Thursday report

OPM

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.”

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • An OPM news release tells us,
    • U.S. Office of Personnel Management (OPM) Director Scott Kupor joined the Ruthless Podcast to discuss a number of wide-ranging topics including OPM’s ongoing efforts to bring top talent into the federal workforce and enhance operational efficiency across government.
    • WATCH HERE
  • The American Hospital Association News informs us,
    • “The House Appropriations Committee today released bill text for a continuing resolution to fund the government through Nov. 21. The bill also extends key health care programs set to expire Sept. 30 through the length of the CR. They include extending the Medicare-dependent Hospital and low-volume adjustment programs, telehealth and hospital at home flexibilities, delaying Medicaid Disproportionate Share Hospital cuts, and extending the Cybersecurity Information Sharing Act. The House is expected to vote on the measure this week. The Senate will follow in an attempt to avert a government shutdown by Sept. 30.”
  • Politico adds,
    • “A group of GOP senators are working on legislation to extend Affordable Care Act subsidies with policy changes designed to win over conservatives, according to four people granted anonymity to disclose private discussions.
    • “This group has gotten “technical assistance” from the Senate Finance Committee, which has jurisdiction over the subsidies, according to two of the sources. The Obamacare subsidies are set to expire at the end of this year.”
  • Per the AHA News,
    • “The House Ways and Means Oversight Subcommittee today hosted a hearing on tax-exempt hospitals. The AHA submitted a statement for the hearing, highlighting the amounts that tax-exempt hospitals spend annually on community benefits and where those funds are spent. The AHA also highlighted its analysis released Sept. 10 that found tax-exempt hospitals provided nearly $150 billion in total benefits to communities in 2022, marking a nearly 50% increase in community benefit spending from 2017. Additionally, the AHA explained why a flexible community benefit approach is best for communities as opposed to suggestions for a definition and evaluation from the Internal Revenue Service.” 
  • Per a Congressional news release,
    • Sens. Chuck Grassley (R-Iowa) and Ben Ray Luján (D-N.M.) reintroduced bipartisan legislation bolstering pharmacists’ ability to serve older Americans in communities that lack easy access to doctors or where pharmacists can provide certain basic medical services.
    • The Pharmacy and Medically Underserved Areas Enhancement Act encourages pharmacists to offer health care services (like health and wellness screenings), immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide them. Many states already allow pharmacists to provide these services. However, there is currently no way for pharmacists to receive Medicare reimbursement for providing them. * * *
    • “Grassley and Luján also requested feedback from stakeholders on pharmacists providing services for chronic care needs, given the unique pressing challenges of chronic care among seniors. Text of the request-for-information (RFI) can be found HERE.
    • “The full text of the legislation is available HERE.”
  • Healthcare Dive reports,
    • “Doctors — especially specialists — are pushing back against proposed changes to Medicare payment that would tamp down on reimbursement next year.
    • “Medicare’s proposed physician fee schedule for 2026 includes a base rate hike of 2.5%. But it also includes an efficiency adjustment that would reduce payment by 2.5% for thousands of procedures and changes to how regulators calculate practice expense that would lower reimbursement for services performed in facilities like hospitals.
    • “The reforms are meant to account for increased efficiency in procedures that doctors perform frequently, realign payment for primary and specialty care, and recognize larger indirect costs for doctors in office-based settings.
    • “Many physicians support those goals. But the policy changes themselves are a bad idea, doctors are warning the CMS.”
  • Fierce Healthcare points out,
    • “In its annual health plan ratings, the National Committee for Quality Assurance (NCQA) found that 11 out of 998 rated plans earning top marks, more than double last year’s total. 
    • “Of the 11 plans to achieve a 5-star rating, eight were commercial plans and three were Medicare plans. They included Blue Cross and Blue Shield of Massachusetts, UPMC Health Plan and several Kaiser Foundation Health Plans.  An additional 55 plans earned a 4.5-star rating. Most plans ranked between 3 and 4 stars, same as in 2024. The NCQA says its ratings help consumers and regulators assess the quality and effectiveness of health plans. 
    • “The report found year-over-year improvements in coordination and continuity of care in Medicare. The NCQA also identified progress across nearly all six diabetes-related measures. The Kidney Health Evaluation for Patients with Diabetes metric showed an average increase of over 5% across all product lines. 
    • “Additionally, the NCQA found improved adult and adolescent immunization rates. Though childhood immunization rates continued to decline, they did so at a slower pace than last year.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not require a product to be immediately removed from the market. However, there are specific recommendations all clinicians should follow. 
    • “The FDA first shared details with the public about these concerns in early August, noting that some of Boston Scientific’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) were associated with a potential risk of rising low-voltage shock impedance (LVSI). If this occurs, it can make the leads less effective over time. 
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” the agency said at the time.”
  • The AHA News adds,
    • “The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.” 
    • “In addition, the FDA issued an early alert for certain Medline convenience kits containing Medtronic DLP Left Heart Vent Catheters due to issues found with certain lots of cannula products where the catheter may not retain its shape. Medline sent a notice to affected customers that recommended they destroy any affected product after completing the list of recall actions.” 

