Monday report

Medical / Rx research

Monday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the healthcare business front,

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

Weekend Report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, OPM, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “The top four congressional leaders will head to the White House on Monday for a meeting with President Donald Trump in a last-ditch effort to prevent a partial government shutdown.
    • “The meeting, confirmed by sources familiar with the plans, comes after the president scrapped a separate discussion planned with just the two Democratic leaders.” * * *
    • “The Senate is back in session on Monday with 48 hours until agencies would have to start shutting down Oct. 1. The House, which on Sept. 19 passed a partisan GOP-drafted stopgap funding bill that would keep the government operating for seven weeks until the Thanksgiving recess, isn’t planning to return until at least Oct. 7.
    • “Speaker Mike Johnson wrote Friday on X that House Republicans “have done our job” and now it’s the Senate’s turn to act.” 
  • Here is link to the Congressional committee schedule for this week.
  • Roll Call notes,
    • “The Senate does have another option in the queue aside from leadership-driven proposals [for a continuing resolution], with a procedural vote expected Monday on a bill from Sen. Ron Johnson, R-Wis., to provide for automatic two-week continuing resolutions.
    • “My new bill simply provides for automatic two-week rolling continuing resolutions for any department for which an appropriation bill or longer-term continuing resolution hasn’t been passed. This would keep spending flat by prorating the previous year’s spending level,” Johnson wrote in a Sept. 21 Wall Street Journal opinion piece.”
  • SCOTUSblog informs us,
    • “Edward Lazarus, a former clerk to the late Justice Harry Blackmun, called it a “single marathon session.” Gregory Garre, who served as the U.S. solicitor general during the George W. Bush administration, described it as the place “where petitions go to die.” Lazarus and Garre were both referring to the “long conference” – a private meeting, taking place this year on Sept. 29, at which the justices will consider the roughly 2,000 petitions for review that have built up since their last regularly scheduled conference (on June 26) before their summer recess.
    • “The long conference is the unofficial start to the court’s new term, which by law officially begins on the first Monday in October. The tradition of a “long conference” at the end of September or in early October, before the justices take the bench to hear oral arguments, dates back to the early 1970s, according to a book by the late Chief Justice William Rehnquist. Until then, the court held its long conference during the first week in October and had oral arguments thereafter. But Blackmun suggested that the court should move its meeting to the last week in September, allowing it to begin oral arguments on the first Monday in October instead.”
  • Modern Healthcare lets us know,
    • “Medicare Advantage enrollment could slip next year, the Centers for Medicare and Medicaid Services announced Friday.
    • “Health insurance companies project Medicare Advantage membership will fall from 34.9 million this year to 34 million in 2026, CMS said in a news release. 
    • “That would mark the first annual decline in Medicare Advantage enrollment since at least 2007, according to CMS data analyzed by the health policy research organization KFF. The annual enrollment period runs Oct. 15-Dec. 7.
    • “Insurers also predict that Medicare Advantage will lose ground to fee-for-service Medicare next year. The privatized program surpassed traditional Medicare in 2023 but will cover 48% of beneficiaries in 2026, down from 50% this year, according to industry estimates reported to CMS.
    • “CMS offered a rosier assessment. “Based on recent historical experience and enrollment trends, CMS anticipates that enrollment in [Medicare Advantage] in 2026 will be more robust than the plans’ projections and that enrollment will be stable,” the agency said in the news release.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has granted de novo classification to a continuous glucose monitor made by Biolinq for people with Type 2 diabetes.
    • “Biolinq says its device is the first CGM that does not require a needle to place the sensor beneath the skin, instead using a microsensor array that sits less deep in the skin.
    • “People with diabetes have a growing number of CGM options as the FDA has authorized new sensors in recent years, including the first over-the-counter sensors and implanted CGMs that can be worn for one year.“
  • P.S. The OPM Director did not add a new post to his Secrets of OPM blog on Friday.

From the public health and medical / Rx research front,

  • Healio tells us,
    • “A federal law required all new cars to be equipped with backup cameras after May 2018.
    • “The mandate was associated with a 62% reduction in back over injuries in a trauma center in Houston.”
  • and
    • “COVID-19 vaccination during pregnancy provides significant protection for mothers and their babies with no associated increase in risk, according to data from more than 1.2 million pregnancies presented at the AAP’s annual meeting.
    • “COVID-19 vaccination reduced admission, mortality and pregnancy-specific complications,” Nikan Zargarzadeh, MD, a postdoctoral research fellow in the division of fetal medicine and surgery at Boston Children’s Hospital, told reporters on Saturday. “On the neonatal side, it reduced NICU admission.”
  • and
    • “Many women suffer complications in the time between giving birth and the 6-week visit.
    • “A Women in Medicine Summit presenter discussed how her own journey informs her work and what she is doing to help new moms.”
  • NPR Shots reports,
    • “For more than four years, Lynn Milam’s life was bound by the pain that radiated from her swollen joints.
    • “My children could not hug me,” she says. “I couldn’t hold my husband’s hand.”
    • “Milam also couldn’t climb stairs or help raise her teenage son. She spent most days on the couch.
    • “The reason was rheumatoid arthritis, which occurs when the immune system starts attacking the lining of joints.
    • “Milam tried everything: physical therapy, acupuncture, steroids and even the latest immune drugs. Nothing worked.
    • “That changed in October of 2023, when a surgeon implanted an experimental device in Milam’s neck. For a minute each morning, it delivers pulses of electricity to her vagus nerve, which connects the brain with internal organs.
    • “Three weeks in, my elbow pain was completely gone,” she says. “Then my hands didn’t hurt anymore, the swelling started going away.”
    • “Eventually, all symptoms of rheumatoid arthritis had vanished. Milam, 60, says she and her husband have regained the life they enjoyed before she got sick.”
  • Per Medscape,
    •  “Tirzepatide was associated with improvements in body weight and body composition, and with lower insulin doses, in the first-ever randomized controlled trial (RCT) of the drug in people with type 1 diabetes (T1D).
    • “Tirzepatide may play a role in weight management in adults with T1D and obesity, even at low doses,” Jennifer R. Snaith, MD, of the Garvan Institute of Medical Research and St. Vincent’s Hospital Sydney, both in Darlinghurst, Australia, said at European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.” * * *
    • [A]sked to comment, independent industry consultant Charles Alexander, MD, noted that, while the data look good, it’s a small study and that Lilly’s two much larger ongoing phase 3 trials of tirzepatide in T1D, SURPASS-T1D-1 (NCT06914895), and SURPASS-T1D-2 (NCT06962280), aimed at obtaining FDA approval, will produce more definitive results.
    • Alexander also pointed out that Novo Nordisk is not conducting a similar RCT of semaglutide in T1D. “At the end of the day,” if it’s approved, “all you’re going to have [in terms of incretin drugs] is tirzepatide licensed for T1D.” 
    • Snaith’s team is also conducting a further study, TIRTLE2, with insulin resistance as the primary outcome.

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Amid rising healthcare costs, Amazon announced benefit updates Sept. 17 that include a “reduced-cost” healthcare plan for its fulfillment and transportation employees. Workers on the plan will only need to pay $5 a week and $5 for copays starting in 2026.
    • “Those costs amount to about $22 per month or $260 per year for employees. This results in reductions of weekly contributions by workers by 34% and copays for primary care, mental health and nonspecialist visits by 87%, Amazon said.
    • “The changes were made based on feedback offered by workers, Udit Madan, senior vice president of Amazon Worldwide Operations, said in the announcement.”
  • Fierce Pharma notes,
    • “Serial entrepreneur Robert Wessman, who has had a golden touch creating, acquiring and spinning off companies that primarily sell generic drugs, has brought together two of his fastest-growing enterprises as Lotus Pharmaceuticals has acquired a 100% equity stake in [U.S. based] Alvogen.
    • “The move, which transforms Alvogen into a subsidiary, catapults Taiwan-based Lotus into a top-20 specialty pharmaceutical company worldwide, according to a release. The deal has a total value of up to $2 billion.
    • The deal could also help shield Lotus—which does most of its business in Asia—from U.S. tariffs on pharmaceutical products. Thursday night, in a post on social media, President Donald Trump wrote that starting Oct. 1, the U.S. would impose a 100% levy on drugs imported by companies that aren’t in the process of building U.S. facilities.
    • “The transaction gives Lotus “access to U.S. R&D, manufacturing and commercial capabilities alongside our established strengths in Asia,” the company said in a release.”

