Friday report

CDC

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NCQA, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democrats blocked Republicans’ stopgap measure that would keep the government funded until late November and insisted that major healthcare spending be added to the bill, raising the odds for a partial shutdown in less than two weeks.
    • “Friday’s vote in the Republican-controlled Senate was 44 in favor and 48 against, short of the 60 votes required. Sens. Rand Paul of Kentucky and Lisa Murkowski of Alaska were the only Republicans to vote against the measure, while Democratic Sen. John Fetterman voted in favor. Several Republicans were absent. 
    • “The GOP-led House narrowly passed the measure earlier in the day in a 217-212 vote largely along party lines.
    • “The failure of the bill in the Senate set the stage for a down-to-the-wire standoff, with both parties standing firm and saying the other one would take the blame for a fall shutdown. * * *
    • Democrats proposed an alternative that would fund the government through Oct. 31 and reverse hundreds of billions of dollars in cuts to Medicaid enacted under the Republican tax-and-spending legislation that Republicans have rebranded the “working families tax cut.” The Democratic alternative would permanently extend certain ACA subsidies that expire at the end of this year. * * *
    • Republicans rejected the Democratic proposal as unserious. It failed in its own vote with 47 in favor and 45 opposed, short of the 60-vote requirement. Republicans control the Senate 53-47.
    • “The Democrats want a ransom payment of more than $1 trillion to keep the government open for only four more weeks,” said Senate Majority Whip John Barrasso (R., Wyo.).
    • [Senator Lisa] Murkowski [(R. AK), who voted against both the Republican plan and the Democratic proposal, said she wants a continuing resolution that extends enhanced ACA subsidies for two years, in addition to addressing some fiscal year 2026 appropriations and funding for the public media.
    • “Both of these were messaging bills,” she said. “They both did what everybody predicted was going to happen, which was, they were going to go down.
  • STAT News reports good news from Atlanta,
    • “A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.
    • “The decision, if signed off on by federal health leaders, would preserve insurance coverage for the shots, and is similar to the Food and Drug Administration’s approvals of the updated vaccines earlier this year. The Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, emphasized that for people under 65, the benefits of vaccination are most clear for people with risk factors for severe Covid-19.
    • “This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services spokesperson said.”
  • and
    • “A key government advisory committee voted Friday to postpone a vote on whether to delay infants’ first hepatitis B vaccine — temporarily alleviating fears that a new recommendation on shot timing could reverse the significant progress made in controlling the disease’s spread in recent decades.
    • “The decision followed a lengthy deliberation on Thursday by the newly reconstituted Advisory Committee on Immunization Practice, which pressed scientists from the Centers for Disease Control and Prevention on the necessity of the birth dose, and brought into question the veracity of the data presented on the risks and benefits of the vaccine. But ultimately, members voted to push the vote.”
    • “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” Robert Malone, a member of the committee, said on Friday. All of the members of the committee, except its chair, Martin Kulldorff, voted to table the vote.”
  • Per a Congressional news release.
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement on the Advisory Committee on Immunization Practices (ACIP) postponing a vote to change the recommendation for the hepatitis B vaccine for newborns. If a recommendation for a vaccine is altered without a scientific basis, insurance companies may decide to no longer cover it for patients free of charge. Additionally, doctors will lack the necessary information to counsel families, so they make the best health care decisions for their children.
    • “At Wednesday’s hearing, Cassidy underscored the importance of families having access to the hepatitis B vaccine at birth.”
  • Here is an informative Blue Cross link to an article about No Surprises Act abusive practices by providers particularly in the arbitration / IDR process.  In my opinion, which supplements the Blue Cross recommendations, the NSA arbitration process would be more equitable if the Tri-Agencies added more substance from the AAA baseball / final offer rules to its IDR procedures. 
  • Beckers Payer Issues informs us,
    • “CMS has finalized a rule requiring Medicare Advantage plans to submit provider directory data for inclusion in the Medicare Plan Finder. 
    • “The change, aimed at improving transparency and beneficiary decision-making, takes effect January 1, 2026.
    • “Under the rule, MA plans must make provider directory information available to CMS in a standardized format for online publication, update the data within 30 days of becoming aware of changes, and attest at least once a year to the accuracy of the information.
    • “CMS said the move is designed to allow beneficiaries to more easily compare provider networks across plans without having to navigate multiple websites. The agency expects to publish an operational guide in the coming months with technical specifications for plans to follow, along with a testing period before the data appears publicly online.”
  • The American Hospital Association News explains that this CMS rule was part of a larger rulemaking.
    • “The Centers for Medicare & Medicaid Services Sept. 18 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2026. Yesterday’s final rule follows one released in April on other changes for MA and prescription drug programs. In the latest final rule, CMS finalized a requirement aimed at increasing beneficiary access to provider directory data in the CMS Medicare Plan Finder platform.”
  • The Government Accountability Office released a report titled “Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services.”
    • “About half of U.S. hospitals are in urban areas. More urban hospitals closed than opened from 2019 to 2023.
    • “All of the 5 hospitals in our review struggled financially before they closed, with inpatient volumes decreasing at 4 of them. The anticipated cost of upgrading or maintaining aging facilities also contributed to the closures of all 5 hospitals.
    • “After closure, 2 of the hospitals still provided outpatient services, while the other 3 stopped all services.
    • “Representatives from local hospitals, providers, and community organizations told us some community residents continued having trouble getting health care after all 5 hospitals closed.”
  • Last but not least, OPM Director Scott Kupor released his regular Friday blog post which concerns OPM’s mine in Boyers, PA, that holds paper personnel records.
    • “The Boyers mine is but one of many examples of opportunities for modernization across the federal government. None of these challenges are rocket science – maybe with the exception of our friends at NASA – but they have been plagued for too long by a system that doesn’t demand inventiveness and efficiency as first-class citizens in the government vernacular. OPM aims to create fluency in this new language – and we are starting with one retirement piece of paper at a time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.
    • “To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.
    • “The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
    • “Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.”
  • Per MedPage Today,
    • “The FDA approved the Altaviva implantable nerve stimulator for urge urinary incontinence (UUI), a common symptom of overactive bladder (OAB), Medtronic announced.
    • “Inserted near the ankle in a minimally invasive procedure, the device generates low-level electronic impulses that stimulate the tibial nerve to restore bladder-brain communication. The device is the third tibial neuromodulator for UUI, joining the eCOIN device approved in 2022opens in a new tab or window and the Revi System approved in 2023.
    • “The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” Kevin Benson, MD, of Sanford Health in Sioux Falls, South Dakota, said in a statement. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
    • “Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients. 
    • “Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.”
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).
    • “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments,” said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Barth syndrome primarily affects males, typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance. The quality of life and daily functioning of patients with Barth syndrome are significantly affected throughout their lives.”

From the public health and medical/Rx 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 activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in adults 65 years and older. Hospitalization numbers are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is very low nationally.
  • The AHA News points out,
    • “The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a public awareness and education campaign; the launch of an online platform for physicians, researchers and health systems to share best practices and clinical insights; and an Agency for Healthcare Research and Quality report also released Sept. 18 that covers the sources of health coverage for adults with long COVID.” 
  • Fierce Pharma lets us know,
    • “The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. 
    • “The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
    • “Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
  • Per Health Day,
    • “Aspirin can cut by more than half the risk that colon cancer will come back following initial treatment, a new clinical trial has found.
    • “Daily aspirin reduced by 55% the risk of cancer recurrence in patients whose colorectal cancer is driven by a genetic mutation, researchers reported Sept. 17 in the New England Journal of Medicine.
    • “Aspirin is a drug that is readily available globally and extremely inexpensive compared to many modern cancer drugs, which is very positive,” lead researcher Anna Martling, a professor of molecular medicine and surgery at Karolinska Institute in Sweden, said in a news release.
    • “The study focused on people whose colon cancer was driven by a mutation of the PIK3 gene, which helps regulate cell growth and division in the human body.
    • “Every year, about 107,320 new cases of colon cancer and 46,950 cases of rectal cancer are diagnosed in the United States, according to the American Cancer Society.”
  • NBC News reports,
    • “Wildfire smoke is responsible for tens of thousands of deaths each year and will do more harm to U.S. residents by midcentury than any other threat driven by climate change, including extreme heat. 
    • “That’s the conclusion of a new research paper that provides some of the most extensive modeling of the growing health toll of wildfire smoke on public health in the U.S. 
    • “The study, which was published in the journal Nature on Thursday, found that each year, on average, wildfire smoke is causing more than 41,400 excess deaths, or more than would be normally expected without smoke given the demographics of the U.S. That figure is more than twice what was previously recognized in other studies. 
    • “By midcentury, the study’s authors expect that number to grow by an additional 26,500 to 30,000 deaths as human-caused climate change worsens and the risk of wildfires igniting increases. 
    • “Wildfire smoke is a much larger health risk than we might have understood previously,” said Marshall Burke, a professor of environmental social sciences at Stanford University and a study author.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are working directly with employers to improve cancer care and lower costs as demand — and employers’ healthcare expenses — surge.
    • “Providers are gearing up to treat more cancer patients, hoping to ease employers’ mounting frustration with steep premium increases, long appointment wait times and unnecessary treatment, health system and care navigation company executives said. Cutting out insurers through direct contracts could add transparency to employers’ healthcare costs and help standardize treatment strategies, they said.
    • “Employers and unions have no choice but to take a really hard look at solutions that are going to steer patients to high-quality and lower-cost care,” said Emily Kauff, executive director of Memorial Sloan Kettering Cancer Center’s MSK Direct. “Employers are in crisis — they need lower costs and better value in cancer care.”
  • Beckers Payer Issues adds,
    • “Patients who get primary care from older adult-focused, value-based care organizations are more likely to use these services regularly, according to a study published in NEJM Catalyst: Innovations in Care Delivery, a digital journal published by The New England Journal of Medicine. 
    • “The study, produced by Humana Healthcare Research and Suhas Gondi, MD, attending physician at Boston-based Massachusetts General Hospital, covered 3.2 million Medicare Advantage members and included six older adult-focused facilities, most full-risk practices, according to Humana Chief Medical Officer Kate Goodrich, MD. The team found value-based care — as opposed to physicians offering a greater volume of services — is linked to increased use of primary care services.
    • “The exciting thing about this paper is that it shows that in those higher or more mature types of practices that are focused on seniors, they’re getting more primary care, and they’re getting more consistent primary care,” Dr. Goodrich told Becker’s.
    • “This research builds from a 2024 study on how older adult-focused organizations can increase access to primary care, particularly among underserved populations.”
  • Per Modern Healthcare,
    • “UnitedHealth Group has named Sandeep Dadlani CEO of its Optum Insight technology arm, Dadlani announced in a social media post Thursday. 
    • “Dadlani previously served as UnitedHealth’s executive vice president and chief digital and technology officer. He succeeds Dhivya Suryadevara, who had served in that role and CEO of the Optum Financial healthcare banking division since May.
    • “In a LinkedIn post, Dadlani wrote that it was his first week as CEO of Optum Insight, which includes the Change Healthcare claims processing division.” 
  • and
    • “VillageMD is selling 32 Texas clinics to Harbor Health, an Austin-based primary and specialty clinic group that also offers health plans.
    • “The deal includes 10 clinics in Austin, 10 in San Antonio, six in El Paso and six in Dallas. More than 80 clinicians will join Harbor as part of the transaction, according to a Thursday news release. 
    • “Financial details were not disclosed.”
  • Beckers Payers Issues looks into why Blue Cross of Massachusetts consistently achieves a very high NCQA scorecard.

Thursday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NCQA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “Top Senate Republicans and Democrats reached a deal Thursday night to tee up two votes on Friday on the two parties’ competing approaches to averting a partial government shutdown when current agency funding expires at the end of the month.
    • “Under the agreement announced by Senate Majority Leader John Thune, R-S.D., and Minority Leader Charles E. Schumer, D-N.Y., assuming the House passes the GOP-drafted, seven-week continuing resolution, then the Senate would take up Democrats’ alternative proposal first. That would be subject to a 60-vote threshold for passage.
    • “If Democrats can’t get 60 votes for their bill — which they aren’t expecting — then the chamber would proceed to a vote on the House-passed CR, also with a 60-vote threshold. That vote is also not expected to succeed.”
    • “However, the idea is for the two sides to head home for the weekend armed with proof that they have to start talking to each other about a compromise that can get 60 votes and get to President Donald Trump’s desk in time to prevent a shutdown.
    • “Schumer had proposed the arrangement earlier in the day, with an eye toward getting the initial votes over with in time for senators to attend conservative activist Charlie Kirk’s funeral in Arizona on Sunday.”
  • Roll Call adds,
    • “Democratic and Republican congressional leaders were engaging in a game of shutdown chicken Thursday, the day before the House’s expected vote on a seven-week stopgap bill due Sept. 30 to prevent a lapse in federal agency funding.
    • “House GOP leaders were feeling good about their odds of getting the bill through their chamber Friday morning, although they still had a little work to do on their side shoring up concerns about added member security funds in the continuing resolution being too skimpy, at $30 million. 
    • “Optimistic, but not certain,” House Appropriations Chairman Tom Cole, R-Okla., responded Thursday when asked for his outlook on passage.”
  • Per Congressional news releases
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, highlighted the importance of delivering President Trump and Secretary Kennedy’s mission to restore radical transparency at the U.S. Centers for Disease Control and Prevention (CDC) to protect children’s health.
    • “This comes after the HELP Committee held a hearing with former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. To deliver on the President’s mission of radical transparency, the Committee is inviting U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and HHS officials to respond by speaking with Committee members.”
  • and
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement following the U.S. Senate passage of the SUPPORT for Patients and Communities Reauthorization Act, which bolsters prevention, treatment, and recovery services for Americans with substance use disorders and mental illness. Earlier this year, the U.S. House of Representatives passed the bill with strong bipartisan support. The SUPPORT Reauthorization Act now heads to President Trump’s desk for signature.
    • “The opioid and mental health crisis is tearing apart families,” said Dr. Cassidy. “The SUPPORT Act equips communities with vital tools to combat this scourge and save lives. I’m grateful to my colleagues for their work to pass this bill and look forward to it being signed into law.”
  • MedTech Dive tells us,
    • “A House of Representatives committee has advanced a bill that would give eligible breakthrough devices four years of Medicare coverage.
    • “The House Ways and Means Committee debated the bill Wednesday, revealing concerns about the risk of fraud, the type of evidence required and the weakening of the Centers for Medicare and Medicaid Services’ authority.
    • “Despite the concerns, the bill received bipartisan support and was passed in a 38 to 3 vote. Two medtech trade groups welcomed progress on a topic that they have lobbied about for years.”
  • Beckers Payer Issues notes,
    • “Senate and House [Democrat] lawmakers have introduced a bill that would bar health insurers from buying independently owned clinics and require existing conglomerates to divert their provider businesses.  
    • “The Patients Over Profits Act would:
      • “Prohibit insurance companies or their subsidiaries from owning Medicare Parts B and C providers 
      • “Require insurers and their subsidiaries who also own Parts B or C providers to divest, and if they do not, a civil lawsuit can be brought by the Federal Trade Commission, state attorneys general, HHS inspector general or the Justice Department’s antitrust division. 
      • “Bars the HHS secretary from contracting with a Medicare Advantage organization that also owns a Part B or C provider.” 
  • and
    • “Three Medicare Advantage plans scored a full five stars in this year’s health plan rankings from the National Committee for Quality Assurance.
      • Kaiser Foundation Health Plan in Southern California – HMO
      • Kaiser Foundation Health Plan in Northern California – HMO
      • Network Health in Wisconsin – PPO
    • “An additional 17 plans, including six more Kaiser Foundation Health Plans from around the country, scored 4.5 stars in 2025.”
  • The Wall Street Journal reports,
    • Health secretary Robert F. Kennedy Jr.’s handpicked slate of vaccine advisers voted [8-3] to no longer recommend a combined shot for measles, mumps, rubella and varicella [chickenpox (MMRV)] for children under age 4. 
    • The move came as some states, insurers, public health leaders and a U.S. senator called into question whether Americans should rely on the committee’s decisions.
  • The FEHBlog listened to a good chunk of today’s meeting, and the ACIP decision was based on a concern about children under age 4 suffering febrile seizures as a result of the MMRV shot.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) today announced it is moving to decertify a major organ procurement organization (OPO) after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. In one 2024 case, a mistake led a surgeon to decline a donated heart for a patient awaiting transplant surgery.
    • “CMS’s decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, is part of Secretary Robert F. Kennedy, Jr.’s reform initiative announced in July. At that time, an HHS investigation into another OPO found that at least 28 patients may not have been deceased at the time of organ preparation, 73 patients showed neurological signs incompatible with donation, and the Biden administration had closed its own investigation without action.”
  • OPM Director Scott Kupor added to his blog last Monday September 15 with a post titled “Sorry, Not Everyone Gets an A.” In a related news release, OPM explains Director Kupor’s latest blog post explains why an OPM final rule published September 15 “promotes excellence and accountability.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is putting a pause on plans to relocate some of its employees, but said “new efforts” to do so are underway.
    • “In February, OPM gave remote employees more than 50 miles away from the office an ultimatum: Agree to a “management-directed reassignment” (MDR) and relocate to office space in another geographic region, or face termination.
    • “OPM said it would cover relocation expenses for employees who accept reassignment and gave employees until March 7 to make their decision.
    • “But in a new memo, obtained by Federal News Network, the agency states “relocation efforts for OPM employees are on pause.”
    • “The memo said all employees should continue to work at their current duty station, and that “there is no longer an expectation that the first cohort of employees will be relocated to their new duty station by December 2025.”
    • “The memo suggests OPM is taking a fresh look at relocation plans under OPM Director Scott Kupor, who took office in July.“
  • Tammy Flanagan writing in Govexec, follows up on her article from last week about picking the best date for federal retirement in 2026.

