Monday report

CMS

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

  • The New York Times reports,
    • “In his first week leading two of the nation’s health agencies, Dr. Jay Bhattacharya has been met with praise and gratitude from federal employees — an unexpected reception for a scientist who spent much of the last few years facing scorn from most other public health experts.
    • “Dr. Bhattacharya, director of the National Institutes of Health, was last week named the acting director of the Centers for Disease Control and Prevention. A medical economist and former Stanford University professor, he replaced Jim O’Neill, a Silicon Valley executive with no medical training.
    • “Like most officials in the Trump administration, Dr. Bhattacharya was staunchly opposed to mandates for Covid vaccines, but unlike many, he has not questioned the safety of childhood vaccines.
    • “In meetings with C.D.C. staff this week, Dr. Bhattacharya offered to publicly endorse immunizations in general and the measles vaccine in particular; extolled the importance of prevention efforts against H.I.V.; and promised to try to extend remote work accommodations, according to several C.D.C. employees with knowledge of the discussions.” 
  • Beckers Payer Issues informs us,
    • “HHS released its third annual report Feb. 9 that evaluates how the No Surprises Act has affected healthcare markets.
    • “The report was produced with analytical support from RAND, and extends claims data trends through 2022, the first full year after the law took effect.
    • “Because most self-insured employer plans were not previously subject to state surprise billing laws, the NSA represented a bigger regulatory change for them than for fully insured plans. Average out-of-network per-claim payments for emergency services in self-insured plans fell 41% during the period, compared to 22% for fully insured plans. Self-insured plans also saw steeper declines in out-of-network billing prevalence and out-of-pocket costs across the board.”
  • Avalere Health tells us,
    • “From 2025 to 2026, overall Part D enrollment increased from 55.4 million to 56.9 million (a 2.7% increase). Over this period, enrollment in PDPs grew by 7.2% while enrollment in MA-PDs decreased by 0.5%. This is a notable shift from trends in recent years. MA-PD enrollment had climbed from 26 million in 2022 to 31.8 million in 2025, with annual growth of 7.4% from 2023 to 2024 and 4.3% from 2024 to 2025. By contrast, PDP enrollment was stable at 23.4 million in 2022 and 23.5 million in 2025, before rising to 25.2 million in 2026.  
    • “PDP enrollees are increasingly selecting lower premiums plans. In 2026, 64% of PDP enrollees chose plans with premiums under $25, up from 49% in 2025. At the same time, the share selecting plans with premiums of $100 or more increased to 17% in 2026, up from 12% in 2025.” * * *
    • “Despite continued declines in the number of standalone PDPs offered in 2025 and 2026 relative to prior years, PDP enrollment has increased while MA-PD enrollment has largely leveled off. For plan sponsors, this divergence may signal changing beneficiary preferences around premium sensitivity, benefit offerings, pharmacy network design, and the value proposition of integrated MA coverage versus a standalone Part D product.” 
        
  • Federal News Network reports,
    • “The Agriculture Department is planning to sell one of its headquarters buildings, as part of an ongoing agency reorganization that will relocate more than half of its workforce in Washington, D.C. to regional hubs across the country.
    • “USDA announced Wednesday that it is turning the department’s South Building over to its landlord, the General Services Administration, which plans to sell the building.”
  • Tammy Flanagan, writing in Govexec, explains “How to make the most of FERS, Social Security and your TSP.”
    • “Understanding each part of your federal retirement can help you plan when and how to retire and avoid surprises.”
  • Govexec relates,
    • “Newly released data from the Government Accountability Office offers some of the most granular glimpses yet of how the Trump administration’s sprint to remake the federal workforce in the president’s image impacted agency headcounts.
    • “The report, published Tuesday, responds to a request by congressional Democrats to catalog data related to a variety of workforce changes undertaken shortly after President Trump returned to office last January, including reductions in force, the purge of recently hired or promoted employees with fewer civil service protections and the deferred resignation program.
    • “GAO said it relied upon data from the Office of Personnel Management and individual agencies in compiling its report. OPM has previously said that around 317,000 federal workers left government in 2025. The watchdog agency’s report captures the first six months of Trump’s second term, capturing a fraction of that throughput.
    • “Of the 134,122 employees who separated from the 23 CFO Act agencies during the period from January to June 2025, a substantial majority (around 77%) retired or resigned,” GAO found. “Another roughly 19% were terminated or removed from their positions. Of these, agencies reported that nearly 4,500 employees (or about 3%) were terminated during a probationary or trial period.”

From the Food and Drug Administration front,

  • ABC News reports,
    • “Frozen blueberries distributed in four states have been voluntarily recalled due to possible listeria contamination.
    • “Oregon Potato Company, which owns the Salem, Oregon-based Willamette Valley Fruit Company, voluntarily recalled 55,689 pounds of frozen blueberries on Feb. 12 over potential contamination with Listeria monocytogenes, according an enforcement report from the U.S. Food and Drug Administration.
    • “The recall was designated as a Class I recall on Feb. 24, the highest FDA classification, which indicates that “use of or exposure to” the affected product can cause “serious adverse health consequences or death.”
  • MedPage Today adds,
    • “The FDA approved dupilumab (Dupixent) for treating allergic fungal rhinosinusitis, a first for the condition, the agency announced on Wednesday.
    • “Approval stipulates use in individuals 6 years and older with prior sino-nasal surgery, as the condition has a high rate of post-operative recurrence.
    • “Allergic fungal rhinosinusitis is characterized by the production of thick, sticky mucus following an allergic reaction to fungi in the sinuses. Left untreated, the type 2 inflammatory disease can expand the sinuses, erode surrounding bone, and lead to vision problems, nerve damage, and even facial deformities.”

From the judicial front,

  • Govexec reports,
    • “A federal appeals court on Thursday declined to enforce a temporary decision blocking the Trump administration from stripping two-thirds of the federal workforce of their collective bargaining rights, dimming though not extinguishing the American Federation of Government Employees’ legal challenges against a pair of anti-union executive orders.
    • “A three-judge panel on the Ninth Circuit Court of Appeals ruled unanimously that it could not uphold a preliminary injunction that would have blocked the Trump administration from implementing a pair of 2025 executive orders that cite a seldom-used provision of the 1978 Civil Service Reform Act to ban collective bargaining at most federal agencies, under the auspices of national security. That injunction had itself been put on hold by the appellate judges since last August.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The last thing someone in their 30s or 40s should worry about is dying of a heart attack. But new research shows more are.
    • “The proportion of adults ages 18 to 54 who died in a hospital of a severe first heart attack rose 57% between 2011 and 2022, according to a new study published Thursdayin the Journal of the American Heart Association.
    • “Most of those who died were men, but women died at higher rates than men.
    • “The study offers the latest evidence of worsening health among younger U.S. adults, including deaths from conditions traditionally tied to aging, such as heart disease and cancer.”
  • The American Hospital Association News relates,
    • “Obesity rates for U.S. children and teenagers have reached record highs, while rates for adults had a slight decline, according to reports by the Centers for Disease Control and Prevention. Both reports examined historical trends using height and weight data from the National Health and Nutrition Examination Survey. From August 2021 to August 2023, an estimated 21.1% of children and teenagers ages 2-19 were obese, up from 19.3% from 2017-2018. Additionally, from 2021-2023, 7% of children and adolescents were severely obese and 15.1% were overweight. For adults, 40.3% were obese from 2021-2023, down from 42.8% in 2017-2018. In addition, from 2021-2023, 9.7% of adults were severely obese and 31.7% were overweight.”
  • BioPharma Dive tells us,
    • “Eli Lilly’s GLP-1 pill orforglipron was associated with greater weight loss and reductions in blood sugar levels than Novo Nordisk’s rival drug Rybelsus in a head-to-head trial in people with diabetes.
    • “The study results disclosed Thursday could help strengthen Lilly’s case for approval as well as orforglipron’s uptake in diabetes. But investigators also flagged higher rates of side effects in orforglipron recipients that led people to stop treatment. 
    • “The data highlight another potential threat to Novo, which has seen its shares tumble amid pricing pressure and competition from Lilly as well as drug compounders. The Denmark-based company markets the only oral GLP-1 medications for diabetes and obesity — Rybelsus and the Wegovy pill, respectively — but that could soon change. Lilly expects the Food and Drug Administration to decide whether to clear use of orforglipron in obesity sometime in the second quarter.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “A study by researchers at The Jackson Laboratory (JAX), the Broad Institute, and Yale University has identified how specific genetic changes function in cells to influence disease risk and other human health traits. By probing regions of DNA previously linked to disease, the scientists created high resolution maps of DNA variant activity, helping pinpoint the exact changes that shape blood pressure, cholesterol levels, blood sugar and other complex human traits.
    • “The study takes on a long-standing challenge in human genetics. Scientists have known for years that certain regions of the genome—often spanning tens of thousands to millions of DNA letters—are associated with diseases. But because these regions usually contain many variants that could potentially drive those associations, performing the necessary experiments to pinpoint which specific DNA changes truly matter has been difficult and time-consuming.
    • “The solution was scale. Using a massively parallel reporter assay (MRPA)—which is a high-throughput approach that simultaneously evaluates the regulatory activity of thousands of DNA sequences—the team tested more than 220,000 previously identified DNA changes in five different cell types. By doing so, they resolved about 20% of these regions across the genome, revealing new insights into what these variants do, which in turn could help improve risk prediction and guide the development of new therapies.
    • “Geneticist Ryan Tewhey, PhD, an associate professor who led the team at JAX, explained that previously making these connections was like searching for a single typo on one page of a massive book. The researchers’ new experimental approach is more akin to speed reading, scanning thousands of pages at once and flagging the exact letters that change meaning, dramatically accelerating genetic discovery.”
  • The Washington Post lets us know that “An all-or-nothing mindset could be hurting your exercise and health goals.
    • “If you’ve given up on your New Year’s resolutions to get fit, here are some tips for getting back in the saddle.”
  • MedPage Today adds,
    • “The cost of sunscreen with an SPF-50 rating varied by 17.5-fold per ounce and 100-fold per application in an economic analysis.
    • “Wearing more protective clothing could significantly reduce the amount of sunscreen needed and could lower application expenses.
    • “Standardization of sunscreen application to achieve desired thickness might influence annual cost.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Cigna has acquired CarepathRx, a large pharmacy backed by private equity that dispenses prescription drugs to nearly 10% of U.S. hospitals.
    • “The acquisition, discovered by STAT in a review of Cigna’s financial filings, reinforces the company’s push to control more of the lucrative flow of pharmaceuticals through the U.S. health care system. Cigna executives have repeatedly told investors that managing prescription drugs has been one of their highest priorities since the company acquired Express Scripts for $54 billion in 2018.”
  • Beckers Health IT relates,
    • “Two years after a merger that created a now $12.1 billion system, St. Louis-based BJC Health is rolling out fresh branding to solidify its market positioning and boost recruitment and retention, leaders told Becker’s.
    • “St. Louis-based BJC HealthCare and Kansas City, Mo.-based Saint Luke’s Health System joined forcesin early 2024, rebranding as BJC Health in late 2025. Now, the organization’s West region is in the midst of a new marketing campaign — “All For Kansas City” — and updating signage to bring the BJC brand to its market.
    • “The new logo puts an exclamation point behind the fact that the Saint Luke’s brand is here to stay, and, at the same time, connects us to BJC Health,” said Julie Quirin, president of BJC Health’s West region (aka Saint Luke’s Health System). “It tells the story that we’re stronger together, while leaning into that brand equity that we’ve built over the last 150 years here in Kansas City.”
  • Per Fierce Pharma,
    • “Already on a roll with its first-in-class FcRn blocker Vyvgart, argenx has reported successful trial results that could pave the way for the fast-rising blockbuster to reach a new indication—ocular myasthenia gravis.
    • “The phase 3 Adapt Oculus study, which is the first to specifically evaluate a targeted treatment for ocular myasthenia gravis (oMG), has achieved its primary endpoint, demonstrating that Vyvgart can improve vision by a statistically significant margin, argenx reported Thursday.
    • “The company hailed the victory the same day it unveiled its 2025 earnings, showing that Vyvgart sales came in at $1.3 billion in the fourth quarter and $4.2 billion for the full year.”
  • Per Healthcare Dive,
    • “Labcorp has expanded its collaboration with PathAI to use a digital pathology platform at its anatomic pathology labs and hospital sites.
    • “The agreement, which Labcorp disclosed Monday, supports the use of PathAI’s AISight Dx to enable digital workflows for case management, slide review, collaboration and annotation.
    • “Quest Diagnostics, Labcorp’s main rival, licensed AISight Dx in 2024 in conjunction with its $100 million acquisition of PathAI’s diagnostic laboratory in Memphis, Tennessee.”

