Friday report

FDA

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today announced that it has awarded $247.9 million in grants to expand access to addiction treatment, mental health services, and recovery support in communities across the country. The investments will strengthen mental health support in schools, expand trauma treatment for children and families, equip first responders and communities to reverse overdoses, and help people in recovery return to work and rebuild their lives.
    • “HHS is investing nearly $250 million to put lifesaving treatment and recovery services directly into communities across America,” said HHS Secretary Robert F. Kennedy, Jr. “Through President Trump’s Great American Recovery, we are expanding addiction treatment, preventing fatal overdoses, helping children and families heal from trauma, and giving Americans in recovery the support they need to rebuild their lives. We are equipping communities with proven tools that save lives and help people recover.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is launching an initiative with a founding group of 37 state partners to focus on how quality is measured in Medicaid and the Children’s Health Insurance Program (CHIP). The effort will put health outcomes — not processes and paperwork — at the center of how success is defined. CMS and its partners will prioritize measures that demonstrate meaningful improvements in prevention, chronic disease management, and behavioral health.
    • “For too long, Medicaid has measured whether boxes are checked instead of whether patients are getting healthier — that must change,” said CMS Administrator Dr. Mehmet Oz. “We should judge success by what matters — preventing disease, managing chronic conditions, and improving patients’ health.”
    • “We are shifting the focus from paperwork and process to real accountability for what matters: health outcomes. We are encouraged at this level of commitment from states, and we are ready to get to work with them to implement this vision,” said CMS Deputy Administrator Stephanie Carlton.”
  • Fierce Healthcare reports,
    • “A new coalition is bringing together employers, clinicians and other stakeholders to push for the expansion of direct contracting.
    • “The Association for Direct Care will advocate for policies that ease barriers to direct contracting arrangements between employers and providers, boost transparency and support new payment models. A key goal, according to the announcement, is to support lower costs and better quality as well as the relationship between providers and their patients.
    • “The organization will focus on the expansion of direct employer contracting in the commercial space as well as in federal health programs.”
  • Healthcare Dive relates,
    • “A new report from a conservative think tank is accusing 340B hospitals of providing less charity care than other nonprofit hospitals, despite receiving discounted drugs.
    • “Hospitals participating in the 340B drug discount program spent 2.16% of their operating expenses on free or discounted care for low-income patients, called charity care, compared with 2.82% at non-340B hospitals, according to a Thursday analysis from the Pioneer Institute and CancerCare.
    • “Hospitals pushed back on the report, with the American Hospital Association saying 340B hospitals provide support for patients in other ways. “This report is another in a long line of misleading studies that wrongly singles out charity care as the only way to measure how hospitals provide for their patients and communities,” Bharath Krishnamurthy, director of pharmaceutical policy at the AHA, said in an email.”
  • Per MedTech Dive,
    • “Diagnostics companies, under pressure from proposed Medicare reimbursement cuts, are renewing calls for Congress to pass legislation that could provide relief by changing how data for setting laboratory test payment rates is collected.
    • “A new clinical laboratory fee schedule proposed this week by the Centers for Medicare and Medicaid Services would usher in the cuts beginning next year. Lab service providers face payment reductions of 15% on 775 tests under the preliminary schedule for 2027, according to the American Clinical Laboratory Association. 
    • “Getting legislation through Congress that would avert the reductions will be a tough task, however. The House of Representatives is now in recess until after the November midterm elections.”

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

  • OPM Director Scott Kupor writes (Substack link) in his Secrets of OPM blog about his efforts to recruit young people into federal service.
    • “My message to students has been really simple – we don’t need you to make a 40-year decision to be a federal employee. Instead, give it a shot for 2-3 years and see if you like it. I hope some will and may re-up for another stint, but for sure many will decide to seek their calling elsewhere. That’s fine; we don’t need to fight that or denigrate that. Any public service is better than none and getting a firsthand understanding of how government works will engender a sense of patriotism that we can’t replicate in any better way.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Eli Lilly received FDA approval Sept. 24 for Onswik, a once-weekly basal insulin injection for adults with Type 2 diabetes.
    • “The FDA approved Onswik for use alongside diet and exercise to improve glycemic control. The drug delivers steady basal insulin levels over seven days. Lilly said the drug is designed to eliminate more than 300 injections per year compared with once-daily basal insulin.”
    • “Onswik is not indicated for Type 1 diabetes because it raises the risk of severe hypoglycemia in those patients.
    • “Lilly plans to launch the Onswik KwikPen in the U.S. in the coming months in two concentrations: 500 units/mL and 1,000 units/mL. The company did not disclose pricing.”
  • Fierce Pharma adds,
    • “In just over a month, the FDA has cleared not one, but two treatments for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic condition that causes soft tissues to turn to bone. 
    • “Regeneron’s Pasatru earned regulatory clearance in late August, and Friday, Mirum Pharmaceutical’s zilurgisertib, to be marketed as Atebrioz, joined the race. The FDA has grantedMirum’s once-daily oral medication a green light to treat FOP in patients ages 12 and up.  
    • “Atebrioz has fallen under Mirum’s purview thanks to a licensing deal between the rare disease pharma and Incyte in April. Under the deal, Mirum paid $16 million up front for global commercial rights to the drug, with additional regulatory and sales milestones potentially to follow.”

From the fraud, waste, and abuse front,

  • Govexec reports,
    • “The Trump administration claims it found more than $1.2 billion in suspected fraud and stopped $41 million more across five COVID-related contracts, according to a Wednesday press release from the General Services Administration.
    • “GSA said although the COVID-19 national emergency and related acquisition flexibilities were cancelled in 2023, unnamed federal contractors continued to receive funding. The alleged fraud was uncovered in collaboration with the Health and Human Services Department and under the direction of the White House Task Force to Eliminate Fraud.
    • “The COVID emergency ended over three years ago, yet fraudsters continue to weaponize outdated emergency contracts to abuse taxpayer dollars,” GSA Administrator Edward Forst said in the release. “GSA will continue to work with the Vice President’s task force to stop improper payments, refer suspected fraud to law enforcement, and fight to recover every dollar.”
    • “GSA estimates that about 93% of the contract funding — which would have been distributed for COVID vaccines and other pandemic-related services — has not yet been distributed to vendors, while roughly 6.78% has already been expended, according to a Fox News exclusive attached to the release. The agency has suspended payments to contractors, although the uncovered funding is not currently tied to criminal charges for contractors, the outlet reported.”

From the judicial front,

  • The Hill reports,
    • “The U.S. Court of Appeals for the D.C. Circuit sided with the Trump administration in its blacklisting of the artificial intelligence firm Anthropic, allowing the Pentagon to label the AI firm a supply chain risk. 
    • “The 2-1 ruling, issued Friday [DC Circuit link], rejected Anthropic’s challenge of the designation, finding the Department of Defense had “ample support” for its belief that the continued use of Anthropic’s Claude models by the agency or its contractors presented a national security risk.” * * *
    • “Friday’s ruling breaks with a California federal judge’s decision last month finding the government violated the First Amendment when it issued the supply chain risk.” * * *
    • “A spokesperson for Anthropic said the firm “respectfully disagrees” with the appeals court ruling.
    • “Another federal court has already held the government’s parallel designation unlawful,” they added. “We remain confident in our position and are considering all options, including further review.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 25, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
      • “COVID-19 activity remains elevated but is declining nationally. COVID-19 hospitalizations remain low.
      • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
      • “RSV activity is very low.
      • “Seasonal flu activity is low.”
  • The University of Minnesota CIDRAP reports,
    • “The US measles count has climbed to 3,659 confirmed cases, with 171 new cases added this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “Of the 3,659 confirmed cases, 18% are in children age 5 and under, 43% in children and teens aged 5 to 19, and 38% are in adults 20 and older. Nine percent of case-patients have been hospitalized. Ninety-five percent of case-patients are unvaccinated or have unknown vaccination status.” * * *
    • “Pennsylvania remains the nation’s hot spot, with 129 new cases in the past seven days and 890 for the year, according to an update today from the Pennsylvania Department of Health. Lancaster County, where two of the state’s measles deaths have been reported, has been the hardest hit, with 342 cases. 
    • “Other states with notable increases in measles cases include Ohio, which added nine new cases this week and now has 189 for the year; Kentucky, which added 10 new cases and has 67 for the year; and Wisconsin, which added four new cases and has 171.”
  • and
    • “The bivalent (two-strain) respiratory syncytial virus (RSV) vaccine made by Pfizer (RSVpreF, or Abrysvo) reduced the risk of hospitalization and emergency department (ED) visits for at least three seasons after vaccination in older adults with a high prevalence of comorbidities, according to a study published last week in Infectious Diseases and Therapy. 
    • “A separate study published the same day in JAMA Network Openfound that RSV vaccines provided substantial protection against RSV-related hospitalization and death among adults aged 65 and older and people with weakened immune systems during the 2023-24 respiratory virus season. 
    • “RSV is a leading cause of lower respiratory tract disease (LRTD) with severe outcomes, particularly among older adults and those with compromised immune systems. The Centers for Disease Control and Prevention estimates that RSV contributes to around 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths among older adults in the United States each year.” 
  • Beckers Clinical Leadership relates,
    • “The death rate tied to three common, treatable emergency surgical conditions increased about 50% between 1999 and 2020, according to an abstract being presented at the American College of Surgeons Clinical Congress 2026 in Washington, D.C., Sept. 26-29.
    • “Researchers at Peoria, Ill.-based OSF HealthCare analyzed nearly 20,000 deaths from the CDC WONDER Multiple Cause of Death database to assess mortality trends tied to emergency general surgery conditions.”
    • “The conditions included in the study were appendicitis, acute cholecystitis and abdominal wall hernia with obstruction or gangrene, recorded as a contributing factor to — not necessarily the main cause of — death.” * * *
    • “The study “raises important questions about whether patients are getting to surgical care in time, especially in rural communities, and whether workforce shortages or other pressures are contributing,” Vishnu Mani, MD, the study’s lead author and emergency general surgery medical director at OSF HealthCare, said in a Sept. 25 news release.”
  • Beckers ASC Review tells us,
    • “Patients who had an appendectomy for acute appendicitis had a 58% lower relative risk of a later colorectal cancer diagnosis than similar patients treated with antibiotics alone, according to new research set to be presented at the American College of Surgeons Clinical Congress 2026 in Washington, Sept. 26-29.” * * *
    • “The management of acute appendicitis has changed significantly over the last decade, and antibiotic therapy is now an accepted option,” Valentine Nfonsam, MD, the study’s senior author and professor and executive vice chair of the department of surgery at Morehouse School of Medicine, said in the release. “We wanted to ask a different question: Are there potential long-term oncologic implications of leaving the appendix in place after appendicitis?”
    • “The exact mechanism behind the association is unclear, but researchers said it could involve earlier detection of an underlying malignancy, removal of a source of inflammation, or the appendix’s role in the gut microbiome and immune system. Dr. Nfonsam cautioned that the findings shouldn’t be read as a reason for every appendicitis patient to undergo surgery, and said age, genetic predisposition, family history and other colorectal cancer risk factors should still guide patient selection and follow-up. The findings are being presented as a research abstract and have not yet been peer-reviewed.”
  • Cardiovascular Business informs us,
    • “For-profit hospitals in the United States may be starting to fall behind their nonprofit counterparts when it comes to heart attack outcomes, according to new data published in JACC: Advances.[1] Readmission rates—a recognized sign of care quality—seem to be falling at nonprofit hospitals while they remain mostly unchanged at for-profit facilities.
    • “The study’s authors reviewed data from more than 4.6 million acute myocardial infarction (AMI) hospital admissions from 2013 to 2022. All data came from the Agency for Healthcare Research and Quality’s Nationwide Readmissions Database. ST-segment elevation myocardial infarction (STEMI) and non-STEMI diagnosis codes were used to identify AMI hospitalizations. 
    • “Overall, the AMI readmission rate at for-profit hospitals remained relatively stable from 2013 (13%) to 2022 (12.7%). At nonprofit hospitals, on the other hand, the AMI readmission rate dropped from 11.5% in 2013 to 10.5% in 2022. This same pattern was true when only looking at patients undergoing percutaneous coronary intervention (PCI) procedures. For patients undergoing coronary artery bypass grafting (CABG), meanwhile, both for-profit and nonprofit hospitals saw readmission rates decline over the course of the study.
    • “The authors also found that for-profit and nonprofit hospitals were linked to comparable in-hospital mortality rates. One area where for-profit hospitals bested nonprofit hospitals was reducing cardiac complications. Respiratory and renal complications, on the other hand, were more common at for-profit hospitals than they were at nonprofit hospitals.”
  • Healio adds,
    • “The stroke incidence rate among young adults nearly doubled from 1993 to 2020 while decreasing among older adults, according to research published in Neurology.
    • “Over that same time, researchers saw an increase in the percentage of patients with stroke who had substance use as well as conditions associated with vascular risk, such as hypertension, diabetes and atrial fibrillation, said Emily R. Fisher, MD, a neurology resident and fellow at the University of Cincinnati.
    • “Our findings highlight the importance of regular primary care, even for younger adults without chronic medical conditions,” Fisher told Healio. “Routine medical care and recommended screenings are very important to detect stroke risk factors and to address them appropriately, as one may not have symptoms from these conditions.”
  • and
    • “The risk for egg or peanut allergy in 1-year-olds was not lower among women who ate high vs. standard amounts of eggs and peanuts during pregnancy and lactation, according to data published in The New England Journal of Medicine.
    • “Based on these new large-scale trial results, clinicians can reassure pregnant women that they do not need to eat high amounts of common food allergy causing foods (such as eggs and peanuts) to reduce the risk of their baby developing these food allergies,” Debra J. Palmer, PhD, associate professor and head of nutrition in early life at The Kids Research Institute Australia, told Healio.”
  • Nature notes,
    • “Most people taking the popular GLP-1 drugs shed substantial amounts of weight — an average of one-quarter of their body weight according to one study1. So why do 10–15% of people using the drugs lose minimal weight or none at all?
    • “There is tremendous heterogeneity” in the response to these medications, says Daniel Drucker, an endocrinologist at the University of Toronto in Canada, whose work aided in the development of GLP-1 drugs. “And we really don’t understand that.”
    • “Solving this mystery might lead to new medications for people who do not benefit from today’s versions of such drugs and could make it possible to match individuals to treatments that are most likely to work for them. Those tantalizing possibilities have made people’s individualized responses to GLP-1s a key line of enquiry for obesity scientists. The Endocrine Society, a leading medical and research organization in Washington DC, has already called for it to be a priority for the field, with scientists looking into various explanations, including biological sex, genetics and behavioural factors.
    • “For now, research to identify the differences between those who do or don’t respond to the drugs is in its early days, and precision medicine for obesity remains “largely aspirational”, according to a scientific statement published by the Endocrine Society earlier this month. But researchers are starting to dig into these questions with energy.”

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

  • Per Tech Target,
    • “Employers can expect to pay 9.5% more for employee health benefits in 2027, with new reporting from professional services firm Aon projecting average employee healthcare costs totaling more than $19,000 in the coming year.
    • “These numbers reflect the fourth consecutive year of healthcare cost growth approaching double digits, the firm said.
    • “At this level, rising health care costs become much more than a budgeting challenge and influence organizational decisions from benefits strategy and employee affordability to broader workforce and financial planning priorities,” Mike Pasterick, North America Health Solutions leader at Aon, said in a statement. “Leaders are undergoing pressure to maintain affordable benefits while continuing to invest in attracting, supporting and retaining talent.”
    • “The drivers behind these healthcare cost increases might not be surprising. According to Aon, trends like increased healthcare utilization, greater chronic disease prevalence and the volume of high-cost claims all contribute to rising health benefits costs.”
  • Modern Healthcare reports,
    • “Penn Medicine, Independence Blue Cross and Regent Surgical are forming a company and plan to build and operate at least 18 ambulatory surgery centers. 
    • “The facilities will be located in Penn Medicine’s service area of Pennsyvania, New Jersey and Delaware. The first one is expected to open next year, a spokesperson said Friday. A timeline for when all facilities will be complete has not been announced.
    • “The venture will be structured as a for-profit company. Additional details were still being finalized, a spokesperson said. Regulatory approvals, market conditions and community needs will factor into the decisions.”
  • and
    • “Rightway, an upstart pharmacy benefit manager covering about 3 million people, is considering an initial public offering in the years ahead as it tries to chip away at a market long dominated by some of the largest healthcare conglomerates in the U.S.
    • “The closely held company was valued at $1.75 billion after it closed a recent fundraising round, according to a person familiar with the matter who wasn’t authorized to speak publicly.
    • “The public markets are where some of the best companies in the world are built,” Chief Executive Officer Jordan Feldman said in an interview. Rightway, which is profitable, is weighing a public market debut in the next four years, he said. “That public currency and transparency are certainly something that we strive toward.” * * *
    • “Rightway’s only revenue stream is a per-enrollee fee that is not related to the price of the drug, Feldman said. That leads to savings for clients on their overall drug expenses and slower spending growth, he said.”
  • The Wall Street Journal relates,
    • “Novo Nordisk agreed to pay up to $1.3 billion to license and develop Swedish pharmaceutical company Nanexa’s drug delivery technology in a deal that could cut the frequency that patients need to inject its obesity and diabetes drugs.
    • “The deal covers Nanexa’s PharmaShell technology, which is designed to enable controlled and sustained release of active pharmaceutical ingredients through an ultra-thin coating applied to individual drug particles.
    • “Under the exclusive deal announced late Thursday, Novo has licensed Nanexa’s technology in up to five development programs covering different drug administration frequencies, with the companies targeting monthly and quarterly administration.
    • “Novo will lead global development and commercialization, with Nanexa eligible to receive upfront consideration and potential milestone payments totaling up to 1.17 billion euros ($1.33 billion).
    • “The Danish drugmaker will pay 615 million euros in upfront and development and regulatory milestone payments, in addition to royalties on future product sales.”
  • Per BioPharma Dive,
    • “RNA drugmaker ADARx Pharmaceuticals on Thursday priced its $446.3 million initial public offering and received an additional boost with a separate investment from development partner AbbVie. 
    • “The biotechnology firm sold more than 26 million shares at $17 apiece, at the top end of the $15-$17 price point it originally laid out in federal filings. It also secured about $89 million through a private stock sale to AbbVie. ADARx begins trading on Nasdaq on Friday under the ticker symbol “ADRX.” 
    • “ADARx is one of a handful of companies specializing in what’s called RNA interference, a form of drugmaking that involves stopping the body from producing problematic proteins. Biotechs like Alnylam Pharmaceuticals and Arrowhead Pharmaceuticals have successfully brought RNAi drugs to market.”
  • Beckers Behavioral Health lets us know,
    • “OpenAI released MentalHealthBench, an open benchmark that measures how AI systems respond in realistic mental health conversations, on Sept. 23.
    • “The company built the benchmark with more than 80 licensed psychologists and psychiatrists from 22 countries. The cohort speaks 19 languages and represents nearly 20 mental health subspecialties. The benchmark scores model behaviors including safety, context-seeking, preservation of user agency and actionable guidance.” * * *
    • “OpenAI, whose ChatGPT reaches more than 1 billion people each week, released the benchmark openly so outside researchers can examine its methods and run their own evaluations.”
  • Per Radiology Business,
    • “Despite the increasingly unpredictable landscape of the healthcare sector, radiologists’ total cash compensation has remained steady, with some of the specialists enjoying an 18% increase in pay since 2024. 
    • “That’s according to new data from SullivanCotter’s 2026 Physician Compensation and Productivity Survey. The consulting firm’s annual survey includes data from 575 healthcare organizations representing approximately 235,000 physicians across 240 specialties. It contains detailed information organizations can use to help them navigate rising physician pay expectations, recruitment pressures and the changing metrics that define productivity. 
    • “According to the data, median total cash compensation increased year over year in 2026 across all major physician specialty categories. Adult medical specialties posted the largest gain, rising 7.2% from 2025 and 25.2% over the past five years.”  
  • Beckers Physicians Leadership tells us,
    • “Sixty-three percent of OB-GYNs and 63% of general surgeons have been named in a malpractice lawsuit, according to a new report from Medscape.
    • “Across all specialties, 33% of physicians said they had been a sole defendant, a co-defendant or both in a malpractice suit. That included 34% of specialists and 31% of primary care physicians.
    • “Medscape’s “Physicians and Malpractice Report 2026,” published Sept. 22, collected data from more than 1,100 full- and part-time physicians across nearly 30 specialties.”
  • Beckers ASC News informs us,
    • “The U.S. is projected to face a shortage of 27,940 surgeons by 2038, and vascular surgery is expected to be hit hardest, according to a study from the American College of Surgeons.
    • “The researchers called it the first unified assessment of the country’s surgical workforce. They used the Health Workforce Simulation Model from HHS to project supply and demand across 10 surgical specialties from 2023 to 2038, according to a Sept. 25 news release from the ACS.
    • “Nationally, surgeon supply is projected to fall 4.2% over the period while demand grows 12.8%. That would leave the workforce meeting 84.3% of need, with larger gaps in rural areas.”
  • Fierce Pharma notes,
    • “Total prescriptions for both Eli Lilly’s Foundayo and Novo’s Wegovy pill have bounced back following a holiday dip and reached new records. Weekly scripts for the Wegov pill jumped 14% sequentially to about 184K, compared with its previous high of 183K, according to IQVIA data cited by Citi. Foundayo climbed 13% to cross 50K for the first time, reaching 53,321.
    • “Foundayo now captures about 1 out of 3 new starts for oral GLP-1 obesity drugs, and “that’s growing week over week,” Lilly CEO David Ricks told CNBC in an interview this week. 
    • “As Leerink Partners analysts noted in a Sept. 23 note, effective Sept. 1, Lilly cut the initial-dose pricing for Foundayo 0.8 mg, 2.5 mg and 5.5 mg to $149, $149 and $199 per month for self-pay patients, respectively. The company framed the promotion as an elasticity experiment and as a push to the first maintenance dose, according to the Leerink note.
    • “As Jefferies analysts pointed out in a Sept. 25 note, the majority of Foundayo scripts seem to be cash pay, with about 80% of patients still on starting doses.”

Thursday report

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

Simplicity is a virtue.

From Washington, D.C.

  • STAT News reports,
    • “Congress is considering the first major overhaul of how Medicare pays doctors in more than a decade, and both Democrats and Republicans appear to agree on the outlines of an approach.
    • “The main policy under consideration would link Medicare’s doctor pay rates to a medical inflation measure, giving doctors guaranteed pay boosts, as hospitals and other parts of the health care system have long received.  
    • “In doing so, Congress would be retreating from the notion that Medicare can control how many services physicians provide on a national basis, an idea that has undergirded Medicare’s doctor payments for decades. And it would reduce the government’s push to get clinicians to engage in value-based care, where they get paid more to keep patients healthy.” * * *
    • “The measure under consideration is called the Patients First Act, and would establish a permanent, annual payment hike linked to the Medicare Economic Index (MEI), minus 1%. 
    • “During a recent House committee hearing, Republicans and Democrats praised the Patients First Act. No one in either party spoke against it. Congressional Medicare advisers also recommended the MEI minus 1% formula.
    • “Following the hearing, Energy and Commerce health subcommittee Chair Morgan Griffith (R-Va.) predicted that Congress would pass some of the doctor pay measures, but he cautioned about the need for “tweaks” due to their cost.
    • “Some of them may need a few tweaks, but I don’t think we would’ve done this today if we weren’t at least going to try to get some of them across the finish line during lame duck,” Griffith said.”
  • Fierce Healthcare relates,
    • “The Senate Finance Committee has advanced the nominees for two key Department of Health and Human Services posts.
    • “The committee members voted 15 to 12 to advance the nomination of Chris Klomp to serve as Deputy HHS Secretary and 14 to 13 to advance the nomination of Ge Bai, Ph.D., as Assistant Secretary for Planning & Evaluation (ASPE) at the agency. The nominees had addressed the committee on Sept. 15 alongside nominees for positions at the Internal Revenue Service and U.S. Tax Court.
    • “Klomp is a rising star at HHS and currently leads the Department of Medicare at the agency. If his nomination is approved, he would become second-in-command at the department, a position that has been vacant since Jim O’Neill departed in February.”
  • and
    • “The Senate Committee on Health, Education, Labor and Pensions (HELP) today questioned Heidi Overton, M.D., Ph.D., the president’s pick for FDA commissioner, in a hearing marked by tightrope-walking on issues like vaccines, abortions, flavored vapes and whether or not Donald Trump is capable of being wrong. 
    • “Overton conceded multiple times during the hearing that vaccines approved by the FDA, as well as the so-called “abortion pill” mifepristone, are safe and effective. But she stopped short of admitting that Trump has been wrong when dispensing medical information out of line with what the scientific evidence shows. 
    • “The committee will next vote on whether to send Overton’s nomination to the full senate for approval.” 
  • Healthcare Dive tells us,
    • “CMS Administrator Dr. Mehmet Oz delivered a candid assessment of artificial intelligence’s impact on healthcare costs Wednesday: It’s going to get worse before it gets better.
    • “Short term, AI is going to be inflationary because it’s going to turbocharge the ability of the current billing systems to work more effectively,” Oz said at Oracle’s annual health and life sciences summit in Orlando. 
    • “It’s the latest signal from the industry that AI could be inflating healthcare costs — even as its proponents argue the technology will lower them over time.” * * *
    • “For providers, AI-powered coding is enabling them to bill insurers for more conditions when they treat patients. They say the technology helps them more accurately bill for care, while insurers say doctors are using AI to charge more money without any actual increase in medical care.
    • “A study released by the insurer group Blue Cross Blue Shield Association on Thursday found that the increase of billing has added nearly $1 billion in healthcare costs between 2023 and 2025. The group said the study “raises concerns” that AI tools are contributing to higher spending.” * * *
    • “Although Oz noted the increase in healthcare costs, he said AI was still essential in the industry.
    • “I guarantee you we will lose lives if we don’t use AI in the day-to-day trench warfare of fighting disease in America,” he said.
    • “Oz said he hoped AI would lower healthcare costs in the long run, and that the government was relying on one particular area to make that happen: accountable care organizations.”

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

  • Following up on yesterday’s post about FedSmith’s helpful breakdown of the FEHB / PSHB questions for which OPM has requested public comment, it turns out that the public already has submitted 113 comments to the agency. You can access those comments here. In contrast to OPM’s limited posting of comments on its modified system of records notice, OPM has posted all 113 comments received to data on this new topic.
  • Tammy Flanagan, writing in Govexec, tells us,
    • “What changed in your federal benefits in 2026 — and what could change next? Agencies updated federal retirement, insurance, Social Security and Thrift Savings Plan programs, while Congress considered proposals affecting future pay and benefits. This article summarizes the changes that took place in 2026 along with the links to official sources.
    • “Review the 2026 changes now and watch for 2027 updates this fall. During Federal Benefits Open Season, OPM will soon begin to publish 2027 plans, premiums and coverage information. The September CPI release on Oct. 14, 2026, will provide the final CPI-W data used to determine 2027 Social Security and federal retirement COLAs.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “With some trepidation, a majority of an FDA advisory committee Thursday endorsed the Galleri multicancer early detection blood test.
    • “By 6-4 and 7-2 (with one abstention) margins, the molecular and clinical genetics panel of the Medical Services Advisory Committee voted that the test was effective and that its benefits outweigh the risks. However, many panel members who voted yes had reservations about their votes.
    • “The panel was more decisive on the question of safety, voting unanimously (10-0) in favor of Galleri.
    • “While most panel members agreed that as a diagnostic test Galleri was safe, effective, and demonstrated a positive benefit/risk profile, particularly for cancers for which screening tests are unavailable, they were concerned about the lack of outcome data supporting the test’s premarket approval (PMA) application, as well as the use of the term “early” in describing the purpose of the test.
    • “I really struggled with this one … I did change my vote twice,” said Jason Dominitz, MD, MHS, of the VA Puget Sound Health Care System in Seattle, explaining his yes vote on Galleri’s effectiveness. “Clearly, there are clinically impactful results of the test. People get a diagnosis work-up, cancers are found, but does that lead to clinically clinical benefit? I don’t see that we have evidence of clinical benefit at this time.”
    • “The question comes down to what do you call clinical effectiveness,” said Stanley Lipkowitz, MD, PhD, of the National Cancer Institute, who voted no. “As an oncologist, I generally look at that as outcome, and we don’t have that data.” * * *
    • “While not bound by its advisors’ recommendations, the FDA usually follows their advice.”
  • USA Today relates,
    • “Officials have classified the risk level of a thyroid medicine recall initiated last month to its most serious category.
    • “On Sept. 22, the U.S. Food and Drug Administration categorized the recall – which applies to one lot of thyroid tablets sold by Vitruvias Therapeutics Inc. – as a Class I recall, its highest risk level.
    • “Last month, Vitruvias Therapeutics Inc. recalled one lot of its 30 mg thyroid tablets because they could be superpotent, or stronger than intended, according to a FDA recall notice published on Aug. 24.
    • “The affected products include thousands of units distributed nationwide from January to September 2025 with an expiration date in September 2026, according to the notice.
    • “A Class I recall – the most serious FDA category – indicates that using the product is likely to cause serious health effects or death, according to the agency.”
  • CBS News considers “whether an FDA crackdown [noted in yesterday’s FEHBlog will] curb access to cheaper GLP-1 weight-loss drugs?
    • Scott Brunner, CEO of Alliance for Pharmacy Compounding, said that the FDA’s warning wasn’t about the volume alone, but the lack of documentation to prove that Empower was appropriately making the drug for individual patient needs.
    • “The FDA is possibly marking a line in the sand,” said Darshan Kulkarni, founding partner of the Kulkarni Law Firm and an expert in healthcare and pharmacy law. For now, though, the FDA’s warning shot is more likely to prompt compounding pharmacies to reframe how they differentiate their weight-loss products than to immediately stop making them, he said.
    • “But with the FDA taking a stance on the limits of compounded weight-loss drugs, he said, “That avenue is definitely getting narrower.”

