Tuesday report

NCQA

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NCQA, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House voted Sept. 1 on a continuing resolution (H.R. 6500) to fund the federal government through Dec. 11. The measure passed on a 370-48 bipartisan vote; the Senate passed its version by a vote of 90-6 on Aug. 8. The CR delays the Office of Management and Budget from finalizing its federal financial assistance proposed rule and prohibits any similar measure from being issued or finalized prior to Dec. 11. The AHA July 13 commented with concerns about the proposed rule, which would revise the Uniform Grants Regulation governing federal financial assistance.”
  • and
    • “The AHA Aug. 31 submitted comments urging the National Association of Insurance Commissioners Health Care Affordability and Mitigation Working Group to take a more comprehensive approach to evaluating healthcare affordability policies in a series of issue briefs being developed as a resource for state regulators and policymakers. The AHA called on the working group to assess consumers’ total financial burden, including premiums, deductibles, cost sharing and access to care, rather than focusing solely on any one measure, such as premium reductions or payer savings. The AHA also encouraged the working group to provide balanced analyses of policy options, including potential tradeoffs and unintended consequences, and to consider how health plan practices, such as prior authorization requirements, claims denials and network design, affect both affordability and patient access to care.”
  • Beckers Hospital Review adds,
    • “Mark Cuban argues the fundamental problem in U.S. healthcare is not whether the system is run by the public sector or the private sector. It is that hospitals do not know what their own services cost.
    • “During an Aug. 18 episode of KFF Health News’ “What the Health?” podcast, the entrepreneur and co-founder of Cost Plus Drug Co. said the lack of granular cost information undermines hospital pricing, reimbursement negotiations and broader debates over healthcare reform.
    • “The fundamental issue is transparency and trust … [and] there are a lot of hospitals that don’t know their costs,” he said. “They just know their cash balance.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today hosted the Live Real Life Symposium at the Hubert H. Humphrey Building in Washington, D.C., bringing together leaders from technology, medicine, research, education, government, and advocacy groups to examine the harms of screen use in children and discuss actionable approaches to supporting healthier childhood development.
    • “Our children get one childhood, and we cannot allow screens to replace the real-world experiences they need to grow and thrive,” said HHS Secretary Robert F. Kennedy, Jr. “Through the Office of the Surgeon General’s Live Real Life initiative, we are giving families practical tools to put technology in its proper place and get children back to playing, exploring, connecting, and experiencing the world around them.”
    • “The symposium is part of the HHS Live Real Life campaign, a national effort to help families, schools, and communities reduce harmful screen use and create more opportunities for children to engage in the experiences essential to healthy development.
    • “The event builds on the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents issued earlier this year, which outlines how factors such as age, content, design, purpose, and duration influence when screen engagement may be beneficial and when it becomes harmful.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $58 million investment is being delivered to improve health outcomes for Hawaiians through the federal Rural Health Transformation Program (RHTP). This investment will strengthen Hawaii’s healthcare workforce, improve infrastructure, advance technology, and support innovative approaches tailored to the unique healthcare needs across the state. 
    • “President Trump understands that every American deserves high-quality healthcare, no matter where they live,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are putting resources directly into rural communities to strengthen the health workforce, modernize infrastructure, expand access, and bring care closer to home. We are giving states the flexibility to build solutions around the people they serve, while demanding accountability for results. That is how we strengthen rural health, improve the lives of patients and families, and Make America Healthy Again.”
    • “President Trump made a historic commitment to rural America, and these investments are turning that commitment into better care for patients in communities across Hawaii,” said Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz. “This is what rural health transformation should look like: federal investment that is putting patients first, driving lasting improvements and expanding healthcare for the hardworking Americans who call these communities home.”
  • Reuters relates,
    • “U.S. Centers for Medicare and ​Medicaid Services Administrator ‌Dr. Mehmet Oz said on ​Monday [August 31] that 600,000 ​seniors have signed ⁠up to receive ​GLP-1 weight loss ​medications in the first two months of ​a new ​federal program created to expand ‌access ⁠to the highly sought-after treatments.
    • “Under the so-called Medicare ​Bridge ​program, ⁠which launched in July, ​millions of ​older ⁠Americans qualify for obesity medications at ⁠just $50 ​a ​month.”
  • GAO’s WatchBlog suggests “Nine Ways Congress Can Combat Fraud in the Federal Government,”
  • Fierce Healthcare tells us,
    • “Komodo Health, an AI-powered healthcare intelligence company, is teaming up with the National Committee for Quality Assurance (NCQA) to modernize how healthcare quality measures are developed.
    • “The multi-year strategic partnership will allow NCQA researchers to tap into Komodo’s Healthcare Map, made up of over 330 million de-identified patient journeys, to analyze care across insurance types, care settings and patient populations from a single longitudinal data source. 
    • “They will have access to Komodo’s Marmot, an AI-powered healthcare intelligence platform, to explore complex questions with transparent, reproducible outputs. NCQA is solely responsible for developing HEDIS measures.” * * *
    • “The goal is to allow NCQA to evaluate new measures more quickly and efficiently and to ensure HEDIS reflects real-world evidence. Developing new quality measures has historically required pulling from disparate datasets, including field testing with individual payers and other partners. This could take two to three months, and often had to be done separately for each population studied.
    • “Using Komodo’s Healthcare Map has greatly streamlined that process,” Tricia Elliott, VP of quality implementation at NCQA, told Fierce Healthcare in emailed comments. “Because the Healthcare Map includes insights from Medicare, Medicaid and commercial populations, our researchers can evaluate measures across multiple insurance types using a single, consistent data source rather than running separate analyses.”

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

  • Govexec reports,
    • “Each portfolio within the federal government’s 401(k)-style retirement savings program gained value last month, snapping a two-month streak of lackluster market performance.
    • “The international stocks of the Thrift Savings Plan’s I Fund sported the best performance, gaining 3.32% last month. So far this year, the I Fund has grown 19.18%.
    • “The C Fund, which is made up of large- and mid-size businesses, increased 2.72% in August, good for 13.12% growth since the start of 2026. And the small- and mid-size companies in the S Fund finished August 2.27% in the black, bringing its 2026 gains to 16.10%.”
  • OPM’s Director Scott Kupor added a new post to this Secrets of OPM blog today.
    • “Last week we at OPM recognized excellence among our team members through the Director’s Awards Ceremony.
    • “It not only gave me a chance to put my tuxedo to good use (which I almost never have a chance to do) and to tell the one joke I could remember that’s appropriate for a work setting, but – all kidding aside – it gave us an opportunity to recognize those who have gone above and beyond in service of the American people. And in doing so gave us the opportunity to walk the walk about what a high-performance culture means – one in which we are not afraid to call out individuals and teams that truly exceed expectations and in which we disproportionately reward excellence.
    • “I’ve written about this before (link to WAPO editorial), but the federal government has under-served its employees by trapping them in a system that treats accountability too lightly and fails to reward its top performers. We see this in the historical annual employee ratings systems – where less than 0.5% of a 2 million strong employee base rates below expectations and where nearly every SES (our most senior executives) is rated above expectations. And, as a result, we see this in the annual bonus system which provides little differentiation between satisfactory performance and those who consistently knock the cover off the ball.
    • “We’ve been working to change this culture into one that holds low performers accountable and forces managers to distinguish among their employees based on actual performance – both in ratings and in rewards (link to performance blog). While the Director’s Awards are not a substitute for the traditional end-of-year evaluation cycle, it is a great venue for us to practice what we preach.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Baxter International has recalled one lot each of 70% Dextrose Injection and Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter.
    • “The 70% Dextrose Injection may contain stainless steel particles, according to an Aug. 25 FDA alert. The affected product is lot Y495066, which expires July 31, 2027. It was distributed July 25-28, 2026, to healthcare providers and distributors in select states, including Alabama, Georgia and Tennessee.
    • “Baxter also recalled lot Y493475 of Anticoagulant Sodium Citrate Solution due to the potential presence of fiberglass. The product, which expires Dec. 31, 2027, was distributed July 2-11, 2026, to one customer in the U.S.” * * *
    • “As of Aug. 25, Baxter had not received any reports of adverse events related to either issue. Customers were instructed to immediately discontinue use of affected units and return them.”
  • Oncology News Central relates,
    • “On Aug. 31, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft (Besremi) for adults with essential thrombocythemia (ET), marking the first approval for the rare blood cancer in nearly three decades.
    • “Regulators based their decision on results from the open-label, multicenter, randomized SURPASS ET clinical trial. The phase 3 study enrolled 174 adults with ET who had an inadequate response to hydroxyurea. 
    • “Today’s FDA approval of [ropeginterferon alfa-2b] for ET is a significant advancement for patients and reflects PharmaEssentia’s longstanding commitment to advancing innovative therapies for people living with myeloproliferative neoplasms,” PharmaEssentia CEO Ko-Chung Lin, PhD, said in a statement. “We have been working closely with the FDA, healthcare providers, advocacy organizations, and payers to bring this important treatment option to the ET community.”
  • STAT News lets us know,
    • “Medical device giant Stryker earlier this summer received Food and Drug Administration authorization for a surgical display system using Apple’s Vision Pro headset. Specifically indicated for imaging during minimally invasive surgery for hip impingement and labral repair, SportSuite Vision allows a surgeon to place multiple displays that are usually scattered around an operating room in their preferred configuration in the Vision Pro’s display. During a procedure, surgeons usually need to swivel their heads and bodies to refer to CT imaging, arthroscopic video, and Stryker software.
    • “The De Novo authorization was based on hundreds of hours of lab testing, including work on cadavers and testing interactions with other staff, but the company is announcing today that a surgeon at Duke Health completed a real procedure using the technology.
    • “Matt Moreau, VP and general manager of sports medicine at Stryker, told me the company has long wanted to create such a “surgical cockpit,” but Vision Pro is the first to deliver on the technical capabilities necessary, including  high-quality passthrough video that allows a surgeon to see the operating room and staff around them.”

From the judicial front,

  • “A panel of three Republican judges (two Trump first term appointees and one George H.W. Bush) from the U.S. Court of Appeals for the 11th Circuit unanimously overruled a district court decision holding the False Claims Act’s qui tam provision unconstitutional.  Here is an 11th Circuit link to the opinion.”
  • In short this is the Court’s holding:
    • “Here, a relator brought an FCA suit against defendants that she alleged committed Medicare fraud, and the defendants moved for judgment on the pleadings or dismissal on the grounds that the qui tam provisions violated the Constitution’s Appointments Clause, Take Care Clause, and Vesting Clause. The district court granted the defendants’ motion and held that the qui tam provisions violate Article II’s Appointments Clause because relators qualify as officers of the United States and, as such, must be (but are not) presidentially appointed.
    • “We disagree and hold that relators are not officers of the United States because they do not occupy a continuing position established by law. Accordingly, we join our sister circuits that have addressed this issue and hold that the qui tam provisions of the FCA do not violate the Appointments Clause. Therefore, we vacate the district court’s order dismissing this case and remand for the district court to evaluate the defendants’ remaining constitutional arguments.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “COVID-19 cases are ticking up in almost every U.S. state as summer draws to a close, according to the latest data from the Centers for Disease Control and Prevention.
    • “COVID-19 activity was still categorized overall as “very low” nationwide by the agency as of Aug. 28, though cases are consistently increasing. This is likely the result of what has come to be known as the “summer surge,” a pattern that doctors have observed each year since around 2022. Unlike other respiratory illnesses such as the flu, COVID-19 tends to flare not only during the typical winter cold and flu season, but also toward the end of summer.
    • “Experts previously told USA TODAY that this is likely caused by multiple factors, including behavioral and environmental changes (the amount of time spent cooped up in AC, going back to school, etc.), as well as the virus’s life cycle and how our immunity to it waxes and wanes.
    • “COVID-19 is rising nationally but from a low baseline,” Dr. Syra Madad, infectious disease epidemiologist at Harvard’s Belfer Center and chief biopreparedness officer for New York City’s public hospitals, previously told USA TODAY. “The increase became apparent in parts of the South and West during July and more clearly nationwide by late July and early August.”
  • Beckers Behavioral Health relates,
    • “The CDC predicts 67,798 drug overdose deaths in the U.S. during the 12 months ending in March 2026, a 12.3% decrease compared to the same time period in the previous year, according to an Aug. 31 news release from the agency.”
  • NPR tells us,
    • “Maria Uloko sees the same scenario in her urology practice in Los Angeles every day: A woman has been diagnosed with recurrent urinary tract infections (which means she’s had at least two in six months or three in a year), taken repeated rounds of antibiotics, and feels confused as to why the infections keep coming back.
    • “Then, Uloko tells these patients something that often feels both revelatory and frustrating. “Most of them don’t actually have UTIs, even though that’s been their diagnosis time and time again,” she says. “In fact, millions of women are being treated for UTIs they may not actually have.”
    • “Uloko is the co-author of a recent study published in The Journal of Sexual Medicine that backs this up. She and her fellow researchers reviewed the medical records of 253 women with recurrent UTIs and found that just 15% showed evidence of problems that were limited to the bladder or urinary tract. The remaining 85% had signs of hormonally driven inflammation of the vulvar region and 75% had pelvic floor dysfunction.
    • “These conditions produce identical symptoms as UTIs — burning with urination, urgency, frequency, and/or lower abdominal pain — but require different treatment.
    • “What we found is that in women with recurrent UTIs, the majority didn’t have a bladder problem at all; they had a vulvar problem,” says Uloko.”
  • STAT News informs us,
    • “New guidelines released Monday highlight the many new treatments that have hit the market in recent years for the prevention of migraine. 
    • “The guidance for health care providers comes from the American Headache Society and the American Academy of Neurology, which last updated their recommendations in 2012. 
    • “There has been a wealth of new treatment available,” said Rebecca Burch, guideline co-author and neurologist at the University of Vermont Medical Center. Burch also co-authored the previous guidance. 
    • “Among the key updates are at least a half dozen medications that were approved for migraine prevention by the Food and Drug Administration since 2012. Many of those focus on blocking the calcitonin gene-related peptide, or CGRP, pathway, which is implicated in migraine. 
    • “The new guidelines advise doctors to offer preventive treatment to people who have at least four migraine or severe headache days per month, or whose migraines interfere with their ability to work or complete daily tasks. An estimated 15% of Americans experience migraines, with women disproportionately affected. Many try to manage their pain with over-the-counter options once an attack has begun.” 
  • Health Day points out,
    • “Adults who spend hours scrolling social media every day are more likely to develop depression, a new study says.
    • “Around 2.5 hours or more of scrolling per day is linked to self-reported depression, researchers recently reported in the journal npj Mental Health Research.
    • “The study found that social media is more closely linked to depression than other factors like your job, your educational background, or your time spent playing video games, surfing the web or watching TV, researchers said.
    • “It’s a damning picture. Social media is harmful for individuals across the lifespan,” senior researcher Hans Breiter, a professor at the University of Cincinnati, said in a news release.
    • “We should not subject ourselves to a product using addiction science to optimize our viewing time,” Breiter said.”
  • Per Reuters,
    • “People taking popular GLP-1 obesity drugs who remain on low starter doses will ​lose some weight but may still experience side effects, although significantly less nausea than those who graduate ‌to higher manufacturer-recommended doses, a new study suggests.
    • “And they are unlikely to experience the double-digit weight-loss percentages seen with the higher doses, the study found.
    • “The GLP-1 drugs semaglutide, sold as Ozempic and Wegovy by Novo Nordisk (NOVOb.CO), and Eli Lilly’s (LLY.N) tirzepatide, sold under the brand names Mounjaro and Zepbound, are prescribed ​initially at a low dose followed by gradual titration to higher doses, to help the body adjust and minimize side ​effects.”
  • Cardiovascular Business notes,
    • “Catheter ablation does not significantly improve the quality of life of patients with symptomatic atrial fibrillation (AFib) more than a sham procedure involving sedation, venous access and electrical cardioversion, according to new late-breaking data presented at ESC Congress 2026. The findings were simultaneously published in The Lancet.[1]
    • “PVI-SHAM-AF was a randomized, double-blind, sham-controlled trial included more than 250 patients with symptomatic paroxysmal or persistent AFib. Patients were randomized to undergo either catheter ablation or a sham procedure. The sham procedure was rather complex, involving sedation, venous access, time in the electrophysiology lab and even cardioversion. Each participant completed an AF Effect on the Quality of Life Questionnaire (AFEQT) at baseline and again after six months. 
    • “Overall, 173 patients were treated with catheter-based pulmonary vein isolation (PVI) ablation and another 89 patients were treated with the sham procedure. After six months, AFEQT scores improved from 61.3 to 81.1 in the catheter ablation group and from 59.2 to 74.9 in the sham procedure group. This was not viewed as a significant difference. 
    • “On the other hand, the authors noted that catheter ablation was still proven to be effective in reducing the risk of recurring episodes of AFib. Freedom from AFib after six months occurred in 73% of catheter ablation patients and 52% of sham procedure patients.”
  • and 
    • “Metformin, a popular type 2 diabetes medication used to reduce blood glucose levels, does not appear to make a significant impact on outcomes for patients with heart failure with reduced ejection fraction (HFrEF). That is according to two separate studies presented at European Society of Cardiology (ESC) Congress 2026.
    • “The first of the two studies, Met-HeFT, included 940 heart failure patients in Denmark who either presented with type 2 diabetes or face an increased risk of developing type 2 diabetes. The mean age was 70 years old, and 84% of patients were men. Study participants were randomized to either undergo treatment with metformin or a placebo.
    • “Overall, after a mean follow-up period of 3.7 years, there was no significant difference in the study’s primary endpoint—a composite of mortality, worsening heart failure symptoms, acute myocardial infarction or stroke—between the two groups. That outcome occurred in 25.1% of metformin patients and 23.4% of placebo patients. Secondary endpoints, including new-onset diabetes and unplanned heart failure rates, were also not significant different between the two treatment options.
    • “It is worth noting, however, that just approximately one in 10 patients presented with type 2 diabetes. The remaining patients were all determined to face a heightened risk of developing type 2 diabetes.”
  • BioPharma Dive adds,
    • “A pill developed by Novartis succeeded in a pair of Phase 3 trials in people with a common form of multiple sclerosis, bolstering confidence in the drug’s prospects and sending company shares up by over 4% on Tuesday.
    • “The Swiss pharmaceutical giant didn’t provide detailed study results. Still, Novartis revealed the therapy, remibrutinib, demonstrated “superiority” over the drug Aubagio in reducing yearly relapse rates and inflammatory brain lesions in study participants. Treatment was associated with “clinically meaningful” effects on disability progress and, notably, didn’t impact liver safety — an issue for multiple drugs in remibrutinib’s class. 
    • “The findings could position remibrutinib, which is already approved as Rhapsido for chronic skin hives, to become a bigger sales contributor in the future. Novartis is looking to remibrutinib and other late-stage prospects to offset revenue losses from multiple patent expirations. It intends to share the MS study results with health regulators.” 
  • and
    • “An experimental drug Alumis has been testing in a form of lupus failed a mid-stage study, but the company will press forward after observing positive signs in a subgroup of trial participants.
    • “According to Alumis, the drug, envudeucitinib, missed all of its main and secondary objectives in systemic lupus erythematosus. Still, “robust” responses were seen in trial volunteers with “high interferon gene signature,” meaning certain genes controlled by interferons are overexpressed. A majority of people with moderate-to-severe SLE fit this description, Alumis said.
    • “Alumis will meet with regulators to discuss a path toward a Phase 3 trial. Company shares plummeted by nearly 55% on the results, though, nearly erasing all of Alumis’ stock gains this year. The company’s market value had soared following positive results in psoriasis in January.” 