Midweek report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

From the U.S. healthcare business front,

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

Monday report,

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

From Washington, DC,

  • The Hill reports,
    • “Lawmakers return to Capitol Hill this week facing an uphill climb to fund the Department of Homeland Security (DHS) as Republicans see an opening after President Trump’s State of the Union address on Tuesday despite few signs that Democrats are willing to compromise on their demands.”
  • The Congressional Budget Office tells us,
    • “The Congressional Budget Office regularly updates the Congress on our projections of the Hospital Insurance (HI) Trust Fund’s financial position as well as changes in our outlook on that position. This blog post serves as that update.
    • “The HI trust fund is used to pay for benefits under Medicare Part A, which covers inpatient hospital services, care provided in skilled nursing facilities, home health care, and hospice care. The fund derives its income from several sources. Over the next 30 years, about three-quarters of its annual income comes from the Medicare payroll tax and roughly one-eighth comes from income taxes on Social Security benefits. The rest comes from other sources.” * * *
    • “The year in which the HI trust fund’s balance is exhausted in our current projections, 2040, is 12 years earlier than in our most recent estimate of that date, which was published in March 2025. Measured in relation to taxable payroll, the trust fund’s 25-year actuarial deficit is 0.17 percentage points greater in the current projections than in last year’s. (Measured in relation to GDP, the actuarial deficit is 0.07 percentage points greater than we projected last year.) Those changes are driven largely by projections of less income to the fund. Projections of greater spending also contribute to the changes.”
  • STAT New reports,
    • “More evidence is starting to show the government’s arbitration process to settle out-of-network bills has morphed into a cash cannon for doctors and medical groups.
    • “Jinghong Chen of Payer Perspectives sifted through the latest federal data covering the arbitration process created by the No Surprises Act and found that not only are medical groups winning nearly nine out of every 10 cases, they are also getting paid more than anyone can imagine.
    • “The NSA’s arbitration process encouraged the use of the “qualifying payment amount” — essentially the average in-network rate that providers in a given area have agreed to — as a benchmark for disputes. How quaint. Instead, medical groups have fought for, and won, astronomically higher amounts. 
    • “Radiologists are winning offers that are, on average, almost 500% of the typical in-network rate, according to Chen’s analysis. Surgeons are getting payments for contested services that are a median 1,320% above the in-network rate. Neurology and neuromuscular procedures have median winning offers of nearly 2,400% above the in-network average.”
  • Govexec informs us,
    • “Federal supervisors are poised to soon face limitations on how many employees they can rate as above average in their annual performance reviews after the Trump administration on Monday proposed upending the process for evaluating civil servants. 
    • “The Office of Personnel Management’s proposed rule would implement the first major overhaul of the federal employee performance management system in decades. The Trump administration is aiming to correct for what it views as inflated ratings within the federal workforce. 
    • “The rule, which OPM will formally release on Tuesday, largely mirrors a draft version Government Executive exclusively obtained and reported on in December.”
  • The Affordable Care Act regulators announced today their decision to extend the public comment period for the proposed rule that appeared in the Federal Register on December 23, 2025, titled “Transparency in Coverage” from February 23, 2026, to March 2, 2026.
  • The New York Times reports,
    • “Adding to a rapid shake-up of the leadership at federal health agencies, the Centers for Disease Control and Prevention announced on Monday that Dr. Ralph Abraham had resigned as the agency’s principal deputy director.
    • “His departure thins the ranks of vaccine skeptics at the agency’s helm, a sign of the administration’s pivot away from the agenda pursued thus far by Health Secretary Robert F. Kennedy Jr. and his appointees.
    • “Dr. Abraham’s resignation, which comes less than three months into the job, was effective immediately, the agency said in a statement on its website.” 

From the Food and Drug Admininstration front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly has launched a multidose version of its blockbuster weight loss drug Zepbound that gives patients a month’s worth of treatment in a single injection pen.  
    • “On Feb. 23, the drugmaker said the FDA approved a label expansion for Zepbound (tirzepatide) to include the four-dose, single-patient-use KwikPen. The device contains four weekly doses, reducing the number of pens patients need each month compared with single-dose injectors.
    • “The KwikPen will be available by prescription for self-paying patients through LillyDirect, Eli LIlly’s direct-to-consumer platform. Prices start at $299 per month for the lowest dose. Patients choosing the self-pay option can access all approved doses in either the multidose pen or single dose vial at the same price, the company said.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations. 
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, specifically discusses genome editing and RNA-based therapies such as antisense oligonucleotides but leaves open the potential that this framework may apply to additional tailored therapeutics provided they directly address the underlying specific cause of the disease.” * * *
    • “The draft guidance, Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause, is available for public comment. Comments must be submitted within 60 days of publication in the Federal Register at Regulations.gov.”
  • Per Fierce Pharma,
    • “Vanda Pharmaceuticals is riding a regulatory roller coaster over the last few months. December brought an FDA thumbs up for its new motion sickness drug Nereus. Then in January, the U.S. regulator re-upped its rejection of Vanda’s Hetlioz for jet lag disorder.
    • “Now in February, the agency has issued another new drug approval to Vanda, signing off on Bysanti as a first-line treatment for schizophrenia or for manic or mixed episodes associated with bipolar I disorder. 
    • :The atypical antipsychotic tablet, also known as the chemical compound milsaperidone, has demonstrated in clinical trials its bioequivalence to Vanda’s Fanpat (iloperidone), which has been approved in the same two indications.”
  • and
    • “Only a month after Jazz Pharmaceuticals said it had signed a deal to sell an FDA priority review voucher (PRV) for $200 million, a new PRV transaction involving Fortress Biotech and an unnamed buyer shows that the trend of rising voucher prices is still going strong.
    • “Monday morning, Fortress said its subsidiary, Cyprium Therapeutics, has entered into an agreement to sell a recently received rare pediatric disease priority review voucher for $205 million. Cyprium got its hands on the PRV as part of the FDA’s recent approval of injected copper replacement therapy Zycubo as the first treatment approved in the U.S. for the rare neurodegenerative disorder Menkes disease.
    • “While another company, Sentynl Therapeutics, is handling development and commercialization of Zycubo under a 2023 agreement, the deal called for Sentynl to transfer the PRV back to Fortress/Cyprium after the approval.”  