From the public health and medical / Rx research front

  • Beckers Hospital Review reports,
    • “A recent study found 11.3% of healthcare personnel surveyed reported persistent long COVID symptoms.
    • “The study, published in the American Journal of Industrial Medicine, used electronic surveys to collect symptom data at three and six months post-infection from 1,496 healthcare personnel. Long COVID was defined as the same moderate or severe symptom reported at both time points. 
    • “Here are the findings.
      • “1. Older age was associated with higher odds of persistent symptoms, and female healthcare personnel had greater odds of persistent symptoms than male personnel. 
      • “2. Prior COVID infection or more than two underlying health conditions were also associated with higher odds of long COVID.
      • “3. Physicians, licensed practical and registered nurses, and therapists or therapy assistants had lower odds of long COVID than nonclinical healthcare personnel.”
  • MedPage Today tells us,
    • Lyme disease is the nation’s most frequently reported vector-borne disease.
    • In a U.S. cohort study, 29.5% of people positive for the bacteria that causes Lyme disease also tested positive for at least one of three other tick-borne pathogens.
    • The study suggests that even with typical Lyme disease symptoms, clinicians should consider the presence of other tick-borne pathogens, which may have implications for treatment.
  • and
    • “Residual lifetime ovarian cancer risk warrants consideration of risk-reducing bilateral salpingo-oophorectomy for healthy older BRCA carriers.
    • “Individualized decision-making about surgery should weigh risk reduction against impact on fertility and quality of life.
    • “Substantial residual risk remains for women who delay surgery to age 50, particularly for BRCA1 carriers.”
  • Health Day adds,
    • “Glucose patterns captured by continuous glucose monitors (CGMs) are linked to cardiometabolic risk in adults without diabetes, according to a study published online Sept. 17 in Diabetes Care.”
  • The American Medical Association lets us know “what doctors want patients to know about high cholesterol.” 
    • “Sorting through the good, the bad and the ugly about high cholesterol can be confusing. Understanding your overall risk, and not just one number, can help.”
  • Cardiovascular Business considers “Semaglutide is improving the heart health of millions—but how? Experts are stumped.”
    • “Professor Helen Colhoun, MBBChBAO, MD, a healthcare researcher and diabetes specialist with the University of Edinburgh, et al. tracked differences related to body weight, waist circumference, lipids, blood pressure and more in patients given semaglutide and those given a placebo. The overall conclusion was improvements in weight loss and waist circumference only partially explain the cardiovascular benefits being seen among patients given semaglutide. There is something more going on there—but what that happens to be is not yet totally clear.
    • “Our analyses could not fully ascribe the effects of semaglutide on cardiovascular disease to known risk factors with any certainty,” Calhoun said. “Whether we combine all risk factors together or look at some subsets of the risk factors, no more than half of the reduction in heart disease could be explained by the changes in these risk factors. These results suggest that semaglutide should be considered as a cardiovascular disease reduction drug and not just as a weight loss drug.” 
    • “She added that more research is still needed to help clinicians learn more about this significant trend. 
    • “Click here to read the full analysis.”
  • Reuters points out,
    • “Scientists have created a detailed map of gene activity within a crucial part of the brain called the prefrontal cortex, gaining insight into normal development and major brain disorders such as Alzheimer’s disease, Parkinson’s disease and ​schizophrenia.
    • “In nine separate studies, the researchers examined changes in individual types of brain cells that occur over time and made progress toward deciphering molecular processes ‌that underlie some of the most devastating brain disorders, a step toward possible new treatments.
    • “The prefrontal cortex is the front part of the brain’s outer layer, located behind the forehead. It helps a person plan, make decisions, regulate emotions and adapt behavior. It also is sensitive to age-related decline, and its functions are affected in many psychiatric and neurodegenerative disorders.” * * *
    • “The research identified patterns shared across some of the diseases as well as some ​specific to individual disorders.
    • “Together, these studies help explain where disease-related changes occur and which biological processes deserve closer investigation,” said Dr. Panos Roussos, director of the Center for Disease Neurogenomics at ​the Icahn School of Medicine at Mount Sinai in New York City and a leader of the research published on Wednesday in Nature, opens new tab and other journals.
    • “A useful treatment needs to influence the right biological process in the right cells. This map helps narrow that search. It can identify vulnerable cell populations, reveal processes associated with preserved brain function and help researchers decide which potential treatment targets to test,” Roussos ​said.”

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

  • Beckers Payer Issues reports,
    • “The Cigna Group is partnering with OpenAI to integrate AI into clinical workflows, with a first focus on cancer care.
    • “Under the collaboration announced Sept. 23, OpenAI’s tools will be built into workflows across Accredo Specialty Pharmacy and the insurance business, Cigna Healthcare. The first new capability will give oncology nurses and case managers an AI-enabled view that pulls together clinical, pharmacy, behavioral and benefits information for each member.
    • ‘The companies said the goal is to identify member needs earlier and personalize support between physician visits, when patients are often dealing with side effects, new symptoms and unanswered questions. The system is designed to feed insights from member responses back into future guidance and workflows over time.”
  • Cotiviti adds,
    • “Cotiviti and MedCity News just published the 2026 Healthcare AI Readiness Index revealing fascinating insights, including a striking contradiction.
    • “AI adoption is essentially universal in healthcare. Investment in AI is accelerating, and executives clearly see operational value. Yet only a minority feel prepared for AI-enabled cyberthreats. Less than 40% have detailed governance policies, more than 60% of respondents report shadow AI usage, and most still require human oversight for the highest-consequence decisions.
    • “Healthcare doesn’t have an AI adoption challenge. It has an AI readiness challenge. Governance, cybersecurity, and human oversight are all evidence of the broader gap between AI adoption and readiness. This gap may be the most important risk that healthcare executives aren’t measuring.”
  • Healthcare Dive points out,
    • “Investment in health IT is a top priority for a majority of providers and payers, though executives are seeking solutions for specific use cases that provide measurable results, a new survey from Bain & Company and KLAS Research shows.
    • “Tools that target revenue cycle management, patient engagement and clinical workflows are attracting attention — and investment dollars — from providers. Payers are focused on utilization management, care navigation and claims processing.
    • ‘Executives are especially emphasizing measurable return on investment when it comes to AI, with some seeking returns of 3x to 3.9x their original investment, according to the survey.”
  • Fierce Healthcare relates,
    • “UnitedHealth Group has named Jodee Kozlak to the newly created role of chief administrative officer, the healthcare giant announced Thursday morning.
    • “Kozlak will take the position on Sept. 28, per the announcement. In this role, she will be tasked with leading the company’s enterprise modernization efforts, including a portfolio that will initially include people, real estate, procurement and corporate security.
    • “Kozlak is currently chair of the board at C.H. Robinson Worldwide, a transportation and third-party logistics company, and is lead independent director for KB Home, a homebuilding company. She served as the global senior vice president for the Alibaba Group from 2016 to 2017, supporting the company’s expansion outside of China.
    • “She also held multiple leadership roles at Target Corporation between 2004 and 2015, including in human resources and legal, UnitedHealth said in the announcement.”
  • Beckers ASC Review informs us,
    • “Private equity ownership has become increasingly common across physician practices over the last decade, with investors backing groups in specialties like anesthesiology, orthopedics, gastroenterology and pain management. 
    • “Now, a new federal bill aims to ban it outright.
    • “Democratic lawmakers introduced the Stop Corporate Takeovers of Physicians Act on Sept. 16. The federal bill would ban private equity firms, insurers and other for-profit corporations from owning or controlling physician practices.
    • “Becker’s connected with 14 physicians, healthcare executives and attorneys to get their take on the bill. Most agreed the legislation is unlikely to pass or to fully undo private equity’s footprint in healthcare, but several said it targets the right problem and could shape future deals. Many also warned that the bill’s exemptions for hospitals and nonprofits could speed up hospital consolidation, and that it does little to address the reimbursement pressures pushing independent practices toward outside investors in the first place.”
  • Cardiovascular Business notes,
    • “The Heart Failure Society of America (HFSA) has released a new comprehensive look at heart failure (HF) clinics in the United States. The report includes more than 300 HF programs located in 47 states that serve approximately 626,000 patients.
    • “HFSA wanted to shine a spotlight on the country’s specialty clinics, often found in academic medical centers, while highlighting care gaps where many patients remain underserved. For instance, many Southern and Appalachian states—areas known for especially high risks of HF and other cardiovascular conditions—still have fewer clinics than are needed to ensure patients can easily access high-quality care.
    • “This report shows where specialty heart failure care exists in the United States and, just as importantly, where it doesn’t,” HFSA President Kenneth B. Margulies, MD, said in a statement. “The clinics in this database represent professional, multidisciplinary care. But the mismatch between where that care is concentrated and where the disease burden is heaviest is the central challenge our country needs to address.” * * *
    • “Click here for the full report. Its release comes just days before ASM 2026, HFSA’s annual scientific meeting.” 

Midweek report

David Ermer–CDC, CMS, Electronic health records, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Healthcare Dive reports,
    • “The leader of an influential congressional advisory group is defending its estimates of Medicare Advantage overpayments amid growing controversy over how to best analyze spending in the privatized Medicare program.
    • “Dr. Amol Navathe, the chair of the Medicare Payment Advisory Commission, or MedPAC, took the stage during an MA industry event in Washington, D.C. on Tuesday in support of the group’s research that the U.S. government is set to spend 14% more — an extra $76 billion — this year on seniors that opt into MA than it would if those same beneficiaries went into traditional Medicare.
    • MedPAC isn’t interested in making MA look bad, Navathe said at the event hosted by the Better Medicare Alliance, an influential MA lobby.
    • “The estimate that MA costs 14% more than traditional Medicare doesn’t mean MedPAC is advocating for a 14% cut to MA. Instead, the legislative agency’s goal is to support competition in the popular Medicare alternative and produce reliable research that spurs meaningful conversations about potential reform, according to Navathe, who was named MedPAC’s chair in May.” * * *
    • “Insurers argue that MedPAC’s estimate — which is broadly cited by members of Congress, health policy experts and other stakeholders in the healthcare industry — is flawed and makes MA seem costlier than it really is. MA plans instead prefer a CMS analysis from January that yields a dramatically lower estimate of overpayments, or industry-funded research that finds MA is actually cheaper for taxpayers.”
  • The Wall Street Journal relates,
    • “More than two million people in the U.S. who take prescription drugs bought them from outside the country to save money, according to a 2020 study published in JAMA Network Open, some of the most recent research available on the topic. 
    • “The practice has operated for decades in a legal gray area: technically barred under FDA rules, importers say it is rarely enforced. Customs agents have historically waved through low-value, personal-use packages rather than individually checking each one against the agency’s criteria.
    • “The U.S. government has already made these imports more difficult. Starting in August of last year, patients ordering medication by mail have had to start paying customs fees on shipments that previously arrived free of charge.
    • “The new rule fully closes the regulatory gap on Oct. 22.
    • “After that, prescription drugs will need to move through a formal entry process with an accountable company or person legally on the hook if a shipment doesn’t qualify.”
    • More than two million people in the U.S. who take prescription drugs bought them from outside the country to save money, according to a 2020 study published in JAMA Network Open, some of the most recent research available on the topic. 
    • The practice has operated for decades in a legal gray area: technically barred under FDA rules, importers say it is rarely enforced. Customs agents have historically waved through low-value, personal-use packages rather than individually checking each one against the agency’s criteria.
    • “The U.S. government has already made these imports more difficult. Starting in August of last year, patients ordering medication by mail have had to start paying customs fees on shipments that previously arrived free of charge.
    • “The new rule fully closes the regulatory gap on Oct. 22.
    • “After that, prescription drugs will need to move through a formal entry process with an accountable company or person legally on the hook if a shipment doesn’t qualify.” * * *
    • “The rule applies to any FDA-regulated mail shipment from any country, including smaller medication pipelines from India, the United Kingdom, Australia and Turkey. It doesn’t change regulations around Americans who buy medication in person while traveling.”
  • Beckers Health IT tells us,
    • “Health systems are not the only groups pushing back against a CMS proposal to restrict remote patient monitoring.
    • “In July, CMS pitched banning Medicare payments for remote patient monitoring services carried out by third-party companies. As proposed, starting Jan. 1, 2027, payments for remote physiologic and therapeutic monitoring would be permitted only when furnished by clinical staff directly employed by the billing practice. CMS accepted comments on the proposed rule until Sept. 14.
    • “On that date, UnitedHealth Group, CVS Health and Kaiser Permanente all voiced concerns in their respective letters to CMS.”
  • The American Hospital Association News informs us,
    • “The AHA Sept. 23 recommended the Department of Homeland Security make healthcare workers exempt from its proposed H-1B visa fee of $103,265 for petitions subject to statutory caps. In a letter to DHS on the proposal, the AHA said it is concerned that the fee would hinder hospitals and health systems’ ability to use the H-1B program to address healthcare worker shortages and would particularly have adverse impacts on hospitals in rural and underserved communities. The AHA also urged DHS to mitigate potential impacts on foreign-trained physicians with a waiver of the home-country physical presence obligation provided through the Conrad 30 Waiver Program. The proposed fee from DHS is separate from the $100,000 H-1B visa fee issued by the administration through a presidential proclamation Sept. 18.”
  • Per Department of Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced $51 million in awards to 28 HRSA-funded health centers to improve access to dental care for children with neurodevelopmental disorders, including autism spectrum disorder, Down syndrome, cerebral palsy, and intellectual disabilities.
    • “The new Quality Improvement Fund – Improving Access to Dental Services for Children with Neurodevelopmental Disorders (QIF-DNDD) investment will help health centers build on evidence-based models and test innovative approaches to improve dental care for children with neurodevelopmental disorders. The funding will support expanded and tailored preventive and other dental services, strengthen the health center workforce, and identify promising approaches that can be replicated in other communities.” * * *
    • “Visit the QIF-DNDD webpage for more information and the list of FY 2026 award recipients.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), today released a Request for Information (RFI), “Improving Patient Access to Deceased Donor Islet Cells and Cell Products,” seeking public input on how the federal government should regulate certain deceased donor islet cells and cell products used to treat type 1 diabetes. The RFI asks whether the current FDA-led biological product framework creates barriers to patient access and whether an alternative transplant-based framework could improve access while maintaining rigorous safety and quality protections.
    • “Under the current framework, therapies made from deceased donor pancreatic islet cells are regulated by the FDA as biological products. FDA’s approval process evaluates product safety, effectiveness, and manufacturing quality, and approved products remain subject to ongoing safety oversight.
    • “Deceased donor islet cells can give some people with type 1 diabetes the ability to produce insulin again,” said HHS Secretary Robert F. Kennedy, Jr. “HHS is taking a hard look at whether federal regulations unnecessarily stand between patients and these potentially life-changing treatments. We will protect rigorous standards for safety and quality while examining every responsible path to expand access and put patients first.” * * *
    • “HHS encourages all interested parties to submit comments by November 8, 2026. To review the RFI and submit a response, visit the federal register and reference Docket No. FDA-2026-N-10738.”
  • Beckers Hospital Review adds,
    • “Nashville, Tenn.-based Vanderbilt Health has been given an up to $11.2 million, five-year HHS contract to develop a platform to test and validate new technologies designed to improve ICU patient outcomes.
    • “The federal program is called CIRCLE — the Critical Illness Immunological Reprogramming and Control Point Learning Engine — and is part of HHS’ Advanced Research Projects Agency for Health, according to a Sept. 22 news release from Vanderbilt Health.
    • ‘Focused on ICU patient care, “CIRCLE will harness advances in diagnostics and AI to speed development of next-generation interventions that identify and respond to harmful immunoinflammatory states before life-threatening complications occur,” the release said.” 

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

  • FedSmith helpfully breaks down the FEHB / PSHB questions for which OPM has requested public comment.
    • “Comments can be submitted through November 16, 2026, on Regulations.gov under docket number OPM-2026-0661. Keep in mind that comments are posted publicly as submitted, including any names or contact details you include.
    • “Sharing specific experiences and suggested improvements is likely to carry more weight than general complaints, for example, how a premium increase affected your plan choice, whether you’ve tried an HDHP, or where the plan comparison tool fell short.”
  • FedWeek tells us,
    • “OPM has set a cap of 40 percent for the top two ratings levels combined in performance evaluations for the large majority of employees under the GS system effective with the rating cycle ending September 30.
    • “A memo assigns a number to the limit on Level 5 and Level 4 ratings under the recently finalized rules implementing a forced—what OPM calls “standardized”—ratings pattern in response to what the administration has criticized as too many employees being rated as “outstanding” and “exceeds fully successful.”
    • “Says the memo, “Distribution caps are intended to address these concerns by establishing a governmentwide ceiling on the share of employees who may receive the highest rating levels. This approach promotes more consistent and credible ratings across agencies, while requiring agencies to make more meaningful distinctions among the levels rather than defaulting to ratings that avoid difficult assessments.”

From the Food and Drug Administration front,

  • Beckers Hospital Review relates,
    • “The FDA has issued a warning letter to Houston-based Empower Pharmacy after an inspection found evidence that certain compounded drugs failed to meet conditions for exemptions under federal law.
    • “The agency said Empower compounded products that appeared to be essentially copies of FDA-approved semaglutide and tirzepatide products “regularly and in inordinate amounts,” according to the Sept. 18 warning letter. FDA investigators also cited insanitary conditions and current good manufacturing practice violations.
    • “Among the issues, investigators said Empower failed to perform adequate smoke studies under dynamic conditions and its media fills were not performed under the most challenging or stressful conditions. The FDA also cited deficiencies involving aseptic processing, environmental monitoring, quality control and production procedures.”
  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has shared an early alert about a new safety issue with certain Impella Automated Impella Controllers (AICs) from Johnson & Johnson MedTech. 
    • “Devices included in this alert should be removed from where they are used or sold so they can be serviced by Johnson & Johnson MedTech. While awaiting service, however, the AICs can still be used as necessary to ensure patients can still undergo treatment. 
    • “This new announcement covers three devices in total:
      • “Impella Controller, Packaged, US – 0042-0000-US
      • “Impella Optical Controller, Packaged, US – 0042-000010-US
      • “Optical, AIC, Impella Controller, Packaged, US – 0042-0040-US
    • “Customers can click here for a list of all serial numbers included in this alert as well as information on how to locate the serial number.” 
  • Radiology Business adds,
    • “The U.S. Food and Drug Administration has cleared a radiology artificial intelligence tool to check for 10 additional findings on abdomen-pelvis CT scans. 
    • “Imaging startup a2z Radiology AI Inc. on Monday touted the regulatory approval, which applies to its Abdo-Triage product. This expands the AI software’s range of suspected findings it can flag for clinical review up to 17, building on a previous clearance earned in late 2025. 
    • “Found in 2024, the Boston-based company says it’s building the “intelligence layer for medical imaging,” hoping to make radiologist interpretations “accessible on demand.” 
    • “Care teams need support that reflects the range of cases they see,” Samir Rajpurkar, co-founder and CEO of a2z Radiology AI, said in a statement Sept. 21. “We’re building a platform around that need. This clearance extends the range of clinically important findings we can flag on CT scans, bringing us closer to our goal of helping teams focus their attention where it is needed.”
  • Cure tells us,
    • “The Food and Drug Administration (FDA) approved Lyrfigtu (lirafugratinib) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 gene fusion or other rearrangement.
    • “Cholangiocarcinoma is a cancer that begins in the bile ducts. Unresectable means the cancer cannot be removed with surgery, while metastatic cancer has spread to other parts of the body.
    • “The approval was based on findings from the REFOCUS trial, which included 116 patients who had previously received chemotherapy or chemoimmunotherapy and had not previously received an FGFR inhibitor.”
  • Beckers Behavioral Health informs us,
    • “The FDA granted Breakthrough Device Designation to the NET Device, made by Costa Mesa, Calif.-based NET Recovery, as an aid in reducing psychostimulant use in adults 18 and older diagnosed with stimulant use disorder.
    • “The designation covers a proposed new indication for the device, including cocaine use disorder and amphetamine-type/methamphetamine use disorder, according to a Sept. 23 news release from the company. No drug is FDA-approved and no medical device is FDA-cleared to treat cocaine or methamphetamine use disorder.
    • “Approximately 4.5 million Americans struggle with both opioid and stimulant use. Stimulant-involved overdose deaths also accounted for 59% of U.S. overdose deaths from January 2021 through June 2024, according to the CDC.”

From the fraud, waste and abuse front,

  • Beckers Hospital Review points out,
    • “Off-label GLP-1 use increased 15-fold between 2021 and 2025, according to a study published Sept. 22 in Obesity.
    • “Researchers analyzed medical records from more than 92 million U.S. adults to examine GLP-1 use among patients without a documented condition that would make them eligible for the medications, such as obesity or diabetes.” * * *
    • “The findings may underestimate off-label use. Researchers said their analysis may not capture prescriptions obtained through telehealth companies or compounded GLP-1 medications.”
  • The New York Times adds,
    • “There is little data on how the [GLP-1] drugs might affect people without obesity or diabetes, because they were largely excluded from major clinical trials.
    • “These medications might pose unique risks to people who are not overweight, Dr. Krüger said. Those risks include malnutrition, as well as muscle mass loss, side effects of the drug that can affect anyone but that could be especially concerning in people with lower starting B.M.I.s.
    • “We don’t know how this will play out,” Dr. Krüger said. “It’s like this big Ozempic experiment.”
  • The Paragon Institute explains that the 760,000 “persons” disenrolled from Obamacare plans yesterday are phantom enrollees.
    • “First, CMS identified enrollees who were likely phantoms using four criteria:
      • “The application was submitted by an agent or broker without a Social Security number or immigration number for the applicant;
      • “The enrollee paid nothing toward the premium because the federal subsidy covered the entire amount;
      • “The enrollee had no medical claims; and
      • “The insurer had no record of actual contact with the enrollee.
    • “Second, for applicants meeting those four criteria, CMS required insurers to send notices through two different modes of communication, providing the enrollee with an opportunity to respond. Insurers had significant incentives to get in touch with these applicants because they were receiving subsidies to cover the full premium.
    • “Third, if there was no response, the enrollment was deemed unauthorized and canceled.
    • “Importantly, CMS has put in place a safeguard if any of the enrollees removed are legitimate: The enrollee can contact the federal exchange, provide verified identifying information, and have their coverage reinstated.
    • “To be clear, most of the fraud and improper enrollment is perpetrated by corrupt agents and brokers. But it is enabled by Obamacare subsidies so large that they produce “free” plans for applicants claiming low incomes, while the resulting improper enrollment financially benefits large health insurance companies.”
  • Federal News Network reports,
    • “The Treasury Department is on track to expand the full use of its Do Not Pay system to all federal agencies in the near term, as Treasury officials aim to fill payment verification gaps and help agencies prevent issues earlier in the payment lifecycle.
    • “Just over a year ago, only 4% of federal programs had done the compliance paperwork necessary to fully access Do Not Pay databases, according to Justin Marsico, executive director for financial integrity at the Treasury Department’s Bureau of Fiscal Service.
    • “But following an executive order and guidance issued by the Trump administration to streamline access to Do Not Pay, Marsico said many more agency programs now have full access to the data, with more progress expected in the coming months.
    • “We’ve gone now from 4% of government programs to 45% of government programs as of last week, and we’re on track for 70-80% by the end of the fiscal year,” Marsico said Tuesday during a fraud prevention conference hosted by AGA. “With another little push into the next fiscal year, we should be able to get to 100[%].”