From the U.S. healthcare business front,

  • Beckers Payers Issues calls attention to the following:
    • “Several of the nation’s largest health insurers rolled out reimbursement policy changes Sept. 1, ranging from new lab testing coverage limits at UnitedHealthcare to a billing overhaul at Blue Cross Blue Shield of Michigan that has drawn pushback from providers.”
  • and 
    • “UnitedHealthcare has released the specific procedure codes it will exempt from prior authorization as part of the insurer’s previous pledge to reduce requirements by 30% before the end of 2026.
    • “The code lists cover 1,700 procedure codes for a range of services across commercial, Medicare Advantage, individual exchange, and Medicaid plans. Effective Oct. 1, providers will no longer need to seek the insurer’s approval for many outpatient procedures, including lesion excisions, fracture treatments, joint injections, arthroscopies, colonoscopies, endoscopies, biopsies, hernia repairs and soft tissue tumor removals. Genetic and molecular testing codes also make up a large  portion of the lists.
    • “UnitedHealthcare CEO Tim Noel said in May that prior authorization “should only be used when it truly protects patients and improves care.” At the time, the insurer said it requires prior approval for just 2% of its medical services, with roughly 92% of submitted requests approved in less than 24 hours on average. The 30% reduction builds on an earlier 20% cut to commercial prior authorization requirements in 2023.”
  • HR Dive reports,
    • “Despite the current economic turbulence, most employees in a majority of companies will be getting a base salary increase for 2027, according to a large survey by Korn Ferry.
    • “Almost half (47%) of the 5,512 participating employers said they expect to provide salary hikes to at least 95% of their employees, while 79% expect to do so for at least 80% of employees. Only 2% said they are planning no increases for anyone.
    • “U.S. organizations expect to boost overall base-salary budgets next year by an average of 3.3% and a median of 3%. The median increase for U.S. executive and senior management is also anticipated to come in at 3.0%. 
    • “The survey was conducted in June of this year.”
  • Fierce Pharma unveiled its Fierce 50 awardees of 2026.
  • Beckers Hospital Review tells us,
    • “Philadelphia-based University of Pennsylvania Health System recorded operating income of $336.9 million (2.5% operating margin) for fiscal year 2026, up from operating income of $246.7 million (2.1% margin) during the same period last year, according to its Aug. 28 financial report.”
  • and
    • “Boston-based Dana-Farber Cancer Institute posted an operating loss of $9.1 million (-0.9% margin) in the third quarter of fiscal 2026, compared with an operating loss of $2.6 million (-0.3% margin) in the same quarter last year, according to its Sept. 1 financial report.”
  • and
    • “From R1 RCM striking an agreement to acquire an AI-powered touchless prior authorization company to IKS Health acquiring TruBridge, [the article identifies] 12 revenue cycle company mergers and acquisitions that have been announced or completed since March 17.”
  • Beckers Clinical Leadership informs us,
    • “Single specialty and multi-specialty groups were the top two highest-paying settings for physicians, followed by hospitals, Doximity found. 
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of nearly  23,000 responses collected in 2025, according to a company news release.  
    • “Among settings, solo practice had the largest drop in compensation year-over-year at -3.8%, while urgent care centers had the highest growth for the second year in a row, the report said.” 
  • and
    • “Most physicians say they’d still choose medicine if they had it to do over again, but nearly half say they’re likely to leave clinical practice within the next two years, according to Doximity’s 2026 Physician Compensation Report.
    • “Doximity, a digital platform for U.S. medical professionals, released the report Aug. 25. The findings are based on a survey of physicians conducted in June on how AI is changing physician careers and pay, along with salary data from more than 23,000 physicians collected in 2025, according to a company news release.”
  • MedTech Dive notes,
    • “Medtronic kicked off its fiscal year with double-digit revenue growth, building on momentum the company posted coming out of its previous year.
    • “Medtronic grew revenue by 13.7% to $9.8 billion in its fiscal first quarter, fueled by double-digit growth in its cardiovascular and medical surgical businesses. The strong quarter prompted the company to increase its organic revenue growth forecast for the full fiscal year.
    • “Importantly, these results reinforce our confidence and the durability of our business,” CEO Geoff Martha told investors on a Tuesday earnings call.
    • J.P. Morgan analyst Robbie Marcus wrote in a note to investors that Medtronic beat Wall Street’s consensus expectations in sales by about $220 million in the quarter.
    • “Much like in the fourth quarter, Medtronic’s cardiovascular unit was a bright spot for the company. The business brought in $3.93 billion in revenue, representing nearly 20% growth year over year.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Beckers Hospital Review reports,
    • “CMS said its enforcement efforts have resulted in blocking more than $1.6 billion in possibly improper Medicare lab payments throughout President Trump’s administration.
    • “An Aug. 28 CMS news release said these enforcement actions included savings of $732 million from 157 providers with revoked Medicare privileges, and a CMS investigation of 600 labs that resulted in 185 payment suspensions with more than $500 million in potentially fraudulent payments stopped. There were also 85 law enforcement referrals from a contractor that led to the prevention of $127 million in possibly fraudulent payments, and there was a recoupment of more than $276 million from 442 flagged overpayments to suspect labs.
    • “CMS had been using AI, among other analytics tools, to mine original Medicare claims. CMS focused on several kinds of lab fraud, such as labs billing for up-coded services. The news release said lab fraud can take place across services, including pathogen detection, high-complexity drug tests and genetic testing.
    • “Since the start of 2026, the CMS Fraud Defense Operations Center has been responsible for more than $371 million in Medicare suspended payments implicating 267 providers and suppliers.
    • “The news release comes amid CMS’ broader anti-fraud push across government programs, including Medicaid.”
  • FEHBlog observation — I find it hard to believe that these scoundrels would similarly attach FEHB plans for which private carriers hold the risk.
  • Beckers Payer Issues relates,
    • “The Labor Department is proposing a rule that would set criteria for employer associations to sponsor association health plans that qualify as employee welfare benefit and group health plans under the Employee Retirement Income Security Act.
    • “Received by the Office of Information and Regulatory Affairs Aug. 11, the rule is under review. ERISA outlines minimum standards for employee benefit plans.”
  • Beckers Behavioral Health adds,
    • “The Drug Enforcement Administration has submitted a final rule on telehealth prescribing of controlled substances to the White House for regulatory review.
    • “The DEA filed the rule Aug. 25 and listed it as “economically significant,” an Office of Management and Budget designation reserved for regulations expected to have an annual economic impact of at least $100 million.
    • “The rule would establish a long-promised special registration pathway allowing DEA-registered practitioners to prescribe controlled substances, including medications for opioid use disorder and attention-deficit/hyperactivity disorder, via telemedicine. It follows a proposed version of the rule that drew more than 6,400 public comments and would replace a series of temporary extensions the DEA has issued since pandemic-era flexibilities suspended the in-person visit requirement for such prescriptions. The agency’s latest extension of those temporary flexibilities runs through Dec. 31, 2026.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services’ six-month moratorium on the enrollment of new durable medical equipment, prosthetics, orthotics and supply companies in Medicare expired Aug. 27. CMS said that national provider enrollment contractors have resumed accepting initial enrollment applications from those suppliers. The agency said that suppliers should submit applications as soon as possible to allow contractors the maximum time for processing before the bidding window opens for the 2028 round of the DMEPOS Competitive Bidding Program.”
  • NCQA informs us,
    • “To align with the industry’s transition to digital quality measurement and the need for more streamlined data exchange, NCQA is creating a new HEDIS® measure for Transitions of Care (TRC) that uses the Electronic Clinical Data Systems (ECDS) reporting methodology.
    • “The current TRC measure assesses performance through a hybrid reporting methodology that combines administrative claims data and medical record review for a sample of eligible members. Because the hybrid TRC measure is included in the CMS Medicare Star Ratings, NCQA is coordinating this effort with CMS and other stakeholders.
    • “This measure is important because it evaluates care transitions, which present opportunities for missed connections that often require patients and families to fill in the gaps,” says Fern M., Director of Digital Quality Informatics at NCQA. “We know that health plans, technology vendors and policymakers are heavily invested in this measure, so we want to be as transparent as possible and allow organizations enough time to prepare for the changes.”
    • “The earliest implementation of the new ECDS TRC measure would be Measurement Year (MY) 2028, with the intention of retiring the hybrid version of the TRC measure in MY 2029.”

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

  • Govexec reports,
    • “Most federal employees would see their pay frozen at 2026 levels next year under an alternative pay plan issued by President Trump this week, though for the second straight year, federal law enforcement officers would receive a 3.8% increase.
    • “Trump first proposed the pay freeze as part of his fiscal 2027 budget proposal. Though the document was silent on federal employee compensation, officials with the Office of Management and Budget quickly clarified that its omission equated to a planned freeze for 2027.
    • “In a letter to House Speaker Mike Johnson, dated Thursday, Trump said increasing most federal employees’ pay would be “unacceptable and unfair” given the inflation that occurred under the Biden administration. Inflation actually has risen from 2.8% when former President Biden left office to 3.3% as of last month.
    • “I have therefore decided to set at zero the pay adjustment to be made for the 2027 pay year,” Trump wrote. “This decision will maintain fiscal responsibility without harming the government’s ability to recruit and retain well qualified employees.”
    • “But in the next paragraph, Trump said that for the second straight year, he instructed the Office of Personnel Management to issue a 3.8% increase in basic pay to federal law enforcement personnel next year, “to increase recruitment and retention” in those roles.”
  • Federal News Network adds,
    • “Up to 400 federal positions can now earn salaries of $400,000. A new final rule from the Office of Personnel Management allows the higher pay rates for hundreds of workers under an authority known as “critical position pay.” The authority is meant to help agencies recruit and retain highly qualified and specialized government workers in mission-critical roles. OPM’s final rule this week aligns with President Donald Trump’s orders earlier this year to use the pay authority for up to 400 national security roles.(Final rule on critical position pay authority – Office of Personnel Management)”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Squawk Box on CNBC to discuss the Trump Administration’s efforts to recruit top tech talent and advance his vision for a more tech-driven federal government.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about an ongoing safety issue with certain intravascular catheters manufactured by Boston Scientific. These devices are being removed from the market, and Boston Scientific has officially decided to discontinue them going forward.
    • “The devices in question are Boston Scientific’s single-use Imager II Angiographic Catheters, which interventional cardiologists, vascular surgeons and interventional radiologists use to capture images of a patient’s peripheral vasculature. They are available in a variety of shapes and lengths. 
    • “This warning, which covers all Imagers II Angiographic Catheters, was put in place due to a manufacturing defect that can cause the catheter tip to degrade or detach from the rest of the device.”
  • MedTech Dive adds,
    • “Medtronic has recalled a pH monitoring capsule over a risk linked to 184 serious injuries, the Food and Drug Administration said Thursday.
    • “The recall, which the FDA communicated in an early alert notice, affects Bravo CF capsules that pose risks including perforation of the esophagus, obstruction of the airway and blood loss.
    • “Medtronic withdrew a subset of the newly recalled Bravo CF lots last year. The FDA said the same failures triggered both recalls, but the underlying causes of the problems are different.”
  • Fierce Pharma relates,
    • “In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk.
    • “On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of adverse cardiovascular events in at-risk patients.
    • “The label expansions came on similar timelines for the rivals. While Novo achieved its heart-helping endorsement three years after the FDA originally approved Ozempic, Lilly gained its expansion four years after the FDA first signed off on Mounjaro.”
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.
    • “Mimrylo offers a new treatment approach for patients whose disease has not been adequately controlled with existing therapies. It is the first approved treatment for polycythemia vera that mimics hepcidin, a hormone that naturally regulates iron in the body. By limiting the iron available to make new red blood cells, Mimrylo helps reduce their overproduction and keep red blood cell levels under control. This novel approach offers a new option for patients who have not achieved adequate control with existing therapies.