From the public health and medical / Rx research front,

  • STAT News reports,
    • “Women’s bodies are different from men’s in ways that medicine is still learning. Meanwhile, their risk of serious cardiovascular events can be underestimated if their distinct risk profiles are blurred with men’s. 
    • “The latest example of important sex differences centers on the plaque burden in coronary arteries — a measure of fat and cholesterol deposits that also accounts for blood vessel size. 
    • “Women tend to have lower volumes of plaque than men, but their total plaque burden is higher because the fatty deposits take up a larger fraction of their smaller coronary arteries. Their risk for a heart attack or hospitalization for chest pain emerged when their plaque burden was lower than men’s, and their risk climbed more steeply, too, a new study published Monday in Circulation: Cardiovascular Imaging concluded.”
  • The Washington Post relates,
    • “Obstetrician Jeanne Conry has long paid attention to the “1,300-day window”— the months before conception through a child’s second birthday. Studies show nutrition and lifestyle during this period can shape pregnancy outcomes and the long-term health of the babies. Conry began to wonder if such factors could also influence autism.
    • “She is now helping lead an educational push aimed at alerting women to their exposure to toxins, stress and infections during this narrow and consequential window — guided by the idea that what happens then may subtly shape eggs or sperm, and in turn, influence a child’s development long before pregnancy begins.
    • “The more we research, the more we see links between different chemical exposures and autism so if we reduce those links we will ideally reduce cases,” Conry said.”
  • STAT News also informs us,
    • “Novo Nordisk’s next-generation weight loss drug CagriSema, one of the company’s key hopes to help it regain its footing in the increasingly competitive obesity market, failed in a key study that compared it to rival Eli Lilly’s tirzepatide, Novo said Monday. 
    • “The open-label REDEFINE 4 study was designed to test whether CagriSema could help patients lose the same amount of weight as those who received tirzepatide, which is sold as Zepbound and Mounjaro. But over 84 weeks, patients in the CagriSema arm saw a weight loss of 20.2%, versus 23.6% for those getting tirzepatide. Statistically, the results did not show that CagriSema performed equivalently to Lilly’s drug — what’s known as non-inferiority.” 
  • The Hill adds,
    • “An ingredient in the prescription diabetes drug Mounjaro was found to reduce alcohol intake in rodents, according to a recent study. 
    • “In the study, published in early January in the medical journal eBioMedicine, researchers in Sweden, South Carolina and Brazil looked at how the ingredient, tirzepatide, affected rodents. The researchers found that alcohol’s “rewarding properties” were lessened by the ingredient and that behaviors including the voluntary consumption of alcohol and binge drinking dropped.
    • * * * “In summary, our findings indicate that tirzepatide influences alcohol-related responses in ways that appear to have clinical potential. Tirzepatide consistently reduced alcohol intake across different drinking paradigms and both sexes without signs of tolerance development,” the researchers wrote.
    • “Perhaps more significantly, tirzepatide’s effects on relapse behaviours suggest it might help decrease relapse vulnerability, a finding that could prove important for therapeutic applications,” they added.”
  • The American Medical Association lets us know “What doctors wish patients knew about food allergies.”
    • “Milk, eggs, peanuts, tree nuts, fish, shellfish, wheat, soy and sesame are the “Big Nine” food allergies. Two allergists share more about food allergies.”
  • NPR adds,
    • “Ultra-processed foods are industrially manufactured products that contain ingredients rarely found in your kitchen, such as preservatives, artificial sweeteners, colorings, natural flavors and emulsifiers. Numerous studies have shown that these foods increase the risk of a host of health problems, including diabetes, heart disease, depression and obesity.
    • “When people ask me about ultra-processed foods, they’re often most confused about grains, carbohydrates and starches,” says Dr. Dariush Mozaffarian, who leads the Food is Medicine Institute at Tufts University. These foods include breads, crackers, pretzels, pea snaps, veggie straws, pastas and puffed rice or corn. “People want to know how to choose more healthful versions of these products,” he says.
    • “So Mozaffarian gives his patients two practical rules of thumb to follow when selecting grains and starches: the 10 to 1 test and the water test.”
  • Cardiovascular Business points out,
    • “The risk of death following percutaneous coronary intervention (PCI) remains incredibly low, according to new findings published in The American Journal of Cardiology.[1] When it does occur, acute myocardial infarction (AMI), cardiac arrest and infection are two of the most common reasons.
    • “Estimating the risk of periprocedural mortality after percutaneous coronary intervention (PCI) is crucial for risk stratification and quality assessment,” wrote Dimitrios Strepkos, MD, a researcher with the Minneapolis Heart Institute Foundation, and colleagues. 
    • “Strepkos et al. examined data from the PROGRESS-COMPLICATIONS registry, focusing on more than 22,000 patients who underwent PCI from 2014 to 2024 at one of two high-volume U.S. facilities. The overall technical success rate was 78.3%. While 14.8% of patients underwent atherectomy as part of the procedure, 6.1% underwent intravascular lithotripsy.”

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

  • The Wall Street Journal reports,
    • “Merck MRK is shaking up the leadership of its main pharmaceutical unit as the U.S. drugmaker braces for sales pressure later this decade.
    • “The Rahway, N.J.-based company said Monday it will split its human-health business into two divisions. One will house its cancer drugs, including the blockbuster Keytruda. The immunotherapy accounts for nearly half of total Merck sales but is due to lose U.S. patent protection in 2028, exposing it to lower-cost copycat competition.
    • “The second new division—the specialty, pharma and infectious-diseases business unit—will sell noncancer products, including the HPV vaccine Gardasil, diabetes drug Januvia and newer products such as lung-disease treatment Winrevair. 
    • “Merck is counting on this unit to generate big sales growth to offset the expected Keytruda sales decline.” 
  • Beckers Hospital Review reports,
    • “Nacogdoches (Texas) County Hospital District is eyeing a new lease agreement with Dallas-based Tenet Healthcare that would merge Nacogdoches Memorial Hospital with Nacogdoches Medical Center, ABC affiliate KTRE reported Feb. 19.
    • “Under the proposed deal, the two hospitals would operate under unified management.
    • “Consolidating the hospitals would help the district sustain care for the community’s underserved population while benefiting from the resources and support of a larger health system, David Schaefer, vice president of the hospital district’s board, told the media outlet.” 
  • MedTech Dive notes,
    • “Guardant Health has acquired MetaSight Diagnostics for $59 million in upfront cash to bolster its multi-disease detection pipeline, the company said Thursday. The deal includes up to $90 million in payments tied to future commercial performance and regulatory approvals.
    • “MetaSight uses mass spectrometry multi-omics technology to find biomarkers associated with acute and chronic diseases in serum samples. Tests for colorectal cancer, an area of focus for Guardant, and liver disease-associated fibrosis were MetaSight’s two most advanced programs just before the acquisition.”  
  • Fierce Healthcare points out,
    • “As providers rapidly adopt artificial intelligence technology for clinical documentation, there is a demand for AI clinical assistants that meet the needs of specialty medicine practices.
    • “Health tech company Nextech recently launched its next-generation AI assistant, called Cora, along with its clinical documentation feature, Cora Scribe, to provide AI technology that was designed with specialty workflows in mind, according to the company.
    • “Nextech provides electronic medical record and practice management software to specialty physician practices as well as revenue cycle management (RCM), customer relationship management (CRM) and other software systems. The company supports 16,000 physicians, more than 5,500 practices and 60,000 office staff members in the clinical specialties of dermatology, ophthalmology, orthopedics, plastic surgery and medical spa practices.”
  • The American Hospital Association News adds,
    • “The AHA responded to a request for information today from the Department of Health and Human Services on the adoption and use of artificial intelligence in clinical care. The AHA urged HHS to synchronize and leverage existing AI policy frameworks to avoid redundancy, remove regulatory barriers that inhibit the development and deployment of AI tools, adopt policies ensuring the safe and effective use of AI, and align incentives and address infrastructural factors necessary to expand AI in health care.  
    • “The AHA’s comments build upon previous responses to RFIs on regulation and reimbursement for AI, including an RFI from the Office of Science Technology Policy on ways to reduce regulatory burden for AI, an RFI from the Food and Drug Administration on measuring and evaluating AI-enabled medical devices, and RFIs from the Centers for Medicare & Medicaid Services on payment for AI tools through the calendar year 2026 Outpatient Prospective Payment System proposed rule and CY 2026 Physician Fee Schedule proposed rule.”

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

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

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

Thursday report

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

From Washington, DC

  • The U.S. Office of Personnel Management promulgated a final rule
    • to amend its career and career-conditional employment regulations. The revision is necessary to implement section 1108 of the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019, which requires OPM to issue regulations implementing hiring authorities that allow agencies to hire certain post-secondary students into positions at specified grades in the competitive service. The intended effect of the authority is to provide additional flexibility in hiring eligible and qualified individuals.
  • Federal News Network adds,
    • “Some senior political appointees, including the vice president, will continue to see a long-standing freeze on their salaries. The Office of Personnel Management announced that pay rates will continue to be capped for certain Executive Schedule employees. Political appointees in Schedules C and G, however, are exempted from the pay freeze. Certain higher-paid positions have continued to see their salary capped for more than a decade. For 2026, the pay ceiling sits at about $197,000.(Updated guidance — pay freeze for certain senior political officials – Office of Personnel Management)
  • and
    • “The Office of Personnel Management will make job offers to the first participants in the TechForce initiative as soon as March 1. OPM Director Scott Kupor said the agency is in the final stages of reviewing the applications for software engineers and data scientists to join the government for two to four years and work on specific modernization projects. Kupor said OPM will soon open up applications for cybersecurity and web design positions. OPM plans to hire 1,000 technologists to work with agencies and private sector companies to solve specific agency technology challenges.(First set of TechForce hires to come in early March – OPM)”
  • Tammy Flanagan writing in Govexec tells us, “Federal workers delay retirement as savings gaps persist.A survey shows most workers expect to retire at 65 or later, but many haven’t calculated savings for health care or emergencies.”
  • JAMA informs us,
    • “Every year over the last 2 decades, the share of Medicare beneficiaries enrolling in Medicare Advantage has increased.1 The number of plans available to Medicare Advantage beneficiaries has also increased year after year, doubling in number over the last 7 years.2 As a result, Medicare Advantage beneficiaries have rarely had to contend with disruptions resulting from Medicare Advantage plans exiting the market (forced disenrollment), which may include adjustment to different provider networks, plan benefit packages, and supplementary benefits. However, recent reports suggest that many insurers will stop offering plans in 2026.3,4 This study characterized the scale and impact of Medicare Advantage plan exits for beneficiaries.”
  • STAT News reports,
    • “After years of grand ambitions, the federal government disclosed that it is months away from rolling out a centralized list of doctors and hospitals filled with up-to-date contact and insurance information.
    • “Details of how the national provider directory will work are scant — federal officials buried the development in a document intended for health insurance companies. The directory will be in a testing phase to start. * * *
    • “The agency plans to conduct an initial beta launch of the National Provider Directory later this year, with iterative improvements and expansions to follow,” federal officials said in the guidance document for Medicare Advantage plans.”