From the judicial front,

  • Beckers Hospital Review reports.
    • “The Department of Justice revised its manual Sept. 18 to support its fight against fraud under the False Claims Act through more clearly outlined standards to promote fairness and effective enforcement.
    • “The first change in the manual reinstates and expands on the department’s 2017 policy that subregulatory guidance can’t impose legal obligations beyond those established by regulation or statute, according to a Justice Department news release.” * * *
    • “The second manual revision flags that the Justice Department should consider exercising its dismissal authority when declining to intervene in a qui tam case. Where it does not look for dismissal, the department should revisit the assessment as needed during litigation.” * * *
    • “The full Justice Manual revisions can be found here and here.” 
  • Per a FDA news release,
    • “A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
    • “The U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction against Gold Star Distribution, Inc., a Minnesota-based multi-commodity warehouse operator, and its owner, Bassam Abu Samrah, after the FDA observed persistent insanitary conditions, including severe rodent and pest infestations, that put food, drugs, medical devices, and cosmetics at risk of potential contamination with filth.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Americans are drinking less for the first time since the coronavirus pandemic began, but drinking levels are still higher than before the pandemic, according to a new study published this week.
    • “Researchers analyzed data from more than 114,000 U.S. adults from the National Health Interview Survey and found that any alcohol use declined by almost 2 percent, and heavy drinking fell by more than 8 percent from 2022 to 2024.
    • “In the same period, Gen Z adults saw the largest decline in any alcohol consumption of around 5 percent, according to the study published in the Annals of Internal Medicine. Millennials saw a 17 percent drop in heavy drinking.”
    • “Not all Americans are following the trend. Drinking among those ages 50-64 is still higher than before the pandemic; the group’s overall alcohol consumption is up by almost 4 percent and heavy drinking increased by 36 percent between 2018 and 2024.
    • ‘Brian Lee, a hepatologist and liver transplant specialist with Keck Medicine of the University of Southern California, said that was especially concerning because that age group faces a higher risk of many alcohol-associated diseases like cirrhosis and alcohol-related cancers.
    • “We’re seeing the increases in exactly the age group that we’re most worried about in terms of health and organ damage,” said Lee, the study’s principal investigator.”
  • Beckers Behavioral Health lists rates of 2025 deaths by opioid overdoses and suicides by State.
    • “New Mexico had the highest opioid overdose death rate in the U.S. in 2025, while Nebraska had the lowest, according to a KFF analysis of provisional CDC data.
    • “The national opioid overdose death rate was 13.1 per 100,000 individuals in 2025. New Mexico’s rate of 33.9 per 100,000 was more than 2.5 times the national figure.”
    • “Alaska had the highest suicide rate in the U.S. in 2025, while New Jersey had the lowest among states, according to a KFF analysis of provisional CDC data.
    • “The national suicide rate was 13.7 per 100,000 individuals in 2025. Alaska’s rate of 31 per 100,000 was more than double the national figure.”
  • Beckers Hospital Review lets us know,
    • “Only 13% of hospital-onset sepsis cases met current U.S. criteria for reportable healthcare-associated infections, but an expanded surveillance system could catch many of these potentially preventable events, a recent study found.
    • “The study, published Sept. 17 in JAMA Network Open, analyzed 558,037 admissions of adults 18 and older at nine Mass General Brigham acute care hospitals between January 2021 and December 2023. Patients with hospital-onset sepsis were identified using the CDC’s Adult Sepsis Event criteria. In total, 5,212 patients, or 0.9%, had hospital-onset sepsis. Researchers randomly selected 250 cases for detailed record reviews by two physicians to determine the likelihood and source of infection. Then 100 infection-related cases were selected for preventability assessments considering patients’ intrinsic risks and extrinsic healthcare-related factors. 
    • “Hospital-onset sepsis events identify serious complications of hospitalization that are largely missed by current HAI surveillance programs yet are highly morbid and often preventable,” the study’s authors wrote. “Hospital-onset sepsis surveillance could provide a more comprehensive framework for identifying preventable harms and expanding opportunities for quality improvement.”
  • MedPage Today informs us,
    • “Hospitalizations complicated by acute kidney injury (AKI) surged among patients in pediatric units or children’s hospitals over the past 25 years, a large retrospective study indicated.
    • “Among more than 24.3 million discharges, hospitalizations involving AKI increased tenfold, rising from 15.7 per 10,000 discharges in 1997 to 168.7 in 2022. Rates of AKI requiring dialysis (AKI-D) more than doubled over the same period, growing from 2.4 to 5.5 per 10,000 discharges.
    • “National weighted annual incidence of AKI cases jumped from 6,318 to 63,923, while AKI-D cases increased from 981 to 2,075, reported Alexander Kula, MD, MHS, of Ann and Robert H. Lurie Children’s Hospital of Chicago, and colleagues in JAMA Network Open.
    • “However, in-hospital mortality among pediatric patients with AKI improved significantly, dropping from 1,814.0 to 643.4 per 10,000 hospitalizations between 2003 and 2022. Mortality for patients requiring dialysis remained stable at approximately 25%.
    • “Rising AKI rates should not be viewed “solely as worsening care,” cautioned Laura Rangel Rodriguez, MD, of Cincinnati Children’s Hospital Medical Center, and David Selewski, MD, of Arkansas Children’s Hospital in Little Rock, in an accompanying commentary.
    • “Children with complex congenital heart disease, malignant neoplasms, transplants, and critical illness are surviving longer and being exposed to therapies and physiologic stressors that increase the risk of kidney injury,” they wrote. “Increasing AKI rates may therefore reflect both improved case identification and the growing medical complexity of contemporary pediatric hospital care.”
  • Healio tells us,
    • “Only about one in six U.S. adults eligible for lung cancer screening discussed the procedure with a health care professional in the past year, according to study results.
    • “Current smokers and those with comorbidities more often reported having those discussions, a finding researchers say suggests clinicians prioritize individuals most at risk.
    • “However, an analysis of Health Information National Trends Survey (HINTS) data revealed what investigators called “persistent gaps” in communication that appeared more pronounced based on individuals’ race, insurance status and social context.
    • “We know lung cancer screening is not well utilized compared with screening for other cancer types, so we expected conversations about this topic would be infrequent. However, it was surprising to see such a low rate,” lead author Sofia W. Viana, MD, research fellow in the department of thoracic surgery at University of Cincinnati, told Healio.”
  • Health Day points out,
    • “There is no evidence that chiropractic neck manipulation increases the risk of a rare artery tear.
    • “Researchers studied over 862,000 adults with new neck pain or headaches and compared chiropractic neck adjustments with ibuprofen
    • “People should still watch for sudden or unusual headaches, different neck pain or neurological symptoms.” * * *
    • “An author of the study said people often ask her whether chiropractic care for neck pain is safe.
    • “This study is some of the best evidence yet that the answer to that question is yes,” said co-author Christine Goertz, a professor in orthopaedic surgery at the Duke Clinical Research Institute.”
  • Genetic Engineering and Biotechnology New notes,
    • “As we age, some of the cells in our body enter a state of senescence, in which they stop dividing but do not die. Those senescent cells can contribute to age-related disorders such as cancer, tissue degeneration, and inflammatory diseases.
    • “In an advance that could lead to better ways to diagnose and treat those diseases, MIT researchers have developed a noninvasive way to detect biomarkers of senescence. Their method is based on Raman microscopy, which can reveal the biochemical composition of cells without harming them.
    • “Using the new technique, “RamanOmics,” which combines Raman microscopy with gene expression data at single-cell resolution from the same cells, the researchers were able to identify unique “barcodes” that can be used to quickly identify senescent cells. And while their reported study was carried out in mouse cells, the scientists are now working on adapting it for use with human tissue.
    • “You can imagine that one day we may develop an endoscope that can look inside your body and identify cellular senescence,” says Jeon Woong Kang, PhD, an MIT research scientist and co-senior author of the team’s published study in Nature Aging, titled “RamanOmics decodes the spatial vibrational–molecular architecture of senescence in aging and repair,” in which they concluded, “Together, RamanOmics provides a tissue-agnostic framework for scalable, multimodal profiling of cellular states.”
  • The Wall Street Journal relates,
    • “Roche Holding RO said a drug candidate for an autoimmune disease known as IgA nephropathy met the primary goal of a late-stage clinical study, paving the way for the company to seek regulatory approval.
    • “The Swiss drugmaker said Wednesday that interim results from a continuing study of its investigational medicine sefaxersen showed it significantly reduced proteinuria—a key indicator of kidney damage—in people with IgA nephropathy, which is also known as Berger’s disease.
    • “The company said it would share the study’s interim data with health authorities with the aim of bringing the treatment to the market as soon as possible.
    • “The data pointed to the drug’s potential to reduce the so-called urine protein-to-creatinine ratio, which is associated with the preservation of long-term kidney function, Roche said. The safety and tolerability results of the medicine—a once-monthly subcutaneous injection—were consistent with known data, it added.”

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

  • Beckers Payer Issues reports,
    • “UnitedHealthcare, Cigna and Centene are among the initial participants in a national shared provider credentialing program, launching in the fall.
    • “CertifyOS, a provider data intelligence company, announced the program Sept. 23. The initiative aims to standardize credentialing and verification, speed up the time to join an insurance network and serve as a reliable source of truth on provider data.
    • “Healthcare providers often face duplicative credentialing requirements that create unnecessary complexities,” Mike Kane, UnitedHealthcare’s senior vice president of provider data operations, said in a CertifyOS news release. “This model will help streamline that process and allow providers to spend more time focused on patient care.”
  • Fierce Pharma relates,
    • “Sign-ups for Medicare’s GLP-1 coverage plan keep expanding, and Eli Lilly is dominating the market with a 70% share, the company’s CEO David Ricks said.
    • “Since its rollout on July 1, the Medicare GLP-1 Bridge has attracted about 700,000 seniors who’ve started treatment, Ricks said in an interview with CNBC.”
  • MedTech Dive adds,
    • “Wearables firm Oura is seeking up to $2.2 billion in an initial public offering, the company disclosed in a Monday securities filing. 
    • “While the IPO has not been priced yet, Oura estimates its shares will be valued at $40 to $44 each. Oura plans to offer 13.5 million shares of common stock, and selling stockholders plan to offer 36.5 million shares, for a total of 50 million shares.
    • “Oura is going public as wearables firms grapple with the line between wellness features and medical devices. Oura currently faces a proposed class action lawsuit over the accuracy of its sleep tracking features.”
  • Beckers Hospital Review points out,
    • “Public threats by hospitals or insurers to end network contracts are concentrated in markets where neither side dominates, according to a study published Sept. 23 in Health Affairs.
    • “The study, by researchers at Brown University in Providence, R.I., examined 14,918 relationships between 3,772 hospitals and 92 in-market commercial insurers for contracts ending between August 2021 and July 2025. Researchers cataloged public threats using a news database and manual review.
    • “Researchers documented 1,249 episodes in which a hospital or insurer publicly announced or threatened network withdrawal, about 8% of relationships. Of those, 348, or 28%, ended with the hospital actually leaving the network, corresponding to about 2% of all relationships studied. Most episodes occurred after August 2023.
    • “The rate climbed to about 16% where the hospital system controlled roughly 23% to 45% of local beds and the insurer held 30% to 44% of commercial lives. “There is a ‘Goldilocks zone’ where hospitals and insurers assess that the anticipated advantages of brinkmanship trump anticipated disadvantages,” the authors wrote, noting a party may be less able to credibly threaten withdrawal when its counterpart controls a very high share of beds or lives.”
  • and
    • “The state of Hawaii and Kaiser Permanente will fund the restoration and reopening of Kula Hospital on Maui, which closed after storm damage in March.
    • “The project is preliminarily estimated at about $65 million, with the state providing $42 million and Oakland, Calif.-based Kaiser Permanente investing $23 million, according to a Sept. 22 news release. The state and Kaiser noted costs may change as planning and construction details are finalized.”
  • and
    • “A growing number of health systems are continuing to push across state lines through acquisitions, affiliations and new facilities, as they seek greater scale, broader population bases and stronger regional footprints.
    • “Cross-market transactions have become an increasingly prominent growth strategy, offering systems opportunities to diversify risk and strengthen negotiating leverage while financially challenged hospitals and portfolio exits create openings in new markets.
    • “[The article identifies] nine health systems that have announced, advanced or completed significant cross-state expansions this year.”
  • Per Modern Healthcare,
    • “Oracle Health announced new artificial intelligence revenue cycle management capabilities and an oncology electronic health record Wednesday at the Oracle Health and Life Sciences Summit. 
    • “The revenue cycle management tools help with the prior authorization process by checking coverage, pulling documentation requirements and automatically adding the information and evidence. The goal is to help reduce delays and denials, the company said in a Wednesday news release.
    • “The new capabilities also include AI agents that evaluate reimbursement documentation and make recommendations to improve coding. Oracle Health also released agents focused on limiting denials and automating appeal packets.”
  • Beckers Health IT lets us know about “10 AI takeaways from Mass General Brigham’s World Medical Innovation Forum.”
  • Per BioPharma Dive,
    • “Colorado-based AI drug discovery specialist Enveda Biosciences has raised $311 million in a Series E financing, a sum rivaling totals secured in some of the biotechnology sector’s larger initial public offerings this year.
    • “In a Wednesday announcement, the startup said it would use the cash to continue advancing its pipeline of drugs through the clinic. Three are in human testing. 
    • “Enveda uses artificial intelligence to identify molecules in living organisms like plants and microbes and predict their structure and function. Its system then ranks these molecules by their drug potential, after which Enveda’s chemists turn the most promising ones into drug prospects. In June, Enveda CEO and founder Viswa Colluru told BioPharma Dive that the company is already evaluating 17 programs to emerge from that research.
    • “As much as the industry has gotten comfortable with the more iterative approaches, the thing that moves the needle for patients and seeds power law returns for companies is first-in-class mechanisms that shift the paradigm,” Colluru said at the time.”
  • Per Cardiovascular Business,
    • “Heart researchers have developed a new way to determine a person’s cardiovascular age, sharing their findings in the European Heart Journal.[1] Their secret? A combination of artificial intelligence (AI) and routine CT exams.
    • “The group, a research team at Emory University’s Empathetic AI for Heart Institute in Atlanta, focused their work on the fat that surrounds a person’s aorta. By evaluating that fat, they believed they may be able to detect whether someone’s cardiovascular health is older or younger than their real age. 
    • “The aorta is the body’s largest blood vessel and carries blood from the heart to the rest of the body,” first author Mendel Lebowtiz, a graduate student with Emory University, explained in a statement. “We wanted to see whether the fat surrounding it could tell us something about how a person’s heart and blood vessels are aging.”
    • “Lebowitz et al. used advanced AI to evaluate more than 48,000 chest CT examinations. More than 4,000 exams were used to train their AI model and then more than 44,000 exams were used to validate that model. By the end, they found that this method was able to estimate an individual’s “true cardiovascular age” and gain a better understanding of the health risks they may face over time.”
  • Per MedCity News,
    • “Pelago, a virtual substance use care provider, launched the Pelago Behavioral Health Platform on Tuesday at the Behavioral Health Tech conference in Nashville, Tennessee. The platform unifies substance use, mental health and behavioral addiction care in one place.
    • “New York City-based Pelago offers treatment for substance use like drinking or prescription pain medication, as well as mental health conditions like stress and anxiety. It also treats patients battling habits like gambling or gaming. The company serves both employers and payers.
    • “Now, the Pelago Behavioral Health Platform allows Pelago’s customers to manage substance use, mental health and behavioral addiction care under one contract and one member record. This allows the company to better treat co-occurring conditions. About half of Pelago’s patients battle co-occurring depression and anxiety, according to Dr. Yusuf Sherwani, CEO and co-founder of Pelago.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, HSA, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

  • Govexec reports,
    • “More than 100 members of Congress urged House and Senate leaders last week to advance legislation rejecting President Trump’s planned pay freeze for most civilian federal workers next year.
    • “Last month, Trump issued his alternative pay plan, which formally confirmed the White House’s proposal to freeze most civilian workers’ pay at 2026 levels. Trump separately instructed the Office of Personnel Management to prepare to issue a 3.8% raise to federal law enforcement officers, and he has proposed pay increases between 5% and 7% for military service members, depending on their rank.
    • “In a letter to House Speaker Mike Johnson, Minority Leader Hakeem Jeffries, Senate Majority Leader John Thune and Minority Leader Chuck Schumer, sent last week but published Monday, a bipartisan group of 110 lawmakers led by Rep. James Walkishaw, D-Va., and Sen. Chris Van Hollen, D-Md., warned that with inflation hovering over 3%, forcing federal workers to forgo a pay raise is “an effective pay cut.”
    • “The administration’s own proposal on federal pay increases demonstrates why such an increase is necessary,” they wrote. “President Trump has proposed that federal law enforcement personnel receive a 3.8% pay increase to improve recruitment and retention, and has proposed a 5-7% pay increase for service members given the critical support they provide our nation. The same rationale applies to all federal workers.”
  • MedPage Today informs us,
    • “A proposal from CMS to cut in half the payment for secondary services performed during outpatient visits is drawing fire from a variety of healthcare groups.
    • “The damage would be extensive to practices who offer procedures and E/M [evaluation and management] visits on the same day as it impacts many clinical scenarios (dermatology, otolaryngology, ophthalmology, and many more),” Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association (MGMA), said in an email to MedPage Today. “MGMA members have relayed to us significant projected financial losses if this cut would go into effect.”
    • “Under the proposed rule, known as the “modifier 25 rule,” if two or more services are performed on the same day, “the most expensive service (either surgical or E/M visit) would be paid at 100%, and all other surgical procedure(s) or E/M visit(s) would be paid at 50%,” CMS explained in a July 16 Federal Register noticeopens in a new tab or window.
    • “For example, suppose a patient goes to the doctor for an outpatient E/M visit, which is billed using CPT code 99212, and then has two skin lesions removed, one billed under CPT code 11300, and the other — a slightly bigger lesion — billed under CPT code 11301. Because the second skin lesion removal code is the highest-paid service of the three, that code will get paid at 100%, while payments for the office visit and removal of the smaller skin lesion will be reduced by 50%.
    • “We continue to believe that there are efficiencies when the same physician (or a physician in the same group practice) provides an E/M service for the same patient in conjunction with a procedure with a global period, and that we are likely duplicating payment under the current payment methodology,” the authors wrote in explaining the proposal, which was originally proffered in 2019 but later withdrawn.” * * *
    • “The comment period on the proposal, which is part of a larger rule on physician payment and other issues, ended Monday. The agency has until Nov. 1 to issue a final rule; it could include the modifier 25 proposal as-is, make changes to it, or leave it out entirely.”
  • Fierce Healthcare points out,
    • “The American Medical Association (AMA) is urging the U.S. Centers for Medicaid and Medicaid Services (CMS) to uphold its Jan. 1, 2027 deadline for electronic prior authorizations under its Interoperability and Prior Authorization final rule.
    • “In a Sept. 18 letter (PDF) to CMS Administrator Mehmet Oz, M.D., AMA President John Whyte, M.D., wrote the agency should maintain its deadline and “reject broad enforcement discretion during 2027.”
    • “CMS should stay the course and remain steadfast in its commitment to ‘axe the fax’ and make [electronic prior authorization (ePA)] a reality for physicians and patients,” Whyte wrote.”
  • The American Hospital Association News relates,
    • “The White House issued a presidential proclamation Sept. 18 renewing the $100,000 fee for new H-1B visa petitions for individuals entering the U.S., initially levied in September 2025. The fee, currently blocked by a court order, was vacated by a district court in June and is pending appeal. The AHA had asked the administration last year to make healthcare personnel exempt from the fee. The Sept. 18 proclamation to renew the fee extends it for an additional year. The administration also issued an executive order that would further scrutinize companies seeking to hire H-1B workers, particularly organizations that directly or indirectly had layoffs within the previous year or plans future layoffs impacting U.S. workers. The renewal of the $100,000 H-1B fee is separate from the Department of Homeland Security’s proposed $103,265 filing fee for H-1B visa petitions that are subject to statutory numerical caps.”
  • Per a Health Resources and Services Administration news release,
    • “The Health Resources and Services Administration (HRSA) today announced nearly $19 million in new awards to expand access to high-quality healthcare through telehealth and technology-enabled learning. Announced during Telehealth Awareness Week, the awards will increase access to nutrition services, expand the use of emerging technologies to improve healthcare delivery, and strengthen the healthcare workforce in rural communities and other areas with limited access to care.
    • “Telehealth and innovative technologies are changing what access to healthcare looks like for Americans,” said HRSA Administrator Tom Engels. “No longer is telehealth the exception to the rule — it is an essential part of the healthcare system, and the Trump Administration is helping providers put these tools to work to expand access and improve health outcomes. For a patient in a rural community, that can mean getting specialized care without traveling hours from home. For a clinician, it can mean having expertise and new tools at their fingertips to better serve their patients. Through these investments, HRSA will help test what works and identify successful approaches that can be replicated in communities across the country.”
    • “The awards announced today include:
      • “Telehealth Centers of Excellence ($8.5 million) will pilot and test innovative telehealth solutions to expand access and improve health outcomes.
      • “Telehealth Nutrition Services Network Grant Program ($5.4 million) will increase access to nutrition services that help prevent and manage chronic diseases through telehealth networks.
      • “Technology-enabled Collaborative Learning Program ($4.75 million) will improve provider retention and expand access to care in rural communities using technology-enabled learning models.
    • “These awards build on HRSA’s leadership in telehealth by advancing innovative, high-value programs that expand access to high-quality care. HRSA’s broader telehealth portfolio includes more than 3,600 awards associated with telehealth.”

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

  • Federal News Network reports,
    • “After finding little change in the number of adverse actions taken against federal employees, the Office of Personnel Management is now looking for more feedback on how to “appropriately incentivize” federal managers to take action.
    • “The push comes after OPM released new data showing that for fiscal 2026, adverse actions involving poor performance and misconduct have been on par with last year.
    • “As of June 2026, OPM reported that there have been 3,105 federal employee terminations and separations based on poor performance or misconduct governmentwide. That’s compared with 3,492 in all of fiscal 2025 — excluding only the Postal Service, intelligence agencies and some other smaller government entities.
    • “Despite President Trump’s significant changes to how federal agencies address poor performance and misconduct, the federal government has not seen significant increases in performance-based and adverse actions,” OPM said in a Sept. 15 Federal Register notice.
    • “As a result of its findings, OPM reopened a public comment period and is soliciting feedback for an additional two weeks on a recent proposal to overhaul agencies’ processes for taking performance-based and adverse actions against federal employees.”
  • and
    • “Agencies will now be able to more easily offer bonuses of up to $25,000 to federal employees for exceptional work. The Office of Personnel Management is delegating authority to agency leaders to approve larger bonuses for feds. Previously, bonuses of that size required OPM approval. OPM says it’s removing the hurdle as a way to help agencies distinguish high levels of performance.” 
  • Serving Those Who Serve discusses funding an health savings account in retirement and optimizing a conversion to a Roth IRA.

From the Food and Drug Administration front

  • Per an FDA news release,
    • “The Food and Drug Administration’s Innovative Science and Technology Approaches for New Drugs (ISTAND) program has accepted a letter of intent (LOI) for a wearable sensor-derived digital outcome measure intended to quantify foot drop severity and its impact on gait in adult patients with Charcot-Marie-Tooth disease type 1A (CMT1A), a progressive, degenerative disease. This LOI represents the first submission to be accepted into the ISTAND program for a digital health technology (DHT) for a rare neurological condition.”
  • OncLine reports,
    • “The FDA has granted final approval to lutetium Lu 177 dotatate (Bravnetsa; PNT2003), a lutetium Lu 177 dotatate (Lutahera) biosimilar for the treatment of adult patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.1
    • “The agent was approved through the FDA’s abbreviated new drug application pathway, and the agency determined it to be bioequivalent and therapeutically equivalent to the reference product.
    • “As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to lutetium Lu 177 dotatate approved in the United States, [the biosimilar’s] approval marks an important milestone, bringing additional treatment options to people living with GEP-NETs,” said Mary Anne Heino, executive chairperson and CEO of Lantheus in a news release. “We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access.”
  • Fierce Pharma relates,
    • “Merck’s Winrevair continues to steadily expand its reach. A new FDA sign-off updated the pulmonary arterial hypertension (PAH) blockbuster’s label to include new data on patients who are newly diagnosed with PAH and receiving treatment for other conditions. * * *  Winrevair came out of Merck’s $11.5 billion buyout of Acceleron in 2021. The drug is a key part of the drugmaker’s plans to offset looming off-patent Keytruda competition.   
    • “Nuvation Bio also has a label addition to boast about. The FDA update allows the oncology drugmaker to add 14 months of additional data to the label of its CNS-active oral tyrosine kinase inhibitor, Ibtrozi. Ibtrozi is cleared by the FDA to treat locally or advanced metastatic ROS1-positive non-small cell lung cancer. Now, the added data from Nuvation’s Trust-I study showed a median duration of response of nearly 50 months in patients who had not received a tyrosine kinase inhibitor. That’s more than four years of “sustained clinical benefit,” the company said in a statement.  The updates came with no changes to the drug’s safety profile.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has cleared the X°Port Heart Preservation System from Ontario-based Traferox Technologies. The new device offers static 50 degrees F (10 degrees C) heart preservation during transport prior to transplantation, which has been shown in studies to improve outcomes.
    • “Peer-reviewed evidence has linked 10 degrees C heart preservation to reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage and exposure to hypothermic temperatures. Improved outcomes were also seen involving transplants of higher-risk donor hearts.[1,2]
    • “The strong clinical evidence supporting 10 degrees C heart preservation, together with the successful adoption of 10 degrees C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport,” Rick Mangat, PhD, chief executive officer of Traferox, said in a statement. “We look forward to working with transplant centers across the US to support the continued adoption of 10 degrees C preservation in routine clinical practice.”

No Surprises Act news,

  • Bloomberg Law reports,
    • “The Trump administration is launching a program to audit arbitrators of disputes between doctors and insurers under the No Surprises Act, stepping up oversight of a process plagued by litigation since it took effect in 2022.
    • “The law bars doctors from balance-billing patients for unexpected out-of-network care in emergencies and when procedures are performed by out-of-network providers at in-network facilities. While it’s largely shielding patients from surprise bills, implementation has increased medical spending, triggered a wave of lawsuits and raised allegations of bad actors on both sides.
    • “The new audits by the Centers for Medicare & Medicaid Services will “allow the Departments to more closely review the work done” by arbitrators, also known as “independent dispute resolution entities,” or IDREs, a spokesperson said.
    • “These audits will assess certified IDR entities’ full compliance with the NSA and its associated regulations and are anticipated to be a much more in-depth review of the process, programs and operational policies utilized by certified IDR entities,” the spokesperson said.”

