FEHBlog

Monday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, SCOTUS, U.S. Healthcare–

Simplicity is a virtue.

From Washington, D.C.

  • Per a White House news release,
    • “First Lady Melania Trump advanced a landmark program to improve women’s health through a new executive order that strengthens research, prevention, diagnosis, treatment, and care for girls and women throughout every stage of life.
    • “Previous generations fought for women’s rights. Our generation will fight to discover the cures that will ensure a woman can live her life in health and to the fullest,” The First Lady said from the White House.
    • “The Executive Order establishes a White House Women’s Health Task Force and establishes a new Women’s Health Division within the National Institutes of Health to accelerate scientific discoveries to improve women’s health outcomes.” * * *
    • “To learn more about the Executive Order, read the fact sheet released by the White House.”
  • Bloomberg Law reports,
    • “The Trump administration’s move to integrate artificial intelligence agents with Medicare patient data is facing concerns the tech push could put sensitive health information at risk.
    • ‘Since 2025, the Centers for Medicare & Medicaid Services has partnered with more than 700 companies, including Google, Microsoft, and OpenAI, to build its Health Technology Ecosystem, an agency revamp seeking to modernize how Medicare patients use their health data.
    • “Patient and privacy groups, though, warn that without safeguards, the rapid expansion into AI could leave Medicare patients vulnerable to the same pitfalls plaguing the broader health industry.
    • “We are at this incredible inflection point right now, but we really need strong consumer protections to keep pace with all of that innovation,” said Lisa Bercu, senior director of health policy at the National Consumers League.”
  • The American Hospital Association News adds,
    • T”he AHA provided recommendations to the Food and Drug Administration Oct. 19 on potential regulatory frameworks for generative artificial intelligence-enabled medical devices. The AHA expressed support for a flexible, risk-based regulatory framework that protects patients without impeding responsible innovation. Among its suggestions, the AHA recommended the FDA refine the proposed risk heuristic for evaluating the risk of GenAI applications and provide labelling guidance on “informational action directing” devices versus “action taking” devices. The AHA also requested the agency to align premarket clearance and post-deployment evaluation and monitoring activities under a total product lifecycle and clarify that GenAI-enabled clinical decision support and administrative tools are not subject to FDA oversight.” 
  • Beckers Health IT notes,
    • “Somerville, Mass.-based Mass General Brigham researchers built an AI foundation model, trained on more than 40 million face images, that estimates biological age and predicts cancer survival from a single photograph.
    • “The model, called FAHR-Face, powers two tools detailed in a study published Oct. 19 in The Lancet Digital Health. FAHR-FaceAge estimates a patient’s biological age more accurately than prior algorithms. FAHR-FaceSurvival predicts survival outcomes directly from a face photo of a patient with cancer.
    • “The gap between a patient’s FAHR-FaceAge and chronological age was independently linked to survival. The two tools’ predictions were only weakly correlated, and combining them improved survival-model fit in an external validation cohort of cancer patients.
    • “Hugo Aerts, PhD, director of the Artificial Intelligence in Medicine program at Mass General Brigham, said the work is, to the team’s knowledge, “the first demonstration” that an AI model can directly predict cancer survival from a photograph, per an Oct. 19 news release.”

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

  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) has finalized a rule removing the governmentwide time-in-grade restriction for advancement to covered competitive-service General Schedule positions at GS-6 and above. The restriction generally required employees to spend 52 weeks at a lower grade before they could be considered for promotion, even if they met the qualifications for higher-level work.
    • “The old rule made the calendar a gatekeeper. If someone is qualified and ready to take on more responsibility, the government shouldn’t make them wait another year just because the clock says so,” said OPM Director Scott Kupor. “This rule allows agencies to reward demonstrated merit over tenure. Employees still have to meet the standards for the job, and promotions still have to follow merit procedures.”
  • Director Kupor further discusses the significance of this rule change in his Secrets of OPM blog here.
  • FedWeek reports,
    • “OPM has issued a “Government-Wide Recruitment Strategic Plan” for senior agency leaders, HR officials and hiring managers that incorporates many of the administration’s previously announced hiring initiatives while setting a goal that one-third of hires should be “early career.”
    • “Aligned to the Trump administration’s workforce management agenda, Federal agencies should hire patriotic Americans and make hiring decisions based on merit, not proxies. A college degree, or years of tenure, may or may not tell us whether someone is the best fit for a job. Demonstrated skills do,” says the document, attached to a memo to agencies.
    • “Agencies will emphasize lawful, fair, and open competition, grounded in job-related competencies and merit-based skills assessments. Nowhere is this more urgent than in early career recruitment. The federal government is exponentially under-indexed on early career talent,” it says.”
  • and
    • “In its newly released “Governmentwide Recruitment Strategic Plan” (see related story), OPM said it is looking for “disciplined execution by all agencies, not just OPM” which will be looking for “indicators of success” by agencies in carrying it out.
    • “Says a cover memo from OPM director Scott Kupor, “Successful implementation requires unwavering commitment and disciplined execution by every agency, not just OPM. Agency leaders and Chief Human Capital Officers must align recruitment with workforce needs, strengthen early-career talent pipelines in pursuit of the Plan’s hiring goals, measure outcomes, and hold their organizations accountable for results.”
  • FedSmith encourages readers to “Look Beyond Premiums: Understanding the Real Cost of Your [FEHB or PSHB] Health Plan.
    • Learn to choose the best FEHB health plan by weighing premiums, deductibles, copays, and out-of-pocket costs for total yearly expenses.