From the Food and Drug Administrationm

  • BioPharma Dive reports,
    • “Going forward, the Food and Drug Administration will generally only require one pivotal trial to support the approval of new medicines, top agency officials announced Wednesday.
    • “Writing in the New England Journal of Medicine, FDA Commissioner Marty Makary and top deputy Vinay Prasad said they are ending the “two-trial dogma,” a standard set in the 1960s to ensure the safety and efficacy of medical products. Technological advancements mean the FDA and sponsors can now focus on designing one high-quality trial that can better assess results, they said.
    • “In practice, many drugs in recent years have sped to market with only one pivotal study, thanks to changes Congress made in 1997. But Makary and Prasad argued that a new official standard is needed. “Default options anchor individuals and institutions psychologically, and we believe that formally articulating the FDA’s new position will spur biomedical innovation,” they wrote.”
  • CNBC adds,
    • “Food and Drug Administration Commissioner Marty Makary told CNBC that he believes “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoring – doubling down on a push that some in the pharmaceutical industry have questioned. 
    • “In an interview Wednesday in Washington, D.C., Makary said the FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC. He noted that the agency is going through “the proper regulatory processes” to update OTC monographs –  the rulebooks that determine which drugs can be sold without a prescription. 
    • “Makary said the FDA is looking at “basic, safe” prescription drugs like nausea medications and vaginal estrogen, which is used to treat menopausal symptoms like dryness and pain. 
    • “In my opinion, everything should be over the counter and not requiring a prescription, unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it could be used for some nefarious purpose or it’s addictive,” Makary told CNBC after the PhRMA Forum, a one-day event organized by the pharmaceutical industry’s largest lobbying group.” 
  • Per MedTech Dive,
    • “Medtronic has received Food and Drug Administration clearance for a next-generation spine surgery system that combines artificial intelligence-based planning, real-time navigation and robotic assistance.
    • “The Stealth AXiS system has a modular design that can be used in both hospital settings and ambulatory surgery centers and can accommodate a range of surgeon preferences, Medtronic said Friday.
    • “The underlying architecture can also support cranial applications and ear, nose and throat surgeries, pending 510(k) clearance, according to the device maker.”
  • and
    • “The Food and Drug Administration posted an early alert Tuesday for a problem with certain Trividia Health blood glucose monitors linked to 114 injuries and one death.
    • “Earlier this month, Trividia issued a correction for four versions of its True Metrix blood glucose system. The company updated the devices’ instructions for use to clarify that patients should seek medical attention if they have symptoms of high glucose and receive an error code.
    • “The affected products may issue an error code in the case of a very high blood glucose result (higher than 600 mg/dL) or in the event of a test strip error, according to the FDA alert.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Data from the National Vital Statistics System
      • “After increasing from 2016 (77.1%) to 2021 (78.3%), prenatal care beginning in the first trimester decreased to 75.5% in 2024.
      • “From 2021 to 2024, care beginning in the second trimester increased from 15.4% to 17.3%, and late or no care increased from 6.3% to 7.3%.
      • “From 2021 to 2024, prenatal care beginning in the first trimester decreased, while care beginning in the second trimester and late or no care increased, for all maternal age groups.
      • “First trimester prenatal care decreased, while second trimester prenatal care and late or no care increased, for nearly all race and Hispanic-origin groups from 2021 to 2024.
      • “From 2021 to 2024, late or no care increased in 36 states and the District of Columbia.”
  • Cardiovascular Business adds,
    • Hypertensive disorders during pregnancy are being recognized more and more as early warning signs of what is yet to come.
    • “We’ve increasingly come to appreciate that pregnancy can really be seen as a red flag or a risk signal of long-term maternal cardiovascular risk when certain complications emerge,” said Michael Honigberg, MD, MPP, a preventive cardiologist and researcher at Massachusetts General Hospital.
    • These complications include preeclampsia and gestational hypertension. He said clinicians have known for more than 25 years that these hypertensive pregnancy disorders are associated with higher, long-term cardiovascular risks. However, widespread integration of this knowledge into daily practice has lagged behind. In fact, only recently have these ideas been embraced by the broader cardiovascular community.
    • “I think the lack of that next step in terms of what do as a cardiologist with that information has sort of hindered people,” Honigberg explained.
    • He emphasized that asking a woman about about pregnancy history takes one second and can yield critical insight into a patient’s future risk.
  • and
    • “After years of implanting left atrial appendage occlusion (LAAO) devices in atrial fibrillation (AFib) patients, an interventional cardiologist with the University of Chicago Medical Center (UChicago Medicine) has developed a new device that could be a more affordable alternative to Boston Scientific’s Watchman and Abbott’s Amplatzer Amulet LAA Occluder. 
    • “Atman P. Shah, MD, a professor of medicine and co-director of the cardiac cath lab at UChicago, found that the currently available devices for LAAO were still associated with significant limitations. Their round shape is a poor fit for many patients, for example, and they require active fixation. With these issues in mind, Shah developed a minimally-invasive device that seals the LAA using a gel that adapts to the AFib patient’s anatomy and then hardens. A catheter delivers the gel, and an umbrella-like piece at the end of that catheter protects the heart during treatment. 
    • “Shah believes this device will reduce the risk of stroke in these patients while also limiting the likelihood of adverse complications while it is being implanted by an interventional cardiologist.” 
  • The Washington Post reports,
    • “Scientists showed in a new study published Thursday that they could use blood draws to build a “clock” for Alzheimer’s disease that could roughly predict when symptoms will develop, findings that could eventually transform how the illness is diagnosed and treated.
    • “A simple blood test can help diagnose Alzheimer’s, but the study in the journal Nature Medicine shows how these kinds of tests could one day play a greater role in preventing the insidious, memory-robbing illness.In the new study, researchers built a model that could use blood test results to forecast symptom onset within a margin of three to four years.
    • “The technique is not yet precise enough to predict the course of a patient’s trajectory. But it could be used to identify which patients would benefit if companies are able to develop drugs to treat the disease before symptoms develop.
    • “In the short term, the approach could accelerate the research to identify such treatments by recruiting the ideal study participants: people withno symptoms, but who are at high risk for developing them soon.” * * *
    • “Suzanne E. Schindler, a dementia specialist at Washington University School of Medicine in St. Louis who helped lead the study, said she’s been involved with research studies that are attempting to test treatments before people have cognitive impairment. When those people receive a positive test, she said, they immediately ask: “So how long do I have before I develop symptoms?”
  • Medscape relates,
    • “Current research supports the idea that remission of type 2 diabetes is increasingly achievable.
    • “A 2023 study published in Diabetes Care showed that an intensive low-energy total diet replacement program in Australian primary care led to diabetes remission at 1 year in about half of the participants with recently diagnosed type 2 diabetes, with higher remission rates tracking with greater weight loss. Meanwhile, a September 2025 systematic review and meta-analysis in the same journal pooled 18 nonsurgical randomized controlled trials and found that structured interventions, particularly those producing substantial weight loss, consistently achieved clinically meaningful remission rates.
    • “Evidence from other journals points in the same direction.”
  • and
    • “The therapeutic variations among patients with chronic obstructive pulmonary disease (COPD) present ongoing treatment challenges. However, the two currently approved biologics, dupilumab and mepolizumab, have shown success for a subset of patients with type 2 inflammation, and more biologics are in the pipeline for COPD, said Don D. Sin, MD, a pulmonologist at the University of British Columbia, Vancouver, Canada, in a presentation at the 2025 GOLD International COPD Conference.
    • “Both dupilumab and mepolizumab were originally approved for asthma but were subsequently studied in patients with COPD who continue to experience symptoms and moderate-to-severe exacerbations despite other treatments and who demonstrate type 2 inflammation based on high blood eosinophil counts, Sin said. The biologics target inflammatory pathways to get to the root of the problem, he added.”
  • Per Health Day,
    • “Cumulative lead exposure is suggested as a potential dementia risk factor, according to a study published online Feb. 12 in Alzheimer’s & Dementia.
    • “Xin Wang, Ph.D., M.P.H., from the University of Michigan in Ann Arbor, and colleagues examined prospective associations between lead exposure and incident Alzheimer disease (AD) and all-cause dementia. Blood lead was measured at baseline and patella and tibia lead were estimated for 6,217 and 5,865 participants, respectively, from the National Health and Nutrition Examination Survey (NHANES)-III (1988 to 1994) and 8,038 and 4,824 participants, respectively, from continuous NHANES (1999 to 2016), and was then linked to Medicare and the National Death Index for incident AD and all-cause dementia.
    • “In continuous NHANES, the researchers found that when comparing quartile 4 with quartile 1, estimated patella lead was associated with AD and all-cause dementia (hazard ratios, 2.96 and 2.15, respectively). Weaker associations were observed in NHANES-III. No association was seen for blood lead.”
  • and
    • “Pain during pregnancy and after delivery can significantly increase a woman’s risk of postpartum depression, a new evidence review has concluded.
    • “Further, there are specific pain-related risk factors that influence the odds of postpartum depression among women in racial and ethnic minorities, researchers reported in the journal Current Psychiatry Reports.
    • “There are multiple interrelated factors that contribute to pain, particularly childbirth-related pain,” researcher Sudhamshi Beeram, a graduate student at the University of Illinois Urbana-Campaign, said in a news release.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “There’s “a hunger for a different kind of dialogue” when it comes to relations between payers and providers, according to Aetna President Steve Nelson.
    • “Mr. Nelson laid out a vision for Aetna that centers on rebuilding trust in the industry, an effort he said is already producing measurable results with some of the country’s largest health systems and that informed Aetna’s recognition as Press Ganey’s inaugural health plan of the year earlier this month.
    • “I can tell you firsthand that the provider community and provider organizations wake up every day trying to do good work. And so do payers,” Mr. Nelson told Becker’s. “I think if we can start with positive intent and change the dialogue — if we can focus on the patient and the member as opposed to our own issues — we end up in a better place.”
    • Mr. Nelson, who took the helm at Aetna in late 2024 after leading UnitedHealthcare and value-based primary care company ChenMed, said the insurer’s strategy rests on three themes: better navigation to help members move through a complex system, an advocacy mindset that treats member interactions as more than transactions, and stronger partnerships with providers.
    • “That last theme, he said, is one the industry needs to focus on getting right. The payer-provider dynamic “has not always been super constructive,” Mr. Nelson said, “and that needs to change. This idea that we can’t work together is not true.”
  • Fierce Healthcare relates,
    • “Despite a string of recent selloffs, executives told analysts Thursday that hospital deals are still likely on the table for Community Health Systems in 2026. 
    • “The Franklin, Tennessee-based for-profit, currently owns or leases 65 affiliated hospitals. It’s cut down its portfolio by about 35% since 2019, with a string of divestitures announced or executed in the past handful of months alone. 
    • “The dealmaking has helped the company turn its first cashflow-positive year in some time, and is fueling both increased investment into CHS’ remaining core hospitals as well as efforts to deleverage. 
    • ‘As of the end-of-year earnings call, Kevin Hammons, CHS director and CEO, told curious analysts that the company is “getting closer to the end of our programmatic divestitures,” but that it was still in the “early stages of discussions” for “a couple transactions” that aren’t guaranteed reach the finish line. CHS is still getting inbound interest on some of its other hospitals in strong markets, he said, but the company is less eager to let those facilities go.”
  • and
    • “In a fourth-quarter conference call, Insmed CEO Will Lewis admitted that it was “audacious” that his company would project sales of newly approved respiratory drug Brinsupri to reach $1 billion in 2026. Then he laid out the case of why the forecast isn’t so cheeky at all. 
    • “We have a number of different data sources we examine,” Lewis said on Thursday morning. “Across all the metrics, we’re seeing [numbers] at or above our targets and that’s very much behind why we have a conviction that we’ll do at least $1 billion in revenue in Brinsupri this year.”
    • “Approved in August with much fanfare as a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, Brinsupri was pegged by analysts at Mizuho Securities for a peak sales potential of $6.6 billion, but even they were surprised by its dynamic launch. Last month at the J.P. Morgan Healthcare Conference, Insmed revealed sales of $145 million in the fourth quarter, promptingMizuho to call it “a ginormous result.” 
    • “On Thursday, Lewis added that the launch “surpassed even our most ambitious expectations,” which were based on “a basket of historically strong respiratory launches as our guide.”
  • Healthcare Dive tells us,
    • “Telehealth use in primary care has held fairly stable in recent years, suggesting the sector has reached an equilibrium after a boom in virtual care amid the COVID-19 pandemic, according to an analysis by Epic Research. 
    • “Telehealth visits accounted for over 8% of primary care encounters in July 2022, according to the research published on Tuesday. By October 2025, telehealth made up just under 6% of visits — a roughly 30% decline. 
    • “But since 2023, the share of virtual care visits in primary care has held relatively steady at around 6% to 7% of appointments.”
  • Per Beckers Hospital Review,
    • “With cancer care growing beyond hospital walls and more cancer patients surviving than ever before, health systems in the U.S. are doubling down on their oncology infrastructure commitments.
    • “Cancer care can no longer be designed around treatment alone. We must intentionally redesignoncology as a continuum of care, where survivorship is not an afterthought but a core clinical strategy,” Robert Stone, CEO at Duarte, Calif.-based City of Hope, told Becker’s.
    • “As breakthroughs in precision diagnostics and cellular therapies accelerate at a rapid pace, leaders are tasked with balancing lifesaving but expensive cancer care investments with other system priorities.
    • “Hospital and health system leaders often underestimate the complexity of patient selection, treatment timing and site-of-care decisions,” Armin Ghobadi, MD, bone marrow transplant specialist and medical oncologist at St. Louis-based Siteman Cancer Center, told Becker’s. “Ultimately, successful immunotherapy programs depend on tight alignment between clinical expertise, operational authority and sustainable financial models — recognizing immunotherapy as an enduring service line rather than a one-time therapeutic event.”
  • and
    • “Select Medical, which operates more than 100 critical illness recovery hospitals in the U.S., plans to close its hospital in Meridian, Miss., by March 13. 
    • “In an online statement, Regency Hospital-Meridian said it is no longer accepting new admissions and will close on or before March 13.
    • “Regency Hospital-Meridian is a 40-bed facility on the second floor of Baptist Anderson Regional Medical Center-South, according to a Feb. 19 report from The Meridian Star. A Select Medical spokesperson told the Star the planned closure is an operational business decision and patients can receive care at Ochsner Specialty Hospital, also in Meridian.”