From the fraud, waste, and abuse front,

  • Beckers Hospital Review reports,
    • “CMS said Sept. 22 that it canceled plan year 2026 ACA policies covering 760,000 people.
    • “CMS canceled 315,000 policies covering these individuals Aug. 31. According to federal rulemaking records — set to publish in the Federal Register on Sept. 23 — these people enrolled with agent or broker help but lacked verified citizenship or immigration documentation. Policy issuers could not identify claims or contact these consumers, either. During a Sept. 22 press conference, Vice President JD Vance said the government will do “additional verification” concerning legal status and income for 419,000 people.
    • In a Sept. 22 news release, CMS said it is anticipating a return of about $2.2 billion in advance payments of the premium tax credit. The removals were spearheaded by the White House Task Force to Eliminate Fraud. 
    • “CMS is also temporarily freezing new agent and broker registrations with federally facilitated exchanges for plan year 2027. This pause will be in effect until Feb. 1. The rulemaking documents said that based on two methodologies, agent and broker noncompliance leading to unauthorized enrollment could amount to roughly $1.5 billion or $6.6 billion in annual improper federal spending.
    • “Temporarily pausing the registration of new agents and brokers narrowly targets the category of agents and brokers that CMS has determined warrant additional scrutiny, while allowing CMS time to implement additional safeguards designed to prevent unauthorized enrollments and other noncompliant practices before new agents and brokers begin assisting consumers on the federally-facilitated exchanges,” the rulemaking document said.
    • “In the release, CMS said it will take on further work with insurance companies to address what may be unauthorized enrollments, focus on terminating noncompliant brokers and agents, and carry out other integrity efforts.”
  • Fierce Healthcare relates,
    • “Health tech company Cotiviti is building out its payment accuracy platform for payers with two new additions that will allow plans to see all inpatient claims in one place.
    • “The company said in an announcement that the enhanced platform reduces administrative complexity and unites elements that insurers typically managed through separate programs or vendors. Reducing those silos can support more accurate claims management, Cotiviti said.
    • “The first add-on is called Itemized Bill Review, which digs into high-cost facility claims to identify potential billing errors including miscoding, upcoding or duplicative charges. The Inpatient Coding Validation tool, meanwhile, supports a stronger diagnosis-related group review process that offers a fuller coding and clinical analysis before payments are made.
    • “Cotiviti said that the tools taken together can identify between 9% and 12% in additional errors for submitted inpatient claims, alongside simplifying the process on the payer’s end.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Suicide moved into the 10 leading causes of death in the U.S. in 2024, even as the number of suicide deaths declined from the year before.
    • “The finding comes from the CDC’s National Center for Health Statistics’ Sept. 22 report, “Deaths: Leading Causes for 2024.” The report is based on final mortality data from all death certificates filed in the 50 states and the District of Columbia in 2024.
    • “According to Paul Nestadt, MD, medical director at the Johns Hopkins Center for Suicide Prevention, limiting access to firearms could have the greatest effect on preventing suicide deaths and “will save the most lives.”  
    • “More than 28,000 people died by gun suicide last year — more than half of all suicide deaths nationwide, based on preliminary federal figures. The overall suicide rate has recently trended down, yet gun suicides have climbed to record levels for a fifth straight year. ” * * *
    • “The other leading causes, in order, were diseases of heart; malignant neoplasms; accidents (unintentional injuries); cerebrovascular diseases; chronic lower respiratory diseases; Alzheimer’s disease; diabetes mellitus; nephritis, nephrotic syndrome and nephrosis; and chronic liver disease and cirrhosis. The 10 causes accounted for 70.9% of all U.S. deaths.” 
  • Beckers Behavioral Health adds,
    • “The CDC released new data Sept. 21 showing improvements in several mental health, suicide risk, and dietary indicators among U.S. high school students from 2023 to 2025. 
    • “The findings are included in the CDC’s Youth Health in Focus report, which examines mental health and suicide risk alongside dietary behaviors, physical activity, sleep and digital behaviors. The report presents national Youth Risk Behavior Survey data from 2023 to 2025 and 10-year trends from 2015 to 2025.”
  • Beckers Hospital Review offers six things to know about the relationship betweek GLP-1 drugs and blindness due to nonarteritic anterior ischemic optic neuropathy (NAION)
    • “NAION is a rare condition that causes sudden, often permanent vision loss in one or both eyes. Sometimes called an “eye stroke,” the condition is caused by disrupted blood flow to the optic nerve. It typically affects people 50 and older, with an incidence of two to 10 cases per 100,000 people annually in that age group, according to the American Academy of Ophthalmology.” * * *
    • “Research remains mixed. A 2024 Mass General Brigham and Harvard Medical School study and a 2025 study in Diabetes, Obesity and Metabolism found an association between semaglutide and NAION but did not establish causation. Other studies, including a Novo Nordisk-funded study from earlier this year, found no association.” * * *
    • “NAION is not the only eye condition studied in connection with GLP-1s. A 2025 study found semaglutide users had a higher risk of neovascular age-related macular degeneration, and the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society have said semaglutide may also worsen diabetic retinopathy, causing macular complications and blurry vision. A 2024 study first drew wide attention to a possible NAION association, and a follow-up study later that year also found an association.”
  • Health Day relates,
    • “Wildfire smoke might pose a greater health risk to humans than other sources of air pollution, two new Mount Sinai studies say.
    • “Particle pollution from wildfires appears to diminish the survival odds of lung cancer patients, a study published Sept. 15 in The Lancet Oncology found.
    • “Wildfire smoke is also linked to an increased risk of hospitalization for heart or lung disease, researchers reported Sept. 17 in the journal Nature Communications.
    • “Wildfire smoke is no longer a regional environmental issue. It is becoming a nationwide public health challenge,” said Yaguang Wei, senior author of both studies. He is an assistant professor of environmental medicine at Icahn School of Medicine at Mount Sinai in New York City.
    • “Our research shows that wildfire-related (particle pollution) appears to be more harmful than equivalent levels of pollution from other sources,” Wei said in a news release. “As wildfire activity increases, public health and environmental policies must account for both the quantity and the source of air pollution.”
  • and
    • “Vitamin D may play a bigger role in pregnancy than simply supporting bone health.
    • “A new study suggests that optimizing vitamin D levels before and during pregnancy may improve outcomes for both mother and baby, including the risk of preterm birth.
    • “We learn about vitamin D’s role in bone health, but no one teaches us about the various roles in pregnancy, especially this relationship with preterm birth we are uncovering,” said study author Anjali Borsum, a student at the Medical University of South Carolina College of Medicine in Charleston.”
  • Cardiovascular Business tells us,
    • “When heart patients are diagnosed with severe aortic stenosis (AS), waiting any longer than six months to perform transcatheter aortic valve replacement (TAVR) is associated with worse long-term outcomes. That was the key takeaway from a new analysis published in Open Heart.
    • “The study’s authors highlighted the fact that asymptomatic severe AS is increasingly being treated. At the same time, however, it is still common for patients to wait and then undergo a follow-up clinical and imaging exam six to 12 months later. The group hoped to learn more about the potential impact TAVR timing may have on patient outcomes, performing a retrospective study on data from 149 patients treated at a single facility from 2021 to 2023. The mean age was 85.8 years old, and 36% of patients were men.” * * *
    • “Click here for the full analysis.”
  • The Wall Street Journal informs us,
    • “Roche ROP Holding said an obesity drug candidate met the main objectives of a midstage clinical trial by helping patients reduce their blood glucose and body weight.
    • “The Swiss pharmaceutical company is seeking to enter the weight-loss drug market that Eli Lilly LLY and Novo Nordisk NOVO currently dominate, and sees the latest trial results reinforcing its ambitions to rapidly develop a portfolio of medicines for people with obesity, diabetes and cardiovascular disease.
    • “Roche said its drug, enicepatide, achieved a mean reduction in blood-sugar levels of 2.65 percentage points, as well as a mean weight loss of 15.5%, after 48 weeks for patients who received the highest dose.
    • “The trial enrolled adults with Type 2 diabetes who also had obesity or were overweight, and follows an earlier study that showed the drug helped patients without diabetes shed weight.
    • “Among patients who were on the highest dose, 62% restored blood glucose to levels considered normal, having started the trial as diabetic, Roche said.
    • “The safety and tolerability profile of enicepatide was consistent with that of similar therapies, and treatment discontinuation rates in the trial due to adverse events were low at 2%, it said.”
  • BioPharma Dive points out,
    • “An experimental Amgen drug has succeeded in the first of two Phase 3 trials in Sjögren’s syndrome, driving the California biotechnology giant’s stock price up as much as 5% on Tuesday. 
    • “Amgen didn’t provide specific details about the performance of its drug dazodalibep. But it said in a Tuesday statement that treatment led to a “statistically significant and clinically meaningful improvement” on a widely used measure of disease activity after 48 weeks, meeting the trial’s primary objective. Positive effects were observed as early as four weeks after treatment and persisted through the evaluation period, Amgen said. 
    • “Investigators didn’t spot an “imbalance” in the rate of blood clots or opportunistic infections in the Phase 3 study, a potential concern of drugs with dazodalibep’s mechanism. Side effects were generally mild to moderate, and study discontinuations were infrequent and balanced across study arms, the company said.”
  • and
    • “Trial enrollees taking Viking Therapeutics’ dual-acting obesity drug maintained nearly all of their weight loss after switching from a weekly shot to less frequent dosing, the company said Tuesday.
    • “Viking enrolled 180 people with obesity and no related health conditions in the Phase 2 trial. They were randomized to receive one of four dosing regimens of VK2735 or a placebo over 21 weeks, and then switched to a biweekly or once-monthly maintenance shot for another 12 weeks. According to Viking, enrollees taking VK2735 ended up retaining as much as 90% of their weight loss.
    • “The “stellar” data “build on [VK2735’s] potentially differentiated profile,” Leerink Research analyst Thomas Smith wrote in a note to clients, potentially allowing the drug to overcome some of the adherence issues associated with GLP-1 medications for obesity.”

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

  • The Wall Street Journal reports,
    • “Western pharmaceutical companies are urging the administration to allow them to keep doing deals with Chinese companies for promising drug candidates, despite a 2025 law restricting U.S. investment in Chinese technology.
    • “The group that represents pharmaceutical companies such as Pfizer, Merck and Eli Lilly has been lobbying to make sure that the new rules the Treasury Department is writing, as part of that 2025 law, maintain the drugmakers’ ability to do deals in China.
    • “At stake are billions of dollars in deals and an increasingly important source of experimental drugs for Western companies, which they need to restock their pipelines as they face big upcoming revenue holes with key drugs losing exclusivity in coming years.
    • “The 2025 law, called the Comprehensive Outbound Investment National Security Act or COINS, requires the federal government to screen deals with certain countries involving sensitive technology. So far, the Treasury Department has been reluctant to fully incorporate pharmaceuticals, according to two people familiar with the matter, as it finalizes regulation for other technology under the law, like AI systems and semiconductors.
    • President Trump is meeting Chinese President Xi Jinping this week, a summit that pharmaceutical leaders believe will be instrumental in determining how far the administration goes with putting curbs on Chinese biotech investment. The rules need to be finalized by March.”
  • Beckers Hospital Review identifies 32 “contract breaks between major health systems and certain Medicare Advantage insurers [that have occurred in] 2026. Providers dropping plans often cite prior authorization denials and slow reimbursement; in other cases, insurers are terminating the contracts themselves.”
  • Kaufmann Hall tells us.
    • “For decades, rural healthcare has been organized primarily around hospitals and clinics connected through traditional referral relationships. But the pressures facing rural providers challenge that structure. Rural communities today are asking what a more sustainable approach should look like.
    • “The hub-and-spoke model is familiar to rural healthcare, concentrating complex services centrally while extending others into local communities. But today’s pressures demand an evolution of that approach. The network of tomorrow must combine physical care sites, digital capabilities, and trusted community connections to deliver the right care in the right place.
    • “That requires adding a new element: the node. The result is a hub-spoke-node network built around the patient.”
  • Beckers Clinical Leadership lets us know,
    • “Adult medical specialties posted the largest increase in median work relative value unit productivity from 2025 to 2026, the second consecutive year the category has led on productivity growth, according to a survey from SullivanCotter.
    • “The Chicago-based consulting firm released findings from its 2026 Physician Compensation and Productivity Survey Sept. 17. The report includes data from 575 healthcare organizations representing about 235,000 physicians across 240 specialties.
    • “Productivity gains were modest across the board, with year-over-year changes ranging from 0.8% to 2.8%. Median total cash compensation rose across all major specialty categories over the same period, led by adult medical specialties at 7.2%.”
  • and
    • “Is pneumonia contagious?” is the most-Googled respiratory health question in the U.S., drawing an estimated 137,000 searches per month, according to a Sept. 22 analysis from healthcare staffing firm Soliant Health.
    • “The data offer a glimpse at patients’ health concerns heading into the 2026-27 virus season. 
    • “To compile the ranking, Soliant Health analyzed 30,000 question-based search queries in September using data from the search engine optimization platform Ahrefs. Soliant identified the medical questions tied to respiratory illness season and ranked them by estimated monthly U.S. search volume. The firm excluded branded queries, entertainment searches and near-duplicate questions. 
    • “Together, the 15 questions draw more than 731,000 estimated searches a month, according to a Sept. 22 news release shared with Becker’s.
    • “Alongside traditional internet search engines, AI platforms are emerging as another key tool patients use to find health answers. Thirty-four percent of Americans use AI chatbots for health information, and symptom diagnosis is one of the top reasons, according to a Pew Research Center survey released in August.”
    • [The article lists the top 15 Googled questions.]
  • Drug Channels notes,
    • “For more than a decade, the answer to “Where do drug wholesalers make their money?” has been generic drugs.
    • “Although wholesaler revenues are linked most closely to sales of brand-name drugs, the majority of wholesalers’ gross profits comes from generic drugs. We estimate that in calendar year 2026, generic drugs will contribute 52% of total drug distribution gross profits of the Big Three wholesalers, but only 9% of drug distribution revenues.
    • “Generic drugs are the long-running hit show that has carried wholesalers’ profits for 15+ seasons. The show is still on the air, but a supporting character is starting a spinoff.
    • “Generic drugs’ share of distribution gross profits has declined, from 68% in 2022 to 52% in 2026. This partially reflects the growth in profits from provider-administered biosimilars. Biosimilars now account for 6% of wholesalers’ drug distribution revenues, but 23% of total gross profits.”

Monday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “To stop payments above market rates for laboratory services in Medicare and save taxpayer dollars, the Centers for Medicare & Medicaid Services (CMS) plans to better align the 2027 clinical laboratory fee schedule rates with private sector payment rates, saving an estimated $1 billion annually. While final rates won’t be released until later this year, CMS is releasing the data and information used to determine the preliminary 2027 Medicare payment rates for laboratory services showing that Medicare has been paying about 16% more for laboratory services than private payors. Basing Medicare’s rates on those paid by the private sector helps ensure that Medicare is paying appropriate amounts for laboratory tests and protecting taxpayer dollars.” * * *
    • By law, Medicare payment for a clinical diagnostic laboratory test cannot be reduced by more than 15% per year through 2029. CMS will gradually phase in the reductions through 2029. 
    • The public has 30 days from today to review and submit comments on the preliminary Calendar Year (CY) 2027 Clinical Laboratory Fee Schedule rates and supporting data. For laboratory tests that didn’t get any private-payor data reported to CMS, CMS held a public meeting September 15 and 16 to decide how to price them. These determinations will be published in early October along with a 30-day comment period.
    • CMS anticipates finalizing the CY 2027 payment rates for clinical diagnostic laboratory tests under the Clinical Laboratory Fee Schedule in November 2026. The final payment rates will go into effect beginning January 1, 2027. 
    • View a fact sheet on the Preliminary CY 2027 Medicare Clinical Laboratory Fee Schedule Payment Rates. 
    • To view the preliminary CY 2027 Clinical Laboratory Fee Schedule rates and data, visit https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs.
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services announced Sept. 18 that all 50 states, Washington, D.C., and Puerto Rico have applied to participate in its initiative to make certain prescription drugs available to people with Medicaid at prices aligned with those paid in other countries, known as most-favored-nation pricing. The initiative, called the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model, is being implemented by the CMS Innovation Center. CMS said that 40 states and Puerto Rico have already signed agreements to participate in the model, and that the remaining applicants have until Sept. 30 to sign agreements. The GENEROUS Model launched in January and will run for five years.”
  • Beckers Hospital Review reports,
    • Pfizer agreed to give HHS a portion of its increased revenue if it is able to charge higher drug prices abroad, according to a “most favored nation” contract released Sept. 19, Bloomberg reported. 
    • The contract, released by consumer watchdog Public Citizen and obtained from a Freedom of Information Act lawsuit, showed documents related to Pfizer and Eli Lilly contracts, though some information is redacted. More than two dozen other deals remain confidential. * * *
    • “Pfizer agreed to share a portion of its net increased revenue from charging higher prices abroad, effective Jan. 1, 2026, through Jan. 20, 2029. The rate and medicines included were redacted. 
    • “The company said it stands “by our belief that the agreement Pfizer voluntarily reached with the administration last September is a win for American patients” and achieves priorities to lower prices for patients, redistribute global research and development costs, and create a predictable investment environment, Pfizer spokesperson Amy Rose told Bloomberg.”  
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) is making its biggest push yet to move biomedical research beyond animal model use, unveiling five major initiatives that could reshape how new drugs and treatments are developed and evaluated. Together, the efforts signal a significant investment into human-based technologies as the future of preclinical science, aiming to make research faster, more predictive, and more directly relevant to human health.
    • “Efforts include more than $88 million in funding for biomedical infrastructure projects nationwide; a new challenge offering over $7 million in awards to demonstrate how quantum-enabled approaches can improve detection and measurement in lab-based New Approach Methodologies (NAMs); a state-of-the-art laboratory at the NIH Clinical Center that will integrate standardized human organoid models, robotics, AI, and advanced data capabilities to enable experiments on reproducible human biological systems; an initiative to recruit grant reviewers who are experts in human-based science; and a new request for information from the scientific community to assess the feasibility of an annual public report tracking the number of vertebrate animals used in NIH-funded research.
    • “NIH is building the scientific infrastructure needed to develop, validate, and scale technologies that better reflect human biology,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “Our goal is to give researchers better tools to understand human disease and translate discoveries into treatments that improve patients’ lives.”

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

  • FedWeek reports,
    • “OPM has proposed to revise regulations governing hiring into the excepted service to align them with several Trump administration policies.
    • “Rules proposed in the September 18 Federal Register would “conform OPM regulations to current excepted-service schedules, including Schedules E, Policy/Career, and G; modernize part 302 procedures while preserving veterans’ preference, compensable-injury restoration rights, and other priority placement rights; authorize and clarify Pathways conversions to Schedule Policy/Career.”
    • “Schedule E was created in the first Trump term relating to hiring of administrative law judges, which Schedule Policy/Career and Schedule G were created during the current term; both apply to certain policy-related positions, with the former applying to career employees and the latter to political appointees.
    • “The Pathways Program is a longstanding program of internships for students and appointments of recent graduates, with the potential for non-competitive conversion to the competitive service; Trump last year abolished one element, the Presidential Management Fellows for those with advanced degrees, typically in public service administration.”
  • and
    • “I’ve promised this article twice now — in Part 3 on SSDI and again in Part 6 on the benefits of disability retirement — because it answers the question every client eventually asks: “If I get both, what do I actually take home?” The word “offset” scares people. Some employees hear it and conclude that SSDI isn’t worth the fight after their initial application is denied (which is very common).
    • “Let me show you why that’s the wrong conclusion, with real numbers. Remember, of course, that SSDI is only available to those who generally cannot work at all — or can earn only very little.”
  • FedSmith adds,
    • “For many federal employees, reaching Minimum Retirement Age (MRA) with 30 years of service feels like the finish line.
    • “The pension becomes available. The FERS Retirement Supplement may begin. FEHB can continue into retirement. The Thrift Savings Plan becomes accessible without early withdrawal penalties.
    • “After decades of federal service, retiring at MRA + 30 often feels emotionally justified and financially achievable. But there is an important distinction many employees overlook: retirement eligibility is not the same thing as retirement readiness.
    • The federal retirement system gives employees the ability to retire relatively early compared to many private-sector workers. That flexibility is valuable.
    • “But it also means employees must evaluate whether they are truly prepared for what may become a 30-year retirement. The question should not simply be: “Can I retire?” It should also be: “Can my retirement survive stress?”

From the Food and Drug Administration front,

  • Per a Department of Health and Human Services news release,
    • “The U.S. Food and Drug Administration (FDA) today issued a direct final rule updating its regulations to remove references to animal testing and implement the FDA Modernization Act.” * * *
    • “HHS also launched a new webpage providing a comprehensive accounting of actions of more than 20 actions the Department has taken to reduce animal testing and advance NAMs.”
  • Reuters reports,
    • “The US FDA’s staff reviewers did not raise major concerns about the accuracy and safety of Grail’s (GRAL.O), blood test designed ​to detect more than 50 cancers, sending the company’s shares soaring 35% on Monday.
    • “The ‌findings on the screening test, called Galleri, will be discussed at the FDA’s external advisers’ meeting on Wednesday [September 23] to review Grail’s request for premarket approval.
    • “The FDA ​has no outstanding questions for the external panel on ​analytical performance, study design and the primary safety analyses of ⁠Galleri, according to the briefing documents.”
  • Fierce Pharma relates,
    • “IntraBio is on a roll with its expansion plans for chemically altered amino acids, Aqneursa.
    • “The Texas-based pharma just secured FDA approval to expand the label of Aqneursa, which is now the first treatment indicated for a rare and prematurely fatal neurodegenerative disease called ataxia-telangiectasia (A-T).
    • “The positive ruling was based on data from IntraBio’s phase 3 IB1001-303 phase 3 data announced earlier this year. In the crossover study, which included 73 A-T patients ages 4 to 50, Aqneursa significantly improved ataxia symptoms and provided functional benefits for everyday life compared with placebo within 12 weeks of starting treatment.” * * *
    • “The FDA cleared Aqneursa, given as an oral suspension, for both children and adults with A-T, as long as they are over 15 kilograms (33 pounds).”
       
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has approved the Cordis Selution SLR (Sustained Limus Release) drug-eluting balloon (DEB) for the treatment of coronary in-stent restenosis (ISR). This is the first sirolimus DEB cleared in the U.S.
    • “The FDA previously designated this device as a breeakthrough device because of its sustained limus release, allowing the anti-proliferative drug to continue to prevent the growth of scar tissue inside a stent over a longer period of time to prevent further ISR. 
    • “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary ISR,” Matt Muscari, president of the Americas at Cordis, said in a statement. “This innovative device will enable physicians to address one of the most complex coronary clinical challenges.”

No Surprises Act News,

  • Fierce Healthcare reports,
    • “Self-funded employers are facing the brunt of costs associated with the No Surprises Act (NSA) arbitration process, a new report from the ERISA Industry Committee (ERIC) found.
    • “The report (PDF)—entitled Employer Exposure Under the No Surprises Act—was in part informed by confidential interviews with larger self-funded employer plan sponsors. 
    • “Employer-sponsored insurance covers approximately 154 million non-elderly Americans, with 67% of covered workers enrolled in self-funded plans, according to the report. With firms of 200 or more employees, the share is 80%.
    • “In Independent Dispute Resolution (IDR) cases, employers fund outcomes, the report notes.
    • “This is no trivial matter,” analysts wrote. “As IDR payouts reach upwards of $15 billion dollars throughout the life of the program, the direct cost to employers is quickly becoming untenable.” * * *
      • “Analysts put forth several policy recommendations, including:
      • “Restoring the “intended role” of qualifying payment amounts (QPAs)
      • “Establishing a limited appeals mechanism
      • “Addressing volume abuse
      • “Enacting transparency reform”
  • FEHBlog Observation – The necessary tranparency report — good faith estimates by providers and advance explanations of benefits by providers — is already law; we just need the No Surprises Act regulators to implement the law for insured people.

From the judicial front,

  • The U.S. Court of Appeals for the Sixth Circuit issued its opinion in the Commonwealth of Kentucky v. Express Scripts case last Friday.
    • The Commonwealth of Kentucky filed this lawsuit in state court, alleging that a group of healthcare firms contributed to Kentucky’s opioid crisis by conspiring with drug manufacturers to increase the supply of prescription opioids. The defendant firms include two Pharmacy Benefit Managers that negotiate with drug manufacturers to provide prescription drug coverage for federal employees. The Pharmacy Benefit Managers removed the case to federal court under the federal officer removal statute. Kentucky moved to remand, arguing that its complaint effectively disclaimed liability for any conduct the firms undertook at the behest of a federal officer. The district court agreed and granted Kentucky’s motion. In view of our decision in Ohio ex rel. Yost v. Ascent Health Services, LLC, 165 F.4th 999 (6th Cir. 2026), we reverse.
  • FEHBlog observation — This opinion is quite favorable to FEHB and PSHB carriers, large providers, underwriters and administrators.
  • Beckers Payer Issues reports,
    • “A New York state court has dismissed a lawsuit brought by two medical practices seeking more than $1.7 million from Elevance Health subsidiaries over unpaid No Surprises Act arbitration awards, ruling that the providers failed to make a viable claim under state law.
    • “Suffolk County Supreme Court Justice Paul Hennings granted the insurer’s motion to dismiss Sept. 17, throwing out all seven claims brought by True North Medical of Manhasset and True North Medical of Suffolk against four Anthem companies.
    • “The two Long Island practices provided out-of-network care to members of Anthem-administered health plans. After disputing certain payment amounts, the providers took their claims through the independent dispute resolution process and won 13 determinations totaling more than $1.7 million, which they alleged Anthem did not pay.
    • “Rather than filing under the No Surprises Act itself, the practices brought claims under New York state law, including unjust enrichment, violation of New York’s Prompt Pay statute, implied contract, insurance bad faith and declaratory judgment. They argued the IDR awards established what they were owed and that state law independently allowed them to collect.
    • “The court found that every claim depended on the IDR determinations for both the obligation to pay and the dollar amount owed. The No Surprises Act does not create a private right of action to enforce those awards, and state-law claims cannot fill the gap when the underlying payment obligation comes entirely from the federal process.”
  • Healthcare Dive relates,
    • “A judge in Texas last week approved a bankruptcy plan for CVS’ Omnicare, winding down the pharmacy services division after it sold its business operations for $250 million and settled an almost $1 billion judgment for improperly billing government healthcare programs.
    • “Judge Stacey G. C. Jernigan of the U.S. Bankruptcy Court for the Northern District of Texas greenlit the plan on Thursday, almost a year after Omnicare filed for Chapter 11 bankruptcy.
    • “The plan, which reorganizes some Omnicare assets and liquidates others, will pay all creditors in full, and go into effect in October, a lawyer for Omnicare told Bloomberg Law.“

