Thursday report

Federal employment benefits

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.”

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.”

Tuesday Report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

Happy Lincoln’s Birthday

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health, medical and Rx research front,

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

From the U.S. healthcare business front,

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

Midweek report

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

From Washington, DC,

  • Roll Call reports,
    • “Republicans and Democrats sparred Wednesday on the potential real-world harms of a partial shutdown for the Department of Homeland Security, as Congress marched toward a funding deadline for the agency amid a dispute over immigration enforcement policies.
    • “The House Homeland Security Appropriations Subcommittee held a hearing with officials from five national security and emergency management agencies to highlight what would happen if a continuing resolution expires Saturday without further action from Congress.”
  • and
    • “Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. 
    • “At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries.
    • “But Guthrie stressed that further changes could be forthcoming.
    • “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.”
    • “Rep. Morgan Griffith, R-Va., chair of the Health Subcommittee, said after the hearing that he hopes to mark up affordability legislation before Memorial Day, but acknowledged the appetite for bipartisan cooperation will be “tough” given the political climate.” 
  • Beckers Payer Issues adds,
    • “Sens. Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., have introduced legislation that would ban health insurers and pharmacy benefit managers from owning medical providers, and would force companies in violation to divest within one year of the bill’s enactment.
    • :The “Break Up Big Medicine Act” would also prohibit a parent company of a prescription drug or medical device wholesaler from owning a medical provider or management services organization.”
  • The American Hospital Association tells us,
    • “The Senate Special Committee on Aging held a hearing Feb. 11 on issues impacting physician burnout. The AHA provided a statement for the hearing and urged Congress to pass legislation to address burnout, including the Improving Seniors’ Timely Access to Care Act (H.R. 3514/S. 1816), legislation that would streamline prior authorization requirements under Medicare Advantage plans by making them simpler and more uniform, and the Save Healthcare Workers Act (H.R. 3178/S. 1600), a bill that would make it a federal crime to assault a hospital employee. The AHA also urged Congress to pass the Resident Physician Shortage Reduction Act of 2025 (H.R. 3890/S. 2439), which would add 14,000 Medicare-funded residency positions over seven years.”
  • Per OPM news releases,
    • [On February 10, 2026], the US Office of Personnel Management (OPM) convened senior administration officials, federal agency leaders, and industry executives at the White House for a US Tech Force (Tech Force) roundtable focused on strengthening the federal government’s technology workforce and accelerating innovation across agencies.
  • and
    • “US Office of Personnel Management (OPM) Director Scott Kupor appeared on Fox Business to discuss the administration’s launch of the U.S. Tech Force, a new initiative aimed at strengthening the federal workforce with top technical talent and modernizing critical government systems.” You can watch the Director’s appearance here.
  • Govexec discusses the tax implications of making Roth IRA conversions in the Thrift Savings Plan.
    • “Beginning Jan. 28, the Thrift Savings Plan now allows participants to convert traditional (pre-tax) balances into Roth (after-tax) balances inside the TSP itself. This long-awaited change gives federal employees and retirees more flexibility over how and when they pay taxes on retirement savings.
    • “While the mechanics of the change are straightforward, the implications are not. A Roth in-plan conversion is a tax event and not just a retirement planning decision. Once it is made, it cannot be reversed. Knowing this beforehand helps you choose effective planning tools and avoid costly errors.”
  • Per an HHS news release,
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “ASTP/ONC released the draft USCDI v7 on January 29, 2026, proposing 29 new data elements and one significantly revised element to strengthen nationwide interoperability. Draft USCDI v7 expands standardized health data to support more efficient adverse event reporting, nutrition information exchange, and quality improvement, ultimately modernizing how health information is used across the entire health care system to Make America Healthy Again.”
    • “In the coming days, ASTP/ONC will launch the EHIgnite Challenge, a two-phase prize competition to improve the usability, readability, and actionability of single-patient electronic health information (EHI) exports. The EHIgnite Challenge will catalyze the development of tools and workflows, focused on the application of AI, that transform raw EHI into clear, usable information to better support care transitions, provider onboarding, and patient understanding and engagement. Awards will support both concept development and prototype solutions through 2027.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For all its success across a wide range of cancer types, Merck’s PD-1 superstar Keytruda has never been able to crack the code for one of the toughest-to-treat indications in oncology—ovarian cancer.
    • “But now, 13 years after the FDA initially blessed it for skin cancer, the U.S. regulator has approved Keytruda as a second- or third-line treatment for patients with a certain type of ovarian cancer.
    • “With the green light, Keytruda becomes the first immune checkpoint inhibitor approved for this indication. 
    • “Keytruda is to be used in combination with the chemotherapy paclitaxel and with or without Roche’s targeted cancer therapy Avastin. The endorsement covers those with platinum-resistant recurrent ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1-positive tumors. 
    • “The nod also covers infused Keytruda and its subcutaneous version, Keytruda Qlex, which the FDA blessed five months ago.” 