From the judicial front,

  • Per a Department of Justice news release,
    • “The Justice Department, together with the Drug Enforcement Administration (DEA), today announced a $50 million settlement with Walmart Inc. (Walmart) to resolve allegations that Walmart pharmacies illegally filled thousands of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA).” * * *
    • “The government’s complaint — filed on Dec. 22, 2020, and amended in 2022 in the U.S. District Court for the District of Delaware — alleged that since June 26, 2013, Walmart filled invalid prescriptions through the knowing actions of individuals on its compliance team and the knowing actions of its pharmacists. * * *
    • “In addition to the monetary payment announced today, Walmart has entered into a memorandum of agreement with DEA to address its future obligations in dispensing controlled substances. This agreement requires Walmart to establish a hotline for both employees and patients to report suspected illegal dispensing of controlled substances, proactively monitor the dispensing patterns of its pharmacies to identify and address potentially illegal dispensing, and establish a process to evaluate prescribers suspected of illegal prescribing.” * * *
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“
  • STAT News adds,
    • “A U.S. appeals court [panel for the 5th Circuit] ruled the Food and Drug Administration went through the proper process when it declared Novo Nordisk and Eli Lilly’s diabetes and obesity drugs are no longer in shortage, Bloomberg Law notes. The order is a loss for the Outsourcing Facilities Association, which representing large-scale compounders and challenged FDA decisions in the last two years that shortages ended for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. That declaration restricted compounders from legally mass-producing versions of the drugs.”

From the public health and medical / Rx research front

  • The Center for Disease Control and Prevention announced today,
    • “As of August 28, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “National and regional COVID-19 activity is increasing. 
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • The American Journal of Managed Care reports,
    • “Children and young adults who were unvaccinated and infected with COVID-19 were at an increased risk of developing myocarditis, pericarditis, and mortality when compared with those who were vaccinated against COVID-19 with the Pfizer-BioNTech vaccine and not infected.1
    • “The recent findings published in Vaccine underscored the BNT162b2 vaccine’s favorable benefit profile, particularly for children and young adults. Prior research, also published in Vaccine, described COVID-19 vaccinations in general as reducing the risk of severe or prolonged disease—such as long COVID—in adolescents.2 These data, in tandem with the more recent study, provide ample evidence supporting preventive action against COVID-19 for children and adults.” 
  • The University of Minnesota CIDRAP adds,
    • “Giving children antiviral drugs within the first two days of the onset of flu symptoms reduces their likelihood of hospitalization by 81%, a study published last week in Pediatrics finds. 
    • “This protective effect remained robust among children aged 5 years or younger,” wrote the authors, led by scientists at Hsinchu Municipal MacKay Children’s Hospital in Taiwan.” * * *
    • “In an accompanying commentary, James Antoon, MD, PhD, MPH, and Kathryn Edwards MD, both of Vanderbilt University, noted that some pediatricians seem reluctant to use antivirals, adding that about 40% of high-risk pediatric flu patients go without them. 
    • “They urged more widespread use of the drugs. “The time has come for antivirals to be used in children with influenza,” they said. “With greater public hesitancy regarding vaccines, declining seasonal influenza vaccination rates, and recent influenza seasons with record pediatric deaths and hospitalizations, providers should strongly consider the use of antivirals in high-risk and hospitalized patients.” 
  • and
    • “Pennsylvania continues to see numbers climb in its ongoing measles outbreak, with 86 new cases added this week, which brings the total number of cases to 460 with 83 hospitalizations, according to an update today of the state’s measles dashboard. None of the cases have occurred in fully vaccinated people.” * * *
    • “For the third week in a row, Utah, which had the largest measles outbreak, reported no new cases. The state’s tally remains at 518. 
    • “The Georgia Department of Health confirmed four cases of measles linked to a daycare in the Atlanta area, with cases occurring in children who were unvaccinated or had not received the full measles, mumps, and rubella (MMR) vaccine series. 
    • “While the Centers for Disease Control and Prevention (CDC) typically update their measles numbers on Friday, a notification said the August 28, 2026, data have been delayed but will be updated as soon as possible. As of August 20, 2026, the CDC said there were 2,777 cases of measles in 47 states. Of those cases, 94% have been in unvaccinated individuals.”
  • Healio relates
    • “Rates of substance use fell among adolescents and young adults across most substances between 2021 and 2025, even as marijuana use increased among adults aged 26 years and older, according to the 2025 National Survey on Drug Use and Health.
    • “Substance use began declining among children aged 12 to 17 years prior to the COVID-19 pandemic, and those trends seem to be continuing among young adults aged 18 to 25 years in the new data, said Chris Jones, PharmD, DrPH, MPH, director of the Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration (SAMHSA).
    • “Coupling that with other surveys that show downward trends, that seems to be a durable effect that we’re seeing in recent years,” Jones told Healio.”
  • Cardiovascular Business tells us,
    • “Patients with peripheral artery disease (PAD) face a significantly higher risk of developing new-onset atrial fibrillation (NOAF), according to a new meta-analysis published in JACC: Advances.[1]
    • “The study’s authors reviewed data from more than 1,500 studies, landing on seven they wanted to focus on for this research. All studies were associated with a low risk of bias. The oldest study was performed in 2013 and the most recent was performed in 2022. All five studies were observational; five were prospective and the other two were retrospective. One study enrolled only women.
    • “In total, this meta-analysis included data from 763,919 patients. Approximately 56,000 of those patients had PAD as determined by ankle-brachial index (ABI) or a clinical diagnosis. In addition, there were approximately 26,000 cases of NOAF during follow-up. 
    • “Overall, researchers noted, PAD was linked to a 34% higher risk of developing NOAF. The hazard ratio was 1.34.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “Researchers at the University of Toronto have developed a next-generation RNA therapeutic strategy that could have the potential to treat a wide range of genetic diseases that share certain types of disease-causing mutations. The team showed that chemically enhanced suppressor transfer RNAs (sup-tRNAs) combined with a lung-targeted delivery system can restore production of a critical protein in models of cystic fibrosis (CF) caused by “nonsense mutations.”
    • ‘These mutations introduce a premature stop signal into the genetic instructions for making a protein. The result is that cells may produce little or no full-length functional protein, disrupting vital functions in ways that are difficult to treat.
    • “The researchers, led by Bowen Li, PhD, an associate professor in U of T’s Leslie Dan Faculty of Pharmacy, engineered sup-tRNAs to help cells read through these premature stop signals introduced by nonsense mutations into the mRNAs, and complete production of full-length proteins that would otherwise be truncated or absent. They tested the approach in bronchial epithelial cells, mouse models, and patient-derived cystic fibrosis organoids and found that the chemical modifications increased the readthrough of premature termination codons and tRNA aminoacylation, prolonged the tRNAs’ functional activity, and reduced innate immune activation. Moreover, the approach restored CFTR protein production and function across cell, animal, and patient-derived organoid models. The researchers also found that the approach can be combined with existing cystic fibrosis drugs, suggesting the potential for combination therapy.”
  • The New York Times points out,
    • “A one-time gene-editing treatment to lower cholesterol had long-lasting effects a year later, scientists reported on Friday. The results highlight the potential to treat even common diseases by altering people’s genes.
    • “In the small study, which followed only 15 patients, participants who got the highest dose saw their cholesterol levels plunge by half — and stay that way for a year. The results were presented at the European Society of Cardiology Congress and published in the New England Journal of Medicine.
    • “Earlier this year, a similar “one-and-done” clinical trial that used a different gene-editing approach also reported significantly reduced “bad” LDL cholesterol in 35 patients.
    • “Both efforts are early safety studies and are years away from becoming an option people will be offered in a doctor’s office. But an approach that once seemed almost outlandishly far out has inched closer to reality as evidence accrues that it works, and that the results stick.”

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

  • Beckers Hospital Review reports,
    • “Health system CEOs are navigating a growing list of financial pressures, including Medicaid coverage and reimbursement changes under HR 1 and ongoing payment and policy challenges surrounding the federal 340B drug discount program. Site-neutral payment adds another consideration as health systems weigh where to invest and deliver care. 
    • “At Winchester, Va.-based Valley Health, concerns about site-neutral payment are already influencing where the system adds outpatient capacity. President and CEO Mark Nantz said Valley Health is keeping new outpatient sites on its hospital campuses in part to preserve hospital outpatient department rates. Peter Slavin, MD, president and CEO of Los Angeles-based Cedars-Sinai, said eliminating the outpatient payment differential entirely could cost Cedars-Sinai Medical Center about $200 million annually. J. Stephen Jones, MD, president and CEO of Fairfax, Va.-based Inova, said the policy has not changed where the system invests, but it has prompted greater focus on site of care when evaluating projects.
    • “It disrupts the financial model that includes things like 340B, hospital outpatient department rates and Medicare disproportionate share,” Mr. Nantz told Becker’s. “All of those things together help us cobble together a pretty fragile financial model. And so if any part of that financial model, somebody starts pulling the string on it, it unravels pretty fast.”
  • Beckers ASC Review lets us know,
    • “Hospital-employed physicians command significantly higher commercial reimbursement rates than independent peers across every specialty, with a $92 average gap in blended evaluation and management rates in the Chicago market, and the cost difference extends well beyond the professional fee, according to 2026 Trilliant Health price transparency data.
    • “Employed urologists averaged $263 per blended E/M visit compared with $141 for independent urologists, a $122 gap. Employed gastroenterologists averaged $240 versus $141 for independents, employed orthopedic surgeons averaged $260 versus $154, and employed cardiologists averaged $234 versus $144. Even the smallest gap, primary care at $196 employed versus $154 independent, represents a 27% premium for identical services.
    • “The stakes are significant given how many physicians have moved into hospital employment. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, and 79.5% of physicians who sold their practices to a hospital or health system cited the ability to negotiate higher payment rates as an important or very important reason for doing so.”
  • Per Beckers Physician Leadership,
    • “More than 60% of physicians are not satisfied with how the medical profession deals with work-life balance, according to a new report from Medscape. 
    • “State of the Medical Profession Index Report 2026,” published Aug. 28, surveyed more than 1,000 physicians across 29 specialties to rate their satisfaction with how the profession is dealing with key issues, and their optimism levels for improvement going forward.” 
  • Healthcare Dive relates,
    • “Virtual healthcare company Sword Health is planning to acquire digital mindfulness company Headspace, according to a regulatory filing.
    • “Headspace’s parent company OrangeDot is seeking to be acquired by Sword in an all-cash deal, the company told regulators in Massachusetts on July 22.
    • “The acquisition is expected to close on Sept. 14. The financial terms of the deal were not disclosed. Neither Headspace nor Sword Health responded to a request for comment by publication time.”
  • Managed Care Executive tells us,
    • “Cancer biosimilars are associated with lower costs for both insurers and patients, according to a new study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center. Patients with cancer who exclusively used biosimilars had average monthly costs that were $3,820 lower for insurers and $39.50 lower out-of-pocket costs compared with patients who exclusively used the branded biologic drugs, according to a study published today in JAMA Oncology.“
    • “Although the savings were substantially greater for insurers than for patients, even modest reductions in out-of-pocket costs may be meaningful for people facing the financial challenges of cancer care,” senior author Tina Shih, Ph.D., director of the Cancer Health Economics Research Program at the UCLA Health Jonsson Comprehensive Cancer Center, said in a news release. Shih is also a professor of Health Economics in the Department of Radiation Oncology.”
  • Fierce Pharma informs us,
    • “Twenty weeks into its launch, Eli Lilly’s Foundayo has finally exceeded 40,000 in weekly prescriptions, according to IQVIA data cited by Citi. The oral GLP-1 drug posted 40,862 scripts last week, bouncing back from a small dip the week prior. Still, the drug’s scripts level is no match for the roughly 57K that Novo Nordisk’s Wegovy pill garnered at week 6 of its own launch.
    • In its 33rd week of launch, the Wegovy pill booked roughly 175K scripts, slightly down from 176K, per IQVIA. The share of the oral version of semaglutide in all Wegovy obesity scripts was flat week over week at 35%. All told, across the pill and the injectable, Wegovy’s weekly scripts were a little over 500K, down 0.8% sequentially.
    • “As Jefferies analysts observed in an Aug. 21 note, Wegovy has been relatively flat since the Medicare GLP-1 Bridge program began July 1.
    • “Overall, the roughly 60%-40% obesity market share split between Lilly and Novo remained stable, as Lilly’s Zepbound held its ground as the most popular drug.”

Midweek update

David Ermer–Agentic & Generative AI, AHRQ, CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a $4 million initiative to expand access to rapid, point-of-care syphilis testing, with a focus on reaching women in emergency departments and other nontraditional healthcare settings.
    • “Congenital syphilis is preventable, yet too many mothers and babies are still suffering its devastating consequences,” said HHS Secretary Robert F. Kennedy Jr. “HHS is putting rapid tests where women receive care so we can detect infections earlier, treat them faster, and protect more babies.”
  • Beckers Behavioral Health adds,
    • “HHS Secretary Robert F. Kennedy Jr., White House Office of National Drug Control Policy Director Sara Carter, and Housing and Urban Development Secretary Scott Turner released a toolkit Aug. 12 focused on addressing homelessness and addiction through treatment.
    • “The “Best Practices Toolkit: Addressing Homelessness and Addiction Through Treatment First” outlines strategies for communities to “help Americans transition from homelessness and addiction to recovery and self-sufficiency,” according to an Aug. 12 news release from HHS.
    • “The toolkit centers on a “Treatment First” model, which prioritizes coordinated and accountability-driven engagement in evidence-based treatment and recovery support services. It supports drug treatment and recovery efforts through the Great American Recovery Initiative.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services today released an advisory for certain clinicians who are qualifying alternative payment model participants and eligible to receive APM incentive payments, notifying them that their current billing information must be updated to receive funds for the 2026 payment year. CMS said that it was unable to identify a taxpayer identification number associated with some participants after processing 2026 APM incentive payments and therefore was unable to disburse payments. The agency said that all information must be received by Oct. 13. Following that date, CMS said any claim to an APM incentive payment for the 2026 payment period based on an eligible clinician’s qualifying APM participant status for the 2024 performance period will be forfeited.” 
  • Beckers Hospital Review adds,
    • “Participation in mandatory value-based payment programs from CMS is associated with significantly higher annual administrative costs for hospitals, according to a study published Aug. 7 in JAMA Health Forum.
    • “Researchers at the Brown University School of Public Health in Providence, R.I., examined 2006 to 2020 Medicare cost report data for 4,332 hospitals, including 2,820 that participated in the Hospital Value-Based Purchasing program, Hospital Readmissions Reduction Program and Hospital-Acquired Condition Reduction Program. They also assessed costs associated with participation in the Comprehensive Care for Joint Replacement model. * * *
    • “Participation in the first three programs was tied to annual administrative cost increases ranging from $650,000 per hospital compared with long-term acute care hospitals to $1.23 million compared with general acute care hospitals in Maryland. Participation in the CJR model was linked to a $1.4 million annual increase in administrative costs per hospital.
    • “Aggregated nationally, the programs accounted for more than $3 billion in additional annual administrative spending.”
  • Beckers Clinical Leadership tells us,
    • “HHS is creating a new pathway to evaluate which conditions should be added to the national newborn screening panel as part of a broader effort to modernize a review process that officials say has lagged behind advances in genetic medicine.
    • “The Health Resources and Services Administration on Aug. 11 launched a framework to streamline evidence reviews for the Recommended Uniform Screening Panel, the federal guideline nearly all state newborn screening programs follow. 
    • :A Federal Register notice published Aug. 12 laid out the mechanism: a National Newborn Screening Stakeholder Workgroup funded through a $700,000 award to the Silver Spring, Md.-based Association of Public Health Laboratories.”