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Chronic kidney disease (CKD) is known to significantly increase a person’s risk of heart disease or stroke. However, women with CKD often receive a delayed diagnosis and are less likely to receive a kidney transplant. It is with these trends in mind that multiple researchers collaborated for a new American Heart Association (AHA) scientific statement. The document, published in Circulation, highlights the importance of diagnosing CKD early in women and includes new recommendations designed to improve care for them going forward.”
    • “Many cases go undiagnosed in women because common tests and research do not always reflect women’s biology and life stages,” Eman Y. Gohar, PhD, MS, volunteer chair of the scientific statement’s writing group and an assistant professor of medicine with Vanderbilt University Medical Center, said in a statement. “Biological differences include genetics, sex chromosomes, hormones, immune-system responses and differences in how the body processes and responds to medication. We also need to acknowledge female-specific factors that do not apply in the same way to male patients. These include menstrual health, pregnancy, postpartum changes and menopause, as well as socioeconomic factors like financial barriers or cultural expectations. Each of these creates considerations that are unique to women and may require tailored care.”
    • “The statement emphasizes that women face many challenges when it comes to receiving kidney care. If clinicians fail to keep these challenges in mind, they risk letting patients with CKD go untreated until symptoms get much worse.
    • “Women are not simply smaller versions of men,” Gohar added. “Their biology, reproductive life stages and responses to medication may differ, and those differences need to be reflected in clinical care and research.” 
  • Health Day relates,
    • “Strength training is not linked to ventricular arrhythmia for people living with arrhythmogenic cardiomyopathy (ACM), according to a study published online Sept. 10 in JACC: Clinical Electrophysiology.
    • “Katia Chiampas, from Johns Hopkins University in Baltimore, and colleagues evaluated the risk for ventricular arrhythmia (VA) in individuals with ACM and/or pathogenic/likely pathogenic ACM gene variants exposed to strength-based exercise. The analysis included 355 individuals (median age, 34 years) identified from the Johns Hopkins Arrhythmogenic Right Ventricular Cardiomyopathy Registry, with follow-up from age 10 years.
    • “The researchers found that overall lifetime risk for VA was higher with increased aerobic exercise (dual + endurance) than without (strength + sedentary). However, there were no differences identified between dual versus endurance athletes or strength athletes versus sedentary. There was also no association between VA and strength training, but there was a significant association with endurance exercise.”
  • MedPage Today tells us,
    • “Patients with frailty are often undertreated with effective medications due to concerns around potentially attenuated benefits and safety risks.
    • “Baseline frailty did not limit the clinical benefits of semaglutide in a post-hoc trial analysis of patients with cardiovascular disease and overweight/obesity.
    • “The most frail participants experienced greater quality-of-life gains and lower treatment discontinuation rates due to adverse events.”
  • Healio discusses us,
    • “When should older adults get a flu vaccine? Experts offer advice.
    • “One expert simplified it for older adults, saying: “Don’t try to fake out flu. Just get your vaccine.”
    • “Another expert who is aged over 65 years said he may get the mRNA flu shot that just hit the market.”
  • Beckers Clinical Leadership informs us,
    • “A blood test correctly identified 87% of stage 1 and 2 pancreatic cancers, according to a study published Sept. 16 in Nature Medicine.
    • ‘For the study, researchers from Duarte, Calif.-based City of Hope tested the PANXEON liquid biopsy in nearly 1,800 patients across the U.S., Europe and Asia.
    • “The test identifies three biomarkers — circulating microRNAs, exosomal microRNAs and the protein CA19-9 — and assigns a single AI-generated pancreatic cancer risk score.
    • ‘The test’s false-positive rate was 3% among low-risk patients and 16% among high-risk patients. It also detected precancerous high-grade dysplasia in more than 64% of cases.
    • “The test is designed to complement, rather than replace, existing diagnostic strategies by flagging high-risk patients for further evaluation, researchers said in the release. 
    • “Read the full study here.”
  • Fierce Pharma notes,
    • “As Johnson & Johnson’s $14.6 billion bet on Intra-Cellular Therapies continues to pay off with blockbuster sales of Caplyta, the atypical antipsychotic has passed a phase 3 test that puts it one step closer to a wider psychiatric label.
    • “Caplyta (lumateperone), first approved back in 2019 under Intra-Cellular’s stewardship for schizophrenia, helped deliver rapid improvement in manic symptoms and improved overall illness severity, among other benefits versus placebo, over three weeks in a late-stage trial in adults with manic episodes associated with bipolar I disorder, J&J said in a release Monday.
    • “The results, which pointed to improvements in bipolar mania on Caplyta starting as early as day 3 of treatment, were presented with a clutch of other J&J readouts at the recent 2026 Psych Congress annual meeting in New Orleans. The study, coded 451, is part of a pair looking at Caplyta in adults with bipolar I-associated manic episodes.”
  • BioPharma Dive lets us know,
    • “A gene therapy from Beacon Therapeutics succeeded in a late-stage study involving people with a rare, often blinding eye condition, setting the company up to seek regulatory approval. 
    • “Called laruparetigene zovaparvovec, or laru-zova, the treatment helped a higher proportion of trial enrollees with X-linked retinitis pigmentosa read at least 15 more letters on a visual acuity test in low-light conditions than untreated participants after a year of follow-up. Beacon said the adverse events associated with treatment were “predominantly mild to moderate.”
    • “Further details from the study will be revealed at a medical meeting in October. The biotechnology firm plans to begin submitting a “rolling” approval application, which can be submitted in piecemeal fashion, by the end of the year.”
  • STAT News points out,
    • “Drugs called orexin agonists have been hailed for their ability to treat rare sleep disorders, but with new data, Alkermes is showing for the first time that the new class of therapies may benefit people with ADHD.
    • “In a randomized Phase 1 study, the company’s new drug, called ALKS 7290, was well tolerated and showed a signal of efficacy, Alkermes said Monday.
    • “Participants in the study started with a median score of 39 on a diagnostic known as the Adult ADHD Investigator Symptom Rating Scale, indicating that they had moderate to severe symptoms. After two weeks, those taking a high dose of 50 milligrams of ALKS 7290 experienced a 19-point reduction on the scale, indicating that their symptoms had become mild.
    • “Common ADHD treatments like stimulants have shown a similar magnitude of effect in trials over a longer period of time, four weeks, said Greg Mattingly, founding partner of St. Charles Psychiatric Associates, who consults for Alkermes.”
  • Per Genetic Engineering and Biotechnology News,
    • “Scientists have traditionally thought of the brain as a single, unified organ. But new research by Stanford Medicine scientists, working with collaborators from the California Institute of Technology and the University of California, San Francisco, indicates that what we call the brain is two distinct organs that evolved independently over hundreds of millions of years.
    • “The discovery overturns a prevailing model of brain development, based on the theory that there is a single progenitor cell early in development that gives rise to the entire brain. This model suggested that all parts of the brain shared a common developmental origin. The newly reported findings show that the human brain consists of two ancient nervous systems cleverly packaged together—a more primitive part that regulates the heart beating, our breathing and other functions, and another part that makes us distinctly human, capable of poetry, mathematics and wondering about our own origins.
    • “The results could help explain why scientists have struggled for decades to grow certain types of brain cells in the laboratory—and it opens new avenues for studying devastating diseases that affect the brain stem, such as spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS).”
    • “We’ve shown for the first time that the front of the brain arises from a totally different progenitor cell than the back of the brain,” said Kyle Loh, PhD, associate professor of developmental biology. “Our discovery means that we can now grow neurons from the back of the brain, the hindbrain, in a petri dish and study their functions.” Loh is senior author, and Carolyn Dundes, PhD, and Rayyan Jokhai are co-first authors of the scientists’ published paper in Nature Neuroscience, titled “Two parallel neural ectoderm progenitors contribute to the developing brain,” in which they concluded that “… the emerging notion of two parallel brain progenitors has a number of ramifications for development, differentiation and evolution.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare is pushing toward an average of 20 outpatient facilities for every hospital by the end of the decade as the company continues to make ambulatory expansion a centerpiece of its long-term growth strategy.
    • “CFO Mike Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference that HCA has already increased its outpatient footprint from about 12 facilities per hospital in 2023 to more than 14 today.
    • “Our goal, based on what we’re seeing in our markets, is that that would likely be 20 outpatient facilities per hospital by the end of the decade,” Mr. Marks said. “That reflects what we’re seeing for demand in our markets and just the value of having a comprehensive network of ambulatory sites to support your hospitals.”
    • “The target builds on several years of accelerated outpatient investment. HCA added about 100 outpatient facilities in 2025 and entered 2026 with roughly 2,700 outpatient sites. CEO Sam Hazen said in January the system had “significant capital in the pipeline” for additional outpatient development in 2026 and 2027, with growth expected through both new construction and acquisitions.”
  • and
    • Financial pressure is accelerating consolidation at a pace not seen in years. Staffing shortages, aging infrastructure, heavy Medicaid and Medicare dependence, and mounting payer denials have left hundreds of community hospitals with a stark choice: find a partner or close. 
    • Academic health systems, large nonprofits and regional powerhouses are all moving aggressively to absorb distressed and independent facilities, expanding geographic footprints, offloading debt and locking in patient pipelines in the process. 
    • [The article identifies] 34 academic health systems that have announced or plan to close strategic mergers, acquisitions or partnerships this year.
  • and
    • “Novo Nordisk unveiled its 2030 strategic targets at a Capital Markets Day in London Sept. 21, aiming to reassure investors it can navigate looming patent expirations for semaglutide, the active ingredient in Ozempic and Wegovy, according to a Sept. 21 report from the Financial Times.”
  • The Wall Street Journal adds,
    • “Ipsen IPN shares fell sharply after the U.S. Food and Drug Administration approved a generic competitor to its flagship hormone drug earlier than expected.
    • “Shares fell 6.6% to a seven-month low of 145.60 euros in morning European trade, making Ipsen the worst performer in the Europe-wide Stoxx 600 index.
    • ‘The FDA approved Amneal Pharmaceuticals’ AMRX 9.25%increase; up pointing triangle lanreotide injection—a generic of Ipsen’s Somatuline drug—at a dose of 120 milligrams, the New Jersey-based drugmaker said in a release after market close Friday.
    • “The drug will launch immediately and be produced in-house, Amneal said.
    • “The launch comes sooner than Ipsen had expected. Following the company’s second-quarter results in July, Chief Financial Officer Aymeric Le Chateliersaid he expected “some delay on the entry of [the] generic,” with Somatuline’s competitor expected to arrive in the fourth quarter.”
  • Beckers Payer Issues relates,
    • “Nationally, employees contribute an average of $7,314 per year toward the cost of employer-sponsored family health insurance, according to an analysis from KFF.
    • “The 2025 data comes from the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey Insurance Component, an annual survey of employers.”
  • Fierce Healthcare tells us,
    • “Zocdoc, the marketplace for booking provider visits, is making its infrastructure available to enterprise partners to support bookings anywhere patients look for care. 
    • “The new enterprise offering, Care Access Network, enables payers and tech or consumer platforms to embed Zocdoc’s appointment-booking capabilities directly into their own websites and apps. The infrastructure is built on two decades of connecting provider orgs, payers, electronic health records (EHRs) and practice management systems with scheduling workflows. Zocdoc’s marketplace today connects to over 200,000 providers across over 200 specialties and 10,000 plans. 
    • “I’m incredibly proud of the door we built with Zocdoc.com, but I’ve come to the conclusion that the front door to healthcare can’t be owned,” Oliver Kharraz, M.D., founder and CEO of Zocdoc, told Fierce Healthcare in an advanced interview. Wherever a consumer is searching, “you should be able to book right there and then.”
  • and
    • “Biological threat intelligence is increasingly becoming a workforce and business issue, not just a public health concern. Emerging threats—infectious disease outbreaks, pandemics and potential bioterrorism events—can cause significant workforce and operational disruptions.
    • “The Business Group on Health is partnering with biological intelligence service BioRadar to help employers better prepare for emerging biological threats. The collaboration will give employers access to BioRadar’s AI-powered biological intelligence platform, designed to identify and assess threats in real time before they escalate into widespread health concerns and business disruptions. 
    • “The collaboration reflects lessons learned during the COVID-19 pandemic, the organizations said, exposing the need for more proactive monitoring and planning rather than relying solely on public health alerts after threats have already spread. The COVID-19 pandemic forced sudden operational shutdowns, severe revenue contractions and historic labor shifts across nearly every sector.”
    • “Through the partnership, employers will also help to shape the next generation of biological intelligence tools so that workforce needs, business continuity considerations and public health priorities are considered from the outset, the organizations said.
    • “The health, well-being, safety and productivity of the workforce increasingly depends on timely insight into emerging biological threats,” Ellen Kelsay, president and CEO of Business Group on Health, said in a statement.”
  • Fierce Pharma points out,
    • “Bayer has decided to offload its aging cancer drug Stivarga to German compatriot Grünenthal as competition mounts.
    • “Grünenthal announced Monday that it will pay up to 375 million euros ($431 million) to acquire Stivarga, an oral multikinase inhibitor. 
    • “According to Grünenthal, patent protection for Stivarga is expected to last until 2029 in the European Union and by 2030 in the U.S. But loss of exclusivity in China has already taken a toll on sales.”

Friday report

David Ermer–CDC, CMS, FDA, Government Contracting, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Avalere Health offers insights concerning HHS Secretary’s decision to fill out the membership of the U.S. Preventive Services Task Force announced yesterday.
    • “For life sciences companies and health plans, the USPSTF’s ability to resume its work—and potential new approaches to evidence review with its new members—will be consequential. The Task Force’s recommendations influence preventive care practice, clinical quality strategies, and, most notably, health plan preventive service coverage requirements.” * * *
    • “Health plans should prepare for the potential release of delayed recommendations and for a more active USPSTF agenda. This includes maintaining processes to assess coverage requirements, benefit configuration, coding, provider-network capacity, member communications, and implementation timelines once final A or B recommendations are issued. USPSTF last shared a recommendation update in August 2025, with four topics pending final recommendation statements.
    • “As the Task Force resumes activity under new leadership and a substantially different membership profile, transparency, methodological consistency, and implementation relevance will be central to maintaining trust in its recommendations.”
  • Per a Centers for Medicare and Medicaid Services (CMS) news release.
    • “The Centers for Medicare & Medicaid Services (CMS) is working to end skyrocketing drug costs as the agency announces today that all 50 states, plus the District of Columbia and Puerto Rico, have applied to participate in an initiative which provides most-favored-nation pricing for certain prescription drugs to people with Medicaid. Forty states and Puerto Rico have already signed agreements to participate in this historic program that will lower Medicaid drug costs to what other countries pay, saving an estimated $64.3 billion in taxpayer dollars over the next ten years, while preserving or enhancing beneficiaries’ quality of care.” * * *
    • “The GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model is a landmark CMS Innovation Center initiative designed to not only lower drug spending in Medicaid but also improve quality of care and health outcomes by increasing access to critical medications and strengthening the Medicaid program overall. Under the GENEROUS Model: 
      • “Participating manufacturers will make covered outpatient drugs available at most-favored nation pricing to participating state Medicaid programs.
      • “Under agreements with states, participating manufacturers will be invoiced by states for supplemental rebates to effectuate international prices. CMS will monitor pricing accuracy. CMS will share in rebates with states via a reduction in the federal share of Medicaid payments.” * * *
    • “Remaining states have until Sept. 30, 2026, to sign agreements with CMS to participate in the model. The GENEROUS Model launched in January 2026 and runs for five years.
    • “For information on states participating the GENEROUS Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/generous.” 
  • In today’s Federal Register, the Federal Acquisition Council promulgated proposed rules implementing the Revolutionary FAR Overhaul’s (RFO) FAR provision deviations.
  • The FAR Council explains on the acquisition,gov website,
    • “The RFO Phase 2 rule-making process has been organized in 12 FAR Cases, as outlined in the chart. The FAR Council has published Proposed Rules (PR) for the first 4 of 12 RFO-related FAR cases.
    • “With this publication, it’s the perfect time to show how public feedback informed key changes from the model deviations to the proposed rules. Your voice made a difference. The FAR Council received almost 1,600 valuable comments, primarily from industry (80%), but also from industry associations (7%) and federal government employees (13%). The public feedback received informed the FAR Council’s work in preparing the proposed rules. 
    • ‘While all public comments received may not be reflected, the tables below highlight examples of key policy updates that resulted from some of the public feedback submitted via acquisition.gov. The tables are organized by the RFO-related FAR rules, and will be continuously updated as the remaining RFO-related rules are published over the coming months.” 
  • Per Department of Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Financial Resources (ASFR), today announced a new Department-wide policy establishing the HHS Personal Protective Equipment (PPE) Forecast. This is the first official, recurring process to identify, consolidate, and publish anticipated HHS purchases of personal protective equipment covered by the Make PPE in America Act.
    • “The new forecast will give U.S. PPE manufacturers a clearer and more predictable signal of future HHS demand. By turning the Department’s acquisition plans into actionable market visibility, the initiative will help domestic companies make better-informed decisions about hiring, production, capital investment, and manufacturing capacity while strengthening the supply chains HHS relies on during routine operations and public health emergencies.” * * *
    • American manufacturers and small businesses can review HHS procurement forecast opportunities through the HHS Small Business Customer Experience platform.
  • and

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

  • OPM Director Scott Kupor resorted to his Secrets of OPM blog [found on Substack) to ably debunk recent challenges to the cost savings created by last year’s massive reduction in federal employment.
    • “GAO estimates that agencies spent about $9.5 billion on all paid administrative leave in 2025 and attributes about $6.7 billion of that to the Deferred Resignation Program. For the sake of argument, let’s charge the entire $9.5 billion to DRP anyway. It was a one-time expense.
    • “What did the taxpayer get for it? Using rough averages, the fully loaded cost of a federal employee is about $150,000 per year. For 270,000 employees, that is more than $40 billion in annual costs. These are not one-time costs, but costs incurred every year in perpetuity.
    • “So, for a one-time expense of at most $9.5 billion, taxpayers save more than $40 billion each year. That’s a 400+% annual return, and the outlay paid for itself in under six months.”
  • Here is a link to Senator Adam Schiff’s (D CA) news release about the letter that he and fifteen other Democrat Senators sent to OPM on October 16 questioning the OPM’s use of FEHB and PSHB protected health information to help OPM’s effort to combat fraud, waste, and abuse in hose programs.
    • “We support responsible efforts to protect the integrity of federal health-benefit programs. However, OPM’s proposals create an unnecessarily broad, decades-long, re-identifiable medical history of millions of workers, retirees, spouses, children, and other family members. We strongly urge OPM to suspend further implementation while these concerns are addressed and to work with Congress, federal employees and retirees, health plans, privacy and civil-rights experts, reproductive-health advocates, and other affected stakeholders to establish safeguards commensurate with the sensitivity of the information at issue. 
    • “We request a written response and briefing by OPM on the office’s efforts related to the above requested actions no later than September 25, 2026.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy.
    • “The approval, announced Sept. 18, 2026, applies to patients whose ESR1 mutation is identified using an FDA-authorized test. The FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1-mutated breast cancer who may be eligible for the treatment combination.
    • “Inluriyo and Verzenio are both manufactured by Eli Lilly and Company.”
  • MedTech Dive relates,
    • “Cognita Imaging recently received a $1.29 million research contract from the Food and Drug Administration to test a new method of evaluating artificial intelligence-generated radiology reports. The goal is to assess whether a “jury” of large language models can evaluate another AI model’s report, and which cases need radiologist oversight.
    • “The contract, which started on June 22 and will run for 18 months, is intended to address a core problem with generative AI. Currently, most tools are evaluated against a panel of radiologist experts, but for models that can evaluate a wide variety of cases and generate different outputs, this becomes more challenging and time-consuming.”
  • STAT News tells us,
    • “In January, a paper published in Science analyzed government mortality figures, data on drugs seized by the DEA, and Reddit posts to determine that decreasing fentanyl potency due to Chinese government crackdowns could explain the recent decline in U.S. opioid overdose deaths. But when another research team tried to replicate that study, they didn’t come to the same conclusion.
    • “A simplistic supply shock is not supported by the evidence,” the authors wrote yesterday in Science Advances.
    • “The researchers noted that as fentanyl purity increased across the country, there was no associated national drop in overdose rates. While there did seem to be a broad association between declining purity and overdoses, it was shared with other, unrelated trends. And importantly, the DEA acknowledged at the time that increasing purity in its drug seizures was likely due to a change in its sampling plan.
    • “It’s also critical not to overlook geographic variability in the drug supply, the replication study authors wrote. As one of them told Lev Facher when the first study was published, many regions had declining overdose rates before potency apparently began to drop. — Theresa Gaffney

From the public health and medical /Rx research front,

  • The Centers for Disease Control and Prevention announced today
    • “As of September 18, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low overall.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 177 new cases added today, the US measles count has climbed to 3,471. * * *
    • “Today’s increase marks the sixth straight week of triple-digit increases in cases.
    • “The CDC today noted 39 outbreaks, one more than last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level in July. 
    • “The 2026 total is already 52% higher than the 2025 total, with more than three months left in the year.
    • “All but 17 of this year’s cases have been locally acquired, with the rest tied to international travel. Cases have been confirmed in 45 states plus New York City and Washington, DC.
  • The Washington Post tells us,
    • “Paul Nestadt is about as steeped in suicide prevention as a person can be.” * * *
    • “Nestadt has sought to intervene in ways that don’t require pinpointing people at risk.
    • “Chief among them: making it harder for people to carry out the act of killing themselves.
    • “Instead of asking every doctor to figure out which patient will die by suicide and locking that patient up, it might be that we need to make sure there aren’t loaded guns available,” Nestadt said.
    • “Although medication and therapy are lifesaving measures, many clinicians, researchers and people who have lost loved ones to suicide agree that more is needed. When it comes to firearms, however, broad policy approaches face major constitutional and political challenges.
    • “Research shows that limiting access to lethal means is one of the most promising approaches to save lives. It can involve erecting barriers on buildings and bridges to prevent people from jumping, as well as decreasing the number of pills someone can buy or be prescribed at once.
    • “And reducing access to guns, which are the most common and lethal method used for suicide in the United States.”
  • Beckers Behavioral Health shares summaries of “34 new behavioral health study findings to know.”
  • MedPage Today lets us know,
    • “A quarter of patients with cirrhosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD) presented before the age of 50 with distinct risk profiles, data from a prospective study showed.
    • “In models adjusting for demographic and metabolic factors, a high genetic risk score and type 2 diabetes were independently associated with early-onset MASLD cirrhosis.
    • “Reliance on age-dependent first-line liver fibrosis tools can miss cases, the researchers suggested.”
  • Per Health Day,
    • “Wearable sensors might be the key to better tracking and treating a person’s knee arthritis, a new study says.
    • “Strapped to the foot, these sensors work as well as motion capture cameras in tracking a person’s natural stride, researchers reported recently in the journal JMIR Formative Research.
    • “This stride data could be used to track how a person with knee arthritis walks, allowing doctors to track arthritis progression and potentially offer individualized therapy, researchers said.”
  • and
    • “More people are seeking emergency help for gambling problems in the face of expanded online betting markets, a new study says.
    • “ER visits for gambling disorders nearly doubled following the legalization of single-event sports betting and expansion of online gambling markets in Ontario, researchers reported Sept. 15 in the American Journal of Preventive Medicine.
    • “Most people experiencing gambling problems will never seek care, so the concern is that the increases in ED visits for gambling disorders we observed may be revealing much larger increases in gambling-related harm,” senior researcher Dr. Daniel Myran said in a news release. He’s research chair at North York General Hospital in Toronto.”
  • Per Genetic Engineering and Biotechnology News,
    • “Diabetic kidney disease is one of the most common and serious complications of diabetes, yet the chain of events linking high blood sugar to kidney damage remains incompletely understood. Now, a stem cell-based model suggests that glucose itself may help trigger an inflammatory response inside kidney tissue—one that can damage key epithelial cells.
    • “Researchers led by Benjamin S. Freedman, PhD, at the University of Washington and University of Miami, report that human kidney organoids exposed to elevated glucose developed tissue-intrinsic inflammation and epithelial cell detachment, including detachment of podocytes, specialized cells essential for the kidney’s filtration barrier. The study, “Elevated glucose in kidney organoids induces tissue-intrinsic inflammation driving epithelial detachment,” was published recently in Stem Cell Reports.
    • “High sugar causes inflammation in these organoids even though they lack an immune system,” Freedman said. “This was unexpected and gives us a new way to think about how diabetes can affect kidneys and other organs.”
  • Per Beckers Hospital Review,
    • “An investigational immunotherapy was found to almost double median overall survival in patients with previously treated squamous non-small cell lung cancer, according to new trial data.
    • “Gotistobart, developed by BioNTech and OncoC4, showed a median overall survival of 18.5 months, nearly double the 10-month median among patients who received standard of care chemotherapy, according to a Sept. 14 news release from the companies.
    • “The trial results were presented Sept. 14 at the International Association for the Study of Lung Cancer’s World Conference on Lung Cancer in Seoul.”

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

  • Modern Healthcare reports.
    • “Molina Healthcare is pulling its all of its Medicare plans from three states for the 2027 plan year, the company notified third-party marketers Friday.
    • “The health insurer announced in February that it would completely exit the national market for individual Medicare Advantage plans to focus on Dual Eligible Special Needs Plans, or D-SNPs, for people who qualify for both Medicare and Medicaid. The company tried to sell the individual Medicare Advantage business but failed to find a buyer.
    • “In Connecticut, Mississippi and Nevada, Molina Healthcare is going a step further by ending individual, D-SNP and other Medicare plan sales, according to the notice.”
  • Beckers Clinical Leadership relates,
    • “Two UC Health emergency departments avoided more than 3,500 unnecessary head and cervical spine CT scans over 23 months with no missed injuries identified, according to a study published in the Western Journal of Emergency Medicine.
    • “The quality improvement campaign ran at University of Cincinnati Medical Center and West Chester Hospital in West Chester Township, Ohio. The campaign paired continuing education on clinical decision rules for head and cervical spine imaging with decision-support software embedded in the EHR, plus quarterly feedback showing physicians how their own ordering compared with peers’. Teams also created patient handouts to reassure those who expected a scan they did not need.
    • “Physician-researchers estimated the effort eliminated 3,542 scans in low-risk trauma patients, avoiding $6.2 million in patient charges at roughly $1,750 per scan and saving 14,168 hours of patient waiting time. The campaign also avoided 6,021.4 millisieverts of radiation exposure — the equivalent of roughly 2,000 years of background radiation for one person.
    • “A safety review identified no patient harm and no missed injuries.” * * *
    • “View the full study here.”
  • Beckers Hospital Review tells us,
    • “Paul Krakovitz, MD, became CEO of Greensboro, N.C.-based Cone Health on March 16, roughly 15 months after the five-hospital system joined Risant Health, the nonprofit created by Oakland, Calif.-based Kaiser Permanente. Dr. Krakovitz previously held leadership roles at Cressey & Company, Intermountain Health and Cleveland Clinic.
    • “Now, Risant is involved in Cone Health’s value-based care work, bringing tools developed through Kaiser Permanente’s experience with the model to the community health system. Risant is also helping fund Cone Health’s $40 million effort to rebuild its Epic platform after years of technical debt limited the system’s ability to adopt newer capabilities.
    • “Dr. Krakovitz discussed with Becker’s the system’s work with Risant, its Epic investment and Cone Health’s efforts to move away from volume and toward more proactive care.
    • “He said Risant has brought additional resources and focus to Cone Health’s value-based care strategy while the health system remains focused on its local community.
    • “The value-based care tools that Risant brings from a national scale is just something that is incredibly unusual to be able to deploy in a community health system, and it’s a huge benefit, both for our clinicians and for our community,” Dr. Krakovitz said.”
  • Beckers Health IT adds,
    • “Techstars and the Mid-Atlantic Permanente Medical Group selected nine startups for a healthcare accelerator focused on emerging technologies and care delivery.
    • “More than 1,200 startups applied for the 2026 Techstars Healthcare Accelerator powered by Permanente Medicine Mid-Atlantic States, according to a Sept. 18 news release.
    • “The three-month program began Sept. 14 and will connect participating companies with Techstars investors and mentors as well as physicians and healthcare leaders from the Mid-Atlantic Permanente Medical Group.”
  • Beckers Hospital Review points out,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • “Here [in the article] are 60 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1, 2026.
  • Fierce Healthcare informs us,
    • “Angle Health raised $600 million in equity financing, reaching a total valuation of $2.7 billion, to continue expanding its artificial intelligence-native healthcare benefits platform for small businesses.
    • “According to the company, the financing includes a $200 million series C funding round and a $400 million tender offer. The startup’s valuation has more than doubled since its December series B round when it raised $134 million, the Wall Street Journal reported. The company raised a $58 million series A round in January 2023.
    • “Vitruvian Partners led the round, with participation from new investor Town Hall Ventures and existing investors Blumberg Capital, Portage Ventures, PruVen Capital and Y Combinator. They expect to close the round later in September.”
  • and
    • “Oura and Counsel Health are teaming up to participate in CMS’ 10-year chronic condition management program, betting that continuous health data from Oura’s smart ring paired with medical AI can help move the needle on conditions like hypertension.
    • “Counsel Health, an AI-native primary care company, plans to participate in CMS’ Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model under the early cardio-kidney-metabolic (eCKM) track, with smart ring maker Oura serving as the preferred wearable partner.
    • “It is an early example of how the CMS chronic care initiative could become a proving ground for AI-powered, wearable-enabled care delivery.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.
    • “The research was published in the Expert Review of Pharmacoeconomics & Outcomes Research.”
  • Fierce Pharma notes,
    • “As expected, the past U.S. Labor Day holiday took a toll on obesity drugs’ prescription numbers. According to IQVIA data cited by Citi, weekly scripts for Novo’s Wegovy pill dropped roughly 12% sequentially to about 161K for the last week. The decline for Foundayo was modest, at just 1%, as the Lilly drug still managed to rake in more than 47K scripts. 
    • “Lilly this week said Foundayo captured more than 30% of new patients in the U.S. market for oral obesity ​treatments, Reuters reported. 
    • “Citing Bloomberg Symphony data, Jefferies analysts suggested in a Friday note that Foundayo’s recent acceleration “has been driven primarily by retail/commercial channels.”
    • “Elsewhere, Lilly’s total Zepbound scripts were down 8.5% week over week, but the GIP/GLP-1 drug expanded its market share by 0.4% versus Novo’s Wegovy franchise, whose scripts decreased 10% during the period.”

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Happy Constitution Day!

From Washington, D.C.,

  • The American Hospital Association News reports,
    • “A Capitol Hill briefing Sept. 17 in Washington, D.C., hosted by 11 national healthcare organizations, including the AHA, highlighted the growing epidemic of workplace violence and its effects on staff well-being and patient safety. At the briefing, titled Protecting Those Who Care: Addressing Violence Against Healthcare Workers, Hill staff heard panelists’ personal experiences with physical and verbal attacks on the job and how hospitals are working to reduce the incidence of violence. The panelists were: Elizabeth Wells, M.D., executive vice president, chief clinical officer, and physician-in-chief, Children’s National Hospital; Jonathan Ripp, M.D., chief wellness officer and dean for well-being, Icahn School of Medicine at Mount Sinai; Tiffany Covarrubias-Lyttle, RN, associate professor of nursing, University of Lynchburg; and, Sheila Roth, Ph.D., professor emeritus, Carlow University. Reps. John Joyce, R-Pa., and Joe Courtney, D-Conn., also made brief remarks during the event.
    • “In a joint statement, the AHA and other participating organizations said, “Workplace violence, including physical assaults, threats, intimidation, and harassment, erodes the safety and dignity of healthcare workers, directly contributes to staff burnout and turnover, and staffing shortages, and compromises the quality of care and patient safety. This violence undermines providers’ ability to ensure safe, healing environments for all.”
    • “The AHA’s Hospitals Against Violence initiative includes resources and best practices for hospitals to use and share to address workplace and community violence.” 
  • Beckers Clinical Leadership relates,
    • “HHS Secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, bringing the influential preventive care panel to 16 members.
    • “Mr. Kennedy made the appointments Sept. 17 through the Agency for Healthcare Research and Quality. The eight join eight members currently serving on the volunteer panel of prevention and evidence-based medicine experts.
    • “The task force carries outsized weight for health system and payer leaders: preventive services that the panel grades “A” or “B” must be covered by most private insurers without cost-sharing under the ACA. Its composition effectively shapes which screenings and preventive services patients can get at no cost.” * * *
    • “Seth Corey, MD, a pediatric hematologist-oncologist at Cleveland Clinic, will chair the task force. The other seven appointees are:
      • “Patrick Hunter, MD, a pediatrician at Pensacola (Fla.) Pediatrics and member of the Florida State Board of Medicine
      • “Ronald Karlsberg, MD, a clinical professor of medicine at Los Angeles-based Cedars-Sinai Medical Center’s Smidt Heart Institute
      • “Venkatesh Murthy, MD, PhD, professor of preventive cardiology at the University of Michigan in Ann Arbor
      • “Stephen Parente, PhD, a health finance professor at the University of Minnesota’s Carlson School of Management in Minneapolis
      • “Goldie Stands-Over-Bull, MD, lead family medicine physician at Texas Native Health in Dallas
      • “Louis Wilson, MD, a gastroenterologist and managing partner at Wichita Falls (Texas) Gastroenterology Associates
      • “Dennis Wulfeck, MD, a diagnostic radiologist and president of the practice board at Radiology Partners’ MBB Radiology in Jacksonville, Fla.” 
  • U.S. News and World Report tells us,
    • “The U.S. Senate ⁠health ⁠committee will hold a confirmation ⁠hearing next week for Dr. Heidi Overton, President Donald Trump’s pick to ​lead the embattled Food and Drug Administration, the panel said on Thursday.
    • “The hearing will take place ‌on September 24, the Senate Health, ‌Education, Labor, and Pensions Committee said in a statement. Trump nominated Overton, a White ⁠House policy aide, ⁠in August, turning to an “America First” ally to steady an agency ​shaken by staff losses, low morale and fights over vaccines, the abortion pill and drug approvals.
  • Per Department of Health and Human Services news releases,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today launched the new Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a major research effort to transform how autism is understood, diagnosed, and supported across the lifespan. SPECTRA will bring together biological, clinical, behavioral, and real-world data with advanced computational tools to enable earlier and more accurate diagnosis, identify factors that shape individual health and developmental trajectories, and develop more precise approaches to care tailored to each person’s needs.
    • “Autism is not one-size-fits-all, and our science and care cannot be either,” said HHS Secretary Robert F. Kennedy, Jr. “Millions of American families are impacted by autism, and they need better answers about why it presents so differently from one person to another and which approaches can best meet each person’s needs. SPECTRA will harness the best of American science and innovation to deliver those answers — and turn them into better outcomes for people with autism and their families.” * * *
    • “Learn more about SPECTRA on its program page, including information about the solicitation.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today issued a Request for Information (RFI) calling on Americans, scientists, physicians, industry, and public health experts to submit evidence and information on the potential health effects of electromagnetic fields (EMFs), radiofrequency (RF) radiation, and wireless radiation exposure.
    • “The RFI will help HHS evaluate the state of the science, compare U.S. and international safety standards and regulatory approaches, identify critical research gaps, and develop practical, evidence-based recommendations for policymakers, families, schools, communities, and public health professionals.
    • “Wireless technologies are part of daily life, and our science must keep pace,” said HHS Secretary Robert F. Kennedy, Jr. “The MAHA Strategy directed HHS to examine electromagnetic radiation and health research, and we are acting on that directive. I encourage scientists, physicians, industry, public health experts, workers, parents, and citizens to bring us the best available evidence so we can identify the gaps and focus federal research where it is needed most.” * * *
    • “More information about the RFI can be found at the Federal Register [PDF].”
  • The International Foundation of Employee Benefit Plans helpfully shares information about “Red Flags for Mental Health Parity Compliance Problems.”