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy weight-loss drug helps patients stop thinking about food, according to a new study.
    • “According to results of the study, which were presented at a medical conference in Austria, patients taking Wegovy for weight-loss experienced a substantial drop in so-called “food noise”—unwanted and intrusive thoughts about food—alongside improvements in their mental well-being and lifestyle.
    • “Novo Nordisk said the number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy, while 64% of respondents reported improved mental health and 80% reported healthier habits while taking the drug.
    • “It is very encouraging to see these new data from people using Wegovy that, in addition to weight-loss, Wegovy may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives,” said Filip Knop, incoming chief medical officer at Novo Nordisk.
    • “The U.S.-based Inform study released Tuesday surveyed 550 people taking Wegovy for weight-loss to assess the impact of the drug on mental well-being and eating habits relating to food noise.”
  • MedPage Today adds,
    • “A higher 7.2 mg dose of semaglutide led to significantly greater weight loss compared with placebo in adults with obesity, with or without type 2 diabetes.
    • “Participants across two randomized trials also had improvements in cardiovascular risk factors.
    • “Secondary and exploratory analyses suggested that the 7.2 mg dose led to a greater change in body weight versus the currently approved highest dose of 2.4 mg.”
  • Per a National Institutes of Health news release,
    • ‘The National Institutes of Health (NIH) has launched effort aimed at reducing the rate of preventable stillbirths in the United States. Investigators will develop tools, devices and other technologies that have the potential to affect diagnosis and prevention efforts relevant to stillbirth, which occurs in 1 in 160 deliveries in the U.S. About 23,600 stillbirths at 20 weeks or greater gestation are reported annually.
    • “More than 60% of stillbirth cases remain unexplained even after exclusion of common causes, such as congenital abnormalities, genetic factors, and obstetric complications. NIH will fund the Stillbirth Research Consortium for more than $37 million over five years, pending the availability of funds, with $750,000 in co-funding from the Department of Health and Human Services.
    • “This consortium will provide an integrated, collaborative program to support cutting edge research to identify the root causes of stillbirth and inform evidence-based strategies to address stillbirth risks,” said Alison Cernich, Ph.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Too many families needlessly face the grief of stillbirth.”
    • “People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. The rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. About 40% of stillbirths that occur during labor and birth are considered potentially preventable.” 
  • Genetic Engineering and Biotechnology News reports,
    • “A novel strategy developed by scientists at Rice University allows scientists to zoom in on tiny segments of proteins inside living cells, revealing localized environmental changes that could indicate the earliest stages of diseases such as Alzheimer’s, Parkinson’s, and cancer. The study results could offer promise for drug screening that targets protein aggregation diseases.
    • “The research team engineered a fluorescent probe known as AnapTh into precise subdomains of proteins, creating a tool that monitors microenvironmental shifts in real time. Unlike conventional techniques that provide only broad signals, this approach reveals how distinct regions of the same protein behave differently during the aggregation process. The work, led by Han Xiao, PhD, professor of chemistry and director of Rice’s SynthX Center, enhances the basic understanding of disease mechanisms and lays the groundwork for identifying drug targets and screening potential therapeutics at an earlier stage.
    • “We essentially built a molecular magnifying glass,” Xiao said. “This allows us to visualize subtle environmental changes that previously went unnoticed, and those early changes often hold the key to understanding protein-related diseases.” Xiao and colleagues reported on their findings in Nature Chemical Biology, in a paper titled, “Real-time imaging of protein microenvironment changes in cells with rotor-based fluorescent amino acids,” in which they concluded: “These results demonstrate that the technology reported in this paper provides a versatile tool for exploring microenvironment changes of protein substructures at high spatial resolution, enabling direct visualization of the local environment around specific amino acid residues.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY unveiled plans to build a $5 billion manufacturing facility in Virginia as part of the drugmaker’s pledge to bolster its domestic medicine production with four new pharmaceutical manufacturing sites.
    • “Eli Lilly said the new plant, located just west of Richmond in Goochland County, will be the first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.
    • “The Indianapolis company said the site also will boost its domestic manufacturing of antibody-drug conjugates.
    • “Eli Lilly said the new plant will create more than 650 new company jobs, along with 1,800 construction jobs.
    • “Eli Lilly in February said it would invest $27 billion to build four new pharmaceutical manufacturing sites in the U.S., more than doubling its U.S. capital expansion commitments since 2020 to more than $50 billion.”
  • and
    • “So far this year, more than a dozen drugmakers [, including Lilly,] have pledged to spend more than $350 billion collectively by the end of this decade on manufacturing, research and development and other functions in the U.S., a Wall Street Journal tally of company announcements showed.
    • “The vast majority of our products going into the U.S. are manufactured in the U.S.,” GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. “This of course adds to it, and it’s about the new pipeline that’s going through.”
  • Modern Healthcare informs us,
    • “Health systems are revamping pediatric care to fight emergency department overcrowding before Medicaid funding cuts further endanger access. 
    • “Many emergency rooms are full, leading to care delays and provider burnout. Hospital operators have responded by tasking social workers with triage duties and setting up virtual consultations with specialists. They are also consolidating emergency services and asking data analytics companies to better track and predict capacity and utilization trends, health system executives said. 
    • “Health systems have crafted many of these strategies around pediatric patients, who may bear the brunt of the Medicaid cuts authorized by the “One Big Beautiful Bill,” among other federal policy changes, experts said.
    • “The population that will get hit the hardest in emergency medicine will be pediatrics,” said Dr. Ken Heinrich, chief medical officer of emergency medicine at staffing company SCP Health. 
    • “Providers are facing a surge in pediatric mental health issues, fueling care backlogs across hospital emergency departments. Providers have enlisted social workers and adjusted their emergency department layouts to meet that demand.”
  • and
    • “Labcorp has completed its acquisition of BioReference Health’s oncology diagnostic testing assets for up to $225 million. 
    • “The independent laboratory company paid $192.5 million at closing and and could pay up to $32.5 million more in an earn-out tied to the assets’ performance, according to a Monday news release.
    • “Labcorp previously acquired select clinical, reproductive and women’s health diagnostic assets from BioReference last September for more than $237 million.”
  • MedCity News notes,
    • “Berry Street, a nutrition therapy company, has launched its GLP-1 Nutrition Pathway Program, which is meant to provide nutrition support for those starting, taking and getting off of GLP-1s.
    • “The New York City-based company works with health plans and connects patients in need of nutrition support to a network of registered dietitians. It provides personalized treatment plans for patients struggling with weight management, diabetes, heart health, kidney disease and numerous other conditions.”
  • Per a UHC press release,
    • “Building on our March announcement committing to modernize pharmacy payment models, Optum Rx has increased reimbursement minimums for brand drugs for approximately 2,300 independent pharmacies – those not affiliated with a pharmacy services administrative organization (PSAO), chain or other entity – across the country. This move, which went into effect on September 1, 2025, will support the long-term sustainability of pharmacies, which play a critical role in patient care. 
    • “This is the latest announcement from Optum Rx, which continues to expand on initiatives to transform how pharmacies are reimbursed for drugs. Optum Rx first launched improved reimbursement earlier this year, with Epic Pharmacy Network, a PSAO representing more than 1,000 independent pharmacies, being the first PSAO to partner with us.”
  • BioPharma Dive lets us know,
    • “Novartis is broadening its bet on drugs that can destroy disease-causing proteins, agreeing Monday to a new deal with biotechnology company Monte Rosa Therapeutics.
    • “Through the collaboration, the companies will work to develop multiple novel protein “degrading” drugs for immune conditions. Monte Rosa will conduct discovery and early testing before Novartis takes over development for programs it chooses to license. The biotech will get $120 million in upfront cash per deal terms. It could also receive as much as $5.7 billion overall should various development and sales milestones be met, plus royalties on sales of any eventual products.”
    • Monte Rosa is among the many companies pursuing “molecular glue” drugs, which force together a target protein with an enzyme that flags it for destruction by the cell’s waste disposal system. The approach is seen as a way to access tough-to-reach drug targets, and is one of several strategies biotechs are using to degrade harmful proteins, rather than bind and block them as traditional drugs do.
  • Per Beckers Hospital Review,
    • “Amazon has added Fay, a dietitian platform, as the first nutrition care service available through its Health Benefits Connector.
    • “The collaboration allows eligible Amazon customers to discover and enroll in Fay’s insurance-covered nutrition services while browsing for wellness and health benefits, according to a Sept. 16 news release.
    • “Fay connects individuals with registered dietitians based on their goals, health history and insurance eligibility. Services include counseling, preventive care and coaching, which the company said are often available at no cost to patients.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Healthcare accreditation body URAC is rolling out the nation’s first accreditation program for users and developers of healthcare artificial intelligence. 
    • “The first-in-the-nation program will evaluate risk management, business management and performance monitoring with specific modules for users and developers. URAC accredits organizations ranging from small pharmacies to multistate payer organizations. 
    • The organization, which has been accrediting healthcare organizations for decades, hopes the URAC gold star will help promote trust in AI.
    • “We think that this is a great opportunity to give people that seal of approval, that gold star, that someone independent has gone in behind the scenes and audited to make sure that this is trustworthy,” Shawn Griffin, M.D., CEO and president of URAC, said in an interview.”
  • and
    • “Aegis Ventures’ digital consortium gained three new members as health systems look to collaborate to develop and scale artificial-intelligence-powered health tech solutions and tackle common pain points.
    • “Yale New Haven Health System, Keck Medicine of USC and Hartford HealthCare joined the collaborative, expanding its reach to 14 regional health systems. The consortium, which includes Northwell Health, UPMC, Stanford Health Care and Vanderbilt Health, will codevelop, invest in and deploy health tech solutions alongside Aegis Ventures. 
    • “The partnerships with the three new health systems will accelerate the consortium’s pipeline of companies with two startups set to launch this fall, according to John Beadle, co-founder and managing partner of Aegis Ventures.
    • “Next year, I think we could be more aggressive, just given that the model of the blueprint worked well. We have the right set of partners, the right team, the resources are in place to do it, but I think we’re most focused on seeing this year out really strong,” Beadle said.”
  • and
    • “Healthcare technology and AI company Innovaccer has acquired Story Health, a digital specialty care platform with health system inroads.
    • “Financial terms of the deal, announced Tuesday, were not disclosed. Innovaccer said the deal adds to its scalable Healthcare Intelligence Cloud offering, which in recent months was bolstered by the company’s other strategic acquisitions.
    • “Healthcare doesn’t change through dashboards alone,” Abhinav Shashank, co-founder and CEO of Innovaccer, said in the announcement. “It changes when data and AI power completely new clinical models. Story Health has proven that in specialty care; and we’re excited to bring this technology and clinical expertise to our health system customers nationwide.”
    • “Cupertino, California-based Story Health, a Fierce 15 2024 honoree, launched in late 2020 and has raised about $27 million in funding from backers such as Northpond Ventures, B Capital Group, LRVHealth, Define Ventures and General Catalyst. Its approach combines virtual coaching, biometric monitoring and care team alerts to support patients with chronic conditions between clinical visits.”

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports that the Democrat “Party wants expanded Obamacare subsidies restored in any deal to keep government funded past Sept. 30.”
    • “Democrats are more confident in their negotiating stance compared with March, when a similar attempt to play hardball fizzled. While today’s talks pit them against Republican leaders who want a two-month spending deal with no big additions, they are finding support among rank-and-file GOP lawmakers fearing political backlash if their voters are hit by higher health-insurance bills next year.
    • “Republicans have to come to meet with us in a true bipartisan negotiation to satisfy the American people’s needs on healthcare, or they won’t get our votes, plain and simple,” Senate Minority Leader Chuck Schumer (D., N.Y.) said Thursday.
    • “Senate Majority Leader John Thune (R., S.D.) said he was open to discussions about extending the subsidies, but not as a condition of a short-term spending bill he has proposed to keep the government open into November. Such an extension would give Congress more time to iron out full-year spending deals.
    • “The fight centers on the extension of expiring Affordable Care Act tax credits. The subsidies, which expanded the payments offered under the existing ACA, or Obamacare, were first passed in 2021 by Democrats as a temporary measure tied to a Covid-19 aid law. Republicans didn’t renew them in their sprawling tax-and-spending legislation President Trump signed in July, meaning they will expire at the end of this year.”
  • According to the legislative calendars for the House of Representatives and the Senate, next week is scheduled for a District / State work break which means that we have seven legislative days before the end of federal government’s fiscal year. Fortunately, with respect to prospects for a government shutdown, there is no national election this year so Congress will be in session for the fourth quarter rather than on the campaign trail.
  • The New York Times reports,
    • “The Food and Drug Administration has warned Hims & Hers, a major telehealth purveyor of widely popular obesity drugs, to stop “false or misleading” marketing, according to a copy of a letter sent to the company and obtained by The New York Times.
    • “The F.D.A.’s letter was one of about 100 warning letters sent to drug advertisers this week. The agency commissioner, Dr. Marty Makary, said on Tuesday that the letters were being sent to traditional pharmaceutical companies as well as to online pharmacies.
    • “The letter, sent on Tuesday to Hims & Hers, warned the company to halt the use of marketing language that falsely implies that one of its products is approved by the F.D.A. The agency has not yet publicly released the letter.
    • “Hims & Hers has capitalized on a huge demand for weight-loss drugs like Novo Nordisk’s drug Wegovy, offering low-cost, copycat versions made through a process of mixing drug ingredients known as compounding. In the past few years, telemedicine companies like Hims & Hers have emerged as an aggressive new type of drug advertiser.”