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

  • My Federal Retirement reports,
    • “Based on CPI-W data through July 2026, the trend toward an estimated 2027 COLA holds at 3.1% for Social Security and CSRS retirees, which would translate to a FERS COLA of approximately 2.1% once the FERS reduction formula is applied — unchanged from last month’s estimate. The official 2027 COLA won’t be announced by the Social Security Administration until mid-October 2026. This page is updated monthly as new CPI-W data is released.”

From the Food and Drug Adminstration front,

  • The Hill reports,
    • The Food and Drug Administration (FDA) is assuring Americans that they should feel confident eating fresh produce again, seeking to ease concerns over the nation’s food supply after a cyclospora outbreak linked to iceberg lettuce spread across more than a dozen states.
    • “We have the safest food supply in the world,” acting FDA Commissioner Kyle Diamantas said in a Tuesday interview with CNBC. “Americans should feel confident in eating fresh produce including leafy greens at this point.
    • “Diamantas added that his agency “remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market” since California-based vegetable producer Taylor Farms voluntarily recalled products linked to the outbreak on July 17.” * * *
    • “The FDA and CDC are still investigating the outbreak, and officials have warned that the number of confirmed illnesses could continue to climb long after the recall because it can take as long as six weeks to determine whether an illness is connected to the outbreak.”
  • Medscape relates,
    • “Following unprecedented results from the RASolute 302 trial, cancer centers across the US are making daraxonrasib available to patients ahead of FDA approval.
    • “The RAS inhibitor has been in the news since it was shown to nearly double median overall survival vs standard chemotherapy — from 6.7 to 13.2 months — among patients with previously treated metastatic pancreatic cancer.
    • “The survival gain, in a notoriously difficult-to-treat disease, earned a standing ovation when the data were presented at this year’s American Society of Clinical Oncology annual meeting. And on July 22, daraxonrasib’s maker Revolution Medicines, announced that the FDA had accepted its approval application.”
  • Beckers Hospital Review tells us,
    • “San Francisco-based Hims & Hers plans to start selling compounded peptides by the end of 2026, with six more to follow pending final FDA rulemaking, executives said Aug. 10.
    • “The direct-to-consumer telehealth company laid out a phased rollout on its second-quarter earnings call. Executives said they expect to offer a first group of already-permitted peptides — including sermorelin, glutathione and a product it markets as MEDplus — by year’s end, then expand to six wellness peptides an FDA advisory committee recommended in July.
    • “We are currently developing a best-in-class peptide experience including U.S.-manufactured products, clinical-led guidance and ongoing blood testing,” co-founder and CEO Andrew Dudum said. He said the company is “waiting on full and final rulemaking from the FDA” before launching the recommended peptides.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit partly struck down a series of federal rules on surprise medical bills, concerning the qualifying payment amount, or median in-network rate. 
    • “The court overturned a provision allowing insurers to include “ghost rates” in the QPA, and rejected a provision excluding bonuses and case-specific rates from the QPA. 
    • “The court sided with the agencies on a provision excluding one-time, case-specific agreements from the QPA calculation, saying the word rate “connotes a per-unit price for multiple units.”
  • Beckers Hospital Review adds,
    • “The court said the agencies can use their enforcement discretion to let insurers keep using existing QPAs while new calculations are completed, preserving balance billing protections for patients in the interim.”
  • The Wall Street Journal relates,
    • “Eli Lilly filed six lawsuits against U.S. entities it alleges are selling a version of its investigational weight-loss drug on the black market.
    • “The lawsuits claim the entities sell retatrutide, a GLP-1 drug that is still in trials and not yet approved by the FDA.
    • “Eli Lilly is calling on social media platforms and payment processors to help stop the black market sales of the drug.”

From the NCQA front,

  • The Cotiviti Blog tells us,
    • “Many health plans wrapped up Measurement Year (MY) 2025 with a smoother HEDIS® season than ever before. The organizations that performed best weren’t necessarily those with the largest teams or budgets—they were the ones with integrated data, aligned workflows, and the ability to identify and act on quality opportunities earlier.
    • For many health plans, MY 2025 brought an unexpected outcome: fewer fire drills. The most successful organizations relied on repeatable steps focused on:
      • Integrated clinical and quality data
      • Aligned teams around clear priorities
      • Chart review productivity reporting
      • Population-level measures dashboards
    • Established repeatable workflows that reduced operational friction throughout the season
    • High-achieving plans started by identifying the right opportunities by using HEDIS logic and integrated data sources to pinpoint the gaps that matter most. Effective approaches centered on opportunities where both impact and intervention are possible, targeting outreach at the provider, care manager, or member level depending on where change can occur most effectively.
    • Next, operationalizing those insights was key during MY 2025. Analytics may reveal performance gaps, but improvement happens when those findings are embedded directly into workflows. Plans that consistently outperform their peers translate data into outreach campaigns, care management activities, and provider engagement efforts with clearly defined accountability.
    • Standardization is equally important. Quality initiatives only create value when the work performed is accurately reflected in reporting. Aligning documentation and coding practices with NCQA-approved value sets helps ensure that quality improvements appear in measure results.
    • Finally, leading health plans embrace continuous measurement. They evaluate intervention effectiveness, monitor gap closure rates, assess outcomes, and create feedback loops that help refine future strategies. Over time, this transforms quality programs from a series of one-off campaigns into a scalable operating model built around continuous improvement.

From the public health and medical / Rx research front,

  • MedPage Today tells us,
    • “Wait times are increasing between cancer diagnosis and the start of first-course therapy for six cancer types, according to a retrospective cohort study.
    • “Predictors of longer wait times included Medicaid insurance, lowest-quartile income, Black race, increased travel distance, and treatment at academic institutions, among other factors.
    • “These results should be considered in the context of previous research linking treatment delays with worse survival outcomes, researchers said.”
  • Beckers Hospital Review notes,
    • “Ascension Saint Thomas in Nashville has rescheduled some elective surgeries and said it could be forced to cancel or delay additional cases because of shortages of blood products.
    • “Platelets are a particular concern at Saint Thomas, according to an Aug. 6 news release from the hospital, which is part of the St. Louis-based Ascension health system. Chief Clinical Officer Brian Wilcox, MD, told NBC News affiliate WNKY that the shortage is affecting hospitals nationwide as donations of blood products have fallen to a four-year summer low even as demand for transfusions holds steady.
    • :The disruption comes as the American Red Cross declared its second national blood crisis in history July 27, with type O blood critically scarce and distributions to hospitals now limited. The shortage began building in May, when a gap widened between the amount of blood hospitals need and the amount being donated. The Red Cross is currently sending hospitals roughly 3,500 more units of blood per week than expected.
    • “An Illinois Red Cross spokesperson told NBC News affiliate WGEM that without a constant blood supply, hospitals could be forced into situations where doctors have to choose who gets blood and who doesn’t, adding that elective surgeries that need transfusions may have to be postponed.”
  • Cardiovascular Business adds,
    • “Clinicians should pay close attention to any incidental lung findings identified when transcatheter aortic valve replacement (TAVR) patients undergo preprocedural CT scans. That is according to new findings published in Heart Lung, a journal from the American Association of Heart Failure Nurses.[1]
    • “Over the past decade, TAVR has transformed the therapeutic landscape of symptomatic severe aortic stenosis (AS),” wrote first author Mustafa Mousa Basha, MD, a researcher with University Hospital Bonn in Germany, and colleagues. “Pulmonary diseases are frequently co-existent in AS patients, often ranging from mild restriction to a mixed restrictive and obstructive pattern, and represent an important risk factor for postoperative complications following TAVR.”
  • STAT News relates,
    • “Not long after guidelines shifted to considering statin therapy as early as age 30, new research from France suggests there may be no harm in stopping the cholesterol-lowering drugs at age 75 in people with no history of cardiovascular disease. The lessons, however, may not translate elsewhere. 
    • “The “non-inferiority” study, published Tuesday in the Lancet Healthy Longevity, does not advise doctors to tear up statin prescriptions for older people. Nor does it conclude that going off statin therapy is better than staying on. It does say patients should talk to their doctors to see if they’d be no worse off for dropping the daily pills.
    • “Invoking patient choice, the authors highlight the lack of scientific literature on older people, noting what research does exist has found the link between cholesterol and cardiovascular events weakens with age. They believe their own study needs to be repeated for a longer period of time and extended to populations at higher cardiovascular risk or otherwise not as healthy as their participants.
    • “For the majority of American patients over the age of 75, this trial will not change anything,” Romit Bhattacharya, a general and preventive cardiologist from the Mass General Brigham Heart and Vascular Institute, told STAT in an interview. He was not involved in the research. “It does give us a little bit of permission and greater flexibility and choice for our individuals who maybe have a short time horizon to live and who are already quite healthy and engaged in care.”
  • The New York Times reports,
    • “President Trump issued an executive order this week calling for immunizations for measles, mumps and rubella, a mainstay of vaccination programs worldwide, to be offered as three individual jabs given at separate times, instead of in one combination shot.
    • “In an Oval Office signing ceremony, the president made a frightening and unsubstantiated claim about the combination shot. “Together, there could be a possibility they’re quite lethal.” 
    • “Researchers have not linked the combination M.M.R. shot to a risk of death, and there is no evidence that it is dangerous or that splitting it into its three components is any safer or more effective, vaccine experts said. Combination shots for the diseases have been used in the United States since 1971, and were introduced only after careful comparison against individual shots. They have been given to hundreds of millions of children.
    • “What’s more, separate vaccines for measles, mumps or rubella have not been available in the United States for many years. Vaccine manufacturers said it would take a minimum of five to 10 years for them to be tested and made available.”
  • Health Day informs us,
    • “Restarting obesity medications, including glucagon-like peptide-1 (GLP-1) receptor agonists, soon after sleeve gastrectomy (SG) surgery is associated with greater one-year weight loss than surgery alone in adolescents, according to a research letter published online July 22 in JAMA Surgery.”
  • and
    • “The 4C meningococcal B (MenB) vaccine confers modest protection against gonorrhea among adolescents, according to a study published online Aug. 4 in Open Forum Infectious Diseases.”
  • Genetic Engineering and Biotechnology News points out,
    • :A multi-disciplinary, multi-institutional group of researchers said they relied on their expertise in genetics, mechanics, chemistry, and biology to create a chip the size of a postage stamp to model a particular class of heart conditions.
    • “The team, led by Guang Li, PhD, an associate professor in the University of Pittsburgh School of Medicine’s department of cell biology, has grown heart valves on organoids. The study “Human iPSC-derived heart valve-like assembloids model valve development and disease pathology” appears in Cell Stem Cell and is an important step toward better understanding and treating a number of serious heart disorders, according to the scientists.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” * * *
    • The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on September 9, 2026.