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

  • FedSmith reports,
    • “Federal retirees and Social Security recipients are only one inflation report away from knowing their 2027 cost-of-living adjustment (COLA). The Bureau of Labor Statistics (BLS) will release the September inflation report on October 14. That report will provide all three CPI-W figures needed to calculate the 2027 COLA.”
    • “The latest estimate from The Senior Citizens League (TSCL) puts the 2027 Social Security COLA at 3.5%. The organization lowered its estimate from 3.6% after the latest inflation report.
    • “Because Social Security and Civil Service Retirement System (CSRS) benefits use the same underlying inflation measure, that estimate also indicates the COLA CSRS retirees may receive. For most Federal Employees Retirement System (FERS) retirees eligible for a COLA, however, a 3.5% increase in the CPI-W would result in a 2.5% FERS COLA because FERS uses a different formula.”
  • Serving those We Serve tells us what federal and Postal employees should know about the redesigned Social Security Statement.
  • Tammy Flanagan, writing in Govexec, lets us know how to navigate the Pay.gov maxe for federal retirement deposits.
    • “Don’t let missing service credits or opaque OPM billing notices shrink your monthly annuity. Here is what you need to know before clicking submit.”
  • MeritTalk informs us,
    • “The Office of Personnel Management (OPM) used governmentwide OneGov deals to give every employee access to six artificial intelligence (AI) platforms, and more than 70% of its workforce actively uses at least one, according to OPM CIO Adam Starr.
    • “Speaking Tuesday at the GovExec Government & AI Summit in Washington, D.C., Starr said OPM has leaned heavily on the General Services Administration’s (GSA) OneGov agreements to rapidly expand employee access to AI.
    • “The OneGov deals were key to our ability to innovate at OPM with AI,” Starr said. “We basically bought all of the AI offerings at $1, and so we gave every employee six AI tools, and we encourage them to use it.”
    • “Those tools include Google’s Gemini, Microsoft Copilot, xAI’s Grok, OpenAI’s ChatGPT, Anthropic’s Claude, and Perplexity AI, Starr said.
    • “The strategy is intentionally multi-model. Starr said he wants employees to have access to several platforms because AI models are evolving quickly and vendors are regularly “leapfrogging each other.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A., MPS IIIA is a rare inherited disease that progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abilities over time. Until today, treatment was limited to managing symptoms; there was no FDA-approved therapy designed to change the underlying course of the disease.
    • “The Trump Administration is committed to bringing safe and effective treatments to patients with the most urgent and unmet needs. The approval of Fayuvi marks a historic moment for children and families living with MPS IIIA, which is a disease that has, until now, offered no approved treatment to alter its devastating course,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Gene therapy holds tremendous promise for rare diseases like Sanfilippo syndrome type A, and this milestone reflects the FDA’s commitment to action.”  
    • “Fayuvi is a one-time, intravenous (given directly into a vein) gene therapy that uses a modified, non-infectious virus called an adeno-associated virus serotype 9 (AAV9) to deliver a working copy of the SGSH gene into the patient’s cells. This enables the body’s cells to produce sulfamidase — the enzyme that is missing or deficient in MPS IIIA — allowing heparan sulfate to be properly broken down in lysosomes and reducing its harmful buildup throughout the body and brain.”
  • Targeted Oncology reports,
    • “FDA 510(k) clearance covers robotic colonoscopy for screening, surveillance, diagnostic evaluation, and advanced therapy including EMR and ESD across the full colon. 
    • “Triton 1 targets limitations of manual scope manipulation by adding robotic control intended to enhance stability, maneuverability, and procedural efficiency during flexible endoscopy. 
    • “CARE I (NCT06935734) reported 100% cecal intubation and no adverse events, meeting primary safety/efficacy end points in a first-in-human cohort. 
    • “Detection performance in CARE I included ADR 54.2% and polyp detection rate 67.5%, exceeding a cited 35% ADR industry threshold. 
    • “Endoscopist ergonomics improved, with a 67% lower perceived procedural workload versus manual colonoscopy on NASA-TLX, suggesting reduced physical and cognitive operator burden.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for a vessel-sealing technology used with its Hugo soft tissue robotic surgery system.
    • “The clearance, which Medtronic disclosed Wednesday, brings LigaSure technology, used in more than 45 million procedures worldwide, to the company’s robotic-assisted surgery platform.
    • “Targeting markets dominated by Intuitive, Medtronic has identified an opportunity to win share by pairing its platform with energy instruments that physicians use in non-robotic surgeries.”
  • MedPage Today informs us,
    • “Unapproved use of deoxycholic acid injection (Kybella) outside of the submental fat region may carry a risk of neuromuscular and other potentially serious adverse events, according to an FDA labeling update.
    • “A review of the FDA Adverse Event Reporting System (FAERS) revealed 129 cases of adverse events associated with use of deoxycholic acid in unapproved areas since the product was approved in 2015, the agency stated in a safety communication. The reports included some serious adverse events, such as blurred or reduced vision with periorbital use of deoxycholic acid injection and muscle or nerve injury, including facial paresis and paresthesia.
    • In announcing deoxycholic acid injection’s approval, the FDA emphasized, “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”

From the judicial front,

  • Bloomberg Law reports,
    • “An out-of-network healthcare provider can’t sue Cigna Health and Life Insurance Co. to recover more than $3 million it won against the plan through the No Surprises Act’s independent dispute resolution process, a federal appeals court said Thursday.
    • “The text and structure of the federal law, which created a process for resolving disputes between health plans and out-of-network providers, make clear that it doesn’t provide a private right of action to enforce arbitration awards obtained through that process, Judge Michael H. Park said. The US Court of Appeals for the Second Circuit thus affirmed the dismissal of East Coast Advanced Plastic Surgery LLC’s suit against Cigna.
    • “Although the NSA gives providers a right to payment from health plans for certain services, it delegates enforcement authority to multiple federal agencies and to states,” Park said for the unanimous panel. “This statutory scheme reflects Congress’s intent that the NSA, including payment of IDR awards, be enforced through administrative action rather than private litigation.”
  • Beckers ASC Review relates,
    • “San Tan Valley, Ariz.-based Rita Ntusa Anagho has been sentenced to 14 years in federal prison for orchestrating a $69 million Medicaid fraud scheme through her addiction treatment clinic, according to a Sept. 17 news release from the Department of Justice.
    • “Ms. Anagho, 54, a licensed nurse practitioner, owned and operated Tusa Integrated Clinic, which fraudulently billed Arizona’s Medicaid agency more than $69 million between about May 2022 and March 2023; the agency paid roughly $54.9 million on the false claims, according to court documents. 
    • “Ms. Anagho and her co-conspirators allegedly targeted patients covered under Arizona Medicaid’s American Indian Health Care Program, which reimburses at higher rates than other Medicaid plans, paid illegal kickbacks to sober home owners for patient referrals, and falsified treatment records to conceal the scheme.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “The U.S. cancer death rate declined 35% between 2015 and 2024, averting more than 4.8 million deaths, according to the American Association for Cancer Research’s 16th annual Cancer Progress Report, published Sept. 16.
    • Here are [three] things [the article has eight] healthcare leaders need to know from the report:
    • Death rates fell an average of 4.2% per year for lung cancer, 1.3% for colorectal cancer and 1.2% for female breast cancer between 2015 and 2024.
    • An estimated 2.1 million new cancer cases will be diagnosed in 2026.
    • By 2050, the number of annual cancer diagnoses is projected to rise to 2.5 million.
    • More than 18.6 million people with a history of cancer were living in the U.S. as of Jan. 1, 2025.
    • AACR researchers expect 22 million people to be living with cancer or a history of cancer by 2035.
    • “Read the full report here.”
  • Healio points out,
    • “Around 2.71 billion people worldwide were exposed to secondhand smoke in 2023.
    • “An expert encouraged clinicians to screen women, children and patients with cardiac issues for exposure.” * * *
    • “Despite the findings, Flor and colleagues highlighted progress from tobacco-reducing policies in the Americas, as “of the 79 countries attaining the highest level of achievement in smoke-free protections globally, 24 are in the Americas, approximately 70% of the countries in that region.”
  • STAT News adds,
    • “For years, researchers have known that, among people diagnosed with lung cancer, the prevalence of nonsmokers has been increasing. But they have been trying to determine what factors — whether genetic, environmental, or something else — might put these “never-smokers” at heightened risk. 
    • “Now, researchers have identified a very rare genetic variant that is associated with 25-fold higher odds of lung cancer, they reported in the journal Science on Thursday. In the U.S., the variant is far more common among people in Southern Appalachia than in other regions. 
    • Experts said that the variant likely only plays a role in a small portion of never-smoker lung cancer cases. But the research provides further evidence that these types of tumors can be tied to distinct risk factors, which may in turn require thinking differently about screening programs and treatment strategies. More broadly, the new study highlights the types of narrow but crucial discoveries that can be made by turning to large datasets replete with health information from millions of people. In this case, the investigators relied on genetic data from 23andMe.” * * *
    • “The variant in question — known as T790M — is a version of a gene called EGFR, which typically helps regulate how cells grow and divide. Select EGFR mutations can crop up over a person’s life and are among the most important drivers of lung cancer, and in turn are targeted by some cancer drugs.”
  • The Washington Post calls attention to “5 movements physical therapists say every adult over 50 should do daily.”
    • These simple moves can help you maintain mobility and independence as you age.”
  • Beckers Behavioral Health informs us,
    • “A 13-item Mental Wellness Tool detected common or severe mental disorders, substance use disorders and suicide risk among patients receiving psychiatric emergency department care at a New York City hospital, according to a Sept. 17 Medscape report.
    • “Existing mental health screening tools typically assess for one disorder, and screening for a range of psychiatric conditions can take well over 45 minutes and require several assessment tools. The mwTool-13 is designed to screen for multiple conditions in a single assessment.
    • “The mwTool-13 can be administered in 2 to 10 minutes, according to a Sept. 3 study published in Psychiatric Services.”
  • The Wall Street Journal shares readers views on patient portals.
  • Health Day tells us,
    • “Nearly two-thirds of suspected poisonings in young children probably do not need the emergency department and can be handled by a call to the local poison control center, according to a study published in the August issue of Clinical Toxicology.
    • “Liam P. McLoughlin, M.D., from Rutgers New Jersey Medical School in Newark, and colleagues investigated the medical necessity of pediatric emergency department presentations for poison cases where a poison control center was not contacted prior to presenting at the emergency department. The analysis included toxicologist reviews of summaries from 348 poison control center cases, originating from a health care facility, involving patients aged younger than 6 years.” * * *
    • “A big takeaway from the paper is that more needs to be done to make sure parents, schools, and communities know the poison center is a resource they can turn to when a poisoning is suspected,” McLoughlin said in a statement. “The poison center is available 24/7, 365, and is staffed by amazing people who can provide life-saving information by phone at no cost.”
  • and
    • “Exercise is already recommended to help people with cancer manage fatigue and improve quality of life. Now, there is evidence the benefits may go further.
    • “A new study finds structured exercise may help people with cancer live longer and have more time free of disease.
    • “Chih-Chen Tzang of the National Taiwan University and colleagues analyzed 21 clinical trials involving more than 8,400 cancer patients.
    • “Some followed supervised exercise programs that included aerobic exercise, strength training or both. Others did not.
    • “Over an average follow-up of about five years, those who exercised were 23% less likely to die and 17% less likely to have their cancer return before death.
    • “The benefits were strongest among people with early-stage cancer, those who did aerobic exercise — alone or with strength training — and those who completed at least 70% of their exercise program.”
  • Per Genetic Engineering and Biotechnology News,
    • “The genome editing toolbox provides unprecedented opportunities to engineer the human genome. However, genome editing for therapeutic benefit continues to have its limitations. Most current methods rely on untargeted gene delivery or short DNA edits that need to be individualized to each patient.
    • “Now, a new paper describes a novel genome engineering method, prime assembly, that allows long DNA fragments to be integrated into precise and programmable target positions within living cells. This approach, which leverages CRISPR-targeted dual flap synthesis, may allow for the development of universal gene therapies.
    • “This work is published in Nature in the paper, “Targeted genomic integration and rearrangement using prime assembly.”
  • Per Fierce Pharma,
    • “Roche’s T-cell engager portfolio has notched another milestone, as a phase 3 trial of the company’s Lunsumio met its primary endpoint in earlier-line follicular lymphoma.
    • “Without sharing any specific data, Roche and its subsidiary Genentech said Lunsumio’s combination with lenalidomide (Revlimid) demonstrated a statistically and clinically meaningful improvement in progression-free survival against rituximab (Rituxan) plus lenalidomide, known as R2, in the phase 3 Celestimo study. 
    • “The trial enrolled follicular lymphoma (FL) patients who have received at least one prior line of treatment, and it serves as the confirmatory study required to convert Lunsumio’s existing accelerated approval as a monotherapy in third-line FL into a full approval, while also potentially moving the drug earlier into the second-line setting.”

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

  • Beckers Payer Issues reports,
    • “The National Committee for Quality Assurance has named the highest quality and most effective health plans of 2026 based on clinical quality, patient experience and health plan accreditation status.
    • “The ratings were released Sept. 16 and are based on 2025 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover approximately 236 million people. Some MA plan data is from 2024 because of reporting schedules, and NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 956 plans received a rating.
    • “Commercial plans that received a five-star rating:
      • BCBS Massachusetts
      • Capital District Physicians’ Health Plan (New York)
      • Capital District Physicians’ Healthcare Network (New York)
      • Harvard Pilgrim Health Care (Massachusetts, Maine)
      • Independent Health (New York)
      • Kaiser Mid-Atlantic (Washington, D.C.; Maryland; Virginia)
      • Kaiser Northern California
      • UPMC Benefit Management Services
      • UPMC Health Plan
  • and
    • “When Providence announced it was shutting down its health plan earlier this year after a $102 million loss in 2025, it joined a growing list of health systems stepping back from the insurance business. Carle Health’s Health Alliance, Michigan Medicine’s U-M Health Plan and others have wound down or are exiting, citing volatility in Medicare Advantage and government payer markets that have made provider-sponsored plans increasingly difficult to sustain.
    • “Terry Gilliland, MD, president and CEO of Danville, Pa.-based Geisinger, is watching the same environment unfold and coming to the opposite conclusion.
    • “Rather than say, this is hard and dump the plan, we’ve made the necessary changes including leadership top to bottom to grow profitably,” Dr. Gilliland said.”
  • and
    • “CVS Health’s Aetna is expanding prior authorization bundles for cancer, available to some Medicaid members as of Sept. 1.
    • “The update impacts Medicaid members with providers in Oklahoma, Illinois, Maryland, New Jersey, Virginia, Florida, Kentucky and West Virginia who use the Eviti portal for prior authorizations. Aetna anticipates broadening eligibility to Medicare and commercial members in the first half of 2027.
    • “According to a Sept. 17 news release, Aetna observed providers submitting four different prior authorizations, on average, for its members needing cancer treatments. These bundles allow a single prior authorization request that could encapsulate medical oncology and radiation oncology services with high-tech imaging needs. The expansion builds upon an early rollout of the bundles. 
    • “By approving a broader set of treatments and related services upfront, we’re removing barriers that can delay care,” Aetna COO and Medicaid President Katerina Guerraz said.”
  • Beckers Hospital Review relates,
    • “St. Louis-based Ascension has reached an agreement to transfer full ownership of its co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna, a spokesperson for Ascension confirmed with Becker’s. 
    • “Ascension co-owns the plan with San Francisco-based CommonSpirit’s Dignity Health, the spokesperson confirmed. The agreement is subject to regulatory reviews and approvals.
    • “Mercy Care has long served vulnerable populations, families and individuals across Arizona through Arizona Health Care Cost Containment System Medicaid programs and Medicare Duals Special Needs Plans,” the spokesperson said. “Aetna has successfully managed Mercy Care’s day-to-day operations and administrative services for over 20 years.”
  • and
    • “HCA Healthcare CFO Mike Marks said payers have outpaced hospitals on AI-driven claims processing, adding another layer to the friction hospitals face on denials, underpayments and prior authorization.
    • “I know there’s a lot of talk about AI in the hospital revenue cycle, we’re behind the payers, in my view,” Mr. Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference in Nashville, Tenn., where the 190-hospital system is also headquartered.
    • “Payers, he said, have real incentives driving their AI investments, including medical loss ratios and patient populations to manage.
    • “They’ve been working really hard on their version of AI in their claims shop,” he said.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare is seeing softer elective surgery volumes as patients lose coverage through the health insurance exchanges, with broader affordability pressures potentially contributing to the slowdown, CFO Mike Marks said Sept. 15 at the Jefferies Healthcare Services and Technology Conference.
    • “The 189-hospital, for-profit system continues to see strong overall demand for healthcare services, but the movement of patients from exchange coverage to uninsured status is weighing on elective procedures.
    • “On the inpatient side of elective, and frankly, on the outpatient surgery side as well, the biggest issue is HICS,” Mr. Marks said, referring to health insurance exchange coverage. “This movement out of HICS to uninsured — as people in our communities have lost coverage on the exchange [and] become uninsured — they generally lose access to elective care. That is the primary driver of the slowdown in our elective surgery volumes is exchanges.”
  • Beckers ASC Review tells us,
    • “Brentwood, Tenn.-based Surgery Partners has completed the sale of its ownership interests in its Idaho Falls, Idaho, facilities to Intermountain Health for $797 million in gross proceeds, according to a Sept. 17 news release.
    • “The deal includes Mountain View Hospital and Idaho Falls Community Hospital, values the combined facilities at about $1.15 billion, and delivered Surgery Partners $587 million in net cash proceeds at closing, subject to customary post-closing adjustments. Physician ownership of Mountain View Hospital will remain unchanged under Intermountain’s leadership, and the proceeds will primarily go toward paying down debt, which is expected to improve the company’s balance sheet leverage by about 30 basis points from 4.4x at the end of the second quarter.
    • “Excluding the Idaho Falls facilities, Surgery Partners expects a 50% reduction in its Medicaid payor mix, to under 2% of revenue, along with the elimination of its neonatology, obstetrics, inpatient pediatrics and retail and compounding pharmacy service lines.”
  • Fierce Healthcare informs us,
    • “Big box retailer Walmart is launching a six-month pilot program that places pharmacists in a new “Health Ambassador” role at five rural stores to help customers navigate health and wellness resources.
    • “Walmart’s Health Ambassador Associate will be able to aid patients in understanding their health goals and help connect them to relevant services and resources.
    • “The Health Ambassador role will be piloted at locations serving rural and underserved communities across the U.S., including in Lexington, Tenn.; Caro, Mich.; Franklin, Va.; Fort Scott, Kan.; and Searcy, Ark.
    • “The pilot will initially focus on three healthcare areas: diabetes, weight management and maternal health. Health Ambassadors can also aid customers in nutrition, movement, sleep and stress management through the program’s in-person conversations and tailored coaching.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.”
  • and
    • “Blue Shield of California announced Thursday that it plans to expand its Virtual Blue program, doubling program enrollment for members.
    • “Beginning in January 2027, the benefit will be included in fully insured preferred provider organization (PPO) plans for employers with 101 to 3,000 employees, as well as for certain individual and family plans, the insurer said.
    • “The expansion will allow an additional 200,000 mid-size employer PPO members and 60,000 individual and family plan members to utilize the program, increasing its total enrollment to more than 410,000 participants, executives say.
    • The virtual-first program, first launched in 2023 in collaboration with Accolade and TeleMed2U, has more than 150,000 members as of April. The program gives members access to a range of virtual health services at no additional cost, along with care from providers in Blue Shield’s PPO network.
  • Per BioPharma Dive,
    • “Novo is investing in oral biologics, signing a deal with fellow Danish company Orbis Medicines to discover multiple “macrocycles” that have the “potential to replace injectable medicines,” Orbis said Thursday.
    • “Orbis could receive as much as $1.4 billion in up front and downstream payouts, as well as sales royalties, in the deal. The companies didn’t specify the number of drugs on which they would collaborate, nor specific diseases, only mentioning that they’ll pursue unnamed cardiometabolic targets.
    • “The use of macrocycles is one way Novo could overcome some of the limitations of standard oral peptide medicines, such as poor digestive absorption. The highest dose of Novo’s Wegovy pill contains 20 times the highest injectable dose because most of the drug’s active ingredient is chewed up before reaching the bloodstream.”
  • and
    • “North Immunology, in the early stages of developing a potential competitor for the widely popular inflammatory disease drug Dupixent, plans to go public next year via a reverse merger with Aethlon Medical.
    • “After the merger, the companies expect North Immunology investors to own 95.25% of the new entity, with the rest going to Aethlon shareholders. Those who own Aethlon stock immediately prior to the merger will also get a contingent value right entitling them to potential proceeds from Aethlon’s legacy Hemopurifier business. 
    • “The new company will operate as North Immunology and trade on the Nasdaq under the ticker symbol “NRTX,” Aethlon said Thursday. North Immunology’s executives will lead the combined entity, and its directors will populate the board, along with some new independent directors. The companies expect the transaction to close in the first quarter of 2027.”
  • Healthcare Dive points out,
    • “Healthcare organizations are rapidly adopting agentic artificial intelligence, but governance frameworks for managing the technology are not evolving at the same pace, according to a new survey from digital identity security firm Imprivata.
    • “More than 85% of leaders responsible for AI strategy at healthcare organizations say they’re confident they have visibility into AI agent activity and are able to fully control and govern an autonomous agent’s actions.
    • “However, 72% of respondents admit AI tools are deployed without IT approval at least occasionally within their organizations, highlighting a disconnect between confidence and reality.”

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, D.C.,

  • STAT News reports,
    • “Normally, discussions about how congressional advisers study Medicare spending are quite dry. Not so at the House Ways and Means Committee on Wednesday.
    • “In a party line vote, committee Republicans pushed forward a bill that seeks to change how the Medicare Payment Advisory Commission studies Medicare Advantage spending. In particular, this bill would direct the nonpartisan agency to study the topic of overpayments to Medicare Advantage plans in a manner that’s more favorable to insurers.” * * *
    • “It’s a bit of a change in tune for some Republicans, especially those who are doctors, who had become frustrated with Medicare Advantage insurers that deny care to patients. 
    • “However, Rep. Greg Murphy (R-N.C.), who is among those doctors who have criticized certain industry practices, said he had no problem supporting the bill. 
    • “Asking for more information so that we can make real choices and reform the Medicare Advantage system, I am absolutely for,” he said.”
  • and
    • “Democrats are vowing to aggressively pursue oversight if they win control of either the House or Senate in November’s midterm elections. Health care issues, including President Trump’s drug pricing deals, are potential targets. 
    • “It’s common for parties to turn to oversight when they take control of a congressional chamber. Lawmakers can use oversight to tell a story about the other side. It also avoids intraparty divisions by focusing attention on what the other party has done. And if Democrats want to keep the focus on Trump, even though he can’t run again, oversight is a good way to do that.”
  • MedPage Today adds,
    • “Nicole Saphier, MD, President Donald Trump’s third surgeon general nominee, was grilled at her confirmation hearing Wednesday about her stance on childhood vaccines, voicing support for immunization as she seeks to serve in an administration that has moved to make sweeping changes to vaccine guidance.
    • Saphier, a radiologist and former Fox News Channel contributor, faced tough questioning about her views on the safety of childhood vaccines by Sen. Bill Cassidy, MD (R-La.), who pressed her to declare whether she believed there was a link between vaccines and autism — which widespread scientific consensus has concluded doesn’t exist, yet which the Trump administration has repeatedly pushed to revisit.
    • “I do not believe childhood vaccines cause autism,” Saphier said. She also said “the MMR [measles, mumps, and rubella] vaccine is our greatest tool for combating measles,” in response to a question by Cassidy over whether parents should give children that shot, and which the president recently ordered be spaced out.
  • Healthcare Dive relates,
    • “Health plans are generally performing better on quality and performance ratings, though nonprofit insurers continue to surge past their for-profit peers.
    • “The National Committee for Quality Assurance released its 2026 ratings on Tuesday, which score commercial, Medicare and Medicaid plans across a range of measures of clinical quality, patient experience and health outcomes. Eighteen plans nabbed the standards organization’s highest 5-star rating, up from 11 last year. All of them are nonprofits.
    • “Of the major publicly traded carriers, CVS had the highest scores, averaging at about 4 stars, according to a Healthcare Dive analysis of the data. Meanwhile, plans’ average rating ticked up slightly, from 3.483 last year to 3.493 in 2026 thanks to improvements in commercial and Medicaid plans, though Medicare insurers’ average rating slipped.”
  • Healthcare Finance News tells us
    • “The American Hospital Association and American Medical Association are urging the Centers for Medicare & Medicaid Services to reconsider proposed reductions to Medicare physician payments for 2027, warning that the cuts could threaten patient access and the financial stability of physician practices.
    • “Comments on the proposed rule, which was released in July, were due Monday.
    • “The AMA voiced its concerns earlier this month about a CMS plan to cut physician pay when doctors provide a separately identifiable office or outpatient evaluation and management (E/M) visit on the same day as most procedures are performed. 
    • “The agency scrapped this same plan eight years ago, the AMA said, after physicians and other stakeholders raised serious concerns. 
    • “But CMS is pitching a similar idea in its 2027 Medicare physician payment schedule proposed rule,” the AMA said. “If finalized, most changes, including this one, would be scheduled to take effect Jan. 1.”
    • “The AMA called for annual physician payment updates tied to medical inflation, arguing that the lack of consistent inflationary adjustments has contributed to the erosion of physician practice sustainability.”
  • The American Hospital Association News tells us,
    • “The Workgroup for Electronic Data Interchange has launched its fall 2026 survey to assess industry readiness for the Centers for Medicare & Medicaid Services’ interoperability and prior authorization final rule. Survey responses are anonymous, and all results are aggregated. The survey will close on Oct. 9. WEDI plans to use the results to make recommendations to CMS, inform stakeholders and assist WEDI in its development of industry guidance and education.” 