From the judicial front,

  • Federal News Network reports,
    • “A federal judge in San Francisco found the Office of Personnel Management unlawfully directed agencies to fire probationary federal employees en masse.
    • “U.S District Court Judge William Alsup ruled late Friday that OPM “exceeded its own powers,” and “directed agencies to fire under false pretense,” telling probationary employees that they were being terminated for poor performance.
    • “The ruling doesn’t reinstate any of the 25,000 probationary federal employees fired around mid-February, but it does direct many agencies to update their personnel records to specify that these employees were not fired for poor performance or misconduct. Agencies must also send letters to impacted employees starting they were not fired for performance.
    • “The ruling, in a lawsuit led by federal employee unions, applies to the departments of Commerce, Defense, Health and Human Services, Labor, Treasury, Transportation and Agriculture. OPM, NASA, the State Department and the Office of Management and Budget are exempt from the ruling.”

From the public health and medical/Rx research front,

  • The Wall Street Journal explains how to start ditching ultraprocessed foods.
    • “When choosing ready-to-eat snacks and meals, check the label and aim for products that clock in at less than 1.5 calories per gram, says Kevin Hall, a former scientist at the National Institutes of Health who led the agency’s research on ultraprocessed foods before he left in the spring. Ultraprocessed foods are often energy-dense, containing more calories per gram than less-processed foods. 
    • “The particular combinations of fat, sugar, sodium and carbs that ultraprocessed foods often contain aren’t generally found in nature. Researchers call these combinations “hyperpalatable,” and they exert a strong effect on our brain’s reward system, which makes us crave them, says Tera Fazzino, associate director of the Cofrin Logan Center for Addiction Research and Treatment at the University of Kansas.”
  • Medscape considers whether oral GLP-1s can transform the obesity treatment landscape?
    • “Experts agreed that there’s room for a wide variety of obesity medications.
    • “Patients could also consider bariatric surgery, said Karan Chhabra, MD, assistant professor in the Department of Surgery and the Department of Population Health at the NYU Grossman School of Medicine in New York City. He is the coauthor of a study recently presented at the American Society for Metabolic and Bariatric Surgery’s 2025 Annual Scientific Meeting that showed that patients who underwent bariatric surgery experienced significantly more weight loss after 2 years than patients who received weekly injections of semaglutide or tirzepatide.
    • “Expanded access to GLP-1s for chronic weight management could help many people, but only time will tell what the specific impact of oral GLP-1 medications will be [e.g., will oral GLP-1 drugs carry a materially lower price?].”
  • The New York Times Well newsletter offers “five simple steps to calm yourself down. These techniques can help you handle the ups and downs of daily life.”
    • “There are lots of ways to deal with the ups and downs of daily life, Marc Brackett, the founding director of the Yale Center for Emotional Intelligence, told me. He’s developed a framework called RULER — recognize, understand, label, express and regulate — and it’s used in over 5,000 schools nationwide.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Imaging company Siemens Healthineers and minimally invasive medical device maker Cook Medical announced a partnership Saturday to offer one of the first turnkey interventional MRI suite solutions.
    • “The solution comprises Siemens Healthineers’ MRI technologies and services like its interventional planning software along with Cook Medical‘s medical devices designed for MRI, including catheters, guidewires and sheaths. Both companies will provide specialized training and ongoing clinical support.
    • “Currently, hospitals that seek to build an interventional MRI suite have to buy the equipment separately and create their own suite.
    • “Interventional MRI provides real-time imaging during minimally invasive procedures including those in oncology for soft tissue tumors, pediatric cases and structural heart conditions. Compared with interventional fluoroscopy and interventional CT, the technology offers superior image quality for soft tissues and eliminates radiation exposure.”
  • and
    • “B. Braun announced Friday it has acquired digital robotic-assisted 3D surgical microscopy company True Digital Surgery for an undisclosed amount.
    • “Previously, B. Braun, a Germany-based global medical device company, held a minority stake in the firm and partnered on developing the Aesculap Aeos robotic digital microscope. The acquisition will allow B. Braun to leverage the firm’s expertise to further advance the microscope’s development.
    • “B. Braun’s surgical division Aesculap launched the microscope in the U.S. in September 2020. It provides surgeons with 3D digital visualization while performing complex ophthalmology, neurosurgery, ENT and spinal surgeries.”
  • BioPharma Dive informs us,
    • “Takeda on Thursday said Rhonda Pacheco will become head of its U.S. business unit on Sept. 29. Pacheco has been at Eli Lilly for more than a decade and, since 2023, has been the group vice president of the pharmaceutical company’s cardiometabolic health unit, where she oversaw the lucrative launches of Lilly’s GLP-1 drugs. At Takeda, she’ll succeed Julie Kim, who was selected this year to take over for retiring CEO Christophe Weber in June 2026 and will serve as “interim” head of the company’s global portfolio ahead of the transition.”
  • Health Exec points out,
    • “Non-profit health system Mayo Clinic said on Monday that it’s planning to close six clinics in Minnesota, its home state, in an effort to remedy staffing shortages. 
    • “Specifically, the clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter and Wells will all be shutting their doors forever. In addition, its hospital in Albert Lea will end elective surgeries in some specialties, including gynecology and orthopedics. However, a spokesperson for Mayo Clinic told HealthExec future procedures will be moving to nearby patient care centers. The hospital is still operating as normal, and its emergency room remains open. 
    • ‘Mayo Clinic said the changes will go into effect Dec. 10. It’s launched a resource webpage to answer common questions patients may have, as it says it’s working to transition all of them to new locations. Patients will “receive a letter and portal message explaining the changes” and presenting them with options, the online FAQ confirms. In some cases, that means shifting in-person visits over to telehealth.” 
  • Per HR Dive,
    • “Pay raise budgets for next year are predicted to mirror 2025’s increases, according to a Sept. 3 report from The Conference Board. On average, companies said they plan to up their salary budgets by 3.4% in 2026.   
    • “Actual increases this year were on average 3.4%, lower than the 4% predicted in last year’s survey but still higher than the 3% average seen prior to 2020, The Conference Board said.
    • “Today’s labor market is one of recalibration, not retreat,” Mitchell Barnes, an economist at The Conference Board, said in a news release. “Companies are rebalancing their workforce and labor strategies,” slowing headcount growth and investing in training, Barnes noted.”

Friday report

David Ermer–Congress, COVID-19, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog was pleased to see that OPM Director Scott Kupor added his regular Friday post to his OPM blog today after adding an insightful special post yesterday about the combined federal campaign. This Friday’s post concerns artificial intelligence.
  • MedTech Dive reports,
    • “A bipartisan bill introduced in Congress this week aims to more accurately determine Medicare reimbursement for laboratories by tying payment rates for diagnostic tests to a not-for-profit commercial claims database.
    • “The legislation would reform the 2014 Protecting Access to Medicare Act, also known as PAMA, which the lab industry for years has argued created a process that sets reimbursement rates artificially low.
    • “Called the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, the new bill would “dramatically improve” the data used to set rates for lab tests, the American Clinical Laboratory Association said Thursday.”
  • OPM released on the Federal Register’s Public Inspection List a final rule titled “Assuring Responsive and Accountable Federal Executive Management. Here’s the summary of the rule,
    • “The Office of Personnel Management (OPM) is issuing this final rule to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Governmentwide SES ratings data have consistently shown that most SES receive the highest rating levels (i.e., Levels 4 and 5) despite documented reports of SES failings. Allowing agencies to limit the highest SES rating levels will increase rigor in SES appraisal and lead to a more normalized distribution of SES ratings across the Federal Government.
    • The rule will be published in the Federal Register on September 15.
  • Per an HHS news release.
    • “The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will hold a meeting on Thursday and Friday, September 18-19, 2025, in Atlanta, GA. * * *
    • “The meeting will be available to the public via live webcast. The link will be available Thursday morning on the ACIP website. 
    • “The September 18-19 meeting draft agenda will be available on the ACIP website.” 
  • The Groom Law Group lets us know,
    • “The HIPAA Security Rule requires covered entities, such as group health plans and health insurance issuers, as well as business associates, to perform a written “security risk assessment” of the potential risks and vulnerabilities to protected health information (“PHI”) maintained on their systems and applications. 
    • Yesterday [September 10], the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) released an updated version of the Security Risk Assessment Tool (“SRA Tool”), which is an easy-to-use interactive application that covered entities and business associates can use to create the required security risk assessment.  The SRA Tool guides users through the required security risk assessment process using a series of multiple-choice questions, providing references and guidance along the way.  The updated SRA Tool offers new features, including a glossary, tips, and a remediation report.  
    • The OCR and Assistant Secretary for Technology Policy will host live webinars with training sessions on September 15 at 12:00 p.m. ET and September 16 at 3:00 p.m. ET.  You can register for the training sessions here.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA is signaling fresh control over the promotion of copycat drugs under President Donald Trump’s executive order to rein in pharmaceutical advertising, staking a position in a regulatory gray area around so-called compounded products.
    • “On Tuesday, Trump’s executive order called for “action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising.” 
    • “The Food and Drug Administration then sent hundreds of letters to drug companies warning of deceptive promotions, which included notices to online telehealth companies that market the compounded products, a spokesperson for the US Department of Health and Human Services said in an email. 
    • “The FDA is clearly looking to take a more aggressive stance with deceptive advertising practices, and that will include non-traditional targets,” said Melissa Wong, a life sciences attorney at Holland & Knight.”
  • STAT News tells us,
    • “Mark your calendars — the Food and Drug Administration will soon convene experts to discuss challenges around regulating mental health products that use artificial intelligence. The announcement arrives as a growing number of companies release chatbots powered by large language models with unpredictable output.
    • “Notice of the Nov. 6 meeting of the Digital Health Advisory Committee, published Thursday in the Federal Register, says newly released mental health products using AI pose “novel risks and, as mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges.” 
    • “The agency has yet to provide clear guidance on how it plans to regulate these devices or what developers must do to show they are safe and effective. But it’s clear the risks are real, as I detailed in my story last week about ChatGPT and other generative AI tools driving users into delusional spirals. Read more from STAT’s Mario Aguilar.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to download report listings or data sets, with reports being updated daily to include the most recent submissions.
    • “Today’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency. It follows the agency’s recent announcement on real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.” * * *
    • Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event. Additionally, the FAERS data is not an indicator of the safety profile of the cosmetic product. To learn more, read the frequently asked questions.
  • On a related note, the Wall Street Journal discusses health concerns raised about gel manicures.