From the public health and medical / Rx resarch front,

  • STAT News reports,
    • “Food fights pitting low-carbohydrate diets against low-fat diets are off the mark when they aim at heart health, a large new study suggests. To reduce heart disease risk, it’s the quality, not the quantity, of those carbs or fats that matter. Diets high in plant-based foods, whole grains, and unsaturated fats led to better heart health, the researchers found. Low-fat dairy also got a nod when part of a diet featuring whole grains, vegetables, and fruits.
    • “Not all carbs are created alike; nor are all fats. Whole grains, fruits, vegetables, nuts, legumes, and olive oil are associated with lower risk of coronary heart disease (CHD), whether they contain carbohydrates or fats. But diets high in refined carbohydrates and animal proteins and fats were associated with a higher risk of heart disease, according to the new study, published Wednesday in the Journal of the American College of Cardiology.” 
  • MedPage Today relates,
    • “The CDC excludes homicide, suicide, and overdose in defining “maternal mortality,” instead focusing on more medical causes.
    • “An analysis of 2018-2023 data showed that drug overdoses, homicides, and suicides accounted for more than a quarter of all deaths among pregnant and postpartum women.
    • “Violence and overdose accounted for 2,018 deaths, while cardiovascular causes, hypertension, infection, and hemorrhage together accounted for 2,141 deaths [over the period 2018-2023].” * * *
    • “Maeve Wallace, PhD, MPH, of the Mel & Enid Zuckerman College of Public Health at the University of Arizona in Tucson, told MedPage Today that the results were not surprising.
    • “Research dating back decades finds that rates of violent death exceed obstetrical causes of death for pregnant women,” Wallace said. “What is disheartening is that this continues to be the case.”
    • “This analysis “can help policymakers concerned with maternal health understand pregnancy as a dangerous condition,” and can encourage policy-level solutions to promote women and girls’ health and safety, she added.”
  • and
    • “A meta-meta-analysis of randomized trials showed exercise reduced depression and anxiety symptoms.
    • “Group aerobic exercise appeared to be most effective for depression, while exercise of shorter duration and lower intensity was most associated with reductions in anxiety symptoms.
    • “The researchers concluded that tailored exercise programs are an “accessible and cost-effective” treatment option for depression and anxiety.”
  • Healio informs us,
    • “Statin use had a statistically significant protective effect against acute asthma exacerbations in mild asthma among Black adults and adults with obesity, according to data published in Annals of Allergy, Asthma & Immunology. 
    • “The pleiotropic effects of statins may extend beyond cholesterol control due to their anti-inflammatory and immunomodulatory properties, prompting interest in their potential use for chronic airway diseases, William Crawford, MD, physician with the department of allergy, Kaiser Permanente Southern California, and colleagues wrote.
    • “But mixed results in prior research including beneficial and null effects in asthma outcomes indicate that determining the patient subgroups that may benefit most from treatment is vital in determining the role that statins may have in asthma management.” 
  • The American Journal of Managed Care observes,
    • “More than half of patients with long-term conditions (LTCs) surveyed said they preferred a remote consult vs an in-person visit with their referring physician, particularly for discussion of results and medication renewal, according to a new study
       published in JAMA Network Open.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. economy added 130,000 jobs in January, its strongest growth in over a year, and a sign that the labor market may be shaking off its recent stagnation.
    • “January’s robust gains surprised forecasters, blowing far past consensus expectations, while solidifying expectations the Federal Reserve will keep rates on hold for the foreseeable future. The unemployment rate dipped to 4.3% from 4.4% in December, the Labor Department said Wednesday. And workers’ wages rose.
    • “The gains were highly concentrated in healthcare and social-assistance fields, which includes jobs like home health aides and residential care workers. Such jobs tend to grow regardless of the economy’s health and have long been an engine of U.S. job growth.”
  • Fierce Healthcare relates,
    • “Humana CEO Jim Rechtin acknowledged the noise around the latest Medicare Advantage rate notice and said that while the flat proposal is a concern, the company will continue to push forward on its performance improvements.
    • “He said that part of the challenge for policymakers, regardless of political alignment, is managing the program as it “sits at the intersection of U.S. fiscal pressures and a program that is incredibly popular with seniors.”
    • “Every administration wrestles with how to balance these two forces,” Rechtin said.
    • “We are committed to always protecting our consumers the best we can, and we are very aware that we must do that within the constraints of the annual funding environment,” he continued. “If that funding environment cannot fully support our benefit structure, then we will adapt as we have in the past.” * * *
    • “Humana reported a $796 million loss in the fourth quarter of 2025, with its losses growing year over year as increased utilization continues to drag Medicare Advantage (MA) plans.
    • “By comparison, Humana reported a $693 billion loss in the fourth quarter of 2024. The company did post a profit for the full year of $1.2 billion, flat from the company’s $1.2 billion haul in 2024.”
  • and