Friday report

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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


Midweek update

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

From Washington, DC,

  • Federal News Network tells us,
    • “Despite being less than a week away from the government’s funding deadline, and with lawmakers still far from reaching a spending agreement, agencies have not published their plans for what would happen during a government shutdown.
    • “Often, leading up to a possible government shutdown, agencies will publish or update their shutdown contingency plans, which are made publicly available on the Office of Management and Budget’s website. Those plans typically detail how many federal employees at each agency would continue to work — and how many would be furloughed — if a shutdown were to happen.
    • “But even with the fast-approaching deadline for Congress to reach a spending agreement for fiscal 2026 appropriations, OMB’s webpage that usually hosts that contingency information is completely blank.
    • “OMB did not respond to multiple requests for comment from Federal News Network, asking if the Trump administration intends to publish agencies’ contingency plans, or if there were any alternative government shutdown planning efforts currently in the works.”
  • Politico adds
    • “The White House budget office is instructing federal agencies to prepare reduction-in-force plans for mass firings during a possible government shutdown, specifically targeting employees who work for programs that are not legally required to continue.
    • “The Office of Management and Budget move to permanently reduce the government workforce if there is a shutdown, outlined in a memo shared with POLITICO ahead of release to agencies tonight, escalates the stakes of a potential shutdown next week.
    • “In the memo, OMB told agencies to identify programs, projects and activities where discretionary funding will lapse on Oct. 1 and no alternative funding source is available. For those areas, OMB directed agencies to begin drafting RIF plans that would go beyond standard furloughs, permanently eliminating jobs in programs not consistent with President Donald Trump’s priorities in the event of a shutdown.
    • ‘The move marks a significant break from how shutdowns have been handled in recent decades, when most furloughs were temporary and employees were brought back once Congress voted to reopen government and funding was restored. This time, OMB Director Russ Vought is using the threat of permanent job cuts as leverage, upping the ante in the standoff with Democrats in Congress over government spending.”
  • Axios reports,
    • “Big drug companies so far are responding to President Trump’s demand they commit to his “most favored nation” pricing policy by raising prices abroad without cutting them in the U.S.
    • “That only gets halfway toward Trump’s goal of ending what he calls “global freeloading” and getting other developed countries to foot more of the cost while lowering costs for Americans.” * * *
    • “The pharmaceutical industry says it agrees with the goal of making other countries pay more and putting an end to “foreign freeloading.” But drastically cutting U.S. prices to match those abroad would hurt innovation, officials argue. 
      • “Industry is more receptive to other Trump ideas like offering sales directly to patients who pay on their own without insurance. 
      • “We must reject foreign price control models that ration care and suppress innovation,” PhRMA CEO Steve Ubl wrote in an op-ed in Stat in June. 
      • “If we instead required hospitals and [pharmacy benefit managers] to pass along the steep discounts they already receive — and ensured wealthy nations paid their fair share — U.S. prices could fall without jeopardizing our life sciences edge.”
  • Per an HHS press release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced it has awarded more than $45 million in new supplemental funding to State Opioid Response (SOR) program recipients to focus on sober or recovery housing among young adults. This investment advances President Trump’s Executive Order, Ending Crime and Disorder on America’s Streets, by providing sober housing and recovery support services, which are critical to combatting our Nation’s challenge of homelessness, addiction, and illness.
    • “President Trump has elevated this issue as a key public health and public safety priority,” said HHS Secretary Robert F. Kennedy, Jr. “All too often, young adults with opioid or stimulant use disorders lack safe housing to support their recovery. This funding can make a life-changing difference for young people working toward long-term recovery.”
    • “Firsthand experience has shown me that wraparound services, especially sober housing, play a vital role in breaking the cycle of addiction,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “This supplemental funding will help expand that lifesaving care and help people pursue a fulfilling life in recovery.”
    • “Sober housing for those in early recovery is a safe and supportive alcohol- and drug-free residence where people can live, build stability and work toward independence. This therapeutic model allows people to actualize their hopes and dreams to live a fulfilling and self-directed life.”