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

  • The Austin American-Statesman reports,
    • “On Wednesday, the University of Texas System Board of Regents’ Facilities Planning and Construction Committee will adopt a timeline and budget for phase one of the much-awaited artificial intelligence-native hospital, UT Dell Medical Center. 
    • “Construction on the $5 billion hospital is expected to begin this fall, and initial site preparation could begin within a month after board approval of this first phase, which does not include the actual building but includes design and site preparation as well as equipment that takes time to arrive such as MRIs. The committee’s agenda includes information such as a timeline and the cost of the project, which has not yet been disclosed publicly. 
    • “The hospital will include both specialty care and an MD Anderson Cancer Center Central Texas location. UT announced the project in 2023 as a $2.5 billion investment to expand access to high-quality healthcare for Central Texas and bring thousands of jobs to Austin, but when a new site chosen and the hospitals were combined into one, the price tag went up to an estimated $5 billion.” 
  • Modern Healthcare relates,
    • “Intermountain Health and AdventHealth have signed a definitive agreement to merge services at multiple hospitals, clinics and medical practices through a joint venture in the Denver area. 
    • “The deal is slated to close in early 2027, pending regulatory approval, according to a Wednesday notice from AdventHealth. The organizations signed the definitive agreement last week.
    • “Financial terms were not disclosed.”
  • KFF Health News explains how “Hospital Prepayment Requirements Add New Wrinkles to Patients’ Financial Responsibility.”
  • Beckers Health IT tells us,
    • “Bethlehem, Pa.-based St. Luke’s University Health Network and UnitedHealthcare have automated claim status updates for 88% of the claims exchanged between the two organizations, using Epic’s Payer Platform, according to Epic’s newly released 2026-2027 Almanac.
    • “The two organizations turned on Epic’s Claim Status feature to give St. Luke’s staff real-time visibility into where claims stand with UnitedHealthcare, replacing manual status checks that previously required calling the payer or logging into external portals. Brian Burd, IT director at St. Luke’s, said the health system’s main motivation was to improve revenue cycle efficiency by reducing manual claim status inquiries and speeding up follow-ups.
    • “UnitedHealthcare manages most of its claims operations outside Epic, so the insurer routes claim data through its own Epic environment first, then delivers it to St. Luke’s through the Payer Platform connection. That setup avoided the time and transaction fees of building a separate direct link between the two systems.
    • “Since the feature went live, UnitedHealthcare has seen a 25% drop in claim status calls from St. Luke’s, while St. Luke’s staff have shifted their time from chasing payer updates to higher-value revenue cycle work.”
  • Beckers ASC Review informs us,
    • “There comes a point when health system’s ASC moves stop being a side project and start requiring a more involved strategy, and, according to Atlas Healthcare Partners CEO Aric Burke it’s when revenue is above roughly $2 billion to $3 billion, and a portfolio has grown past about five centers.
    • “I think health systems over two to three billion in revenue probably need to have a real, dedicated ASC strategy,” Mr. Burke told Becker’s.”
  • and 
    • “Anesthesia has become one of the most persistent staffing headaches for ASCs and hospitals alike.
    • “It’s not just a bad labor market, but a pipeline problem stacked on top of an aging workforce, a bottlenecked training system and a reimbursement environment that’s making it harder to attract new anesthesiologists and certified registered nurse anesthetists into the specialty.”
  • and
    • “GI procedure demand keeps climbing while Medicare keeps cutting what it pays for the exact setting where those procedures are cheapest to perform.”
  • Beckers Hospital Review notes,
    • “U.S. News & World Report released its debut ratings Aug. 12 for the best GLP-1 telehealth platforms, its first evaluation of the online companies prescribing brand-name weight loss drugs.
    • “The media company rated 20 platforms offering FDA-approved, brand-name GLP-1 medications, including Wegovy, Zepbound, Ozempic and Foundayo, according to an Aug. 12 news release. Companies that offer only compounded GLP-1s were excluded, and for platforms selling both, U.S. News evaluated only the branded portion of the business.”
    • Here are the top five:
      • “Amazon One Medical: 4.8
      • “Found: 4.6
      • “Mochi Health: 4.4
      • “Ro: 4.4
      • “Noom: 4.3”
  • MedTech Dive lets us know,
    • “Abbott and Google plan to pair Abbott’s over-the-counter glucose sensor with Google’s artificial intelligence and consumer technology, the companies said Tuesday.
    • “The multiyear partnership is focused on making metabolic insights from Abbott’s device easier to use, helping people proactively manage their health. 
    • “The two companies plan to launch a large study that could inform Google’s AI health coaching and future features for Abbott’s Lingo sensor. Abbott did not disclose how many people they plan to enroll in the study.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “Senate leadership on Sunday released the text of a bipartisan government funding stopgap measure that would block the White House’s proposal to give political appointees control over federal research grants. 
    • “The continuing resolution would fund the government until Dec. 11. It would only block the Trump administration’s new grants proposal until that time, but it will be more difficult for Republicans to allow the White House’s plan to take effect now that they’ve agreed to blocking it, even if temporarily.” 
  • Roll Call adds,
    • “Just as Senate GOP leaders plan to begin moving several big-ticket items ahead of a planned August recess, President Donald Trump will head out west for a Los Angeles-area fundraiser and an economic speech in Las Vegas.
    • “Trump is set to return to Washington, D.C., Wednesday night — when the chamber could be a few votes away from a monthlong recess in a midterm election year. And the president’s recent statements, threats and willingness to shift on policy shows he’s capable of slowing things down.” * * *
    • “[Senate Majority Leader John] Thune has teed up an ambitious week as he tries to move several big-ticket measures while also freeing vulnerable GOP senators to get back home to campaign until mid-September. He wants to pass a continuing resolution to fund the government until Dec. 11, including a number of White House-requested priorities the House did not have when it passed its own continuing resolution before leaving for the summer last month.
    • “Also on Thune’s list: a cryptocurrency bill, over 70 executive branch nominations and a Russia sanctions bill largely crafted by the late Sen. Lindsey Graham, a South Carolina Republican and close Trump ally.”
  • and
    • “The Senate is back on track to consider acting Attorney General Todd Blanche’s nomination to lead the Justice Department permanently after two key GOP holdouts said they were “pleased” with a deal they struck. 
    • “The DOJ said in a statement posted Sunday night that it has “rescinded” a $1.8 billion “anti-weaponization” fund meant to compensate people targeted by the federal government. The fund was part of a settlement brokered by Blanche that resolved President Donald Trump’s $10 billion suit against the Internal Revenue Service tied to the release of his tax returns during his first term in office.
    • “It was enough to satisfy Sens. John Cornyn, R-Texas, and Thom Tillis, R-N.C., who expressed “gratitude” in a Monday statement and wrote, “We look forward to voting to advance his nomination out of the Senate Judiciary Committee soon.”
    • “The Judiciary panel is now scheduled to vote on Blanche’s nomination Tuesday morning, after canceling a meeting last week.”
  • Govexec relates,
    • “Federal employees and contractors whose sensitive personal data was stolen in the massive Office of Personnel Management breaches disclosed a decade ago would receive identity protection for the rest of their lives under new bicameral legislation.
    • “Senate Intelligence Committee Vice Chair Mark Warner, D-Va., and Del. Eleanor Holmes Norton, D-D.C., plan to introduce the RECOVER PII Act on Monday, aiming to prevent the federal government’s identity-protection program for victims from expiring Sept. 30, according to bill text first seen by Nextgov/FCW.” * * *
    • “Congress responded to the breach in a 2017 appropriations law by requiring OPM to provide victims with at least 10 years of complimentary identity protection and no less than $5 million in identity-theft insurance. The new bill would replace that limit with coverage lasting for the remainder of each affected person’s life while retaining the insurance requirement.
    • “We have a responsibility to stand by the federal workers who were put at risk through no fault of their own,” Warner said. “This legislation will ensure those affected continue to receive the identity protection they need, while helping better safeguard personal information from future exploitation.”
    • “The bill would also allow agencies to reimburse federal employees and contractors for privacy tools and services, such as those that remove or limit their personal information online. Agencies would decide whether to offer the reimbursements, which would not be limited to OPM breach victims and would come from their salary-and-expense budgets.”
  • Per Health and Human Services news releases,
    • U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today traveled to southwest Virginia as part of his “Take Back Your Health” tour to highlight Trump Administration’s efforts to expand addiction recovery, strengthen American agricultural and food supply chains, and recognize President Trump’s historic $50 billion Rural Health Transformation Fund.
    • “On Monday, Secretary Kennedy joined Congressman John McGuire for visits to Tranquility Grove Rehabilitation Center and the Virginia Tech Controlled Environment Agriculture Innovation Center. Under President Trump’s leadership, combating addiction and mental illness remains a national priority. The Administration is also advancing innovative agricultural technologies that strengthen domestic food production, improve supply chain resilience, and help deliver healthier food to the American people.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today marked National Health Center Week by announcing that Health Resources and Services Administration (HRSA)-funded health centers served more than 32.7 million patients in 2025 — an increase of more than 350,000 patients from 2024 and the highest number of patients served in the Health Center Program’s 61-year history.”
  • Per a Centers for Medicare and Medicaid Service news release,
    • “The Centers for Medicare & Medicaid Services (CMS) recently hosted the one-year celebration of the Health Technology Ecosystem, bringing together leaders from the government, healthcare, and technology sectors to feature the significant progress made over the past year in advancing interoperability, improving health data sharing, and expanding patient access to digital health tools.
    • “The event featured remarks from U.S. Department of Health and Human Services (HHS) leadership, with speakers reflecting on Health Technology Ecosystem accomplishments during its first year, highlighted industry collaboration, and outlined priorities for the initiative’s next phase.” * * *
    • “The event concluded with a discussion of the next phase of the Health Technology Ecosystem and opportunities to expand industry participation. Leaders also introduced new areas for future collaboration, including real-time benefits, price transparency, advanced appointment scheduling, clinical trial matching, bulk HL7® Fast Healthcare Interoperability Resources (FHIR®) capabilities, and provider add-on services. CMS encouraged additional organizations to join the initiative as the Health Technology Ecosystem continues to evolve through collaboration across government and the private sector.”
    • “A recording of opening session highlights is available at: https://youtu.be/ATVSdE4cnVQ?si=03QLFmQ2tuRx7w-O
    • “The recording of the full event is available at: https://www.youtube.com/playlist?list=PLaV7m2-zFKpgncdcV8Wnzv42DQo2ZqkUD“
  • Per an NCQA blog post,
    • “The Healthcare Effectiveness Data and Information Set (HEDIS®) is continuously evolving to reflect clinical best practices and to support the needs of organizations that deliver and coordinate care.
    • “For HEDIS Measurement Year (MY) 2027, NCQA introduced several updates:
      • “Added 6 new measures.
      • “Updated 3 existing measures.
      • “Transitioned 1 measure to Electronic Clinical Data Systems (ECDS) reporting.
      • “Restructured ECDS-reported measures reorganized by clinical domain.
      • “Made minor adjustments made across multiple measures.”
    • “NCQA seeks feedback about the proposed retirement of select HEDIS measures for Measurement Year (MY) 2027. The ad hoc public comment period is open from August 3 to August 17. Read on to learn more about the measures proposed for retirement and visit our public comment webpage to submit your comments.
    • “The newest additions to HEDIS address follow-up after a positive colorectal cancer screening, prenatal syphilis screenings, person-centered outcome goals and the use of continuous glucose monitoring.”

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

  • Federal News Network reports,
    • “The Trump administration is giving agencies the green light to implement a new performance management system for federal employees — while also saying significant portions of those changes are “non-negotiable” with federal unions.
    • “In recent guidance issued to agencies, OPM detailed which aspects of the government’s new performance review system override collective bargaining obligations — and what is still subject to negotiation.
    • “Generally, the guidance narrows federal unions’ ability to bargain over performance appraisals. Any collective bargaining provisions that allow for grievances over performance ratings, or that would prevent agencies from using a forced distribution system, are now non-negotiable with unions, according to OPM’s memo.
    • “But some aspects of performance management are still negotiable, according to OPM, as long as they remain consistent with both the final rule and any applicable laws. Those include employees’ informal requests for a reconsideration of their rating; rules on awards and recognition programs; and feedback procedures between supervisors and employees.”
  • The AI Journal relates,
    • “ACI International Inc (NYSE: CACI) announced today that it will serve as one of Oracle’s technology partners for the U.S. Office of Personnel Management’s (OPM) Federal Human Resources Information Technology (HRIT) Modernization contract. Working alongside Oracle, Baker Tilly, and Deloitte on this 10-year contract worth nearly $400 million, CACI will modernize and consolidate disparate federal human resource systems into a single, secure, cloud-based platform for federal civilian employees, including HR professionals and leaders. The consolidation of federal HR systems into a single shared platform is expected to reduce taxpayer costs by more than 90 percent while improving efficiency, security, and service delivery across the government.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Novartis’ blockbuster radioligand therapy Pluvicto has cleared a key milestone on its quest to hit $5 billion in peak sales, securing a U.S. nod in an earlier form of prostate cancer that nearly doubles the number of patients that could benefit from the drug. 
    • “Late Friday, the FDA signed off on Pluvicto in tandem with an androgen receptor pathway inhibitor (ARPI) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC).”
  • Alzheimers’ News Today relates,
    • “The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals is developing for hallucinations and delusions associated with Alzheimer’s disease psychosis.
    • “The FDA grants this designation to investigational medicines intended to treat serious conditions and fill an unmet medical need. Fast track status provides benefits such as more frequent communication with the FDA, with the goal of speeding a therapy’s development and review.
    • “FDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer’s disease psychosis, a serious condition for which there are currently no FDA-approved therapies. This is an important milestone for the remlifanserin program,” Catherine Owen Adams, CEO of Acadia, said in a company press release.”
  • Parkinson’s News Today tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to sasineprocel (ANPD001), an experimental cell therapy to treat Parkinson’s disease.
    • “The designation, given to promising regenerative therapies (treatments that aim to replace or restore disease-damaged tissue) that could substantially improve care for serious diseases, provides developer Aspen Neuroscience with perks such as more intensive FDA guidance.
    • “This significant milestone highlights the transformative nature of sasineprocel as a potentially disease-modifying therapy for patients facing a serious disease with substantial unmet medical need,” Damien McDevitt, PhD, president and CEO of Aspen, said in a company press release.” 

From the judicial front,

  • Beckers Payer Issues reports,
    • “Five federal employees are suing U.S. Office of Personnel Management Director Scott Kupor over alleged sex discrimination due to the rollback of coverage for gender-affirming care.
    • “Plaintiffs, backed by the Human Rights Campaign Foundation, filed the lawsuit Aug. 3 in the U.S. District Court for the District of Columbia. The potential class action focuses on OPM’s coverage policy following a January 2025 executive order from President Donald Trump. The order said “sexes are not changeable,” and the country recognizes only male and female sexes.” * * *
    • “The lawsuit calls for two classes, one seeking injunctive relief and the other seeking damages. The complaint also requests retroactive coverage.”
  • STAT News relates,
    • “Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.
    • “Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Two people have died in connection with the cyclosporiasis outbreak that has spread across the U.S. this summer, according to public-health officials in Michigan, marking the first deaths tied to the unusually large flare up of the food-borne illness.
    • “Both of the people had “significant underlying health conditions” that may have been exacerbated by cyclosporiasis and dehydration, Michigan’s Department of Health and Human Services said. It didn’t provide any additional information about the people who died but said cyclosporiasis deaths are uncommon in the United States.” * * *
    • “The Centers for Disease Control and Prevention said it has received reports of more than 6,700 laboratory-confirmed cases of cyclosporiasis, with another 11,500 suspected. Typically, the U.S. sees about 250 reported cases by this time of year.
    • “The exact source of the parasite remains unclear. Authorities have been probing various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them. Food-safety experts say the vast majority of fresh fruits and vegetables are still safe to eat.
    • “The largest outbreak has been linked to Taylor Farms’ shredded iceberg lettuce, which was sold at retailers including Taco Bell. On July 17, Taylor Farms said it was removing all iceberg lettuce sourced from central Mexico from the U.S. market. Taco Bell finished pulling potentially affected product from its supply chain on the same day. 
    • “Yum Brands, the parent company of Taco Bell, was in communication with Michigan public-health authorities weeks before the recall, according to emails the health department shared with The Wall Street Journal on Monday. 
    • “In an email to a Yum Brands employee on July 2, a state epidemiologist said the department had “a strong signal from our epidemiologic interviews that we need to continue to work with Taco Bell.” 
  • Fox Business relates,
    • “Marijuana is officially leading the pack for the most-used daily drug among Americans.
    • “New data from the 2025 National Survey on Drug Use and Health, from the Substance Abuse and Mental Health Services Administration (SAMHSA), reveals that there are 21.4 million daily or near-daily marijuana users in the U.S.
    • “This surpasses the 19.9 million people who smoke cigarettes and the 17.2 million who consume alcohol.” * * *
    • Although marijuana is now the most commonly used substance on a daily or near-daily basis, alcohol remains the most widely used substance overall. During the previous month, about 129 million people drank alcohol while 43.8 million used marijuana.
  • Cardiovascular Business tells us,
    • “Twenty years after its launch, the Get With The Guidelines-Heart Failure (GWTG-HF) registry from the American Heart Association (AHA) has grown into one of the nation’s most influential cardiovascular databases, helping accelerate the adoption of guideline-directed medical therapy (GDMT) while generating evidence that has reshaped heart failure care.
    • “Since its inception in 2005, the registry has collected more than 1.6 million patient records from more than 800 hospitals, representing about 60% of U.S. hospitals. The database has produced more than 150 peer-reviewed publications and is increasingly being used to support implementation science, registry-based clinical trials and long-term outcomes research.
    • “What started as a quality improvement initiative has led to substantially better processes of care and, most likely, improved survival, fewer symptoms and a tremendous learning platform,” Clyde W. Yancy, MD, MSc, chief of cardiology and professor of medicine at Northwestern University, said in a video interview with Cardiovascular Business.
    • “He added that the registry was created to solve a longstanding challenge in medicine: the fact that it often takes years for clinical evidence to truly influence changes in daily practice.” 
  • Drug Topics informs us,
    • “A survey study published in JAMA Network Open found that pregnant women and parents of young children generally prefer maternal respiratory syncytial virus (RSV) vaccination over infant RSV antibody shot administration as a means of protecting infants against RSV-associated hospitalization. The 2 concurrent national cross-sectional surveys, fielded in April 2024 among 174 pregnant women and 1765 parents of children aged 0 to 5 years, found that only about half of participants reported positive intentions toward either immunization option, underscoring a persistent gap between product availability and uptake.”
  • Fierce Healthcare lets us know,
    • “A new study evaluating the impact of virtual lactation support found it boosted maternal health and breastfeeding success outcomes. 
    • “The study evaluated SimpliFed, a virtual baby-feeding platform led by UMass Chan Medical School. Participants who completed three or more telelactation visits breastfed for nearly 16 weeks longer than those who did not engage with any visits. The impact was even more drastic for moms with mental health conditions, where average feeding duration increased by 24 weeks. The study, presented as a poster, is not yet published online.
    • “The researchers recruited a group of 200 participants from prenatal through postpartum. All were offered unlimited access to the SimpliFed platform for 12 months. Utilization was evenly split: a third did not complete any visits; a third completed one to two; and a third completed three or more.
    • “Dropping breastfeeding rates over time were common, mirroring national trends. Most participants, regardless of whether they engaged with SimpliFed, breastfed at one week postpartum; three-quarters did by six months; and about half did at 12 months. However, completing three or more SimpliFed visits led to longer duration of breastfeeding compared to others in the cohort.”
  • MedPage Today adds,
    • “A study of U.S. children found no evidence linking neonatal male circumcision with autism spectrum disorder, prospective data from the ECHO cohort showed.
    • “Among nearly 2,800 boys in 14 ECHO sites, 6% of those who were circumcised had autism compared with 9% of uncircumcised males, according to Monica McGrath, ScD, MHS, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and co-authors.
    • “After adjusting for confounders, circumcision was not associated with an autism diagnosis (OR 0.83, 95% CI 0.59-1.17), McGrath and colleagues reported in JAMA Pediatrics.
    • “Stratifying data by region, preterm birth, and neonatal intensive care unit (NICU) admission yielded either an inverse or no association. Circumcision also was not associated with autism-related traits or behaviors.”
  • Beckers Hospital Review points out,
    • “Active U.S. drug shortages increased to 227 in the second quarter of 2026, marking the third consecutive quarterly increase, according to the American Society of Health-System Pharmacists. Nearly half of all new shortages this year involve medications made by a single manufacturer, a concentration that increases supply chain vulnerability, and the FDA’s database continues to reflect new discontinuations weekly.”
    • The article identifies the nine drugs most recently placed in shortage status.