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “The FDA gave premarket approval to the first medical device for the treatment of women with symptomatic moderate-to-severe intrauterine adhesions, known as Asherman syndrome, maker Womed announced on Tuesday.
    • “The resorbable adhesion barrier device (Womed Leaf) is intended for women undergoing hysteroscopic surgery for Asherman syndrome.
    • “Asherman syndrome is caused by scarring of the uterus after procedures such as dilation and curettage or fibroid removal and can occur in 20% to 45% of those procedures. The condition can cause female infertility, pelvic pain, and recurrent miscarriages. Current treatment options for intrauterine adhesions have high recurrence rates.” * * *
    • “Womed said the device will be available in the U.S. in early 2026.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 federal district court decision that also vacated the FDA’s 2024 final rule. The AHA previously urged the FDA to not apply the 2024 final rule to hospital and health system LDTs when it was proposed. 
    • “The AHA appreciates that FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care,” said Roslyne Schulman, AHA director of outpatient payment, emergency readiness and public health policy. “The return to enforcement discretion for LDTs rightly recognizes that applying the device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely. This action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government.”
    • “Today’s final rule will become effective following official publication in the Federal Register Sept. 19.”

From the public health and medical/Rx research front,

  • The Wall Street Journal relates,
    • “Novo Nordisk’s daily Wegovy pill led to similar weight loss as the weekly injection in a late-stage trial.
    • “The Wegovy pill, already under review, could be the first GLP-1 pill approved for weight loss.
    • “Trial results showed improved cardiovascular risk factors and increased daily activity for patients.
    • “Currently, less than 2% of individuals with obesity in the U.S. receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” Martin Holst Lange, chief scientific officer and head of research & development at Novo Nordisk, said.
    • “Pending FDA approval, ample supply will be available to meet the expected U.S. demand as we hope to set a new treatment benchmark for oral weight loss medications,” he added.”
  • and
    • “Lilly and Novo Nordisk haven’t disclosed specific pricing plans for their pills, but some analysts expect them to be priced at a discount to the injectables.
    • “The leading weekly injected medicines, Novo Nordisk’s Wegovy and Lilly’s Zepbound, have been highly effective at helping people lose significant weight. Zepbound’s highest dose has been shown to help people lose an average of more than 22% of their body weight after more than a year of treatment, while Wegovy can help people lose about 17%. 
    • “Yet their manufacturers have struggled to make enough to meet demand, partly because of limited manufacturing capacity for the complex task of making sterile injectable drugs packaged in an auto-injector device. Making pills is less complex, and there is more global capacity. And, pills don’t require cold-chain distribution and storage, while the injectables need to be kept refrigerated.” * * *
    • “Novo Nordisk may be constrained in how much of its new weight-loss pill it can manufacture because it must cram a lot of the main ingredient into each pill to ensure each person absorbs enough by ingestion, analysts have noted. That is because, like injected semaglutide, the pill is made up of peptides, which are larger than the small molecules that pills are traditionally made of.” * * *
    • Lilly took a different approach than Novo Nordisk. The main ingredient for its GLP-1 pill, orforglipron, is a small molecule, meaning the pills can be manufactured in a more traditional way.
  • Fierce Pharma adds,
    • “Over the last six years, three GLP-1 drugs have been approved for children aged 10 and older with type 2 diabetes. Now this rapidly growing patient population is a step closer to gaining access to Eli Lilly’s dual-action GLP-1/GIP treatment Mounjaro, as its effectiveness in controlling blood sugar has been demonstrated in a phase 3 trial of kids ages 10-17.
    • “The SURPASS-PEDS study—which enrolled 99 children with type 2 diabetes who do not get adequate blood sugar control with metformin, insulin or a combination of both—achieved its primary and secondary endpoints. After 30 weeks of treatment, Mounjaro provided improvements over placebo in the blood sugar measurement, A1C, and in patients’ body mass index (BMI).
    • “The study’s primary endpoint was accomplished, with Mounjaro-treated patients experiencing an average A1C reduction of 2.2% versus .05% for those on placebo from a mean baseline of 8.05%.
    • “Lilly said that it has submitted the results to regulators in a bid to gain an expanded indication for the juggernaut diabetes medication.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “Researchers led by a team at INSERM and King’s College London have shown how stretching the skin stimulates immune cells and increases the skin’s ability to absorb large molecules, including those present in vaccines.
    • “Using a device that applies suction pressure to stretch the skin, the researchers reported that skin stretching activated a local immune response and increased skin permeability without tissue damage via the opening of hair follicles. They also reported that applying vaccines topically while stretching the skin resulted in more effective immunization than subcutaneously injecting the vaccine in mice.”
    • “Just stretching the skin was more effective than delivering the same vaccine with a needle, which shows the practical relevance of this immune activation,” said Stuart Jones, PhD, at King’s College London. “This new pathway into the skin could be used in lots of different ways—we showed its potential for vaccine delivery, but we’re also starting to think about delivering cell therapies and whether it could be used for diagnostics.”
  • Per Healio,
    • “People with obesity and diabetes who undergo bariatric surgery face a significantly lower risk for several adverse health outcomes vs. those treated with GLP-1s, new data show.
    • “Surgery should not be reserved as a last resort; it should be part of early, shared decision-making for patients with type 2 diabetes and obesity,” Ali Aminian, MD, director of Cleveland Clinic’s Bariatric and Metabolic Institute, told Healio. “Evidence shows that surgery provides added, durable benefits beyond medications alone.”
  • Per MedPage Today,
    • “Oral bacteria and fungi may help reshape the pancreatic microbiome and promote carcinogenesis.
    • “Earlier research has connected periodontal disease and clinical candidiasis with greater pancreatic cancer risk.
    • “Altogether, the study identified a more than threefold increase in cancer risk for everyone standard deviation rise in a microbial risk score comprised of 27 bacteria and fungi.”
  • and
    • “One in 10 childhood blood cancers may result from medical imaging-associated radiation exposure.
    • “Cancer risk increased with cumulative radiation dose, ranging from 1.41 times higher to 3.59 times higher.
    • “Children exposed to at least 30 mGy had 25.6 excess blood cancers per 10,000 by age 21.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ascension wrapped its 2025 fiscal year with a $490.9 million operating loss (-1.9% operating income) but a $917.7 million net income, an improvement over the prior year it attributed to greater volumes, improved labor productivity and a tighter rein on non-labor spending.
    • “The major Catholic nonprofit is coming off of a $1.8 billion operating loss in fiscal 2024 and a $3 billion operating loss in fiscal 2023, though those dip to $1.4 billion and $1.5 billion, respectively, when removing impairment and nonrecurring losses. It’d also suffered a major cybersecurity incident at the end of fiscal 2024, the recovery from which leadership said spanned multiple quarters and included consistent volume recovery.
    • “We have been intentional in directing resources toward initiatives that generate measurable impact, from service line growth to process redesign, while also ensuring both stewardship and sustainability,” Saurabh Tripathi, executive vice president and chief financial officer, said in a statement. “This combination of operational discipline and strategic investment increases our flexibility to expand access, enhance services, and ensure the commitment to our mission.”
    • Ascension, which owns or has interests in about 120 hospitals and other healthcare facilities across 16 states, logged $25.3 billion of total operating revenue in fiscal 2025, a roughly $3.2 billion decline (-11.3%) largely reflecting the system’s recent divestments.”
  • The Wall Street Journal relates,
    • “Roche ROG Holding said it agreed to buy 89bio ETNB for up to $3.5 billion, seeking to bolster its drug pipeline by adding an experimental treatment for a liver disease linked to obesity.
    • “The Swiss drugmaker has been looking to enter the weight-loss drug field, a key target of its recent dealmaking activity. With Eli Lilly and Novo Nordisk ahead in the race due to approved drugs that are generating billions of dollars in sales, Roche is betting that a new generation of treatments and potential drug combinations for adjacent conditions can help it to carve out a future role in the market.
    • “The main asset in the pipeline of San Francisco-based 89bio is a drug candidate for a fatty liver disease known as MASH, or metabolic dysfunction-associated steatohepatitis, that is mostly due to obesity.
    • “We intend to be a leader in the cardiovascular space going forward, and being a player in the obesity space is important to make that happen,” Teresa Graham, chief executive of Roche Pharmaceuticals said in an interview.”
  • Per Modern Healthcare,
    • “Cigna aims to strengthen its grip on the specialty pharmacy market through a recent deal with Shields Health Solutions.
    • “The company’s Evernorth Health Services subsidiary, which includes the pharmacy benefit manager Express Scripts and the specialty pharmacy Accredo, announced a $3.5 billion investment into Shields Health Solutions on Sept. 2.
    • “The move shores up a slice of the specialty pharmacy market Cigna wanted to bolster, President and Chief Operating Officer Brian Evanko said during the Morgan Stanley Global Healthcare Conference Sept. 10.” * * *
    • “What caught a lot of people off guard by the [Cigna] transaction is it’s not intuitively the best fit with a retail-oriented PBM,” said Aryeh Sand, a partner at investment banking firm Solomon Partners. “Shields historically is more aligned with health systems.”
  • and
    • “Ten Wisconsin rural hospitals formed a clinically integrated network, following dozens of rural providers that have joined similar initiatives over the past two years. 
    • “The Wisconsin High Value Network looks to pool the expertise and scale of the independent rural hospitals, which have combined $880 million in net revenue, to improve care and lower costs. The Cibolo Health-backed network, announced Thursday, will give providers the data infrastructure and bargaining power to hone primary care services and expand alternative payment models, said David Hartberg, CEO of Vernon Health in Viroqua, Wisconsin, and board chair of the Wisconsin High Value Network.
    • “Cibolo, a rural hospital advisory firm, helped launch similar coalitions in North Dakota, Minnesota, Ohio, Montana and Nebraska. Cibolo will manage daily operations of the Wisconsin High Value Network.”
  • Per BioPharma Dive,
    • “Biogen is buying Alcyone Therapeutics after working with the company for more than two years on a better delivery system for neurological medicines built around antisense oligonucleotides.
    • “Under terms announced Thursday, Biogen will spend $85 million upfront to acquire the privately held company and promise additional payments to Alcyone investors if certain development and regulatory goals are reached. Biogen will gain all rights to ThecaFlex DRx, an implantable subcutaneous port and catheter device it’s been developing with Alcyone since 2023.
    • “The companies have two studies underway testing the system’s delivery of Biogen’s Spinraza drug for spinal muscular atrophy, Biogen said. Lowell, Massachusetts-based Alcyone has been developing ThecaFlex DRx since 2019 and manufactures the product locally.”
  • Per MedTech Dive,
    • “Siemens Healthineers and Stryker are partnering to develop a robotic system that can perform a range of elective and emergency neurovascular procedures, including treatment for strokes and aneurysms, the companies said Wednesday.
    • “The collaboration includes system design, access device and implant integration, imaging for robotic navigation and procedural workflow optimization. The project will combine Siemens Healthineers’ expertise in robotics and imaging with Stryker’s experience in neurovascular technologies.
    • “Carsten Bertram, head of advanced therapies at Siemens Healthineers, said the partnership will focus on creating an ecosystem of image guidance, robotics and devices to help physicians provide faster and more precise care to patients.”
  • Per Fierce Pharma,
    • “With both companies on an upward trajectory, argenx and its manufacturing partner Fujifilm Biotechnologies are taking a logical next step by expanding their collaboration.
    • “In addition to manufacturing drug substance for argenx’s autoimmune blockbuster Vyvgart at its facility in Hillerød, Denmark, Fujifilm will also make the product at its large-scale complex in Holly Springs, N.C. The CDMO will initiate production of Vyvgart at the plant in 2028.
    • “Fujifilm’s Holly Springs is slated to become operational this year and has already secured contracting work from several large drugmakers.” * * *
    • “Fujifilm began building the $2 billion Holly Springs campus in 2021, billing it then as the largest end-to-end biologics production plant in the world, with the expectation to employ roughly 725 at the facility.
    • “Then, in April of last year, Fujifilm upped its ante on the site, earmarking an additional $1.2 billion for its construction and increasing its expected headcount at the facility to 1,400 by 2031.” 

From the artificial intelligence front,

  • Beckers Payer Issues reports,
    • “Hawaii Medical Service Association and Blue Cross and Blue Shield of Kansas joined Blue Shield of California as co-founders of Stellarus, according to a Sept. 18 news release from the technology company. 
    • “Stellarus said it aims to help health plans of all sizes integrate AI and fresh technology to expedite prior authorization, reduce administrative costs and elevate member experience.
    • “Given Hawaii’s size and geographic position, we are better off if we enhance our ability to innovate and grow our technological capacities by investing in Stellarus with like-minded, mission-driven, not-for-profit health plans that are trying to accomplish the same things and solve the same problems,” said President and CEO of Hawaii Medical Service Association Mark Mugiishi, MD.” 
  • Beckers Hospital Review lets us know,
    • “Rochester, Minn.-based Mayo Clinic nurses and informatics teams have developed a [patent pending] in-house AI tool to help streamline clinical workflows.
    • “The tool, called the Nurse Virtual Assistant, integrates directly into Mayo’s EHR and provides a nurse-specific patient summary with links to resources including Lippincott guidelines, intravenous administration protocols and a clinical policy library, according to a Sept. 17 news release.
    • “Mayo Clinic said the tool is designed to reduce the time nurses spend navigating multiple systems, allowing them to focus more on patient care. It was tested and validated in a research study approved by Mayo’s institutional review board before being expanded to more than 9,600 nurses across inpatient and emergency department units.”
  • Per AHA News,
    • “The Joint Commission and the Coalition for Health AI released guidance Sept. 17 on the responsible use of artificial intelligence in health care, the first installment from their partnership that launched in June. The guidance includes recommendations on AI policies, local validation, monitoring and use for interpretation and integration into new or existing processes. CHAI and the Joint Commission plan to release further guidance and a playbook by year’s end.”

Midweek update

David Ermer–CDC, COVID-19 vaccine, FDA, HSA, Medical / Rx research, NCQA, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Roll Call lets us know,
    • “House Republican leaders overcame a key procedural hurdle Wednesday evening, paving the way for floor consideration of the short-term stopgap funding measure they will need to pass with GOP votes later this week due to near-uniform Democratic objections.
    • “The chamber adopted the rule for floor debate on the bill on a 216-210 party-line vote.” * * *
    • “If the GOP bill can get out of the House, [Senate Minority Leader Chuck] Schumer [(D NY)] did offer an exit strategy of sorts on Wednesday night, offering a chance to look at a future commitment to deal with the expiring exchange subsidies once the CR passes rather than insist on changes to the bill now before the Sept. 30 deadline.
    • “Well look, we have two weeks [until October 1, the beginning of the new federal fiscal year]. They should sit down and talk to us, and we maybe can get a good proposal,” Schumer said. “We’ll sit down and negotiate if they will sit down and negotiate. We don’t have a red line, but we know we have to help the American people.”
    • “Republican leaders argue the current income thresholds to qualify for the tax credits are too high, and GOP senators are discussing lowering those in any extension.”
  • The Wall Street Journal reports,
    • “The former director of the Centers for Disease Control and Prevention [Susan Monarez] said she was fired after refusing to compromise her scientific integrity, testifying that Robert F. Kennedy Jr. asked her to preapprove vaccine recommendations and remove career scientists.” * * *
    • “Republican senators largely defended Kennedy and sought to cast Monarez as either untrustworthy or disloyal. Some questioned her hiring of lawyers who have represented Hunter Biden and other officials targeted by Trump.” 
  • Here is a link to the Senate Health, Education, Labor and Pension Committee’s website on this hearing.
  • Roll Call tells us, “Senate Republicans took a final procedural step Wednesday to speed up consideration of President Donald Trump’s lower-level nominees, setting up the confirmation of dozens of appointees as early as this week.”
  • Modern Healthcare points out,
    • “The House passed the Lower Costs More Transparency Act of 2023 with a PBM provision in the last Congress. The Senate, however, only advanced PBM bills as far as committee consideration. At the end of 2024, a version of all those measures was added to a popular bipartisan package of healthcare legislation, in part because of the work of Rep. Buddy Carter (R-Ga.), a pharmacist who pushed the PBM provisions with House leaders. 
    • “The bill was on the verge of passing as part of the annual government funding bill when leaders pulled it from consideration because then-presidential adviser Elon Musk and President Donald Trump raised objections. PBM industry groups argued the provisions aimed at them were giveaways to drug companies, which they say are ultimately responsible for drug prices.
    • “In an interview [with Modern Healthcare], Carter said he expects PBM legislation to pass this year. 
  • The Plan Sponsor Council of America notes,
    • “The PSCA’s 2025 HSA Survey shows employees are increasing contributions to their health savings accounts, and more are investing those assets when given the opportunity, leading to an increase in average account balances for the third consecutive year.
    • “PSCA’s seventh annual HSA survey, sponsored by HSA Bank, was conducted in the summer of 2025 and reflects responses from nearly 600 employers with an HSA program. The survey tracks employee and employer HSA trends from 2024.
    • “The survey shows that 20 percent of participants now invest their HSA savings, up from 18 percent the prior year. Also, two-thirds of employers now offer investments, a 12 percent increase over a two-year period.”
  • Per MedTech Dive,
    • “The Food and Drug Administration posted two notices on Tuesday warning about unauthorized blood pressure and infant monitoring devices sold over the counter.
    • “Many devices for measuring blood pressure and monitoring infant vital signs are currently sold over the counter without FDA marketing authorization, the agency said. The FDA recommended looking for an authorized device.
    • “The regulator has sent warning letters in the past to companies for selling monitoring devices without authorization.” 
  • From Justice Department news releases,
    • “Today, the Antitrust Division of the Department of Justice announces its collaboration with the Federal Trade Commission (FTC) to identify over 125 anticompetitive regulations in response to the President’s Executive Order on Reducing Anti-Competitive Regulatory Barriers. Under the leadership of President Trump, the Antitrust Division, in close coordination with the FTC and federal agencies, conducted a comprehensive, government-wide effort to identify and reform anticompetitive regulations that distort markets and stifle competition.
    • “In America we believe in free markets, not central planning by government regulators or powerful monopolists,” said Assistant Attorney General Abigail Slater of the Justice Department’s Antitrust Division. “Lowering barriers to entry by removing anticompetitive regulations will free America’s innovators and entrepreneurs to do what they do best: drive America’s future success.”
  • and
    • “An indictment was unsealed Friday charging two Florida men for their roles in a scheme to submit approximately $34.8 million in false and fraudulent claims to Medicare for medically unnecessary products. As part of the scheme, the defendants and their co-conspirators targeted thousands of Medicare beneficiaries and, through deceptive telemarketing, persuaded them to accept medical equipment that they did not need, such as orthotic braces and continuous glucose monitors.” * * *
    • “According to court documents, Kenneth Charles Kessler III, 42, of Miami-Dade County, Florida, and Michael Andrew Gomez, 42, of Broward County, Florida, are charged in connection with their ownership and operation of seven durable medical equipment (DME) supply companies based in Florida. Kessler and Gomez are accused of paying illegal kickbacks and bribes to purported marketing companies that targeted thousands of Medicare beneficiaries with deceptive and aggressive telemarketing campaigns. The indictment alleges that these marketing companies obtained the beneficiaries’ personally identifiable information and arranged for purported telemedicine companies to generate doctors’ orders for unnecessary medical equipment. Kessler and Gomez allegedly used these doctors’ orders to submit false and fraudulent claims to Medicare through their network of DME companies.
    • “Kessler and Gomez are both charged with conspiracy to commit health care and wire fraud, two counts of health care fraud, conspiracy to defraud the United States and to offer and pay health care kickbacks, and two counts of offering and paying kickbacks in connection with a federal health care program. If convicted, Kessler and Gomez each face up to 65 years in prison. A federal judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.”

