which the review team determined was reasonably likely to predict Avlayah’s clinical benefit.”
  • and
    • “With a new U.S. green light in certain ovarian cancer patients, Corcept Therapeutics has redeemed its lead asset relacorilant after stumbling at the finish line in a separate indication late last year. 
    • “The FDA has given the all-clear to Corcept’s class-first selective glucocorticoid receptor antagonist (SGRA) to treat adults with platinum-resistant ovarian cancer. Patients must have tried one to three prior lines of systemic treatment, at least one of which had to include bevacizumab (Avastin). 
    • “The FDA approval covers a regimen of relacorilant, to be sold as Lifyorli, alongside the chemotherapy nab-paclitaxel (Abraxane), according to a March 25 press release. The drug is taken orally the day before, of and after treatment with the regimen’s chemotherapy component, Corcept explained.” “

From the public health and medical / Rx research front,

  • Infectious Disease Advisor relates,
    • “The high rate of persistent physical and psychosocial sequelae of mpox suggests clinicians should consider screening affected individuals for symptoms of depression as well as social and occupational disruptions following acute illness.”
  • Health Day adds,
    • “New fathers might be proud poppas, but their mental health might be shaky as they adapt to their increased responsibilities, a new study says.
    • “Men have a 30% increased risk of depression and stress disorders by the end of their first year of fatherhood, researchers reported March 23 in JAMA Network Open.
    • “This follows a mental health boost among men during pregnancy and the first few months following birth, researchers found.”
  • Healio tells us,
    • “Limiting sedentary time and increasing light-intensity physical activity may reduce risk for developing a hypertensive disorder of pregnancy, according to study findings.
    • “Clinicians should consider counseling pregnant patients not only about exercise, but also about their everyday movement patterns. Based on our findings, limiting sedentary time to no more than 10 hours per day, and ideally closer to 8 hours, may help reduce the risk of developing a hypertensive disorder of pregnancy. Encouraging frequent light-intensity movement throughout the day appears to be an important and achievable target for improving pregnancy health,” Kara M. Whitaker, PhD, MPH, FAHA, associate professor in the department of health, sport and human physiology at University of Iowa, told Healio.”
  • Pharmacy Time adds,
    • “Compositional modeling of sedentary time, light activity, moderate-to-vigorous physical activity (MVPA), and sleep quantified insulin-resistance impacts of time reallocation while adjusting for sociodemographic and seasonal covariates. 
    • “Replacing 30 sedentary minutes with MVPA correlated with approximately 15% lower the homeostatic model assessment of insulin resistance, a clinically meaningful shift in a validated proxy for type 2 diabetes risk. 
    • “Shifting sedentary time to sleep also improved insulin resistance, supporting sleep duration as a metabolic cotarget alongside physical activity in adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck MRK has reached a nearly $6 billion cash deal to buy the cancer biotech Terns Pharmaceuticals TERN and its promising leukemia treatment.
    • If it proves to work safely, the experimental drug would give Merck a boost as the company prepares for its top-selling drug, Keytruda, to lose patent protection [in 2028].
    • Under the terms, Merck would pay $53 a share for Terns, Merck said Wednesday. The deal is worth $5.7 billion including the cash that Terns has on hand.” * * *
    • “Merck said it expects the deal to close by the end of June and result in a second-quarter charge of about $5.8 billion, or about $2.35 a share.”
  • MedTech Dive relates,
    • “Thermo Fisher Scientific said Tuesday that it has closed the $8.9 billion takeover of Clario, expanding its capabilities for handling clinical trial endpoint data.
    • “The buyout, which was announced in October, gives Thermo Fisher a platform for capturing and managing safety data, efficacy results and patient-reported outcomes in clinical trials.
    • “Thermo Fisher will integrate Clario’s platform with its existing capabilities for analyzing biological samples to create a high-growth business, CEO Marc Casper said at a recent investor event.”
  • BioPharma Dive informs us,
    • “Sarepta Therapeutics shares jumped 25% Wednesday morning after the company unveiled promising early clinical data for two medicines that it gained rights to through a deal with Arrowhead Pharmaceuticals worth more than $1 billion.
    • “The experimental drugs, dubbed SRP-1001 and SRP-1003, aim to treat two rare, genetic conditions that cause dangerous muscle deterioration. The therapies work by delivering small interfering strands of RNA, or siRNA, into muscle tissue to target the genetic abnormalities.
    • “Results from two Phase 1/2 studies released Wednesday show both medicines achieved high muscle concentrations without severe side effects, according to Sarepta. The company said it also has proof-of-concept data showing these treatments can hit their genetic targets.”

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

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

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

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

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

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Sen. Markwayne Mullin (R., Okla.) won confirmation to replace Kristi Noem as the next secretary of the Department of Homeland Security.
    • “The final vote Monday night was 54-45 with Sen. Rand Paul (R., Ky.) voting against him over a personal dispute, and Sens. John Fetterman (D., Pa.) and Martin Heinrich (D., N.M.) breaking with all other Democrats to support the Trump nominee.” * * *
    • “Mullin will inherit a department that has been shut down for more than a month over Democrats’ concerns about Immigration and Customs Enforcement’s tactics. Though ICE has continued to operate with money from Republicans’ One Big Beautiful Bill, employees who work other parts of the DHS, such as the Transportation Security Administration, have gone without pay.
    • “Mullin will likely help the administration negotiate with Democrats to reopen his agency. The administration deployed ICE agents to several U.S. airports Monday to help manage long security lines.”
  • Beckers Payer Issues reflects on the 16th anniversary of then President Barack Obama signing the Patient Protection and Affordable Care Act into law.
  • The American Hospital Association News tells us,
    • “The Workgroup for Electronic Data Interchange announced that it is conducting a survey on how health care providers are implementing good faith estimates for uninsured and self-pay individuals under the federal No Surprises Act. The deadline for responses is March 31. WEDI said responses are anonymous and that the data is being collected for informational purposes only.” 
  • Beckers Hospital Review brings us up to date on the prescription drugs available for purchase for cash paying customers on TrumpRx.gov.
  • OPM announced,
    • “The Office of Personnel Management (OPM) withdraws a proposed rule to amend its Freedom of Information Act (FOIA) regulations published on July 24, 2008. [That’s not a typo.] Due to the time that has elapsed, OPM is withdrawing the proposal. OPM will propose amendments to its FOIA regulations in future rulemaking.”

From the Food and Drug Administration front,

  • Fierce Pharm reports,
    • “A common drug combo for Parkinson’s disease will require a new FDA warning after the agency flagged 14 cases of seizures in patients using the medications. 
    • “The agency is mandating (PDF) that drugmakers marketing products incorporating levodopa and carbidopa update their prescribing information to note that the drugs can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures. Healthcare providers should evaluate patients’ baseline vitamin B6 levels prior to and during treatment and supplement patients with the vitamin as necessary, the warning says.
    • “The label update affects Amneal’s Crexont and Rytary; Avion Pharmaceuticals’ Dhivy; Merck’s Sinemet and controlled-release Sinemet CR; Novartis’ Stalevo; and AbbVie’s Duopa. Also affected is AbbVie’s newer Vyalev, a subcutaneous treatment that delivers prodrugs of carbidopa and levodopa via an infusion pump system. Vyalev’s ingredients of foscarbidopa and foslevodopa are drug derivatives of carbidopa and levodopa that become active after entering the body.” 
  • The Wall Street Journal relates,
    • “An experimental Lyme disease vaccine from Pfizer PFE and Valneva VLA didn’t conclusively succeed in a large study, raising questions about the shot’s prospects.
    • “While the shot was more than 70% effective at preventing the tick-borne disease in the trial, not enough people contracted the disease for the findings to be conclusive. Pfizer is pushing ahead with its plans to seek regulatory approval anyway, saying the study hit a different statistical measure and the shot showed “meaningful efficacy.” * * *
    • “The vaccine, if approved, would provide a much-needed addition to the arsenal against Lyme disease. The tick-borne disease has been spreading across the U.S., but there have been few good medical options beyond antibiotics. A vaccine was pulled two decades ago after questions about its safety hurt demand.
    • “No safety concerns were identified in Pfizer and Valneva’s 9,400-person trial. Annaliesa Anderson, Pfizer’s chief vaccines officer, called the study’s results “highly encouraging” and said it “creates confidence in the vaccine’s potential to protect against this disease that can be debilitating.”

From the public health, medical and Rx research front,

  • Cardiovascular Business tells us,
    • “Giving patients tirzepatide early on after an acute myocardial infarction (AMI) or stroke is associated with several benefits, according to new findings published in The American Journal of Cardiology. The study exclusively enrolled patients with no history of diabetes.
    • “Tirzepatide is a popular dual GIP/GLP-1 receptor agonist sold by Lilly under the brand names Zepbound and Mounjaro. It was originally developed for patients with type 2 diabetes. Like other GLP-1 drugs, tirzepatide is starting to be evaluated for more and more uses in patients with and without type 2 diabetes.
    • “Evidence supporting the use of tirzepatide in patients without diabetes, particularly in the early period following AMI or ischemic stroke, is limited,” wrote first author Ibrahim Mortada, MD, a researcher with The University of Texas Medical Branch, and colleagues. “Patients in the post-event setting represent a high-risk population in whom early intervention may modify long-term cardiovascular and cardiorenal outcomes, yet randomized data evaluating tirzepatide for secondary prevention in this context are lacking.”
  • The American Medical Association lets us know what doctors wish their patients knew about social media’s health impact.
  • MedPage Today reports,
    • “A sharp increase in the number of young people hospitalized with eating disorders immediately after the onset of the COVID-19 pandemic was followed by decreases, returning to pre-pandemic levels 5 years later.
    • “The cross-sectional study included 8- to 25-year-olds hospitalized for eating disorders at 41 pediatric hospitals across the U.S.
    • “Further research is needed to understand the increase and the subsequent return to normal.”
  • and
    • “An EEG-derived brain age index predicted dementia risk across five cohorts.
    • “Each 10-year increase in the brain age index was linked with a 39% higher dementia risk.
    • “The findings indicate that the predictive value of the index should be further assessed, the researchers said.”
  • Health Day relates,
    • “Doctors often stop prescribing ADHD stimulants once a patient is diagnosed with a substance use disorder
    • “Treating ADHD in young adults with addiction issues was tied to 30% lower risk of death over five years
    • “Proper ADHD medication led to significantly fewer emergency room visits, hospitalizations and suicidal thoughts.”
  • Genetic Engineering and Biotechnology News points out,
    • “A new Nature Biotechnology paper describes the process of engineering a lab-grown esophagus that can safely replace a full section of the native organ and restore normal functions, including swallowing, in a growing animal without requiring immunosuppression. The paper, which is titled “Functional integration of an autologous engineered esophagus in a large-animal model,” describes “an integrated strategy to engineer a 2.5-cm esophageal segment by microinjecting autologous pericyte-like myogenic precursors and fibroblasts in a decellularized porcine scaffold to repair circumferential defects in 10-kg minipigs … modeling pediatric use.” 
    • “According to scientists from Great Ormond Street Hospital (GOSH) and University College London (UCL) who led the study, their work demonstrates for the first time that a donor pig esophagus can be decellularized, repopulated with the recipient pig’s own cells and implanted in a growing, large-animal model. Other studies have previously shown parts of this technology but this marks the first time that the full process has been completed with this level of success, they said.
    • “Importantly, this development is a major leap towards creating personalized regenerative treatments for children born with life threatening esophageal conditions. Specifically, it could benefit children born with a condition called long-gap esophageal atresia (LGOA). People with this condition have an interrupted esophagus with a wide gap between the upper and lower segments. Patients cannot survive without surgery, but the gap is often too large to close immediately after birth. As a work around, babies with LGOA typically have a feeding tube placed directly into their stomach, so that they can receive adequate nutrition while their hospital teams develop a treatment plan.”