From the judicial front,

  • Fierce Pharma notes,
    • “It was another swing and a miss for the biopharma industry on Thursday, when a federal appeals court in Philadelphia unanimously rejected (PDF) a challenge by Novartis on the legality of the Inflation Reduction Act (IRA) Medicare price negotiation program.
    • “It was the second time this month that the U.S. Court of Appeals for the Third Circuit swatted away an IRA challenge from Big Pharma. Last week, the same three-judge panel turned back (PDF) an appeal from Bristol Myers Squibb and Johnson & Johnson, although that decision was split.
    • “Judge Thomas Hardiman, a George W. Bush appointee, registered a dissenting opinion in the appeal brought by BMS and J&J. The other judges on the panel are Joseph Biden appointee Arianna Freeman and Donald Trump appointee Peter Phipps.”
  • Beckers Payer Issues points out,
    • “The U.S. Bankruptcy Court for the Middle District of Florida has approved a bid from Humana’s CenterWell to acquire the assets of The Villages Health, the health system serving The Villages retirement community in Florida.
    • “TVH filed for Chapter 11 bankruptcy in July. The court’s Sept. 9 decision allows the organizations to move forward with the transaction, which is expected to close in the fourth quarter, pending regulatory approvals, according to a Sept. 9 news release.
    • “The deal will bring TVH’s eight primary care centers and two specialty care centers serving more than 55,000 patients under CenterWell. CenterWell operates as a payor-agnostic provider, so TVH patients will be able to continue using their current insurance plans after the transition.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. “Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in children 5-17 years old and adults 65 years and older. Hospitalizations numbers are elevated in adults 65 years and older.”
    • “Influenza
    • “RSV
      • “RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection of infants in the 2025–26 respiratory virus season.
      • “Recommendations for use of 2025-2026 seasonal influenza vaccine have also been published in CDC’s MMWR.”
  • The American Hospital News informs us,
    • “The flu hospitalization rate during the 2024-25 flu season was the highest since 2010-11, according to a report published Sept. 12 by the Centers for Disease Control and Prevention. For all age groups, flu hospitalization rates were 1.8 to 2.8 times higher than median historical rates. Like previous seasons, most hospitalized patients (89%) had one or more underlying medical conditions, nearly 17% were admitted to an intensive care unit, 6% received assistance from a mechanical ventilator and 3% died while in the hospital.
    • “Additionally, the CDC said 32% of hospitalized patients received a flu vaccine and nearly 85% received antiviral treatment. Children and adolescents aged 5-17 received the lowest proportion of antiviral treatment at approximately 62%. The CDC recommended that all individuals older than six months receive a flu vaccine annually.”
  • The New York Times adds that a “Rare but Serious Complication Shows Flu’s Potential Harm, Acute necrotizing encephalopathy, or A.N.E., can result from influenza or other infections, including Covid-19.”
  • Health Day notes that “Comorbidities are seen less often in severe respiratory syncytial virus (RSV) infection in infants younger than 3 months compared with older children, according to a study published online Sept. 9 in The Lancet Regional Health: Europe.”
  • Per the University of Minnesota’s CIDRAP,
    • “The Los Angeles County Department of Public Health (LADPH) yesterday urged residents to make sure family members are protected from measles following the death of a school-age child who was infected with the virus during infancy and developed a rare complication from the disease called subacute sclerosing panencephalitis (SSPE). Health officials said SSPE is typically fatal in people who were infected with measles during early life.” * * *
    • “In related news, the Georgia Department of Public Health today announced another measles case, which involves an unvaccinated Fulton County resident who has no known history of international travel. The patient is no longer infectious but may have exposed others from September 2 to September 11. 
    • “Some of the exposure locations include Georgia State University, a restaurant on multiple days, and soccer games and practices.”
  • Per a National Institutes of Health press release,
    • “According to a study funded by the National Institutes of Health (NIH), older Americans with chronic low back pain who received acupuncture had greater improvement in physical function and reduced pain than those who received usual medical care only, generally prescribed medications or physical therapy. Chronic low back pain is the leading cause of disability worldwide and affects over one-third of older adults in the United States. Treatment options range from pain-relieving drugs to complementary therapies, including acupuncture. There is an urgent need for safe, effective, and non-addictive pain management approaches.
    • “Of the different treatments we have for chronic low back pain, most have a somewhat modest effect. They often reduce pain by about a third at best and can help people function better,” said lead author Lynn L. DeBar, Ph.D., Kaiser Permanente distinguished investigator. “Our clinical results suggests that acupuncture is working as well as many things that are more familiar to people. We found that the size of this effect, while modest, was positive and sustained.”
  • The Washington Post relates,
    • “Exercising muscles pumps out substances that can suppress the growth of breast cancer cells, according to an important new study of exercise and cancer.
    • “The study, published last month, involved 32 women who’d survived breast cancer. After a single session of interval training or weightlifting, their blood contained higher levels of certain molecules, and those factors helped put the brakes on laboratory-grown breast cancer cells.
    • “Our work shows that exercise can directly influence cancer biology, suppressing tumor growth through powerful molecular signals,” said Robert Newton, the deputy director of the Exercise Medicine Research Institute at Edith Cowan University in Perth, Australia, and senior author of the new study.”
  • Per the AHA News,
    • “A Gallup report published Sept. 9 found that nearly 48 million Americans currently have or are being treated for depression. The total, which equals 18.3% of the population, has significantly increased since 2019 (12.5%). The rate increased to 13.8% in 2020 — the onset of the COVID-19 pandemic — and continued to sharply increase. Adults who report having been diagnosed with depression in their lifetime are at 28.5%, nearing the record high of 29% recorded in the first quarter of 2023. The report said that reduced stigma in seeking mental health treatment may partly explain rising depression diagnoses, as 70% of Americans now prefer that their doctor ask about both physical and mental health concerns.”
  • BioPharma Dive lets us know that “signs point to potential benefits of GLP-1s in oncology. Early academic research suggests various ways weight loss drugs could have an impact in cancer care.”

From the U.S. healthcare business front,

  • The Employee Benefits Reseach Institute informs us,
    • “There were 13.1 million individuals with health care claims having employment-based benefits in 2022. However, the use of health care services is far from evenly distributed across the population. In fact, a small portion of the population accounts for a disproportionately large share of health care spending. These “high users” often have significant and complex medical needs and usually require ongoing or intensive care for one or more medical conditions. This Fast Fact is the second in a series of EBRI Fast Facts related to the concentration of health care spending and examines health care spending among individuals in employment-based health plans with the top medical conditions.”
  • Willis Towers Watson calls attention to the fact that “high-cost claims are rising fast, driven by complex conditions and specialty drugs. Employers must shift to data-driven, clinically focused strategies to manage risk and improve outcomes.”
  • Milliman explains “how to build a long-range GLP-1 forecast with the goal of estimating when could commercial health plans see a plateau?”
    • “In recent years, new treatment options for type-2 diabetes and obesity have resulted in substantial changes in clinical guidelines and prescribing patterns. Commercial payers have experienced a recent surge in the utilization of glucagon-like-peptide-1 (GLP-1) medications. Also, approved indications are expanding, including those for sleep apnea and cardiovascular conditions. This white paper provides a framework for building a long-range forecast and can help employers covering these drugs understand how trends associated with these drugs may change over time.”
  • Per Health Affairs Forefront,
    • “Industry and HHS should collaborate to develop a voluntary standardized identifier for provider networks that is consistent across all segments of the health insurance markets. To accomplish this, we propose convening a working group within an accredited standards body or industry collaboration to define the details of the standard and oversee implementation.
    • “This article examines how the lack of standardized identifiers for provider networks creates many frustrations for consumers and other health care stakeholders. It also reviews the role that standardized identifiers and standards bodies play in developing seamless consumer experiences in other industries and the roles they could play in health care in assisting consumers and other stakeholders.”
  • Beckers Hospital Review warns,
    • “Seven-hundred and fifty-nine rural U.S. hospitals are at risk of closure due to financial problems, with about 40% of those hospitals at immediate risk of closure.
    • “The counts are drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through August 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure.”