From the Food and Drug Administration front,

  • Per MedTech Dive,
    • “Olympus told customers last week to stop using certain lots of its ViziShot 2 FLEX (19G) needles due to the risk that components may detach during procedures. 
    • “Olympus started the recall after receiving reports of patient injuries and one death. Olympus did not immediately respond to a request for comment or specify how many injury reports it had received.
    • “The medtech company has faced quality concerns in recent years, with the Food and Drug Administration sending multiple warning letters to Olympus in 2023 related to its endoscopes, and blocking some of the devices from entering the U.S. in June.”
  • and
    • “Johnson & Johnson has recalled certain automated controllers for its Impella heart pumps over a fault linked to five serious injuries, the Food and Drug Administration said Tuesday.
    • “The company’s Abiomed unit told customers to return the affected devices when contacted by its field servicing team because of potentially fatal purge pressure issues. Abiomed will make a design change during device servicing to correct the problem. Hospital inventory can continue to be used, according to the FDA’s alert.
    • “J&J’s recall, which triggered an FDA early alert, follows other recent safety actions to address two problems with Impella that were collectively linked to four deaths.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit confronted the limits of agency rulemaking in arguments over a Biden administration rule for a surprise medical billing law.
    • “The en banc appellate court in New Orleans heard an appeal Wednesday on whether federal agencies exceeded their authorities in a rule on the calculation of a key figure under the No Surprises Act. That law is meant to protect patients from excessive medical bills.
    • “The billing law mandates that medical providers and health insurers settle out-of-network disputes through arbitration. The measure is aimed at protecting patients from medical bills stemming from out-of-network emergency care and from out-of-network clinicians’ care received at in-network facilities.
    • “Justice Department attorney Kevin Soter told the appellate court’s 17 active judges that the statute left it up to federal agencies—the Department of Labor, the Department of Health and Human Services, and the Office of Personnel Management—to come up with details on the arbitration process for surprise medical bill disputes.
    • “Judges Leslie Southwick and Catharina Haynes asked about impact of the US Supreme Court’s 2024 ruling in Loper Bright Enterprises v. Raimondo, which eliminated deference to agencies in interpreting vague laws. Soter said that through the statute, “Congress did clearly put this in the hands of the departments.” * * *
    • “The case is Texas Medical Association v. HHS, 5th Cir. en banc, No. 23-40605, oral argument 9/24/25.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “In its weekly measles update, the Centers for Disease Control and Prevention (CDC) said there are now 1,514 confirmed measles cases in the United States reported this year, with 23 new cases reported in the past week. 
    • “Eighty-six percent of the cases have been part of 40 outbreaks reported to the CDC. Of note, 92% of case-patients are unvaccinated or have unknown vaccination status, 4% have only one measles, mumps, and rubella dose, and 4% were fully vaccinated. 
    • “Twelve percent of cases have required hospitalization, with 29% of those hospitalized aged 19 years or younger. There have been 3 confirmed measles deaths this year.” 
  • The Centers for Disease Control and Prevention announced,
    • “A new report from the Centers for Disease Control and Prevention (CDC), published in the Annals of Internal Medicine, highlights a dramatic increase in a dangerous type of drug-resistant bacteria called NDM-producing carbapenem-resistant Enterobacterales (NDM-CRE). 
    • “In a 2022 special report, COVID-19: U.S. Impact on Antimicrobial Resistance, CDC noted that in 2020 there were approximately 12,700 infections and 1,100 deaths in the U.S. due to CRE. The rise in NDM-CRE, documented in the new study, threatens to increase CRE infections and deaths.
    • “Between 2019 and 2023, NDM-CRE infections surged by more than 460% in the United States. These infections —including pneumonia, bloodstream infections, urinary tract infections, and wound infections—are extremely hard to treat and can be deadly. Detection is also challenging, as many clinical laboratories lack the necessary testing capacity.
    • “This sharp rise in NDM-CRE means we face a growing threat that limits our ability to treat some of the most serious bacterial infections,” said Danielle Rankin, an epidemiologist in CDC’s Division of Healthcare Quality Promotion. “Selecting the right treatment has never been more complicated, so it is vitally important that healthcare providers have access to testing to help them select the proper targeted therapies.”
  • Per MedPage Today,
    • “Sexually transmitted disease (STD) rates for U.S. adults fell last year, but syphilis in newborns continued to rise, according to new government data posted Wednesday.
    • “The CDC provisional data for 2024 showed a third consecutive year of fewer gonorrhea cases, and the second year in a row of fewer adult cases of chlamydia and the most infectious forms of syphilis.
    • “But congenital syphilis cases, in which infected moms pass the disease to their babies, aren’t seeing the same improvements. Such infections in infants can lead to deaths or lifelong health problems such as deafness, blindness, and malformed bones.”
  • and
    • “Drinking any amount of alcohol increased dementia risk, data from a combined observational and genetic study suggested.
    • “Light alcohol consumption was associated with low dementia risk in observational analyses, and genetic analyses showed a monotonic increasing dementia risk with higher alcohol intake, reported Anya Topiwala, DPhil, of the University of Oxford in England, and co-authors.
    • “Mendelian randomization suggested a causal role of alcohol consumption in increasing dementia risk with no evidence supporting a protective effect at any consumption level, Topiwala and colleagues wrote in BMJ Evidence-Based Medicine.”
  • BioPharma Dive informs us,
    • “UniQure said Wednesday it will ask the Food and Drug Administration next year to approve its gene therapy for the neurodegenerative disorder Huntington’s disease following positive data from a Phase 2 study that showed it slowed signs of disease progression by 75% after three years.
    • “Though from only 12 patients who’d received the highest tested dose of the therapy, AMT-130, and had been evaluated for at least 36 months, the effects were “greater than what we even anticipated and expected and hoped for,” said Sarah Tabrizi, director of the University College London Huntington’s Disease Center, on a conference call.”
  • and
    • “Acadia Pharmaceuticals is giving up on a drug to treat the insatiable hunger associated with Prader-Willi syndrome after a Phase 3 trial failed to prove the experimental medicine was more effective than a placebo.
    • “The 12-week study tested the effects of ACP-101 in 175 patients with the rare genetic syndrome. The main goal was improvement on a questionnaire measuring the hunger, known as hyperphagia. But the drug didn’t show advantages over a placebo on that primary endpoint or any secondary endpoint, Acadia said Wednesday.”
  • MedPage Today notes,
    • “Supplementing digital breast tomosynthesis (DBT) with molecular breast imaging (MBI) increased the detection of cancers in women with dense breasts, a prospective study suggested.
    • “In an analysis involving nearly 3,000 women with dense breasts, adding MBI to DBT led to incremental cancer detection rates of 6.7 and 3.5 cancers per 1,000 screenings in year 1 and year 2, respectively (both P<0.001), reported Carrie B. Hruska, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.
    • “Supplemental MBI also increased invasive cancer detection by more than 2.5 times that of DBT alone at both screening rounds, they noted in Radiology.
    • “Across both screenings, there were 30 cancers detected in 29 women with MBI only. Most of these incremental cancers (71%) were invasive. Additionally, 90% of the cancers detected only with MBI were node negative, “indicating that MBI screening provides early detection,” Hruska and colleagues wrote.”
  • Per Health Day,
    • “Providing immediate bedside hepatitis C virus (HCV) consultation at discharge from labor and delivery for women with HCV-affected pregnancies is associated with higher rates of treatment completion than referral for outpatient follow-up, according to a study published in the October issue of O&G Open.
    • “Leah Madeline McCrary, M.D., from Washington University in St. Louis (WashU), and colleagues evaluated the associations of a traditional postpartum outpatient referral (92 women) compared to an opportunistic inpatient consultation (33 women) for HCV treatment initiation on HCV treatment completion. 
    • “The researchers found that all individuals in the inpatient referral group had an inpatient consultation; however, a majority (55.4 percent) of those in the outpatient referral group did not present for consultations. Inpatient referral was associated with higher rates of HCV treatment completion (20 of 30) among women who were prescribed direct-acting antivirals compared with standard care (14 of 41). Inpatient treatment was associated with higher odds of treatment completion (adjusted odds ratio, 4.7).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Premier is going private through an acquisition by healthcare-focused investment firm Patient Square Capital, the companies announced Monday.
    • “The deal values Premier at roughly $2.6 billion and is set to take the company, which provides supply chain, technology and consulting services to thousands of U.S. providers, off the public markets after more than a decade.
    • “Premier and Patient Square expect the deal to close by the first quarter of 2026 subject to regulatory approval and other closing conditions.”
  • and
    • “Privia Health is acquiring a value-based primary care business from Evolent Health as the physician enablement company continues to expand its care delivery network into new geographies.
    • “Evolent has agreed to sell its accountable care organization business, called Evolent Care Partners, for $100 million in cash, the companies announced aftermarket Tuesday. Another $13 million is contingent on the ACO’s performance in traditional Medicare’s largest value-based care program in 2025.
    • “The transaction is expected to close in the fourth quarter and positively contribute to Privia’s adjusted earnings next year. Analysts said the deal is favorable for both parties.”
  • Fierce Healthcare relates,
    • “UnitedHealthcare is rolling out a new offering that aims to make it easier for employer plan members to shop for health and wellness solutions that meet their needs.
    • “The UHC Store is embedded in the insurer’s member portal and app and is now available to 6 million people enrolled in its employer-sponsored health plans. The payer giant plans to expand to 18 million members this year.
    • “Members who access the store are eligible for discounts of up to 15% of health and wellness programs of their choice, according to its announcement. The team initially focused on programs that fit within some of the most in-demand and high-cost areas, such as women’s health, musculoskeletal conditions and diabetes, according to Amy Jordan, vice president of consumer experience for UnitedHealthcare’s commercial business.”
  • and
    • “Harbor Health continues to expand its clinical footprint in Texas with the acquisition of 32 clinics from VillageMD.
    • ‘The deal expands the company’s reach into three new markets: San Antonio, El Paso and Dallas. Harbor Health also grew its established clinical footprint in its home base of Austin. Financial terms of the deal were not disclosed.
    • “The acquisition nearly quadrupled Harbor Health’s clinical presence, growing from 11 to 43 total clinics and adding more than 80 clinicians to its team of physicians and advanced practice providers. The acquisition also advances the company’s philosophy that having a denser network of clinics improves quality of care through enhanced accessibility.” 
  • Fierce Pharma informs us,
    • “Excitement around Fujifilm Biotechnologies’ massive new cell culture facility in Holly Springs, North Carolina, has been growing steadily since 2021, prompting a beefed-up investment from the company last April and a string of high-profile manufacturing contracts this year.
    • “Now, some four years since the project’s reveal, Fujifilm Biotechnologies is opening the doors to the facility, which might look familiar to anyone who’s worked with the CDMO in Denmark.
    • “The opening of the Holly Springs site, which will focus on antibody-based drugs, marks the debut of one of the largest cell culture biomanufacturing sites in the U.S., Fujifilm Biotechnologies said in a Sept. 24 press release.”
  • and
    • “Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.
    • “Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.
    • “The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.”
  • Beckers Payer Issues discusses an Experian Health report about the 2025 State of [Health Plan] Claims.
  • Avalere Health explains how “CMS Continues to Refine Value-Based Care Approach for Kidney Care.”
  • Radiology Business reports,
    • “Medical imaging accounts for 4 of the 5 most prevalent low-value healthcare services among Medicare beneficiaries, according to new research published Friday. 
    • “Imaging for plantar fasciitis” was the most frequently delivered unnecessary exam, occurring nearly 84 times per 100 Medicare beneficiaries, experts write in JAMA Health Forum. Low-value imaging for headache (76/100), syncope (72/100) and lower back pain (39/100) also made the top five, with vertebroplasty and kyphoplasty at No. 4. 
    • “The findings are based on a review representing claims from over 3.7 million Medicare beneficiaries treated between 2018 and 2020. Altogether, the payment program spent approximately $484 million on 15 different low-value imaging services, a figure that balloons to nearly $584 million when factoring in beneficiaries’ out-of-pocket costs.  
    • “Findings of this cross-sectional study highlight that reforms aimed at reducing spending for low-value services are feasible to achieve billions in savings without compromising patient health,” David D. Kim, PhD, and A. Mark Fendrick, MD, with the universities of Chicago and Michigan, respectively, wrote Aug. 1.”