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

  • Per a Cigna news release,
    • “Cigna Healthcare, the health benefits division of The Cigna Group (NYSE: CI), today announced that Dr. Stanley Crittenden has joined the organization as Chief Medical Officer. Dr. Crittenden will lead Cigna Healthcare’s clinical organization, advancing initiatives that deliver personalized, high‑quality, affordable care and an exceptional experience for customers and clinicians across the health care system.
    • “Dr. Crittenden will oversee the evolution and implementation of Cigna Healthcare’s clinical solutions and programs, leveraging data and analytics to deliver innovative solutions for clients. Partnering with leaders across The Cigna Group, Dr. Crittenden will help advance the company’s commitments. to providing easier access to care and simplifying the health care experience for customers and physicians.”
  • Fierce Healthcare takes “a look at how Optum Rx is using AI to address pharmacy fraud, waste and abuse.”
  • STAT News reports,
    • “Earlier this year the startup Doctronic launched a provocative, first-in-the-nation experiment to renew drug prescriptions with a chatbot. Now it’s refilling its coffers with $40 million in fresh funding.
    • “Doctronic on Monday announced the Series B investment round led by Abstract and Lightspeed Venture Partners. It has now raised $65 million across three funding rounds in less than a year. The company’s core service uses a chatbot to talk to patients about symptoms and health concerns before transferring them to a clinician over telehealth for diagnosis and treatment, for a $39 fee.  
    • “Doctronic, which describes itself as the world’s most popular AI doctor, plans to use the funding to expand hiring to keep up with growth that has progressed at a breakneck pace. The company was founded in 2023 and only started offering a service with human clinicians in January 2025. Now it’s on track to earn more than $10 million in revenue this year and is preparing to launch versions of its technology with partners, including digital health companies, health systems, and payers.” 
  • MedTech Dive notes,
    • “Labcorp has closed a deal to buy assets from Crouse Health’s pathology reference laboratory, the company said Thursday.
    • “As well as completing the acquisition of assets from Crouse’s Laboratory Alliance of Central New York, Labcorp agreed to manage daily operations at the healthcare provider’s inpatient lab.
    • “Labcorp will assume operation of Lab Alliance’s 12 patient service centers, furthering the testing company’s recent deal-driven push to expand its capabilities in New York.”

Weekend Update

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Notable Death

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

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iranian War front,

  • The Wall Street Journal reminds us,
    • “Iran pulled off likely the most significant wartime cyberattack against the U.S. in history, leveraging its hacking powers to cause major disruptions at a global medical-equipment firm that struggled to bring itself back online in recent days.
    • “The attack brought a conflict that until now had been largely confined to the Gulf region to the American homeland and offered a preview of the potential for how Iran may broaden its response to the U.S. and Israeli military campaign.
    • “Stryker, the Michigan-based firm hit in the hack, said it experienced “global disruption” and quickly contained it. The company said it believed the incident had been limited to its internal Microsoft systems. The company added that some hospitals may be experiencing temporary pauses in transmissions of medical data, but that its connected products “are not impacted and are safe to use.” Microsoft hasn’t commented on the hack.”
  • The American Hospital Association News adds,
    • “The Cybersecurity and Infrastructure Security Agency [CISA] March 18 released an alert urging U.S. organizations to harden their endpoint management systems following the March 11 cyberattack against Stryker, a U.S.-based medical technology and supply firm. The attack impacted the company’s Microsoft environment, and Stryker said there was no indication of ransomware or malware. The CISA alert provides various recommendations and resources, as well as best practices for securing Microsoft Intune.”
  • Cybersecurity Dive informs us,
    • “The Department of Justice on Thursday [March 19] said four domains used for Iranian-backed hacking and intimidation of political opponents have been taken down in a court-ordered operation. 
    • “Two of the domains were connected to Handala, the state-linked threat group that authorities confirmed was behind the hack of Stryker, a Michigan-based medical technology giant. 
    • “A partially redacted FBI affidavit did not specifically identify Stryker by name, but the details of the attack match with the circumstances of the same incident.” * * *
    • “The sites were part of a larger effort by Iran’s Ministry of Intelligence and Security (MOIS) to intimidate dissidents, conduct malicious attacks, target Israelis and conduct violent attacks against journalists, according to court records. 
    • “Federal authorities obtained a seizure warrant Thursday, according to the FBI affidavit filed Thursday at U.S. District Court in Maryland.
    • “The FBI seizure is not expected to have a major impact on Handala’s ability to conduct attacks, said the Foundation for the Defense of Democracies (FDD).”  
  • Bleeping Computer offers “a five-step playbook to stop Iranian wiper campaigns before they spread.”

From the cybersecurity policy and law enforcement front,

  • Politico reports,
    • “The White House offered additional immigration enforcement concessions to Democrats Friday evening [March 20] as border czar Tom Homan met a second time with a bipartisan group of senators seeking to end the Homeland Security shutdown, according to lawmakers who attended.
    • “Leaving the private meeting, Republican senators said they hope Democrats respond over the weekend to the Trump administration’s bolstered proposal of immigration enforcement changes meant to address Democratic demands for funding DHS.”
  • The Wall Street Journal adds,
    • “March 27 is a make-or-break day for TSA officers.
    • “If Congress leaves that day for a scheduled two-week recess without reaching a deal to fund the Transportation Security Administration, officers are set to miss more than a month of paychecks.” 
  • Cybersecurity Dive lets us know,
    • “The Trump administration will make sure that new AI technologies are secure by design, a senior U.S. official said on Tuesday. [March 17]
    • “What we are working for in my lane is to ensure that the technical security is not seen as a barrier to that innovation, but is seen as a fundamental piece of the ability to scale it and move it as quickly as possible,” National Cyber Director Sean Cairncross said at an event hosted by the McCrary Institute for Cyber and Critical Infrastructure Security.”
    • “Cairncross addressed the audience in Washington two weeks after the Trump administration released its cybersecurity strategy, a short, high-level document that discussed critical infrastructure protection, emerging technologies and digital deterrence. Cairncross said the government wanted to work closely with the U.S. companies that operate important online infrastructure, including to counter foreign adversaries — but he stressed that the government would be the one conducting offensive operations.”
  • Per a March 12 FBI news release,
    • “The Federal Bureau of Investigation (FBI) is publishing this Public Service Announcement (PSA) to raise awareness of residential proxies, the risks they pose, and steps the public can take to safeguard their devices from becoming part of a residential proxy network. Cyber threat actors use residential proxies to facilitate illicit activities, while obfuscating their true identities and locations by routing internet traffic through home and small business internet networks.”
  • Per a NIST news release,
    • “The Domain Name System (DNS) plays an integral role in every organization’s security posture by translating domain names into IP addresses. It can serve as an enforcement point for enterprise security policy and an indicator of potential malicious activity on a network. A disruption or attack against the DNS can impact an entire organization.
    • “NIST Special Publication (SP) 800-81r3 (Revision 3), Secure Domain Name System (DNS) Deployment Guide, describes the different roles of DNS and gives recommendations for protecting the integrity, availability, and confidentiality of DNS services, including:
      • “The role DNS plays in supporting a zero trust architecture, such as serving as both a policy enforcement point (PEP) and a source of information when evaluating access requests
      • “The role of hosting DNS information (authoritative DNS), including guidance on protecting the integrity and authenticity of DNS information using DNSSEC
      • “The role of recursive DNS, including guidance on protecting the confidentiality of client DNS queries.”
  • Cyberscoop reports,
    • “Three American men were sentenced Friday [March 20] for crimes they committed in furtherance of North Korea’s vast scheme to get operatives hired at U.S. companies, the Justice Department said.
    • “The trio — Audricus Phagnasay, 25, Jason Salazar, 30, and Alexander Paul Travis, 35 — pleaded guilty in November to wire fraud conspiracy for providing U.S. identities to remote North Korean IT workers.”
  • and
    • “A 27-year-old North Carolina man was found guilty of six counts of extortion for a series of crimes he committed while working as a data analyst contractor for a D.C.-based international technology company, the Justice Department said Thursday [March 19].
    • “Cameron Nicholas Curry, also known as “Loot,” stole a trove of corporate data, including sensitive employee and compensation information, which he used to extort his employer, according to court records. Curry ultimately made off with approximately $2.5 million from the victim organization in January 2024.
    • “The insider attack underscores immeasurable risks companies accept when employees, or contractors placed in roles by a third-party recruitment company, as was the case with Curry, are allowed to access sensitive data on a company-owned laptop. Officials did not name the company.”
  • and
    • “Authorities seized infrastructure powering four botnets that hijacked a combined three million devices and launched more than 300,000 DDoS attacks collectively, the Justice Department said Thursday [March 19].
    • The botnets — Aisuru, Kimwolf, JackSkid and Mossad — enabled operators to sell access to the infected devices for various cybercrimes. The aftermath spanned thousands of attacks, including some demanding extortion payments from victims, officials said.

From the cybersecurity breaches and vulnerabilities front,

  • Cyberscoop reports,
    • “Russian intelligence-affiliated hackers have gained access to thousands of users’ messaging apps with a global phishing campaign, the FBI and the Cybersecurity and Infrastructure Security Agency warned in a public service announcement on Friday [March 20].
    • “The high-value targets they’re pursuing include current and former U.S. government officials, political figures, military personnel and journalists, the two agencies said in the joint PSA about the hackers’ attempts to infiltrate commercial messaging applications (CMAs).
    • “The U.S. alert comes on the heels of an earlier warning from Dutch authorities, who said last week that Russian hackers were “engaged in a large-scale global attempt” to take over WhatsApp and Signal accounts. The Dutch warning likewise followed a similar warning from Germany in February.
    • “The U.S. agencies emphasized that the hackers had not been able to bypass end-to-end encryption, instead manipulating users into giving up access. The scheme involves hackers posing as Signal help personnel, then inviting them to click a link or provide verification codes or account personal identification number.”
  • and
    • “Researchers and threat hunters are scrambling to contain a maximum-severity defect in Ubiquiti’s UniFi Network Application that attackers could exploit to take over user accounts by accessing and manipulating files.
    • “The path-traversal vulnerability — CVE-2026-22557 — affects software used to manage UniFi networking devices, including access points, gateways and switches. The vendor disclosed and released patches for the defect in a security advisory Wednesday.
    • “As of this morning, we have not observed any public proof-of-concept exploits or confirmed reports of exploitation in the wild,” Matthew Guidry, senior product detection engineer at Censys, told CyberScoop.
    • “However, because this is a path-traversal vulnerability, the technical complexity for an attacker is typically lower than memory-corruption or buffer-overflow bugs,” he added. “Given that the CVSS 10 rating implies low attack complexity, we anticipate that once the specific vulnerable endpoint is identified, exploitation will be trivial to automate.”
  • Cybersecurity Dive reports,
    • “North Korea’s remote IT worker schemes rely heavily on Western collaborators, an elaborate hierarchy of roles and the extensive use of an open-source messaging application, IBM and the cybersecurity vendor Flare said in a report published on Wednesday.
    • “The new research details the tactics and technologies that North Korean operatives use to trick companies into hiring them and fly under the radar while they funnel their salaries to Pyongyang.
    • “Flare and IBM said the report could help businesses improve their ability to root out North Korean operatives posing as legitimate employees.”
  • and
    • “Threat groups are increasingly targeting critical infrastructure for malicious attacks by using direct access to cyber-physical systems, according to a report released Wednesday by Claroty, a firm that specializes in industrial security. 
    • “These attackers, which often are state-sponsored or hacktivist groups, are abusing virtual network protocol in a majority of cases to gain remote access to exposed internet-facing assets. 
    • “In two-thirds of the tracked incidents, attackers are compromising human-machine interfaces or supervisory control and data acquisition systems, which are used to control various industrial processes in factories and other operational technology environments.” 