Midweek report

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

From Washington, DC,

  • The New York Times reports,
    • “The director of the National Institutes of Health, Dr. Jay Bhattacharya, will take on the additional role of acting director of the Centers for Disease Control and Prevention, two administration officials said on Wednesday.
    • “Dr. Bhattacharya will continue to run the N.I.H., according to the officials, who insisted on anonymity to speak about personnel decisions before President Trump announces them. He will serve until Mr. Trump appoints a permanent director — a position that now requires confirmation by the Senate.
    • “The C.D.C. has run through a series of leaders since Mr. Trump returned to the White House last year.
    • “A physician and medical economist who left Stanford University to join the Trump administration, Dr. Bhattacharya has no formal training in public health. But his research has focused on the well-being of populations, which is the core mission of public health, and thus the C.D.C.”
  • Bloomberg Law relates,
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz said Tuesday that potential legislation to codify the Trump administration’s plan to link US drug prices to lower prices in other countries would need to take into account the needs of the pharmaceutical industry. 
    • “I think we’ve established a deep passion to preserve innovation,” Oz said at an annual forum hosted by the Pharmaceutical Research and Manufacturers of America, as he discussed the Trump administration’s most-favored-nation proposal. “If it’s not done right, a future administration will take more drastic, draconian steps in ways that would hurt this industry.”
    • “Oz also said during his fireside chat at the PhRMA forum with Pfizer Inc. CEO Albert Bourla that he wanted to “codify MFN in a way that industry finds is reflective of what was signed in the contracts.”
  • The American Hospital Association tells us,
    • “The Department of Health and Human Services Office for Civil Rights Feb. 13 announced the launch of a program to implement and enforce statutory and regulatory requirements under 42 CFR Part 2, which protect the confidentiality of substance use disorder patient records. As of Feb. 16, the program uses a range of civil enforcement mechanisms, including civil money penalties, to ensure compliance with new provisions from section 3221 of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. This section aligns federal privacy standards for SUD records more closely with those under HIPAA and strengthens confidentiality protections. In compliance with the provisions, HHS OCR has begun accepting complaints of alleged confidentiality violations and SUD record breach notifications.”
  • Adam Fein, writing in his Drug Channels blog, let us know,
    • “The Centers for Medicare & Medicaid Services (CMS) has just released its initial 2026 data on enrollment in Medicare Part D prescription drug plans (PDPs).
    • “DCI’s exclusive analysis shows that 83% of seniors remain enrolled in PDPs with preferred pharmacy networks—essentially unchanged from 82% in 2025, but sharply lower than the 99% peak in 2023. Meanwhile, the number of major Part D plans offering preferred networks has fallen to a record-low eight.
    • “The new enrollment data reveal a clear shift in competitive positioning: Albertsons and Publix are now preferred in every major plan. Walgreens is holding strong. Walmart—the company that invented the Part D preferred network model—has slipped to the middle of the preferred pack.
    • “Meanwhile, smaller pharmacies have fully abandoned PDPs’ preferred networks in 2026. 
    • “At the same time, the IRA’s expansion of the Low-Income Subsidy (LIS) means a growing share of beneficiaries have little financial incentive to use a preferred pharmacy at all. Add in the PBM reforms in the Consolidated Appropriations Act of 2026, and the preferred network model will gradually lose relevance.” 

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration reversed course and agreed to begin a review of Moderna’s MRNA 6.08%increase; green up pointing triangle application to sell a new seasonal flu shot after the vaccine maker agreed to conduct additional testing in the elderly.
    • “The move means that Moderna’s experimental flu shot is largely back on track after the FDA’s surprise decision earlier this month to refuse to start a review of its application. The decision came after discussions with White House and health department officials, people familiar with the matter said. Moderna said it also met with the FDA and proposed a revised approach. 
    • “Now, the FDA will review the application and is expected to make a decision by August, though approval isn’t guaranteed. If approved, Moderna’s flu shot, mRNA-1010, could become available for the 2026-27 flu season.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration has accepted Bristol Myers Squibb’s approval application for its experimental multiple myeloma drug iberdomide, setting a decision deadline of Aug. 17, the company said Tuesday. The drug, from a new class of protein-degrading treatments, is intended for use in combination with Johnson & Johnson’s Darzalex and the steroid dexamethasone in people whose disease has advanced or become resistant to early lines of treatment.” 
  • MedTech Dive informs us,
    • “Medtronic has received Food and Drug Administration clearance for a next-generation spine surgery system that combines artificial intelligence-based planning, real-time navigation and robotic assistance.
    • “The Stealth AXiS system has a modular design that can be used in both hospital settings and ambulatory surgery centers and can accommodate a range of surgeon preferences, Medtronic said Friday.
    • “The underlying architecture can also support cranial applications and ear, nose and throat surgeries, pending 510(k) clearance, according to the device maker.”
  • and
    • “Medtronic said Tuesday that a surgeon completed the first U.S. procedure for its Hugo robotic surgery system, shortly after the company received Food and Drug Administration clearance for the platform.
    • “The first surgery was a prostatectomy procedure performed at the Cleveland Clinic. Along with the Cleveland Clinic, Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first hospitals in the U.S. to install Hugo, with Atrium Health being the first hospital in the U.S. to do so that was not part of the investigational device exemption clinical study.”
  • Beckers Hospital Review notes,
    • “The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy.
    • “Filkri is indicated for patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia undergoing induction or consolidation therapy, bone marrow transplant recipients, individuals with severe chronic neutropenia and patients exposed to myelosuppressive radiation.
    • “The biosimilar marks the sixth FDA-approved product in Accord BioPharma’s biosimilar portfolio and the seventh overall, according to a Feb. 17 news release.”