From the Covid vaccine front,

  • STAT News informs us,
    • “Amid growing concern about Americans’ access to vaccines, the country’s biggest health insurance association said its member plans will continue to cover all shots recommended by a federal advisory committee prior to any changes by its new slate of appointees.
    • “America’s Health Insurance Plans’ announcement comes just ahead of the first meeting of the Advisory Committee on Immunization Practices’ 12 members handpicked by Health and Human Services Secretary Robert F. Kennedy Jr. The selection of the five newest members was announced Monday, and their meeting is Thursday and Friday. Experts have speculated that, among other steps, the panel will drop the existing recommendation that newborns receive the hepatitis B vaccine, a move that could lead to a resurgence of the virus and, as a result, liver disease and cancer.” * * *
    • “AHIP said its plans will cover all vaccines recommended by ACIP as of Sept. 1, 2025, and that there would be no cost sharing for patients through the end of 2026. That includes updated Covid-19 and influenza vaccines. Health insurers are required to make vaccines free if they are recommended by ACIP and adopted by the Centers for Disease Control and Prevention, but AHIP’s pledge ensures coverage will continue even if the new members change the panel’s recommendations.” 
  • The Washington Post warns that ACIP could increase the age at which senior citizens can receive the Covid vaccine without cost sharing from 65 to 75.
    • “The people familiar with the deliberations cautioned that the situation is fluid and rapidly changing. The recommendations would also need to be approved by the acting director of the Centers for Disease Control and Prevention before taking effect, and it’s unclear how quickly that would happen.
    • “If a senior is concerned about losing access to a coronavirus vaccine, “they should absolutely try to get vaccinated as soon as possible,” said Caitlin Donovan, senior director at Patient Advocate Foundation. But even if more restrictive guidelines take effect, she noted most seniors have an underlying condition such as diabetes, heart issues or a history with smoking. * * *
    • “If you can’t find an appointment quickly, contact your primary care physician and discuss your options,” Donovan said. “They should be willing to write you a prescription after considering your risk levels.”
  • The New York Times adds,
    • “Four Democratic-controlled Western states on Wednesday issued their own recommendations on who should get three common seasonal vaccines, a sharp rejection of efforts by Health Secretary Robert F. Kennedy Jr. to upend vaccine policy at the federal level.
    • The so-called West Coast Health Alliance — which includes health officials in California, Oregon, Washington and Hawaii — recommended that every resident 6 months and older receive the flu vaccine this fall. They also recommended that broad swaths of the population receive a Covid-19 shot, including pregnant women and all children from 6 months to 2 years old, and that R.S.V. vaccines be given to infants under 8 months and adults over 75, as well as to others with certain risk factors.
    • “The detailed guidance generally mirrors clinical recommendations that have been made by the federal government and by national medical organizations such as the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.”

From the public health and medical/Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Today in its weekly update, the Centers for Disease Control and Prevention (CDC) said there are 1,491 confirmed measles cases in the United States this year in 42 jurisdictions, an increase of 37 cases in the past week. 
    • “Eighty-six percent of cases have been linked to one of 38 reported outbreaks, and roughly 12% of all case-patients have required hospitalization. 
    • “Last year the country recorded only 285 measles cases, and 2025 has been the worst year for measles activity in the United States since the virus was officially declared to be eliminated in 2000.”
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) has launched an effort to advance research on whole-person health and create an integrated knowledge network of healthy physiological function. Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote health. For example, a multicomponent lifestyle intervention including healthy diet, physical activity and stress management may improve multiple and interconnected aspects of health including cardiovascular (e.g. blood pressure), metabolic (e.g. glucose metabolism) and musculoskeletal function (e.g. muscle strength).
    • “Biomedical research is largely organized around the study of specific organs and diseases. In contrast, we do much less research on health itself, which is an integrated process involving the whole person,” said Helene M. Langevin, M.D., director of NIH’s National Center for Complementary and Integrative Health, which leads the NIH-wide program.
    • “The five-year research initiative will proceed in several stages, drawing from existing scientific knowledge to develop a complete, working model of healthy human physiology. It will build on the NIH Human Reference Atlas and the Human BioMolecular Atlas Program (HuBMAP) to connect the complex anatomy and function of the body’s different organs and systems into a single “map.”
    • “Future stages of the project will link common clinical measures, such as blood pressure, blood glucose and cholesterol, to major physiological functions. This initiative will also populate the framework with existing human data and ultimately build and test an interactive model of whole-person health.
    • “By organizing healthy physiological function into a whole-body knowledge network, researchers will be able to explore scientific questions about health in a new way,” said Dr. Langevin. “With our ability to acquire new scientific data at an increasingly dizzying speed, the importance of integrating and connecting new data to what we already know is greater than ever. The Whole Person Reference Physiome will lay a foundation for understanding the factors that drive declines in health and mechanistic pathways to health restoration.”
  • and
    • “Research supported by the National Institutes of Health (NIH) shows that repeated head impacts from contact sports can cause early and lasting changes in the brains of young- to middle-aged athletes. The findings show that these changes may occur years before chronic traumatic encephalopathy (CTE) develops its hallmark disease features, which can now only be detected by examining brain tissue after death.
    • “This study underscores that many changes in the brain can occur after repetitive head impacts,” said Walter Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “These early brain changes might help diagnose and treat CTE earlier than is currently possible now.”
    • “Scientists at the Boston University CTE Center, the U.S. Department of Veterans Affairs Boston Healthcare System and collaborating institutions analyzed postmortem brain tissue from athletes under age 51. Most of them had played American football. The team examined brain tissue from these athletes, using cutting-edge tools that track gene activity and images in individual cells. Many of these tools were pioneered by the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. The researchers identified many additional changes in brains beyond the usual molecular signature known to scientists: buildup of a protein called tau in nerve cells next to small blood vessels deep in the brain’s folds.
    • “For example, the researchers found a striking 56% loss of a specific type of neurons in that particular brain area, which takes hard hits during impacts and also where the tau protein accumulates. This loss was evident even in athletes who had no tau buildup. It also tracked with the number of years of exposure to repetitive head impacts. The findings thus suggest that neuronal damage can occur much earlier than is visible by the currently known CTE disease marker tau. The team also observed that the brain’s immune cells, called microglia, became increasingly activated in proportion to the number of years the athletes had played contact sports.”
  • The American Journal of Managed Care informs us,
    • “Early-onset T2D is rising in the US, especially among underserved populations, with a worse cardiometabolic profile than later-onset cases.
    • “Financial hardships are more significant for younger adults, women, and minority groups with T2D, necessitating policies addressing medical and financial well-being.
    • NHANES data from 1999 to 2020 shows increased prevalence of early-onset T2D, highlighting the need for improved screening and diagnosis in younger adults.
    • ‘Study limitations include cross-sectional data, potential recall bias, and exclusion of institutionalized populations, affecting generalizability and causal inferences.’
  • Per Healio,
    • “Walking quickly for 15 minutes per day was associated with a significant reduction in all-cause mortality and CVD mortality, according to a cohort study published in American Journal of Preventive Medicine.
    • “Many studies have explored the health benefits provided by regular walking, including recent findings on the ideal step count and how walking can improve life expectancy for middle-aged adults.”
  • The Wall Street Journal reports,
    • “Eli Lilly’s diabetes pill, orforglipron, showed better blood sugar control than Novo Nordisk’s oral semaglutide in a Phase 3 trial.
    • “Orforglipron met primary and secondary goals across doses, with some participants reaching near-normal blood sugar levels.
    • “Lilly said the results, combined with the pill’s scalability, show its potential as a key Type 2 diabetes treatment.”
  • Per BioPharma Dive,
    • “Roivant and subsidiary company Priovant said Wednesday their inflammatory disease pill succeeded in a Phase 3 trial in the rare condition dermatomyositis, significantly reducing signs and symptoms of the disorder by more than placebo when used for one year.”
    • “Company executives said they plan to ask the Food and Drug Administration to approve the pill, called brepocitinib, in early 2026, based on trial results they called “the first ever positive registrational trial for a targeted therapy” in dermatomyositis.
    • “Brepocitinib is being developed by Priovant Therapeutics, which is part owned by Pfizer. The big drugmaker licensed the pill to Roivant in 2022 as part of a pipeline cull.”
  • and
    • AstraZeneca reported divergent outcomes from two late-stage studies on Wednesday. In one Phase 3 trial, a subcutaneous form of its marketed medicine Sophnelo helped lower signs of disease activity in people with the most common form of lupus. In the other, its drug Fasenra, used to treat asthma and a few other conditions, failed meaningfully lower the rate of moderate or severe chronic obstructive pulmonary disease attacks. The under-the-skin injection of Sophnelo is being reviewed by regulators. AstraZeneca will analyze the Fasenra data to “further understand the results,” the company said.
  • Per Fierce Pharma,
    • “SK Biopharmaceutical’s Xcopri (cenobamate) met the bar in a phase 3 trial that could support the company’s ambitions of building a blockbuster with an expansion into another seizures subtype.
    • “The South Korean pharma won FDA approval for Xcopri in 2019 as a treatment for partial-onset seizures, also known as focal seizures, in adults. Since then, with rapid global growth, SK has outlined blockbuster ambitions for the drug by 2029. 
    • “Now, with a positive phase 3 trial, another indication for primary generalized tonic-clonic (PGTC) seizures could be on the table.”
  • Beckers Hospital Review identifies “four new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports
    • “Baltimore-based Johns Hopkins Medicine has ended contract negotiations with UnitedHealthcare without a new deal, The Baltimore Banner reported Sept. 15. 
    • “Johns Hopkins went out of network with UnitedHealthcare on Aug. 25 after eight months of negotiations and several extensions of their existing agreement. 
    • “Health system leaders did not rule out an agreement in the future, but a spokesperson told The Banner they decided to make patients “aware of this stalemate now, to provide our patients and their employers the time they need to explore alternative insurance options during the upcoming open enrollment season.” 
    • “Both parties have said the impasse was not about money but other provisions in the contract, according to the report. Johns Hopkins said UnitedHealthcare was demanding overly burdensome prior authorization requirements. The payer said the system wanted to be able to exclude certain employer-sponsored plans.
    • “UnitedHealthcare Mid-Atlantic CEO Joseph Ochipinti told the news outlet the payer remains at the negotiation table. He said they expect “network providers to honor their commitment to care for the individuals and families who rely on them as in-network providers.”
  • and
    • lists the top NCQA rated commercial health plans in each state.
  • Per a Healthcare Cost Institute news release,
    • “Primary care offers patients a critical connection point to the health care system. With contact, continuity, comprehensiveness, and coordination as its base1, primary care has been shown to improve health outcomes and population health, reduce health disparities, and save health care dollars. Despite the virtues and benefits of primary care, it seems to be getting harder to access. In 2025, there were 7,901 primary care health professional shortage areas. A recent report found that primary care physicians per capita declined between 2012 and 2021, and fewer trainees chose to pursue primary care than specialty care over the same period.
    • “In response, a number of states are innovating to increase investment in primary care. By one estimate, nearly 20 states have taken action to improve primary care with initiatives ranging from defining and measuring primary care to setting specific primary care spending targets.
    • “This analysis assesses what portion of total health care spending is dedicated to primary care, in alignment with many of the primary care spending targets that are expressed as a percentage of total health care spending. We defined the percentage of primary care as the portion of ambulatory spending rendered by primary care providers (PCPs) relative to total medical and prescription spending among people with Employer-Sponsored Insurance (ESI) and Medicare Fee-for-Service (FFS) between 2018 and 2022. 
    • “The results presented below are based on a narrow definition of primary care provider based on provider specialty. We conducted the same analysis using an expanded list of specialties, (e.g., obstetrics and registered nurses and other allied practitioners). As expected, the share of primary care spending was higher using the broader definition. Otherwise, the patterns observed with the narrow definition also applied to the broader definition. The results of the analysis using both definitions are available in the downloadable data.
    • “Approximately 4% of spending went to primary care in 2022.”
  • Beckers Health IT lets us know,
    • “Epic’s revenue rose to $5.7 billion in 2024, a company spokesperson told Becker’s, as the EHR vendor continues to add health system customers.
    • “That number is up from $4.9 billion in 2023 and $1.2 billion in 2012. Epic has continued to consolidate its U.S. market share lead over the past few years, from 31% of acute care hospitals in 2021 to 42.3% in 2024, per KLAS Research. Its nearest competitor, Oracle Health, clocked in at 22.9%. Epic is the market share leader for all U.S. acute care hospital types except standalone facilities with 200 beds or fewer.”

Monday report

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

From Washington, DC

  • Federal News Network tells us,
    • “Less than two months away from this fall’s Open Season, Democrats in Congress are raising concerns that the Office of Personnel Management may not be fully prepared to administer the major health insurance program for millions of Postal Service employees and annuitants.
    • “Top Democrats from several congressional committees sent a letter Friday to OPM Director Scott Kupor to push for answers about key issues recently identified in the new Postal Service Health Benefits program. The letter comes a few months after the agency’s inspector general office found “critical” staffing vacancies and funding issues in the PSHB’s central enrollment platform, which all program participants must use to enroll or make changes to their insurance options.
    • “Given the potential for severe consequences among PSHB enrollees, the Postal Service, and carriers, we urge that OPM immediately address the critical issues identified in OPM OIG’s flash report,” the lawmakers said in Friday’s letter, signed by the top Democrats on the Senate Homeland Security and Governmental Affairs Committee and the House Oversight and Government Reform Committee as well as both congressional appropriations committees.” ***
    • “The concerns in Congress come just ahead of OPM’s anticipated announcement of the 2026 premium rates for both the PSHB and FEHB programs by the end of September. It also comes a couple months ahead of this year’s Open Season, when millions of federal employees and annuitants will be able to update their health enrollment options ahead of plan year 2026. This year’s Open Season will run from Nov. 10 to Dec. 8 for the 2026 plan year.
    • “The lawmakers gave OPM until the end of the week to explain in more detail when it will staff up to the 11 employees it determined it needs to run the platform. They’re also pushing OPM for answers on its contingency plan if the data platform fails, and how it will ensure the PSHB is appropriately funded for the upcoming budget cycle.”
  • Healthcare Dive informs us that “a key CDC panel meets this week [September 18 and 19] to discuss vaccines. Here’s what to know. Advisers hand-picked by HHS Secretary Robert F. Kennedy Jr. are set to vote on guidelines for measles, hepatitis B and COVID vaccines.”
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of five new members to the CDC Advisory Committee on Immunization Practices (ACIP). [The appointees are named in the release.] These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, evidence-based science, and diverse expertise in guiding the nation’s immunization policies. In June, Secretary Kennedy reconstituted ACIP to restore public trust in vaccines.
  • and
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Sept. 15 announced that states can now apply for funding from the Rural Health Transformation Program created under the One Big Beautiful Bill Act. The program will fund $50 billion to rural providers from fiscal year 2026 to FY 2030. CMS said the funds would support goals of promoting preventative health and addressing root causes of diseases, improving efficiency and sustainability, strengthening workforce recruitment and retention, initiating innovative care models, and fostering the use of innovative technology for efficient care delivery, data security and access to digital health tools.  
    • “CMS said half of the funds would be distributed evenly to states with an approved application, while the other half would be awarded to states based on individual state metrics and applications that “reflect the greatest potential for and scale of impact” on rural communities. States have until Nov. 5 to apply, and CMS will announce the recipients by Dec. 31.”
  • Per MedPage Today,
    • Reaction is generally positive to a federal initiative aimed at increasing electronic health record (EHR) interoperability and giving patients and providers quicker access to information about visits.
    • The voluntary initiative, announced on July 30, would require all participating EHR companies to connect directly to national data-sharing networks approved by the Centers for Medicare & Medicaid Services (CMS), the American Medical Association (AMA) noted in a Sept. 5 statement. “These systems must now deliver real-time, full patient information, including clinical notes, images, and medication lists that physicians actually use in care, rather than the basic data fields that are now available.
    • “EHR companies that have agreed to participate in the initiative include Epic, Amazon, eClinicalWorks, Oracle Health, and TruBridge.”
  • Deloitte points out in a white paper,
    • “Strategic investments in disease prevention, early detection, and other proactive measures could save the US health care system up to $2.2 trillion a year by 2040—more than $7,000 per person—according to new research from Deloitte’s actuarial and health care teams. These investments could also help save Medicare more than $500 billion a year on medical and prescription drug claims, strengthen the program’s long-term financial outlook, and expand the number of years beneficiaries live in good health. Deloitte analysis suggests that lowering Medicare spending in this way could delay potential insolvency and ease the need for benefit reductions or tax increases to maintain the program as it currently exists.”
  • Per Fierce Pharma,
    • “Forty-two years after approving the potent diuretic Bumex (bumetanide) as both an oral and infused treatment for edema, the FDA has endorsed a new version of the drug to be delivered as a nasal spray.
    • “The U.S. regulator has signed off on Corstasis Therapeutics’ Enbumyst to relieve the edema associated with congestive heart failure (CHF), chronic kidney disease (CKD) and liver disease. Edema is the accumulation of fluid in the body’s tissues that causes swelling.
    • “It is the first FDA nod for Nevada-based Corstasis, which develops outpatient therapies for the treatment of fluid overload in patients with cardiorenal and hepatic diseases. Edema is the leading cause of hospitalization and readmission for patients with CHF, CKD and cirrhosis of the liver, accounting for more than 1 million visits annually, Corstasis explained.”