    • “Hinge Health’s shares were up 13% in after-hours trading Tuesday after the digital health company reported a strong fourth quarter and a bright outlook for 2026.
    • “The digital musculoskeletal (MSK) care provider, which went public in late May, brought in fourth-quarter revenue of $171 million, up 46% from the same period a year ago and easily topping Wall Street analyst estimate of $155 million for fourth-quarter revenue. The company posted fourth-quarter adjusted earnings of 49 cents per share, significantly exceeding analyst estimates of 14 cents per share. Hinge Health’s non-GAAP income from operations increased 124% to $48 million during quarter.
    • “Free cash flow for the quarter was $61.5 million, representing a free cash flow margin of 36%.
    • “The company’s full-year 2025 revenue jumped 51% year over year to reach $588 million compared to revenue of $390 revenue in 2024, according to its fourth-quarter and full-year financial results.” 
  • KFF lets us know,
    • “National spending on health has increased rapidly over time—rising to $5.3 trillion and 18% of GDP in 2024—and is projected to continue to do so into the future. Growth in health spending contributes to higher costs for families, employers, Medicare, Medicaid, and other payers. In 2025, average annual premiums for employer-sponsored family coverage reached $26,993, with workers paying $6,850 for their coverage, according to KFF’s annual survey of employers.  Hospital care accounted for nearly one-third of national health expenditures in 2024, and more than doubled in nominal terms over the preceding two decades, making hospitals a major driver of health spending growth over time.” * * *
    • “National health expenditures increased by $692 billion between 2022 and 2024, from $4.6 trillion to $5.3 trillion. During this period, spending on hospital care alone accounted for $277 billion of spending growth, or 40% of the total increase in national health spending (Figure 1). The large contribution of hospital care to overall health spending growth reflects the fact that hospital spending accounted for nearly a third of national health expenditures in 2022 (30%) and grew more quickly than national health expenditures overall in both 2023 (10.6% versus 7.4%) and 2024 (8.9% versus 7.2%).”
    • FEHBlog note — Hospitals and health systems are not included in the Break Up Big Medicine bill discussed above.
  • Beckers Hospital Review tells us,
    • “Dallas-based Tenet Healthcare reported $21.3 billion in revenue in 2025, up from $20.7 billion in 2024, as the system posted strong fourth-quarter results and outlined a positive outlook for 2026. For the fourth quarter, Tenet reported net operating revenue of $5.5 billion, compared to $5.1 billion during the same period in 2024.
    • “2025 extended Tenet’s track record of strong revenue growth, disciplined operations, improved margins and robust free cash flow generation,” Tenet Chair and CEO Saum Sutaria, MD, said in a Feb. 11 news release. “We see continued demand for acute care and ambulatory surgical services in our markets and are confident in our ability to execute on our strategy and achieve our full-year 2026 expectations.”
  • and
    • “There are 417 rural hospitals that are vulnerable to closure, according to a Feb. 10 report from Chartis, a healthcare advisory services firm. 
    • “Chartis’ Rural Hospital Vulnerability Index assesses more than a dozen indicators to identify which are statistically significant for determining the likelihood of closure.
    • “The number of overall rural hospitals vulnerable is down from 432 last year, but Chartis said there are “notable shifts at the state level.” In Tennessee, the percentage of vulnerable hospitals increased from 44% to 61%. In South Dakota, the percentage increased from 28% to 42%. Mississippi, which Chartis said has long been a “weak spot in the rural health safety net,” saw an improvement from 49% to 42%. Kansas also saw an improvement from 47% to 44%. 
    • “”Chartis’ analysis found that 17 states have 10 or more rural hospitals vulnerable to closure this year. Texas has the most with 50, followed by Kansas (44), Tennessee (27), Georgia (25), and Mississippi (24). These states are receiving a combined $1.1 billion in the first round of CMS’ Rural Health Transformation Fund initiative.”  
  • BioPharma Dive informs us,
    • “Shares of Gilead Sciences slid after the stock market closed Tuesday in spite of a fresh earnings report in which the company’s top products beat Wall Street forecasts.
    • “Gilead recorded $7.9 billion in product sales over the final three months of 2025, a 5% increase from the same period a year prior. Brian Abrahams, an analyst at RBC Capital Markets, called it a “strong commercial quarter” with “major beats” in Gilead’s HIV business, which was up 6% year-over-year.
    • “Biktarvy, a three-in-one pill for HIV treatment, and Descovy, a daily tablet often used to stave off infections from the virus, respectively brought in $4 billion and $819 million during the quarter. That’s higher than the roughly $3.84 billion and $720 million the average analyst had penciled in, according to Abrahams.”
  • MedTech Dive notes,
    • “Edwards said study data supporting earlier use of its Sapien heart valves to treat patients who have severe aortic stenosis without symptoms is changing clinical practice and helping to accelerate sales of the devices.
    • “The company on Tuesday posted a second consecutive quarter of double-digit sales growth in its transcatheter aortic valve replacement business.
    • “CEO Bernard Zovighian said momentum is coming from long-term data presented last fall confirming the durability of the Sapien valves and the “practice-changing” EARLY TAVR trial results that showed asymptomatic patients who had the procedure fared better than those who remained under clinical surveillance alone. Edwards is the only TAVR system with asymptomatic approval.”