Tuesday report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “President Donald Trump abruptly canceled his meeting with top Democratic leaders that had been planned for Thursday to search for a deal that might avert a partial government shutdown next week.”
  • The American Hospital Association News tells us,
    • ‘The Department of Homeland Security today released a proposed rule to amend the process for selecting among prospective applicants — known as registrants — for H-1B visas that are subject to statutory numerical caps. The rule would change the agency’s current process of conducting random selections to a weighted selection process. Weighted selections would be based on an individual’s wage level, with higher wage levels weighted more heavily. The rule would also apply the process to registrations subject to the regular cap and to those asserting eligibility for the H-1B advanced degree exemption. The proposal would require the use of additional wage level information, including the Occupational Employment and Wage Statistics wage level, Standard Occupational Classification code and the area of intended employment.”
  • and
    • “The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following reports of device components detaching during procedures. The company was alerted to incidents resulting in one patient death and one injury. The product is designed to be used with ultrasound endoscopes for lung cancer biopsies. In response to the reports, Olympus has implemented an automated inspection procedure during assembly to help improve the detection of device damage, which is a step that was previously done through a visual inspection. The FDA said health care personnel treating patients with the product must ensure it is not from an affected lot.”
  • Milliman delves into why “many Medicare beneficiaries will spend less than expected to reach the IRA’s new $2,000 out-of-pocket spending limit.”
    • “Among other changes to the standard Part D benefit design, the IRA introduces a hard MOOP—once the beneficiary attains $2,000 in TrOOP costs in 2025, they are no longer responsible for any cost sharing—aligning the TrOOP more closely with the typical definition of a MOOP.5 Another important change introduced by the IRA is that cost sharing for basic Part D coverage counts toward the MOOP, even if that basic coverage is reduced by certain other payers.6 Federal regulators refer to the amount of drug cost that accumulates (or counts) toward the MOOP in Part D as “TrOOP eligible cost.”7 For enhanced plans,8 TrOOP eligible cost is based on the greater of defined standard benefit cost sharing and the actual patient out-of-pocket (including any cost-sharing subsidies), such that actual patient out-of-pocket will never be higher than TrOOP eligible costs.9 This regulatory guidance has been referred to as the “greater of” logic.
    • “This “greater of” provision is impactful because the defined standard benefit is frequently leaner (i.e., has higher cost sharing) than the benefit a beneficiary may actually have. In fact, around 90% of non-low-income (unsubsidized) beneficiaries are enrolled in plans with enhanced benefits.10 Enhanced plans generally offer fixed copays on generic tiers, either coinsurance or copays on brand tiers, and coinsurance on specialty tiers. Plans are considered “enhanced” if they are meaningfully richer than the defined standard benefit. Other plans are considered “basic” and are roughly equivalent in richness to the defined standard benefit.11
    • “The IRA’s accumulation logic means many beneficiaries who satisfy their MOOP will do so without spending $2,000 out-of-pocket—i.e., their specific MOOP will be less than their $2,000 limit in TrOOP eligible costs. Assuming enhanced benefits similar to 2024, we expect roughly half of non-low-income beneficiaries who reach MOOP will spend less than $1,200 out-of-pocket in 2025.12
    • “Most likely, the only beneficiaries who will pay the full $2,000 to satisfy their MOOPs in 2025 will be non-low-income beneficiaries who are enrolled in a plan with basic Part D coverage13 or who are in an enhanced plan but exclusively utilize drugs with cost sharing greater than or equal to what is under (i.e., leaner than) the defined standard benefit. The most common instance of the latter occurs for specialty drugs on tier 5, which are almost always subject to a coinsurance greater than or equal to the defined standard coinsurance amount. In some cases, this could also occur for non-preferred brand (tier 4) drugs, where the plan offers a coinsurance benefit (typically 40% to 50%, compared to the defined standard 25%).”
  • The HHS Inspector General released a report
    • “Congress appropriated $178 billion to HHS to provide funds to eligible providers for health care-related expenses or lost revenue attributable to COVID-19 under the Provider Relief Fund (PRF) program. HHS was responsible for initial PRF program oversight and policy decisions, and HRSA administered the PRF program.
    • “Under the PRF terms and conditions, if a patient had health insurance and sought COVID-19 treatment from an out-of-network provider that received PRF payments, the provider would not seek to collect out-of-pocket payments greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. (We refer to this as the “balance billing requirement.”)
    • “This audit assessed whether selected hospitals that received PRF payments complied with the balance billing requirement for COVID-19 inpatients.
    • “Of the 25 selected hospitals, 17 billed patients an amount that did not comply or may not have complied with the balance billing requirement. For example, one hospital billed a patient $6,000 when the patient’s insurance carrier had waived all patient cost-sharing responsibility.
    • “Hospitals stated that they were uncertain how to comply with the requirement because HRSA did not provide sufficient guidance. If HRSA developed and provided early and detailed guidance, hospitals might not have improperly billed selected patients a total of $637,035 for services provided.”
  • Per a Justice Department news release,
    • “The Justice Department’s Criminal Division today announced the expansion of its Health Care Fraud Unit’s New England Strike Force to the District of Massachusetts. This expansion brings enhanced federal enforcement resources to one of the nation’s most significant health care and life sciences hubs.
    • “The U.S. Attorney’s Office for the District of Massachusetts has a national reputation in health care enforcement and has developed a significant record of success in investigating and prosecuting health care fraud, including complex cases involving pharmaceutical and medical device companies, providers, and executives. In FY 2025 alone, working together on health care fraud enforcement, the U.S. Attorney’s Office’s Health Care Fraud Unit and Affirmative Civil Enforcement Unit recovered more than $450 million in fraudulently obtained funds. Building on the U.S. Attorney’s Office’s historic track record and the success of the Criminal Division’s Health Care Fraud Unit’s specialized prosecutors and data-driven, multi-agency Strike Force model, the Department is deploying a powerful force multiplier, allowing it to accelerate the detection, investigation, and prosecution of complex fraud schemes throughout the District of Massachusetts.”