From the public health and medical/Rx research front,

  • The American Medical Association lets us know what doctors wish their patients knew about healthy aging.
  • Per Health Day,
    • “A new type of noninvasive brain stimulation may help people with moderate to severe depression feel better faster than standard treatments, researchers in a new report say.
    • “The method, called high-definition transcranial direct current stimulation (HD-tDCS), uses small electrodes on the scalp to deliver mild electrical currents to specific parts of the brain involved in mood regulation.
    • “In the trial conducted by UCLA researchers, 71 adults with major depression were randomly assigned to receive either active HD-tDCS or a sham treatment for 20 minutes a day over 12 working days. 
    • “The group receiving real treatment showed a greater drop in their depression scores than the control group, according to findings published Sept. 11 in JAMA Network Open.”
  • and
    • “Women who overcome cervical cancer might have another potentially life-threatening health crisis on their horizon, researchers say.
    • “Cervical cancer survivors have nearly double the risk of developing anal cancers compared to the general population, researchers reported Sept. 11 in JAMA Network Open.
    • “And their risk increases as they grow older, and as time passes since their cervical cancer treatment, results show.
    • “Both types of cancer are linked to infection with human papillomavirus (HPV), researchers noted. The virus is mainly spread during intimate contact.
    • “We’ve known for a long time that both cervical and anal cancers are caused by HPV, the human papillomavirus,” senior researcher Ashish Deshmukh said in a news release. He’s the co-director of the Cancer Prevention and Control Research Program at the Medical University of South Carolina Hollings Cancer Center in Charleston.
    • “But what hasn’t been well-understood is how that shared risk might connect the two diseases over a woman’s lifetime,” Deshmukh said.”
  • Per Healio,
    • “A telephone-based weight-loss intervention helped women with breast cancer and obesity lose almost 5% of their baseline body weight, according to results of a randomized phase 3 trial.
    • “Participants lost significant weight regardless of race, ethnicity, menopause status, income and more.
    • “The data are the first from the Breast Cancer Weight Loss (BWEL) trial, which is evaluating whether weight loss can reduce recurrence, development of new cancers and mortality.”
  • Beckers Hospital Review calls attention to “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”
  • Per BioPharma Dive,
    • “An experimental drug from biotechnology company aTyr Pharma missed its main goal in a Phase 3 trial, failing to help people with an inflammatory lung condition called pulmonary sarcoidosis significantly cut down on their use of steroids after nearly a year of treatment.
    • “The drug, called efzofitimod, is aTyr’s only clinical-stage prospect, and the company believed it might help reduce the inflammation and accompanying steroid use in people with pulmonary sarcoidosis. ATyr is also testing the drug in a Phase 2 trial in systemic sclerosis-related interstitial lung disease.” 

From the U.S. healthcare business front,

  • Willis Tower Watson explains how “alternative plan designs help employers offer affordable, high-value care; guiding members to better providers with transparent costs. Success depends on clear goals, smart design & strong analytics.”
  • The Employee Benefits Research Institute reports,
    • “The 2025 EBRI Employee Mental Health Survey, based on a survey of 3,103 employees in March and April 2025, explored workers’ experiences with both physical and mental health care to better understand their behaviors and attitudes toward health care generally and mental health care more specifically. The survey also explored access to care and patterns of health care use. For this report, all employees who reported that they or a covered family member used mental health care services are referred to as respondents reporting a mental health condition. Of note, a number of respondents who reported utilizing mental health services did not report a mental health condition. This is consistent with the well-documented underreporting of mental health conditions.”
  • Healthleaders Media considers why patients are filing more complaints against hospitals, thereby illustrating oversight gaps and trust issues that demand CEO attention.
  • MedCity News discusses what’s next for Walgreens following its private equity sale.
  • Per MedTech Dive,
    • “Intuitive Surgical unveiled new software capabilities for the da Vinci 5 robot that give surgeons more information, such as a replay of key moments in a procedure. Surgeons can review the video as the procedure is ongoing without removing their head from the console.
    • “Another new feature is a gauge displaying measurements of the force applied to the patient’s tissue by instruments. Intuitive’s force feedback technology already allows surgeons to sense the instrument pressure applied to tissue.
    • “The updates, which received 510(k) clearance from the Food and Drug Administration, are the first in a planned series of new system capabilities designed to improve patient outcomes and surgeon and hospital efficiency, the company said Friday.”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will develop a special report for the Centers for Medicare & Medicaid Services (CMS) for treating Crohn’s disease and ulcerative colitis. ICER will evaluate Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.). This report will be submitted to CMS as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028.  
    • “While the final list of drugs subject to negotiation will not be released until February 2026, ICER is developing this report with the expectation that Entyvio® will be subject to negotiation next year.  
    • “Building on our two previous reports, ICER’s expertise in comparative clinical effectiveness and value will continue to help inform the important conversations around Medicare drug price negotiation,” said ICER’s President and CEO Sarah K. Emond, MPP. “While we know CMS may consider many different factors and inputs during negotiations, we believe ICER’s approach to applying the guidance in a consistent framework.”

Thursday report

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

From Washington, DC,

  • The Washington Post reports,
    • “Republicans moved Thursday to speed up Senate confirmation of President Donald Trump’s nominees by changing the chamber’s rules over the objections of Democrats.
    • “Senators voted 53-45 to allow themselves to change the rules with a simple majority instead of 60 votes — a move known as the “nuclear option.”
    • “The rules change will allow the Senate to confirm multiple people at once, helping to clear a backlog of nearly 150 nominees awaiting floor votes. Republicans argue it is necessary because Democrats have held up the confirmation process by forcing time-consuming votes on each nominee rather than allowing some of them to be confirmed by voice votes, which is faster.
    • “The change excludes Cabinet officials, Supreme Court justices and federal judges, who must be confirmed one by one.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) announces the 2025 Combined Federal Campaign (CFC), running from October 1, 2025, to December 31, 2025. The CFC provides federal employees and military personnel opportunities to support charitable causes.
    • “OPM supports the generosity of federal employees but is reviewing the program’s administrative costs and declining participation for potential changes in 2026. Read more in OPM Director Scott
    • “Kupor’s latest blog here and read the memo to agencies here.”
  • OPM Director Scott Kupor explains in his blog,
    • “Over the years, participation in the program has continued to decline from its peak – donations have been hovering around $65-70 million over the past few years. At the same time, the costs to administer the program have continued to increase. This year, the Office of Personnel Management (OPM) estimates the program will consume $22 million in outside contractor fees and listing fees to administer the program.
    • “This means for every $1 a federal employee donates, about $0.33 (or 33%) does not reach the charity for which it was intended. Rather, dollars that could be deployed to help sick children, help veterans in need, or help victims of natural disasters get back on their feet, are instead diverted to overhead. * * *
    • “Despite all of this, we at OPM will shortly launch the 2025 CFC, only because many charities have already spent time and money preparing for this over the course of this year. We hope 2025 will be a successful campaign.
    • “But, at the same time, OPM is concerned about excessive administrative costs associated with the CFC, along with steadily declining participation, and it is evaluating changes to the CFC for 2026 (including whether to continue the program).
    • “We believe strongly in charities and in the generosity that Americans continue to show in donating in support of charities – roughly 50% of American households donate. But we also believe donors expect their dollars to benefit the very causes they intend to support and not to lose the effectiveness of their donations because of excessive administrative costs.”      
  • Tammy Flanagan, writing in Govexec, explains what to know before setting your 2026 retirement date.
  • CNBC reports,
    • “Millions of Social Security beneficiaries may see a 2.7% to 2.8% increase to their monthly checks in 2026, according to new estimates based on the latest government inflation data.
    • “A 2.8% Social Security cost-of-living adjustment may go into effect next year, estimates Mary Johnson, an independent Social Security and Medicare policy analyst. That increase would push the average retirement benefit up by about $54.70 per month, she said. * * *
    • “Those estimated increases would be up from the 2.5% boost to benefits that went into effect in 2025. The COLA has averaged 2.6% over the past 20 years, according to the Senior Citizens League.”
    • “The COLA projections are based on new consumer price index data for the month of August that was released Thursday.
    • “The official Social Security cost-of-living adjustment will include one more month of inflation data.”
  • The American Hospital News tells us,
    • “The Federal Trade Commission announced yesterday that it sent letters to many large health care employers and staffing firms, urging them to review their employment agreements — including any noncompete agreements — to ensure they are in compliance. The commission’s announcement follows one from Sept. 5, when it moved to vacate a 2024 noncompete final rule, voting 3-1 to dismiss appeals initiated by the previous administration attempting to uphold it. On Sept. 4, the FTC issued a request for information on noncompete agreements, seeking to “better understand the scope, prevalence, and effects of employer noncompete agreements, as well as to gather information to inform possible future enforcement actions.”
    • The public comment deadline is November 3, 2025.
  • Healthcare Dive informs us,
    • “The 340B drug discount program incentivizes hospitals to purchase outpatient clinics and prescribe more and higher-cost drugs — behaviors that tend to increase costs for the federal government and commercial health plans, according to a new report from the nonpartisan Congressional Budget Office.
    • “Only one-third of the sharp growth in 340B spending since 2010 is due to rising drug costs and higher prescribing of more expensive drugs, the CBO estimates. Instead, the growth has mostly been fueled by hospitals acquiring off-site clinics and contracting with more independent pharmacies, along with more providers becoming eligible for 340B.
    • “Though the CBO stressed it doesn’t have enough data to quantify the influence of each factor individually, the agency believes that the biggest driver of snowballing 340B growth is probably hospital-clinic M&A.”

From the Food and Drug Administration front,

  • BioPharma Dive tells us,
    • “Senior Food and Drug Administration official Vinay Prasad has reclaimed a role as the agency’s top doctor and scientist six weeks after his dramatic departure and one month after his surprising return to lead the regulator’s biologics medicine division.
    • “On the FDA’s website, Prasad, a physician and prolific researcher, is now listed as the agency’s chief medical and scientific officer in addition to his role as director of the Center for Biologics Evaluation and Research, or CBER. A spokesperson for the Department of Health and Human Services, the FDA’s parent agency, confirmed via email Prasad’s reappointment to his former role.
  • MedTech Dive adds,
    • “Patient groups called for substantial changes to medical device user fees in comments submitted to the Food and Drug Administration. Negotiations recently kicked off for the medical device user fee amendments, which will determine how much funding the FDA’s device center can collect from the industry in fiscal years 2028 through 2032.
    • “After a public hearing last month, clinicians and patient groups submitted comments calling for an increase to user fees, bolstering FDA staffing and more emphasis on product safety. They also called for greater transparency around negotiations and for patients to have more input on the final agreement. 
    • “The FDA received a total of 27 comments by Sept. 4, including several submissions from patients and medical groups. Two large medtech industry lobbying firms, Advamed and the Medical Device Manufacturers Association, which had opposed user fee hikes in the public hearing, had not posted comments as of Thursday.”
  • Beckers Hospital Review provides us with an update on State actions to expand access to the Covid vaccine.

From the public health and medical/Rx research front,

  • The New York Times reports,
    • “Chronic diseases like heart disease, cancer and diabetes are some of the leading causes of death around the world. A new global study shows that deaths from such “noncommunicable” conditions have been declining in most countries — but the pace of that decline, including in high-income countries like the United States, has slowed in recent years.
    • “The probability of dying from a chronic disease between birth and age 80 dropped in about 150 countries from 2010 to 2019, the study, published Wednesday in The Lancet, found. But compared to the previous decade, there was a widespread slowdown — in some cases, even a reversal — in progress.
    • “In the United States, the overall probability of dying from a chronic disease fell markedly between 2001 and 2010 but remained nearly flat over the following nine years. Among younger adults (20 to 45 years old), this probability increased — a rarity among high-income countries. The chance of dying specifically from neuropsychiatric conditions like Alzheimer’s disease and alcohol and drug use disorders also rose in the United States during this period.””
  • Cardiovascular Business notes,
    • “Diets that prioritize plant-based foods while limiting meat and dairy products are associated with reduced risks of all-cause mortality, cardiovascular disease (CVD), coronary heart disease, stroke and diabetes. 
    • “That was the primary takeaway from a new study of more than 3.4 million adults who participated in the National Health and Nutrition Examination Survey (NHANES), UK Biobank or one of 37 different clinical trials. The full analysis was published in Science Advances.” * * *
    • Click here to read the full study.
  • The Hill points out,
    • A DermaRite Industries hand soap recall has been expanded to more than 30 products, including deodorant, lotions, shampoo, hand sanitizer and more.
    • The recall was initiated in July and was expanded recently over concerns that more of its products may include Burkholderia cepacia complex. Exposure to the bacterium could “result in serious and life-threatening infections,” the company said in a release.”
    • “For healthy individuals with minor skin lesions, the use of the product may result in local infections, whereas in immunocompromised individuals the infection could spread into the blood stream, potentially leading to life-threatening sepsis,” the release noted.
    • “Symptoms of bacteria exposure include fever, fatigue and possible respiratory infections for patients with compromised immune systems, according to the Centers for Disease Control and Prevention (CDC).
    • “The products were distributed nationwide in the U.S., including Puerto Rico.”
  • The Wall Street Journal reports,
    • “More women are using cannabis during pregnancy, driven by fears about prescription drugs and beliefs it’s safe for conditions like nausea.
    • “Research on cannabis use during pregnancy is limited, but recent studies suggest potential risks to fetal brain development.
    • “Dispensary practices and conflicting advice from various sources add to confusion, highlighting the need for more research.”
  • BioPharma Dive relates,
    • “Capsida Biotherapeutics has suspended a recently begun clinical trial of an experimental gene therapy after the first participant in the study died following treatment.
    • “Capsida disclosed the death in a letter Wednesday to the patient community for the rare neurodevelopmental disease its gene therapy is designed to treat. In it, the biotechnology company noted it has informed the Food and Drug Administration and will soon provide regulators a full report of the patient’s death.
    • “We understand this devastating news will raise questions and uncertainty, and we are working with urgency to gather information and find answers,” Capsida wrote in its letter.”
  • Per Fierce Pharma,
    • “Approved 15 months ago as a pneumococcal disease vaccine for adults—and billed as the first shot designed for seniors—Merck’s Capvaxive now has data supporting its potential in children and adolescents.
    • “In a phase 3 study of 882 participants aged 2 through 17 who have completed a primary pediatric pneumococcal vaccination regimen and have one or more chronic medical conditions that put them at an increased risk of the respiratory disorder, Capvaxive made the grade in three key measures.”
  • Per Medscape
    • Pavani Chalasani, MD, MPH, is professor of medicine and director of the Division of Hematology/Oncology at The George Washington University. In this interview, Chalasani discusses how liquid biopsies are used to guide therapy in breast cancer and reviews the role of antibody-drug conjugates in current practice.