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

  • Beckers Hospital Review reports,
    • “The FDA has granted accelerated approval to an immunotherapy that may spare some patients with locally advanced rectal cancer from undergoing chemotherapy, radiation and surgery.
    • “The approval covers London-based GSK’s dostarlimab-gxly — sold under the brand name Jemperli — as a standalone treatment for adults with previously untreated stage 2 or 3 locally advanced rectal cancer, according to an Oct. 19 news release from the agency.
    • “Eligible patients’ tumors must be identified by an FDA-authorized test as mismatch repair-deficient or microsatellite instability-high, the release said.” 
  • Reuters relates,
    • “Haemonetics (HAE.N) said on Monday the US Food and Drug Administration ​approved its device designed to seal ‌arterial openings created during minimally invasive heart and vascular procedures.
    • “The device, PerQseal ⁠Elite, uses a fully absorbable ​patch that dissolves over time ​and does not leave a permanent implant in the body.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration has cleared the Twiist automated insulin delivery, or AID, system for use in adults with insulin-treated Type 2 diabetes. 
    • “Sequel Med Tech, which sells the device, disclosed the 510(k) clearance on Friday. The FDA granted the clearance to Deka Research and Development, Sequel’s partner on Twiist.
    • “The FDA cleared Twiist after researchers linked the AID system to reduced blood sugar and increased time in the target glycemic range in a clinical trial.”
  • Cardiovascular Business adds,
    • “Masimo, a California-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its smartSET pulse oximetry platform to identify signs of atrial fibrillation (AFib) and deliver alerts to its Radius Vital Signs Monitor. The newly cleared feature continuously evaluates a patient’s pulse waveform data, flagging clinicians when additional follow-up care may be necessary.
    • “When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds,” Basil Matta, BA, MB, BCh, BAO, Masimo chief medical officer, said in a statement. “By bringing AI-driven pattern recognition directly into the pulse oximetry workflow, smartSET helps clinicians see subtle physiological shifts earlier. It bridges the gap between spot checks, giving care teams actionable insight when minutes count.”
    • “For more than three decades, Masimo has expanded what clinicians can expect from pulse oximetry,” added Tim Benner,Masimo president. “With smartSET, we are bringing intelligent sensing and AI-enabled detection to the bedside—building on our signal-processing expertise to turn continuous monitoring data into meaningful clinical insight.”
  • and
    • “A new size-adjustable pulmonary valve approved by the U.S. Food and Drug Administration (FDA) could reduce the number of open-heart surgeries children with congenital heart disease need as they grow.
    • “Cardiovascular Business spoke to Emile Bacha, MD, chair of the department of surgery and surgeon-in-chief at NewYork-Presbyterian Hospital/Columbia University Medical Center, to learn more. Bacha, a lead investigator in the clinical trial that supported FDA clearance of the Edwards Lifesciences Autus size-adjustable pulmonary valve, said this device addresses the longstanding challenge of valves not being able to grow with pediatric patients into adulthood.
    • “This is indeed an important new advance in the field of treatment of pediatric heart disease,” Bacha, a past president of the American Association for Thoracic Surgery (AATS), explained. “When we replace a valve in a one-year-old they will grow, but the valve is not going to grow. As a consequence, we have to constantly reoperate on this child to upsize the valve. It’s very traumatic for the kids. And those are very big surgeries that involve sternotomy. So it’s not insignificant at all. Instead of having two, three, four or more surgeries, that child will have two, three or four catheterization procedures, which are much, much less invasive.”