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

  • Govexec reports,
    • “Senate Democrats again urged the Trump administration Wednesday to abandon its plans to collect detailed health information from federal workers, retirees and their families, saying recent tweaks to “de-identify” records are insufficient to protect employees’ privacy.
    • “Last December, the Office of Personnel Management published an information collection request in the Federal Register that would require insurers who participate in the Federal Employees Health Benefits and Postal Service Health Benefits programs to provide monthly reports with identifiable health data on their enrollees.
    • “Following pushback from federal employee groups and medical ethicists, OPM in June revised its proposal, purporting to take steps to mask employees and retirees’ identities in the data collection. But organizations that represent federal workers and retirees warned that the agency still hadn’t done enough to protect patients’ privacy.
    • “In a letter to OPM Director Scott Kupor, a group of six Senate Democrats, led by Sens. Adam Schiff, D-Calif., and Mark Warner, D-Va., who previously requested the proposal’s withdrawal, wrote that the proposed pseudonymization of records does not their “fundamental” concerns with the plan, particularly the agency’s insistence that it may re-identify insurance claimants in the future.”
  • FedWeek relates,
    • “OPM has provided some additional information on agency responsibilities to conduct the annual survey of federal employees—which it plans to shift to them from itself under a pending rules proposal—although still not setting a schedule for conducting this year’s version.
    • “A September 17 Federal Register notice states that the survey traditionally called the Federal Employee Viewpoint Survey will be renamed as the Annual Employee Survey, and reaffirms the intention in the earlier rules proposal to reduce the number of core questions from 16 to 10.
    • “That is to include dropping longstanding questions asking employees about their overall level of satisfaction with their job; with the recognition they receive for doing good work; with their organization overall; with the information they receive about what is going on in it; with their level of involvement with decisions that affect their work; and whether they would recommend their organization as a good place to work.
    • “OPM traditionally used those satisfaction-related questions in creating an index that was widely—although not officially—seen as a proxy for morale.”

From the U.S. Food and Drug Administration front,

  • Good Housekeeping reports,
    • “FDA issued a Class II recall on September 11 for six hand soap products from Intercon Chemical Co. distributed across 15 states. The original recall happened on June 29 due to potential bacterial contamination.
    • “Two soap variants contained harmful bacteria including Pseudomonas aeruginosa and Serratia marcescens, which can cause serious infections like pneumonia, UTIs, and blood infections, especially in immunocompromised individuals.
    • “Consumers should identify recalled products by UPC codes and lot numbers listed for Intercon, Clearly Better, Summit, Vestis, and Laura Lynn brands, then stop use immediately and seek medical attention if symptoms develop.”
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new generic radiopharmaceutical alternative from drugmaker Curium, aimed at competing with another treatment on the market. 
    • “Bexlutry (lutetium Lu 177 dotatate) is a radioligand therapy designed to deliver targeted radiation for treating a group of rare cancers originating in the digestive track and pancreas. Boston-based Curium scored the approval through the FDA’s 505(b)(2) pathway, supported by published evidence and targeted bridging data. 
    • “This demonstrated that Bexlutry achieved a similar biological and chemical profile to the previously approved Lutathera, manufactured by rival firm Novartis. 
    • “Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer,” Mike Patterson, Curium’s CEO of North America, said in a statement Sept. 14. “Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.”

No Surprises Act News

  • Politico reports,
    • “A Senate committee held stakeholder roundtables on Tuesday to discuss reforms to the 2020 No Surprises Act, which set up how doctors and insurers are paid for unexpected medical bills, Simon reports.
    • “The act, originally co-sponsored by Health, Education, Labor and Pensions Chair Bill Cassidy, shielded patients from unexpected out-of-network emergency care bills. But it has come under fire for creating a case backlog in a system that critics argue can pay disproportionately in favor of doctors.
    • “Employers, physicians, insurers and unions — groups typically at odds — held a cordial, constructive talk about possible solutions, according to four people familiar with the meetings who were granted anonymity to speak candidly. Committee staff also met separately with the arbitrators responsible for overseeing and resolving payment disputes.
    • “Over three hours, the stakeholder group didn’t settle on any policy changes, but they agreed on the need to eliminate the dispute backlog by filtering out ineligible claims and encouraging faster payouts. The group emphasized the importance of benchmark rates for medical services, known as qualified payment amounts, when determining payouts and that only emergency care bills should be eligible for arbitration.
    • “It is early, and the devil will be in the details, so to speak, as conversations continue, but overall a positive vibe,” said one of the four people familiar with the discussion. Another of the four, who was a provider attendee, said, “It was pointed but respectful.” * * *
    • “What’s next: The Senate HELP Committee will hold a roundtable with members next week to talk through legislative solutions.”

From the judicial front,

  • Healthcare Dive reports,
    • “A group of independent pharmacies in Arkansas are suing Express Scripts, one of the largest pharmaceutical middlemen in the U.S., for allegedly underpaying for tens of thousands of prescriptions.
    • “The lawsuit filed Tuesday, which seeks hundreds of millions of dollars in damages, is the first filed under a state law passed last year giving Arkansas pharmacies the ability to go after PBMs for reimbursing them below the acquisition cost of drugs, according to lawyers for the plaintiffs.
    • “We’re committed to reimbursing pharmacies at competitive rates and will defend ourselves against these allegations,” an Express Scripts spokesperson said.

From the public health and medical / Rx research front,

  • The New York Times offers advice on whether you are eating enough fiber in your diet.
    • “With so much attention on protein lately, you’d be forgiven for forgetting about fiber.
    • “But if you’re like most adults in the United States, you’re probably falling short of the recommended minimum of 21 to 38 grams per day, depending on your age and sex. The average U.S. woman consumes about 15 grams of fiber daily, and men consume about 18 grams per day.
    • “Closing that gap may be one of the best strategies for improving your health. Fiber nourishes gut microbes, lowers blood pressure and cholesterol, improves digestion and reduces the risks of heart disease, Type 2 diabetes and certain cancers.
    • “It can seem like a big challenge to eat enough fiber, but nutrition experts say it doesn’t have to be. You just have to know where to look.”
  • Cardiovascular Business adds,
    • “Eating four to six servings of whole-grain foods per day is associated with multiple cardiovascular benefits, according to a new meta-analysis published in European Heart Journal. 
    • “The authors focused on data from more than 6,500 adults from the United States, Europe, Asia, Canada, Australia or Brazil who participated in one of 87 different clinical trials. Overall, eating 48 grams of whole-grain food—oats, brown rice or quinoa, for example—each day was associated with improvements in body weight, waist circumference, total cholesterol, blood pressure, LDL cholesterol, glucose and interleukin-6 levels. These are all known risk factors of cardiovascular disease.
    • “This is the largest and most comprehensive meta-analysis of randomized controlled trials on whole grain intake and cardiovascular risk factors,” senior author Helda Tutunchi, PhD, a nutrition specialist with Tabriz University of Medical Sciences in Iran, explained in a statement. “Unlike previous reviews, we looked specifically at how much whole grain people need to eat to get the greatest benefits. We also evaluated the certainty of the evidence and found high-certainty evidence for improvements in several outcomes, including body weight, waist circumference and total cholesterol.”
    • “Tutunchi added the impact of eating more whole-grain foods appears to be through “several modest improvements acting together” as opposed to “one large effect on a single risk factor.”
  • Health Day relates,
    • “Women’s risk of having a harmless tumor caught and treated as a result of breast cancer screening is much lower than once thought, a new evidence review has concluded.
    • “Overdiagnosis — the detection of breast cancers that never would have harmed a woman’s health during her life — occurs in fewer than 5% of cancer screenings, researchers reported Sept. 14 in the Journal of the National Cancer Institute.
    • “That’s far lower than previous estimates, which held that as many as 30% to 50% of breast cancer detected through screening might represent overdiagnosis, researchers said.
    • “These earlier studies were inaccurate because they tracked breast cancer screenings for a limited period of time, the research team argued.”
  • and
    • “ADHD is linked to a nearly 50% increase in GI problems, a new evidence review says.
    • The association was even stronger for specific GI problems, including an almost doubled risk of constipation, a 58% increase in irritable bowel syndrome and more than four times higher odds of losing bowel control, researchers reported Sept. 10 in the Journal of Attention Disorders.
    • “Almost every gut symptom we looked at: constipation, IBS, even indigestion, appeared to be associated with ADHD,” said lead researcher Sarah Blake, a medical student at the University of Warwick Medical School in the U.K.
    • “These symptoms can have a real impact on daily life, but they could easily be overlooked if the focus is on ADHD itself,” she added in a news release.
    • “There are several potential explanations for these links, including ADHD-related eating patterns, side effects from medication and even ties between ADHD and gut bacteria, researchers said.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Scientists studying Alzheimer’s disease have long focused on genes, proteins, and cells, but one class of molecules has remained largely outside the playbook: microproteins. These small proteins, produced from small open reading frames (ORFs) and typically measuring 150 amino acids or fewer, have been difficult to detect and study. Yet growing evidence suggests they may have important roles in health and disease.
    • “Now, researchers at the Salk Institute have created what they describe as the first microprotein atlas of the human frontal cortex with and without Alzheimer’s disease. The study, “A microprotein atlas of the human frontal cortex in Alzheimer’s disease,” was published in Nature Aging. The resource integrates transcriptomics, mass spectrometry, and deep-learning-predicted spectra across postmortem brain samples to identify microproteins that have been overlooked in standard protein catalogs.
    • “We still do not fully understand the molecular mechanisms of healthy aging, and that is especially true for microproteins, which have been inadvertently overlooked for decades,” said senior and co-corresponding author Alan Saghatelian, PhD, professor and the Dr. Frederik Paulsen Chair at Salk, in a press release. “Our atlas allows scientists to systemically investigate microproteins in aging and neurodegeneration, which should bring us closer to understanding and tackling diseases like Alzheimer’s or Parkinson’s.”
  • Per an Institute for Clinical and Economic Review (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 tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “Downloads: Evidence Report | Voting Questions | Public Comments | Response to Public Comments
    • “Parkinson’s disease is a chronic and progressive neurological condition largely characterized by the loss of motor skills and physical function,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “There are currently no disease-modifying treatments, so symptom management is paramount. While tavapadon provides some relief from key symptoms, benefits were similar to those of older, generic drugs, and discontinuation from tavapadon due to adverse events was relatively high. The combination of modest benefit and uncertainties around discontinuation raise important questions about tavapadon’s long-term value.”
    • Register here to watch the live webcast of the October 1st ICER public meeting.

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

  • Beckers Hospital Review reports,
    • St. Louis-based Ascension narrowed its operating loss by $371 million in fiscal 2026, as stronger revenue, higher patient volumes and operational improvements moved the health system closer to breakeven, according to financial documents published Sept. 16.
  • and
    • “Fitch revised Chicago-based CommonSpirit Health’s rating outlook to negative from stable on Sept. 16, while affirming the health system’s “A-” rating. 
    • “The revision follows CommonSpirit’s financial results through the quarter ended March 31, which fell short of management’s internal margin targets, Fitch said in a Sept. 16 report. Fitch pointed to an uneven path to sustained profitability as the system executes several overlapping initiatives at once, including an Epic EHR rollout, insourcing revenue cycle operations and its multiphase Project Impact plan, which targets an 8% EBITDA margin by fiscal 2029.” 
  • Beckers Behavioral Health relates,
    • “U.S. News & World Report named 50 hospitals to its 2026-2027 Best Children’s Hospitals Pediatric & Adolescent Behavioral Health list.
    • “U.S. News evaluated 91 hospitals for their care of children and teens with mental and behavioral health conditions, including autism, anxiety, depression, eating disorders, ADHD, bipolar disorder, schizophrenia, language and learning disorders, and substance abuse and addiction.
    • “Programs and care in areas such as medication screening and safety, speed and efficiency of the emergency department, and management of side effects were among the factors used to rank hospitals.”
  • Beckers Payer Issues tells us,
    • “SCAN Health Plan has emerged as a major Medicare Advantage partner for retailers, with Walmart now partaking in a co-branded plan.
    • “The health insurer and retailer are launching the plan in two states, according to a Sept. 16 SCAN news release. More than 2 million enrollees are expected to have access.
    • “The MA offering could tie in pharmacy and vision services, food, and over-the-counter benefits, pending regulatory approval. The news release also said Walmart will leverage Everyday Health Signals, its AI-driven platform for tailored nutrition and wellness, in the collaboration.
    • “What makes this collaboration unique is Walmart’s role in customers’ everyday lives. Because customers regularly turn to Walmart for groceries and other everyday essentials, we have an opportunity for those who choose to participate, to use insights from their shopping experiences to make nutrition guidance more relevant and actionable,” said Pravene Nath, MD, group director for consumer health and data solutions at Walmart U.S.” * * *
    • “In August, SCAN announced plans to roll out insurance products with Costco, as well.” 
  • Beckers Physician Leadership shares the new math of physician independence.
    • “Independent physicians have spent more than a decade watching the share of their peers who own their own practices shrink. 
    • “New data exists that tells the story of what it now costs to stay independent, how much deal-making and closure activity is still working against that choice, and where regulators and a new wave of physician-owned infrastructure are starting to push back.
    • “Taken together, the figures describe less a single trend than a recalculated equation — one where the cost of going it alone, the cost of selling and a growing set of options in between are all moving at once.”
  • MedCity News informs us,
    • “Thatch, a health benefits platform, announced on Tuesday that it raised $108 million in funding, reaching a $1 billion valuation.
    • “Thatch helps employers offer Individual Coverage Health Reimbursement Arrangements (ICHRAs) — which recently rebranded as CHOICE Arrangements — in which employers can provide their employees tax-free money so they can purchase their own individual health insurance plans. Employees can also use the funds for certain healthcare expenses, including GLP-1s and therapy. More than 5,000 employers use the company, including Jersey Mike’s and Smoothie King. 
    • “The Series C funding round was from The General Partnership, Index Ventures, General Catalyst and Andreessen Horowitz. ADP Ventures, Paychex, Eli Lilly and Company, Scale Venture Partners, QuantumLight, SemperVirens, Quiet Capital and Avid Ventures also participated. In total, Thatch has raised $192.5 million in equity funding.”
  • Fierce Healthcare adds,
    • “Ayble Health secured a $16 million oversubscribed series A funding round to accelerate its expansion into artificial intelligence-driven precision digestive and autoimmune healthcare.
    • “Neon led the funding round, with participation from Unum Ventures, Upfront Ventures, M13, Cleveland Clinic Ventures, DigiTx, Accomplice and several individual investors. 
    • “I’ve been tracking the GI space closely for years, and what Ayble has built is different,” said Kimmy Scotti, Neon founding and managing partner, in a statement. “Having invested early in top digital health companies, I’ve seen what it takes to build a category-defining company in healthcare. Ayble has spent years building the clinical evidence before they scaled the business. That earns trust from the full ecosystem: health systems, payers, and most importantly, patients, and it’s what makes a durable market leader.”
  • BioPharma Dive points out,
    • “Novartis will pay $125 million up front for rights to a delivery platform designed to get drugs into the brain.
    • “Sironax, a Boston-area biotechnology company, said Tuesday that Novartis has exercised an option to acquire full ownership of that startup’s brain delivery platform. Sironax’s technology is meant to overcome a major challenge in neurological drug development: delivering therapeutics across the “blood-brain barrier.”
    • “Sironax will receive the nine-figure payout following the close of the transaction and will continue to retain rights to develop, manufacture, and commercialize certain assets with the platform. The company currently has three programs in early-stage trials that it plans to move forward using the purchase proceeds.”
  • Cardiovascular Business notes,
    • “Jaguar LAA, a new California-based medtech startup, has purchased key assets related to performing left atrial appendage (LAA) closure procedures from Johnson & Johnson. 
    • “Johnson & Johnson has owned these assets since it acquired the medtech company Laminar for $400 million back in 2023. Now, some original Laminar employees have partnered with investment firm Santé Ventures to buy back the assets and push forward as Jaguar LAA, a brand new company.
    • “The financial terms of this acquisition have not yet been made public.” 
  • The Wall Street Journal lets us know,
    • “Novo Nordisk NOVO.B, the Danish drugmaker behind blockbuster diabetes and weight-loss drugs Ozempic and Wegovy, is partnering with Anthropic to use artificial intelligence for drug research.
    • “Novo said Wednesday it would use Anthropic’s science-specific platform, known as Claude Science, to help speed up the discovery and development of new medicines and strengthen the pharmaceutical company’s software development.
    • “The partnership is the latest by a slate of major drugmakers, including Eli Lilly, Merck and Roche, that are placing big bets that AI can help them discover and produce medicines more quickly. 
    • “AI can help us increase productivity in R&D and compress the path from research to marketed product. But beyond this, AI tools can also offer completely new scientific opportunities and aid reasoning and understanding of human biology and drug mechanics,” Novo Chief Executive Mike Doustdar said.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health held a hearing Sept. 15 to discuss more than a dozen legislative proposals regarding Medicare provider payment and healthcare cybersecurity. The AHA provided comments to the subcommittee on bills designed to improve long-term physician payments, including proposals to increase the budget neutrality threshold in the Medicare physician fee schedule and a bill to replace the Merit-based Incentive Payment System with the Data-driven Performance Payment System. The AHA also commented on bills to provide grants for the adoption of cybersecurity best practices, direct the Department of Health and Human Services to create a strategy for rural hospital cybersecurity staff training, and improve obstetric emergency preparedness in rural healthcare settings.” 
       
  • MedPage Today relates,
    • “Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearing Tuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • “Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • Chris Klomp, President Donald Trump’s nominee for deputy HHS secretary, declared his support for the measles, mumps, and rubella (MMR) vaccine at a Senate Finance Committee confirmation hearingopens in a new tab or windowTuesday, but that wasn’t good enough for one of the Democratic senators on the committee.
    • Klomp, who currently serves as HHS chief counselor, told Sen. Ron Wyden (D-Ore.), the committee’s ranking member, that “Unquestionably, the MMR vaccine is the single most effective public health tool that we have against measles. It’s 97% effective after two doses [in] preventing transmission, and this is the single best thing that we can do to eradicate” the disease, Klomp said.
    • “Committee chairman Sen. Mike Crapo (R-Idaho) took the opposite view. “You have met all of the requirements and standards of this committee in vetting a nominee, and you are completely and well qualified to be deputy secretary at the Department of Health and Human Services,” he told Klomp.” 
  • The Wall Street Journal adds,
    • “Pennsylvania health officials announced Tuesday a fourth measles-associated death, the latest fatality in the commonwealth where recently reported deaths from the vaccine-preventable disease have inflamed politics at the local and national level.
    • “The death follows those of two infants in the state’s Lancaster County in mid-August amid a growing measles outbreak. The state health department’s classification of those deaths spurred a highly politicized debate over vaccinations and sparring between the state’s Democratic governor and the nation’s health secretary.
    • “Over the weekend, a coroner in Pennsylvania’s Jefferson County said a 40-year-old woman there died from complications from measles. The Mifflin County Coroner’s Office on Tuesday said an 18-year-old resident died due to a rare neurological complication from measles. The state health department said it worked with local coroners’ offices to determine both individuals tested positive for measles and the deaths didn’t result from an unrelated cause.
    • “That’s four total measles-associated deaths in our Commonwealth and the first Pennsylvania has seen in 35 years,” Pennsylvania Gov. Josh Shapirosaid in a post on social media Tuesday. “These are tragedies, and four families are grieving.”
  • Per a U.S. Census Bureau news release,
    • “The U.S. Census Bureau today announced that real median household income was $87,460 in 2025, the highest on record dating back to 1967.
    • “The official poverty rate fell 0.5 percentage points to 10.2% in 2025. The following 2025 findings were not statistically different from 2024: the Supplemental Poverty Measure (SPM) rate in 2025 was 13.1% and in 2025, 26.7 million people (7.9%) were uninsured for the entire year, according to the 2026 Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • ‘These findings come from three Census Bureau reports, “Income in the United States: 2025,” “Poverty in the United States: 2025” and “Health Insurance Coverage in the United States: 2025.”
  • Beckers Hospital Review tells us,
    • CMS will add four condition tracks to its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model starting in spring 2027, the agency said in a Sept. 15 news release.  
    • Four things to know: 
      • “The expansion adds heart failure, chronic obstructive pulmonary disease, substance use disorders and tobacco cessation to the model. CMS will also expand support for chronic musculoskeletal pain, extending coverage for certain conditions beyond the model’s initial 12-month care period.
      • “The model already covers hypertension, diabetes, chronic musculoskeletal pain and depression. CMS says 3 out of 4 Medicare beneficiaries qualify for at least one track.
      • “The ACCESS model ties Medicare payments to measurable improvements in patient health rather than paying solely for individual services. Participating organizations can offer virtual care, health coaching, remote monitoring, and connected devices and wearables between regular doctor visits.
      • “There are currently 160 organizations participating in the ACCESS model, and CMS said Medicare will continue to add to the list throughout the model’s 10-year run. The model supports those with traditional Medicare. Medicare Advantage enrollees are not eligible, but CMS said MA plans may offer similar programs.”

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

  • OPM included the following additions in today’s Federal Register.
    • Rules
      • Reduction in Force; Correction
      • Shared Certificates and Pooled Hiring Actions
    • Proposed Rules
      • Promoting Employee Accountability
  • Federal News Network reports,
    • “The fewest number of federal employees submitted their retirement papers in August as compared to the rest of 2026. The Office of Personnel Managements says it received only 7,618 retirement claims last month. This is down from more than 10,000 claims OPM received in July. Additionally, OPM’s backlog of retirement claims is at the lowest of the year at just over 15,400. The average number of days to process a claim for August also dropped considerably: to 70 days for a digital claim, down from 98 days the month before, and to 79 days for all claims, down from 109 days in July. (Federal retirement claims down, as the backlog hit lows for 2026 – OPM)”
  • Kevin Moss, writing in Federal News Network, discusses
    • “Healthcare affordability series part 8: Enrollment flexibility for two-person families can lead to premium savings.”
      • “Most of the time, self-plus-one is cheaper, but there are plans where you’ll save more enrolling as self & family.”
  • Govexec relates,
    • “More ‘Big Balls’-type young feds are what the OPM chief wants 
      • “In an interview on Monday, Scott Kupor also discussed implementing skills-based hiring, which had been a priority of the Biden administration as well.”

From the U.S. Food and Drug Administration front,

  • STAT News relates,
    • “The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. 
    • “The pilot was first announced in June as part of Operation TrialBlazer, the Department of Health and Human Services initiative that pledged to shorten the FDA’s drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia.
    • “Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the department wrote in the TrialBlazer roadmap.”
  • and
    • “Vera Therapeutics said Tuesday that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease, according to final, two-year results from a Phase 3 clinical trial. 
    • “In July, the Food and Drug Administration granted accelerated approval to Trutakna for the treatment of IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.
    • “With the final data from the study in hand, Vera said it will seek full approval of the drug from the FDA during the fourth quarter.”
  • Cardiovascular Business tells us,
    • “XCath Robotics has received the FDA’s breakthrough device designation for its Iris surgical robotic system that performs remote robotic-assisted mechanical thrombectomy in acute ischemic stroke patients.
    • “This represents a significant step forward for the Houston-based medtech company. The FDA’s breakthrough devices drogram helps support the development of medical devices that have the potential to provide more effective treatment for patients with life-threatening or irreversibly debilitating conditions. This provides XCath Robotics with more opportunities to interact with FDA experts and receive support as the company works toward U.S. regulatory approval for the Iris system.
    • “Back in March, the Iris system was used to complete the world’s first telerobotic stroke thrombectomy. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the system to perform the historic procedure in Santiago, Panama, while the patient was 120 miles away in Panama City.”

No Surprises Act News

  • The FEHBlog did receive his CMS invitation to join its Independent Dispute Resolution Gateway this morning, and the FEHBlog promptly took CMS up on its offer. The process went smoothly.
  • The Paragon Institute September 15, 2026, Newletter’s kicks off with an article about “Fixing the No Surprises Act’s Broken Arbitration System.”
    • “Congress already required much of this transparency through the NSA’s Advanced Explanation of Benefits provisions, but those requirements have yet to be fully implemented. The administration should finish that work. Once patients have meaningful advance information about networks and prices, there is no justification for a federal arbitration system setting payments for elective care.
    • “For emergency services, a different approach is needed, and Congress has two reasonable options. It could eliminate federal IDR entirely while maintaining the prohibition on balance billing, leaving insurers and providers to settle payment disputes through private arbitration, litigation, or state law.
    • “Alternatively, Congress could retain IDR solely for emergency services but impose meaningful guardrails. Awards should have a reasonable upper limit so arbitration does not continue producing payments wildly disconnected from market prices. Congress should also reform how arbitrators are paid, and if an upper limit is implemented, insurers should face penalties when they fail to pay awards on time.
    • “The administration can make additional improvements now: require arbitrators to explain their decisions, audit firms with unusually high provider win rates or awards, strengthen eligibility reviews, improve arbitrator training, prohibit conflicts of interest and forum shopping, and restore a meaningful filing fee.
    • “The No Surprises Act solved a real problem by protecting patients from bills they could neither anticipate nor avoid. Those protections should remain. But protecting patients from surprise bills does not require a federal arbitration system that rewards providers for staying out of network and raises health care costs for everyone.”