From the judicial front,

  • Bloomberg Law reports,
    • “A prominent US physicians group is suing the Trump administration, alleging it violated its free-speech rights over its public support of gender-affirming care for minors.
    • “The American Academy of Pediatrics said it was hit in January with a Federal Trade Commission civil investigative demand for a “sweeping array of information” that includes comments the group has made about gender dysphoria treatment and communications with other groups regarding the development of clinical guidance on gender-affirming care.
    • “Filed Tuesday in the US District Court for the District of Columbia, the complaint is the latest turn in an ongoing battle between the AAP and the Trump administration.
    • “The parties are fighting in another federal court over Trump administration vaccine policy under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr.”

From the public health and medical / Rx research front,

  • Progeny Health released its “2026 Progeny Health Trends Report — your essential guide to the evolving landscape of maternal and infant health in America.” Check it out.
  • Cardiovascular Business reports,
    • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
    • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
    • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
    • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.” 
  • Per a National Institutes of Health news release,
    • “A study in mice found that after a bone fracture, the nerves that sense pain also promote healing by signaling for bone repair and wound healing.
    • “The findings could lead to new treatments that stimulate bone repair and might be used to drive bone formation in bone disorders such as osteoporosis.”  
  • Per Healio,
    • “Less than 2 extra hours of walking per week could help mitigate the increased mortality risk among women with breast cancer who also have a higher genetic predisposition to obesity.
    • “An analysis of more than 4,000 women with breast cancer found those who have the highest value of genetic score genes linked to obesity had a 15% greater risk for death than those with the lowest value.
    • “However, if women in that highest tertile of the genetic score walked approximately 15 additional minutes per day, their mortality risk would be similar to those with lower scores.”
  • Per Health Day,
    • “A new advance might help doctors improve movement in people with Parkinson’s disease by tracking their gait-related brain waves in real time.
    • “An experimental brain implant can capture the signals of movement-related brain regions while Parkinson’s patients perform daily activities like walking to the kitchen or strolling through a park, researchers reported Feb. 13 in the journal Science Advances.
    • “What’s more, researchers have figured out how to read those brain recordings, allowing a deeper understanding of the gait problems associated with Parkinson’s, researchers said.”
  • Per Fierce Pharma,
    • “With their blockbuster obesity drugs, Eli Lilly and Novo Nordisk have uncovered a variety of ailments the incretin treatments can combat.
    • “Chalk up another new potential expansion for Lilly as it has found in a phase 3b trial that combining Zepbound and its autoimmune treatment Taltz can provide added benefits for psoriasis patients who are obese or overweight.” 
  • and
    • “Less than half a year after winning an inaugural green light in chronic hives, Novartis’ oral BTK inhibitor Rhapsido is jockeying to expand its urticaria reach into a new indication where it has the potential to become the first targeted therapy. 
    • “In top-line results issued Wednesday, Novartis revealed that a phase 3 trial of Rhapsido (oral remibrutinib) met its primary endpoint in patients with the three most prevalent types of chronic inducible urticaria (CIndU): symptomatic dermographism, cold urticaria and cholinergic urticaria. 
    • “Specifically, the company’s BTK inhibitor helped patients achieve “significantly higher complete response rates” compared with placebo after 12 weeks of treatment, Novartis said in a Feb. 18 press release.” 

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

  • Beckers Payer Issues points out
    • “Paul Markovich, president and CEO of Ascendiun, the parent company of Blue Shield of California, is not one to sugarcoat the state of the healthcare system.
    • “I don’t see how you can look at it and say there isn’t a fundamental problem. It’s systemic in nature,” Mr. Markovich said on the Becker’s Healthcare podcast.
    • “Mr. Markovich was one of five health insurance CEOs who testified before House lawmakers in January over the broad topic of rising healthcare costs. The hearings lasted more than nine hours and covered industry consolidation, prior authorization and executive compensation. Most people would be nervous to be summoned before Congress in general, much less to speak to lawmakers about controversial topics — but not Mr. Markovich.” * * *
    • “His message to the industry is blunt: Stop asking for more money.
    • “This is our new normal. We have to, as many other industries have, figure out how to make an impact and do better with fewer resources and be more productive. That has not been the mindset of the industry for most of my career,” he said.
    • “We have to get into a different mindset: How do we make healthcare affordable? We all have to be financially viable, but how do we make healthcare affordable and worthy of our family and friends? That means we have a cost problem that we need to address,” he added. “I’m hopeful that creating that kind of budgetary, top-down pressure helps create that mindset and gets us into a much more innovative phase in healthcare, one where we really are focused on how to make things better for the patient and more efficiently.”
    • “To listen to the full conversation with Mr. Markovich about PBM reform, the company’s efforts to unbundle pharmacy benefits and keep Blue Cross Blue Shield plans competitive, plus his scathing rebuke of fax machines, you can tune in here.“
  • Modern Healthcare reports,
    • “More than 20 health systems have teamed up in a bid to use technology to improve access to care in rural and underserved areas. 
    • “The National Specialty Care Access Coalition, which launched Wednesday, will prioritize standardizing care models, reforming policy and deploying pilots to speed innovation, a news release said.
    • The model enables shared learning and a unified perspective, among other advantages, according to its website.
  • MedCity News tells us,
    • “Daffodil Health, an AI platform for health plan administration and claims processing, has raised $16.3 million in Series A funding to help scale the company, it announced on Tuesday.
    • “The San Francisco-based startup provides AI-based software for U.S. health plans and third-party administrators to manage claims pricing and payment integrity. Its platform allows payers to handle out-of-network repricing in-house, using transparent benchmarks and real-time reporting. This work has historically been outsourced to vendors that have built “multi-billion dollar businesses sitting between providers and payers,” according to Navin Nagiah, CEO and co-founder of Daffodil Health. It offers a SaaS pricing model, versus a percentage-of-savings pricing model that companies like MultiPlan and Zelis use.
    • “We have automated that entire workflow end-to-end,” he said. “When a claim comes in, we benchmark it against market data, Medicare rates, historical allowed amounts by MSA, percentile distributions, and even provider-specific acceptance history. It takes minutes to configure, and then the system runs automatically claim by claim. Our goal is to give plans control, automation, and transparency at a fraction of the historical cost.”
  • Fierce Healthcare adds,
    • “Optum is rolling out a new AI tool that aims to address some of the key barriers to value-based care, from data fragmentation to administrative burden.
    • “The company said in an announcement on Wednesday that the Value Connect platform supports both payers and providers in value-based care work, leaning on artificial intelligence to surface ways to improve and identify areas where programs are underperforming. The tool can also identify and quickly facilitate interventions that improve outcomes, either directly or embedded within other platforms, Optum said. 
    • “The goal of Value Connect, per the company, is to make it easier for payers and providers to collaborate as well as improve the performance of value-based care programs.
    • “We’re accelerating the shift to value-based care by meeting payers and providers where they are in their journey,” said Beth Merle, senior vice president of provider enablement at Optum Insight, in the announcement. “The solution empowers organizations to proactively manage risk and costs while improving outcomes for the people they serve.”
  • Health Data Management informs us,
    • “Clinician turnover and burnout have been two of the core issues threatening healthcare, with staffing trends already having been exacerbated by the COVID-19 pandemic. 
    • “However, there are growing indications that some of the churn caused by revolving-door policies to staffing are abating. But a recent report suggests that some of the negative effects of staffing upheaval remain, including restrictions on access, rising cost pressures and inconsistent outcomes. 
    • “Still, the suggestion that staff churn is abating suggests that healthcare organizations are improving efforts to find appropriate clinicians and staff, and then keeping them happier and willing to stay where they are.” 
  • Per MedCity News,
    • “Eli Lilly has been scouting for drugs to follow the trail blazed by its blockbuster cardiometabolic medicines. Its latest pipeline-building deal has the pharmaceutical company paying $100 million for rights to a clinical-stage CSL Limited drug addressing an increasingly competitive target associated with chronic inflammation.
    • “Under deal terms announced late Tuesday, CSL retains rights to the drug, clazakizumab, for prevention of cardiovascular events in patients with end-stage kidney disease while Lilly gains rights in other indications. Lilly has not disclosed its plans for the antibody but cardiovascular disease has become a particular area of interest for the company and it’s also the focus of clinical-stage programs in clazakizumab’s drug class.
    • “Clazakizumab is a monoclonal antibody designed to bind to and block IL-6, a signaling protein that in excessive amounts plays a role in inflammation. While FDA-approved antibody drugs that block this target have already reached the market in certain inflammatory disorders, there’s renewed industry interest in expanding this approach to more diseases, particularly the inflammation that drives cardiovascular conditions.”
  • Per Fierce Pharma,
    • “With $55 billion earmarked to bolster its U.S. operations, Johnson & Johnson is the latest drugmaker to zero in on expansion plans that are aimed, at least in part, at abating the Trump administration’s pharmaceutical tariff threats. 
    • “J&J will spend more than $1 billion to build out a next-generation cell therapy production plant in Montgomery County, Pennsylvania, the company said in a Feb. 18 release. Once up and running, the facility will create some 500 new permanent biomanufacturing positions, not to mention more than 4,000 construction jobs while the plant is being developed, J&J said. 
    • “J&J did not lay out a timeline for the plant’s expected completion, nor did the company specify the types of “cutting-edge cell therapy technologies” it plans to employ at the new site. 
    • “Still, Wednesday’s announcement adds more color to J&J’s overall $55 billion U.S. investment plan, unveiled last March, which came with a pledge to construct three new domestic manufacturing sites and expand others in the company’s existing drug and medtech network.” 