From the ransomware front,

  • The Record reports on March 17,
    • “A prominent ransomware gang has taken credit for a devastating attack on the biggest hospital in Mississippi and a large county in New Jersey. 
    • “The Medusa ransomware operation, which experts believe is run out of Russia, said recently it was behind the cyberattack on the University of Mississippi Medical Center (UMMC).” * * *
    • “The hospital fully reopened on March 2, and the Medusa ransomware gang claimed the attack last Thursday, demanding an $800,000 ransom. The hackers threatened to leak data stolen from the hospital by March 20.  
    • “A UMMC spokesperson declined to comment on the ransom threat.   
    • “Experts believe the Medusa operation is based in Russia due to its avoidance of targets in Commonwealth of Independent States, its Russian-language forum activity and the use of Cyrillic script in operational tools.” 
  • Cyberscoop adds,
    • “Ransomware remains a scourge that shows some signs of relenting, but incident responders and threat hunters are busier than ever as more financially-motivated attackers lean exclusively on data theft for extortion.
    • “Attacks that only involve data theft for extortion may not be more prevalent than traditional ransomware when attackers encrypt systems, but momentum is moving in that direction, Genevieve Stark, head of cybercrime intelligence at Google Threat Intelligence Group, told CyberScoop.
    • “When you look at the actors in the English-speaking underground, those actors are almost all just focusing on data-theft extortion right now,” Stark added. This includes groups like Scattered Spider, ShinyHunters, Clop and other groups that have been responsible for some of the largest and farthest-reaching attacks over the past few years.
    • “Google Threat Intelligence Group’s research report on ransomware, which it shared exclusively and discussed with CyberScoop prior to release, underscores how the evolution and spread of cybercrime can cloud a collective understanding of ransomware, or attacks that use malware to encrypt or lock systems.” 
  • eSecurity Planet explains,
    • “Why BYOD Is the Favored Ransomware Backdoor.
    • “80% of ransomware attacks come from unmanaged devices. Explore how BYOD could be ransomware’s favored method and how to protect against attacks.”
  • and
    • “Ransomware’s Opening Play: Target Identity First
    • “Ransomware attackers now target identity systems like Active Directory first. Learn how identity resilience can help you prevent and recover from attacks.”

From the cybersecurity defenses front,

  • Cyberscoop asks,
    • “Can Zero Trust survive the AI era?
    • “As AI increases the speed of cyber attacks, governments and businesses must weigh the tradeoffs that come with deploying semi-autonomous AI agents to stop them.”
  • Cybersecurity Dive adds,
    • “Corporate cybersecurity leaders believe AI will be essential to their missions, but, so far, few are seeing big gains from agentic security products, according to a new EY survey.
    • “With AI governance dominating C-suite agendas, the survey released on Thursday found that companies are making progress in integrating risk management frameworks into their operations, even if those ways of thinking have yet to fully permeate corporate cultures.
    • “The survey findings prompted EY to make four high-level recommendations to businesses still deciding how to adopt and use AI for cybersecurity.”
  • The ISACA Blog considers,
    • “A report by the Neuro-rights Foundation examined the privacy practices of around 30 compelling consumer neuro-technology companies and found that more than 90% relied on vague safeguarding language with no concrete protection of consumers’ neural data. Researchers at Bitbrainreported the possibility of neural signals being captured by attackers using man in the middle attacks, with modified information being readily re-injected since applications do not check the devices they are connected to.
    • “The enterprise security perimeter has now moved beyond networks and terminals into the brain itself as thoughts become potential attack vectors.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–

Happy first day of Spring!!

From Washington, DC

  • Roll Call reports,
    • “Senators are sticking around Washington this weekend after a busy week on the Hill highlighted partisan divides, intraparty friction and growing tension between the two chambers. One thing is clear — everyone is ready for spring break.
    • “The Senate has largely been wrapped up in an extended debate on the GOP’s marquee voter ID legislation, dubbed the SAVE America Act. Debate on the bill began Tuesday and is anticipated to extend through the weekend, at least. 
    • “We’re in through this weekend,” Senate Majority Leader John Thune, R-S.D., said on Fox News on Friday morning. “There will be a vote on this bill. We will find out where everybody stands.” * * *
    • “After Senate appropriators of both parties held a face-to-face meeting Thursday with White House “border czar” Tom Homan — some of the first signs of progress in weeks — Thune set a deadline of next week for resolving the DHS funding standoff.”
  • Bloomberg Law relates,
    • “The Trump administration’s Medicare chief said the version of the program run by private insurers doesn’t do enough to control costs, raising questions about how much the US will pay companies in a crucial upcoming rate update.
    • “Chris Klomp, a top health official at the US Centers for Medicare and Medicaid Services, said the private Medicare Advantage program “does not sufficiently have control of costs,” in remarks at a STAT conference in New York on Thursday.”
  • STAT News adds,
    • “President Trump’s Medicare director said Thursday his team is considering a policy that would automatically enroll Medicare beneficiaries into Medicare Advantage plans, a controversial idea that was touted in the conservative Project 2025 policy blueprint. 
    • “Chris Klomp said the Centers for Medicare and Medicaid Services is mulling the feasibility of models that would either automatically enroll beneficiaries into the private form of Medicare or accountable care organizations, such as those that participate in the Medicare Shared Savings Program. Individuals could still opt into a different insurance arrangement. Right now, people who don’t make a choice are covered by traditional Medicare.
    • “Would either of those, in my view, be superior to a default enrollment into a fee-for-service arrangement, where there’s not this long-term, secular relationship between the beneficiary, the patient, and their provider? Yes,” Klomp said. 
    • “He made the comments in an interview with STAT reporter Mario Aguilar on the sidelines of STAT’s Breakthrough Summit East in New York.”
  • Health Affairs Forefront tells us,
    • “The only truly clear and formally stated goal of the MFN [most favored nation drug pricing] policies is to lower the prices that Americans pay for drugs. How can we begin to evaluate the extent and impact of this kind of change?
    • “It is notoriously difficult to know, precisely, what most Americans “pay” for drugs. We have a complicated system of confidential manufacturer rebates and arrangements with pharmacy benefit managers that often tie out-of-pocket payments to “list” prices that may or may not actually be paid by anyone. People far smarter than I have made careers of shedding light on the cost of drugs in the US, and ultimately, it will be up to them to track whether any person or entity ends up paying less for drugs (and for which drugs) than prior to the policies’ enactment. Until then, Observatory members are watching developments in a few key areas that could influence the reach of MFN policies in the US.
    • “First, they are watching the relationship of the MFN policies to the employer-based insurance market, which covers 160 million people, or more than 50 percent of those with health insurance in the US. To date, MFN policies have been announced for Medicare and Medicaid recipients and for individuals who purchase drugs out of pocket on TrumpRx. But even at discounted prices available through TrumpRx, many drugs will remain too costly for consumers unless they can use the insurance for which they already pay premiums.
    • “The reach of the new, “lower” prices will be limited if there isn’t a mechanism for those with employer-sponsored insurance to access those prices. Part of such “access” includes having purchases through TrumpRx (or other direct-to-consumer platforms) count toward the deductibles and out of pocket maximums that characterize private coverage. Without explicit mechanisms to enable this kind of accounting—or federal or state mandates to require it—the purchase of drugs at the MFN prices will likely be unappealing to more than half of the US population, significantly diluting the policies’ effectiveness and reach. Further, if employer-sponsored health plans cannot access the MFN prices, then those lower prices cannot be reflected in their overall premiums, which consistently rise far faster than both general inflation and wage growth with escalating pharmaceutical costs being an important contributor.”
  • and
    • “As reported by the Centers for Medicare and Medicaid Services (CMS) in supplemental tables and public use files, the volume of cases submitted into the [No Surprises Act Independent Dispute Resolution] IDR process continues to exceed all expectations and grew rapidly in the first six months of 2025. During that period, parties submitted 1.2 million new disputes to the IDR portal—more than double the volume of the first two quarters of 2024 when nearly 590,000 disputes were filed. This amounts to a total of 3.4 million disputes from 2022 through June 2025.
    • “And the number of disputes is only continuing to increase: Even more recent bi-monthly updates from CMS show that nearly 1.4 million cases were filed from July 2025 through December 2025. This has resulted in a whopping 4.8 million total cases through the end of 2025. As a reminder, federal officials expected approximately 17,000 disputes per year.” * * *
    • “Consistent with prior trends, providers continued to initiate (and win) the vast majority of disputes.” * * *
    • Four provider groups and provider representatives—mostly backed by private equity—initiated the majority of these disputes: HaloMD, Team Health, Radiology Partners, and SCP Health. HaloMD—a middleman organization that specializes in arbitration—initiated the most disputes, accounting for 17 percent of all disputes in the first quarter of 2025 and 22 percent of all disputes in the second quarter of 2025. For an organization that initiated a mere 1 percent of line-item claims in 2023, this is a rapid rise to prominence. The second most frequent initiator, Team Health, has long been a high-volume IDR participant and initiated 16 percent of all disputes in the first six months of 2025, a level that is consistent with prior years. Combined, the top four initiators accounted for more than half (56 percent) of disputes filed in the first two quarters of 2025.
    • Providers also won 88 percent of disputes—the highest provider win rate to date—as compared to 85 percent in 2024 and 81 percent in 2023. Radiology Partners prevailed most often, winning favorable IDR awards in 92 percent and 95 percent of its cases in the first two quarters of 2025, respectively. Team Health saw similar win rates of 94 percent across both quarters. HaloMD won slightly less often but still prevailed in 87 percent and 82 percent of its disputes in the first two quarters of 2025, respectively.
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) has finalized the Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures Final Rule (CMS-0053-F).
    • “This groundbreaking final rule establishes the first-ever Health Insurance Portability and Accountability Act (HIPAA)-adopted standards for health care claims attachments, enabling the secure electronic exchange of health care claims-related supporting clinical documentation such as medical records, x-rays and imaging, clinical notes, telemedicine visit documentation and laboratory results.
    • “The rule also establishes requirements for electronic signatures to ensure health care claims attachment transactions are secure, authenticated, and compliant with federal standards.” * * *
    • “Health care providers and payers should begin preparing to implement the finalized standards. This final rule is effective on May 26, 2026. The compliance deadlines for all requirements in this rule are set for 24 months from the effective date of the final rule. Stakeholders are encouraged to review the rule and begin implementing the new standards promptly. The final rule can be viewed at: https://www.federalregister.gov/.” * * *
    • To view the final rule fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/administrative-simplification-adoption-standards-health-care-claims-attachments-transactions.
    • For more information, visit: https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/events-latest-news.
  • PCMA points out,
    • “The Pharmaceutical Care Management Association (PCMA) is urging the Labor Department to roll back a proposed rule aimed at boosting price transparency in pharmacy benefit management relationships now that Congress has passed industry reforms.”
  • Beckers Payer Issues informs us,
    • “Nine percent of people who had ACA Marketplace coverage in 2025 are now uninsured, with healthcare costs as a major reason many enrollees either switched Marketplace plans or dropped coverage, according to a KFF poll. 
    • “The KFF follow-up survey of Marketplace enrollees was conducted Feb. 12 to March 2 and included 1,117 U.S. adults who had Marketplace insurance in 2025. The sample was drawn entirely from respondents to KFF’s original 2025 Marketplace survey, which included 1,350 participants.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA issued a safety communication today warning of a potential increased risk of seizures tied to certain medications used to treat Parkinson’s disease.
    • “The agency will require manufacturers of carbidopa/levodopa products to update their labels with clearer warnings, to better inform patients and clinicians of this risk. The revised prescribing information will specify that these medications can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures.
    • “The warning also instructs healthcare professionals to assess baseline vitamin B6 levels before initiating carbidopa/levodopa therapy and to monitor these levels periodically during treatment, supplementing with vitamin B6 as needed.”
  • MedTech Dive adds,
    • “Intuitive Surgical has recalled stapler reload cartridges after receiving reports of four serious injuries and one death.
    • “The Food and Drug Administration communicated the recall in an early alert Wednesday, one week after Intuitive asked customers to quarantine and return all affected and unused reloads.
    • “An Intuitive spokesperson said in an email to MedTech Dive that the company is still investigating the root cause of rare reports of incomplete staple lines when using the recalled 8 mm SureForm gray reload cartridges.”
  • Fierce Pharma relates,
    • “Rhythm Pharmaceuticals is switching up the tempo for its melanocortin-4 receptor (MC4R) agonist Imcivree. After its initial approval more than five years ago to treat certain patients with genetic-driven obesity, the drug is moving into a different and broader realm with an FDA nod for acquired hypothalamic obesity (HO). 
    • “Acquired HO, for which Imcivree is the first approved treatment, represents an “expanded thinking” on the weight-regulating MC4R pathway that Rhythm’s product targets, Chief Scientific Officer Alastair Garfield, Ph.D., explained in a recent interview with Fierce. 
    • “Until now, all of Imcivree’s approved uses have centered around specific genetic causes. HO, on the other hand, is a result of a hypothalamic injury such as a tumor or stroke that impairs the MC4R pathway and causes weight gain and insatiable hunger (hyperphagia).”
  • Per an FDA news release,
    • “As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program. The agency also announced a public hearing on June 12, to allow stakeholders to present information and views about the program.
    • “The public hearing, consistent with 21 CFR § 15.1 et seq., will seek feedback about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.” * * *
    • “The June 12 public hearing will be held at the FDA’s White Oak Headquarters with both an in-person and virtual option for participation. The FDA panelists will include subject matter experts from the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center of Excellence, as well as a presiding officer. Requests to speak are due by May 1. The FDA is also soliciting written comments until June 27. For more information about the hearing: https://www.fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026.”