From the Medicare Advantage front

  • KFF offers
    • [an explainer that] tackles such subjects as what changes Medicare beneficiaries can make during open enrollment; how Medigap and other forms of supplemental coverage factor into coverage decisions; how Medicare Advantage plans and Part D stand-alone prescription drug plans vary; and the tradeoffs involved when deciding whether to enroll in traditional Medicare versus Medicare Advantage. Get the details.
    • Additional analyses explore how the average Medicare beneficiary will have 28 Medicare Advantage prescription drug (MA_PD) plans available for general enrollment in 2027 (the number of plans varies widely across states), and how Medicare Advantage plan availability varies widely by county in 2027.
    • An analysis of the Part D stand-alone prescription drug plan (PDP) marketshows that there will be a modest reduction in the number of PDPs for 2027, along with modest premium increases less than $10 per month for many enrollees — but much larger monthly premium increases of $50 or more for others if they don’t switch plans.

No Surprises Act News

  • STAT News reports,
    • “Before it won a lucrative government contract, iMPROve Health’s very future was in question.   
    • “The Michigan-based nonprofit lost over $2 million in 2022 alone — over a third of its revenue — on top of losses in previous years. There were budget cuts; it ditched the office, went remote, and even discussed selling the company. 
    • “We had conversations about, ‘Should we merge and be an organization that someone acquires?’ We had those conversations,” said Richard Murdock, a former iMPROve board member.
    • “Three years later, iMPROve boasts a 70% profit margin, almost as high as that of tech giant Nvidia. Its revenue has grown 13-fold. The turnaround is thanks to the company’s new government-backed role: picking winners in high-stakes payment disputes between health care providers and health insurers.
    • “It’s not the only nonprofit making massive sums by acting as an arbitrator in the program, created under a 2020 law to protect patients from unexpected out-of-network bills. Two others, C2C Innovative Solutions and IPRO, are raking in cash as well. For every dollar the three nonprofits made last year, about half was pure profit.” 