From the public health and medical/Rx research front,

  • NBC News reports,
    • “One of the largest measles outbreaks in the U.S. is now centered in bordering areas of southwestern Utah and Arizona. 
    • “In Southwest Utah, all but one of the 23 confirmed cases are among unvaccinated, school-age kids, the Southwest Utah Public Health Department reported. In Mohave County, Arizona, which health officials believe is connected to the Utah outbreak, there have been 42 confirmed cases of the highly contagious virus.
    • “An NBC News investigation, done in collaboration with Stanford University, has found that much of the United States doesn’t have the vaccine protection to prevent outbreaks of communicable diseases such as measles.”
  • Cardiovascular Business informs us,
    • “Approximately 6.7 million Americans over the age of 20 have heart failure, according to a new data-driven analysis published by the Heart Failure Society of America (HFSA). That number is expected to rise, the group added and could hit approximately 11.4 million by 2050.
    • “Those were just some of the eye-opening statistics included in a new HFSA report published in the Journal of Cardiac Failure.[1] In addition, the group wrote, approximately one in four Americans will develop HF in their lifetime. And the odds are even greater for Black individuals than those from other racial and ethnic groups.”
  • The Washington Post points out what researchers suspect may be fueling cancer among millenials.
  • Genetic Engineering and Biotechnology News notes,
    • “Neurological disorders, such as schizophrenia and bipolar disorder, remain challenging to diagnose due to the absence of objective biomarkers. Current assessments largely rely on subjective clinical evaluations. 
    • “In a new study published in APL Bioengineering titled, “Machine Learning-Enabled Detection of Electrophysiological Signatures in iPSC-Derived Models of Schizophrenia and Bipolar Disorder,” researchers from Johns Hopkins University (JHU) present a computational analysis pipeline designed to identify disease-specific electrophysiological signatures from patient-derived cerebral organoids and two-dimensional cortical interneuron cultures. The findings may help reduce human error when diagnosing mental health disorders that currently only rely on clinical judgement.”
  • Health Day lets us know,
    • “Tattoos might protect against melanoma
    • “People with more tattoos were less likely to develop melanoma
    • “They might take better care of their skin, or the tats might provide some sort of screen from UV rays, researchers say.”
  • Per the American Journal of Managed Care,
    • “Colorectal cancer (CRC) screening rates remain lower in rural areas compared with urban communities, according to a new analysis of more than 535,000 adults in the US. Although education, income, insurance coverage, and provider access explain part of the disparity, more than 70% of the gap remains unaccounted for, pointing to deeper structural and cultural barriers that require equity-focused interventions.
    • ‘This analysis is published in Cancer Causes & Control.“
  • Per Fierce Pharma,
    • “Moderna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus.
    • “Moderna’s updated mNEXSPIKE vaccine showed an average greater-than-16-fold increase in neutralizing antibodies against the LP.8.1 sublineage in individuals 12 years of age or older, the company said Tuesday. The result comes from a postmarketing clinical study of the latest 2025-26 formula of mNEXSPIKE, which is designed to target LP.8.1.
    • “By comparison, the company’s first-generation mRNA vaccine, Spikevax, generated a greater-than-eightfold increase in LP.8.1-neutralizing antibodies across the same age groups, Moderna said.”
  • Per BioPharma Dive,
    • “A drug combination involving Bristol Myers Squibb’s experimental medicine iberdomide met one of its main goals in a Phase 3 clinical trial, helping to eliminate signs of multiple myeloma in significantly more enrollees than a standard regimen, the company said Tuesday.
    • “The data are from an interim analysis of a study that will continue so trial investigators can measure other goals like an impact on disease progression and survival. Bristol Myers will submit the results to health regulators, although executives have previously said an approval would probably only come if iberdomide meets its other objectives.
    • “Iberdomide is one of three protein-degrading drugs Bristol Myers is positioning as successors to blockbuster blood cancer drugs like Revlimid and Pomalyst, which it acquired through its merger with Celgene. Many of the products in its large portfolio of cancer drugs have either plateaued or are in decline.”
  • Per Medscape,
    • “A compound comprising five agonists that together tackle weight loss, glucose reduction, insulin sensitization, and blood fat normalization has shown promise in mouse models of obesity.
    • “The compound under investigation is called a quintuple agonist because, together with GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, it contains lanifibranor, a molecule that activates three different peroxisome proliferator-activated receptors (PPARs) — the alpha, delta, and gamma variants — all of which are involved in energy regulation.
    • “Notably, this is not a combination therapy — the five agonists are included in a single molecule.
    • “Daniela Liskiewicz, PhD, Institute for Diabetes and Obesity, Helmholtz Zentrum München, Neuherberg, and the German Center for Diabetes Research, both in Munich, Germany, discussed the development of the novel agonist at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.”
  • Here’s a link to the National Institutes of Health’s Research Matters newsletter.
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • Per MedTech Dive,
    • “Multi-cancer blood tests, with the promise of detecting many cancer types from a single sample, have the potential to transform cancer screening.
    • “However, evidence is lacking to support broad use of the tests in people who do not have symptoms, according to research commissioned by the Agency for Healthcare Research and Quality and published last week in Annals of Internal Medicine.
    • “Researchers identified no completed, controlled studies reporting benefits in cancer detection, mortality or quality of life from screening with multi-cancer detection tests. They also found insufficient evidence on the accuracy and potential harm of the tests, mostly due to study limitations and unknown or inconsistent findings.
    • “Researchers from the RTI International – University of North Carolina Evidence-based Practice Center and The Ohio State University College of Medicine conducted the review.”

From the AI front,

  • The Wall Street Journal relates,
    • “AI models are being designed to predict a woman’s near-future risk of breast cancer using mammograms.
    • “Clairity’s AI model received FDA authorization and can predict a woman’s five-year breast-cancer risk.
    • “AI models outperform older risk-score calculators, but some doctors want more evidence of long-term impact.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY said it plans to build a $6.5 billion facility in Houston to make active pharmaceutical ingredients, including for a new oral weight-loss drug.
    • “The plant will bring 615 jobs to the area, including engineers and lab technicians, as well as 4,000 construction jobs while it is being built, the company said Tuesday.
    • “Eli Lilly plans to manufacture orforglipron, its first oral, small molecule GLP-1 receptor agonist, at the facility. The company expects to submit orforglipron to global regulatory agencies as a treatment for people with obesity by the end of this year.”
  • Per Fierce Healthcare,
    • “Compared to their peers, hospitals acquired by private equity reduced salary spending, cut staffing levels and experienced higher mortality rates within their emergency departments, according to a Medicare claims analysis published this week in Annals of Internal Medicine.
    • “The research, which reviewed data from 2009 to 2019, also found salary and staffing cuts among the acquired hospitals’ intensive care units, but, unlike EDs, there was no significant difference in mortality compared to other hospitals. Patient transfer rates increased in both settings among the private-equity-acquired hospitals, particularly among sicker patients, and ICU length of stay decreased.
    • “The analysis from University of Chicago, Harvard Medical School and University of Pittsburgh researchers is the latest contribution to a body of peer-reviewed evidence critical of private equity’s increasing presence among healthcare providers. It also follows a similar analysis from 2023 conducted by many of the same authors that spotted a rise in hospital-acquired adverse events among inpatients receiving care at a private-equity-acquired facility.”
  • and
    • “Pharmacy benefit manager Capital Rx has secured $400 million in fresh funding and announced a rebrand to better reflect its expansion beyond the pharmacy space.
    • “The investments include a $252 million series F round and other funding toward its securities, which is expected to close in October. Wellington Management and General Catalyst led the round, and additional supporters include Generation Investment Management, Growth Equity at Goldman Sachs Alternatives, 9Yards Capital, B Capital, Edison Partners, Prime Health Investments and Transformation Capital.
    • “With the infusion of cash, Capital Rx said it plans to lean more into its broader capabilities as a health benefits technology provider and will rebrand as Judi Health, the name of its proprietary tech stack. The company said the shift “marks a pivotal moment in addressing the fundamental inefficiencies of health benefits administration and the rising cost of care in the U.S.”
    • “The funding will also support the expansion of its PBM operations, Capital Rx said.”
  • and
    • “Health insurance startup Sidecar Health inked a partnership with Carrum Health to bring its specialty care network onto its platform.
    • “Carrum Health, a Fierce 15 of 2025 honoree, launched 10 years ago to develop value-based Centers of Excellence for employers, with the aim to revamp how the healthcare industry pays for and delivers specialty care. 
    • “Sidecar Health members will now have access to more than 1,200 vetted COE providers for surgical, cancer and substance use treatment—accessible to 90% of Americans within 50 miles of a Carrum provider, according to the companies. 
    • “Carrum’s solution makes specialty care services available at bundled prices and connects members to dedicated care navigation. The service also includes a 30-day warranty on surgery and two years on cancer care.”
  • Beckers Hospital Review relates,
    • “Walmart has expanded same-day pharmacy services to include refrigerated and reconstituted medications. 
    • “The expansion includes refrigerated access for medications such as insulin, GLP-1s and pediatric amoxicillin, according to a Sept. 22 news release from the company. Refrigerated medications make up over 30% of Walmart pharmacy sales and the company is the first retailer to deliver refrigerated prescriptions alongside everyday orders. 
    • “Once a prescription is filled, customers are notified through their Walmart pharmacy account and from there, can choose same-day scheduled delivery, on-demand delivery and express delivery with insurance applied.” 
  • BioPharma Dive tells us “why Xoma, a drug royalty firm, is hunting biotech ‘zombies.’ Distressed biotechs are facing rising investor pressure to close down, giving firms like Xoma an opportunity to step in and liquidate them for a profit.”
  • MedTech Dive explains “how SS Innovations is expanding robotic surgery’s reach. Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in over 5,000 surgeries.”