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “AbbVie has struck a deal with generic drugmakers aimed at extending patent protection for its blockbuster autoimmune drug Rinvoq well into the next decade.
    • “AbbVie on Thursday said it has settled litigation with all generic manufacturers that have filed applications with the Food and Drug Administration for generic versions of Rinvoq, which is approved for use in several autoimmune diseases.
    • “The North Chicago, Ill., biopharmaceutical company said it now doesn’t expect any U.S. generic entry for Rinvoq prior to April 2037, given the settlement and license agreements and assuming the company wins pediatric exclusivity.
    • “Analysts at William Blair, who had previously assumed a 2033 loss of U.S. patent exclusivity for Rinvoq, said the settlements are a big win for AbbVie that support longer-term protection for the franchise.”
  • STAT News reports,
    • “Consumers can now purchase Exact Sciences’ liquid biopsy early detection test, Cancerguard, and get an indication of whether they might have one of 50 different cancers included in the test’s analysis. The biotechnology company launched the test on Wednesday, and Tom Beer, Exact’s chief medical officer, relayed the news with elation.
    • “I am feeling fantastic. This is what I came to Exact to do,” Beer said. A practicing oncologist, Beer said that he’s reminded every Friday in clinic of the world of difference that catching cancer early can make. The promise of liquid biopsy tests is to do that for dozens of cancers, not just breast, prostate, colorectal, lung, and cervical cancer.”
  • Per Modern Healthcare,
    • “CVS Health has named Jon Thiboutot as president of retail health, effective immediately.
    • “Thiboutot was most recently vice president of operations at CVS MinuteClinic. He succeeds Dr. Creagh Milford, who had served as interim president of retail health since May and will continue to lead primary care provider Oak Street Health, CVS said Thursday.
    • “A CVS spokesperson declined to say whether the company will fill Thiboutot’s former role.”
  • and
    • “The American Medical Association released nearly 300 new Current Procedural Terminology billing codes Thursday as part of its proposed 2026 code set.
    • “Two other codes can be used to report remote monitoring treatment management after 10 minutes of services per calendar month, down from 20 minutes, according to an AMA news release. 
    • “Several augmented and artificial intelligence services were also included in the new code updates, ranging from tools that assess coronary disease to burn wound classification, according to the release. 
    • “The updates signal potential broader acceptance and reimbursement for digital health services in standard billing codes.
    • “The AMA’s CPT Editorial Panel organizes the association’s CPT code system, which is used in billing and reimbursement by the Centers for Medicare and Medicaid Services, as well as other payers and providers. CMS and others have the option to adopt the changes and put them into effect starting Jan. 1.” 
  • Beckers Hospital Review informs us
    • “The District of Columbia holds the highest ratio of nurses to population, to a significant degree, at 7.14 per 100 residents, while Utah has the lowest, at 1.38, according to a Becker’s analysis. [The full list is displayed in the article.]
    • “The analysis is based on U.S. Census Bureau state population estimates as of July 1, 2024, and active registered nurse and practical nurse license counts from the National Council of State Boards of Nursing database. The number of nurses per 100 residents was calculated by dividing the total number of active licenses in each state by its population and multiplying by 100. In California, the total reflects RN and vocational nurse licenses, rather than PN.”
  • and
    • “Landmark Hospital of Cape Girardeau (Mo.), a long-term acute care facility, has shared plans to close “in the coming weeks,” according to a Sept. 10 news release.
    • “The hospital has been open since early 2006 and is part of Cape Girardeau-based Landmark Holdings of Florida, which operates six long-term acute care hospitals across the U.S. The hospital operator sought Chapter 11 protection in early March and plans to find buyers for its facilities to relieve mounting financial challenges.”

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “The Trump administration is calling on Congress to pass a four-month stopgap spending bill, in order to avoid a government shutdown, according to congressional appropriators.
    • “House Appropriations Committee Ranking Member Rosa DeLauro (D-Conn.) said in a statement Tuesday that the Trump administration is seeking a continuing resolution through Jan. 31, 2026.
    • “The administration is seeking a longer CR than some lawmakers previously considered. But the House and Senate aren’t close to getting 12 spending bills for fiscal 2026 through the normal appropriations process.”
  • The American Hospital Association adds,
    • “The House Appropriations Committee Sept. 9 advanced the fiscal year 2026 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies by a 35-28 vote. The bill provides a total discretionary allocation of $108 billion for HHS, representing roughly $7 billion or 6% below the FY 2025 enacted level. Within that total, the Health Resources and Services Administration was allocated $7.4 billion, marking an $880 million decrease. The agency was provided $1.3 billion for workforce initiatives, a $37 million decrease, and $515 million for rural health, marking a $150 million increase. 
    • “Additionally, the bill maintains funding for the Hospital Preparedness Program ($65 million), Children’s Hospitals Graduate Medical Education ($395 million), National Institutes of Health ($47 billion), as well as other key initiatives within the health care workforce, behavioral health and maternal and child health programs.”  
  • Roll Call informs us,
    • “Democrat James Walkinshaw won Tuesday’s special election for Virginia’s 11th District to fill the unexpired term of his former boss, the late Democratic Rep. Gerald E. Connolly.
    • “Walkinshaw, a Fairfax County supervisor, was leading Republican Stewart Whitson, an Army veteran and former FBI official, 75 percent to 25 percent, when The Associated Press called the race at 7:36 p.m. Eastern time. 
    • “Walkinshaw’s win was expected in the deep-blue Northern Virginia district, which encompasses the Washington, D.C., suburbs heavily populated by federal workers.” * * *
    • “Once Walkinshaw is sworn in, House Republicans will hold 219 seats to 213 for Democrats, with three vacancies that will be filled by upcoming special elections. 
    • “A special election in Arizona’s 7th District will take place later this month to elect a successor to the late Democratic Rep. Raúl M. Grijalva, who died in March from complications of his cancer treatment. There will also be special elections in Texas’ 18th District for the seat of the late Democratic Rep. Sylvester Turner and in Tennessee’s 7th District, where the Republican incumbent, Mark E. Green, resigned in July for a private sector job.”
  • The Wall Street Journal reports,
    • “U.S. population growth will slow to a crawl over the next few decades as fertility rates decline and net immigration shrinks because of stricter enforcement, the Congressional Budget Office said Wednesday. 
    • “Deaths are now projected to exceed births in 2031. Just eight months ago, CBO had projected that threshold wouldn’t be crossed until 2033.  
    • “By 2055, the U.S. population will be about 367 million, up from 350 million today. In January, CBO had projected a 2055 population of 372 million. From 1975 through 2024, U.S. population growth averaged 0.9% annually. By the early 2050s, according to the latest projections, population growth will effectively be zero.” 
  • Bloomberg Law tells us,
    • “The share of individuals in the US lacking health coverage held steady at 8%, or roughly 27 million people, in 2024, according to data the US Census Bureau released Tuesday.
    • “The data show fluctuations in the uninsured rate for different demographics, although the numbers were not considered statistically significant. Working-age Black Americans’ uninsured rate ticked up from 11.1% to 12.3%, while Hispanic Americans’ uninsured rate dipped from 23.6% to 23%. Foreign-born workers were more than twice as likely to lack health insurance as native-born workers.
    • “Coverage through public programs dropped 0.8 percentage points to 35.5%, driven by a 1.3 percentage point reduction in Medicaid enrollment. Medicaid coverage totaled 17.6% in 2024, while Medicare accounted for 19.1%.
    • “Private market coverage covered 66.1% of Americans, with 53.8% covered by their employer. Private coverage increased 0.7 percentage points, fueled by an increase in the individual market.
    • “The individual market covered 10.7% of Americans in 2024. Of that, the Affordable Care Act exchanges accounted for 4.3%.”
  • Modern Healthcare reports,
    • “A little over a month before the annual enrollment period, the Centers for Medicare and Medicaid Services is urging Medicare Advantage insurers to make significant changes to how they present their offerings to beneficiaries.
    • “Perhaps most notably, CMS will incorporate provider network lists into the Medicare Plan Finder tool enrollees use to select plans, it notified insurers last month. The agency is simultaneously developing a national provider directory that will not be ready in time for the 2026 Medicare Advantage and Part D sign-up campaign, which runs Oct. 15-Dec. 7.
    • “CMS also intends to add more details about Medicare Advantage supplemental benefits and a prescription drug pricing search tool powered by artificial intelligence.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million – the largest-ever seizure of this kind. The seizures were part of a joint federal operation in Chicago to examine incoming shipments and prevent illegal e-cigarettes from entering the country.
    • “Almost all the illegal shipments uncovered by the operation originated in China. FDA and CBP personnel determined that many of these shipments contained vague and misleading product descriptions with incorrect values, in an apparent attempt to evade duties and the review of products for import safety concerns.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA is planning to call on the health-care industry and consumers to provide information on the benefits of switching a prescription drug to over-the-counter, the agency’s drug chief said Tuesday.
    • “What we want people to do is focus on the benefit that we can provide to society by that switch,” George Tidmarsh, director of the Center for Drug Evaluation and Research, said at a regulatory conference held by the Consumer Healthcare Products Association.
    • “I encourage industry to really focus, in the broadest way, on the benefit of the switch,” Tidmarsh added. “Not just the specifics of that, but the impact broadly in the health-care system.” 
    • “The agency will announce the request for information in the Federal Register, the drug chief said.
    • “Switching a prescription drug to over-the-counter is a highly regulated process that widens the range of medicines available to consumers.”
  • Per the AHA News,
    • “The Food and Drug Administration Sept. 10 released draft guidance on non-opioid treatments for treating chronic pain and reducing prescription opioid misuse. The guidance includes regulatory considerations regarding the categorization of multiple chronic pain conditions versus individual chronic pain indications; the design of clinical trials that ensure safety and efficacy; the evaluation of non-opioid drugs to avoid, reduce or eliminate opioid use; and the inclusion of statistical principles, patient-reported outcomes and use of expedited programs to support non-opioid drug development. The FDA is accepting comments on the guidance for 60 days following publication in the Federal Register.”
  • BioPharma Dive lets us know,
    • “The Food and Drug Administration on Tuesday approved a drug-device combination for bladder cancer that its developer, Johnson & Johnson, claims represents “a new, potentially practice-changing approach.”
    • “The treatment, which J&J will sell as Inlexzo, is a medical device that releases the chemotherapy gemcitabine into the bladder. It’s approved for use in people whose disease hasn’t yet spread but doesn’t respond or stopped responding to a commonly used immunotherapy. Historically, those patients have had have their bladders surgically removed.
    • “J&J executives have predicted Inlexzo will achieve blockbuster sales, and highlighted how the company’s internal sales estimates are more than three times higher than Wall Street’s predictions. “We really think that we’ve got a winner there,” Jennifer Taubert, the head of the company’s pharmaceuticals business, said on a conference call in July.”
  • Genetic Engineering and Biotechnology News adds,
    • “There are multiple different types of drugs available for the treatment of Alzheimer’s disease: cholinesterase inhibitors to treat symptoms from mild to severe, and disease-modifying immunotherapies to remove amyloid plaques and slow disease progression. In addition, vaccines that aim to clear the amyloid-beta plaques that accumulate in the brains of Alzheimer’s patients—or the neurofibrillary tangles formed by abnormal tau proteins—have been an area of active study.
    • “Now, a vaccine moves one step closer to approval. The Swedish biopharmaceutical company Alzinova recently announced that the FDA has approved the company’s Investigational New Drug (IND) application for its planned Phase II clinical study with the vaccine candidate ALZ-101 for Alzheimer’s disease. The company’s clinical development specializes in the treatment of Alzheimer’s disease, at the starting point of attacking toxic amyloid-beta oligomers.” * * *
    • “ALZ-101, a vaccine that stimulates the production of antibodies against the toxic Aβ oligomers, is Alzinova’s lead candidate. The company ran a first-in-human clinical study to evaluate the safety and immunogenicity of the oligomer-specific therapeutic vaccine ALZ-101 and released favorable data from part A of its Phase Ib clinical trial in November 2023.”

From the public health and medical/Rx research front,

  • ABC News reports,
    • “The United States death rate decreased by 3.8% in 2024 as COVID fell out of the top 10 leading causes of death for the first time in four years, new provisional federal data shows.
    • “The overall rate declined from 750.5 per 100,000 people in 2023 to 722 per 100,000, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS).
    • “This marks the lowest death rate recorded since 2020, during the first full year of the COVID-19 pandemic and follows declines that began in 2022.
    • “The report also found that overall deaths fell from 3.09 million in 2023 to 3.07 million in 2024.
    • “Additionally, the report showed the three leading causes of death stayed the same from 2023 to 2024, with heart disease as the leading cause, followed by cancer and unintentional injury, respectively.
    • “‘It’s pretty noteworthy that COVID-19 fell off the top 10 and suicide, which had been had fallen off in recent years, is … ranked again,” Farida Ahmad, corresponding author of the report and health scientist at NCHS, told ABC News. “I think that’s a pretty interesting finding given where we spent the last five years.”
    • “Ahmad said fewer deaths from COVID in 2024 compared to 2023 may be a reason behind the 3.8% decline.”
  • STAT News points out,
    • “Many Americans take a dark view of nicotine. The stimulant, which occurs naturally in tobacco plants, is what makes cigarettes so addictive, with smoking responsible for 490,000 American deaths each year. When people try to quit smoking, it’s often cravings for nicotine, and the surge of dopamine it releases in the brain, that foil their attempts.
    • “In this sense, nicotine is responsible for many health problems. But public health experts say that while nicotine poses risks, some nicotine products are safer than cigarettes — and they worry popular misconceptions about the chemical’s effect on the body are doing more harm than good. 
    • “A majority of people in the U.S. wrongly believe that nicotine is the substance in cigarettes that causes cancer. In fact, “the harm from smoking comes from the burning of the ingredients in a cigarette, not from the nicotine itself,” said Jamie Hartmann-Boyce, a health policy researcher at the University of Massachusetts Amherst. More than 70 carcinogens have been identified in the cigarette smoke produced by the combustion of tobacco, which can damage people’s DNA and lay the groundwork for cancer.
    • “For many years, cigarettes were the main way that most Americans consumed nicotine. That meant it wasn’t a big problem from a public health perspective if people conflated the dangers of smoking with the dangers of that particular chemical, so long as that helped deter them from lighting up.
    • “Now, thanks to the more recent introductions of smoke-free options like e-cigarettes and nicotine pouches, “we are in a totally different landscape when it comes to commercial nicotine products,” Hartmann-Boyce said.”
  • The University of Minnesota’s CIDRAP notes,
    • “One more measles case has been reported in Wisconsin’s Oconto County measles outbreak. The new case raises the state’s total to 25. All 25 cases have been in unvaccinated individuals, and 2 people have required hospitalization.  
    • “The Centers for Disease Control and Prevention (CDC) has posted its weekly measles update, and 23 more cases have been recorded since last week, raising the national total to 1,454. There are two more outbreaks, raising the total number of outbreaks to 37. Eighty-six percent of cases reported this year are linked to outbreaks.”
  • and
    • “A new survey of more than 21,000 US adults shows that those who reported food insecurity had a 73% higher chance of reporting post–COVID-19 condition, or long COVID. 
    • “The study was published yesterday in JAMA Network Open and adds to a growing body of literature that links food insecurity with delayed or forgone medical care, worsened mental health, and racial disparities during the COVID-19 pandemic, the authors said. This is the first known study to link food insecurity to long COVID.”
  • Per MedPage Today,
    • “The American Academy of Family Physicians (AAFP) split with federal health officials and recommended that all U.S. adults get an updated COVID-19 vaccine for the upcoming respiratory virus season.
    • “In particular, people 65 years or older, those at increased risk for severe outcomes, and anyone who has never received a COVID-19 shot before should be prioritized for vaccination, AAFP said.
    • “The move follows recent recommendations from the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG), which broke with federal COVID-19 vaccine guidance for children and pregnant women.”
    • “History shows us that vaccines have eradicated diseases that were disabling and deadly in the past, and we can keep it that way, if we continue to vaccinate,” Margot Savoy, MD, the AAFP’s chief medical officer, said in a statement. “AAFP’s recommendations are closely aligned with other medical societies to ensure continuity for both patients and physicians.”
    • :Like the recent AAP guidance, AAFP says that all children ages 6 to 23 months should be vaccinated against COVID-19. For children and teens ages 2 to 18 years, clinicians should use a risk-based, single-dose approach, according to the new recommendations. The AAFP said it supports immunization access for any family wanting COVID-19 vaccination.
    • The AAFP also recommends that women who are pregnant at any stage or lactating should get a COVID-19 shot, in line with ACOG’s recent recommendations.
  • The Washington Post reports,
    • Persistent sleeplessness may be far worse than a passing annoyance — gradually unraveling memory and mental sharpness, according to new research.
    • A study published Wednesday in Neurology, the journal of the American Academy of Neurology, identifies a troubling link: Older people who have chronic insomnia appear more likely to experience accelerated aging of the brain. These changes are revealed in both cognitive tests and imaging scans showing the altered structure of the brain.
    • The research involved 2,750 cognitively healthy adults with an average age of 70. The participants, who were tracked on average for 5.6 years, underwent annual testing of executive functioning, visual-spatial reasoning and other dimensions of cognition.
  • Per Beckers Hospital Review,
    • “A study found that GLP-1 drugs are associated with a lower risk of fractures, including hip and osteoporotic fractures. 
    • “The research, led by scientists from China and published in Acta Diabetologica, analyzed more than 490,000 adverse event reports from the FDA’s Adverse Event Reporting System between 2004 and 2022. Of the reports, 99,000 involved GLP-1 receptor agonists. 
    • “The study found that compared to other diabetes medications, GLP-1 receptor agonists had the lowest reporting odds ratio of any fracture-related adverse events, at 0.44. 
    • “The trend surfaced across fracture types, including osteoporotic and hip fractures. Among individual GLP-1 receptor agonist drugs, albiglutide showed the most pronounced reduction in fracture risk, researchers said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “U.S. businesses are facing the biggest health-insurance cost increases in at least 15 years, after already-steep boosts in recent years that have pushed the annual expense for family coverage high enough to equal the price of a small car.
    • “Costs for employer coverage are expected to surge about 9.5% in 2026, according to an estimate from Aon, while an employer survey by WTW suggested 9.2%. Both benefits-consulting firms’ projections, which were provided exclusively to The Wall Street Journal, would represent the fastest rate of increase since at least 2011, when the price tags for employer coverage were far lower than the recent average of roughly $25,500 for a family plan.
    • “Other employer surveys conducted this year have generated similar findings—sharp hikes in health-coverage spending for next year, on top of two years of significant increases.”
  • Modern Healthcare reports,
    • “Kaiser Permanente and Renown Health signed an agreement to form a joint venture to operate a health plan and ambulatory care services in Nevada. 
    • “As part of the deal, Kaiser would acquire a majority stake in Renown’s insurance arm, Hometown Health, which has more than 73,000 members. Kaiser plans to start offering health plan coverage in northern Nevada as Kaiser Permanente Nevada with an open enrollment period late next year, according to a Wednesday news release.
    • “Kaiser Permanente Nevada would also open ambulatory sites with Renown in the Reno, Nevada, area. 
    • “The deal is expected to close in early 2026, pending regulatory approval.
    • “If approved, the joint venture would mark Oakland, California-based Kaiser’s expansion into Nevada. Kaiser already has more than 12.6 million health plan members in eight states and Washington, D.C.”
  • and
    • “Dr. Craig Albanese, CEO of Duke University Health System, will step down from his role to become president of integrated care and coverage for Kaiser Permanente effective Sept. 29.”
  • STAT News tells us,
    • Lilly “has signed a collaboration agreement with Remedium Bio to develop gene therapies for obesity and type 2 diabetes, Remedium said yesterday.
    • “This is part of a movement by pharma companies to develop longer-lasting treatments for obesity, which they argue will be more attractive to patients than the current therapies that are injected once a week. Novo Nordisk, along with Wave Life Sciences and Arrowhead Pharmaceuticals, have been studying the potential of using RNA-interference to treat obesity.
    • “However, it’s not yet clear how feasible it would be to create a long-lasting treatment for obesity, much less one that is a one-time therapy. Some experts also fear an over-medicalized approach to addressing the issue of high obesity rates. (We wrote about all that in an earlier story here.)
  • Per MedTech Dive,
    • “Boston Scientific has agreed to buy Elutia’s two bioenvelope products for $88 million, the companies said Tuesday.
    • “The agreement will give Boston Scientific control of Elupro and Cangaroo, devices designed to promote wound healing to prevent complications after pacemaker or defibrillator implantation. 
    • “Elupro and Cangaroo compete with Medtronic’s TYRX. BTIG analysts said in a note to investors that they believe “the Elupro bioenvelope may offer clinical and handling advantages over TYRX.”
  • Per Fierce Healthcare,
    • “Oracle Health is using its data and technology muscle to move out ahead in the healthcare AI arms race.
    • “Electronic health record companies are moving quickly to integrate AI tools into their platforms as advances with agentic AI open up new opportunities to tackle clinical workflows along with revenue cycle, patient communications and even clinical trial recruitment.
    • “Oracle, which owns EHR company Cerner (now Oracle Health), touted its latest AI capabilities for providers and AI-powered EHR features Thursday morning during its Health and Life Sciences Summit in Orlando, Florida.
    • “The data and technology company is putting more focus on its AI, data and cloud capabilities as rival Epic is also ramping up its AI tech within its EHR while also extending its reach to payers, life sciences and medical device companies.”
  • Radiology Business adds,
    • “Experts are pushing for new generalist radiology artificial intelligence models that move beyond single tasks and consolidate image interpretation assistance into one total package. 
    • “Scientists made their case in an editorial published Tuesday by Radiology, noting that narrow AI solutions suffer from financial limitations such as unsustainable price scaling and market fragmentation. Generalist AI could address these and other clinical and operational challenges, producing comprehensive reports that reduce radiologist effort and “unlock new value propositions.” 
    • “Recent advancements such as foundational models—trained on diverse datasets and adaptable to a wide range of downstream tasks with minimal training—pave the way for this method.”