Thursday report

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

From Washington, DC

  • Govexec reports,
    • “The House Oversight and Reform Committee on Wednesday unanimously advanced legislation aimed at updating the federal government’s buyout programs to encourage employees to leave.
    • “Voluntary Separation Incentive Payments are one of the government’s main tools for reducing agency headcounts, alongside Voluntary Early Retirement Authority and reductions in force. But VSIP offerings max out at $25,000, where the cap has sat since the 1990s.
    • “The Federal Workforce Early Separation Incentives Act (H.R. 7256), introduced by Rep. Nick Langworthy, R-N.Y., would remove the $25,000 hard cap on VSIP payments and replace it with a maximum of six months of a federal worker’s salary, subject to agency head approval. The new model is based off how federal agencies already calculate severance pay for laid-off feds.
    • ‘Langworthy said an update to the federal government’s buyout program was long-overdue, and that the changes will allow agencies to move more agilely—and humanely—in workforce planning.”
  • The Wall Street Journal relates,
    • “The Trump administration is planning to make it easier to discipline—and potentially fire—career officials in senior positions across the government, a move that would affect roughly 50,000 federal workers. 
    • “The U.S. Office of Personnel Management, which oversees the federal workforce, issued a final rule on Thursday that creates a category of worker for high-ranking career employees whose work focuses on executing the administration’s policies. Workers who fall into that category would no longer be subject to rules that for decades have set a high bar for firing federal employees.
    • “While political appointees at agencies are considered at-will employees who serve at the discretion of the president, career employees have long enjoyed strong job protections, including the ability to appeal firings, suspensions, or disciplinary action to an independent board. Workers that fall under the new category wouldn’t be able to appeal to the board.”
  • An OPM news release adds,
    • “The final rule was published for public inspection in the Federal Register on February 5, 2026, and will take effect 30 days after publication. Following the rule’s effective date, specific positions may be placed in Schedule Policy/Career by presidential executive order. Read Director Kupor’s blog post on the rule here.”
  • Tammy Flanagan, writing in Govexec, points out “the federal leave options employees can use when annual and sick time run out.”
    • “From unpaid leave to parental and military leave, federal workers have multiple options for time off under specific circumstances.”
  • STAT News informs us,
    • “President Trump on Thursday night is planning to announce the launch of TrumpRx, the website that he and his aides have touted for months as a platform aimed at lowering prescription drug prices. 
    • “The website, which uses technology from health care company GoodRx, is expected to display the cash prices — that is, the prices available when paying without insurance — for certain drugs and direct patients to other sites where they can buy the therapies. It’s part of Trump’s plan to lower drug prices in the U.S., but some experts are skeptical the platform will meaningfully affect affordability.” * * *
    • “TrumpRx will not sell medications. It is expected to be a searchable website that links to other sites through which patients can directly buy brand drugs. That might be a drug company’s own website, such as Eli Lilly’s LillyDirect or Novo Nordisk’s NovoCare Pharmacy, or an online pharmacy that partners with a drugmaker, such as Amazon Pharmacy and Truepill.”
  • The American Hospital Association News notes,
    • “The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology announced the selection of nine pilots as part of the Behavioral Health Information Technology Initiative to help improve behavioral health data exchange across care settings. The BHIT Initiative is a $20 million effort led by ASTP/ONC in coordination with the Substance Abuse and Mental Health Services Administration to support standard data elements and foster data exchange. The pilots, which will be completed by the end of this year, will be used to inform future standards, technical specifications, guidance and policy considerations. The pilots span across 45 exchange partners and eight states and Washington, D.C. The states are Colorado, Connecticut, Delaware, Florida, Massachusetts, North Carolina, Oregon and Rhode Island.”
  • Healthcare Dive calls our attention to the fact
    • “More than one-fourth of doctors enrolled in Medicaid didn’t actually deliver care to any Medicaid beneficiaries in 2021, according to new research adding to worries about low physician participation in the safety-net insurance program.
    • “Almost 28% of doctors enrolled in Medicaid were “ghost providers” and didn’t treat a single patient that year, the study published in Health Affairs on Monday found. Another 10% treated fewer than 10 patients, while the remaining 62.2% were standard or “core” providers treating the brunt of Medicaid enrollees.
    • “Participation varied widely by specialty, with psychiatrists most likely to be ghost providers and primary care physicians and cardiologists least likely to be ghost providers, the study found.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The nation’s top drug regulator said he wants to do away with pharmaceutical ads that employ “dancing patients, glowing smiles, and catchy jingles that drown out the fine print.” On Super Bowl Sunday, the drug industry will treat him to lounging football stars, a shouting DJ Khaled, and the soothing tones of Enya.
    • “Sunday’s game, the annual zenith of American advertising, is the first since Food and Drug Administration Commissioner Marty Makary began a self-described “crackdown” on drug marketing last year. And, based on the ads released in advance, little has changed in the eyes of the industry.” 
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply from the use of artificial petroleum-based colors to alternatives derived from natural sources. Companies will now have flexibility to claim products contain ‘no artificial colors’ when the products do not contain petroleum-based colors. In the past, companies were generally only able to make such claims when their products had no added color whatsoever — whether derived from natural sources or otherwise.