From the judicial front,

  • Fierce Healthcare reports,
    • “A federal judge has dealt a blow to the Trump administration’s push to restrict gender-affirming care for minors.
    • “Per the New York Times, Oregon [U.S.] District Court Judge Mustafa Kasubhai ruled Thursday that Department of Health and Human Services Secretary Robert F. Kennedy, Jr. overstepped his legal authority in issuing a declaration late last year that would bar hospitals from providing gender-affirming care to minors if they want to participate in Medicare and Medicaid.” * * *
    • “Restricting access to gender-affirming care for minors has been a key priority for the Trump administration, and NYT reports that legal experts believe Kasubhai’s decision will likely be appealed.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. Seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. COVID-19 activity is decreasing in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing in most areas of the country.
    • “Influenza
      • “Overall seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. Influenza A activity continues to decrease while trends in influenza B activity vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • Vaccination
      • “RSV is a leading cause of hospitalization among U.S. babies.
      • “To help keep babies safe from severe RSV, babies younger than 8 months of age should get protection in their first RSV season (which usually starts in the fall) in one of these ways:
        • “The pregnant mother gets the RSV vaccine during pregnancy, or
        • “The baby gets an RSV antibody (nirsevimab or clesrovimab) just before the start of the RSV season or soon after birth, if born during the season.
      • “A CDC report showed that these protections are working. During the 2024–25 RSV season, infant RSV hospitalization rates were reduced by up to half compared to rates during seasons before when RSV prevention products were available.
      • “Interim estimates for the 2025–26 seasonal influenza vaccine show getting the vaccine reduced the risk of flu-related doctor visits and hospitalizations, supporting CDC’s vaccination recommendations. For children and teenagers, the vaccine was 38%–41% effective at preventing doctor visits and 41% effective at avoiding hospitalizations for the flu. For adults aged 18 and older, it was 22%–34% effective at preventing doctor visits and 30% effective for preventing hospital stays. Read more here: MMWR.
      • “Talk to your doctor or trusted healthcare provider about what may be recommended for you and your family.”
  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention announced today that there are now 1,487 confirmed measles cases nationwide so far this year. The CDC said 5% of cases have been hospitalized, and no deaths have been reported. The vaccination status of 92% of cases is unvaccinated or unknown. The South Carolina measles outbreak, which began in October 2025 and is currently the largest outbreak of any state, is at 997 cases. Utah, which has the second-largest outbreak, is now at 443 cases.” 
  • Health Day points out,
    • “Psychedelic-assisted therapy (PAT) is no more effective than traditional antidepressants (TADs) for treatment of major depression, according to a review published online March 19 in JAMA Psychiatry.” 
  • Medscape explains how “New Nanoparticles Can Destroy Undruggable Cancer Proteins.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Current schizophrenia (SZ) medications treat symptoms such as hallucinations and delusions, but do little for cognitive symptoms, such as disorganized thinking or executive dysfunction. As a result, many patients are unable to work, rely on family for lifelong support, become homeless or, in some cases, experience suicidal thoughts and actions.
    • “A study in humans and mice, headed by a team at Northwestern University, has discovered a novel biomarker of schizophrenia that could also serve as a new drug candidate to treat cognitive symptoms of the disorder. Their research in a mouse model of schizophrenia showed that treatment with a synthetic protein, SEAD1, corrected overexcited brain circuits. “A lot of people with schizophrenia cannot integrate well into society because of these cognitive deficits,” said Peter Penzes, PhD, professor of neuroscience, pharmacology and psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine. “Our discovery could solve these challenges by establishing the basis of a revolutionary and completely novel treatment strategy through a tandem biomarker-peptide therapeutic approach.”

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

  • BioPharma Dive reports,
    • “Novartis will pay $2 billion up front to acquire a drug that could improve upon existing treatments for patients with a particular form of breast cancer.
    • “Through a deal announced Friday, Novartis will purchase Pikavation Therapeutics, a subsidiary of privately held, Delaware-based Synnovation Therapeutics. The buyout hands Novartis an experimental pill called SNV4818, which targets tumors driven to growth by mutations to the PIK3CA gene. Alterations to this gene are implicated in a wide variety of cancers, including an estimated 40% of patients whose breast tumors are hormone-receptor positive, but don’t express the protein HER2, according to Novartis.”
  • Healthcare Innovation relates,
    • “Mary Bacaj, president of value-based care at Conifer Health Solutions, recently spoke with Healthcare Innovation about misconceptions around preventive care. She argues [in the interview found in the article] that self-insured employers should take a multi-year approach to assessing ROI rather than taking a single-year snapshot.” Check it out.
  • Beckers Hospital Review identifies and discusses six healthcare systems which are innovating primary care models to expand care.
  • Kaufman Hall informs us,
    • “Healthcare bankruptcy filings decreased for a second consecutive year, according to a recent report from Gibbons Advisors. The report finds a 21% decline in bankruptcy filings year-over-year, with the bulk of the 45 filings in 2025 occurring in the first quarter. The bankruptcy activity appears to be tempering, adjusting to pre-pandemic trends. By sector, senior care and pharmaceuticals comprise about half of the bankruptcies, with hospitals only accounting for 13.6% of all healthcare bankruptcy filings in 2025.”
  • The Withum CPA and consulting firm delves into “Artificial Intelligence and the Rise of Duplicate Claims: What Plan Sponsors Should Understand.”
    • “Artificial intelligence is fundamentally changing how healthcare claims are generated, submitted, and processed. As these technologies mature, both claim volume and complexity are likely to increase, placing additional pressure on traditional payment-integrity controls.
    • “While duplicate and near-duplicate claims are a visible result of this shift, AI also affects other aspects of the payment-integrity lifecycle, including coding accuracy, claim edits, resubmission behavior, and post-payment recovery.
    • “For plan sponsors, the question is no longer whether AI will influence claims administration, but whether current oversight frameworks have evolved to address these broader changes. Understanding duplicate-claim risk, evaluating vendor controls across the payment-integrity continuum, and ensuring transparency are increasingly important for prudent fiduciary governance in an AI-driven claims environment.
    • “As AI continues to reshape healthcare billing and claims processing, plan sponsors should periodically reassess whether their oversight frameworks and vendor controls remain aligned with an increasingly automated claims environment.”