From the judicial front,

  • Bloomberg Law reports,
    • “The Trump administration requested the US Supreme Court weigh in on its latest loss over regulation of surprise medical bills, asking whether courts can use the Administrative Procedure Act to universally vacate federal rules.
    • “A ruling in favor of the administration could potentially upend a sprawling web of litigation over federal regulation, including ramifications for lawsuits over rules governing the Affordable Care Act, Medicare, and Medicaid.
    • “The US Court of Appeals for the Fifth Circuit improperly used universal vacatur as a default remedy to overturn provisions of a rule calculating payment benchmarks in arbitration disputes for unexpected out-of-network bills, the administration argued in its petition for certiorari filed Wednesday.”
  • Fierce Healthcare relates,
    • “Healthcare AI startups OpenEvidence and Doximity settled a contentious legal fight over allegations of corporate espionage and cyberattacks, alongside counterclaims of defamation and misinformation.
    • “The two companies reached a settlement in principle on Thursday, leading to a dismissal of all claims and counterclaims with prejudice on Friday, according to court filings in the U.S. District Court in the District of Massachusetts. As part of the dismissal, the judge also ruled that each party would bear its own costs and attorneys’ fees.
    • “Legal representatives for both companies did not respond to requests for comment. The joint notice of settlement did not provide details on the agreement.”
  • Per a Justice Department news release,
    • “Somerset Lifesciences Inc. (Somerset) has agreed to pay $4 million to resolve common law claims for causing Medicare Part D (Medicare) to pay for its prescription-only (Rx-only) generic drug Olopatadine when it was no longer eligible for Medicare coverage. Medicare does not cover drugs that can be purchased by retail customers over-the-counter (OTC) without a prescription. In 2020, the brand name version of Olopatadine switched from Rx-only to OTC, and Somerset was required to change Olopatadine’s label from Rx-only to OTC as well. Instead, Somerset continued to label and sell Olopatadine as Rx-only and caused Medicare to wrongfully pay claims for an OTC drug.” * * *
    • “Except for the admissions contained in the settlement agreement, the claims resolved by the settlement are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Regular exercise is an essential piece of the puzzle when trying to prevent or manage cardiovascular disease (CVD), according to a new scientific statement from the American College of Cardiology. The team behind the document recommends prescribing exercise to patients whenever appropriate, explaining even a little bit of movement can make a major impact.
    • “The most important message is that some activity is better than none,” Jonathan N. Myers, PhD, chair of the statement’s writing committee and a health research scientist with the Palo Alto VA Healthcare System, said in a statement. “Patients do not need to become athletes to improve their cardiovascular health. Small increases in physical activity can produce meaningful benefits, particularly for those who are currently inactive.”
    • “Myers et al. emphasized that poor cardiorespiratory fitness is a “powerful and independent predictor” of adverse health outcomes. In fact, the risks of poor cardiorespiratory fitness are comparable to what clinicians see with smoking, hypertension, diabetes and other well-known risk factors. 
    • “To this day, however, cardiologists and other cardiovascular care professionals often meet with patients without prescribing any kind of regular exercise routine.” 
  • The American Medical Association lets us know “what doctors want patients to know about food poisoning.”
    • “Food poisoning can cause vomiting, diarrhea and dehydration. Learn how to spot warning signs, recover safely, prevent illness and when to call your doctor.”
  • MedTech Dive shares the opinions of “5 doctors [who] weigh in on the promise, limitations of Grail’s multicancer test.”
    • “As the closely watched screening test moves closer to Food and Drug Administration approval, MedTech Dive asked cancer experts what encourages and concerns them most about Galleri.”
  • Beckers Hospital Review tells us,
    • “Patients taking GLP-1 medications had lower rates of major cardiovascular complications and infections after surgery than those not taking the drugs, according to a study of more than 2 million adults presented Oct. 18 at the American Society of Anesthesiologists’ Anesthesiology 2026 annual meeting in San Diego.”
  • and
    • “As healthcare leaders celebrate the FDA’s approval of daraxonrasib — a pancreatic cancer drug that nearly doubled survival in clinical trials — two harsh realities remain: most pancreatic cancer patients are still diagnosed at a late stage, and those treated with daraxonrasib will eventually develop resistance to it.
    • “Pancreatic cancer is the third-leading cause of cancer death in the U.S., representing 3.2% of new cancer cases but 8.4% of cancer deaths. Only 14.6% of pancreatic cancers are diagnosed before they spread to other parts of the body, according to SEER data. 
    • “To catch pancreatic cancer before it spreads, researchers are turning to AI.”
  • Healio informs us,
    • “In the years after becoming eligible for biologic therapy, 70% of adults with severe asthma achieved a lower yearly rate of exacerbations with just standard care, according to data published in CHEST.
    • ““In patients with severe asthma and frequent exacerbations, review their blood eosinophil counts from previous years,” Freda Yang, MBChB, MD, honorary clinical senior lecturer at the National Heart and Lung Institute, Imperial College London, and consultant respiratory physician at Royal Brompton Hospital, told Healio.
    • “Persistent eosinophilia suggests continued frequent exacerbations and a likely need for long-term biologics,” Yang said. “Patients without it may improve with standard care or need biologics for a shorter period. As an observational study, these findings need confirming in prospective trials.”
  • STAT News points out,
    • “An oral treatment from Gilead Sciences eliminated the symptoms experienced by patients with a type of inflammatory bowel disease, mid-stage study results reported Monday that could boost the biotech’s push to develop new drugs for inflammatory and autoimmune conditions. 
    • “A 200-milligram daily dose of the Gilead pill, called emvistegrast, taken for 12 weeks resulted in a 23% placebo-adjusted clinical remission rate for patients with moderate to severe ulcerative colitis, the Phase 2 study showed. The statistically significant improvement exceeded Wall Street analyst expectations.
    • “Emvistegrast has the potential to be a best-in-class oral for patients with ulcerative colitis,” Swati Tole, Gilead’s senior vice president overseeing clinical development of its inflammatory disease medicines, told STAT on Friday. “Patients with inflammatory bowel disease, while they have other therapies available, still have persistent symptoms. A majority do not achieve remission, so seeing these data was encouraging for us.” 
  • BioPharma Dive adds,
    • “A rare disease drug previously spurned by the Food and Drug Administration will get another shot at approval after positive Phase 3 results that sent shares of its developer, Disc Medicine, soaring by more than 35%. 
    • “Disc said Monday that the treatment, bitopertin, met all of its main and secondary objectives in a Phase 3 trial in erythropoietic porphyria, an uncommon disease causing hypersensitivity to light. The findings position Disc to resubmit an approval application to the Food and Drug Administration by the end of the year and possibly launch the therapy in 2027.” 