    • “The agency sent a letter to industry providing notice of the FDA’s intent to exercise enforcement discretion related to these voluntary labeling claims.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Chronic exposure to pollution from wildfires has been linked to tens of thousands of deaths annually in the United States, according to a new study. 
    • “The paper, published Wednesday in the journal Science Advances, found that from 2006 to 2020, long-term exposure to tiny particulates from wildfire smoke contributed to an average of 24,100 deaths a year in the lower 48 states.
    • “Our message is: Wildfire smoke is very dangerous. It is an increasing threat to human health,” said Yaguang Wei, a study author and assistant professor in the department of environmental medicine at Icahn School of Medicine at Mount Sinai. 
    • “Other scientists who have studied the death toll from wildfire smoke were not surprised by the findings. 
    • “The estimates they’re coming up with are reasonable,” said Michael Jerrett, professor of environmental health science at the University of California, Los Angeles who was not involved in the study. “We need more of them. It’s only if we’re doing multiple studies with many different designs that we gain scientific confidence of our outcomes.”
  • Bloomberg Law tells us,
    • “Chris Womack is one of a dwindling number of Texas ranchers who can remember fighting the New World screwworm, a once-vanquished pest threatening to make an unwanted encore in the US after its recent return to northern Mexico. 
    • “You never forget the smell,” Womack, 60, said of his first encounter with a calf being devoured by screwworm maggots. It was one of many he and his father would treat in the early 1970s as an outbreak of the parasite — which can kill cattle in less than two weeks — devastated Texas ranchers.
    • “More than 50 years later, Womack and other Texas cattlemen are bracing for the screwworm’s potential comeback. Cases are proliferating in a Mexican state that borders Texas, with the pest having escaped containment by an international eradication program that banished it for decades. Texas Governor Greg Abbott issued a disaster declaration last week to open up state resources for the screwworm response.
    • “The pest’s resurgence would squeeze the $130 billion US cattle industry, which is already struggling with a record-low herd and rising costs. The screwworm prompted the US to ban cattle imports from Mexico for much of the last 14 months, crimping American beef producers at a time when record prices for the meat are adding to the pressure on shoppers angry about the cost of food.”
  • MedPage Today lets us know,
    • “New research challenged the longstanding belief that autism is much more common in males versus females.
    • “In a Swedish study of 2.7 million people, male-to-female ratios in autism diagnoses were nearly equal by age 20.
    • “Diagnosis rates peaked earlier for males, but females experienced a significant catch-up in adolescence.”
  • Genetic Engineering and BioTechnology News relates,
    • “Some types of CD8+ T cells (killer T cells) may play a role in the development of multiple sclerosis (MS). This is according to data from a new study published in Nature Immunology. Specifically, scientists found specific T cells that are abundant in people with MS, which also target the Epstein-Barr virus (EBV). They suggest that this points to a possible role for the virus in triggering the immune response seen in the autoimmune disease.   
    • “Full details are published in a paper titled “Antigen specificity of clonally enriched CD8+ T cells in multiple sclerosis.” For Joe Sabatino, MD, PhD, senior author on the study and an assistant professor of neurology at University of California, San Francisco’s Weill Institute for Neurosciences, “these understudied CD8+ T cells [connect] a lot of different dots.” That is because scientists have known for several years that EBV, a common virus carried by about 95 percent of adults, is present in virtually everyone who develops MS. This data “gives us a new window on how EBV is likely contributing to this disease,” he said.” 
  • Per BioPharma Dive,
    • “Bayer’s experimental blood thinner asundexian cut the relative likelihood of a repeat stroke by 26% without increasing the risk of internal bleeding, the company said Thursday, boosting hopes that the company might become a new option for “secondary treatment” of the disorder.
    • “The news could also elevate the outlook for medicines like asundexian, which are called Factor XIa inhibitors and are being advanced by a handful of the world’s largest pharmaceutical companies.
    • “Members of that drug class, including asundexian and a similar therapy from Bristol Myers Squibb and Johnson & Johnson, have previously suffered clinical setbacks in different types of cardiovascular illnesses. But asundexian’s success, first announced in November, lifted Bayer shares and indicated the drugs might be able to fulfill at least some of their commercial potential.
    • “The German drugmaker released full data from its positive study, “Oceanic-Stroke,” at the International Stroke Conference in New Orleans on Thursday.” 
  • Per the AP,
    • “A new kind of pill sharply reduced artery-clogging cholesterol in people who remain at high risk of heart attacks despite taking statins, researchers reported Wednesday.
    • “It’s still experimental but the pill helps rid the body of cholesterol in a way that today can be done only with injected medicines. If approved by the Food and Drug Administration, the pill, named enlicitide, could offer an easier-to-use option for millions of people.
    • “Statins block some of the liver’s production of cholesterol and are the cornerstone of treatment. But even taking the highest doses, many people need additional help lowering their LDL, or “bad,” cholesterol enough to meet medical guidelines.
    • “In a major study, more than 2,900 high-risk patients were randomly assigned to add a daily enlicitide pill or a dummy drug to their standard treatment. The enlicitide users saw their LDL cholesterol drop by as much as 60% over six months, researchers reported in the New England Journal of Medicine.”