Friday report

David Ermer–ACA, CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • This week’s blog post from OPM Director Scott Kupor concerns the value of incentives.
    • “Charlie Munger wasn’t talking about the federal General Schedule (GS) pay scale when he addressed a 1995 Harvard crowd on the critical role that incentives play in driving employee behavior, but he may as well have been. Because, unfortunately, 30 years later, his premonition remains true: how we pay federal employees remains one of the most critical – and backward – drivers of employee behavior.”
  • Bloomberg Law tells us,
    • “The Trump administration is rewriting the playbook for government hiring, allowing managers to select from a broader list of qualified candidates instead of having to choose from the top three scorers on a competitive exam.
    • “The new rule replaces the “rule of three,” under which civil service examiners narrow down a list of qualified applicants for a position while still giving the president and other senior officials the final say.
    • “The change will give hiring managers more latitude on which job candidates they exclude, allowing them to eliminate applicants if they’re passed over more than three times for the same position.’
  • Federal News Network informs us,
    • “Just three federal agencies, when combined, make up more than half of the total federal workforce reductions that have occurred so far under the Trump administration.
    • “The departments of Defense, Treasury and Agriculture have cut their staffing levels this year by a cumulative total of about 106,000 employees, according to data compiled by the non-profit Partnership for Public Service. That’s out of an estimated 199,000 federal employees governmentwide who have left their jobs since January, either voluntarily or by force.
    • “In terms of scale, the Defense Department has lost the most at 55,000 employees. The Treasury Department follows just after DoD with a loss of 30,000 employees — mostly from the IRS. And the Agriculture Department has 21,000 fewer employees, the Partnership found in its data report, which compiles findings from agency documents and media reports.”
  • Govexec considers how yesterday’s semi-annual regulatory agenda could impact federal employees.
  • STAT News reports,
    • “The Food and Drug Administration is now publishing complete response letters to drugmakers shortly after they are issued, marking a major shift in transparency into regulation by the agency. Yesterday, the FDA disclosed 89 previously unreleased CRLs from 2024 and 2025, including rejections for Replimune, Capricor Therapeutics, and Ultragenyx.
    • “Traditionally, it’s been up to companies to disclose the reasons for an FDA rejection, a process that critics contend can lead drugmakers to misrepresent what the agency said. In July, the agency announced its intention to release letters in “real time,” and published a batch of letters for drugs that had eventually won approval. Yesterday’s release went beyond that.”
  • The FDA adds, “Decision letters are accessible to the public as a centralized dataset at openFDA.”

From the public health and medical/Rx research front,

  • The Centers for Disease and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. Emergency department visits for COVID-19 are elevated in children 0-4 and 5-17 years old. Hospitalizations are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • ‘RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection for infants in the 2025–26 respiratory virus season.”
  • Beckers Hospital Review points out steps that states are taking to override the FDA’s limited Covid vaccination recommendation which the CDC’s Advisory Committee on Immunization Practices (ACIP) will take up at a September 18-19 meeting.
  • Beckers Payer Issues adds that the “Massachusetts’ Division of Insurance and Department of Public Health has issued a bulletin Sept. 3 requiring insurance carriers to cover vaccines as outlined by the state, not just the CDC.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “In a weekly update, the US Centers for Disease Control and Prevention (CDC) today [September 3] reported 23 more measles cases, lifting the country’s total to 1,431, the most since the country reached elimination status in 2000.
    • “For the first time, health officials divided out the cases confirmed in international visitors, which account for 18 of the national cases.
    • “The number of outbreaks remained the same, at 35, double the number for 2024. So far, 86% of cases are linked to outbreaks, compared to 69% last year. To date, 92% of patients were unvaccinated or have an unknown vaccination status. School-age kids are the most affected group, followed closely by adults ages 20 years and older.”
  • The New York Times identifies “6 More Things E.R. Doctors Wish You’d Avoid. Stay out of the emergency room with these tips.
    • “Last winter, I wrote about things emergency room doctors wish you’d avoid, and many more E.R. doctors wrote in to tell me what I had missed.”
      • “Never put your feet on the dashboard.
      • “Don’t forget your eyes when doing yardwork.
      • “And never mow the lawn in open-toed shoes.
      • “Watch out for the front burner.
      • “If you’re choking, forget about privacy.
      • “Don’t take another person’s prescription medication.”
  • The American Hospital Association News notes,
    • “A Health Affairs study published Sept. 2 found that less than 40% of Medicare beneficiaries with opioid use disorder received standard care in alignment with quality measures. Researchers analyzed Medicare enrollment, claims and encounter data to assess the extent to which beneficiaries with OUD received treatment in alignment with eight nationally recognized quality measures in 2020. The study found that Medicare Advantage performed worse than fee-for-service Medicare on six of eight measures, and that Medicare performed worse than Medicaid on all three comparable OUD quality measures available.
    • “The authors said a variety of initiatives could be used to improve OUD treatment for Medicare beneficiaries, including enhanced Medicare coverage, policies enabling more providers to treat beneficiaries with OUD, policies and programs to facilitate care connections following hospitalization or an emergency department visit, and initiatives encouraging beneficiaries to seek treatment.”
  • Medscape explains “Everything Patients Need to Know About Aging on GLP-1s.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CVS Health is tapping into health system partnerships as it rapidly expands primary care offerings.
    • “CVS has added primary care services at more than 400 MinuteClinic sites across 12 states and Washington, D.C., in the last year or so, said Dr. Creagh Milford, interim president of retail health at CVS Health and president at CVS-owned Oak Street Health. The goal is to offer primary care at all MinuteClinic sites and build a payer-agnostic network to serve patients, he said.
    • “However, the strategy requires buy-in from residents, which isn’t a guarantee in all communities.
    • “The healthcare conglomerate has formed primary care clinical affiliations with three health systems to help with the primary care shift and is looking for more partners. Milford said several dozen conversations are underway about similar agreements. 
    • “We’re seeing a lot of traction,” Milford said. “One of the things that had been a challenge between MinuteClinic and our health system partners is, how do we better coordinate care?” 
    • “The clinical affiliations are another way for health systems to respond to physician shortages and expand access to care.
    • “CVS’ first primary care-driven affiliation was with Atlanta-based Emory Healthcare Network, which was announced in February. As part of the agreement, MinuteClinic offers in-network adult primary care at all 35 clinics in Georgia to most payers through Emory’s integrated network.” 
  • Per Cardiovascular Business,
    • “Congenital heart disease surgical procedures are relying more on 3D echocardiography as it is rapidly transforming the way congenital heart procedures are planned, guided and help manage patients afterwards. The technology is offering cardiac surgeons and interventional cardiologists clearer images, better communication, and safer procedures for even the smallest patients.
    • “3D echo captures the heart in real time and with the full structure of the heart. You can cut through with. So pre-surgical planning and it is now moving into the operating room. Because of the release of the pediatric 3D transesophageal echo (TEE) probes, we can characterize the valve tissues that the surgeons are repairing quite nicely,” explained Pei-Ni Jone, MD, FASE, director of the echocardiography laboratory at Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee.
    • “She said 3D echo offers a surgical view of the valve non-invasively and it can visualize valve failures that happen in the operating room or help determine if a surgeon needs to go back on bypass to repair something.”
  • Per MedTech Dive,
    • “A clinical trial of Medtronic’s Hugo robot has met its primary effectiveness and safety endpoints, the company said Thursday.
    • “Physicians used the robotic-assisted surgery system to treat 193 patients. All of the surgeries were successfully completed. Two people had surgical safety events in the 30 days after treatment that were resolved without complication. 
    • ‘Medtronic has filed for authorization of the system in a urology indication and plans to expand into hernia repair later. The company will compete with Intuitive Surgical for the hernia market.”
  • The American Journal of Managed Care notes,
    • “Rideshare transportation for abnormal [fecal immunochemical test] FIT results can double colonoscopy completion rates, reducing [colorectal cancer] CRC cases and deaths significantly.
    • “The intervention is cost-saving, generating more than $330,000 savings per 1000 people screened due to earlier cancer detection.
    • “Early FIT screening, starting between ages 40 and 49 years, is crucial as CRC rates rise among younger populations.
    • “The study’s microsimulation model projects long-term CRC outcomes, supporting further trials to validate rideshare intervention effectiveness.”

Thursday report

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

From Washington, DC,

  • Per a Congressional news release,
    • “[Yesterday,] the House Appropriations Committee met to consider the Fiscal Year 2026 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 35 to 28.”
    •  Among other provisions, the bill “prohibits the Federal Employees Health Benefit Program from covering puberty blockers, hormone therapy, or surgical procedures for gender affirming care.”
  • Healthcare Dive notes,
    • “At a House subcommittee hearing on Wednesday, lawmakers expressed concerns about whether artificial intelligence is being appropriately used in healthcare and called for stronger guardrails to supervise the quickly evolving technology.
    • “With all these innovative advancements being leveraged across the American healthcare ecosystem, it is paramount that we ensure proper oversight is being applied, because the application of AI and machine learning will only increase,” said Energy and Commerce subcommittee Chair, Rep. Morgan Griffith, R-Va.”
  • The Wall Street Journal reports,
    • “Health Secretary Kennedy faced bipartisan Senate [Finance Committee] questioning regarding CDC turmoil and changes to U.S. vaccine policy.
    • “Kennedy defended his actions as necessary to restore the CDC, while critics raised concerns about vaccine access and his appointees.
    • “The CDC is facing internal strife after the ouster of its director and calls for Kennedy’s resignation from employees.”
  • MedPage Today adds,
    • “HHS Secretary Robert F. Kennedy Jr. has chosen seven new members for the CDC’s Advisory Committee on Immunization Practices (ACIP), according to information obtained by MedPage Today‘s editor-in-chief Jeremy Faust, MD.
    • ACIP’s next meeting is set to take place Sept. 18-19, and the posted agenda states that “recommendation votes may be scheduled” for immunizations against hepatitis B, COVID, and respiratory syncytial virus, as well as the measles, mumps, rubella, and varicella shot.
  • STAT News tells us,
    • “After months of uncertainty, the Trump administration confirmed that it will work with Gilead Sciences and The Global Fund to Fight AIDS, Tuberculosis and Malaria to provide a groundbreaking HIV prevention drug to up to 2 million people in low- and middle-income countries.
    • “The ambitious effort was first announced late last year but doubts quickly emerged after the Trump administration began to drastically cut foreign aid. The move appeared to jeopardize the future of the President’s Emergency Plan for AIDS Relief, or PEPFAR, which has long been the world’s leading provider of HIV prevention drugs. Only about half of its $6 billion budget has reportedly been appropriated.
    • “Nonetheless, The Global Fund, which pools money from public and private donors, maintained it would proceed with plans to purchase and distribute the Gilead medication, called lenacapavir. The antiviral offers virtually complete protection against contracting HIV with just a single administration every six months and has been hailed as a tool that could bring the 45-year-old pandemic to heel.” 
  • and
    • “A key government study about alcohol and its health harms will not be released publicly, despite several years of taxpayer-funded work and a growing body of evidence connecting drinking with disease. 
    • “A final version of the Alcohol Intake and Health Study led by the Substance Abuse and Mental Health Services Administration will not be published, “to the detriment of the people’s health,” scientific review panelist Priscilla Martinez told STAT in an email Thursday morning. Another panel member confirmed that they have not heard from the Trump administration since submitting their work months ago. News of the killed report was first reported by Vox.”
  • The American Hospital News informs us,
    • “The Department of Health and Human Services Sept. 4 announced new hardship exemption guidance that would allow consumers ineligible for premium tax credits or cost-sharing reductions to enroll in catastrophic health coverage. Consumer eligibility will be based on projected annual household income. The Centers for Medicare & Medicaid Services made this change in light of the significant anticipated rise in individual market premiums and the expiration of the enhanced premium tax credits at the end of the year.”
  • Modern Healthcare relates,
    • “The Federal Trade Commission asked the public to weigh in on noncompete contract provisions, even though district courts have blocked the commission’s nationwide ban on most of those agreements. 
    • “The agency issued a request for information Thursday, seeking detail about employers who unfairly restrict employees from working for a rival organization through noncompetes. These agreements can stunt wage growth, limit competition, reduce innovation and inflate prices, the FTC said.
    • The commission said the consequences are magnified in healthcare where noncompete agreements can restrict patient access, particularly in rural areas. The comment period will close Nov. 3. 
  • Axios interviews OPM Director Scott Kupor.
    • Q “You’re nominated in December but not confirmed until July. In the meantime, Elon Musk and DOGE make lots of major personnel decisions via OPM. Were you just sitting on your hands?
    • A “The short answer is yes. That’s the rules. I wasn’t even allowed to go into the building, so I was just trying to interpret what was happening. The only time I got more insight was when I started prepping for the Senate confirmation hearing, because I got briefed so I wouldn’t look like a complete idiot.” * * *
    • Q You’ve also talked about establishing more of a merit-based system for federal workers. But DOGE often fired probationary workers, not because of merit but because of where they were on the totem poll.
    • A “It was only around 5,800 probationary employees out of 2.4 million across the entire government. Yes, I’m sure many of those were under 30, and the government has a real problem getting younger workers — only 7% under 30 compared to 24% in the normal workforce — but you still need to view it in context.”
    • Q Of that 2.4 million, how many do you want still working for the government at year-end?
    • A “Around 2.1 million, which is where we were when the first Trump administration took office … That doesn’t include the military, which OPM isn’t responsible for.”
  • FedSmith points out,
    • “The percentage of federal employees working on site has more than tripled from its low point of the last three years according to new data released by Gallup.
    • “The new Gallup poll data show that as of the second quarter of 2025, 46% of federal employees in Washington, DC now work fully on site. This is more than double the national average of 21% and more than triple the low point of 14% back in Q1 2022.
    • “Also, the percentage of federal employees working in a hybrid model (employees who work both on-site and remotely) dropped sharply since President Trump took office, going from 61% at the end of 2024 to 28% in Q2 2025.”
  • At long last, the Spring 2025 semi-annual regulatory and deregulatory agenda has appeared on reginfo.gov.
    • OPM agenda has one FEHB entry reading
      • “The Office of Personnel Management (OPM) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that would have amended the Federal Employees Health Benefits (FEHB) regulations at 5 CFR part 890 that would have allowed FEHB coverage to take effect at the beginning of the pay period that an employee in pay status has an initial opportunity to enroll. OPM is withdrawing the proposed rule as additional research determined that the potential costs to agencies for making updates to business systems and processes for an additional two weeks of FEHB coverage is not an effective use of resources.” 