From the healthcare business front,

  • Beckers Hospital Review reports,
    • “Austin, Texas-based Ascension Seton has signed a definitive agreement to acquire a hospital and two urgent care centers in the north Austin area from Cedar Park, Texas-based Family Hospital Systems.  
    • “The deal includes Austin-based Family Hospital at Lake Travis, according to an Oct. 1 news release from Ascension Seton shared with Becker’s. The hospital provides 24/7 emergency care and inpatient care, according to Family Hospital Systems’ website. 
    • “The deal also includes Cedar Park-based Family Medical Center at Lakeline and Family Medical Center at Round Rock (Texas), which offer urgent care, primary care and on-site imaging, according to Family Hospital Systems’ website. 
    • “Ascension Seton, which is part of St. Louis-based Ascension, said the acquisition will give families in Austin’s outer metro area more access to emergency services. The health system said the move supports the market’s growth, patient care and long-term sustainability.”
  • and
    • “UnitedHealth Group’s count of subsidiaries and related entities has reached 2,807, according to the latest “Sunlight Report,” updated in October.
    • “The report comes from the Center for Health & Democracy and is funded by Arnold Ventures. The updated report identified more entities since the findings published in July 2025, factoring in 2024 year-end and 2025 Schedule Y state insurance filings, publicly confirmed 2026 transactions and U.S. Securities and Exchange Commission filings through the second quarter of 2026.” * * *
    • “UnitedHealth’s acquisitions have slowed since the original report’s data window. From early 2024 to the end of 2025, 368 entities joined and 268 left. The report documented two acquisitions in 2026: benefits administration platform Alegeus Technologies and six surgery centers through a Federal Trade Commission order.” 
  • Beckers Clinical Leadership relates,
    • “Nurse scientists are calling on hospitals, payers and credentialing bodies to overhaul how they measure nursing care, arguing that today’s metrics capture only a sliver of what nurses actually do.
    • “In a viewpoint published Oct. 19 in JAMA Internal Medicine, three nurse researchers — led by Lori Kennedy, PhD, RN, director of the Center for Nursing Science at Sacramento, Calif.-based UC Davis Health — proposed a set of nurse-sensitive outcome measures spanning nine domains of acute and critical care nursing practice, along with a framework to develop them.
    • “Their central critique: the nurse-sensitive metrics CMS relies on focus almost entirely on patient harm, including hospital-acquired infections, falls, pressure injuries and restraint use. Those measures matter, the authors wrote, but they “measure nursing by its absence.”
    • “When nursing value is expressed only as harm incurred, the economic case for nursing investment becomes purely defensive,” they wrote. Institutions tally the cost of each central line-associated bloodstream infection, they noted, but not the value of a nurse catching signs of sepsis before a patient becomes hypotensive and requires an ICU transfer.” * * *
    • “The proposed framework builds on the 2024 “Blueprint for Change in Acute and Critical Care Nursing,” a call to action from a national panel of nursing science leaders that included Dr. Kennedy.”
  • Beckers ASC Review tells us,
    • “Chicago-based Northwestern Medicine has opened a new outpatient center on the Northwestern Medicine Huntley (Ill.) Hospital campus. 
    • “The 80,000-square-foot facility will provide services including general surgery, cardiovascular, gastroenterology and pulmonary medicine, according to an Oct. 19 news release from Northwestern Medicine. 
    • “The expansion will add about 300 new jobs over the next three years.” 
  • Beckers Payer Issues informs us,
    • “Cigna Healthcare in the first quarter of 2027 will roll out Health Sense, a tailored customer and clinical support model that brings together health, benefits and cost information. 
    • “While the model will initially roll out for customers with oncology and cardiometabolic needs, Stanley Crittenden, MD, chief medical officer at Cigna Healthcare, told Becker’s that the team is just getting started.
    • “Don’t look at this as just a one-time product launch, but think about this as a more iterative process where we’re going to be adding more conditions,” he said.
    • “Cigna chose to roll out Health Sense to those with oncology and cardiometabolic conditions first because they often have complex and costly care journeys, Dr. Crittenden said. He did not share which conditions could be on the horizon next, but he said the team is considering other areas where patients have “the greatest needs and the highest complexity that would benefit from earlier intervention.” Dr. Crittenden said Cigna is currently focused on learning from the initial rollout and validating outcomes.”
  • and
    • “CVS Health named Maria Wilson, MD, as chief medical officer of Oak Street Health, the company’s value-based primary care centers for older adults. 
    • “Dr. Wilson has been with Oak Street Health since 2017, most recently serving as an executive medical director, according to her LinkedIn profile. 
    • “It’s a privilege to take on this role in a place where I’ve seen firsthand what our providers and care teams can do,” Dr. Wilson said in an Oct. 16 LinkedIn post. “Value-based care is about getting the right care to patients at the right time while supporting the provider care teams who deliver it, and I’m excited to help lead that work.”
  • The New York Time points out “professionals [who] may be the best kept secret in elder care.
    • “They can arrange a move to a senior living facility, deal with Medicare and Medicaid, recommend doctors, drive a client to the dentist, and much more.”
  • NBC News notes, “Many Women Are Still Struggling to Fill Estrogen Patch Prescriptions. What to Do If You Can’t Get Yours
    • “As demand for menopause treatment increases, estrogen patches are hard to find at pharmacies. Here’s what to do if you can’t refill your prescription.”
  • Per the Wall Street Journal,
    • “Roche Holding entered a licensing agreement with Hansoh Pharmaceutical Group that could net the Chinese drugmaker more than $15 billion.
    • “Hansoh will receive $400 million upfront and $110 million after a year, plus potential payments subject to targets and royalties on sales.
    • “The collaboration aims to advance a portfolio of antibody-drug conjugates, which are targeted cancer therapies, across multiple cancer types.”
  • and
    • “Germany’s Merck KGaA agreed to buy U.K. biotech company Silence Therapeutics for $1.3 billion.
    • “Merck is offering $20 in cash for each American depositary share of Silence Therapeutics, more than double its Friday closing price.
    • “The deal aims to strengthen Merck’s rare-disease pipeline by adding divesiran, an experimental drug ready for late-stage clinical trials.”