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

  • Healthcare Dive reports,
    • “Cigna posted fourth quarter 2025 results Thursday morning that outperformed analysts’ consensus expectations, with adjusted revenue of $72.5 billion up more than 10% and adjusted operational income of $2.1 billion up 16%.
    • “Cigna Healthcare, the company’s insurance division, saw its revenue drop 16% in the quarter due to the sale of its Medicare Advantage business to Health Care Service Corporation. Cigna Healthcare’s operational income rose 44% year over year, however, after the company jacked up premiums for its stop-loss products after seeing those costs spike in the fourth quarter of 2024.
    • “But the lion’s share of attention on Thursday morning’s call was devoted to Express Scripts, and how the FTC settlement might impact the massive PBM’s profits.
    • “Short answer? It won’t, executives said.”
  • BioPharma Dive relates
    • “Hims & Hers Health is launching a copycat form of Novo Nordisk’s newly launched obesity pill, ushering in the latest contentious battle between the makers of branded weight loss medications and their drug-compounding counterparts. 
    • “Hims said Thursday that it’s now enabling healthcare providers to prescribe a compounded pill with the same active ingredient, semaglutide, as Novo Nordisk’s oral Wegovy. That treatment will be sold as part of treatment plans that begin at $49 for the first month — $100 lower than the price Novo is charging under a deal with the Trump administration. Hims also claimed that its treatment is formulated differently and involves a different delivery method to protect the active ingredient during digestion. 
    • “In a statement issued in response to Hims’ announcement, Novo spokesperson Ambre James-Brown called Hims’ move “illegal mass compounding and deceptive advertising” and threatened litigation. The compounder is “unlawfully” mass-marketing an “unapproved, inauthentic, and untested knockoff” of Novo’s medication, she said.” 
  • Modern Healthcare tells us,
    • “Adtalem Global Education has become Covista, the Chicago-based education company said, with a plan to expand its healthcare career network.
    • “Covista serves nearly 100,000 students and has a community of 385,000 alumni across its five accredited institutions.
    • “Covista touts it puts 24,000 new professionals annually into the healthcare workforce — more than any other U.S. institution — including 10% of America’s new nurses.”
  • Beckers Payer Issues lets us know,
    • “Participating Medicare Part D plans can officially begin covering weight-loss treatment in 2027. 
    • “The initiative falls under CMS’ voluntary “Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth” — or BALANCE — model. The December news followed President Trump’s negotiations with Eli Lilly and Novo Nordisk to secure most-favored-nation pricing for drugs that treat obesity, diabetes and related conditions.
    • “To better understand Medicare usage and spending shifts, KFF analyzed CMS data from 2019 through 2024 [as discussed in the article].
  • and
    • “Here are 12 payer tools that achieved “Best in KLAS” recognition for 2026:
      • “Care management solutions: Cognizant (TriZetto CareAdvance Enterprise) 
      • “Claims & administration platforms: Cognizant (TriZetto Core Claims/Administration Solutions)
      • “CMS payer interoperability: Edifecs (XEngine Server for FHIR)
      • “Data analytics platforms: Innovaccer (Healthcare Data Platform)
      • “Payer/provider data exchange: Moxe (Digital ROI)
      • “Post-payment accuracy & integrity solutions: Trend Health Partners (TRENDConnect) 
      • “Pre-payment accuracy & integrity solutions: HealthEdge (Source)
      • ‘Quality measurement & reporting: Inovalon (Converged Quality) 
      • “Risk adjustment (coding, retrieval & compliance solutions): Datavant (Risk Adjustment Suite)
      • “Risk adjustment (POC & in-home health assessments): Cozeva (PayerOne Risk)
      • “IT consulting services: Huron
      • “Employer-sponsored healthcare services: Premise Health
    • “The full report is accessible from KLAS Research here.“
  • Per Beckers Hospital Review,
    • “Chicago-based CommonSpirit Health now has 242 artificial intelligence applications live across its hospitals, up from 230 last year.
    • “We are expanding our use of AI across CommonSpirit by deploying new capabilities and scaling the most impactful of our existing tools,” CIO Daniel Barchi told Becker’s.
    • “In 2025, the health system generated more than $100 million in annual savings through its use of AI and robotic process automation tools across multiple areas of the organization. Mr. Barchi said the value generated in fiscal year 2026 is expected to exceed last year’s total.
    • “More important than the financial impact is the expanded clinical and operational value we are seeing from these tools — value that is not measured only in dollars,” he said. “Our sepsis surveillance tool has contributed to continued reductions in sepsis-related mortality. Screening tools for colon and breast cancer are helping us identify high-risk patients, leading to thousands of additional screenings. AI tools for imaging are reducing scan times by up to 50%, supporting a better experience for patients and providers.”
    • “As CommonSpirit expands its AI footprint, Mr. Barchi said the health system has also declined or scaled back AI tools that failed to deliver expected value.”