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

From the U.S. healthcare business front,

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

Tuesday report

David Ermer–CMS, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “The Trump administration released its ‘Make America Healthy Again’ strategy to improve children’s health.
    • “The strategy includes a vaccine framework, lenient approach to pesticides, and focus on processed foods and dyes.
    • “The FDA will modernize infant-formula nutrient requirements and increase testing for heavy metals and other contaminants.”
  • and
    • “President Trump signed an executive order to increase federal enforcement of pharmaceutical advertisements.
    • “The FDA is sending thousands of enforcement letters to drugmakers regarding misleading advertisements on multiple platforms.
    • “HHS wants to amend FDA guidance, closing a loophole allowing abbreviated descriptions of drug side effects in TV ads.”
  • Per a Congressional news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced that the HELP Committee will hold a hearing next week on delivering President Trump’s mission to restore radical transparency at the Centers for Disease Control and Prevention (CDC). This is crucial to protecting the health of American children.
    • “At the hearing, the HELP Committee will hear from former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. The Committee is also planning to invite current officials at the Department of Health and Human Services to respond by speaking with Committee members at a future hearing.”
  • STAT News tells us,
    • “More than 160 U.S. lawmakers have urged the Trump administration to abandon a newly announced pilot program that would allow pharmaceutical companies to offer rebates for a small number of therapies to hospitals that participate in a federal drug discount program.
    • “At issue is the 340B discount program, which was created to help hospitals and clinics care for low-income and rural patients. Drug companies that want to take part in Medicare or Medicaid must offer their medicines at a discount — typically, 25% to 50%, but sometimes higher — to participating hospitals and clinics. Right now, drug companies generally provide the discounts at the time of purchase.” * * *
    • “The latest controversy has been over double discounts, an issue that can be traced, in part, to the Inflation Reduction Act, which allows Medicare to negotiate the prices of some drugs. The concern is a significant issue for drugmakers, since certain medicines, including big-selling heart and cancer treatments, have been selected by Medicare for price negotiations.
    • “The Inflation Reduction Act imposes a maximum fair price on drugs paid for by Medicare and obligates the companies to pay added inflation rebates in Medicare. But the requirement overlaps with 340B, because drugmakers must offer hospitals the lower of the maximum fair price or 340B price, and pay inflation rebates only on drugs not sold at the 340B price.”
  • The American Hospital Association is opposed to the rebate pilot.
    • “The AHA Sept. 8 urged the Federal Trade Commission and Antitrust Division of the Department of Justice to investigate several drug companies’ concerted efforts to impose rebate models within the 340B Drug Pricing Program, saying the actions may violate antitrust laws. 
    • “These drug companies sought to switch from providing ‘upfront discounts’ on 340B drugs to a model in which 340B hospitals must purchase even the costliest drugs at full price and then submit for a rebate,” AHA wrote. “If successful, this concerted effort would essentially obligate America’s safety-net hospitals to advance interest-free loans to the world’s largest and most profitable drug companies. This new ‘rebate model’ would inflict untold harm on hospitals, patients and communities. And for your purposes, the publicly available information suggests potential anticompetitive activity.”  
    • “The AHA letter details a timeline of many actions taken by several drug companies over a six-month period highlighting a potential antitrust conspiracy to limit 340B discounts.”
  • STAT News also informs us,
    • “Medicare is delaying implementation of a Biden-era rule that would have made Medicare Advantage plans notify members about their unused supplemental benefits — services such as vision and dental. 
    • “Medicare didn’t say how long it’s delaying implementation but disclosed in a notice late Monday that insurers had asked questions and sought technical guidance on the rule. The agency said it’s delaying implementation “for contract year 2026 and beyond” because of “logistical concerns.” 
  • Per a Government Accountability Office news release,
    • “When Medicare beneficiaries need medical devices or health care services, they can choose from among the items and services that Medicare has decided to cover. 
    • “Medicare sets time frames for determining coverage and meets its goals more than 80% of the time. However, the agency doesn’t systematically identify the reasons why some decisions are delayed, which may make it harder to improve timeliness.
    • ‘There are also concerns that Medicare isn’t transparent about how it prioritizes reviews of new coverage requests. Making this information available could improve the quality of requests.
    • “Our recommendations address these issues.”
    • Here is a link to the full report.
  • Federal News Network points out,
    • “Federal employees, on average, are waiting longer to see their retirement applications processed. New data from the Office of Personnel Management for August shows it takes an average of 70 days to process a claim from a retiring fed. But if retirement claims are coming to OPM in less than 60 days, those cases take on average 45 days to complete. At the same time, OPM received more than 9,400 retirement claims last month. OPM’s backlog of retirement claims dropped by 2,000 to 24,300.” 
  • Per MedTech Dive,
    • “Microbot Medical has received 510(k) clearance for its Liberty Endovascular Robotic System, the company said Monday.
    • “The Food and Drug Administration clearance positions Microbot to start marketing the single use, remotely operated robotic system for peripheral endovascular procedures.
    • “Siemens Healthineers launched a robotic system for peripheral vascular interventions in 2021 but withdrew from the market to focus on neurovascular procedures two years later.”

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “‘Kissing bug’ disease is now endemic in the [southern] U.S., CDC says. What is it?
    • “The U.S. is seeing a rise in Chagas disease, which is a life-threatening illness transmitted through “kissing bugs” known to bite human faces. Pets can be carriers.”
  • MedPage Today tells us,
    • “The monoclonal antibody romosozumab (Evenity) increased bone mineral density (BMD) in premenopausal women with idiopathic osteoporosis, according to a small, phase II open-label study.
    • “Among the 29 women enrolled, treatment with romosozumab was associated with a 15% gain in BMD in the lumbar spine, a 5.3% increase at the total hip, and a 5.4% increase at the femoral neck as measured by dual-energy x-ray absorptiometry at 1 year (all P<0.001), reported Lauren Lynch, MD, PhD, of Columbia University Irving Medical Center in New York City.”
    • “Increases in BMD at all three spots were significant by month 6 of treatment, she said at the American Society for Bone and Mineral Researchopens in a new tab or window annual meeting.
    • “Treatment with romosozumab was also tied to a 3.4% gain in trabecular bone score at 1 year (P<0.001).
    • “These promising data provide support for future randomized controlled trials that test romosozumab as a therapeutic option for premenopausal idiopathic osteoporosis,” said Lynch.”
  • Per Healio,
    • “Body composition measurements may be better predictors of colorectal cancer incidence than BMI.
    • “An evaluation of more than 9,000 postmenopausal women who had dual-energy X-ray absorptiometry-determined adiposity found those with higher visceral adipose tissue and android fat had greater risk for developing the malignancy. Those with increased subcutaneous adipose tissue, more closely related to BMI, did not.”
  • and
    • “The prevalence of mild, moderate and severe obstructive sleep apnea in U.S. adults are each expected to rise by 2050, according to results published in The Lancet Respiratory Medicine.
    • “By projecting a rise in OSA prevalence, the research helps fill a critical gap in public health planning and ensures that health systems, payers and policymakers can prepare for rising demand,” Carlos M. Nunez, MD, chief medical officer at Resmed, told Healio.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “Many people could benefit from a nudge to help them exercise more, improve their finances or get a recommended health screening.
    • “A recent report from the International Foundation of Employee Benefit Plans suggests that organizations that provide motivation in the form of incentives tend to have better participation in their wellness programs, likely leading to improvement in several workforce measures.
    • “Workplace Wellness and Financial Education: 2025 Survey Report uncovers insights into the types of wellness incentives organizations offer and their impact on program participation as well as overall worker wellness and organizational goals.
    • “More than four in ten (44%) survey respondents said they offer an incentive for at least one of their wellness initiatives. In addition, 19% said incentives are offered through a vendor or health care provider. Thirty-eight percent said they do not offer incentives.” 
  • Beckers Hospital Review identifies the states that vaccinate their populations the most and those that vaccinate their populations the least based on a Wallet Hub report published Sept. 9.