Monday report

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

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump is planning to meet with top congressional Democrats this week about the government funding impasse, White House and Capitol Hill officials said Monday, after lawmakers left Capitol Hill for a week on Friday with little movement toward averting a partial shutdown starting Oct. 1.
    • “A date and time haven’t yet been set, and Trump has a packed schedule on most days other than Wednesday.” 
  • Govexec explains the extent to which a government shutdown would affect federal employee pay and benefits. As the FEHBlog has previously noted, because Congress is in session in October, a political compromise is more likely than a government shutdown.
  • The Government Accountability Office released a report titled “Health Care Consolidation: Published Estimates of the Extent and Effects of Physician Consolidation.”
    • “Studies show physician practices have increasingly been acquired by hospital systems, insurance companies, private equity firms, and other entities.
    • “At least 47% of physicians were consolidated with hospital systems in 2024—up from less than 30% in 2012. Studies show this consolidation can increase spending and prices, with one finding significant increases for office visits occurring in hospitals. Care quality may be the same or lower. It’s unclear how this type of consolidation affects access to care.
    • “There’s less evidence on the effects of physician consolidation with insurance companies or private equity.”
  • The American Hospital Association News tells us,
    • “The AHA expressed support Sept. 22 to House and Senate sponsors of the Medicare Advantage Prompt Pay Act (H.R. 5454/S. 2879), legislation that would apply a federal prompt payment standard to MA plans to help ensure that health care providers receive timely payments from MA plans for necessary patient services. The measure calls for plans to pay at least 95% of clean claims within 14 days for in-network claims and 30 days for out-of-network claims. MA plans would face civil monetary penalties if they miss any deadlines and also would have to publicly report compliance data, including the number of claims paid on time.”
  • and
    • President Trump Sept. 19 signed a proclamation increasing the fee to $100,000 for new H-1B petitions filed by employers, as well as implementing other restrictions on entry of certain nonimmigrant workers. The restrictions began on Sept. 21 and expire, absent extension, after 12 months. 
    • The proclamation authorizes the Department of Homeland Security and the Department of State to coordinate to take all necessary and appropriate action to implement the policies in the proclamation. 
    • According to an FAQ issued by the U.S. Citizenship and Immigration Services, the proclamation does not apply to any previously issued H-1B visas or any petitions submitted prior to Sept. 21. It also does not change any payments or fees required to be submitted in connection with any H-1B renewals. 
    • The proclamation said that the application fees can be waived if the Secretary of Homeland Security determines the hiring of these workers on an individual basis, or to work for a specific company or industry, is in the national interest. It is currently unclear if health care workers could qualify for the exemption process.” * * * 
      “In a statement shared today with the media, the AHA said, “One of the short-term strategies used by U.S. hospitals to address personnel shortages is the use of foreign-trained health care workers. While we work to educate more health care staff, the H-1B visa program plays a critical role in allowing the hospital field to recruit highly skilled physicians and other health care professionals to ensure access to care for communities and patients, including in rural and other areas where there are well-documented shortages of health care workers. The AHA is reviewing the recent memo from the Department of Homeland Security and evaluating the potential impact of these policy changes on hospitals and the communities they serve. We will also work with the Administration to stress the importance of including health care personnel in potential exemptions to these changes.” 
  • Bloomberg News informs us,
    • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.
    • “The initiative is part of Trump’s demands that drugmakers reduce their prices to align them with what other developed countries pay, according to the people, who spoke on condition of anonymity to discuss plans that are not yet public. 
    • “The proposed website would allow patients to search for specific medicines and be connected with platforms that sell them, the people said. Officials have discussed creating a Trump brand for the website, with “TrumpRx” one name that’s been considered, they added.
    • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.”
  • Per HHS news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today allocated more than $1.5 billion in FY25 continuation funding awards for the State Opioid Response (SOR) and Tribal Opioid Response (TOR) grants. This funding provides critical resources to states and Tribal communities to address the overdose crisis through prevention, opioid overdose reversal medications, treatment (including medications for opioid use disorder, or MOUD), and recovery support.
    • “America’s addiction and overdose crises are tearing apart families and communities, and meeting this challenge requires honesty, courage, and bold action,” said HHS Secretary Robert F. Kennedy Jr. “We are putting power back in the hands of states and Tribes to build solutions that reflect their people and their traditions. This investment is about saving lives, restoring hope, and making our communities whole again.”
    • “With the rise of polysubstance abuse and increasing role of stimulants in overdose deaths, it has never been more important to comprehensively address the disease of addiction and the root drivers of this crisis,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “State and Tribal Opioid Response funding provides critical resources to help prevent addiction, provide evidence-based treatment, and support long-term recovery and sobriety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today announced the mobilization of more than 70 Public Health Service officers from the U.S. Public Health Service (USPHS) Commissioned Corps to Indian Health Service (IHS) facilities across the country. This action delivers on Secretary Kennedy’s promise to strengthen the IHS, revitalize tribal health care, and ensure Native communities receive the high-quality medical support they deserve.
    • ‘Public Health Service officers, drawn from both leadership and frontline ranks, will be detailed to priority IHS sites identified as facing the most urgent staffing shortages. Senior Public Health Service officers will be detailed to strengthen leadership and operations, while additional officers will address the most urgent frontline staffing needs at IHS facilities. Today’s announcement represents one of the largest single details of Public Health Service officers to the IHS in recent years and underscores the Trump Administration’s commitment to improving health outcomes in Indian Country.”

From the Food and Drug Administration front,

  • Per FDA News releases,
    • “The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The agency also issued a related letter alerting physicians nationwide.  
    • “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.” 
  • and
    • “The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination.
    • “The FDA has conducted a systematic analysis of literature published between 2009-2024, including published case reports with patient-level information, as well as mechanistic data, and has determined that the information supports a finding that leucovorin calcium can help individuals suffering from CFD.  
    • “We have witnessed a tragic four-fold increase in autism over two decades,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people.”  
    • “The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD. As the New Drug Application (NDA) holder for this medicine, GSK has preliminarily agreed to work with the FDA on this relabeling effort.”
  • The Wall Street Journal explains “What to Know About Taking Tylenol During Pregnancy”
    • Studies looking at a link between acetaminophen and autism are inconclusive; some show a link between its use during pregnancy and autism risk, while others don’t. 
    • A 2019 study published in JAMA Psychiatry found that higher concentrations of acetaminophen in umbilical cord blood samples taken at birth were linked to greater risk of autism and attention-deficit hyperactivity disorder. 
    • Another in JAMA in 2024 of nearly 2.5 million children in Sweden found no increased risk in children when mothers took acetaminophen during their pregnancy, compared with their siblings who weren’t exposed to the medication in the womb.  
    • Part of the challenge with such studies is wading through the myriad other confounding factors when analyzing the results. 
    • Women take Tylenol during pregnancy because they are running a fever or have pain or an infection. Those problems could be the root of a potential autism risk, rather than the medication used to alleviate them, researchers said. 
    • “All of those factors in fact pose a somewhat higher risk to the developing fetus than does the Tylenol itself,” said Helen Tager-Flusberg, director of the Center for Autism Research Excellence at Boston University. 
    • “For studies that control for that, we see a far reduced or lowered impact of the Tylenol.”
  • STAT News discusses “What the evidence tells us about Tylenol, leucovorin, and autism. The questions of whether acetaminophen can cause the condition, or leucovorin can treat it, have been studied to a fair degree.”
    • “The case of leucovorin is simpler to explain: There are several studies that indicate the medicine can improve the performance of people with autism on standardized tests used to measure verbal ability. But these studies are quite small.
    • “One study, published in the European Journal of Pediatrics, followed 80 patients between the ages of 2 and 10 who were randomly assigned to receive either leucovorin or a placebo. Neither their families nor their doctors knew who received the treatment. At the end of 24 weeks, the children who received leucovorin scored 1.2 points higher on a 60-point scale used to measure autism severity than the children who did not.
    • “The result was statistically significant, but smaller studies are prone to false positive results. The normal course for researchers before making a recommendation would be to conduct a much larger randomized controlled trial to verify that the treatment is beneficial. Most such trials include hundreds or thousands of patients and provide the best evidence of efficacy and safety.
    • “For both acetaminophen and leucovorin, another problem exists: Generally, high-quality studies of medicines are done by pushing manufacturers to test them. But even though Tylenol, the leading brand of acetaminophen, is a big seller, both acetaminophen and leucovorin are available as generics, which means companies are less likely to pay for large observational studies or randomized controlled clinical trials.”
  • Per a related NIH press release,
    • “The National Institutes of Health has launched the Autism Data Science Initiative (ADSI), a landmark research effort that will harness large-scale data resources to explore contributors to the causes and rising prevalence of autism spectrum disorder. More than $50 million in awards will support 13 pioneering projects that draw on genomic, epigenomic, metabolomic, proteomic, clinical, behavioral and autism services data. These projects will integrate, aggregate and analyze existing data resources, generate targeted new data and validate findings through independent replication hubs.
    • “Our Autism Data Science Initiative will unite powerful datasets in ways never before possible,” said NIH Director Jay Bhattacharya, M.D., Ph.D., “By bringing together genetics, biology, and environmental exposures, we are opening the door to breakthroughs that will deepen our understanding of autism and improve lives.”