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

  • The Wall Street Journal reports,
    • “AstraZeneca AZN shares fell sharply and Bristol Myers Squibb’sBMY  climbed, after media reports that the two drugmakers held merger talks.
    • “London-listed shares in AstraZeneca were down 6.4% in European morning trading. Meanwhile, Bristol’s shares were up 5.5% in U.S. premarket trading.
    • “The stock moves came after the Financial Times reported, citing unnamed sources, that AstraZeneca held discussions with Bristol about a tie-up in recent months, which could lead to a deal in the near future or fall apart.
    • “An AstraZeneca spokesman declined to comment, while Bristol didn’t respond to a request for comment.
    • “A potential deal between AstraZeneca and Bristol Myers Squibb would create a pharma giant with a combined market value of roughly $400 billion and more than $100 billion in annual sales.”
  • Beckers Hospital Review relates,
    • :Gaithersburg, Md.-based Adventist HealthCare recorded operating income of $18.2 million (3% operating margin) through the first six months of fiscal 2026, up from an operating loss of $205,000 (-0.1% margin) during the same period last year, according to its July 29 financial report.” * * *
    • “Among the system’s hospitals, Silver Spring, Md.-based White Oak Medical Center posted $11.9 million in operating income through Q2, up from a $2.8 million operating loss during the same period last year. Rockville, Md.-based Shady Grove Medical Center posted $16.5 million in operating income, up from $10.2 million. Fort Washington (Md.) Medical Center Medical Center posted a $1.2 million operating loss, widened from a $960,000 loss during the same period last year.”  
  • Beckers Behavioral Health tells us,
    • “Ochsner Behavioral Health Acadiana welcomed its first patients July 8, marking the official launch of a regional behavioral health network built jointly by Ochsner Lafayette (La.) General and Plano, Texas-based Oceans Healthcare. 
    • “The network pairs a newly built hospital in Lafayette with the former Oceans Behavioral Hospital Broussard, now renamed Ochsner Behavioral Health Acadiana-Broussard, giving the partners 100 inpatient beds across the two campuses under a single license — more than double the 38 beds they previously operated in the region.
    • “The logic behind the partnership, Oceans Healthcare COO Jeff Pritchard said, comes down to completing the continuum.
    • “Many patients come through the doors of a health system; they have ERs, they have hospitals, they have various clinics,” he said. “By forging a connection with them, we can create a path to those patients who need behavioral health support, so there’s no loss of care in the transition.”
  • Cardiovascular Business informs us,
    • “Cleerly, a Denver-based artificial intelligence (AI) company, has partnered with New York-based Allelica to launch the new Cleerly Polygenic Cardiovascular Risk Score Test. 
    • “Allelica specializes in polygenic risk scores (PRS) that predict a patient’s genetic risk of developing different diseases. Cleerly, meanwhile, its known for its AI-powered coronary CT angiography (CCTA) evaluations. Together, these two companies have collaborated on a new test designed to help physicians diagnose and manage heart patients with suspected coronary artery disease.
    • “Genetic risk and imaging answer two different questions for a physician,” James K. Min, MD, FACC, FESC, MSCCT, founder and CEO of Cleerly, said in a statement. “Inherited risk points to who is biologically predisposed to coronary disease, and our imaging analysis shows what is actually present inside the arteries. Bringing those two views together gives physicians a clearer, more individualized picture of each patient’s coronary risk.”
  • Per BioPharma Dive,
    • “Brain drug developers Supernus and Individor on Monday announced plans to merge, bringing together two companies specializing in drugs for central nervous system disorders that had combined revenues of $2 billion in 2025.
    • “Per deal terms, Supernus shareholders will receive 1.54 shares of Individor for every Supernus share they own, and Individor shareholders will receive a one-time $1 billion cash dividend before the deal’s close, financed by a $650 million loan and the combined companies’ cash on hand. After the close, the former Individor shareholders will own around 57% of the combined company and Supernus’ will own around 43%.
    • “Following the close, the company will be called Supernus, headquartered at Supernus’ Rockville, Maryland offices, and will be headed by its current CEO, Jack Khattar. Individor board member Tony Kingsley will become the combined company’s board chair. The board is expected to consist of eight members evenly split between Individor and Supernus.”
  • Per MedTech Dive,
    • “Global investment firm KKR said Monday it has agreed to buy device manufacturer Integer Holdings for about $5.7 billion.
    • “The companies expect to close the deal before the end of the year, at which point Integer would become a private company. Shares of Integer rose by nearly 20% to $121.21 Friday afternoon following a Wall Street Journal report that the two companies were nearing a deal.
    • “Integer, which bills itself as one of the largest global medical device contract development and manufacturing organizations, expects the acquisition would provide flexibility and long-term capital to invest in its capacity, technology and innovation.”

Friday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

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.” 

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.” 

Friday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Senate Democrats again blocked Republicans’ seven-week stopgap spending bill, effectively guaranteeing that the government shutdown will stretch into next week, while the Trump administration froze funding for a Chicago transit project in its latest swipe at blue cities and states.
    • “The GOP measure failed with 54 in favor, and 44 opposed. Republicans control the chamber 53-47 but needed 60 votes to advance the measure under Senate rules.
    • “Earlier Friday, the Trump administration said it is freezing $2.1 billion in federal funds allocated for Chicago in its latest budgetary maneuver targeting Democratic priorities and projects during the shutdown.” 
  • Our OPM Director remains on the job. Today’s Secrets of OPM blog post from Director Scott Kupor discusses OPM’s efforts to handle the retirement surge stemming from the Fork in the Road program.
  • Tammy Flanagan, writing in Govexec, offers “Some good news for federal employees: TSP shows steady growth and healthy fund performance. The Thrift Savings Plan has surpassed $1 trillion in assets, providing steady returns in 2025.”
    • “There has been a lot to worry about for federal employees and their benefits in 2025, but one thing that has been doing very well is the Thrift Savings Plan! The TSP will continue its normal daily operations during the current lapse in appropriations. Visit tsp.gov/shutdown/  for additional information and updates.”  
  • NCQA, writing in LinkedIn, discusses what the organization has learned about defining best practices in wellness and patient engagement.

From the Food and Drug Administration front,

  • Per MedPage Today,
    • “The FDA approved lurbinectedin (Zepzelca) plus either atezolizumab (Tecentriq) or atezolizumab and hyaluronidase (Tecentriq Hybreza) as first-line maintenance therapy for extensive-stage small cell lung cancer, the agency announced on Thursday.
    • “As the first approved combination in this setting, lurbinectedin-atezolizumab is indicated for patients whose disease has not progressed after atezolizumab, carboplatin, and etoposide induction therapy.”
  • and

From the judicial front,

  • SCOTUSblog provides us with news from this week’s long conference.
    • “The Supreme Court on Friday morning agreed to hear oral arguments this winter in a challenge to a Hawaii law that makes it a crime for someone who has a concealed carry permit to carry a handgun on private property without the property owner’s affirmative permission. The announcement that the justices will take up Wolford v. Lopez came as part of a short list of cases from the court’s “long conference” on Monday, at which they considered all of the petitions that became ripe for review during the justices’ summer recess.
    • “In addition to the Hawaii case, the justices added four other new cases – on topics ranging from Cuba’s liability for its confiscation of property in that country in the 1960s to the Fifth Amendment’s takings clause – to the list of cases in which it will hear oral arguments during the 2025-26 term.”
  • Beckers Payer Issues points out,
    • “A federal judge in Massachusetts denied a bid by a coalition of 21 Democratic-led states to halt new ACA rules they argue will impose significant barriers to receiving health coverage.
    • “The lawsuit was filed in July challenging a final rule that CMS introduced earlier this year to amend ACA marketplace regulations, which the states argued will lead to millions of people losing access to health insurance, raise costs for states, and reduce the availability of essential health benefits.”
  • Modern Healthcare adds,
    • “The [District of Massachusetts] decision also sets the stage for a potential larger legal battle if various courts reach differing decisions on the rule’s implementation. The regulation was partially stayed across the country in August as part of a separate case out of the U.S. District Court for the District of Maryland, meaning several provisions in the rule aren’t in effect despite the latest ruling.” * * *
    • “Katie Keith, a director of the Center for Health Policy and the Law at the Georgetown University Law Center’s O’Neill Institute for National and Global Health Law, said the Maryland injunction keeps the same provisions being challenged in Massachusetts from kicking in. That includes a minimum $5 monthly premium for those automatically re-enrolled into fully subsidized health plans and new income verification requirements.
    • “It’s like the rule never went into effect,” Keith said.
    • “But if the attorneys general appeal, their case would head to the 1st U.S. Circuit Court of Appeals, Keith said. That could potentially set up differing rulings on the same regulation, known as a circuit split, since an appeal is pending at the 4th U.S. Circuit Court of Appeals in the Maryland case.”

From the public health and medical / Rx research front,

  • Health Day informs us,
    • “Cardiovascular diseases (CVDs) were the leading cause of disability-adjusted life-years (DALYs) and deaths in 2023, according to a study published online Sept. 24 in the Journal of the American College of Cardiology.
    • “Gregory A. Roth, M.D., M.PH., from the University of Washington in Seattle, and researchers from the Global Burden of Cardiovascular Diseases and Risks 2023 Collaborators described the global, regional, and national burden of CVDs and risk factors including 18 subdiseases and 12 associated modifiable risk factors in 1990 to 2023 in 204 countries and territories.” * * *
    • “Our analysis shows wide geographic differences in CVD burden that can’t be explained by income level alone,” Roth said in a statement. “Given this kind of variation, our findings offer the opportunity to tailor local health policies to target the most relevant risks for specific populations.”
  • The Wall Street Journal explains why it is so important for infants to receive the Hepatitis B vaccine at birth.
    • “It’s the first and only shot most U.S. babies receive: the hepatitis B vaccine—a constant for decades in U.S. newborn care that doctors say is responsible for virtually eliminating childhood cases of the disease.
    • “Now that routine protection could be at risk as the Trump administration considers delaying the shot, the latest in a string of moves that undercut longstanding vaccine recommendations. The president recently quipped that perhaps the vaccine could be delayed until as late as age 12.
    • “Say what? Doctors warn that even delaying the vaccine by a few months would lead to more childhood cases and, ultimately, deaths.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A new study in npj Dementia using data from the UK Biobank shows that COVID-19 survivors aged 50 and older had a higher likelihood of developing new-onset dementia (NOD) compared to uninfected controls. 
    • “A total of 54,757 participants met the inclusion criteria for the study, including 16,017 with COVID-19 and 38,740 non-COVID participants. The median observation period was 24.1 months.
    • “According to the authors, compared with matched non-COVID controls, prior COVID-19 infection was associated with a 41% increased risk of all-cause dementia (hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.13 to 1.75). Men, unvaccinated participants, those with high blood pressure, and those with frequent alcohol use had the highest association with NOD.”
  • Per MedPage Today,
    • “A decline in maternal smoking in the U.S. corresponded with a decline in infants born with gastroschisis, researchers found.
    • “In an examination of more than 25 million live births, maternal smoking fell from about 9.5% in 2017 to about 4% in 2023, and concurrently, the incidence of gastroschisis, a birth defect in which organs are outside the body, dropped from about 2.5 to about 1.5 per 10,000 births, reported Zane Hellmann, MD, MHS, of Yale University in New Haven, Connecticut.
    • “Mothers who had any history of smoking within 3 months of conception were significantly more likely to have a baby with gastroschisis, at a rate of 5.0 per 10,000 births — a nearly 3-fold increase compared to mothers without a history of smoking, at a rate of 1.75 per 10,000 births, Hellmann noted in a presentation during the American Academy of Pediatrics annual meeting.
    • “I think that this highlights the effects that national public health can have on the general population [and] on future generations,” Hellmann said.”
  • Per Medscape,
    • In adults with obesity who achieve ≥ 5% weight loss on a low-calorie diet, a 1-year exercise program produces a greater increase in late-phase postprandial GLP-1 response compared with usual activity, a change that may help curb appetite and prevent weight regain.
  • and
    • The benefits of omega-3 fatty acids (FAs) are well known to medical professionals, but your patients may not be as well versed on their benefits or where to find them or how to add them to their diets. [The article shares] some tips to help explain omega-3 FAs.

From the U.S. healthcare business front,

  • Kaufman Hall considers “Rethinking payer-provider relationships after the One Big Beautiful Bill: Where will the money come from?”
  • Per MedPage Today,
    • “With all the changes to the healthcare sector — from vaccine recommendations to efforts to crack down on pharmacy benefit managers — how are health insurers responding? 
    • ‘MedPage Today Washington Editor Joyce Frieden talked with Paul Markovich, CEO of Ascendiun, a healthcare company based in California, about how his company — which includes Blue Shield of California — is meeting the challenges.“
  • The University of Minnesota’s CIDRAP alerts us,
    • “Direct mailing human papillomavirus (HPV) self-testing kits to women’s homes was cost-effective for those who regularly undergo cervical cancer screening, those overdue for screening, and those with unknown screening histories who opted in, per a Kaiser Permanente–led study published today in JAMA Network Open.
    • “The cost-effectiveness and budget-impact analysis was based on the results of a randomized clinical trial conducted from November 2020 to July 2022. The test-delivery costs of Kaiser Permanente Washington and Medicare included wellness-based or screening-only visits. The 31,355 participants, aged 30 to 64 years, were identified through electronic medical records (EHRs).
    • “Regularly screened participants were randomly assigned to usual care (UC), education (UC and mailed educational materials), direct mail (UC, education, and mailed self-sampling kit), or opt-in (UC, education, and mailed invitation to request kit). 
    • “Participants overdue for screening were assigned to UC, education, or direct mail. Those with an unknown screening history were assigned to UC, education, or opt-in.
    • “Home-based testing addresses well-documented screening barriers and can mitigate the impact of appointment backlogs and scheduling constraints on patients and health care systems,” the study authors wrote. “However, cost-effectiveness has not been evaluated across other screening histories.” * * *
    • “In this economic analysis of a randomized clinical trial, directly mailing HPV kits to individuals who were screening adherent and overdue for screening was economically dominant over other strategies,” the researchers wrote. “Program costs declined rapidly over 4 years. Results support directly mailing HPV kits to eligible individuals as an effective, efficient, and affordable outreach strategy.”