From the U.S. healthcare business front,

  • The American Hospital Association reports
    • A JAMA internal medicine study published Sept. 8 found that since the COVID-19 pandemic, Medicare Advantage beneficiaries have been experiencing longer hospital stays than those under Traditional Medicare. The study examined more than 89 million hospitalizations from 2017 to 2023 and found the average length of stay for MA admissions during that period increased from 6 to 7.1 days, while Traditional Medicare admissions grew from 5.8 to 6.3 days. The researchers noted that these trends “may reflect insurance-related discharge barriers” and that the results “are consistent with hospital industry reports.” They point to prior authorization or limited post-acute care networks as possible causes. 
  • The Wall Street Journal informs us,
    • Novartis agreed to buy Tourmaline Bio in a roughly $1.4 billion-dollar deal that boosts its cardiovascular drug pipeline with access to the targeted therapy drug pacibekitug.
    • The Swiss pharmaceutical company said Tuesday that it would offer Tourmaline Bio shareholders $48 a share, valuing the company at approximately $1.4 billion on a fully diluted basis. Tourmaline’s board has approved the deal.
    • Tourmaline Bio [which is based in Massachusetts] is a clinical-stage biopharmaceutical company developing pacibekitug which is a treatment option for atherosclerotic cardiovascular disease.
  • Per STAT News,
    • “Eli Lilly has developed artificial intelligence models that can help predict the behavior of potential drug candidates, based on the data the drugmaker has collected over the last two decades and at the cost of more than a billion dollars. Now, it’s opening up some of those models to biotech companies that want to use them to jumpstart their science.
    • “The only catch? Lilly wants to use data from those other companies to improve its models.”
  • Modern Healthcare tells us,
    • “The vast majority of UnitedHealthcare Medicare Advantage members will be enrolled in policies with high quality scores next year, parent company UnitedHealth Group announced Tuesday.
    • “UnitedHealthcare anticipates that 78% of its Medicare Advantage enrollees in 2026 will have plans in contracts that earned at least four out of five stars under the Star Ratings quality measurement program. That compares with 71% this year.
    • “The performance is consistent with expectations. UnitedHealth Group wrote in a filing to the Securities and Exchange Commission. The company also reaffirmed its full-year adjusted earnings outlook of at least $16 per share on revenues of $445.5 billion-$448 billion.”
  • Per Healthcare Dive,
    • “Mayo Clinic plans to close six of its clinics in Minnesota by Dec. 10 and reduce services at its Albert Lea hospital, the nonprofit provider said Monday.
    • “The health system will shutter clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter, and Wells and stop offering elective surgeries and procedures in ophthalmology, gynecology, endoscopy, orthopedics and podiatry at the hospital and clinic in Albert Lea.
    • “Mayo said it is consolidating services in part to address lower patient volumes and staffing shortages. Consolidating services will help the system “strengthen rural health care delivery and ensure safe, high-quality and sustainable care for generations to come,” Mayo said.”
  • Fierce Pharma reports,
    • “Amid a yearslong wave of enthusiasm and uptake for Eli Lilly and Novo Nordisk’s blockbuster obesity medicines, the drugs have scored a strong endorsement from an independent U.S. cost watchdog.
    • “In a draft report (PDF), the Institute for Clinical and Economic Review (ICER) determined the drugs are “highly cost-effective” because of their ability to help patients lose weight, reduce metabolic risk factors and address obesity-related health complications. The group specifically looked at Novo’s injectable semaglutide at the 2.4-mg dose, Novo’s investigational oral semaglutide 25-mg dose and Lilly’s injectable 15-mg dose of tirzepatide.
    • “After reviewing the health benefits of the medicines, the cost watchdog said the drugs met the mark on “commonly used cost-effectiveness thresholds.”
    • “Because treatment with all three drugs results in substantial weight loss and improvement in metabolic risk factors, we have high certainty that all three drugs have substantial net health benefit over lifestyle modifications alone,” ICER reviewers said in the report.”
  • Per Fierce Healthcare,
    • “Hospitals’ operating margins continued to soften through July as volumes remained strong, but spending on supplies and drugs inched upward, according to Kaufman Hall’s latest monthly performance report.
    • “The firm’s operating margin index of nationwide hospitals was a median 1.7% across seven months when including health system allocations for the cost of shared services and 5.3% when excluding those. That’s a low point for 2025 but still above hospitals’ performance during the same period in 2024.
    • “Looking at July alone, the index showed a 2.6% median operating margin with health system allocations and 6.2% without. In June, those were 3.4% and 7%, respectively.
    • “While performance has generally been strong this year, profitability has decreased slightly over the past few months,” Erik Swanson, managing director and data and analytics group leader with Kaufman Hall, said in a release.”
  • and
    • “Telehealth GLP-1 company Remedy Meds, founded in 2024, announced its intent to acquire health tech unicorn Thirty Madison for $500 million in an all-stock deal. 
    • “The deal will create a larger, multibrand platform across women’s, men’s and metabolic health, executives said. The deal also positions Remedy Meds as a more competitive player in the direct-to-consumer health space, up against Hims & Hers and Ro. 
    • “Thirty Madison was valued at $1 billion in June 2021, launching it to unicorn status. In the years since, the company has completed several mergers and acquisitions, including with women’s-health-focused company Nurx. 
    • “Remedy Meds is a relative newcomer compared with the company it plans to buy, having only been founded in January 2024. Its founder Haris Memon founded and sold a home goods company called Miracle Brands in July 2023 before entering the healthcare market.”
  • Per MedTech Dive,
    • “Senseonics has struck a deal to retake control of the commercialization and distribution of its implantable continuous glucose monitors, the company said Wednesday.
    • “Ascensia Diabetes Care is currently the exclusive worldwide distributor of the Eversense devices. That will change at the start of 2026, when Senseonics will resume responsibility.
    • “BTIG analysts said in a note to investors that the move shows “Senseonics is doubling down on its view that the one-year sensor will finally enable an inflection in patient demand for the implantable glucose monitor.”

Monday report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Federal News Network discusses OPM recent hiring reforms, including last Friday’s Rule of Many.
  • Here’s a link to OPM’s fact sheet on the Rule of Many.
  • FedSmith recommends the FEHB and PSHB enrollees and covered family member “have your annual physical ahead of the Health Care Open Season” which starts in early November. Doing so allows the enrollee to “review health changes and update your FEHB coverage.” Intriguing idea.
  • Per a Congressional news release,
    • “Nearly five years after the No Surprises Act (NSA) was signed into law, delays and inconsistent rulemaking by Biden-era regulators have resulted in a patchwork system that fails to provide the transparency and protection for patients that Congress intended. In a letter to Secretaries of the Departments of Health and Human Services, Treasury, and Labor, Ways and Means Committee Republicans urged the Trump Administration to build on its previous work and the work of Congress and successfully implement the crucial patient protections provided under the No Surprises Act.
      • “The [Ways and Means] Committee is the first and only congressional committee to hold hearings examining challenges cited by patients and other stakeholders regarding the NSA’s implementation… Nearly five years after the NSA’s passage, and spanning multiple administrations, many of these identified challenges remain unresolved… We look to this Administration to continue building on the work done by the Committee to prioritize necessary regulatory and sub-regulatory improvements so patients can realize the full potential and benefits of the NSA,” wrote Committee members.”
  • In the FEHBlog’s view, patients are reaping the benefits of the NSA while health plans are getting the short end of the stick. The federal government should take steps to improve the arbitration process.
  • The American Hospital Association News tells us
    • “The Federal Trade Commission Sept. 5 voted 3-1 to vacate the noncompete final rule issued last year by the previous administration. The rule banned, as an unfair method of competition, contractual terms prohibiting workers from pursuing certain employment after their contract with an employer ends.” * * * 
    • “The FTC Sept. 4 issued a request for information on noncompete agreements, saying it seeks to “better understand the scope, prevalence, and effects of employer noncompete agreements, as well as to gather information to inform possible future enforcement actions.” 
  • and
    • “The White House Sept. 5 issued an executive order modifying the scope of reciprocal tariffs announced in April to establish a framework of trade deals with international partners on certain goods such as critical minerals and pharmaceutical products.   
    • “The order established a Potential Tariff Adjustments for Aligned Partners Annex, consisting of a list of products to which President Trump would be willing to apply the “most favored nation” tariff, pending any future reciprocal trade deal. Pharmaceuticals and their ingredients were one of four product categories listed.”

From the Food and Drug Administration front,

  • Reuters reports,
    • “The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be adulterated and pose a safety risk.
    • “The move comes as the FDA cracks down on unapproved compounded drugs, which had filled the gap during shortages of patented treatments. Soaring demand for Novo Nordisk (NOVOb.CO), opens new tab and Eli Lilly’s (LLY.N), opens new tab obesity drugs has fueled a booming global market for cheaper, and sometimes even counterfeit versions.”
  • STAT News informs us,
    • “On Monday, eGenesis, a Cambridge-based biotechnology company, announced that it had been cleared by the Food and Drug Administration to begin a trial of kidneys from donor pigs that have been CRISPR’d to make their organs more human-friendly. Now, Massachusetts researchers will be performing more surgeries like [Bill] Stewart’s to see whether these animal parts could serve as a lifeline for people with end-stage renal disease.
    • “It’s the latest advance in a scientific swine race some hope might solve America’s organ shortage.” * * *
    • “Meanwhile, Revivicor, a subsidiary of Maryland-based United Therapeutics, has been trying its own porcine organs — including the first pig-to-human heart and kidney transplants — from animals with fewer genetic modifications. In February, United Therapeutics got the okay from the FDA to begin a clinical trial of its so-called “UKidney.” A spokesperson told STAT the company is “at least a month away” from performing the first transplant of the trial.”