Thursday report

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

From Washington, DC

  • Fierce Healthcare reports,
    • “Leading Senate Democrats are outlining their own healthcare policy priorities as they look to develop plans that could counter changes proposed by the Trump administration and included in the One Big, Beautiful Bill Act.
    • “In a letter (PDF) led by Finance Committee Ranking Member Sen. Ron Wyden, D-Oregon, the 12 senators establish three goals that will define their policymaking endeavors: reversing Republican policies that may drive up costs, simplifying the healthcare experience and taking on corporate profiteering.”
  • and
    • “Insurers and hospitals have come together to rebuke a Trump administration proposal to roll back limits of plan designs that may be listed on the Affordable Care Act’s (ACA’s) exchanges. 
    • “In February, the Centers for Medicare & Medicaid Services (CMS) included in its Notice of Benefit and Payment Parameters for 2027 Proposed Rule a plan to allow some non-network plans to obtain qualified health plan (QHP) status, which is necessary to be listed. 
    • “Non-network plans refer to offerings that do not have contracts in place with providers outlining specific services and rates, or conditions outlining different benefits for enrollees based on whether a provider is in network. CMS proposed that such plans could still obtain QHP status for plan year 2027 if they can ensure access to multiple providers who accept the non-network plan’s benefit amount as full payment.” * * *
    • “The plan does not appear to have landed with industry groups. In a rare move, groups representing health plans (AHIP, Association for Community Affiliated Plans and Alliance of Community Health Plans) as well as hospitals (Federation of American Hospitals and America’s Essential Hospitals) crossed the aisle to submit a joint comment letter to CMS calling on the administration to rethink its approach.”
  • Insurance NewsNet tells us,
    • “A new National Association of Insurance Commissioners working group aims to identify policy solutions to rising health care costs and insurance premiums, intending to produce a practical guide for state policymakers by the end of the year.
    • “The Health Care Affordability and Mitigation Working Group met for the first time last week. Members discussed a 2026 work plan, outlining a fast-paced schedule to develop affordability recommendations for regulators and lawmakers.
    • “The initiative will focus on examining factors that drive health care costs and insurance premiums, including expenses within the health system that ultimately flow into insurance pricing.”
  • STAT News relates,
    • “Chris Klomp, a top official at the federal health department, offered a reality check on President Trump’s drug discount platform, TrumpRx, while speaking at a STAT event on Thursday. 
    • “Even as Trump has spoken about the platform in grandiose terms, calling it “transformative” and promising the “largest reduction in prescription drug prices in history,” Klomp offered a more measured perspective on stage at STAT’s Breakthrough Summit East event in New York. He said it was never meant to be used by Americans with health insurance — which is the vast majority — and rejected the suggestion that Trump’s drug policies amount to price caps. 
    • “The goal was not actually some massive reach,” Klomp said, adding that “170 million Americans are commercially insured, 68 million Americans are on Medicare, the balance are on Medicaid and CHIP largely. TrumpRx is not for most of them, it’s cash pay.” 
    • “That said, the platform has shown lower prices for GLP-1s and fertility drugs, which often aren’t covered by health insurance, Klomp said. “But for many, your insurance benefit, where you already have insurance coverage, can be just as good so you may as well go there,” he said.” 
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is leading the historic $50 billion Rural Health Transformation Program, partnering with states to strengthen rural health systems, expand access to care, and tackle chronic disease. To advance that work, on March 18, 2026, CMS convened leaders from all 50 states for the first Rural Health Transformation Summit, bringing together state officials and experts to accelerate implementation of the program.
    • “State leaders highlighted practical approaches to strengthening local care delivery — including mobile care units, remote patient monitoring, community-based partnerships, and regional data-sharing platforms designed to improve coordination and expand access close to home. The summit also fostered cross-state dialogue, allowing participants to exchange best practices and build relationships that will support continued collaboration beyond the meeting itself.
    • “Participants emphasized that long-term success would depend on embedding these initiatives into durable financing and workforce structures, including alignment with Medicaid and Medicare payment models  and expansion of rural residency and training programs.”
  • Tammy Flanagan, writing in Govexec, reminds us “how federal retirement benefits have changed over the years.”
    • “From FERS to TSP to recent legislation, decades of policy shifts have reshaped how federal employees earn, save for and receive retirement benefits.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Novo Nordisk NOVO.B said the U.S. Food and Drug Administration approved a higher dosage of its Wegovy weight-loss medication, a boost for the Danish drugmaker as it faces growing competition in the obesity market.
    • “The group said Thursday that the FDA had expedited approval of the Wegovy injection with a higher dose based on results from a trial that showed 20.7% mean weight loss for participants with obesity.
    • “The company said its higher dosage Wegovy medication contains 7.2 milligrams of semaglutide, injected once weekly, and it complements Wegovy’s medication containing 2.4 mg semaglutide. The group expects to offer Wegovy HD in a single-dose pen in the U.S. next month.”
  • The New York Times adds,
    • “The blockbuster weight loss drug sold as Ozempic and Wegovy will soon go generic in countries that are home to 40 percent of the world’s population, significantly lowering the price of a costly medicine that had been largely unaffordable to nearly all but the wealthiest people.
    • “On Saturday, Novo Nordisk, the company that until now has had a monopoly on selling the drug, will lose patent protection in several of the world’s most populous countries. The first generic versions are expected to arrive in India as soon as this weekend. In the coming months, the generics are also expected to become available in China, Canada, Brazil, Turkey and South Africa.
    • “The availability of these drugs, which have been restricted to high-income countries to very wealthy people, will now be democratized by the generics,” said Leena Menghaney, an activist in New Delhi focused on treatment access.”
  • Beckers Hospital Review tells us,
    • “The FDA has launched a nationwide recall of children’s ibuprofen affecting nearly 90,000 bottles due to contamination concerns.
      “The recall involves children’s ibuprofen oral suspension, USP, 100 milligrams per 5 milliters, 4-fluid ounce or 120-milliter bottles manufactured for Taro Pharmaceuticals U.S.A., according to a March 16 FDA enforcement report.
    • “Strides Pharma recalled 89,592 bottles after receiving complaints of a gel-like mass and black particles in the product. The affected lots are 7261973A and 7261974A, with an expiration date of Jan. 31, 2027.
    • “The recall was initiated March 2 and remains ongoing, with products distributed nationwide.
      The FDA designated the event as a Class II recall, meaning exposure may cause temporary or medically reversible adverse health consequences with a low risk of serious harm.”
  • and
    • “The number of active drug shortages has declined sharply since June, according to the FDA’s database.
    • “As of March 19, 76 drugs are in shortage, down from 194 in mid-June.”
    • The article identifies eight recent drug shortages.

From the public health and medical research front,

  • USA Today reports,
    • “People who quit taking popular GLP-1 drugs such as Ozempic might not only gain back lost weight. They also might be jeopardizing their heart health, according to a new report.
    • “A study of Veterans Affairs patients published March 18 found those who quit the weight-loss medication reversed health gains from weight loss and had a higher risk for heart attack, stroke or death.
    • “Researchers tracked more than 330,000 VA patients with Type 2 diabetes over three years who took either a GLP-1 drug or another diabetes medication, sulfonylureas.
    • “Those who steadily took the GLP-1 medications over three years saw an 18% reduction in risk for heart attacks or strokes. Those who quit the medications for six months saw slightly higher risk. Those who halted the weight loss drugs for two years saw their risk rise 22%, according to a study published March 18 in the medical journal BMJ Medicine.”
  • BioPharma Dive adds,
    • “An experimental, triple-acting metabolic drug from Eli Lilly met the main goals of a Phase 3 study in people with Type 2 diabetes, helping treatment recipients significantly cut blood sugar levels and body weight compared to those who got a placebo. 
    • “Lilly said Thursday that the 40-week trial of retatrutide, which targets three gut hormones, showed the two highest doses lowered blood sugar an average of 1.9 percentage points from a baseline average of 7.9%. Those in the placebo arm, by comparison, had a 0.8 percentage point reduction from the study’s start. 
    • “The results are the first from a late-stage study of retatrutide in diabetes. In December, the company disclosed that retatrutide succeeded in a trial in people with obesity and arthritis-related knee pain, findings that were seen by Wall Street analysts as the most striking of any weight loss medication to date. Large studies in obesity are ongoing.” 
  • The American Hospital Association News relates,
    • “A JAMA study published March 18 found that women who experience premature menopause have a 40% higher lifetime risk of coronary heart disease. Approximately 15% of Black women in the study experienced premature menopause compared to about 5% of white women. The study found that Black women had a 41% higher risk of coronary heart disease compared to 39% for white women.” 
  • Medscape tells us,
    • “The American Headache Society (AHS) is recommending annual screening for migraine as part of routine preventive care for girls and women — from adolescence through menopause 
    • “Despite its high prevalence — especially among girls and women — and substantial negative impacts, migraine is “under diagnosed and under treated. Diagnostic screening for migraine enables more patients to receive timely, appropriate, and effective management,” said the guideline authors, led by Todd Schwedt, MD, with the Department of Neurology, Mayo Clinic, Phoenix. 
    • ‘The position statement was published in the February issue of Headache.” 
  • Health Day informs us,
    • “Want to figure out your heart health risk?
    • Look at your belly fat, not your body mass index, a new study says.
    • “Excess fat stored around the waist is more strongly associated with heart failure risk than BMI, an estimate of body fat based on height and weight, researchers will report at a meeting of the American Heart Association.
    • “This research helps us understand why some people develop heart failure despite having a body weight that seems healthy,” lead researcher Szu-Han Chen, a medical student at National Yang Ming Chiao Tung University in Taiwan, said in a news release.
    • “By monitoring waist size and inflammation, clinicians may be able to identify people with higher risk earlier and focus on prevention strategies that could reduce the chance of heart failure before symptoms begin,” Chen said.”
  • and
    • “Wastewater-based epidemiology is feasible as a community-level and population-level surveillance tool for colorectal cancer (CRC), according to a study published online March 17 in the Journal of Epidemiology & Community Health.” * * *
    • “This basic proof-of-concept for a novel wastewater surveillance application to track potential cancer burden demonstrates that CDH1, which is associated with CRC, is detectable in wastewater and may accelerate the field’s development for epidemiological studies,” the authors write. “The finding that CDH1 is detected is promising and needs an expanded research agenda and larger sample size for statistical power to enable more definitive findings.”
  • Medical Economics points out,
    • “Evidence links ZIP code–level poverty to higher utilization, costs, and striking life-expectancy gaps, reframing equity as a clinical and fiscal imperative. 
    • “Effective implementation requires health systems to pair screening with dependable community resources; absent housing, food, or transport supports, identifying needs rarely changes outcomes. 
    • “Grant-funded pilots show scalable models, such as food-pantry cardiometabolic screening clinics that expanded to multiple sites and revealed high rates of prediabetes and diabetes among food-insecure participants. 
    • “Clinicians can start by building trust and asking about social risk with empathy and respect, supporting referrals while recognizing SDOH work as integral to workforce sustainability.”
  • Per Genetic Engineering and Biotechnology News,
    • “The Trillion Gene Atlas, an initiative to generate and model biological data at the trillion-gene scale, has been launched by Basecamp Research in collaboration with Anthropic, Ultima Genomics, and PacBio. Powered by NVIDIA AI infrastructure, the Trillion Gene Atlas aims to expand known evolutionary genetic diversity 100-fold by collecting genomic data from more than 100 million species across thousands of sites worldwide. The initiative, which was unveiled during the Health Track at SXSW and the NVIDIA GTC conference in San Jose, is made possible by Basecamp’s growing network of global biodiversity partners.
    • “The initiative is built on three pillars: large-scale DNA sequencing, global data supply partnerships, and advanced computing. Together with AI systems capable of reasoning across complex data, these foundations can help turn vast datasets into therapeutic discoveries. By increasing the evolutionary data available to AI by another 100x, Basecamp Research aims to make drug design faster and more systematic.”