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Democrats made their case to President Trump for restoring billions of dollars in healthcare spending as part of any deal to avoid a government shutdown, but they said there was no breakthrough in talks, further dimming hopes of a last-minute deal.
    • “It was a frank and direct discussion” with the president and Republican leaders, “but significant and meaningful differences remain,” said House Minority Leader Hakeem Jeffries (D., N.Y.) after leaving the meeting at the White House.” * * *
    • “The open question headed into Monday’s meeting was whether Trump the dealmaker would show up, or if he was content to let Democrats go home empty-handed. Trump believes he is in a strong position and that Democrats will be blamed for shutting down the government, according to allies. A Republican close to the talks said that while Trump likes to be a dealmaker, there may not be much of a deal to be made.
    • “[Senate Minority Leader Chuck] Schumer [D., N.Y.] and Senate Majority Leader John Thune (R., S.D.) have signaled any deal would likely focus on extending health-insurance subsidies. Those enhanced Affordable Care Act tax credits, first passed in 2021 by Democrats, are set to expire at year’s end. Democrats and some Republicans want an extension, but Republicans are seeking some new income limits on who receives subsidies. They also say discussions should only take place after Congress passes the stopgap bill keeping the government funded through late November.
    • The Senate was set to vote again before the Wednesday deadline on the same GOP bill that Democrats had previously rejected. Republicans have a 53-47 majority, but they need 60 votes to pass most legislation. With the House out this week, that is currently the only option available.
  • Modern Healthcare adds,
    • “The federal government is on track to shut down at midnight EST Wednesday, when fiscal 2026 begins. President Donald Trump and the Republican-led Congress have failed to enact annual appropriations bills to finance government operations. Negotiations with Senate Democrats continued Monday.
    • “Medicare, Medicaid, the Children’s Health Insurance Program and the federal health insurance exchanges would continue operating for the immediate future, HHS announced. The first three programs are mandatory and not subject to annual appropriations and CMS would cover exchange expenses with insurance company user fees.”
  • Federal News Network reminds us,
    • “Even if an agency doesn’t pay health premiums on time to OPM, federal employees and other enrollees in the Federal Employees Health Benefits (FEHB) program, as well as participants in the Postal Service Health Benefits (PSHB) program, maintain coverage throughout the duration of a shutdown, OPM has said in shutdown guidance.
    • “Those same rules apply to coverage through the Federal Employees Dental and Vision Insurance Program (FEDVIP), the Federal Employees’ Group Life Insurance (FEGLI) program and the Federal Long Term Care Insurance Program (FLTCIP).
    • “While all FEHB and PSHB participants maintain health coverage during a shutdown, those who are excepted or furloughed are not expected to pay health premiums while a shutdown is ongoing. Enrollees, however, will have to make any payments for premiums that accumulate during a shutdown, once the shutdown ends.”
  • Govexec offers part 2 of a series of commentaries about OPM in the second Trump Administration while FedSmith reminds folks about five mistakes to avoid during the upcoming FEHB / PSHB / FedFlex Open Season.
  • Avalere Health calls attention to key health policy actions to watch for during the rest of this year.
  • Mercer Consulting informs us,
    • “The 2026 changes to the Medicare Part D drug benefit passed under the Inflation Reduction Act are generally modest compared to the significant adjustments made in 2025. However, new instructions related to determining the creditable coverage status of prescription drug coverage allow plan sponsors to utilize a revised methodology for 2026. Plan sponsors should review the new methodology as they determine the most suitable one for their particular group health plan.
    • “Prior to Oct. 15 each year, plan sponsors providing prescription drug coverage must notify Part D-eligible individuals enrolled, or seeking to enroll, in their group health plan about whether the plan’s drug coverage is creditable — generally, whether it’s expected to pay, on average, at least as much as the Part D standard prescription drug coverage. Additionally, plan sponsors are required to report the creditable coverage status of their prescription drug plans to the Centers for Medicare and Medicaid Services each year, within 60 days of the plan year’s start.
    • “The IRA significantly enhanced Medicare Part D beginning in 2025, raising concerns among some plan sponsors about whether their drug coverage would remain creditable.  Instructions provided by CMS for 2026 take into account the IRA’s enhancements and increased flexibility in how plan sponsors may determine whether their drug coverage is creditable going forward, updating their Simplified Determination Methodology for 2026. And for the first time, some Health Savings Account-qualifying High-Deductible Health Plans may be able to use the SDM to determine creditable coverage status.”
  • The American Hospital Association News tells us,
    • “The Office of Science and Technology Policy issued a request for information Sept. 26 seeking feedback on federal regulations that hinder AI development, deployment or adoption. The OSTP is requesting comments on regulations across all sectors, including health care, where the underlying assumptions, technical requirements or compliance frameworks may create unnecessary barriers to beneficial AI applications. The agency is accepting comments through www.regulations.gov until Oct. 27.”
  • and
    • “The AHA Sept. 29 sent recommendations to the Department of Health and Human Services and the Centers for Medicare & Medicaid Services to help ensure insurance plans adhere to the agencies’ health insurer pledge to reform prior authorization processes. They include monitoring plans’ progress in fully implementing existing regulations, such as the interoperability and prior authorization final rule and reforms issued in the 2024 Medicare Advantage final rule. “As a result of the enormous detrimental impact that certain prior authorization practices routinely place on patients, physicians and hospitals, the AHA has been actively pushing for reforms in this area for a long time and working with health plans to collaboratively reduce the burdens associated with these programs,” the AHA wrote.”
  • and
    • “The AHA Sept. 29 asked the Trump administration to provide exemptions for health care personnel from the proclamation issued Sept. 19 announcing changes to the H-1B visa program. The proclamation increases the fee to $100,000 for new H-1B petitions filed by employers, as well as implements other restrictions on the entry of certain nonimmigrant workers. Of nearly 400,000 H-1B petitions approved in fiscal year 2024, 16,937 of those, or 4.2% of the total filed petitions, were for medicine and health occupations, and half of those approved petitions were for physicians and surgeons.” 
  • The Labor Department’s Bureau of Labor Statistics issued its annual report
    • “Seventy-two percent of private industry workers had access to medical care plans and 45 percent of workers participated. Dental care was available to 30 percent of private industry workers in establishments with less than 100 workers, 50 percent of private industry workers in establishments with 100-499 workers, and 70 percent of private industry workers in establishments with 500 workers or more. Vision care benefits were available for 21 percent of workers in establishments with less than 100 workers, 34 percent of private industry workers in establishments with 100-499 workers, and 44 percent of private industry workers in establishments with 500 workers or more. on employee benefits in the United States.
  • Per Beckers Payer Issues,
    • “The National Committee for Quality Assurance has named Vivek Garg, MD, as its next president and CEO, effective Jan. 5.
    • “Dr. Garg succeeds NCQA founder and current president Margaret O’Kane, who will retire at the end of this year. He currently serves as chief medical officer at Humana’s CenterWell Senior Primary Care.
    • “Dr. Garg previously held leadership positions at CareMore and Aspire Health, Oscar Health and One Medical Group.”

From the Food and Drug Administration front,

  • Fierce Pharma lets us know,
    • “Kedrion Biopharma has scored an FDA approval for Qivigy for adults with primary humoral immunodeficiency (PI), a group of disorders that prevent the immune system from operating effectively. 
    • “As an intravenous immunoglobulin (IVIG) therapy, Qivigy provides patients with antibodies that are intended to help them ward off infections.
    • “Along with the approval, the Italian plasma collection specialist was quick to point out in a release that it plans to increase its investments in the United States. To support the production of Qivigy, Kedrion announced plans to invest more than $260 million in expanding its U.S. network with over 40 new plasma collection centers. 
    • “The company also said it will invest more than $60 million to expand capacity at its manufacturing facility in Melville, New York.”
  • and
    • “Johnson & Johnson’s Tremfya continues to expand its reach as now the FDA has approved the IL-23 inhibitor as a treatment for two pediatric patient populations.
    • “The agency endorsed Tremfya as a treatment for children 6 years and older who weigh at least 40 kg (88 pounds) with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
    • “In addition, children 6 and older with active psoriatic arthritis are now eligible for the drug, provided they weigh at least 40 kg, J&J said in a Sept. 29 release.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “About 58 million pounds of corn dogs and other sausage-on-a-stick products were recalled across the U.S. because pieces of wood may be embedded in the batter. (AP)
    • Meanwhile, supermarket chain Albertsons recalled several of its store-made deli products because they may contain Listeria, shortly after federal health officials warned consumers not to eat certain pasta meals sold at Walmart and Trader Joe’s over Listeria concerns. (AP)
  • and
    • “Widespread HPV vaccination slashed infection risk and delivered protection for vaccinated and unvaccinated adolescent girls and young women alike, according to a cross-sectional analysis of six regional surveillance studies.
    • “Between 2006 and 2023, the adjusted proportion of vaccinated women in the six studies who were positive for the high-risk HPV-16 and HPV-18 types covered by the first FDA-approved 2-valent HPV vaccine (2vHPV) dropped 98.4%, said Jessica Kahn, MD, MPH, of Albert Einstein College of Medicine in New York City, and colleagues.
    • “In the 17-year period, the proportion of vaccinated women who tested positive for HPV types covered by the later 4-valent vaccine (4vHPV) dropped 94.2% and fell 75.7% for types covered by the current 9-valent vaccine (9vHPV).
    • “Those declines were paired with evidence of herd protection. The proportion of unvaccinated adolescent girls and young women who were positive for at least one HPV type covered by 2vHPV dropped 71.6%. The proportion positive for at least one HPV type covered by 4vHPV fell 75.8%, they noted in JAMA Pediatrics.”
  • and
    • “In the Southern Hemisphere, the adjusted flu vaccine effectiveness rates against outpatient visits and hospitalizations were 50.4% and 49.7%.
    • “Only 21.3% of flu outpatients and 15.9% of hospitalized flu patients were vaccinated.
    • “Health authorities in the Northern Hemisphere might expect similar levels of protection against influenza, experts said.”
  • STAT News notes,
    • “Heart attacks, heart failure, and strokes don’t come out of nowhere, a new study concludes. The first time they strike, patients, clinicians, and researchers might think there were no red flags.  
    • “But a prospective cohort study reports that more than 99% of people who experienced these illnesses had at least one of four risks for cardiovascular disease. They had “suboptimal” high blood pressure, cholesterol, or blood glucose, or they were current or former smokers. More than 93% of the more than 9.3 million people in two national cohorts followed for 20 years had more than one risk factor.
    • “Among women under 60, often considered to be at lowest risk, more than 95% had at least one nonoptimal risk factor before heart failure or stroke.
    • “This almost universal prevalence of warning signs is far higher than reported in other studies, the new paper asserted.
    • “Every practicing cardiologist has seen cases in which individuals without any known risk factors sustain an MI or develop significant coronary disease,” Neha Pagidipati of the Duke Clinical Research Institute wrote in a companion editorial, referring to myocardial infarction, or heart attack. “However, the prevalence of CVD without traditional risk factors may be significantly lower than previously described.”
  • MedPage Today adds,
    • “The increase in early-onset cancers is not necessarily due to a rise in clinically meaningful cancers, researchers argued, but may be due to increased diagnostic scrutiny and overdiagnosis.
    • “Of the eight fastest-rising cancers, only two — colorectal and endometrial cancer — have shown a slight increase in early-onset mortality.
    • “For the six other cancers, stable or declining mortality rates alongside rising diagnoses suggest that greater detection (rather than more disease) may account for the trend.”
  • Per Health Day,
    • “Acute cystitis may signal the presence of urogenital cancers in middle-aged adults, according to a study published online Sept. 16 in BMJ Public Health.
    • “Filip Jansåker, M.D., Ph.D., from Lund University in Sweden, and colleagues examined the subsequent risks for urogenital cancers in men and women aged 50 years and older diagnosed with acute cystitis. The analysis included roughly 1.67 million men and 1.89 million women, including 177,736 men and 427,821 women diagnosed with acute cystitis (first event) from 1997 to 2018.” * * *
    • “It is plausible that urogenital cancer, and perhaps even precancerous changes in the urogenital organ, might increase the risk of cystitis because of compromised urinary tract and host defense,” the authors write.”
  • Genetic Engineering and Biotechnology News relates
    • “Bispecific antibodies and chimeric antigen receptor (CAR) T cells demonstrate potent cancer immunotherapy in clinical use, yet most cancers remain poorly targetable. High-affinity antibodies needed to maximize cancer killing also detect low antigen expression in normal tissue, which causes toxicity in healthy tissue. Identifying cancer-restricted cell-surface protein antigens remains an ongoing challenge. 
    • “In a new study published in Cell titled, “Safe immunosuppression-resistant pan-cancer immunotherapeutics by velcro-like density-dependent targeting of tumor-associated carbohydrate antigens,” researchers from the University of California (UC), Irvine, have reported that targeting cancer-associated glycans with binding proteins can trigger tumor cell death without toxicity to surrounding tissue. The biologically engineered immunotherapies, known as glycan-dependent T cell recruiter (GlyTR) compounds, were shown to be safe and effective in models for a spectrum of cancers, including breast, colon, lung, ovaries, pancreas and prostate. 
    • “It’s the holy grail—one treatment to kill virtually all cancers,” said Michael Demetriou, MD, PhD, a professor of neurology, microbiology and molecular genetics at the UC Irvine School of Medicine and corresponding author of the study. “GlyTR’s velcro-like sugar-binding technology addresses the two major issues limiting current cancer immunotherapies: distinguishing cancer from normal tissue and cancer’s ability to suppress the immune system.”