From the judicial front,

  • Bloomberg Law reports,
    • “Top pharmacy benefit managers UnitedHealth Group Inc., Express Scripts Inc., and CVS Caremark notched a win after a federal judge partially dismissed certain class action claims that they conspired in an unfair pricing scheme for insulin products.
    • “The claims by the plaintiffs, which included self-funded payors and state attorneys general, are barred by an indirect purchaser rule and certain state laws, Judge Brian Martinotti for the US District Court for the District of New Jersey said in an order filed Sept. 5.” * * *
    • “Because the claims are barred by the indirect purchaser rule, the court is compelled to dismiss the civil claims under the Racketeer Influenced and Corrupt Organizations Act, Martinotti said.” * * *
    • “The order, however, denied the PBMs’ motion to dismiss the plaintiff’s unjust enrichment claims under Illinois law. “Unjust enrichment under Illinois law is not prevented by the indirect purchaser rule, and therefore, SFP Plaintiffs’ unjust enrichment claims in Illinois are sustained,” Martinotti said.”
  • Healthcare Dive relates,
    • “A federal judge dismissed several claims in the high-profile antitrust lawsuit against electronic health record giant Epic on Friday, but allowed other allegations by startup Particle Health to continue.
    • “Last year, Particle sued the EHR vendor, arguing Epic had used its large market share to crush competition in tools for payers. Epic filed a motion to dismiss the suit in December. 
    • “The judge agreed with Epic on five of the nine claims, dismissing Particle’s assertions that the vendor had maintained a conspiracy to uphold its market dominance, as well as claims of defamation and trade libel. However, the court declined to throw out three federal antitrust claims and Particle’s allegation that Epic had interfered with a business contract.” 
  • Per Federal News Network,
    • “A federal appeals court is ordering the dismissal of a case led by a group of states challenging the Trump administration’s termination of probationary federal employees, striking a significant blow to one of the two major cases that had challenged this year’s efforts to downsize the workforce by firing probationary workers en masse.
    • “Nineteen states and the District of Columbia filed the lawsuit in March, arguing that widespread firings at many agencies led to a sharp increase in unemployment claims and other sudden pressure on state budgets.
    • “In some cases, states said they had to expend “substantial resources” —sometimes creating new websites or opening new phone lines — to handle the volume of unemployment claims coming from fired probationary employees.
    • “But the U.S. Court of Appeals for the Fourth Circuit ruled in a 2-1 opinion on Monday that the plaintiffs “failed to allege a cognizable and redressable injury” from the widespread terminations.”

From the public health and medical/Rx research front,

  • Genetic Engineering and Biotechnology News reports,
    • “The global pandemic may be over, but SARS-CoV-2 continues to infect people around the world. Indeed, the United States has recorded roughly 750 deaths from COVID-19 over the past month.
    • “Now, an siRNA screen performed by scientists at Scripps Research has pinpointed dozens of human proteins that SARS-CoV-2 uses to complete its replication cycle. These findings could open the door to new drugs that target host proteins rather than the virus. This strategy may lead to new treatments effective against SARS-CoV-2 and other coronaviruses, even as the pathogens continue to evolve.
    • “This work is published in PLOS Biology in the paper, “Global siRNA screen identifies human host factors critical for SARS-CoV-2 replication and late stages of infection.”
  • BioPharma Dive adds,
    • “Pfizer and partner BioNTech said Monday their updated COVID-19 booster spurred strong immune responses against currently circulating coronavirus strains in late-stage testing, adding a key piece of evidence in support of the recently approved shot.
    • “According to Pfizer and BioNTech, the booster led to at least a four-fold increase in levels of LP.8.1-neutralizing antibody titers in a study cohort of people either over 65 or who are between 18 and 64 and have an underlying health condition. No new safety concerns were identified.
    • “The two companies ran the study to provide to the Food and Drug Administration additional information about the vaccine’s immunological impact. The results have been submitted to the agency, they said.”
  • Medscape notes that long Covid has been hitting doctors and nurses hard.
  • Per a National Institute of Standard and Technology news release,
    • “A type of drug called monoclonal antibodies (mAbs) can halt the growth of breast tumors, block the effects of rheumatoid arthritis, and treat many other diseases, from leukemia and colon cancer to asthma and osteoporosis. To manufacture these drugs, pharmaceutical companies genetically engineer living cells, grow those cells in large bioreactors, and harvest the mAb proteins that the cells produce.
    • “To support the manufacturing of these drugs, researchers at the National Institute of Standards and Technology (NIST) have collaborated with biotech company MilliporeSigma and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop a “living” reference material: specially tailored living cells that make mAbs with well-known properties.”
  • The American Medical Association lets us know what doctors wish parents knew about when to obtain emergency care for their children.
  • Per Healio,
    • “Individuals younger than 50 years with COPD faced an elevated risk for premature death and incident hospitalization/death due to chronic lower respiratory disease or heart failure, according to results published in NEJM Evidence.
    • “Clinicians can take away from our article that COPD is not uncommon in younger adults and should be considered as a possible diagnosis in young adults with 10 pack-years of smoking or respiratory symptoms,” Elizabeth C. Oelsner, MD, DrPH, general internist, respiratory epidemiologist, and Herbert Irving Associate Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, told Healio.
  • Per BioPharma Dive,
    • “BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of people with small cell lung cancer who were enrolled in a Phase 2 trial, and stabilized disease in all of them, the company said Monday.
    • “Company executives said the study’s results at an interim data checkpoint confirmed the dose it has selected for an ongoing Phase 3 trial with chemotherapy in the “extensive stage” form of the disease that can’t be treated with surgery or radiation. That trial may not have data until 2028.
    • “Pumitamig, also known by the code-name BNT327, is a drug targeting the PD-1 immune pathway and the cancer growth driver VEGF, a hotly contested area of biotech development. Opdivo maker Bristol Myers Squibb signed a deal with Germany-based BioNTech to co-develop pumitamig for $1.5 billion upfront and $2 billion a year through 2028.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. labor market is slowing, and job gains are largely in health services, which include healthcare and social services.
    • “Health services have been a consistent source of job growth, but impending Medicaid cuts could hinder the sector’s growth.
    • “There are concerns that Labor Department data might be overstating strength in health services, which could be revised lower.”
  • Fierce Health points out,
    • “Despite the hype about weight loss drugs known as GLP-1s, serious questions have remained about their efficacy when patients wean off the drugs.
    • “To date, studies have cast doubt on whether patients who stop taking the drugs can keep off the weight long-term. Some data suggest that those who discontinue regain between 14%and two-thirds of what they lost.
    • “But Omada Health, a virtual chronic care provider, is challenging the notion of inevitable weight gain with new data.
    • “When coupled with wraparound lifestyle support, 63% of Omada members maintained or continued to lose weight 12 months after discontinuing GLP-1s. At one year post-discontinuation, members showed just 0.8% average weight change. The analysis was based on 816 patients.”
  • Beckers Hospital Review informs us,
    • “Cleveland Clinic is expanding its presence in Florida with plans to build a $500 million hospital in West Palm Beach. The project will mark the system’s 24th hospital and significantly increase its footprint in Palm Beach County
    • “The hospital will be built on newly acquired land and comprise about 150 inpatient beds, an emergency department, a medical office building and an ambulatory surgery center.
    • “Palm Beach County has long been an area where we have planned to grow to enhance care for the community,” Cleveland Clinic President and CEO Tom Mihaljevic, MD, said in a Dec. 19 news release. “Our expansion plan will transform care for the community with a new hospital and outpatient clinics that provide a broad range of specialties, greater access and innovative patient experience programs.” 
  • BioPharma Dive reports,
    • “Drug developers from around the world rang in a new era of sleep medicine Monday, as data from a series of clinical trials show narcolepsy can be effectively treated by amplifying a specific brain protein.
    • “That protein, called orexin-2, helps regulate important body functions like appetite, arousal and wakefulness, which has in turn made it a promising target for drug companies. Johnson & Johnson, for instance, hopes that by blocking orexin-2, its experimental medicine seltorexant can be used to combat insomnia in patients with major depression.”
    • “More commonly, though, developers are looking to boost this protein to keep people with narcolepsy awake longer. The furthest along in this pursuit is Takeda Pharmaceutical with its drug oveporexton, which recently met the main and secondary goals of two late-stage clinical trials that focused on the most common, “Type 1” form of narcolepsy.
    • “On Monday, at a medical conference focused on sleep therapies, Takeda presented more detailed results from these studies.”
  • and
    • “Rapport Therapeutics’ market value doubled on Monday after the neurology-focused drugmaker unveiled mid-stage study results for an experimental seizure medicine that widely beat analyst and investor expectations.
    • “Treatment with Rapport’s drug, called RAP-219, reduced the frequency of clinical seizures by 78% versus the study’s baseline, a result that was matched by a similar reduction in electrographic seizure signs measured by a brain implant.
    • “As a result, Rapport said it plans to advance RAP-219 into two Phase 3 trials in the third quarter of next year. Shares in the company climbed by as much as 194% Monday morning to swell its capitalization above $1 billion”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of brensocatib (Brinsupri™, Insmed Incorporated) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
    • “NCFB is an incredibly burdensome condition with impacts that go well beyond its respiratory effects and include social, emotional, and productivity challenges,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “ICER’s analyses found that brensocatib, the first medication to be specifically indicated for NCFB, reduces the rate of pulmonary exacerbations and may also somewhat slow the rate of deterioration in lung function. Despite these benefits, however, we found that brensocatib’s expected discounted price was far out of alignment with the modest clinical improvements demonstrated in clinical studies. Pricing policy that balances innovation signals while addressing affordability and value will be an important topic at the public meeting.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on September 25, 2025. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