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

  • Kaufmann Hall reports,
    • “Hospital financial performance is challenged in early 2026 as rising bad debt and continued increases in expenses create ongoing pressure. Navigating this uncertain economic climate requires hospitals to be strategic about where to allocate resources.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.
    • “Key Takeaways
      • “Patient volume in January declined across inpatient and outpatient services. This decline could be due to postponing of elective procedures around the holidays, as well as a change in payer mix.
      • “Bad debt continues to increase. Carrying over from 2025, bad debt and charity care continue to go up.
      • “Expenses continue to put pressure on hospitals. In addition to the persistent increases in drugs and supplies, there was a big increase in labor expenses in January.
  • Radiology Business relates,
    • “GE HealthCare has officially completed its acquisition of imaging software provider Intelerad. 
    • “The health technology giant announced on Wednesday that the $2.3 billion purchase (base price) had been completed. GE previously said that the acquisition was a reflection of its “continued commitment to cloud-enabled and AI-powered solutions.” 
    • “In Wednesday’s announcement, Roland Rott, GE HealthCare’s president and CEO of imaging, shared his enthusiasm for how the move can further advance the company’s mission to improve radiology and data sharing workflows. 
    • “Intelerad’s cloud-enabled software will support GE HealthCare’s imaging technologies and AI capabilities by simplifying complex workflows, and providing patients and customers with more precise, connected care across the continuum,” Rott said. 
    • “Intelerad enhances our ability to deliver a cloud-first enterprise imaging platform at scale,” added Scott Miller, GE HealthCare’s CEO of solutions for enterprise imaging. “Together, we are connecting imaging across care settings with interoperable, AI-enabled solutions that simplify operations, improve clinical insight, and help our customers deliver more precise, personalized care.” 
  • and
    • “Radiologists spot significantly more suspicious lung nodules with the help of artificial intelligence support, a new study suggests. 
    • “New data shared in the American Journal of Roentgenology detail a comparison of interpretation times and detection rates of radiologists both with and without the help of AI. Though the study of AI in lung cancer screening is not new, prior retrospective research has made it challenging for to determine the real-world impact of such tools. This latest study addresses this shortcoming by offering prospective insight into how an AI-based lung nodule detection tool performs in clinical practice for asymptomatic patients undergoing lung cancer screening.” 
  • Modern Healthcare tells us,
    • “Perplexity is making its debut on the consumer health market. 
    • “The artificial intelligence-enabled search engine announced the launch of Perplexity Health, which looks to provide users with personalized responses to health questions.
    • “The AI tool relies on medical literature and user-provided patient records to answer health-related inquiries. It also offers an individualized dashboard with insight on users’ behavioral patterns such as their sleep and activity levels.
    • “Through a partnership with data network b.well Connected Heath, users can give Perplexity Health access to electronic health records from more than 1.7 million providers, the company said in a Thursday news release. Users can additionally integrate data from sources such as Apple Health and Fitbit.
    • “Perplexity Health is available to users of the company’s paid tiers, a spokesperson said in an email.”
  • Per a Google news release,
    • “Last year, we introduced the vision of a personal health coach built with Gemini to move beyond basic metrics and provide truly personalized guidance. Today at The Check Up, our annual health event, we’re taking the next step. We’re introducing significant updates to help you understand and improve your sleep, sharing how we’re advancing health through new research, and integrating clinical history to provide a more comprehensive view of your well-being.
    • We’re launching our most significant update yet, delivering an additional 15% increase in sleep staging accuracy for Public Preview users.
    • Trained on diverse, inclusive datasets, our models now better distinguish between when you are aiming to sleep and when you are asleep. These improvements more accurately capture interruptions, naps and transitions between stages, aligning with clinical gold-standard measurements.” * * *
    • “Starting next month for Public Preview users in the U.S., you’ll be able to link your medical records to the Fitbit app for a fuller picture of your health including your lab results, medications and visit history, all in one place and under your control.
    • “To make this possible, we’re collaborating with partners like b. well and CLEAR. You can search for your healthcare provider and then link to their portal, or simply verify your identity with CLEAR and we will search for records on your behalf. By using IAL2-certified standards — requiring only a selfie and a valid ID — this enhanced security allows the app to automatically locate and sync your records across different providers (availability varies per provider).”

Midweek report

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

From Washington, DC

  • The American Hospital Association News reports,
    • “America’s hospitals and health systems are deeply committed to providing high-quality, accessible and affordable care, AHA President and CEO Rick Pollack March 18 told the House Committee on Energy and Commerce Subcommittee on Health during a hearing focused on lowering health care costs. 
    • “Pollack shared several efforts that hospitals are leading to make care more affordable, including increasing efficiencies, adopting innovative technologies and rethinking how they deliver care. 
    • “Many are investing in preventive care and care coordination programs that help patients better manage chronic diseases, avoid unnecessary hospital visits and stay healthier at home,” Pollack said. “These efforts improve outcomes, and they help lower costs for patients, families and the entire health care system.” * * *
    • “Pollack also said that there is more work to do to make health care more affordable for Americans and outlined several solutions focused on improving the health of individuals and communities; advancing value through care transformation; reducing regulatory and administrative waste; and innovating to improve care quality and outcomes. 
    • “We also know that to truly make care affordable for Americans, all stakeholders, including government, commercial health insurers, drug companies, providers and patients, must work together,” Pollack said.” 
  • MedPage Today relates,
    • “NIH Director — and CDC Acting Director — Jay Bhattacharya, MD, PhD, had little trouble Tuesday responding to questions from House members during an oversight hearing.
    • “While the promise of the NIH is strong, we must reflect upon policies and evolve with changing technology,” Bhattacharya told members of the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. “And reform is already underway. A new office within the [Office of the Director] will support rigorous analysis of the NIH portfolio to strengthen performance management, accountability, and promote reproducibility of our research, because … it’s vital that the research that we do is reproducible, that an independent team looking at the same result find the same answer.”
    • “Committee members on both sides of the aisle seemed generally pleased with the way Bhattacharya was running things.” 
  • Noah Peters, an OPM senior advisor, writing in the OPM Director’s Substack blog, explains why “Modernization is Essential to Effectively Manage the Executive Branch.”
  • The Wall Street Journal tells us,
    • “The Trump administration, which has been skeptical of vaccines that prevent infections, is going all in on a new initiative to deploy novel vaccines against cancer.
    • “The Department of Health and Human Services, through the National Cancer Institute, has initiated a potential $200 million public-private partnership to fund clinical trials of vaccines that spark an immune attack on tumors. These vaccines may ward off cancer in patients who have been treated for the disease, but are at high risk for recurrence. 
    • “Dr. Anthony Letai, who became NCI director in September, said he wants to finance larger trials of vaccines that in smaller studies have shown potential to keep aggressive cancers at bay.
    • “What’s exciting about this is that there are early signals from clinical trials that we can actually have an impact even in some very difficult settings where we have very little to offer patients,” he said. 
    • “Instead of protecting against infection, these vaccines train the immune system to fight tumors. And unlike flu or Covid-19 shots, which are injected into healthy people, these vaccines would be used in patients who have been treated for cancer.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Johnson & Johnson said Wednesday it won Food and Drug Administration approval to sell what it calls a “game-changing” pill to treat psoriasis.
    • “The drug is part of a class of medicines that work by blocking the action of a protein called IL-23, a key player in the body’s inflammatory response. It’s an approach that has proved extremely effective, spurring a generation of blockbuster injectable medicines including AbbVie’s Skyrizi and J&J’s own Tremfya.
    • “J&J’s new entry is the first in the class that can be taken orally, offering patients the convenience of a once-daily pill. The drug, icotrokinra, will be sold as Icotyde and is available to treat moderate-to-severe plaque psoriasis in patients over the age of 12 who weigh at least 40 kilograms, or 88 pounds.”
  • MedTech Dive relates,
    • “MiniMed, the diabetes tech firm spun out of Medtronic earlier this month, received Food and Drug Administration clearance for a smaller insulin pump.
    • “The device, called MiniMed Flex, is about half the size of the company’s previous 780G pump and is controlled using a smartphone.
    • “The new insulin pump is MiniMed’s first launch since the company went public in early March.”
  • and
    • “JenaValve has received premarket approval from the Food and Drug Administration for its transcatheter heart valve to treat symptomatic, severe aortic regurgitation in patients who are at high risk for surgical valve replacement.
    • “The Trilogy valve is now the first transcatheter device with a dedicated indication for the condition, the company said Wednesday. 
    • “Edwards Lifesciences in January canceled its planned acquisition of JenaValve after the Federal Trade Commission challenged the $945 million deal, arguing it would combine the only two companies conducting U.S. clinical trials for transcatheter aortic valve replacement devices to treat aortic regurgitation.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued a draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data.  
    • “This marks another major milestone in the implementation of the FDA’s roadmap to reducing animal testing, and reflects the FDA’s commitment to moving away from using animal testing as the default method for gaining drug safety information. The draft guidance describes the Center for Drug Evaluation and Research’s (CDER’s) general recommendations to consider for validating NAMs when nonclinical NAMs data are provided in support of a drug application or regarding an order issued under section 505G of the FD&C Act for an OTC monograph.”
  • A National Institutes of Health news release adds,
    • “The National Institutes of Health (NIH) today announced more than $150 million to develop and scale research methods that better simulate human biology and reduce reliance on animal models, a priority of the Trump Administration. The funding marks the first awards under the Complement Animal Research in Experimentation (Complement-ARIE) program, an initiative to develop, implement, and standardize lab or computer-based methods, also known as new approach methodologies (NAMs). Research teams across the United States will lead projects designed to produce more predictive models of human disease. 
    • “This is an exciting opportunity to create a repertoire of human-focused methods that are so sophisticated and comprehensive that successful clinical translation will rise and we will be able to answer questions beyond our reach with current research models,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. “These new projects are key steps in expanding and strengthening our scientific toolbox. NIH’s investment in NAMs is critical to our mission to carry out gold-standard research.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Leapfrog Group is withdrawing safety grades for nearly 500 hospitals dating back to fall 2024. 
    • “A federal judge this month ordered Leapfrog to unpublish the grades for five Tenet hospitals that alleged in a 2025 lawsuit they received worse grades from the watchdog group after they stopped participating in its surveys as of the fall 2024 report.
    • “Although the judge’s order only applied to the five hospitals, Leapfrog is applying it to all hospitals that did not participate in the surveys during the same period.” * * *
    • “Leapfrog will not assign grades in its spring 2026 report to any hospital that has not participated in the survey in the past two years, Binder said. The next report is expected to be released by early May.
    • “The group plans to develop new methodology applicable to all hospitals in time for its fall 2026 report, she said.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Little Rock, Arkansas, is the No. 1 most overweight city in the United States, according to a new WalletHub report. McAllen, Texas, came in at No. 2, followed by Memphis, Tennessee, at No. 3.
    • “WalletHub compared a total of 100 U.S. metro areas for this report, focusing on obesity rates among adults and children, cardiovascular health, food access and physical fitness levels. The final results reinforced trends that have been identified again and again: Americans in some parts of the country—particularly southern states and the Midwest—face an especially high risk of developing cardiovascular disease.  
    • “Click here for the full report.
    • “What can cardiologists living in these parts of the country do for their patients? According to Romit Bhattacharya, MD, a preventive cardiologist with Massachusetts General Hospital and member of the American College of Cardiology’s Prevention of Cardiovascular Diseases Council, it is critical for clinicians to consider proactive patient care whenever possible.”
  • and
    • “New early clinical data from a study using artificial intelligence (AI) to monitor widely available consumer wearables may help transform how heart failure patients are monitored and managed outside the hospital.
    • “At the THT 2026 meeting in Boston, Afnan Tariq, MD, JD, an interventional cardiologist and assistant clinical professor of medicine at the University of California, Irvine, presented first-in-man results from a passive, device-agnostic AI platform designed to turn data from consumer wearables into actionable clinical insights. The technology was able to lower the number of hospitalizations required over time thanks to earlier interventions.” 
  • STAT News adds,
    • “CAR-T cells, immune cells engineered to fight cancer, are one of oncology’s most powerful tools. But making them is arduous, as the patient’s immune cells must be extracted, manipulated in a lab, then returned to the patient’s body. Instead, scientists at Azalea Therapeutics, a spinout from the lab of Nobel laureate Jennifer Doudna, are seeking to make the engineered cells right in the patient’s own body.
    • “In a new paper published in Nature on Wednesday, the researchers showed some early signs of success with the process, known as in vivo CAR-T. With an infusion of gene editing particles, scientists were able to create CAR-T cells that could clear both solid and blood tumors in mice, a step forward for the field.
    • “Azalea Therapeutics isn’t the only group developing in vivo CAR-T. But, said Justin Eyquem, a cancer researcher at the University of California San Francisco and senior author on the paper, what makes their method unique is the ability to reliably genetically edit the right cells and the right part of those cell’s genomes. The method should practically eliminate the chances of accidentally editing the wrong cell or the wrong part of the genome, Eyquem said, both of which could pose serious risks to the patient.”
  • The American Journal of Managed Care tells us,
    • “Maintaining or improving a healthy lifestyle after a hypertension diagnosis significantly lowers the risk of developing cardiovascular disease (CVD) and type 2 diabetes (T2D), according to a new study.
    • “This prospective, population-based cohort study is published in JAMA Network Open.“
  • Pulmonology Advisor points out,
    • “Women experience more frequent asthma attacks, and prior attack history is a statistically stronger predictor of future attacks in men vs women, according to study findings published in Chest.” * * *
    • “The overall annualized asthma attack rate was higher in women than men,” the investigators stated, concluding, “Prior attack history had stronger prognostic value for future attacks in men, while other clinical risk factors and type-2 biomarkers (blood eosinophils and FeNO) showed no major sex differences.”
  • Healio notes,
    • “More than 80% of patients implanted with a transvenous phrenic nerve stimulation device for central sleep apnea had at least 4 hours of usage per night for 70% of nights at follow-up visits, according to study findings.
    • “The percentage of patients receiving adequate [transvenous phrenic nerve stimulation] therapy, based on the CMS CPAP adherence definition, appears to be higher than that for mask-based therapies reported in the literature,” Rami Khayat, MD, director of Penn State Health sleep services and division chief of pulmonary, allergy and critical care medicine at Penn State College of Medicine, and colleagues wrote in the Journal of Clinical Sleep Medicine.”