Weekend update

David Ermer–CDC, CMS, Congress, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Congress remains on the campaign trail this week.
  • Beckers Hospital Review reports,
    • :CMS is pitching new guardrails for pharmacy benefit managers and Medicare Advantage plans under a proposed rule released Oct. 16.
    • “The proposed rule would implement sections of the Consolidated Appropriations Act of 2026. Comments are due Dec. 15.
    • “Starting Jan. 1, 2028, PBMs and their affiliates would only be able to accept flat-dollar, itemized service fees for Part D drugs. The fees could not depend on drug prices or rebates. Manufacturer rebates and discounts would remain allowed if they are fully passed through to the plan sponsor.” * * *
    • “Beginning in contract year 2028, MA organizations would need to estimate “a letter grade” for their provider directory accuracy based on a provider sample. In 2029, CMS would publicly post these scores, and plans would need to show them in their directories.
    • “If an MA enrollee books a provider listed as in network, that enrollee would pay no more than the lesser of the in-network or other cost-sharing. This would still apply if the provider ends up being out of network. That protection would begin in contract year 2028.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services announced that it will exercise enforcement discretion for inpatient rehabilitation facility admissions from Oct. 1, 2026 through March 31, 2027, with respect to the timing of the initial interdisciplinary team meeting requirement. As of Oct. 1, the initial IDT meeting must occur on or before four days from the date a patient is admitted to an IRF in order to implement appropriate treatment services; establish or review the patient’s stated rehabilitation goals; and identify problems that could impede those goals. This requirement was finalized in the fiscal year 2027 IRF prospective payment system final rule. The AHA had urged CMS not to finalize this requirement, in part due to its inconsistent descriptions of when the four-day threshold would be met relative to admission. 
    • “During this six-month moratorium, Medicare Administrative Contractors will enforce the initial IDT meeting timing requirement that had been in effect during FY 2026. This means they will not deny or non-affirm a claim based solely on the timing of the initial IDT meeting if an IDT meeting occurs at least once per week throughout the duration of a patient’s stay. CMS said that all other applicable IRF coverage and documentation requirements remain in effect.” 

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

  • The FEHBlog has noticed that 2027 FEHB and PSHB brochures are beginning to shown up in downloadable form on plan open season websites.
  • OPM posted in the Federal Register a Paperwork Reduction Act notice about its efforts to extend its Postal Service Health Benefits Program portal for collecting family member documentation to the FEHB Program. The public comment deadline is December 18. 2026.
  • OPM’s Office of Inspector General posted its Top OPM Management challenges for the current 2027 federal fiscal year.

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services announced that the submission period opened Oct. 16 for petitions to deny the recertification of five independent dispute resolution entities. Members of the public, providers, facilities and others can submit a petition, which must identify the IDR entity seeking recertification and detail the reasons for the petition. The five organizations seeking recertification are Maximus Federal Services, Inc.; ProPeer Resources LLC; C2C Innovative Solutions, Inc.; Medical Evaluators of Texas ASO, LLC; and Federal Hearings and Appeals Services, LLC. The petition period is open through Oct. 23. The departments of Health and Human Services, Labor, and the Treasury will make a final decision on recertification after reviewing any petitions submitted.” 