From the healthcare business front,

  • STAT News reports,
    • “Perimenopause is the new buzzword in the business of women’s health.
    • “The menopause market has proved so successful that companies are increasingly pushing products aimed at younger women too.”
  • Beckers Hospital Review breaks down the massive 138-hosptial Common Spirit health system’s revenue by region for the fiscal year ending June 30 in 2025 and 2024.
  • MedPage Today points out,
    • “Among more than 3 million Medicare Advantage enrollees, value-based payment models outperformed fee-for-service models for all 15 clinical quality outcomes.
    • ‘The mean score differences for blood glucose control and blood pressure control indicated “markedly better performance” with value-based payment models.
    • “Clinical quality performance consistently improved as financial arrangements moved toward 2-sided risk sharing.”
  • The Brown & Brown consulting firm discusses “Practical Approaches for Employers to Manage High-Cost Claimants in Health Plans.”
    • “Managing high-cost claimants requires a delicate balance of cost control, care quality and employee experience. Employers who invest in data-driven decision making, proactive care management and thoughtful plan design are best positioned to reduce the financial impact of high-cost claimants without sacrificing the well-being of their workforce.
    • “By taking a strategic and holistic approach, employers can turn a major cost challenge into an opportunity to enhance healthcare delivery, improve outcomes and foster a healthier, more productive employee population.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “today that it will assess the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Novavax) for the prevention of COVID-19, including both the short- and long-term effects of the infection.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in June 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The Wall Street Journal reports,
    • “Novartis NOVN said it is launching a direct-to-patient platform in the U.S. to sell a discounted version of its Cosentyx drug, the latest big pharma company to move to cut prices ahead of the Trump administration’s deadline.
    • “The Swiss pharmaceutical company said Monday that it would offer select units of Cosentyx—a drug treating immune-mediated inflammatory conditions like psoriasis and psoriatic arthritis—at a 55% discount to cash-paying patients with a prescription. The platform will come into effect on Nov. 1.
    • “Novartis’s launch of a direct-to-patient platform and the discount comes after President Trump said in a letter to pharmaceutical companies in July setting a deadline of Sept. 29 to impose cuts on drug prices.”
  • Fierce Pharma adds,
    • “As pharma companies face an imminent deadline from President Donald Trump related to his “Most Favored Nation” (MFN) drug pricing demands, the industry’s top U.S. lobbying group is touting three “major actions” by its members and calling for some policy shifts of its own.
    • “The timing of the Sept. 29 press release by the Pharmaceutical Research and Manufacturers of America (PhRMA) coincides with the deadline set by the president when he laid out the steps pharma companies “must take” to align certain U.S. prices with lower prices overseas. 
    • “But rather than directly addressing the core component of Trump’s demand, the PhRMA communication centers on its members’ infrastructure spending, patient financial assistance programs and a new website designed to compile drugmakers’ direct sales offerings.
    • “PhRMA members are planning $500 billion in U.S. investments over the next 10 years, including $100 billion in projects that haven’t been announced yet, PhRMA CEO Steve Ubl wrote in an accompanying Washington Post op-ed piece Monday.
    • “Besides the capital projects, the industry trade group also plans to launch a website compiling its members’ direct sales offerings. Over the last several months, Big Pharma players have been rolling out new direct-to-patient sales platforms that offer cash-paying patients steep discounts to list prices for certain medicines. This is one component of the president’s push to rein in U.S. prices, and pharmaceutical companies are happy to stick it to middlemen in the U.S. whenever possible.”
  • Per BioPharma Dive,
    • “Antibody drug specialist Genmab on Monday agreed to acquire Dutch biotechnology company Merus in an $8 billion deal centered around a drug that’s shown potential treating head and neck cancer.
    • “Per deal terms, Genmab will pay $97 per share in cash to acquire Merus, representing a 41% premium to the biotech’s closing price on Friday of about $68.  
    • “The deal hands Genmab a drug called petosemtamab and that’s in late-stage testing for head and neck cancer. Phase 2 data presented at the American Society of Clinical Oncology meeting in May showed that the drug helped extend survival when used alongside Merck & Co.’s immunotherapy Keytruda, a result that boosted shares and suggested it could change care for those tumors.”
  • and
    • “Emma Walmsley, the first woman to lead a big pharma company as CEO, will step down from that post Dec. 31, handing the reins of one of Britain’s premier drugmakers to commercial chief Luke Miels.
    • “In a statement Monday, GSK said Walmsley, who has been running GSK since 2017, will depart as part of a succession plan. Miels’ selection was the outcome of a “rigorous process” conducted over the last few months and that included consideration of “internal and external candidates.” He’ll start serving as GSK’s full-time CEO on Jan. 1.
    • “The CEO change ends a nine-year run for Walmsley atop GSK. During that time, Walmsley steered the big drugmaker through a turbulent period, during which it spun out its consumer health business to focus on innovative drugs while facing persistent investor pressure to boost its productivity and growth prospects.
    • “GSK also deepened its investment in oncology, expanded its HIV drug portfolio and brought to market the first vaccine for respiratory syncytial virus.
    • “Yet GSK missed an opportunity during the COVID-19 pandemic, when it decided against developing its own vaccine and partnerships with Sanofi and CureVac hit setbacks and delays.” * * *
    • ‘Miels joined GSK in 2017 after stints at AstraZeneca, Roche and Sanofi, in positions in Europe, Asia and the U.S. He will be paid a base salary of nearly 1.4 million pounds and qualify for bonuses of up to 300%, in addition to other incentives and benefits, according to GSK’s statement.
    • “Walmsley, meanwhile, will also step down from GSK’s board effective Dec. 31, but will remain with the company through Sept. 30, 2026, to support Miels “given the potential impact to GSK’s operating environment arising from geopolitics and new technologies.”

Friday report

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

From Washington, DC,

  • Govexec tells us,
    • “Federal employees have been asking a lot of questions since the White House put out guidance this week suggesting large swaths of them would face layoffs under a government shutdown if one occurs next week.
    • “So far the answer many of them are getting is: we are planning to send you home without pay, but only until the shutdown ends. That is to say, agency officials are telling employees they will face their normal shutdown furloughs, but not reduction-in-force notices. 
    • “We were told we won’t be RIF’d, regardless of whether we have to work,” said one General Services Administration employee, whose office is typically furloughed during a funding lapse. 
  • The Centers for Medicare and Medicaid Services announced,
    • [A]verage premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program are expected to remain stable in 2026. Average premiums are projected to decline in both the MA and Part D programs from 2025 to 2026.
    • CMS is committed to ensuring these programs work for Medicare beneficiaries while maintaining access to high-quality, affordable healthcare options, safeguarding taxpayer dollars, and making sure beneficiaries have the information they need to make informed choices about what is best for them. 
    • CMS releases this key information, including 2026 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2025, to December 7, 2025.
    • “Millions of Medicare beneficiaries will continue to have access to a broad range of affordable coverage options in 2026,” said CMS Administrator Dr. Mehmet Oz. “We want every beneficiary to take advantage of Open Enrollment—compare your options and choose the plan that gives you the right care at the best price.”
  • The American Hospital Association News informs us,
    • President Trump, late Sept. 25, announced that starting Oct. 1, the U.S. will impose a 100% tariff on any branded or patented pharmaceutical product, unless a company is building its pharmaceutical manufacturing plant in America. The president’s post on Truth Social said “is building” will be defined as “breaking ground” or “under construction” and that there would be no tariff on “these Pharmaceutical Products if construction has started.”   
    • As of 3 p.m. ET on Sept. 26, the administration has not released any official documents related to the tariff announcement.  
  • BioPharma Dive adds,
    • “The new pharmaceutical tariffs President Donald Trump announced on Thursday, which will go into effect on Oct. 1, could have a limited impact on the pharmaceutical industry due to multiple exemptions for generics, exports from Europe and companies already onshoring manufacturing.
    • “The tariffs, unveiled via a post on the social media platform Truth Social, haven’t been accompanied by legal documents, leaving key details unclear. However, the 100% levies, which are much smaller than the figure previously floated by the Trump administration, alleviate some uncertainty around U.S. drug pricing policy.
    • “The announcement comes days before the expected release of programs meant to align U.S. drug prices with what’s paid in Europe and elsewhere. Published reports have suggested those policies may be more modest than Trump originally proposed, however.”
  • FedWeek points out,
    • “A new bipartisan group of House members has been formed with a focus on the impact on jobs and delivery performance of the Delivering for America reorganization initiative.
    • “The Congressional Postal Service Caucus will focus on improving on-time delivery rates, protecting postal employees, and stopping harmful facility consolidations that reduce access in rural and underserved areas,” said a statement from the founding members. A caucus is a less formal organization than a congressional committee, typically focusing on issues—and trying to build consensus on them—that cross committee areas of jurisdiction.”
  • NCQA, writing in LinkedIn, lets us know about NCQA researchers sharing findings on emerging topics in health care.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza and RSV activity is low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. The percentage of emergency department visits for COVID-19 are highest in children 0-4 years old. Hospitalization numbers and the percentage of emergency department visits are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is low nationally.
  • The University of Minnesota CIDRAP adds,
    • “The current COVID wave began in June, marked by a slow rise that never approached levels seen last summer.
    • “Wastewater SARS-CoV-2 detections are now at the moderate level and are highest in Northeast, followed by the West and the South.”
  • Prevention notes,
    • “The Stratus COVID variant, a.k.a. XFG, is currently the dominant strain of the virus in the U.S., causing 78% of cases in the country, according to CDC data.
    • “It’s an Omicron variant, and it’s a hybrid of two strains—LF.7 and LP.8.1.2,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.
    • Stratus has several mutations to the spike protein, which the virus uses to infect your cells and make you sick, per the World Health Organization (WHO). But the WHO also notes that the threat posed by Stratus is “low.”
  • The Wall Street Journal reports,
    • “President Trump’s return to office has supercharged the debate about childhood vaccinations. Trump himself recently stated that “children get these massive vaccines…like you give to a horse…they get like 80 vaccines,” while Health Secretary Robert F. Kennedy Jr. asserts that babies get up to 92 vaccine doses. In justifying Florida’s decision to end mandatory vaccine mandates for children, state surgeon general Joseph Lapado asked: “Who am I to tell you what your child should put in [their] body? I don’t have that right.”  
    • “These statements misstate the amount and number of vaccines administered to children. Over the course of 18 years, it’s typically 30 doses—in quantities about a tenth of a teaspoon—for about 16 different pathogens. But the critics raise important questions that parents have every right to ask. Why give vaccines so early in a baby’s life? And why shouldn’t parents just pick and choose what goes into their child?  
    • “The crucial context for this discussion is two facts. First, vaccines constitute only a minuscule fraction of the exposure to pathogens that children’s immune systems must contend with. Second, our bodies develop the most enduring antibodies in the early years of life.”
  • JAMA relates,
    • “For years, most observers attributed the higher number of Alzheimer disease cases among women to the simple fact that they live longer than men on average.
    • “Recently, though, scientists have come to recognize that the explanation for the sex gap in the prevalence of Alzheimer disease, the cause of most cases of dementia, is far more nuanced and complex, involving both biological and sociocultural factors.
    • “Research has focused on such potential contributors as women’s exposure to sex hormones, the genes in the X chromosome, the prevalence and effect of risk factors such as hearing loss, the apolipoprotein E ε4 (APOE4) variant, and diminished cognitive reserve related to lower education levels.
    • “Approximately 2 out of every 3 people living with Alzheimer disease in the US is a woman, Harvard neuropsychologist Rachel Buckley, PhD, noted. “Women actually tend to live with dementia for much longer than men.”
  • Per Health Day,
    • “An experimental pill can significantly reduce hot flashes and night sweats for women after menopause a new clinical trial has determined.
    • “Elinzanetant produced a nearly 74% reduction in the frequency and severity of these menopause symptoms within three months, researchers reported recently in JAMA Internal Medicine.
    • “Further, this relief lasted for a year, the trial found.
    • “This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” researcher Dr. JoAnn Pinkerton said in a news release. She’s director of midlife health at University of Virginia Health in Richmond.”
  • and
    • “Routine screening can help find kids who are suffering from undiagnosed asthma in communities with high levels of the breathing disorder, a new study says.
    • “Asthma screening during well-child visits found that more than two-thirds (35%) of children with no previous diagnosis of asthma had at least one risk factor for the disease, researchers will report Monday at an American Academy of Pediatrics’ meeting in Denver.
    • “Further, about 24% of kids with risk factors were subsequently diagnosed with asthma, researchers said.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Commercially insured patients pay substantially different rates for the same procedure, with negotiated costs for inpatient procedures varying by an average ratio of 9.1, according to an August report from market intelligence firm Trilliant Health.
    • “The report reviewed health plan transparency data from Aetna and UnitedHealthcare, focusing on 11 inpatient and outpatient procedures.
    • “A coronary bypass without cardiac catheterization, excluding major complications or comorbidities, had negotiated rates ranging from $27,683 to $247,902. Another finding: Outpatient procedures at ambulatory surgery centers would often cost less than those taking place in a hospital’s outpatient department. Colonoscopies, for example, would cost 67.5% less on average than the median hospital rate.
    • “By reviewing a sample of 10 hospitals featured on a collection of “best hospitals” rankings, the researchers also found no correlation between cost and quality.”
  • and
    • “Regional, nonprofit health plans are falling behind large national insurers, with 71% recording an operating loss in 2024 and more than half having two years or less before regulatory intervention is triggered, according to a Sept. 24 report from HealthScape Advisors.
    • “Executives and boards of directors now face the most important decision of their leadership tenures: How do we survive?” the report said.” 
  • Kauffman Hall explains,
    • “The rise of ambulatory surgery centers (ASCs) marks a shift in how surgical care is delivered across the U.S. Amid soaring healthcare costs, tighter reimbursement and advancing surgical technology, health systems are rethinking where and how procedures are done. Many are moving complex surgeries like total joint replacement and spine out of hospitals and into ambulatory settings. Once limited in scope, ASCs are becoming key players in strategically important service lines like orthopedics.” * * *
    • “ASCs are not a magic wand for health systems. While they offer savings to payers, the economics are fragile for providers. Healthy margins require lean operations, smart sourcing and trusted partnerships.
    • “There’s a growing demand for more complex procedures in outpatient settings, but ASCs need to strategically position themselves to meet this demand in an operationally and financially sustainable way.
    • “With advances in surgical technology and care coordination, ASCs are ready to deliver on the promise of value-based care. The challenge for health systems isn’t just to shift where care is delivered, but to rethink how surgical care is structured, managed and financed for long-term performance.”
  • Optum, writing in LinkedIn, discusses how “breakthrough cancer drugs offer better outcomes – but soaring costs pose challenges.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it will offer its asthma and diabetes drugs at an up to 70% discount in the U.S. ahead of a Trump administration deadline for pharmaceutical companies to cut drug prices.
    • “The company said it would launch a direct-to-consumer platform on which eligible patients with prescriptions will be able to purchase its Airsupra and Farxiga drugs in cash at a discount. The platform will be available beginning Oct. 1.
    • “In July, President Trump sent pharmaceutical companies a letter setting a Sept. 29 deadline to propose cuts to their drug prices.
    • “In response, several drugmakers have rolled out direct-to-consumer platforms to offer discounted drugs. Earlier this week, Bristol Myers Squibb said it would offer its plaque psoriasis drug at an up to 80% discount, expanding on its discounted program for blood clot drug Eliquis, which it announced in July.”
  • Fierce Pharma adds,
    • “In an expansion of its previous moves to cut insulin prices, Sanofi will cap the price of each of its insulin products at $35 per month in the U.S. regardless of a patient’s insurance status.
    • “The move, which goes into effect at the start of next year, comes two years after the company slashed the price of its most popular insulin, Lantus, to $35 monthly for those with commercial insurance.
    • “Before that, in June of 2022, Sanofi reduced the price of an unbranded Lantus biologic from $99 per month to $35 for those in the U.S. without insurance.
    • “Sanofi’s cost-cutting efforts have mirrored those of the world’s other two primary sellers of insulin—Novo Nordisk and Eli Lilly—and come as advanced insulin products and insulin biosimilars are reaching the market.”