Tuesday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

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

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

Thursday report

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

From Washington, DC

  • The New York Times reports,
    • “Senate Democrats have struck a deal with Republicans and the White House to pass five spending bills to fund a large portion of the government for the remainder of the fiscal year, as well as a stopgap measure to fund the Department of Homeland Security for two weeks while they continue negotiating guardrails to rein in immigration agents. Republicans had pushed to fund the department for several weeks, but Democrats insisted on a shorter-term measure. It is unclear how quickly the House can and will process those funding bills after the Senate passes them. The shutdown deadline is midnight on Friday.”
  • The Washington Post lets us know which government operations will remain open in the event of a partial shutdown.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced the appointment of a new Chair and 10 new public members to the Advisory Council on Alzheimer’s Research, Care, and Services. Established in 2011 under the National Alzheimer’s Project Act (NAPA), the Advisory Council meets quarterly to advise the Secretary on reducing the burden of Alzheimer’s disease and related dementias.” * * *
    • “The new Chair is Michelle Branham, Secretary of the Florida Department of Elder Affairs. Appointed by Florida Governor Ron DeSantis in 2021, Secretary Branham leads the state agency serving nearly 6.5 million Floridians. She brings more than 25 years of experience in Alzheimer’s disease public policy, public health, and public relations.”
  • Healthcare Dive tells us,
    • “The Trump administration has negotiated deals with major Medicaid systems vendors that it says will save states hundreds of millions of dollars as they hustle to implement massive changes to the safety-net insurance program from the GOP’s “Big Beautiful Bill.”
    • “On Thursday, CMS officials shared a list of 10 companies that have agreed to provide IT services and products at low or no cost to states to help them stand up work requirements, a controversial policy tying Medicaid eligibility to work or other approved activities.”
  • and
    • “Almost 23 million Americans signed up for health insurance coverage on the Affordable Care Act exchanges this year, the CMS said on Wednesday. That’s down 5% from last year’s record high, but not the nosedive some market watchers predicted given steep premium increases for ACA plans.
    • “Some 3.4 million people are new to the marketplaces, while 19.6 million already had ACA coverage and re-enrolled.
    • “Enrollment trends differ across the country. Much of the volume was driven by Texas alone, where more than 200,000 additional people signed up for coverage in 2026 compared to 2025. Texas led the pack of 9 states and Washington, D.C. that had more residents sign up for ACA plans. The remaining 41 states experienced enrollment declines, with particularly steep drops in North Carolina, down 22%, and Ohio, down 20%.”
  • Bloomberg Law relates,
    • “President Donald Trump on Wednesday announced the nomination of a veteran federal prosecutor to lead a new Justice Department unit focused on fraud, as the administration looks to refocus attention on the justification for its immigration crackdown in Minnesota that has grown increasingly unpopular.
    • “Trump, in a post on his Truth Social platform, nominated Colin McDonald as “assistant attorney general for national fraud enforcement,” a role that requires Senate approval.”
  • and
    • “The Trump administration proposed a rule Thursday requiring transparency in pharmacy benefit managers’ compensation and referral fees they pay to brokers.
    • “The proposed rule (RIN: 1210-AB37) is part of President Donald Trump’s broader push on price transparency in the health-care sector, where PBMs have come under fire for what critics say is opaque and anticompetitive behavior. 
    • “The Labor Department released the proposal after an executive order Trump signed in February 2025. The rule follows recent updates to a set of price transparency rules for health insurers and hospitals that Trump initially finalized in his first term.” * * *
    • “The rule would require PBMs and affiliated brokers to disclose their compensation to fiduciaries of self-insured health plans under the Employee Retirement Income Security Act, so they can “assess the reasonableness of the contracts” required under ERISA and the Consolidated Appropriations Act of 2021 (CAA).”
    • The public comment deadline is March 31, 2026.
  • Tammy Flanagam writing in Govexec, offers a summary of the “annual adjustments to retirement benefits, FEHB costs, Social Security rules and TSP limits are now taking effect” for federal and postal annuitants.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Combining two eye drops that have been on the market for at least 30 years each has earned Tenpoint Therapeutics an FDA approval (PDF) for Yuvezzi, a treatment for presbyopia, a common, age-related condition that makes it difficult to focus on nearby objects.
    • “Yuvezzi, which is a solution of 2.75% carbachol and 0.1% brimonidine tartrate, becomes the first combination treatment for presbyopia, which affects roughly 2 billion around the world and 128 million in the United States.
    • “Carbachol reached the market in 1972 as Alcon’s Miostat to dilate pupils during cataract surgeries. Brimonidine tartrate was commercialized in 1996 by Allergan as an ocular hypertension eye drop and most recently by Bausch+Lomb as Lumify, a treatment to reduce eye redness.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Life expectancy in the U.S. reached a record high in 2024 following a substantial decline of drug-overdose deaths, according to figures released by the federal government Thursday.
    • “The life expectancy at birth for the average American was 79 years old in 2024, up 0.6 year from the year prior, according to a report from the Centers for Disease Control and Prevention’s National Center for Health Statistics. The increase signals a rebound from declines in life expectancy during the coronavirus pandemic and progress in combating the opioid crisis.
    • “The agency reported that deaths related to drug overdose decreased by more than 26% between 2023 and 2024, marking the largest year-to-year drop in those types of fatalities recorded by the federal government.
    • “You’ve got those two things working together: improvements coming out of the pandemic and then declines in overdose deaths,” said Robert Anderson, chief of the Statistical Analysis and Surveillance Branch at the National Center for Health Statistics. “The result is increased life expectancy to a level a little bit higher than what we saw prepandemic.”
  • The New York Times tells us,
    • “Your potential life span is written in your genes, according to a new study. You can lengthen it a bit with a healthy lifestyle. But if your genetic potential is to live to be 80, for example, it is unlikely that anything you do will push your age at death up to 100.
    • “That, at least, is the conclusion of a paper published Thursday in Science.
    • ‘Uri Alon of the Weizmann Institute of Science in Israel and other researchers drew the data for the study from three sets of data from pairs of Swedish twins, including one set of twins that was reared apart. To test how generalizable the results are, the group also examined data from a study of 2,092 siblings of 444 Americans who lived to be over 100. Their goal was to identify outside factors that can affect how long someone lives, like infections or accidents, separate from the intrinsic factor of genetics.
    • “They report that aging is mostly hereditary, a conclusion that flies in the face of much conventional medical wisdom regarding dieting, exercising and healthy habits. These habits are important for the quality of a person’s life, but they run into another form of conventional wisdom: You can’t make someone into a centenarian, unless that person also has a genetic inheritance of longevity.”
  • NBC News adds,
    • “The early bird may not only catch the proverbial worm but also have a healthier heart, new research suggests.
    • “People who naturally stay up late, self-described night owls, are likelier to have poor heart health than people with more traditional sleep-wake schedules, according to a study published Wednesday in the Journal of the American Heart Association.
    • “The findings were particularly strong among women.”
  • MedPage Today notes,
    • “Roughly 126 million U.S. adults ages 20 and older are projected to have obesity by 2035, according to estimates from a cross-sectional analysis.
      “In 1990, 19.3% of U.S. adults had obesity; in 2022, this rose to 42.5%. By 2035, 46.9% of the adult population is expected to have obesity, reported Catherine O. Johnson, PhD, MPH, of the Hans Rosling Center for Population Health in Seattle, and colleagues.
      “The results, with data collected over three decades, provide insight into future levels of persons living with obesity, if past trends continue. Effective policies may be identified by examining populations with consistently lower rates of obesity,” Johnson and her team wrote in JAMA.”
  • Genetic Engineering and BioTechnology News points out,
    • “Organoids have helped create a comprehensive map showing how eight different genetic mutations associated with autism spectrum disorder affect early brain development. This work provides new insights into the ways diverse genetic causes may lead to shared features and symptoms of the disorder.
    • “Over the past two decades, more than 100 genes harboring rare mutations linked to autism have been identified. This genetic heterogeneity has raised a fundamental question: if autism can be caused by so many different genetic changes, why do individuals with autism often share common features?
    • “A new study published in Nature in the paper, “Developmental convergence and divergence in human stem cell models of autism,” provides new insights by demonstrating that while different mutations affect the developing brain in initially distinct ways, they increasingly impact overlapping molecular pathways as development progresses.”