From the public health and medical/Rx research front,

  • Swiss Re, a life insurance company, considers “The future of metabolic health and weight loss drugs; Projecting mortality reductions in the US and UK populations.
    • “In the US and UK general populations, our modelled baseline scenario projects 4% and 3.2% reductions in cumulative all-cause mortality respectively by 2045, based on GLP-1 drug use. Here we assume majority use in the target overweight and obese population, with some sustained lifestyle changes but variable weight loss outcomes.
    • “Under our pessimistic scenario, in which drug use is limited and impacts are modest, the cumulative reduction would be 2.3% (US) and 1.8% (UK), we project. Yet semaglutide and tirzepatide are not risk-free drugs, and our assessment incorporates many caveats. In real world use, where people do not benefit from support to alter their lifestyle, the risks of discontinuation of the treatment, weight regain and rebound effects are all common. The loss of lean muscle mass and bone density as well as fat is also a risk.”
  • Per Beckers Clinical Leadership,
    • “In 2024, healthcare facilities voluntarily reported 1,575 serious harmful events to The Joint Commission, which has been tracking sentinel events since 1996. 
    • ‘The Joint Commission defines a sentinel event as a patient safety event that results in severe temporary harm, permanent harm or death. Because the reports are voluntary, the organization says its dataset represents a small portion of actual sentinel events and that “no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”
    • “Of the 1,575 events, 21% were associated with patient death, 49% with severe harm, 21% with moderate harm, 5% with mild harm, 2% with psychological harm and 2% with no harm, according to the commission’s report. 
    • ‘With 776 voluntarily reported events, patient falls were the most frequently reported sentinel event in 2024. Falls led The Joint Commission’s annual lists in 2021, 2022 and 2023. In 2024, 51 of the reported falls resulted in patient death, 503 in severe harm and 199 in moderate harm.” 
    • The article goes onto list the other ten most common sentinel events last year.
  • Beckers Hospital Review points out,
    • “Sixty-two National Cancer Institute-designated cancer centers are urging health systems, physicians and hospital leaders to promote human papillomavirus vaccination as a form of cancer prevention.
    • “The cancer centers, alongside leading cancer research organizations and advocacy groups, have published a joint statement to raise awareness of lagging HPV vaccination rates.
    • “Even though 90% of HPV-related cancers are preventable through on-time vaccination by a child’s 13th birthday, HPV vaccination coverage has stagnated over the last three years, according to a Sept. 16 news release from MD Anderson.” * * *
    • “Read the full joint statement here.” 
  • Per MedPage Today,
    • “Adenotonsillectomy wasn’t better than just keeping an eye on young children with mild to moderate obstructive sleep apnea (OSA) over 3 years of follow-up in a small, randomized trial.
    • “Watchful waiting did result in many crossovers to surgery during follow-up, particularly among those with large tonsils at baseline.
    • “Researchers suggested that clinical decisions weigh Obstructive Apnea-Hypopnea Index values if available, evaluation of symptoms, tonsil size, the age of the child, risks of surgery, and evaluation of obesity or other comorbidities associated with increased risk of OSA.”
  • The American Medical Association lets us know what doctors wish patients knew about women’s sleep health.
  • Per Health Day,
    • “Type 2 diabetes appears to double a person’s risk for life-threatening sepsis, a new study says.
    • “Men and people under 60 with diabetes are particularly at risk for sepsis, a condition in which the immune system overreacts to infection, researchers reported this week at the annual meeting of the European Association for the Study of Diabetes in Vienna.
    • “The research confirms an association between type 2 diabetes and sepsis that’s been noted in earlier studies, said lead researcher Wendy Davis, a principal research fellow with the University of Western Australia.
    • “The best way to prevent sepsis is to quit smoking, normalize high blood sugar and prevent the onset of the micro- and macrovascular complications of diabetes,” Davis said in a news release. “That’s why this study is important.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer PFE has agreed to pay up to $7.3 billion for weight-loss drug developer Metsera MTSR in a deal that gets the New York drugmaker back into the burgeoning market for obesity drugs.
    • “Pfizer on Monday said it would pay an initial $47.50 a share, or about $4.9 billion, for Metsera, a nearly 43% premium to Friday’s closing price of $33.32 for the New York company.
    • “The deal, slated to close by the end of the year, includes up to an additional $22.50 a share tied to milestones that could bring the total consideration to $70 a share, more than double Friday’s closing price.
    • “Pfizer, which earlier this year scrapped its experimental weight-loss pill danuglipron over concerns about potential liver damage, said the Metsera acquisition adds four clinical-stage programs to its pipeline, including a GLP-1 receptor agonist that is in Phase 2 development as both a weekly and monthly injectable treatment.
    • “Metsera also has two weight-loss pill candidates expected to begin clinical trials imminently.”
  • and
    • “Roche plans to move one of its weight-loss treatment candidates to late-stage trials next year, as the Swiss pharmaceutical group aims to become a top-three player in the booming market.
    • “The group said Monday that the experimental drug, called CT-388, showed strong efficacy in early-stage studies and that mid-stage trials were under way. A late-stage, or phase 3, study is set to begin in the first half of 2026, it said.
    • “Roche’s aim is to become a strong entrant in the weight-loss market before 2030 and eventually a top-three competitor in the field, the head of the group’s pharmaceuticals business, Teresa Graham, said at a company event with investors in London.” * * *
    • “CT-388 is a medication injected weekly that, like Lilly’s Mounjaro and Zepbound drugs currently on the market, activates both glucagon-like peptide 1, or GLP-1, hormones and a second class of hormones to help suppress appetite and shed weight.
    • “Roche said the drug stands out by more precisely activating appetite- and metabolism-related pathways while avoiding those linked to side effects such as nausea and vomiting. Phase 1 results showed participants lost an average 18.8% of their body weight over 24 weeks.”
  • Per BioPharma Dive,
    • “MapLight Therapeutics, a biotechnology company making medicines for neurological diseases, filed plans for an initial public offering on Friday.
    • “In outlining an offering, MapLight aims to become the second drugmaker to recently price a sizable IPO following a monthslong drought. LB Pharmaceuticals raised $285 million earlier this month, but the last company to carry out a large offering before that was Aardvark Therapeutics in February, according to BioPharma Dive data. 
    • “The Redwood City, California biotech is developing its lead drug as a potential treatment for schizophrenia and Alzheimer’s disease psychosis. MapLight’s ML-007C-MA activates a pair of proteins called muscarinic receptors, which help control the release of the neurotransmitter acetylcholine. In that way, the drug is designed similarly to Cobenfy, the focus of Bristol Myers Squibb’s $14 billion acquisition of Karuna Therapeutics.”
  • Beckers Payer Issues notes,
    • “Aetna is expanding a program that aims to reduce readmissions for its Medicare Advantage members to ten hospitals by the end of 2025.
    • “The insurer is currently implementing the clinical collaboration program at Merriam, Kan.-based AdventHealth Shawnee Mission, Houston Methodist, and Raleigh, N.C.-based WakeMed Health & Hospitals, according to a Sept. 22 news release. 
    • “The initiative aims to reduce 30-day readmission rates and hospital stays by integrating Aetna nurses directly into hospital care teams, focusing on post-discharge care to help MA members transition back home or into skilled nursing facilities.” 
  • Modern Healthcare adds,
    • “The number of hospitals faced with readmissions penalties of at least 1% come Oct. 1 is set to rise to the highest number since fiscal 2022.
    • “Prior to fiscal 2026, the number of hospitals facing readmissions penalties of 1% or more had dropped for five consecutive years. But preliminary data released Friday by the Centers for Medicare and Medicaid Services showed the number of hospitals set to pay penalties of 1% or more under the Hospital Readmissions Reduction Program will increase to 8.1%, or 240 hospitals, in fiscal 2026 compared to 7%, or 208 hospitals, in fiscal 2025.
    • “However, the number of hospitals facing no readmissions penalties next fiscal year, which starts Oct. 1, remained relatively flat compared to fiscal 2025, rising to 21.8%, or 641, from 21.4%, or 638.”
  • Healthcare Dive reports,
    • “CVS pharmacy services subsidiary Omnicare has filed for Chapter 11 bankruptcy after being hit with a $949 million federal judgment over improper billing of government healthcare programs.
    • “Omnicare claimed up to $500 million in assets and between $1 billion and $10 billion in debts in its bankruptcy petition with a Texas court on Monday.
    • “Omnicare has brokered an agreement to receive $110 million in debtor-in-possession financing, a type of loan which it expects will allow it to continue operating through the bankruptcy process, the company said.”