Weekend update

David Ermer–Congress, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • Beckers Payer Issues tells us,
    • “A group of House Republicans are backing the newly filed Bipartisan Premium Tax Credit Extension Act, which would extend enhanced ACA subsidies for one year beyond their current expiration date at the end of 2025.
    • “Under the legislation, the premium tax credits would expire Jan. 1, 2027. The bill would also maintain the expanded eligibility criteria that allows households earning more than 400% of the federal poverty level to qualify for subsidies.
    • “Insurers nationwide have requested a median 15% rate increase for 2026, citing both the anticipated expiration of the tax credits and rising medical costs. The tax credits, first expanded under the American Rescue Plan and extended by the Inflation Reduction Act, have helped drive record marketplace enrollment, with more than 24 million people signing up for coverage in 2025.
    • “The group of 10 Republican lawmakers supporting the bill is made up of some of the most politically vulnerable incumbents heading into the midterms, per Politico.”
  • The AP informs us,
    • “Republican senators say they are prepared to change the chamber’s rules to get around the Democratic blockade of President Donald Trump’s nominees and are discussing a proposal to make it easier to confirm multiple nominees at once.” * * *
    • “GOP senators discussed one proposal in a private meeting on Wednesday [September 3] that would enable them to confirm large tranches of nominees “en bloc,” or several at once, if a majority of senators agree, according to multiple senators who attended the meeting. 
    • “Currently, the objection of a single senator forces multiple votes on most nominations. The rules change would likely only apply to executive branch nominations, not lifetime judicial appointments, and would exclude many of the most high-profile positions, such as Cabinet nominees, that require a longer debate time.”
  • Here’s a link to the Federal Register’s PDF version of OPM’s September 8, 2025, final rule titled “Reinvigorating Merit-Based Hiring Through Candidate Ranking in the Competitive and Excepted Service (Rule of Many).” The rulemaking was first mentioned in last Friday’s FEHBlog.
  • HR discusses the Labor Department’s recently posted semi-annual regulatory agenda.
    • “The U.S. Department of Labor said Thursday it intends to revisit its overtime regulations under the Fair Labor Standards Act but did not disclose a deadline by which to issue an update on the subject, according to a press release.”

From the public health and medical/Rx research front,

  • The New York Times considers “Why Are More Older People Dying After Falls? Some researchers suspect that rising prescription drug use may explain a disturbing trend.”
    • “The Beers Criteria, a directory of drugs often deemed inadvisable for older adults, recently published recommendations for alternative medications and nonpharmacological treatments for frequent problems. Cognitive behavioral therapy for sleeplessness. Exercise, physical therapy and psychological interventions for pain.
    • “It’s a real tragedy when people have this life-altering event,” Dr. Steinman, co-chair of the Beers panel on alternatives, said of falls. He urged older patients to raise the issue of fall risk increasing drugs (FRIDs) themselves, if their doctors haven’t.
    • “Ask, ‘Do any of my medications increase the risk of falls? Is there an alternative treatment?’” he suggested. “Being an informed patient or caregiver can put this on the agenda. Otherwise, it might not come up.”
  • NPR Shots reports,
    • “By age 40, more than half of Americans have high blood pressure, but many are unaware of it. Hypertension has long been known as the silent killer. When it’s left untreated it can be deadly. And it’s considered a silent threat since most people have no symptoms. You can’t feel the pressure in your blood vessels increasing.
    • New recommendations from the American Heart Association aim for early treatment, including lifestyle changes and medications, once systolic blood pressure rises above 130/80 mm Hg, (which stands for millimeters of mercury, a measure of pressure). Experts say it’s clear that the sooner you take action, the more you can protect yourself.
  • Medscape lets us know,
    • “The proportion of patients taking a GLP-1 weight-loss drug following bariatric surgery increased substantially in recent years, although the timing of initiation after surgery varied widely, a large retrospective cohort study showed.
    • “GLP-1 initiation was also more common among women, those who underwent sleeve gastrectomy, and those with lower postoperative weight loss as measured by BMI.
    • “Some patients do not lose as much weight as expected, or they regain weight after a few years. In such cases, GLP-1 therapies are emerging as an important option for weight management,” said principal investigator Hemalkumar Mehta, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health in Baltimore.”
  • and
    • identifies natural remedies for folks with gastrointestinal issues.
      • “Almost two thirds of Americans are burdened by gastrointestinal (GI) symptoms like heartburn, abdominal pain, bloating, diarrhea, and constipation. And for almost 40% of Americans, uncomfortable bowel symptoms are bad enough that they forgo routine activities such as exercising or spending time with their families.
      • “Medications, both over the counter and prescription, targeting GI conditions are plentiful. Yet more and more patients are requesting natural routes to relief, doctors told Medscape Medical News, and it’s likely your patients are, too.
      • “Here are some examples from doctors on how they’ve integrated natural remedies into their practice for specific common complaints. Some remedies have published research to back them up, while others are anecdotal, but backed by patients and doctors reporting that they do work.”
  • Per Fierce Pharma,
    • “Industry watchers who cheered on Summit Therapeutics’ claim that the first global phase 3 trial of its Akeso-partnered PD-1xVEGF [cancer] drug showed consistent benefit between China and Western populations may be disappointed, although hopes for an approval remain alive thanks to newly calculated patient survival data from a longer follow-up.”
  • and
    • “Facing increased EGFR [mutation] competition from a new drug combination by Johnson & Johnson, AstraZeneca has come up with its own solution to prolong the lives of patients who take the company’s decade-old medicine Tagrisso.
    • “The method involves pairing Tagrisso with chemotherapy. The combo significantly reduced the risk of death by 23% compared with Tagrisso alone in patients with previously untreated EGFR-mutated advanced non-small cell lung cancer, an updated analysis of the phase 3 Flaura2 trial has found.
    • “Patients who received Tagrisso and chemo lived a median 47.5 months, versus 37.6 months for the Tagrisso monotherapy group, according to data presented at the 2025 World Conference on Lung Cancer in Barcelona, Spain.
    • “The latest data drop helps re-level the playing field for Tagrisso after J&J’s combination of Rybrevant and Lazcluze recently became the first regimen to demonstrate an overall survival benefit against Tagrisso in first-line EGFR-mutated NSCLC.”

From the U.S. healthcare business front,

  • Medical Economics shares a slideshow about “health care spending per person in the 12 states where it is highest.”
  • Beckers Payer Issues points out,
    • “For more than two years, Becker’s has reported on the intensifying trend of Medicare Advantage reimbursement fights between hospitals and insurers that has contributed to a dizzying and ever-changing environment for older adults to navigate each enrollment period. 
    • “Now, that environment is experiencing more upheaval as the nation’s largest insurers pull backfrom Medicare Advantage markets to protect profit margins amid new federal cost-containment measures and rising medical expenses.
    • “This retrenchment is not entirely new, with some regional and mid-sized health plans scaling back their MA offerings for 2025 coverage. But with the biggest players now also making cuts, the ripples are getting bigger, and a wave of market exits and membership losses are reshaping the program for 2026.” * * *
    • “As national players retreat, some nonprofit and provider-owned MA plans are moving to make up ground that’s been lost in recent years. BCBS Wyoming, SCAN Health Plan, and WVU Medicine’s Peak Health have announced plans to launch or expand within the program for 2026, for instance.”
  • Fierce Pharma notes,
    • “Specialty and orphan drugs continue to dominate the development pipeline, and a new report from Optum Rx spotlights three products payers should be watching.
    • “The pharmacy benefit manager recently released its summer Notable New Drugs report, highlighting three products: Brinsupri (brensocatib), tolebrutinib and a subcutaneous version of Leqembi (lecanemab-irmb). All three are specialty drugs that aim to treat chronic conditions—non-cystic fibrosis bronchiectasis, multiple sclerosis and Alzheimer’s disease, respectively.
    • “Arash Sadeghi, senior clinical pharmacist on OptumRx’s pipeline and drug surveillance team, told Fierce Healthcare that specialty products represent between 70% and 75% of novel drugs approved each year, making it critical for health plans to monitor what’s coming to market.
    • “Any time we talk about the pipeline or drugs that are going to be high impact or blockbusters, so much of that time is devoted to specialty products, specifically,” Sadeghi said.”
  • Per Kaufman Hall,
    • “One-third of discharged patients go to a different hospital when requiring a readmission, according to data from Vizient’s CMS Qualified Entity Public Report, published last month. The highest proportion of different-hospital readmissions were for behavioral health (61.3%) and neurosciences (55.6%). Readmission rates were higher in urban areas (16.7%) than rural areas (15.4%), but rural patients were more likely to be readmitted to a different hospital, 35.1% vs. 32.3% for patients residing in urban areas. These “invisible returns” complicate care coordination and outcome tracking. Such fragmentation disproportionately affects high-risk populations, particularly those in vulnerable areas (as measured by the Vizient Vulnerability Index) and those covered by Medicaid or Medicare. The implications for patient retention are clear: if patients aren’t satisfied with the treatment at your hospital, they’ll go somewhere else.”
  • The Wall Street Journal reports,
    • “How much would you invest in the possibility of living to 150 or beyond? Or having 20 extra healthy years?
    • “For the ultrawealthy, it’s more than $5 billion over the past 2½ decades, according to a Wall Street Journal analysis of longevity investment deals in PitchBook, public company statements and regulatory filings.
    • “Silicon Valley giants Peter Thiel, Sam Altman, Yuri Milner and Marc Andreessen are among the boldface names behind the influx of money in the longevity industry. Thiel’s quest for longer life spans nearly a dozen companies—some of which were funded by his venture firm and others by a nonprofit foundation he backed—that raised more than $700 million, according to the Journal’s analysis.”

Friday report

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

From Washington, DC

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

From the public health and medical/Rx research front,

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

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

From the U.S. healthcare business front,

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