From the U.S. healthcare business front,

  • The Health Care Cost Institute reports,
    • “Urgent care spending among people with employer-sponsored insurance increased by more than 50% from 2018 to 2022, according to a new analysis released today by the non-profit Health Care Cost Institute (HCCI). Unlike most health care categories where rising prices have driven spending growth, this increase was fueled primarily by a sharp rise in utilization.
    • “Urgent care centers have become a critical access point for patients seeking timely care, and this was especially true during the pandemic,” said Katie Martin, president and CEO of HCCI. “Our analysis shows that while prices remained relatively stable, utilization skyrocketed – underscoring the role urgent care plays in meeting patient needs outside traditional settings. While urgent care may be filling a critical gap and easing ER demand, with spending up 50% over five years it deserves close attention from employers, insurers and policymakers.”
  • The Wall Street Journal relates,
    • “Drugmakers are doing something unusual this year: slashing prices for several widely used medicines.
    • “The companies made their typical round of price increases to start the year. In addition, they also made big cuts to U.S. list prices for widely used drugs for diabetes, blood clotting and other conditions.
    • “A big factor: federal government policy changes, including lower prices that Medicare negotiated and took effect for the first time this year.
    • “All told, 20 brand-name drugs had list-price cuts this month, ranging from 9.8% to 91.7%, according to 46brooklyn Research, a Dayton, Ohio-based firm that analyzes drug pricing.
    • “Among them were a 43% cut to the list price for bloodthinner Eliquis from Pfizer and Bristol-Myers Squibb and a 44.4% drop for diabetes treatment Jardiance from Boehringer Ingelheim and Eli Lilly.
    • “These are heavyweight drugs, and to see them crater in price like this is historic,” said Antonio Ciaccia, chief executive of 46brooklyn.
    • “For patients who have to pay the full price or a copay based on a percentage of list price, the price cuts will mean lower costs. Patients with insurance who pay a fixed monthly copay might not see much of a change.”
  • Modern Healthcare tells us,
    • “Hospitals discharge about 40% of patients to post-acute care, but not always to the most appropriate setting.
    • “Some health systems have special teams to ensure patients go to the correct place for additional care.
    • “Providers are successfully appealing some denials by insurers for referrals to nursing homes and inpatient rehab facilities.”
  • Per Beckers Hospital Review,
    • “The Pennsylvania Department of Health on Jan. 28 approved Franklin, Tenn.-based Community Health Systems’ plan to sell its three Pennsylvania hospitals to the Tenor Health Foundation. 
    • “The approval comes after CHS, a for-profit system, signed a definitive agreement in October to sell Commonwealth Health to Tenor, a newly formed nonprofit organization. 
    • “Under the deal, Tenor will acquire Regional Hospital of Scranton (186 beds), Moses Taylor Hospital in Scranton (122 beds) and Wilkes-Barre General Hospital (369 beds).
    • “The sale would see CHS exit the Pennsylvania market. CHS previously attempted to sell the hospitals to WoodBridge Healthcare for $120 million in 2024, but the deal collapsed because WoodBridge was unable to satisfy the funding requirements.  
    • ‘CHS and Tenor will now work to finalize the transaction “as quickly and smoothly as possible,” a CHS spokesperson told Becker’s in a statement. The terms of this deal were not disclosed.”
  • Per Radiology Business,
    • “Premier Radiology Services is acquiring another rival teleradiology group, the private equity-backed imaging outfit announced on Wednesday. 
    • “The Deerfield Beach, Florida-based company said it has reached a deal to buy National Radiology Solutions, or NRad, for an undisclosed sum. Founded in 2013 by industry veteran Robb Kolb, MBA, Premier said NRad is a “highly regarded teleradiology provider,” known for its “deep expertise” across all subspecialties. 
    • “Adding the Winter Garden, Florida-based firm will allow Premier Radiology to grow its national footprint, strengthen clinical coverage and enable more efficient interpretations.
    • “Welcoming the NRad team marks another important milestone for Premier and meaningfully expands the scale and capabilities of our platform,” CEO Andy Copilevitz, MBA, said in a statement Jan. 28. “Our organizations share a deep commitment to advancing the practice of teleradiology and supporting the physicians who make it possible.”
  • Per Fierce Healthcare,
    • “Sword Health, a company that provides an artificial-intelligence-first care model, plans to acquire rival Kaia Health for $285 million, the company announced Wednesday.
    • “Kaia, which has headquarters in New York and Munich, is a digital therapeutics company focused on musculoskeletal (MSK) and pulmonary care.
    • F”ollowing the acquisition, Sword will move Kaia’s U.S. members onto its MSK platform, the company said in a press release. Kaia’s millions of American members will gain access to Sword’s expanded AI Care platform.” 

Notable Obituary

  • The New York Times reports,
    • “Dr. Angella D. Ferguson, a pediatrician whose groundbreaking research aided in the early diagnosis and treatment of sickle cell anemia, a painful and deadly disease that disproportionately afflicts people of African descent, died on Jan. 6 at her home in Chevy Chase, Md. She was 100.
    • “Her death was confirmed by her nephew Roger W. Ferguson Jr., an economist and former vice chairman of the Federal Reserve.
    • “Dr. Ferguson was one of a small group of pediatricians — including Yvette Fay Francis-McBarnette and Doris Wethers — who as Black women physicians were rarities for their time, and who as researchers focused on sickle cell, a field that many white clinicians had overlooked.”
  • RIP