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Kardium has received premarket approval for its Globe pulsed field ablation system, as well as 510(k) clearances for both the Globe Introducer sheath and mapping software, the company said Wednesday. 
    • “The Food and Drug Administration authorization positions Kardium, which raised $250 million to fund commercialization in July, to launch the system as a treatment for atrial fibrillation.
    • “Kardium is entering a fast-growing market served by Boston Scientific, Johnson & Johnson and Medtronic. The company cited Boston Scientific and Medtronic devices as 510(k) predicates.”

From the public health and medical/Rx research front,

  • The New York Times fills us in about flu shots this fall.
  • Health Day reports,
    • “A single dose of RSV vaccine might protect seniors for two cold and flu seasons in a row, a new study says.
    • “Vaccination reduced seniors’ risk of hospitalization by 58% during two RSV seasons, researchers reported Aug. 30 in the Journal of the American Medical Association.
    • “These results clearly demonstrate that the RSV vaccines prevent hospitalizations and critical illness due to RSV infection among older Americans,” said principal investigator Dr. Wesley Self, senior vice president for clinical research at Vanderbilt University Medical Center in Nashville, Tennessee. “It is exciting to see the public health benefits of this new vaccination program.”
    • “However, the vaccine’s effectiveness waned between the first and second years, raising questions regarding how often seniors should get the jab.” * * *
    • “Redosing the vaccine at some interval after the initial dose could be a strategy to maintain protection over longer periods of time,” Self said. “It will be important to continue to closely monitor vaccine effectiveness over time to understand how long the benefit lasts after a single dose and if repeat dosing should be considered.”
  • Per Tech Target,
    • “One in six women have missed a routine cancer screening in the past year, underscoring deep care gaps imperiling health outcomes, according to new data obtained via email.
    • “The data, gleaned from the full dataset from the Prevent Cancer Foundation’s annual Early Detection Survey, showed that women tend to stay up to date on other ordinary tasks — like getting a haircut, renewing their driver’s license or donating their old clothes — more than their preventive cancer screenings.
    • “Instead, women mostly only schedule a preventive screening when they are experiencing the signs or symptoms of disease, with 33% of respondents saying as much.
    • “Early detection equals better outcomes, so we can’t wait until our bodies are screaming at us to check our health. Women need to prioritize their own health by going to the doctor even when everything feels fine,” Jody Hoyos, CEO of the Prevent Cancer Foundation, said in an emailed statement. “Routine checks and screenings provide an opportunity to stay ahead of cancer, so if there is an issue, you can deal with it before it becomes a bigger problem down the road.”
  • Per STAT News,
    • “One of the worst places for cancer can spread is the leptomeninges, the inner membranes encasing the brain and spine. Patients with these metastases have limited treatment options and tend to succumb to the disease rapidly. But a new study suggests that using proton beam therapy might make it possible to more effectively treat these cancers with radiation and dramatically extend survival.
    • “There’s so little we have to offer patients with leptomeningeal metastasis that really, truly works,” said Lauren Boreta, a radiation oncologist at the University of California San Francisco, who did not work on the study. Treatments that increase survival, the way this study showed proton beam radiation did, is “unheard of for these patients,” she said. “It’s shocking. We haven’t had an advance in this space for maybe ever.” * * *
  • The Washington Post explains “the health risks from plastics almost nobody knows about Phthalates, chemicals found in plastics, are linked to an array of problems, especially in pregnancy.”
  • Per MedTech Dive,
    • “Cardiologists are welcoming the arrival of a new device-based hypertension treatment called renal denervation and asking Medicare to cover the procedure for a large patient population.
    • “Doctors, medical groups and others have endorsed national reimbursement for renal denervation in dozens of public comments submitted to the Centers for Medicare and Medicaid Services ahead of a final Medicare coverage decision expected by early October. Many cite concern about the high numbers of patients whose blood pressure remains poorly controlled despite the availability of multiple drug treatments.” 
  • Genetic Engineering and Biotechnology News reports.
    • “A key to understanding the brain lies in unpacking how hundreds of interconnected brain areas process information that leads to various outputs. In order to try to understand this, researchers investigate both single neurons and groups of neurons together. Now, a major advance in this area of neuroscience study has been published: the first complete activity map of the brain has been unveiled by a large international collaboration of neuroscientists.
    • “Two papers published in Nature reveal insights into how decision-making unfolds across the entire brain in mice at the resolution of single cells. This brain-wide activity map shows that decision-making is distributed across many regions in a highly coordinated way.”
    • “This is the first time anyone has produced a full, brain-wide map of the activity of single neurons during decision-making,” explained Professor Alexandre Pouget, PhD, co-founder of the International Brain Laboratory (IBL) and group leader at the University of Geneva. “The scale is unprecedented as we recorded from over half a million neurons across mice in 12 labs, covering 279 brain areas, which together represent 95% of the mouse brain volume. The decision-making activity, and particularly reward, lit up the brain like a Christmas tree.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Employees of large and small companies are likely to face higher health care costs, with increases in premiums, bigger deductibles or co-pays, and will possibly lose some benefits next year, according to a large survey of companies nationwide that was released on Thursday.
    • “The survey of 1,700 companies, conducted by Mercer, a benefits consultant, indicated that employers are anticipating the sharpest increases in medical costs in about 15 years. Higher drug costs, rising hospital prices and greater demand for care are all contributing factors, experts said.
    • “With the projected increases, this is the fourth consecutive year in which employers — and their workers — have faced significantly higher costs for health insurance, with next year representing the biggest jump since 2010.” * * *
    • “Without making any changes to benefits — which would involve moves like shifting more costs to workers or reducing benefits — employers said they expected next year’s increases in health costs to reach nearly 9 percent on average. By altering plans, they projected increases overall of 6.5 percent on average in health costs next year.
    • “A quarter of those surveyed projected double-digit increases for 2026 even after changes to plans.”
  • Modern Healthcare relates,
    • “Elevance Health will cut some Medicare Advantage plans and fully exit the Medicare Part D standalone prescription drug market next year. 
    • “The for-profit Blue Cross and Blue Shield licensee will eliminate unprofitable Medicare Advantage plans covering approximately 150,000 individual and group members in total, Chief Financial Officer Mark Kaye said Thursday during the 2025 Wells Fargo Healthcare Conference. The company has prioritized HMO and Dual Special Needs Plan coverage for 2026, he said.
    • “Elevance Health is the fourth-largest Medicare Advantage carrier, with 2.3 million enrollees. It counts 400,000 standalone Part D members, making it the sixth-largest carrier, according to a July report by KFF, a healthcare research firm. It is one of seven companies that sell standalone Part D plans, KFF said. Fee-for-service Medicare beneficiaries purchase the coverage to help offset their prescription drug costs.” 
  • Beckers Payer Issues adds,
    • “UCare has asked CMS to mutually terminate its Medicare Advantage plans for 2026, citing rising medical costs and challenges within the broader market.
    • “This decision was not made lightly,” President and CEO Hilary Marden-Resnik said Sept. 4 “UCare remains deeply committed to the health of Minnesotans and to supporting members through upcoming transitions.”
    • “UCare has more than 600,000 members in Minnesota and parts of western Wisconsin, including 158,000 MA members. It is the second largest MA carrier in the market, with 26% percent market share. The company will continue to offer Medicaid, special needs plans, Medicare supplement and ACA coverage.”

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Beckers Health IT informs us,
    • “Federal lawmakers have introduced a bill to extend Medicare telehealth flexibilities and CMS’ hospital-at-home waiver.
    • “The Telehealth Modernization Act of 2025 would prolong the telehealth program through Sept. 30, 2027, and CMS’ reimbursement of acute hospital care at home through 2030. The measures otherwise expire Sept. 30.
    • “Telehealth is a vital part of our healthcare system, and we must ensure that it is available to patients who need it,” said U.S. Rep. Earl “Buddy” Carter, R-Ga., in a Sept. 2 news release. “By extending telehealth flexibilities for patients, we are making healthcare more accessible, regardless of their physical location.”
    • “Mr. Carter introduced the House bill with Rep. Debbie Dingell, D-Mich., while a companion Senate bill is being led by Sens. Tim Scott, R-S.C., and Brian Schatz, D-Hawaii. Nearly 50 health systems have called for the telehealth extension.”
  • Federal News Network reports,
    • “The Office of Personnel Management is taking a closer look at the details for implementing President Donald Trump’s proposal for a larger pay raise for federal law enforcement personnel next year.
    • “The announcement from OPM comes a couple days after Trump called for a 3.8% pay raise in 2026 for federal employees working in law enforcement jobs.
    • “Certain frontline law enforcement personnel are critical to implementing the President’s strategy to secure the border, protect our country and keep American citizens safe,” OPM said this week in new guidance. “Without special salary rates, the government may find it difficult to recruit and/or retain the number of these personnel needed to properly enforce our borders, uphold our immigration laws and protect law-abiding citizens.”
    • “It’s not yet clear which specific positions or how many law enforcement officials will be included in the new special salary rate. OPM said it plans to consult with the departments of Homeland Security, Justice and Interior to define which jobs will be eligible for the larger law enforcement pay raise next year.
    • “Generally, though, OPM said the upcoming special salary rate will cover agents in the Border Patrol and the Drug Enforcement Administration, criminal investigators at Immigration and Customs Enforcement (ICE), Secret Service personnel, officers at the Federal Protective Service and the FBI, and correctional officers at the Federal Bureau of Prisons — among several other groups.”
  • and
    • “After unveiling a series of immediate acquisition changes over the summer, the Trump administration is on track to debut a formal rulemaking to overhaul and streamline the Federal Acquisition Regulation, or the FAR, this fall.
    • “Larry Allen, the associate administrator for General Services Administration’s Office of Government-wide Policy, discussed the ongoing FAR revisions and the forthcoming rulemaking during AFCEA Bethesda’s “Health IT” conference in Washington on Wednesday.
    • “Under an April executive order, the White House Office of Federal Procurement Policy and the FAR Council are leading an effort to “return the FAR to its statutory roots, rewritten in plain language, and remove most non-statutory rules.”
    • “In recent months, the FAR Council has issued a series of “class deviations” for multiple parts of the FAR. Recent deviations have focused on prioritizing the use of governmentwide contracts and simplifying commercial acquisition.” * * *
    • “In follow-up guidance to the executive order, the Office of Management and Budget said the FAR Council will turn to formal rulemaking after it has posted model deviations for all FAR parts.”
  • It’s worth adding that reginfo.gov no longer carries an “under repair” warning and while the regulatory review pages are up to date, the regulatory agenda page still features the Fall 2024 edition.
  • Govexec considers whether FEGLI Option B is really the best life insurance choice? FEGLI plans remain a solid life insurance option for federal employees, but, depending on the coverage, it may also be wise to look to the private market.
  • Following up on yesterday’s FEHBlog, Beckers Hospital Review notes,
    • “A federal rule enabling real-time access to prescription drug pricing, coverage details and prior authorization requirements is set to take effect Oct. 1. 
    • “The regulation, finalized in July as part of the CMS Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System final rule, will require healthcare providers to use certified health IT systems to electronically submit prior authorization requests, check real-time prescription drug pricing during patient encounters and share electronic prescription data with pharmacies and insurers.”
  • Fierce Healthcare adds,
    • “The Department of Health and Human Services’ investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday. 
    • “The news comes as Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability. 
    • “A press release by HHS says Health Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
    • “The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to HHS’ Office of the Inspector General to assist their investigations, Assistant Secretary Thomas Keane said in a statement.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness.
    • “Drug developers – and the patients they hope to treat – deserve clear, consistent information from the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “These principles ensure that FDA and sponsors are aligned on a flexible, common-sense approach within our existing authorities, and that we incorporate confirmatory evidence to give sponsors a clear, rigorous path to bring safe and effective treatments to those who need them most.”    
  • BioPharma Dive reports,
    • “Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago.
    • “After some delays, the Food and Drug Administration is set to issue an approval verdict on this medicine sometime between October and the end of December. If cleared for market, the oral drug would be sold as Vyglxia and used to treat patients with spinocerebellar ataxia, a type of genetic disorder where the progressive erosion of nerve cells causes problems with movement, coordination and brain function.”
  • Per MedTech Dive,
    • “Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
    • “Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
    • “The FDA decision also expands the insulin pump to adults with Type 2 diabetes.”

From the public health and medical/Rx research front,

  • The American Hospital News tells us,
    • “The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory syncytial virus this upcoming respiratory virus season compared to last year’s, according to its 2025-26 outlook released Aug. 25. The agency is predicting higher peak weekly COVID-19 hospitalization rates this season, particularly if a variant with moderate immune-escape properties emerges.”
  • and
    • “The AHA Sept. 3 released a study conducted by KNG Health Consulting that found Medicare patients who receive care in a hospital outpatient department are more likely to come from geographically isolated and medically underserved communities and be sicker and more complex to treat than Medicare patients treated in independent physician offices. Specifically, the study found that Medicare patients who are seen in HOPDs — including those with cancer — are more likely to be from rural and lower-income areas, living with more severe chronic conditions, dually-eligible for both Medicare and Medicaid, previously hospitalized or cared for in a hospital emergency department, and under 65 and eligible for Medicare based on disability.”
  • The Wall Street Journal discusses how to get the new Covid vaccine.
  • NBC News adds,
    • “An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday.
    • “The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown.” * * *
    • “Our findings suggest azelastine could serve as a scalable, over-the-counter prophylactic against Covid, especially when community transmission is elevated or in high-risk settings such as crowded indoor events or travelling,” said Dr. Robert Bals, professor of internal medicine and pneumology at Saarland University and the study’s senior author.
    • “The trial had limitations, namely that the participants were all young and relatively healthy, he said. 
    • “Bals said that azelastine should not be seen as a replacement for vaccinations, and larger studies were needed before recommending it as a routine preventative measure for the general public, and especially vulnerable groups.”
  • Per a National Institutes of Health news release,
    • “Researchers funded by the National Institutes of Health (NIH) have found that a single injection of the antibiotic benzathine penicillin G (BPG) successfully treated early syphilis just as well as the three-injection regimen used by many clinicians in the United States and elsewhere. These findings from a late-stage clinical trial suggest the second and third doses of conventional BPG therapy do not provide a health benefit. The results were published today in The New England Journal of Medicine.
    • “Benzathine penicillin G is highly effective against syphilis, but the three-dose regimen can be burdensome and deter people from attending follow-up visits with their healthcare providers,” said Carolyn Deal, Ph.D., chief of the enteric and sexually transmitted infections branch of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “The new findings offer welcome evidence for potentially simplifying treatment with an equally effective one-dose regimen, particularly while syphilis rates remain alarmingly high.”
    • “Syphilis is a common sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The United States reported 209,253 total syphilis cases and 3,882 congenital syphilis cases in 2023, representing 61% and 108% increases over 2019 numbers, respectively. Without treatment, syphilis can result in neurological and organ damage as well as severe pregnancy complications and congenital abnormalities. Syphilis can also increase a person’s likelihood of acquiring or transmitting HIV.
    • “BPG is one of the few antibiotics known to effectively treat syphilis, and stockouts are common worldwide. The antibiotic is currently being imported to the United States to resolve a nationwide shortage.”
  • Per Beckers Hospital Review,
    • “Researchers have successfully used repurposed cancer drugs to target dormant breast cancer cells, aiding in the delay or prevention of recurrence, according to a study published Sept. 2 in Nature Medicine. 
    • “Researchers from Philadelphia-based University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine enrolled 51 breast cancer survivors to identify and target the cells with existing cancer drugs.” * * *
    • “Read the full study here.” 
  • Per Healio,
    • “Nonsurgical treatments may offer long-term reductions in pain and disability for patients with chronic low back pain.
    • “Treatment options included cognitive behavioral therapy, mindfulness and exercise.”
  • Per Health Day,
    • “Guidelines recommend that preschoolers diagnosed with ADHD first get six months of behavioral therapy before drug therapy is initiated
    • “New research shows this rule is followed by U.S. doctors only about 14% of the time, and that could mean poorer outcomes for kids
    • “A lack of access to therapists is often cited as a reason for starting meds soon, but experts say there are ways around that.”