From the fraud, waste, and abuse front,

  • Healthcare Dive reports,
    • “The federal government is once again targeting fraud in durable medical equipment suppliers, publishing a report Monday through the HHS’ Office of the Inspector General that urges regulators to crack down on suspect billing in Medicare Advantage.
    • “The OIG found that, in addition to other issues, MA organizations don’t screen for fraudulent medical equipment suppliers as often when they’re out of network, compared to in-network suppliers.
    • “MA organizations should tighten the screening process for suppliers and the CMS should use its fraud prevention tool more regularly, the OIG said.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “In recognition of Suicide Prevention Month, Susan Szulewski, M.D., president and chief operating officer, McLean Hospital and vice president, Mass General Brigham Behavioral and Mental Health, wrote on the importance of healthcare organizations working to reduce the stigma surrounding suicide and create a supportive environment with timely access to care and a clear path forward. READ MORE“
  • Per a CDC news release,
    • “Today, the Centers for Disease Control and Prevention and the Ad Council are launching a new round of public service announcements (PSAs) encouraging people to understand their risk of prediabetes and take action to prevent or delay type 2 diabetes.
    • “Now in its 10th year, the national “Do I Have Prediabetes?” campaign encourages viewers to take a 1-minute prediabetes risk test on DoIHavePrediabetes.org. This year’s “Undo It” PSAs spotlight that while there are many scenarios in life we can’t undo, prediabetes is something that can be reversed. 
    • “Prediabetes is a serious health condition that increases the risk of type 2 diabetes, heart attack and stroke. Because prediabetes often has no symptoms, many people do not know they have it. Research shows that early diagnosis can inspire individuals to adopt healthier habits, including eating better, being active and managing weight, that can reverse prediabetes and delay or prevent type 2 diabetes.
    • ‘If someone receives a high score on the risk test, that person is encouraged to speak to a doctor to confirm a diagnosis of prediabetes with a blood test, then enroll in the National Diabetes Prevention Program.” 
  • Healio tells us,
    • “Development of alcohol use disorder, depression or stress after a traumatic event was a strong predictor of major adverse cardiac and cerebrovascular events for both men and women, researchers reported.
    • “Evaluation of psychiatric predictors of major adverse events may be an important step in the prediction of CV risk after a traumatic event, according to data published in the Journal of the American Heart Association.
    • “Experiencing traumatic events can have long-lasting consequences for mental health that can take many forms, but research to date had yet to comprehensively consider these. Indeed, nearly all work on trauma and CVD had focused on PTSD and other stress-related disorders — the quintessential trauma-related mental health disorders — but depression, anxiety and substance use disorders are also common following trauma and are relevant to cardiovascular disease risk,” Jennifer A. Sumner, PhD, associate professor of psychology at the University of California, Los Angeles, told Healio. “We wanted to comprehensively investigate different posttraumatic mental health conditions as possible predictors of CVD onset. Also, given sex differences in both posttraumatic psychopathology and CVD, we examined whether links between various psychiatric disorders following trauma and CVD might differ for men vs. women.”
  • Health Day informs us
    • “New research suggests that the blood pressure and heart rate guidelines doctors use to guide emergency treatment in children are misleading in cases of traumatic injury. 
    • “These thresholds for “hemodynamic instability” — the inability of the circulatory system to get blood to organs — may be different for children with traumatic injuries versus healthy children, researchers wrote Sept. 9 in the Journal of the American College of Surgeons.
    • “Recognizing hemodynamic instability is fundamental in trauma care because these vital signs tell us when a child may be at increased risk of death or complications and when we may need to intervene,” explained study senior author Dr. Zain Hashmi. He’s an assistant professor of trauma and acute care surgery at the University of Alabama at Birmingham.
    • “Blood pressure and heart rate guidelines are often used by doctors to decide when to start resuscitation treatments, including blood transfusions, Hashmi said in a news release. However, the values used in children were not developed specifically for trauma patients and may not accurately reflect when the risk of death begins to rise in injured children, he added.” 
  • Medscape points out,
    • “A new international consensus statement providing evidence-based guidance on smoking cessation for people with type 2 diabetes (T2D) has been issued by a multidisciplinary international panel called the DiaSmokeFree Working Group. 
    • “The central message “is that smoking cessation needs to be treated as an integral part of diabetes management rather than as generic lifestyle advice,” statement co-author Riccardo Polosa, MD, PhD, professor of internal medicine at the University of Catania in Catania, Italy, told Medscape Medical News.
    • “There is evidence that this is under-prioritized in diabetes care,” he added. “Clinicians understandably focus on glucose, blood pressure, lipids, and medications, while smoking may receive only brief and mostly ineffective advice.”
  • Today’s issue of NIH’s Research Matters covers the following topics:
    • “Depression may stall development of new neurons 
      • “Researchers found that a part of the brain important for memory struggles to make new neurons in people with depression.
      • “The study sheds light on how the brain is altered in depression and suggests new treatment targets.”
    • GLP-1 drug slows aging in mice 
      • A GLP-1 drug extended lifespan and prevented age-related decline in older female mice.
      • Understanding how calorie restriction and GLP-1 drugs slow aging could lead to new ways to treat age-related diseases.
    • Antibodies may prevent tick-related syndrome 
      • “Researchers identified rare antibodies that may help combat alpha-gal syndrome, a condition that causes allergic reactions to red meat and dairy products.
      • “With further development, the finding could lead to treatments for this tick-related allergic condition.”

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

  • Beckers Payer Issues reports,
    • “Aetna’s two-year financial turnaround has taken hold following a leadership overhaul, thousands of ongoing cost management initiatives and a margin recovery plan expected to complete by 2027.
    • “Once you get the fundamentals in place, you start getting credibility, not only with investors, but internally with our employees, and then, in particular, with our members,” Aetna President Steve Nelson said Sept. 9 at the Wells Fargo Healthcare Conference. “We can be a little more disruptive and innovative. Aetna has a legacy of being innovative in terms of product and clinical programs, and we are getting back to that.”
    • “The insurer has spent the past two years in recovery mode after a period of financial turmoil driven by Medicare Advantage cost pressures, previously unfavorable star ratings and major losses in the ACA business, which it exited for 2026. Mr. Nelson, who also serves as executive vice president at CVS Health, was tapped to lead the insurer in late 2024.”
  • and 
    • “Health Care Service Corp. has completed the rebranding of its Medicare supplement and supplemental health and life products under the HealthSpring name.
    • “The move finishes a transition that began last year, when HCSC shifted the Medicare Advantage and Part D business it acquired from Cigna for $3.3 billion to the HealthSpring brand. 
    • “HealthSpring has more than 3 million members. HCSC said it is the second-largest Medicare supplement carrier by policyholders, with plans available in 48 states and Washington, D.C. Its supplemental health and life products, which include hospital indemnity and dental, vision and hearing benefits, are offered in 49 markets and D.C.”
  • and
    • “The Blue Cross Blue Shield Association has tapped Daniel Serrano to serve as CFO.
    • “The president and CEO of the BCBS Association, Kim Keck, announced the update Sept. 14 on LinkedIn. 
    • “With critical capabilities for this moment, including a practitioner’s orientation to data-driven financial management and a strong track record of aligning financial performance with operational outcomes, Dan is a great fit for our organization,” she said.”
  • Fierce Healthcare adds,
    • “Member trust in insurers is on the decline among Gen Z and Millennials, down 10.5% between 2023 and 2026, new research from Accenture found.
    • “This trust gap, according to analysts, could cost $3 billion in future member lifetime value for the largest commercial payers over the next decade. 
    • “When members don’t trust their health plan, they don’t just disengage; they route around it,” said Bracken Flynn, Accenture’s Health industry principal director, in a statement. “Our data shows that younger consumers aren’t asking for less from their insurer. They want more. They’re looking for a partner that helps them navigate care, understand costs, and make confident decisions. The insurers that earn that trust now will define what health coverage means for the next generation.”
    • “During a Sept. 14 AHIP webinar, Flynn said the report—which polled 1,200 consumers—found members trust insurers when they believe the health plan will help them make good healthcare decisions and navigate them to the best care.
    • “That’s across clinical and administrative touchpoints,” Flynn said. “And so it’s a partnership. In practice, it’s a partnership.”
    • “The lack of trust in insurers is causing younger members to turn to artificial intelligence tools, with 62% of respondents saying they have used AI to help choose a health plan.”
  • The American Hospital Association News relates,
    • “A new report from Kaufman Hall prepared for the AHA highlights new insights and data on hospital mergers and acquisitions. An AHA blog accompanying the report is also available.
    • “The report discusses how hospital merger reviews should look beyond the potential impact on commercial insurance prices and consider what proposed transactions mean for all patients, particularly the nearly 60% of hospital patient days attributable to Medicare, Medicaid and Medicare Advantage beneficiaries whose payment rates are largely set by government programs. Drawing on analyses of challenged and canceled transactions, the report also finds that hospitals seeking partners often serve more vulnerable communities and face greater financial pressures, and that when proposed deals do not move forward, struggling hospitals can experience significant financial deterioration that threatens services, workforce stability and access to care.
    • “These findings suggest that a more comprehensive analysis of hospital M&A transactions, one that considers impacts on all patients served, broadens the focus to impacts beyond pricing, and considers the consequences if an M&A transaction is not permitted to proceed, would ensure not only competitive but also healthy hospital markets that can continue to provide the fullest possible range of services,” the report says.”
  • AHIP relates,
    • “New data highlighted by Washington Post Intelligence show hospital system consolidation continues to accelerate, with 40 new mergers and acquisitions announced already in the first half of 2026 — nearly as many as throughout all of 2025. 
    • “Clear evidence demonstrates that anticompetitive hospital consolidation leads to higher healthcare costs for patients, families and employers. Hospital spending already makes up the largest share (40%) of insurance premiums, accounting for over $1.6 trillion in spending nationwide.”
  • Beckers Hospital Review adds,
    • “Salt Lake City-based Intermountain Health has acquired the nine-story, 235,000 square-foot Fairbourne Building in West Valley City, Utah, and plans to convert it into a medical campus.”
  • and
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said.”
  • Cardiovascular Business points out,
    • “U.S. News & Report has published its annual ranking of the top children’s hospitals in the United States, once again producing a separate list for the best hospitals for cardiology and heart surgery. This represents the 20th year that U.S. News.& World Report has compiled these rankings.
    • “For two decades, U.S. News has helped guide families to top-tier pediatric care,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement. “Finding the right medical team for a rare diagnosis or complex surgery can be overwhelming, and U.S. News’ annual evaluation of the Best Children’s Hospitals provides a clear starting point for parents and referring pediatricians alike.”
    • “Nearly 200 U.S. facilities were eligible for these rankings. Each one is either a freestanding children’s hospital or a large multidisciplinary pediatric department working within a major medical center.
    • “This latest ranking of the Best Children’s Hospitals for Cardiology and Heart Surgery includes some familiar names at the top. For instance, Texas Children’s Hospital in Houston is No. 1, just like it was in 2019, 2020, 2021, 2022, 2023, 2024 and 2025. 
    • “Meanwhile, Children’s Hospital Colorado and Duke Children’s Hospital and Health Center are No. 2 and No. 3, respectively. That is where each one landed in the previous year’s ranking as well. 
    • “Going a bit deeper, Children’s Hospital of Philadelphia came in at No. 4, and Children’s Health Dallas came in at No. 5.” 
  • MedCity News lets us know,
    • “Virtual solutions for chronic kidney disease (CKD) management don’t slow disease progression, nor do they reduce total healthcare spending, according to a new analysis by the Peterson Health Technology Institute (PHTI).
    • “PHTI is an independent evaluator of digital health solutions. For the analysis, PHTI reviewed more than 5,400 articles and other evidence. The solutions evaluated in the report include DaVita IKC, Evergreen Nephrology, Healthmap Solutions, Interwell Health, Kidneylink, Monogram Health, Somatus and Strive Health. These companies take on financial responsibility for the total cost of care for patients with stage 3–5 CKD, and typically work with Medicare Advantage plans and Medicare’s Kidney Care Choices model.
    • “The assessment focuses on managing chronic kidney disease before patients progress to end-stage kidney disease, including the need for dialysis or a kidney transplant.”
  • Managed Healthcare Executive tells us,
    • “GLP-1s now dominate market momentum, with obesity products surging from near-zero in 2022 to $55B annually and diabetes GLP-1s sustaining double-digit year-over-year growth. 
    • “Independent pharmacies are reassessing dispensing economics, with refusal rates declining to 35% for weight-loss GLP-1s and 8% for diabetes GLP-1s. 
    • “Distribution remains retail-heavy (~80%), but mail fulfillment is increasing, reaching 12.9% of GLP-1 prescriptions as direct-to-consumer channels expand. 
    • “Diabetes category mix is shifting away from insulin, whose sales share has dropped to 9.8% and prescription share to 16%, reflecting GLP-1 substitution dynamics. 
    • “Medicare Part D Bridge uptake appears immediate, with 9,000 paid claims in three days, alongside a large pipeline exploring neuropsychiatric, SUD, cancer-risk, women’s health, and systemic inflammation indications.”
  • The Wall Street Journal informs us,
    • “Legend Names Novartis Executive as CEO
      • “Ingrid Zhang takes the helm of the cancer therapy company, filling a post vacant since its previous CEO abruptly resigned in July.”
  • Per Beckers Health IT,
    • “Oracle has expanded its fiscal 2026 restructuring plan by approximately $700 million, bringing expected costs to roughly $2.8 billion as the company pursues strategic initiatives and operational efficiencies that include adopting and integrating AI across certain functions.
    • “The Sept. 11 Securities and Exchange Commission filing does not specify what actions the additional $700 million will cover or how many employees could be affected. Oracle said restructuring expenses under the broader plan include employee severance, contract termination and other exit costs.
    • “As of Aug. 31, prior to the additional $700 million, Oracle estimated total restructuring costs of up to $2.1 billion.
    • ‘The disclosure comes as Oracle employees across social media reported a recent round of layoffs, including at Oracle Health. Business Insider first reported the layoffs Sept. 14, citing three people affected and an email notification.”
  • and
    • “Mayo Clinic and Thermo Fisher Scientific have launched Precure, a joint venture designed to detect biological signs of disease before patients develop symptoms, according to a news release shared with Becker’s.
    • “Rochester, Minn.-based Mayo Clinic, will serve as majority owner of the entity and Thermo Fisher joins as a minority partner. Precure will build one of the world’s largest human multi-omics datasets — integrating proteomic and genomic data with longitudinal clinical information drawn from 1 million biospecimens collected over several years, according to the release.
    • “At Mayo Clinic, we are committed to transforming patient care through innovation,” said Gianrico Farrugia, MD, president and CEO of Mayo Clinic. “By harnessing the full potential of multi-omics data, Precure, LLC aims to help us better understand disease before symptoms appear.”
    • “Thermo Fisher will contribute its Olink Explore HT proteomics platform and Orbitrap mass spectrometry technology to the effort. Marc Casper, Thermo Fisher Scientific’s chairman and CEO, said the venture has “the potential to create a step change in how we generate and apply multi-omics data to improve human health.”
    • “Target disease areas include cancer, cardiometabolic conditions, neurological disorders and immune-mediated disease — conditions where biological changes often precede clinical diagnosis by years. Advanced AI and large-scale data analytics will be used to identify patterns across the datasets and translate them into actionable insights.”
  • Per Beckers Clinical Leadership,
    • “The nonprofit parent organization of OpenAI — the Open AI Foundation — has given $40 million to Chapel Hill, N.C.-based UNC Lineberger Comprehensive Cancer Center to generate data that can be used to develop more precise, personalized cancer vaccines. 
    • “UNC Lineberger researchers, led by immunologist Benjamin Vincent, MD, and computational biologist Alex Rubinsteyn, PhD, will gather deidentified tumor tissue and immune cell data that will train AI models to identify cancer cell targets for vaccines, according to a Sept. 15 news release from the cancer center. 
    • “Researchers will also conduct clinical trials to compare multiple vaccine formulations for triple-negative breast cancer, the release said. 
    • “These efforts aim to create a public, multimodal dataset to “help reach a future where cancer patients can get rapid personalized cancer vaccines when they are diagnosed,” the OpenAI Foundation said in a Sept. 15 news release. 
    • “UNC Lineberger’s $40 million grant is part of a $125 million funding program, called Public Data for Health, established by the foundation.”
  • and
    • “Ambient artificial intelligence handed many physicians their evenings back. For nurses, the same promise is proving harder to keep, and the reason is buried in the flow sheet.
    • “Physician ambient scribes listen to a visit and draft a narrative note when it ends. Nursing documentation does not work like that. It lives in structured flow sheets, entered field by field across a shift, every time a nurse assesses, medicates or turns a patient.
    • “Nursing documentation occurs throughout the entire shift. It’s every time we interact with a patient,” said Stephanie Clements, BSN, RN, senior vice president and chief nurse executive at Chesterfield, Mo.-based Mercy. “It’s very different than summarizing care at the end of a period.” 
    • “That difference is why early attempts to copy the physician model — record the encounter, generate the note — have not mapped cleanly onto the bedside, and why some nurses have found the tools slower, not faster, at first.
    • “Yet the systems furthest along say the payoff is real when the technology is built for nurses from the get-go.” 

Notable Deaths

  • The New York Times reports
    • “Harold P. Freeman, an influential oncology surgeon whose knowledge of the devastating effects of breast cancer on poor Black women inspired him to create a landmark program at Harlem Hospital Center, helping patients navigate the health care bureaucracy, died on Aug. 11 in Atlanta. He was 93.
    • “His death, at a hospital, was confirmed by his son Neale.
    • “Dr. Freeman’s patient navigation program became a model for hospitals around the world, helping to eliminate barriers to early cancer detection. The program’s success influenced the passage of the federal Patient Navigator Outreach and Chronic Disease Prevention Act of 2005, which provided $25 million for similar programs across the United States. In 2024, Medicare began providing providers with reimbursement for some navigation services for cancer, heart failure, H.I.V./AIDS and other high-risk conditions.
    • “There are no navigation events or meetings that don’t acknowledge Dr. Freeman’s role in patient navigation,” Dr. Shanthi Sivendran, the interim chief patient officer of the American Cancer Society, said in an interview. “There wasn’t a patient navigation concept before him.”
  • and
    • “The milk truck would pull up to the house, and out would come the groceries — not just milk, but also eggs, cheese, juice, cereal and baby formula. It might have stopped at a rich family’s house, or a poor one. No one could tell the difference, which was precisely the point.
    • “Vermont’s supplemental food program for low-income women, infants and children, the first in the nation to be implemented statewide, began in 1974. It was the brainchild in part of Dr. Anthony Robbins, then one of the country’s youngest state health commissioners, at 33; he had secured a federal grant to made the program possible.
    • “Not only did the program provide much-needed supplies, but it also shielded families from the stigma of receiving public assistance.
    • “The milk truck was stopping at practically every house — high income, low income, whatever,” Donna Bister, a former director of the program, known widely as WIC, said in an interview. The program is now available in all 50 states.” * * *
    • “Dr. Robbins died on July 5 at his home in Rockport, Mass. He was 85. His death, which was not widely reported at the time, was caused by complications of long Covid, heart disease and Parkinson’s disease, his wife, Phyllis Freeman, said.
    • “He was considered to be on the cutting edge of health care,” Madeleine Kunin, a former governor of Vermont, said in an interview. “He was a bright light.”
  • RIP Doctors.

Weekend update

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

Simplicity is a virtue.

From Washington, DC

  • The Hill explains,
    • “House and Senate lawmakers will return to Washington this week with a packed agenda before much of their focus shifts to the fast-approachingmidterm elections.
    • “The Senate is expected to continue talks over the budget resolution and hold a procedural vote on the cryptocurrency regulation bill, among other priorities. The House, meanwhile, will reportedly consider a Senate-passed Russia sanctions bill prior to departing again until mid-November, after House Republican leaders recently cut two weeks from the chamber’s September schedule ahead of the midterms.”
  • MedPage Today reports,
    • “Healthy Moms, Healthy Babies America, a bipartisan campaign founded by philanthropists Olivia and Tom Walton, announced a $100 million pledge to make giving birth in the U.S. safer.
    • “The 5-year commitment aims to cut the maternal mortality rate in the U.S. in half by 2031.
    • “For millions of moms in America, maternal health is bad and getting worse,” Olivia Walton told the Associated Press in an interview. “There’s just so much bipartisan consensus around wanting to fix this. I really think the political will is there and part of our job is to help surface that with an information campaign.” * * *
    • “According to the most recent data available, the U.S. has one of the highest maternal mortality rates among wealthy nations. The CDC said 688 people died in 2024 during pregnancy or shortly after giving birth. The maternal mortality rate rose to 19 deaths per 100,000 live births in 2024, up from 18.6 the year before.
    • “Improving data collection and accelerating hospitals’ reporting of deaths is an important pillar of the new Healthy Moms, Healthy Babies America initiative, Walton said. The most recent state-level data on maternal mortality is still from 2022, with annual totals based on provisional data available through 2024.”

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

  • Per Department of War news release,
    • “The Department of War has extended and expanded the Pilot Health Insurance Enhancement for DOW Civilian Employees in Japan, reaffirming its commitment to securing high-quality healthcare navigation and mitigating upfront medical costs for its overseas civilian workforce and their families.
    • “The contract extension, awarded to International SOS Government Services, Inc., begins Sept. 30, 2026, and runs through Sept. 29, 2027. In direct response to feedback from the DOW civilians, eligibility is now expanded to include authorized dependents of DOW civilian employees, provided they are enrolled in a participating Federal Employee Health Benefit plan.” * * *
    • “The pilot program, which originally launched on Jan. 1, 2025, was designed to provide no-cost supplemental health support services to DOW civilian employees. The program addresses longstanding challenges in navigating Japan’s healthcare system and managing upfront medical costs. In response to DOW civilian employee feedback, the program previously added interpreter services to address language barriers and improve access to care.
    • “Alongside the expansion of eligibility to dependents and as part of the contract extension, the program is updating call center hours. Beginning Sept. 30, 2026, the bilingual call center will operate Monday through Friday, from 7 a.m. to 7 p.m. Japan Standard Time.
    • “To participate in the pilot, DOW civilian employees and their dependents must be enrolled in one of the following participating FEHB plans:
      • “Federal Blue Cross Blue Shield
      • “Foreign Service Benefit Plan
      • “Hawaii Medical Service Association
      • “Government Employees Health Association
      • “Mail Handlers Benefit Plan
    • “Nonappropriated Fund employees and their dependents in Japan are also eligible if enrolled in Aetna International and should coordinate support through their insurance carrier first.”

From the Food and Drug Administration front,

  • MedCity News reports,
    • “Nutromics landed FDA breakthrough device designation this week for its wearable patch that monitors vancomycin levels in real time. 
    • “Vancomycin is a widely used antibiotic for treating life-threatening infections like sepsis, but it’s notoriously difficult to dose correctly, with doctors typically relying on periodic blood draws to track it.
    • “Nutromics was founded in 2017 with the goal of replacing these blood draws with continuous data for the roughly 2.9 million patients in the U.S. who receive vancomycin each year. The new designation gives the company faster, closer engagement with the FDA as it works toward an eventual commercial launch.”

No Surprises Act News

  • On September 15, 2026, the Centers for Medicare and Medicaid Services will open its Independent Dispute Resolution Gateway to registration by non-initiating parties, typically health insurers and plans.
    • “All potential users of the IDR Gateway can begin creating accounts on September 15, 2026.
    • “Your organization should select at least one IDR Gateway administrator (CMS recommends two, and no more than 10) to set up your organization in the IDR Gateway.
    • “The Federal IDR Team will email selected administrators instructions to create their accounts and set up their organizations.
    • “If your organization selects you as an administrator and the Federal IDR Team did not email you instructions, email IDRGatewayHelp@cms.hhs.gov.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A 40-year-old Pennsylvania woman died Saturday from complications associated with measles, the local coroner said.
    • “It was the first measles-related death in Jefferson County, according to county coroner Greg Furlong. The woman was unvaccinated, Furlong said.” * * *
    • “Measles cases in the U.S. are at their highest level in three decades, with 3,924 confirmed cases so far this year, according to the Centers for Disease Control and Prevention. There were 2,289 confirmed measles cases in the U.S. last year, including the first measles-related death in a decade.
    • “The rapid spread illustrates a new normal in the U.S., where falling vaccination rates have made more communities vulnerable to the highly infectious disease that the country declared eliminated more than 25 years ago.”
  • The Washington Post relates,
    • “The number of cancer deaths estimated to be attributable to alcohol in the United States doubled from 1990 to 2023, particularly among men and people aged 55 years and older, according to a University of Miami study published this month, adding to the body of recent research underscoring the health risks of alcohol consumption.
    • “Around 23,126 people died of alcohol-attributable cancer in 2023, up from 11,361 in 1990, according to the study, which estimated the deaths using a global database of disease mortality and population-level estimates of alcohol exposure.
    • “The impact of alcohol, a known carcinogen, increased over the past decades as cancer mortality decreased overall, according to the study. 
    • “Even though overall the cancer mortality was going down for some of these cancers … alcohol-associated mortality was going up,” said Chinmay Jani, a hematology-oncology fellow at the University of Miami’s Sylvester Comprehensive Cancer Center and one of the authors of the study. “Which means that alcohol as a risk factor was impacting more cancer deaths in 2023 than it was in 1990.” * * *
    • “Gilberto Lopes, chief of the division of medical oncology at Sylvester and another author of the study, added that the data did not establish a safe threshold for alcohol consumption. 
    • “It is difficult to ascertain exactly what the safe level of alcohol is,” Lopes said. But “it is quite clear that we do know the mechanisms through which alcohol causes cancer. So that there’s no dispute about.”
  • The New York Times considers whether “Motion Sickness is Preventable?”
    • “Experts say there are ways to stave off that dreaded queasy feeling.”
  • Health Day tells us,
    • “A widely used weight-loss and diabetes drug may offer a surprising bonus: healthier lungs.
    • “Researchers compared tens of thousands of patients prescribed either a GLP-1 medication or another type of diabetes treatment to see if they helped with asthma or COPD.
    • “The results: Only one — semaglutide, the active ingredient in drugs like Ozempic and Wegovy — made a difference.
    • “It was associated with nearly 40 percent fewer asthma attacks and 20 percent fewer COPD flare-ups.
    • “No significant association was found with the other GLP-1 meds, regardless of dose or underlying lung disease.
    • “The lead researcher calls the findings encouraging but says, for now: “People with asthma or COPD should not start GLP-1 receptor agonists specifically for their lung condition outside current prescribing guidance.”
  • STAT News informs us,
    • “AstraZeneca said Friday that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors, a result that could limit the use of the medicine.
    • “The drug, camizestrant, in combination with another medicine did not outperform standard treatment on a measure of how long patients went before their cancer progressed. The SERENA-4 trial enrolled patients with ER-positive, HER2-negative advanced cancer who hadn’t had another systemic therapy for advanced disease.”
    • “Camizestrant earlier this month won accelerated approval in the U.S. as Etcamah as a treatment for patients who develop a mutation in their tumors that’s a sign of emerging drug resistance. The SERENA-4 trial, had it been successful, could have opened up a much larger market for the drug. 
    • “AstraZeneca is also testing camizestrant in early breast cancer.
    • “Early breast cancer represents an important opportunity, and we remain confident in the long-term potential of Etcamah in the early setting as we advance our broader program,” Susan Galbraith, AstraZeneca’s head of oncology R&D, said in a statement, adding that the company was “disappointed by the SERENA-4 outcome.”
  • The New York Times points out,
    • “Until last Friday, cardiologists thought they were on the verge of a new frontier in treating heart disease.
    • “Three companies were conducting large clinical trials on experimental drugs that slash levels of a blood protein, Lp(a), thought to cause heart attacks and stroke. Doctors were eagerly awaiting the results, hoping the drug could be as important as a statin.
    • “When Novartis, the first company to complete its trial, announced its results, late Friday afternoon, after the markets closed, cardiologists were shocked. The drug could lower Lp(a) levels by 80 percent, but it did not prevent heart attacks and strokes. It had failed.
    • “There’s something we don’t understand here,” said Dr. John Alexander, a cardiologist at Duke.
    • “Cardiologists regularly see patients who have had heart attacks even though their cholesterol and blood pressure levels are low. They do not have diabetes or obesity, and they do not smoke, either. All too often, though, they have high levels of Lp(a).”
    • “About 20 percent of Americans have elevated levels; people with the highest levels of the protein can have double or triple the risk of a heart attack.
    • “So there was no question that Lp(a) was important. A drug to lower the level of the protein, cardiologists hoped, could provide a way for these patients to protect themselves.
    • “But the failure of the Novartis study raised an uncomfortable possibility: Maybe Lp(a) is not a cause of heart disease, but instead is a marker of heart disease risk, like white hair is a mark of aging.
    • “If Lp(a) is a marker, though, what is it marking? Is there another cause of heart disease that no one has thought of?
    • “That is “the nagging question we are all pondering,” said Dr. David Maron, president of the American Society for Preventive Cardiology.”

From the U.S. healthcare business front,

  • Benefits Pro reports,
    • Executives from Aetna and its parent, CVS Health, are hoping that focusing on Aetna’s relationships with doctors will be good medicine for soaring health coverage costs.
    • Steve Nelson — an executive vice president at CVS and president of Aetna — talked about Aetna’s efforts to hold down health coverage cost increases today [September 9, 2026], in Boston, during a session at a health care conference for investors organized by Wells Fargo.
    • “Absolute health care costs are still much higher than any of us would like to see them,” Nelson said.
    • “Aetna is organizing about 2,000 different initiatives to get cost trends under control, he said.
    • “If initiatives to support relationships with the providers succeed, that should make many of the initiatives work more smoothly, Nelson said.
    • “CVS streamed audio of the call live on the web and posted a recording online.”
  • Reuters relates,
    • “GE HealthCare Technologies (GEHC.O) is ​in talks over a possible $1 ‌billion deal to buy radiopharmaceutical developer Sofie Biosciences, the Financial Times reported on ​Sunday [September 13, 2206], citing people familiar with ​the matter.
    • “A deal ⁠for Sofie, which specializes in ​radioactive chemicals used in cancer scans, ​could be announced as soon as next week, the report said.
    • “Reuters could not immediately ​verify the report. GE HealthCare ​declined to comment while Sofie Biosciences could ‌not ⁠be immediately reached for comment outside regular business hours.”