Thursday report

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

Happy Lincoln’s Birthday

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC,

  • The Hill reports,
    • “The Trump administration on Monday proposed stripping the power of an independent board to review challenges from fired federal workers while barring employees from taking the matter to court.
    • “The new proposed rule would impact federal workers fired through a Reduction in Force (RIF), the process used at 22 different agencies last year as the Trump administration conducted widespread layoffs.
    • “If finalized, any federal worker fired in a future RIF would not be able to plead their case before the quasi-judicial Merit Systems Protection Board (MSPB), which last year found that some agencies had “engaged in a prohibited personnel practice” in firing the workers. 
    • “Instead, any challenges would be reviewed by the Office of Personnel Management (OPM), which last year alongside the Office of Management and Budget instructed agencies to begin RIFs.”
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) proposed regulations to lower health care costs, promote competition, and strengthen program integrity in the Federal and State-Based Health Insurance (Exchanges). The proposed Notice of Benefit and Payment Parameters for 2027 would crack down on fraud and misleading practices by agents and brokers, restore accountability for taxpayer-funded subsidies, and remove federal barriers that have limited plan innovation and driven up premiums—helping ensure coverage is more affordable and works better for consumers, taxpayers, and states.” * * *
    • “To review the proposed rule, visit https://www.federalregister.gov/d/2026-02769. 
    • “Public comments must be submitted by March 11, 2026. 
    • “To review the proposed rule fact sheet, visit https://www.cms.gov/newsroom/fact-sheets/hhs-notice-benefit-payment-parameters-2027-proposed-rule.” 
  • Bloomberg Law adds,
    • “The Notice of Benefit and Payment Parameters from the Centers for Medicare & Medicaid Services would allow certain plans that offer preset dollar amounts for care—such as indemnity plans—to meet the requirements of a “qualified health plan” under the ACA if they demonstrate a sufficient number of doctors would accept the plan’s payment terms.” * * *
    • “The rule likewise expands hardship exemptions to permit more individuals to buy “catastrophic” plans with the lowest level of cost-sharing and coverage, and allows catastrophic plan issuers to offer multi-year terms. The proposal would also permit plans with low deductibles and higher out-of-pocket costs
    • “The rule also reverses changes made under the Biden administration, including requiring insurers to offer standardized plan options that were meant to simplify choices.”
  • Healio observes,
    • “A voluntary program designed to help Medicare Part D beneficiaries manage drug costs[, which took effect last year,] could provide considerable benefit to people with cancer, according to study results.
    • “The Medicare Prescription Payment Plan (M3P) provides flexibility that may ease financial distress — particularly for those with limited or fixed incomes — and reduce the potential for cost-related treatment nonadherence, researchers concluded.”
    • “However, many patients and health care professionals are unaware of the program, according to Aryana Sepassi, PharmD, MAS, assistant professor of clinical pharmacy at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “The Food and Drug Administration’s breakthrough program has made a steady start to the 2026 financial year, granting designations at the same pace as in the two prior years.
    • “After years of growth that peaked in 2021, designations have settled at a lower rate in recent years. The agency awarded 164 to 166 designations per financial year three times from 2022 to 2025.
    • “The FDA is on course to grant a similar number of breakthrough designations in its 2026 financial year. After one quarter, the agency had awarded 42 designations, a pace that would result in 168 breakthrough statuses if maintained across the full financial year.”
  • MedPage Today tells us,
    • “Oncology specialists should inform patients about a risk of serious toxicity related to dihydropyrimidine dehydrogenase (DPD) deficiency and should test for DPYD variants before starting treatment with capecitabine (Xeloda) and fluorouracil, the FDA announced.
    • “In a safety update communicationopens in a new tab or window, the agency noted that DPYD encodes DPD, which breaks down more than 80% of fluorouracil. Certain homozygous or compound heterozygous DPYD variants result in complete or near-complete absence of DPD activity, increasing the risk for serious, potentially fatal toxicities when exposed to capecitabine or fluorouracil, which are widely used in cancer treatment. Potential adverse reactions include mucositis, diarrhea, neutropenia, and neurotoxicity. The reactions also can occur in patients who have partial DPD activity.
    • “Capecitabine and fluorouracil, or 5-FU, are routinely used in treatment regimens for breast, colorectal, gastric, and pancreatic cancers.”
  • STAT New informs us,
    • “The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday. 
    • “The one-time treatment, called RGX-121, is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome, an ultra-rare disorder that causes physical and cognitive impairments.”
    • “Regenxbio had applied for accelerated approval, a type of conditional market clearance, based on RGX-121’s ability to significantly reduce in the short term a specific biomarker in cerebrospinal fluid believed to correlate with longer-term cognitive improvements in patients with the severe form of Hunter syndrome. 
    • “But the FDA, in its letter rejecting the therapy, raised questions about the appropriateness of using the surrogate biomarker, called CSF HS D2S6, as a predictor of clinical benefit. The agency also questioned the eligibility criteria  Regenxbio used to enroll patients into its clinical trial and the use of a natural history comparator arm, the company said.”  

From the judicial front,

  • Bloomberg Law reports,
    • “Medical providers are testing a new legal strategy to recoup unpaid arbitration awards as health insurers rack up victories in surprise billing disputes.
    • “The shift underscores the difficulties both sides face in arbitration under the No Surprises Act, which requires doctors and insurers to settle most unexpected out-of-network bills themselves rather than balance-billing the patient. The volume of disputes has exposed cracks in the system, leading to a series of lawsuits around ineligible claims, fraud, and unpaid awards.
    • “Courts have largely concluded that the law doesn’t grant doctors the right to sue over unpaid awards in most circumstances. Most recently, the US Supreme Court denied two air ambulance companies’ petition to hear their case after the US Court of Appeals for the Fifth Circuit ruled against them.
    • “Providers are now adapting their legal strategy by arguing insurance companies are guilty of improper denial of benefits under the Employee Retirement Income Security Act and unjust enrichment under common law. Hundreds of cases in the US District Court for the District of New Jersey were paused last month pending a decision on the amended claims in Rowe Plastic Surgery of NJ LLC v. Aetna Life Insurance Co .
    • “But the doctors are likely to face problems, at least in overcoming ERISA preemption on their unjust enrichment claims, said Leslie Howard, co-founder of Cohen Howard, a firm representing out-of-network providers.”
  • The American Hospital Association News relates,
    • “The 5th U.S. Circuit Court of Appeals Feb. 9 affirmed a district court ruling upholding Louisiana’s 340B contract pharmacy law. The state law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. Three drug companies — AbbVie, PhRMA and AstraZeneca — challenged the law, arguing that it was unconstitutional in several ways. “Rejecting those arguments, the appeals court held that Louisiana’s law was not preempted by federal law, did not violate the Fifth Amendment’s Takings Clause, did not violate the Constitution’s Contract Clause and was not unconstitutionally vague. “States regulate pharmacies — and the distribution of drugs to those pharmacies — every day,” the 5th Circuit explained. “Act 358 fits comfortably within that tradition.
    • “The AHA filed friend-of-the-court briefs supporting Louisiana’s law last year.” 
  • The Society for Human Resource Management notes,
    • “On Feb. 6, a federal appeals court vacated a preliminary injunction of two executive orders (EO) — EO 14151 on “Ending Radical and Wasteful Government DEI Programs and Preferencing” and EO 14173 on “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” — finding they were not unconstitutional on their face. The court had previously stayed the injunction, pending appeal. This ruling was the first by a federal appeals court to find the two EOs facially constitutional. Both EOs focused on infrastructure inside the federal government with an emphasis on contracts and grants.
    • “EO 14173, issued Jan. 21, 2025, “was the most significant EO for the private sector” last year, said W. John Lee, an attorney with Morgan Lewis in Philadelphia. Established on May 19, 2025, the U.S. Department of Justice’s Civil Rights Fraud Initiative “is a direct result of the EO and is a prominent example of how it is reshaping federal enforcement of civil rights law.” EO 14151, issued Jan. 20, 2025, set the tone for EO 14173. EO 14173 reshaped compliance obligations for federal contractors and grantees. It also revoked EO 11246, ending EO-based affirmative action programs for women and minorities.
    • “On Jan. 21, 2025, U.S. Equal Employment Opportunity Commission (EEOC) Chair Andrea Lucas made it clear that the EEOC’s enforcement priorities had shifted in alignment with President Donald Trump’s EOs.
    • “While the 4th U.S. Circuit Court of Appeals vacated the injunction, it sent the case back to the district court for further proceedings and left open the possibility of challenges based on individual application of the EOs.”
  • The Wall Street Journal points out,
    • “A lawsuit that drugmaker Novo Nordisk filed on Monday against telehealth firm Hims & Hers shows how fierce the maneuvering over the booming obesity-drug market has become.
    • “In the lawsuit filed in a federal court in Delaware, Novo Nordisk accused Hims & Hersof violating the patents covering its Ozempic and Wegovy drugs used for weight loss by trying to sell custom-made versions of those medicines.
    • “The pill from Hims & Hers threatened to undermine Novo Nordisk’s efforts to recapture momentum in the $70 billion weight-loss drug market by providing a lower-cost alternative to a Wegovy pill the Danish company recently launched.
    • “Novo Nordisk has been pulling out the stops to reclaim the momentum it lost to Eli Lilly in the booming market.” 