From the U.S. healthcare business front,

  • Fierce Pharma points out,
    • “After joining multiple other drugmakers on the U.S. investment bandwagon earlier this year, Gilead Sciences is providing further details on where it plans to channel its $32 billion pledge.
    • “Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday.
    • “The new facility, which will reach five stories and cover 180,000 square feet, will serve the company’s technical development and manufacturing teams, leveraging a mix of digitalization, autonomous robotics and real-time digital monitoring. Additionally, the project is expected to boost Gilead’s capabilities and capacity around biologics, which the company described as a “central pillar” of its broader growth strategy.”
  • Beckers Hospital Review lets us know,
    • “Cincinnati-based TriHealth has completed the acquisition of Clinton Memorial Hospital, a 140-bed facility in Wilmington, Ohio, marking its sixth acute care hospital.
    • “The facility will be renamed TriHealth Clinton Regional Hospital and serve as a hub for the system’s specialized services, including women’s health, cancer, heart and vascular, neurosciences and stroke care.
    • “This new name will extend TriHealth’s brand promise to ‘see, to hear and to heal … delivering surprisingly human care’ to the residents of Clinton County,” TriHealth President and CEO Mark Clement said in a Sept. 2 news release. “And it will also affirm TriHealth’s commitment to invest in the hospital and expand services locally, establishing it as a regional hub for TriHealth’s exceptional, nationally recognized care.”
  • Fierce Healthcare reports,
    • “HonorHealth, an Arizona-based health system, is acquiring a number of Evernorth Care Group locations across Phoenix.
    • “Evernorth Care Group lists 18 centers offering integrated primary care services to nearly 80,000 patients throughout the metropolitan area. The clinics will become part of HonorHealth at the close of the deal, slated for January 2026, pending regulatory approvals.
    • “This acquisition enhances the services we offer and expands Valley residents’ access to care,” HonorHealth CEO Todd LaPorte said in the announcement. The financial terms were not disclosed.” 
  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s prior authorization gold card program has seen a more than 40% increase in the number of qualifying provider groups in 2025, the company shared with Becker’s.
    • “Launched in October 2024, the program reduces prior authorization requirements in favor of advance notification for provider groups that consistently adhere to evidence-based care guidelines.
    • “Providers can lose gold-card status because of patient safety issues, failure to cooperate with quality and patient safety activities, failure to make timely responses to requests for information, or because they no longer meet program requirements. UnitedHealthcare conducts annual evaluations for gold card qualification, with determinations effective on Oct. 1 every year. 
    • “On Sept. 1, provider groups could begin viewing their program status in the UnitedHealthcare Provider Portal. Starting Oct. 1, additional groups will be eligible.”
  • and
    • “Economic uncertainty and policy changes from the current administration have changed the way health plans operate over the past year. Many have found workarounds to continue efficiency and growth.
    • “Becker’s connected with five leaders to learn their biggest accomplishments so far in 2025.”
    • Check it out.
  • Milliman has posted its “2025 Milliman Retiree Health Cost Index.”
  • McKinsey & Co. discusses “the quantum revolution in pharma: Faster, smarter, and more precise.”
    • “Quantum computing presents a multibillion-dollar opportunity to revolutionize drug discovery, development, and delivery by enabling accurate molecular simulations and optimizing complex processes.”
  • Radiology Business notes,
    • “Hospital- and private equity-affiliated radiology practices command significantly higher prices than their independent practice counterparts, according to new research published Tuesday. 
    • “Consolidation of imaging groups has accelerated in recent years, with limited evidence on how this change impacts economics within the specialty. Researchers with Brown University recently set out to understand how such M&A activity has changed prices for radiology services, sharing their findings in the Journal of the American College of Radiology (JACR). 
    • “They found a noteworthy gap, with negotiated professional prices for hospital-based radiology services about 43% higher than independents. That’s compared to about 16% higher for investor-backed radiologists versus others in private practice. 
    • “Our findings demonstrate significant differences in negotiated radiologic service prices by practice ownership, with hospital and PE-affiliated practices able to negotiate higher professional fees than independent practices,” corresponding author Yashaswini Singh, PhD, MPA, a healthcare economist and professor with the Providence, Rhode Island, institution, and colleagues concluded. “These results highlight the financial implications of ongoing consolidation in radiology and underscore the need for continued research into how these trends affect radiologists, insurers and patients.”

Tuesday Report

David Ermer–AHRQ, CDC, CMS, Electronic health records, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services today announced prescription drug reforms that will become effective Oct. 1 originating from the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule. Health IT tools certified by the HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology will allow drug prescribers to compare drug prices in real time and identify lower-cost alternatives available under a patient’s insurance coverage, particularly if they are covered under Medicare Part D. Providers will also be able to submit prior authorizations for medical services electronically to accelerate the process. The HTI-4 rule was released in July as part of the Centers for Medicare & Medicaid Services’ inpatient prospective payment system final rule for fiscal year 2026.”
  • Beckers Hospital Review informs us,
    • “HHS launched a [public] dashboard Aug. 27 to track organ transplants that skip patients next in line on transplant waiting lists. 
    • “The practice, called “allocation out of sequence,” is growing in frequency. In 2024, organ procurement organizations skipped waitlisted patients for 19% of transplants from deceased donors, six times more often than from a few years prior. The frequency increase is partly driven by clinicians prioritizing favoritism and ease over fairness, according to The New York Times. 
    • “The Organ Procurement and Transplantation Network’s policies and national law mandates organ allocation follow a “match run” to rank eligible recipients based on medical urgency, distance and other factors, according to HHS. 
  • Beckers Payer Issues points out,
    • “Medicare Shared Savings Program Accountable Care Organizations generated record savings and continued to improve quality performance in 2024, CMS said Aug. 28.
    • “In 2023, the program saw $2.1 billion in net savings.” * * *
    • “Nearly all ACOs met quality reporting requirements, with more shifting to digital measures that use electronic health information. ACOs also saw health outcomes improve around controlled blood pressure, poor A1c control and depression screenings.” 
  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM), in collaboration with the Assistant to the President for Domestic Policy, today sent a comprehensive Frequently Asked Questions (FAQ) document to agencies to help support the implementation of the Merit Hiring Plan, pursuant to President Trump’s Executive Order 14170. The FAQ provides detailed guidance to federal agencies on reforming the hiring process to prioritize merit and fairness.
    • A key highlight of the Merit Hiring Plan is the introduction of a two-page resume limit for federal job applications submitted through USAJOBS, taking effect September 27, 2025. This reform ensures hiring managers focus on the most relevant qualifications and experience, streamlining the review process. OPM is providing a transition period until the deadline, along with updated USAJOBS guidance and resume-building tools online to assist applicants in meeting the new standard.
  • The Government Accountability Office released a report titled “Illicit Fentanyl: DHS Has Various Efforts to Combat Trafficking but Could Better Assess Effectiveness.
    • “With about 48,000 deaths in 2024, fentanyl continues to be the primary cause of overdose deaths in the United States.
    • “The Department of Homeland Security has various efforts to combat the trafficking of illicit fentanyl. For example, it inspects incoming travelers and shipments and conducts patrols along the border.
    • “We reviewed these efforts and found issues with how DHS assesses their effectiveness. For example, DHS hasn’t set performance goals and measures—so it’s hard to know if DHS is making progress in its efforts to stop the flow of fentanyl.
    • ‘We recommended, among other things, that DHS set such performance goals and measures.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.
    • Nicotine pouches contain concentrated nicotine that can be harmful or potentially fatal to young children, even in small amounts. Toxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams. Symptoms of nicotine poisoning may include confusion, vomiting, and loss of consciousness. 
    • “I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children. Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion.” 
    • “The FDA is also issuing information for consumers on how to properly store nicotine pouches and prevent accidental exposure to children.” * * *
    • To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging, which are listed at www.fda.gov/authorizednicotinepouches.  

From the public health and medical/Rx research front,

  • The AP reports,
    • “A New York City hospital and another city-run building were sources for a deadly outbreak of Legionnaires’ disease in Harlem that killed seven people and sickened dozens of others, health officials announced Friday. 
    • “The New York City Health Department said bacteria from cooling towers atop Harlem Hospital and a nearby construction site where the city’s public health lab is located matched samples from some of the ill patients.
    • “The agency said they consider the bacterial cluster officially over since the last day anyone reported symptoms of Legionnaires’ disease was three weeks ago on Aug. 9. Since the outbreak, seven people have died and 114 people have been diagnosed with Legionnaires’ disease, while six people are in the hospital.” * * *
    • “City health officials said all facilities in the affected area have cleaned and disinfected their cooling towers. 
    • “They also are considering a series of changes to try to prevent future outbreaks. Among them are requiring building owners to test for Legionella every 30 days instead of the current 90-days and increasing the fines for violations for failure to comply with local cooling tower regulations.”
  • Beckers Hospital Review points out,
    • “Following almost a decade of decline, prostate cancer incidence in the U.S. increased 3.0% per year between 2014 through 2021, according to a report published Sept. 2 in CA: A Cancer Journal for Clinicians. Incidence of advanced-stage prostate cancer at diagnosis had the highest rate of increase at about 4.7% per year.
    • “At the same time, prostate cancer mortality continued to decline, though at a slower rate than the previous two decades. Prostate cancer mortality declined by 0.06% over the past decade, compared to the 3% to 4% annual decline seen in the late 20th and into the early 21st centuries.
    • “For the report, researchers analyzed cancer incidence and mortality data collected by the CDC and the National Cancer Institute through 2021 and 2023, respectively.” * * *
    • “Read the full report here.” 
  • NPR Shots relates
    • “People who inherit two copies of a gene variant called APOE4 have a 60% chance of developing Alzheimer’s by age 85.
    • “Only about 2% to 3% of people in the U.S. have this genetic profile, and most of them don’t know it because they’ve never sought genetic testing.
    • “But three scientists are among those who did get tested and learned that they are in the high-risk group. Now, each is making an effort to protect not only their own brain, but the brains of others with the genotype known as APOE4-4.”
  • Check out their stories.
  • Per Health Day,
    • “Common over-the counter painkillers might be quietly fueling antibiotic resistance, a new study warns.
    • “Ibuprofen and acetaminophen appear to enhance mutations in E. coli, making the common bacteria more resistant to the broad-spectrum antibiotic ciprofloxacin, researchers reported in the journal npj Antimicrobials and Resistance.
    • “What’s more, the two drugs amplify this effect when used together, researchers found.
    • “Antibiotic resistance isn’t just about antibiotics anymore,” said lead researcher Rietie Venter, an associate professor with the University of South Australia.
    • “This study is a clear reminder that we need to carefully consider the risks of using multiple medications – particularly in aged care where residents are often prescribed a mix of long-term treatments,” she said in a news release.”
  • BioPharma Dive relates,
    • “Ionis on Tuesday said its new lipid-lowering drug Tryngolza met the main goals of two Phase 3 clinical trials that could expand its use. Results showed the drug significantly reduced triglyceride levels in people with severely elevated levels of the fat in their bloods and prevented accompanying pancreatitis episodes.
    • “The company will ask the Food and Drug Administration by the end of the year to add severe hypertriglyceridemia to Tryngolza’s label. The drug, Ionis’ first wholly owned product, gained approval in December for a rare inherited condition called familial chylomicronemia syndrome, for which it recorded $25.6 million in sales over the first six months of 2025.”
  • Per a corporate news release,
    • “United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its TETON-2 study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo.
    • “Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL (Hodges-Lehmann estimate, p <0.0001) from baseline to week 52 in patients with IPF. Benefits of Tyvaso were observed across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental oxygen use.
    • “Statistically significant improvements relative to placebo were also observed in most secondary endpoints, including time to first clinical worsening event, as well as changes from baseline to week 52 in percent predicted FVC, King’s Brief Interstitial Lung Disease quality of life questionnaire (K-BILD), and diffusion capacity of lungs for carbon monoxide (DLCO). While not statistically significant, both time to first acute exacerbation of IPF and overall survival at week 52 trended in favor of Tyvaso. Treatment with Tyvaso was well-tolerated, and the safety profile was consistent with previous Tyvaso studies and known prostacyclin-related adverse events. No new safety signal was seen.
    • “It is a profound honor to witness the power of scientific innovation realized for patients in need,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “TETON-2’ssuccessful outcomeaffirms the anti-fibrotic power of Tyvaso. We have unlocked new hope for patients with IPF and their families.”
  • The American Medical Association lets us know what doctors wish their patients knew about rebound congestion.
  • Per MedPage Today,
    • “Patients with type 2 diabetes who were treated with GLP-1 receptor agonists were less likely to develop peptic ulcer disease (PUD), a nationwide study found.
    • “In an analysis of more than 65,000 patients, GLP-1 users had 44% lower odds of PUD compared with non-users (adjusted OR 0.56, 95% CI 0.45-0.71, P<0.001), reported Trisha Pasricha, MD, MPH, of Beth Israel Deaconess Medical Center in Boston, and colleagues.
    • “In a subgroup of patients with a history of metformin use, switching to a GLP-1 receptor agonist for second-line treatment was associated with a 56% lower hazard of PUD compared with switching to insulin (adjusted HR 0.44, 95% CI 0.30-0.63, P<0.001). By 2 years, the cumulative PUD risk was 1.8% in the GLP-1 group versus 4.5% in the insulin group, the authors reported in Clinical Gastroenterology and Hepatology.”
  • and
    • “A personalized message about advanced colorectal neoplasia risk to patients and providers had no effect on colorectal cancer screening uptake, a randomized trial showed.
    • “Among 1,084 average-risk patients, the predicted probability of completing colorectal cancer screening with a personalized decision aid was 36.8% versus 41% with a generic decision aid (P=0.18), reported Peter H. Schwartz, MD, PhD, of the Indiana University School of Medicine in Indianapolis, and colleagues.
    • “For the 214 providers who were sent personalized notifications about patients’ risk, the predicted probability of the patient completing screening was 41.5% versus 36.4% for those who received a generic notification (P=0.135), they noted in the Annals of Internal Medicine.
    • “The overall result was negative, although there were some really interesting results in subgroups,” Schwartz told MedPage Today.”
  • and
    • “Among older adults, the incidence of myocarditis or pericarditis was lower among those who received the high-dose inactivated flu vaccine versus the standard-dose vaccine.
    • “There were only two cases of myocarditis observed among over 300,000 study participants, both in the standard-dose group.
    • “These results may not be generalizable to younger people, who are at greater risk of inflammatory cardiac conditions.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s health services division Evernorth has invested $3.5 billion in Shields Health Solutions as the company continues to build out its lucrative specialty pharmacy business.
    • “Shields, which helps hospitals and other providers create and manage their own specialty pharmacies, is one of five standalone businesses created from pharmacy behemoth Walgreens, which was acquired and chopped up by private equity firm Sycamore Partners last week.
    • “Evernorth’s investment in the form of preferred stock does not give Evernorth a controlling stake in Shields and is not expected to materially impact Cigna’s earnings guidance for 2025. The deal does give the company the option to invest more in Shields in the future.”
  • Fierce Healthcare announced its “FIERCE 50 OF 2025, the people and organizations advancing what’s possible in health, science and patient care.”
  • Beckers Hospital Review tells us,
    • “The University of Texas at San Antonio merged with The University of Texas Health Science Center at San Antonio on Sept. 1 to become The University of Texas at San Antonio. 
    • “The University of Texas System shared plans to merge the two entities into a unified institution in late August 2024. 
    • “The institution, which is now Texas’ third-largest public research university, comprises 15 colleges and schools across six campuses, around 40,000 students, 17,000 employees, more than 320 undergraduate and graduate degrees, $486 million in annual research expenditures and a $1.3 billion endowment, according to a Sept. 1 news release.”
  • Hook’em. 
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative effectiveness of apitegromab (Scholar Rock Holdings), as well as the disease-modifying therapies nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). Apitegromab is an investigational new drug seeking FDA approval for improving motor function in patients with SMA.” * * *
    • ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.\
    • ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, carers and patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include: 
      • The manufacturer should set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments. Given the small average improvement in motor function for patients treated with apitegromab and the uncertainty about serious adverse events, manufacturer pricing should reflect ICER’s value-based price range in moderating launch pricing.
      • The use of SMN-directed therapy after gene therapy or in combination should only be done in the context of research studies.
      • A randomized trial should be performed of first-line therapy in asymptomatic patients identified through newborn screening to better understand the comparative advantages and disadvantages of each of the three SMN-directed therapies.
    • ICER’s detailed set of policy recommendations is available in the Final Evidence Report and in the standalone Policy Recommendations document. 
  • Per Healthcare Dive,
    • “Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. 
    • “The study, published on Aug. 22, looked at 950 AI medical devices authorized by the Food and Drug Administration through November 2024. Sixty of the devices were associated with 182 recall events. 
    • ‘The most common causes of recalls were diagnostic or measurement errors, followed by functionality delay or loss. About 43% of all recalls also took place within one year of FDA authorization. 
    • “Tinglong Dai, lead author of the study and a professor at the Johns Hopkins Carey Business School, said the “vast majority” of recalled devices had not undergone clinical trials. For the majority of AI-enabled devices, which went through the FDA’s 510(k) pathway, clinical studies are not required. 
    • “Unfortunately, it’s not required, and so people don’t do it,” Dai said in an interview. “So, that’s why we believe it is one of the most important drivers of the recalls.”
    • “By comparison, the study found that devices that had gone through retrospective or prospective validation were subject to fewer recalls.” 
  • Per BioPharma Dive,
    • “Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions of dollars.
    • “The deal, announced Monday, revolves around a preclinical drug that Arrowhead designed to silence the genetic instructions for “alpha-synuclein,” a protein tied to Parkinson’s disease and other brain-eroding illnesses. Novartis has now agreed to pay $200 million for an exclusive license to research, develop, manufacture and commercialize the drug.
    • “Arrowhead could receive an extra $2 billion or more by hitting certain development goals and collecting royalties on any resulting products. Per deal terms, Novartis will also be able to select additional disease targets outside of Arrowhead’s current pipeline to advance using the latter’s drug making technology, which centers on a technique called RNA interference.
    • “The companies plan to close their agreement sometime this year.”
  • and
    • “The biotechnology careers of John Maraganore and Clive Meanwell have brought them into collaboration time and time again.
    • “As the respective founders of Alnylam Pharmaceuticals and The Medicines Company, the two previously partnered on the drug that would ultimately become Leqvio, which was later bought in a $10 billion acquisition of Medicines Co. by Novartis. And before Alnylam, Maraganore had led development at Biogen of Angiomax, which was later licensed to Meanwell’s company.
    • “Now, the two have partnered to launch and run Corsera Health, which aims to make a preventive medicine for cardiovascular disease as well as an artificial intelligence tool to identify who could benefit from earlier heart intervention. 
    • “Corsera’s target are younger people who are not “willing to wait 40 years to see whether they have a heart attack,” Meanwell said. “They’re saying, ‘What can I find that will help me?’”
    • “Corsera’s lead drug, an RNA interference therapeutic now in preclinical testing, is designed to be a once-yearly injection that blocks two targets known to drive cardiovascular disease: PCSK9 and angiotensinogen. The company expects to begin clinical testing by the end of the year.”