From the judicial front,

  • Beckers Hospital Review reports,
    • “AbbVie, Bristol Myers Squibb, Boehringer Ingelheim and PhRMA are asking to intervene in the hospital industry’s lawsuit seeking to block HRSA’s revised 340B Rebate Model Pilot Program, according to court filings in the U.S. District Court for the District of Maine.
    • “AbbVie and its Pharmacyclics unit, Bristol Myers Squibb and Boehringer Ingelheim filed a motion to intervene Oct. 14, and PhRMA filed its own motion Oct. 15 in American Hospital Association v. Kennedy. The drugmakers said they want to defend the rebate plans HRSA approved for their drugs, including AbbVie’s Imbruvica, Linzess and Vraylar, Bristol Myers Squibb’s Eliquis and Pomalyst and Boehringer’s Jardiance, Ofev and Tradjenta. They argued that the government’s representation of their interests “may be inadequate,” the standard for intervening, because, unlike HRSA, they face duplicate discount losses and civil penalties.”

From the public health and medical/Rx research front,

  • Beckers Clinical Leadership reports,
    • “The share of flu tests coming back positive rose from 3.9% to 5% in the week ending Oct. 10, the CDC’s first FluView report of the 2026-27 season shows. ED visits and outpatient visits for flu also climbed.
    • “Seasonal flu activity remains low, but test positivity, outpatient visits for flu-like illness, ED visits with a flu diagnosis and lab-confirmed hospitalizations have all been rising since late August or early September. Activity is highest on the West Coast, and the CDC said early-season levels are higher than typical for this time of year but within expected seasonal variation. Influenza A(H1N1) accounted for 96.4% of the influenza A viruses that public health labs subtyped during the week.”
  • Health Day relates,
    • “Poorer maternal dietary quality is associated with infantile colic and eczema, according to a study published online Oct. 12 in JAMA Network Open.
    • “Emily Oken, M.D., M.P.H., from Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston, and colleagues estimated associations of maternal diet quality and intakes of specific allergenic foods with infant eczema and colic in a prospective cohort of 2,128 mother-child pairs unselected for atopic risk. Food frequency questionnaires were administered in early and mid-pregnancy, and the Mediterranean Diet Score (MDS) and Dietary Inflammatory Index (DII) were calculated.”
  • and
    • “If you’re in your 60s, 70s or even older, you might think your days of productively pumping iron are behind you.
    • “That’s just not true, said Dr. Adil Ahmed, an assistant professor in the Joseph Barnhart Department of Orthopedic Surgery at Baylor College of Medicine in Houston.
    • Building and maintaining muscle is a great way to stay all-round healthy, he said.
    • “The protective effect of muscle and muscle mass has been well studied — everything from the musculoskeletal system to orthopedics and even brain health,” Ahmed said in a Baylor news release. “Building muscle in your body has been well shown to delay dementia and the effects of dementia and preserve cognitive function.”
    • “Strength training also helps your bones. It’s one of the best ways to help aging bones stay dense and strong, Ahmed said.
    • “It’s a very good protective long-term process,” he said.” 

From the U.S. healthcare business front,

  • Modern Healthcare tells us,
    • “Health systems are increasingly selling their real estate to ease financial pressure and fuel expansion, and regulators are pushing back.
    • “Health systems are seeking relief from higher costs and lower reimbursement by selling the buildings and land that house their hospital and outpatient facilities. Those deals provide an immediate capital infusion to shore up finances and fund growth, but can expose providers to higher long-term costs as buyers become more selective and state and federal policymakers increase oversight. 
    • “This is trading a short-term fix for a long-term cost,” said Jim Baker, founder and executive director of the Private Equity Stakeholder Project, a nonprofit watchdog group that opposes private equity investment in healthcare.” 
  • BioPharma Dive reports,
    • “Estuary Biotherapeutics, a California-based genetic medicines developer, officially launched on Friday, backed by nine figures worth of funding and a management team stocked with former Biogen leaders.
    • “Forged in 2022, Estuary is built around research conducted by its scientific co-founders Stefan Somlo and Michael Caplan, both professors at the Yale School of Medicine. Somlo’s lab has made major discoveries about an inherited disorder where certain genetic mutations cause cysts that progressively damage the kidneys and often lead to renal failure. Through a landmark study published in the journal Nature Genetics, Somlo’s team found that, in mice, reactivating proteins called polycystins could shrink the cysts and reverse kidney inflammation and scarring.
    • “And in Caplan’s lab, scientists determined that only a small piece of the full polycystin protein is needed to suppress this “autosomal dominant polycystic kidney disease.” Those findings suggest that helpful genetic material can be successfully packaged up and delivered to the kidneys with the standard “viral vectors” used for gene therapy.
    • “Taken together, Estuary believes its technology and expertise will bring about the first-ever treatment that can halt or reverse, rather than just slow, the most common inherited kidney disorder. Estimates hold that ADPKD affects about 1 in every 400 to 1,000 people. Just one drug, tolvaptan, is specifically approved to treat it.”
  • Fierce Pharma offers us a look inside “Teva’s Weltruza launch and Novo’s GLP-1 strategy.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Congress, Cybersecurity–