From the public health and medical / Rx research front,

  • Health Day tells us,
    • “Americans could be facing an uphill battle when it comes to protecting their heart health as they age, a new Cleveland Clinic poll reveals.
    • “Nearly 3 of 4 Americans (72%) feel confident in their ability to maintain heart health as they age, the survey found.
    • “But nearly as many (69%) also report that they have at least one known risk factor for heart disease.
    • “Worse, nearly 1 in 4 (24%) aren’t sure whether they are at increased risk for heart disease, according to the survey.
    • “Healthy aging is about prevention,” said Dr. Samir Kapadia, chair of cardiovascular medicine at the Cleveland Clinic.
    • “Heart disease often develops silently over decades, which is why staying active, understanding your risk factors, and addressing them early can make a profound difference in both quality of life and longevity,” Kapadia said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about the shingles virus.”
    • “If you’ve ever had chickenpox, then the virus that causes shingles is present in your body and can resurface at some point in the future. Find out more.”
  • The New York Times relates,
    • “If you think your daily doses of espresso or Earl Grey sharpen your mind, you just might be right, new science suggests.
    • “A large new study provides evidence of cognitive benefits from coffee and tea — if it’s caffeinated and consumed in moderation: two to three cups of coffee or one to two cups of tea daily.
    • “People who drank that amount for decades had lower chances of developing dementia than people who drank little or no caffeine, the researchers reported. They followed 131,821 participants for up to 43 years.
    • “This is a very large, rigorous study conducted long term among men and women that shows that drinking two or three cups of coffee per day is associated with reduced risk of dementia,” said Aladdin Shadyab, an associate professor of public health and medicine at the University of California, San Diego, who wasn’t involved in the study.”
  • NBC News relates,
    • “Bad,” or LDL, cholesterol is a major risk factor for heart disease and most people are screened for it as part of their yearly physicals.
    • There’s another marker in the blood that may be a better predictor of heart disease risk, a recent large review suggests. But it’s not part of routine blood testing.
    • “Apolipoprotein B (apoB) is a protein that attaches to harmful fat particles in the blood. The apoB protein is found on the surface of harmful lipoproteins like low density lipoprotein, or LDL, that contribute to heart disease. Since each one of the harmful particles contains one apoB molecule, testing for it essentially captures the overall number of harmful plaque-producing compounds.” * * *
    • “ApoB testing is hot among health influencers and increasingly touted in the commercial blood testing market. Recently, the Sweetgreen salad chain — which has tied itself to anti-seed-oil influencers — launched a collaboration with the testing company Function Health and is promoting apoB screening along with its menus.
    • “Dr. Michael Shapiro, a preventive cardiologist and the chair of the American Heart Association Council on Lipidology, Lipoprotein, Metabolism & Thrombosis, said that he typically uses an apoB test in select patients.” * * *
    • “In some cases, insurance may cover the test. If not, it typically costs around $70 at a lab.
    • “There aren’t clear guidelines for what target apoB levels should be. In healthy people, apoB values less than 90 mg/dL are typically considered acceptable, with some saying lower targets closer to 70 mg/dL may be more optimal for preventing heart disease.”
  • MedPage calls attention to
    • “Most women said they preferred clinic-based cervical cancer testing over at-home self-sampling, with demographics and life experiences shaping those preferences, a cross-sectional study indicated.
    • “In a nationally representative survey, 20.4% of women said they would prefer to do their own at-home self-sampling for cervical cancer screening, while 60.8% said they prefer clinic-based testing and 18.8% said they were uncertain on their preference, reported Sanjay Shete, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA.
    • “The survey showed that women who had experienced prejudice or discrimination while receiving medical care had higher odds of preferring self-sampling at home (adjusted OR 1.94, 95% CI 1.16-3.22), while Black women had lower odds of preferring at-home self-sampling compared with their white peers (aOR 0.45, 95% CI 0.21-0.96).
    • “When women were asked why they preferred at-home self-sampling, privacy was the most common reason (54.9%), followed by time constraints (35.1%) and fear of embarrassment (33.4%).”
  • and
    • “The CDC’s Advisory Committee on Immunization Practices recently voted to stop recommending a universal dose of the hepatitis B vaccine at birth.
    • “An evidence review found that universal hepatitis B vaccination at birth is safe, effective, and protective for individual and public health.
    • “There was no improvement in safety or effectiveness with a delayed first dose of the hepatitis B vaccine.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a study using gut microbiome samples from over 11,000 people across 39 countries, a single group of bacteria (CAG-170) has been found in higher numbers in the gut microbiomes of healthy people. CAG-170 remain unculturable in the lab, and are only identifiable from their genetic fingerprints.
    • “Further analysis of CAG-170 revealed the bacteria have the capacity to produce high levels of Vitamin B12 and enzymes that break down a wide range of carbohydrates, sugars, and fibers in our gut. The researchers suggest that Vitamin B12 supports other species of gut bacteria, rather than supporting the humans whose guts it is being produced in. CAG-170 could, in the future, be used as an indicator of our gut microbiome health or serve as the basis for the development of probiotics specifically designed to support and maintain healthy levels of CAG‑170 in the gut.”
  • Per Cardiovascular Business,
    • “An oral PCSK9 inhibitor from Merck is associated with significant reductions in low-density lipoprotein (LDL) cholesterol, according to new data published in The New England Journal of Medicine.[1] All PCSK9 inhibitors on the market today are injectable—an oral option that does not require needles could make a major impact on patient care. 
    • “Fewer than half of patients with established atherosclerotic cardiovascular disease currently reach LDL cholesterol goals,” lead author Ann Marie Navar, MD, PhD, an associate professor of cardiology at the University of Texas Southwestern Medical Center in Dallas, said in a statement. “An oral therapy this effective has the potential to dramatically improve our ability to prevent heart attacks and strokes on a population level.”
    • “Back in November, researchers presented initial findings from this study at the American Heart Association’s Scientific Sessions 2025 conference. Now, however, the analysis can be read in full.
    • “The CORALreef Lipids trial focused on nearly 3,000 heart patients with high LDL cholesterol who were randomized to either receive enlicitide, Merck’s experimental oral PCSK9 inhibitor, or a placebo. Two patients received the new drug for every one patient treated with a placebo.”
  • Per Radiology Business,
    • “A new MRI-specific artificial intelligence tool could significantly improve the diagnosis of neurological conditions in busy settings. 
    • “Developed by researchers at the University of Michigan, the tool can read brain scans in just seconds. The tool, named Prima, is a video language model that can simultaneously process video, images and text in real time. Experts involved in its development are hopeful it can help address the rising imaging volumes.
    • “As the global demand for MRI rises and places significant strain on our physicians and health systems, our AI model has potential to reduce burden by improving diagnosis and treatment with fast, accurate information,” said senior study author Todd Hollon, MD, a neurosurgeon at U-M Health. 
    • “Researchers trained Prima using more than 200,000 MRI exams collected at the university over several decades. Imaging data were included alongside patients’ medical histories and clinical indications for the scans. The team tested the model on more than 30,000 brain studies over a one-year period. Unlike earlier AI tools that focus on just one disease, Prima was designed to analyze all available imaging and clinical information at once, similar to how a radiologist reviews a case, giving it broad applicability.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Kaiser Permanente nearly tripled its operating income last year, even as the integrated healthcare conglomerate weathered rising expenses.
    • “Kaiser, which recorded results alongside its subsidiary Risant Health, recorded operating income of $1.4 billion last year, up from $569 million in 2024 as the nonprofit continued to invest in operational improvements, according to earnings results released last week. 
    • “Still, expenses rose by more than $11 billion last year as Kaiser said rising medication costs and other line items made providing care more expensive.”
  • Beckers Hospital Reviews identifies eleven rapidly growing health systems.
  • BioPharma Dive relates,
    • “Eli Lilly will acquire biotechnology startup Orna Therapeutics, saying Monday it will pay up to $2.4 billion to buy the privately owned company and a technology able to reprogram immune cells within the body.
    • “The Indiana-based drugmaker didn’t disclose how much upfront cash it’s shelling out for Orna, which specializes in “circular” RNA medicines that are believed to be more stable and easier to pair with the lipid nanoparticles used for delivery. But it noted in its statement that it intends to use Orna’s technology to develop cell therapies for autoimmune conditions.
    • “In announcing the deal, Lilly cited its interest in Orna’s lead project, which instructs immune cells to latch onto B cells that are attacking patients’ tissue in inflammatory diseases. The company presented data from preclinical studies at the American Society for Hematologymeeting in December that it’s using to support advancing into Phase 1 studies.”
  • and
    • “Japan’s largest drug company is teaming up with an artificial intelligence specialist to find new medicines for cancer and other diseases, through a deal that could be worth more than $1.7 billion.
    • “Announced Monday, the multiyear collaboration grants Takeda Pharmaceutical access to two technologies at Iambic Therapeutics. The first is an AI-driven platform used to discover and develop new drugs. The second is a model meant to predict how proteins will interact with certain receptors.
    • “The companies haven’t disclosed the deal’s upfront cost, nor any specific disease targets. The focus, though, will be on small molecule drugs for cancers and conditions rooted in the digestive or immune systems. Iambic will get milestone payments based on the partnership’s level of success, and is also eligible to receive royalties on net sales of any products it generates.”
  • Per Beckers Payer Issues,
    • “Patients who take advantage of zero-cost preventive screenings see better health outcomes and reduced spending, according to January research from BCBS Association and Blue Health Intelligence.
    • “The groups reviewed claims data of BCBS members with breast or colorectal cancer. The research pointed to lower likelihood of invasive tests and treatment.
    • “Eighty-one percent of members who were diagnosed with colorectal cancer through a preventive screening were classified in an early stage, compared to a 73% rate overall. For breast cancer, that figure was 86% during preventive screening. The early-stage rate was 82% overall.” 
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “IgA nephropathy has historically been thought of as a relatively benign form of kidney disease, but it has become increasingly recognized that it frequently progresses to end-stage kidney disease,” said ICER’s Chief Medical Officer, David Rind, MD. “Management of progressive disease has typically included treatments targeted at B-cells, but such therapies, such as systemic glucocorticoids, have serious side effects. New therapies offer the possibility of better outcomes with fewer harms.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on February 26, 2026. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.”