Weekend update

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
  • Congress is on a District/State work break this week.
  • Govexec tells us,
    • “Newly elected Rep. James Walkinshaw, D-Va., this week formally took over for his predecessor, the late Rep. Gerry Connolly, in leading advocacy for an array of bills aimed at improving the pay and civil service protections of federal workers.” * * *
    • “The House on Tuesday granted Walkinshaw’s unanimous consent request to become lead sponsor for four bills that Connolly had previously introduced, all relating to federal personnel policy.”
  • Plan Sponsor lets us know,
    • “The Senate confirmed Daniel Aronowitz as assistant secretary of labor for the Employee Benefits Security Administration on Thursday.
    • “EBSA is responsible for enforcement of the Employee Retirement Income Security Act and related laws and regulations, along with protecting employer-based retirement, health and welfare benefits for workers and retirees.
    • “During his June 5 confirmation hearing, the former president of Encore Fiduciary pledged to streamline retirement plan oversight and end the ‘war’ on employee stock ownership plans, also known as ESOPs.”
  • OPM typically announces the next year’s FEHB / PSHB government contributions in the second half of September. OPM shares this information with Congress before making the announcement which suggests that the announcement will be made next week when Congress returns to Capitol Hill.
  • Nextgov/FCW points out,
    • “The Office of Personnel Management is rolling out ChatGPT to its employees this week, its director told employees Tuesday. 
    • “This is part of our broader effort to equip you with AI tools that help you work faster, think bigger, and collaborate better,” the agency’s director, Scott Kupor, told staff in an email shared with Nextgov/FCW by the agency. 
    • “Employees already can access Microsoft 365 Copilot chat, the email says, but now they’ll have access to OpenAI’s ChatGPT-5, too. 
    • “AI is a great assistant, but you’re still the expert. I know some of you are excited, some are curious, and some are wary. In the coming weeks, [the Office of the Chief Information Officer] will host brown bag sessions to help clarify and ensure you get the most out of these tools,” the email reads. “Let’s lead the way in using AI thoughtfully and effectively — starting now.”

From the ACIP recommendations front,

  • The Pharmacy Times article offers more details about the Covid vaccination decisions made at the ACIP meetings last week. 
    • “The Advisory Committee on Immunization Practices (ACIP) has voted 12-0 to recommend COVID-19 vaccines be administered based on individual-based decision-making, also known as shared clinical decision making, for adults aged 65 and older, rather than a universal recommendation. 
    • “They voted to recommend the same language for individuals aged 6 months through 64 years, with an emphasis that risk-benefit for vaccination is most favorable for individuals at increased risk and lowest for individuals not at increased risk.1
    • “Another vote on the belief that state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccine failed 6-6, with the chair, Martin Kulldorff, PhD, breaking a tie to ensure the vote’s failure.
  • The Covid vaccine is not the first time that ACIP recommended shared decision making. The ACIP website includes an FAQ on shared decision making. A pharmacist is a healthcare provider for purposes of shared decision making. 
  • From a maintaining the status quo standpoint, it’s very important that ACIP rejected a recommendation to require a prescription for Covid vaccines. 
  • The New York Times reports yesterday,
    • Before the C.D.C. panel voted, CVS and Walgreens, the nation’s two largest pharmacy chains, were requiring prescriptions in some states because of laws forbidding pharmacists to administer vaccines in the absence of a recommendation from the panel.
    • But if the head of the C.D.C. adopts the panel’s recommendations, CVS will start providing the shots without prescriptions nationwide, including to people outside the F.D.A.-approved groups, according to a CVS spokeswoman, Amy Thibault.
    • Walgreens did not immediately confirm what it would do.
  • ACIP’s website explains
    • “The Advisory Committee on Immunization Practices (ACIP) develops recommendations on how to use vaccines to control disease in the United States.
    • “These recommendations become official CDC policy once adopted by CDC’s Director.
    • “This page provides resources related to ACIP recommendations and lists recommendations from ACIP meetings that are pending publication in CDC’s Morbidity and Mortality Weekly Report (MMWR).”
  • An HHS news release on Friday states,
    • “I commend the committee for bringing overdue scientific debate on vaccination to the American people,” said Deputy Secretary of Health and Human Services and CDC Acting Director Jim O’Neill. A recommendation from ACIP becomes part of the CDC immunization schedule if it is adopted by the CDC director.”
  • The CDC director typically adopts ACIP recommendations promptly. The FEHBlog will keep an eye out.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The FDA, under President Trump’s directive, is cracking down on direct-to-consumer pharmaceutical ads.
    • “The FDA sent letters to drugmakers citing issues with ads that potentially violate drug-marketing laws.
    • “The FDA is scrutinizing ads that it says overhype drug effectiveness, not just those omitting side effects, marking a shift in enforcement.”
  • The Washington Post informs us,
    • “The Trump administration is expected to unveil new efforts on Monday exploring how one medication may be linked to autism and another one can treat it, according to four people with knowledge of the plans who spoke on the condition of anonymity because the announcement was not yet public.
    • “Federal health officials are expected to raise concerns about pregnant women’s use of acetaminophen, the active ingredient in Tylenol and one of the most widely used medications globally. Officials have been reviewing previous research — including an August review by Mount Sinai and Harvard researchers — that suggests a possible link between Tylenol use early on in pregnancy and an increased risk of autism in children. They plan to warn pregnant women against using Tylenol early on unless they have a fever, according to the four individuals.
    • “In addition, officials plan to tout a lesser-known drug called leucovorin as a potential autism treatment. Leucovorin is typically prescribed to counteract some medications’ side effects and to treat vitamin B9 deficiency. Early double-blind, placebo-controlled trials administering leucovorin to children with autism have shown what some scientists describe as remarkable improvements in their ability to speak and understand others. Officials at the Food and Drug Administration have recently been reviewing new language that could apply to the drug.”

From the public health front,

  • Per Medscape,
    • “Use of GLP-1 receptor agonists (GLP-1s) was associated with a reduction in fragility fractures among older women with type 2 diabetes (T2D) in a retrospective analysis of data from a global health network. The results suggest that GLP-1 therapy could contribute to bone health.”
  • Medscape also identifies benefits and risks to watch out for when older adults take GLP-1 drugs.
    • “In adults over 65, GLP-1 use has both potential benefits and risks for age-related health. Physicians should stay alert, monitor closely, and address side effects proactively.’
  • NPR notes,
    • “Doctors who perform skin cancer surgeries often recommend nicotinamide — which is a form of Vitamin B3 — to their patients. It’s been shown to protect cells from UV radiation damage.
    • “Now, a new study of nearly 34,000 veterans, finds this over-the-counter supplement is linked to a reduction in non-melanoma skin cancers among people who’ve already had skin cancer. The research was published in JAMA Dermatology.
    • “The biggest reduction was seen among people who began taking the supplement after being diagnosed with their first skin cancer. Researchers found those who took 500 mg of nicotinamide, also known as niacinamide, twice daily, for at least one month, had a 54% reduced risk of developing another skin cancer, compared to patients who did not take the supplement.”

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.”