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

  • The Peterson KFF Health System Tracker identifies eight trends shaping health care costs in 2026.
    • 1. Healthcare costs remain top of mind for many Americans.
    • 2. Premiums have increased across commercial and individual marketplaces.
    • 3. The public and private sectors are looking for solutions as U.S. spending on prescription drugs continues to increase.
    • 4. Price transparency for healthcare prices has momentum.
    • 5.  Federal and state policymakers show interest in addressing the impacts of healthcare consolidation.
    • 6. The use of artificial intelligence in healthcare is likely to accelerate coding intensity, placing upward pressure on healthcare spending.
    • 7. States are responding to funding and program implementation pressures with changes to Medicaid beginning in 2027, and
    • 8. Effective distribution of the Rural Health Transformation Funds will require rapid state action.
  • MedCity News reports,
    • “San Diego-based startup Turquoise Health closed a $40 million Series C financing round on Tuesday, bringing the company’s overall fundraising total to $95 million.
    • “The round was led by Oak HC/FT, with participation from Andreessen Horowitz, Adams Street Partners and Yosemite.
    • “Turquoise, founded in 2020, originally built its business around collecting and analyzing price transparency data from hospital and payer disclosures. Providers used that data primarily for benchmarking and contract negotiations, said CEO Chris Severn.”
    • With its new funding, the startup plans to move beyond analyzing healthcare prices and into facilitating the transactions themselves, he stated. The goal is to enable guaranteed upfront prices for patients while reducing administrative waste between payers and providers.
  • STAT News informs us,
    • “Today, 13 years, a sprawling mansion, a private jet, and a five-day Italian wedding later, Alla and Scott LaRoque are living lavishly. It’s all funded by their long-running strategy of squeezing as much money as possible from the health care system. 
    • “While they portray themselves as Robin Hood-esque heroes helping doctors take on big insurance, their story is emblematic of an American health care system that’s rife with profit-seekers who critics say repeatedly test the lines of legality. Each effort by lawmakers to rein in the excesses is met with retooled tactics.
    • “The LaRoques own a little-known middleman called HaloMD, which helps providers navigate a new federal arbitration process to resolve billing disputes with insurance companies. HaloMD is fighting lawsuits from four different Blue Cross Blue Shield insurers accusing it of rigging the system and triggering huge payouts for itself and its provider clients.” 
    • “HaloMD’s strategy works like this, according to lawsuits from health insurers: It floods the overburdened federal arbitration system with thousands of disputes, many of them ineligible, and demands much more money than providers had originally charged. Disputes aren’t eligible if they should go through state arbitration, if the patients are covered by Medicare and Medicaid, or if the parties didn’t negotiate beforehand. 
    • “This new tactic is possibly even more lucrative for providers than surprise billing was, said Chris Whaley, an associate professor of health services, policy, and practice at Brown University. 
    • “If you were balance-billing patients, you had to chase money down from patients,” Whaley said. “Now, you have a means to get that money directly from insurers.”
  • Fierce Healthcare points out,
    • “Maven Clinic has introduced Maven Intelligence, an artificial intelligence-powered infrastructure embedded across its virtual clinic, care programs and benefits platform. 
    • “The company refers to Maven Intelligence as an orchestration layer that integrates agentic AI with longitudinal data and clinical expertise to personalize care. The layer is built on over 1 billion structured data points from Maven care journeys and will begin rolling out to members in March.
    • “Women’s health has [long been] a major gap in healthcare,” Jaya Savkar, senior vice president of product at Maven, told Fierce Healthcare. “We really believe that we have an opportunity to help close the gap … We’re the largest virtual clinic for women and families, and by coupling that with women’s health-focused AI, we believe that humans and AI can do more together.”

Notable Death

  • Cardiovascular Business reports,
    • “Amir Lerman, MD, a veteran cardiologist with Mayo Clinic, died unexpectedly on Feb. 23. He was 69 years old. 
    • “Lerman was known as a leading voice in interventional cardiology, writing nearly 1,000 peer-reviewed publications and holding several leadership positions during his long tenure with Mayo Clinic. He helped found the hospital’s Chest Pain and Coronary Physiology Clinic, for example, and served as the director of its Cardiovascular Research Center at the time of his death. He has also been cited more than 69,000 times, highlighting the critical impact his work had on generations of cardiologists. 
    • “Lerman’s research covered a variety of subjects, but he is perhaps best known as a pioneer in the treatment of nonobstructive coronary artery disease (CAD), particularly those with coronary microvascular dysfunction (CMD).”
  • RIP

Tuesday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • MedCity News reports,
    • “In a letter to lawmakers on Monday, employer advocacy groups applauded the introduction of the Healthy Competition for Better Care Act, a bill that aims to increase competition in healthcare.
    • “The letter was signed by the American Benefits Council, the ERISA Industry Committee, the National Alliance of Healthcare Purchaser Coalitions, the Purchaser Business Group on Health, the Silicon Valley Employers Forum and the Small Business Majority.
    • “The bill was introduced in the Senate last week by Jon Husted (R-Ohio). Reps. Jodey Arrington (R-Texas), Rick Allen (R-Georgia), Donald Davis (D-North Carolina) and Chuck Edwards (R-North Carolina) previously introduced a companion bill in the House.
    • “Specifically, the Healthy Competition for Better Care Act aims to improve competition in healthcare by banning several types of anticompetitive contracts between insurers and healthcare providers. It would prohibit all-or-nothing clauses that force insurers to include every provider in their network, anti-steering and anti-tiering clauses that limit employers’ ability to direct patients to lower-cost or higher-quality providers, most-favored-nation clauses that require insurers to receive the lowest price and can drive prices up overall and gag clauses that restrict sharing cost information.”
  • Federal News Network relates,
    • “After more than four weeks of a shutdown across the Department of Homeland Security, many federal unions and employee organizations are calling for relief for the impacted agency employees.
    • “Out of more than 260,000 DHS personnel, tens of thousands of employees have been feeling financial strain after working over a month without pay. That includes workers at the Transportation Security Administration, FEMA, Coast Guard, Secret Service and Cybersecurity and Infrastructure Security Agency. Many employees missed a full paycheck last Friday — the first entirely skipped payday since the shutdown began.
    • ‘Despite no real progress by lawmakers toward a DHS spending agreement, National Treasury Employees Union President Doreen Greenwald demanded Congress find a way to reach a bipartisan solution to immediately end the funding lapse, which started Feb. 14.
    • “These frontline employees have had to wonder whether they’ll be able to pay their mortgage or buy groceries; a month of not knowing how long this shutdown will last,” Greenwald wrote in a recent letter to Congress. “Yet even with such uncertainty hanging over their heads, they still come to work every day to keep our country safe.”
  • and
    • “The Postal Service is less than a year away from running out of cash and is calling on Congress to increase its limit to borrow money from the Treasury Department.
    • “Postmaster General David Steiner told members of the House Oversight and Government Reform Committeeon Tuesday that USPS is set to run out of cash in less than 12 months and that lawmakers need to act soon to keep the agency running.” * * *
    • “A Government Accountability Office report released Tuesday said the Postal Service’s business model is “unsustainable,” and that “urgent action” is needed to get ahead of a looming cash crisis.
    • “It’s highly unlikely that USPS will be able to fix its financial condition on its own. Congress will need to act,” David Marroni, GAO’s director of physical infrastructure, told lawmakers.”
  • Per a U.S. Office of Personnel Management (“OPM”) news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of its new HR Shared Service Center,  a governmentwide initiative designed to modernize and streamline human resources service delivery across federal agencies.  
    • “Building on the Federal HR 2.0 vision, the Shared Service Center will deliver high quality, cost effective HR operations and strategic advisory services that strengthen agency mission delivery and improve efficiency. Services will be available to agencies on a voluntary, fee for service basis through OPM’s revolving fund authority.” * * *
    • “Agencies can view a full list of services or initiate onboarding by visiting opm.gov/sharedservice or contacting sharedservice@opm.gov.”  
  • The Secrets of OPM blog written by OPM Director Scott Kupor has moved from OPM’s website to Substack. The Director added a new blog post today titled “Pulse Check.”
  • WEDI has released the results of its latest survey of payers and providers about coming into compliance with new CMS rules on prior authorizations.
    • “The Workgroup for Electronic Data Interchange (WEDI) released results of its recent survey assessing industry readiness to meet the requirements of the Centers for Medicare & Medicaid Services (CMS) Advancing Interoperability and Improving Prior Authorization Final Rule, also known as CMS-0057-F. With just under a year until the compliance deadline, the new survey results demonstrate that while the industry has made some progress, there is more work remaining in implementing, testing, and training to meet the regulatory requirements. This survey, conducted in February, is a follow up to the first two conducted by WEDI in October 2025 and January/February 2025.
    • “CMS-0057-F mandates the use of Patient Access, Provider Access, Payer-to-Payer, and Prior Authorization Application Programming Interfaces (APIs) with the goal of increasing data sharing to streamline prior authorization and patient data exchange. Once implemented, these new data exchange methodologies are expected to deliver much-needed reduction in overall payer, provider, and patient burden. Impacted entities are required to implement the API requirements by January 1, 2027. The rule also requires covered payers to publicly report designated prior authorization metrics by January 1, 2026.”

From the judicial front,

  • The New York Times reports,
    • “When a federal judge on Monday blocked the changes in vaccine policy set in motion by Health Secretary Robert F. Kennedy Jr. over the last year, public health groups hailed the ruling as a victory for science and evidence-based government recommendations.
    • “Their jubilation may be short-lived. The Trump administration is planning to appeal the decision, and if it does so quickly enough, an appeals court could overturn Monday’s ruling before the end of the week.
    • “The ruling revoked the authority of advisers appointed to the Advisory Committee on Immunization Practices by Mr. Kennedy to make vaccine recommendations, and ordered a return to the childhood vaccine schedule from before their appointment.
    • “On Tuesday, experts in public health, law and government said they were still trying to understand its ramifications.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “People who eat around nine servings a day of ultraprocessed foods like chips and doughnuts have about a 67% higher risk of heart attacks, strokes and dying from heart disease compared with those who eat about one serving a day, according to a new study.
    • “The risks rose with each additional serving a person ate, according to the study published Tuesday in JACC: Advances, a journal of the American College of Cardiology.
    • “The findings add to a growing body of research linking diets high in ultraprocessed foods to a range of health problems. They were released as the Department of Health and Human Services under Secretary Robert F. Kennedy Jr. takes steps to discourage eating junk foods, including issuing new dietary guidelines advising Americans to avoid highly processed foods with added sugars and salt, such as packaged chips, cookies and candy.”
  • STAT News relates,
    • “The cigarette smoking rate among U.S. adults fell below 10% for the first time in recorded history in 2024.
    • “That’s a big deal in itself. Also remarkable is how everyone is finding out about it. 
    • “Reports of the historic dip in smoking didn’t come from the U.S. government, which had collected the data. Instead, the news came via an analysis in the digital journal NEJM Evidence by Israel Agaku, the founder and CEO of research technology company Chisquares.” 
  • MedScape tells us,
    • “In patients without diabetes being treated with GLP-1s for overweight/obesity, persistence rates (rates of patients remaining on the drugs without treatment gaps) have significantly improved over the last 5 years, results from two new studies showed.
    • “This real-world analysis of high-potency, weight loss-indicated GLP-1 products among individuals without diabetes found that 1-year treatment persistence has nearly doubled from 2021 to the first half of 2024,” reported the authors of the first of the two studies, recently published in the Journal of Managed Care & Specialty Pharmacy.”
  • MedPage Today adds,
    • “An earlier diagnosis and intervention strategy for Alzheimer’s disease is on the horizon, signaling a need to overhaul current detection methods and patient care protocols, experts at the Alzheimer’s Association Research Roundtable (AARR) said.
    • “Advances in biomarker technology, digital cognitive assessments, and amyloid-targeting therapies have redefined the opportunities for accurate and early diagnosis and care of Alzheimer’s disease,” reported Christopher Weber, PhD, of the Alzheimer’s Association in Chicago, and co-authors in Alzheimer’s & Dementia: Translational Research & Clinical Interventionsopens in a new tab or window.
    • “These advances create new possibilities to intervene before the onset of cognitive impairment, Weber and colleagues wrote. Targeting the earliest stages of Alzheimer’s, Weber said, “is similar to how doctors treat other diseases like heart disease and some cancers, where early detection and prevention are key parts of care.”
  • Health Day informs us,
    • “Loneliness can impact a woman’s brain health as she begins menopause, a new study says.
    • “Loneliness and social isolation are both linked to the cognitive decline a woman feels as she begins to transition into menopause, researchers recently reported in the journal Menopause.
    • “Further, women experiencing both loneliness and social isolation are at greatest risk for brain decline, researchers found.” * * *
    • “These findings highlight the importance of psychosocial factors in cognitive health during the menopause transition,” researchers added.”
  • and
    • “It’s long been known that exercise improves a person’s brain health – and researchers now think they better understand at least one of the factors at play.
    • “Just one 15-minute session of aerobic exercise floods the brain with brain-derived neurotrophic factor (BDNF), a protein known to support the health of new and existing brain cells, researchers will report in the June 2026 issue of the journal Brain Research.
    • “What’s more, as a person’s fitness increases, so does the amount of BDNF released following exercise, researchers found.”
  • Genetic Engineering and Biotechnology News points out,
    • “The explosion of mRNA vaccines brought on by the COVID-19 pandemic have proven that the delivery vehicles for those vaccines work incredibly well. Despite that, researchers are still working on improvements: to increase efficacy and reduce side effects from the vaccination. Now, researchers report modifications to lipid nanoparticles (LNPs) that outperform leading, commercially available formulations while reducing common vaccine side effects in preclinical tests of human cells and mouse models.
    • “Changing the structure of the ionizable lipid of the LNPs boosted the metabolism of key immune cells, providing the energy necessary to gird the body’s defenses while dialing down the inflammatory signals that often cause fever and fatigue. The chemical tweak also enhanced on-target delivery of the nanoparticles to immune organs like the lymph nodes.
    • “This work is published in Nature Materials in the paper, “Crosslinked ionizable lipids reprogram dendritic cell metabolism for potent mRNA vaccination.”
    • “This is an early step, but it opens the door to a new generation of mRNA vaccines that are more potent and better tolerated,” says Michael J. Mitchell, PhD, associate professor in bioengineering at the University of Pennsylvania. “Instead of accepting a trade-off between efficacy and side effects, we’re beginning to see that chemistry can help us improve both.”
  • Per BioPharma Dive,
    • “Pfizer on Tuesday said a key experimental medicine helped stave off disease progression in a Phase 2 trial of patients with metastatic breast cancer.
    • “Atirmociclib is designed as a next-generation improvement on Pfizer’s Ibrance, the pioneer in a class known as cyclin-dependent kinase, or CDK 4/6 inhibitors. The drugs, which block proteins that tumors use to grow and multiply, have become a pillar of care for a common type of breast cancer known as HR+/HER2-.
    • “The new study, dubbed Fourlight-1, tested atirmociclib in patients who had previously tried CDK4/6 inhibitors. Researchers found that those given the experimental drug in combination with a widely used hormone therapy called fulvestrant had a 40% reduction in the risk of disease progression or death compared with those on another combination of medicines.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “The health insurance industry’s credit outlook for the year remains negative as medical costs continue to rise, according to a new report from Moody’s Ratings.
    • “The Moody’s analysts said that in the current environment, payers will have “limited prospects for profitable growth” this year. Given the margin pressures facing the industry, plan redesigns, benefit cuts and exits from low-performing markets remain likely, per the report.
    • “Medical cost inflation has impacted every business line insurers have—Medicare Advantage (MA), Medicaid, the Affordable Care Act exchanges and commercial plans—and that trend is set to carry through the coming months. In addition, reimbursement rates have generally lagged these inflation rates, putting further pressure on plans, according to Moody’s.
    • “Key cost drivers range from pricey pharmaceuticals, increased intensity alongside higher utilization and higher coding intensity from providers, according to the report.
    • “Making improvements to earnings and margins has been a key focus for the major companies in this space, according to the report, making for a pivot from the growth mindset that was central for many of these firms.”
  • and
    • “Highmark and Blue Cross and Blue Shield of Kansas City have secured the necessary regulatory approvals to move their affiliation plans forward, the insurers announced Tuesday.
    • “The deal secured an O.K. from the Missouri Department of Insurance and is set to close on March 31, according to the announcement. Through the affiliation, Blue KC aims to improve outcomes and accelerate key innovations to support its members in the Kansas City region.
    • “The affiliation was first announced in December. Once it closes, the two insurers expect that integration will “take place over a phased period of time.” At present, nothing will change for members of either plan, according to the announcement.”
  • Chief Health Executive informs us,
    • “Long known for its rankings of America’s best hospitals, U.S. News & World Report has been examining providers of outpatient care in recent years.
    • “Today, U.S. News released its list of the 2026 Best Ambulatory Surgery Centers. Working in partnership with Arcadia, a healthcare analytics firm, U.S. News examined 4,421 ambulatory surgery centers in specialties including colonoscopy & endoscopy; ophthalmology; orthopedics and spine; and urology.
    • “In its analysis, U.S. News named 911 surgery centers as worthy of recognition as the best, about one in five (21%) of those reviewed. Last year, 733 ambulatory surgery centers, or about 17% of those examined, earned U.S. News honors as the nation’s best performers.
    • “Ben Harder, chief of health analysis and managing editor at U.S. News, said the analysis of top surgery centers comes as more complex procedures are being done in outpatient facilities.
    • “Overall we found that ambulatory surgical care continues to be a very safe option for the vast majority of patients, even as utilization grows,” Harder said in an email to Chief Healthcare Executive®. “That’s reassuring for patients and suggests that the ongoing shift of care from hospitals to ASCs is likely to continue and, if anything, gather steam.”
  • Beckers Hospital Review lets us know,
    • “Sacramento, Calif.-based Sutter Health and Minneapolis-based Allina Health have signed a letter of intent for Allina to join the health system, creating a combined nonprofit organization spanning California, Minnesota and Wisconsin.
    • :The proposed transaction would create a system with 39 hospitals and more than 400 care sites, serving more than 5 million patients, according to a joint news release.
    • “Upon closing, the combined system would include 18,000 physicians and 88,000 employees across Northern and Central California and Minnesota and Wisconsin.
    • “Based on 2025 revenues, the combined organization would generate about $26 billion.”
  • and
    • “The top 15 U.S. pharmacies accounted for nearly 75% of the nation’s $751 billion of prescription dispensing revenue in 2025, according to Drug Channels.
    • “CVS Health led all dispensing organizations with $119 billion in revenue, followed by Walgreens at $90.8 billion and Cigna’s Express Scripts at $80.5 billion. GLP-1 medications drove nearly 60% of retail revenue growth over the last five years and contributed significantly to a 10% year-over-year increase in total prescription spending.
    • “Centene entered the top 15 for the first time, reflecting its expanding presence in specialty pharmacy. Rite Aid’s continued store closures and bankruptcy reshaped market dynamics, while CVS and Walgreens have acquired more than 6,000 pharmacy locations since 2010.”