From the frontier AI front,

  • Beckers Health IT reports,
    • “OpenAI said one of its internal AI models broke through security on a government statistics website to get hospital-bed data the site had refused to give it.
    • “The model was in reinforcement learning training at the time, according to a misalignment report the company updated Oct. 15.
    • “The incident happened June 17, and OpenAI discovered it Aug. 13. The model’s task was to find a district’s historical hospital-bed totals on the site. OpenAI did not name the website or the country.
    • “After the site denied it access several times, the model used the site’s file-download feature to pull application and configuration files from outside the folder that feature was meant to serve. “Those files contained a database connection string, a secret used to sign authorization tokens and email login credentials.
    • “The model then found that the site’s code read identity data from authorization tokens without checking their signatures. It built unsigned tokens, got past the statistics endpoint’s authorization checks and saved 24 years of data, far more than the single year it had been asked for.”
  • Bleeping Computer lets us know,
    • “Anthropic is warning that small AI models could soon be able to self-replicate across consumer IoT devices, from Android TV boxes to smart ovens, creating distributed botnets capable of running AI workloads without relying on data centers.
    • “The company’s experiments showed that models could identify unfamiliar devices, connect them into a network, and prepare them to run an AI model.
    • “Although the researchers successfully distributed the Gemma4-26B-A4B model from Google DeepMind on 15 off-brand Android TV boxes, they did not demonstrate a fully autonomous, self-replicating AI worm running on real IoT hardware.
    • “However, they estimate that smaller models could achieve self-replication by the end of the year if they continue to improve at their historical rate.
    • “Our experiments suggest that small AI models may be months away from being capable enough to self-replicate on commercial internet-of-things (IoT) devices, like smart ovens and off-brand Android TV boxes,” Anthropic warns.”
  • Cyberscoop adds,
    • “The federal government is advising AI companies to set more industry standards for securing agents in sandbox testing environments.
    • “In joint guidance from the Cybersecurity and Infrastructure Security Agency, the National Security Agency and the Center for Advancing Innovation and Standards for Super Intelligence (CAISSI) at the Department of Commerce, AI companies are encouraged to lean more heavily on cybersecurity technical controls, independent testing and evaluation of new models and develop “shut down policies” that govern when a model or test should be taken offline.
    • “The guidance comes after a summer when OpenAI, Anthropic, Google, Meta and other companies say their AI models escaped from testing environments and hacked real organizations and websites. The problem has bedeviled frontier AI companies, with many of their own researchers saying it’s possible that hundreds – even thousands – of similar sandbox escapes may have occurred over the summer, raising major questions about the lack of effective monitoring in place.
    • “While these incidents highlight the importance of traditional cybersecurity principles and practices, they also introduce novel considerations for incident prevention, response, and reporting,” the agencies wrote. “These novel considerations primarily stem from the agentic nature and advanced cyber capabilities of cutting-edge SI systems.”
  • Federal News Network notes,
    • “Artificial intelligence is accelerating cybersecurity threats, while AI adoption is posing urgent risks around data, identity, trust and operational decision-making. Agencies grappling with those challenges are exploring how to securely adopt AI for both general purpose use and cyber defense.
    • “Thomas Edgar, the chief cybersecurity scientist at Pacific Northwest National Laboratory, said PNNL’s research explores both the risks and opportunities posed by advanced AI models.
    • “Trying to benchmark and understand how bad these models could be if they’re used to target our critical infrastructure,” Edgar said during AI driven defense and the future of the SOC discussion. “But we do prototypes and proof of principle type research, and so AI has been a boon for us to help us kind of iterate and try things faster, supporting our reverse engineering, vulnerability analysis, protocol analysis, data analysis. We’re really looking at how we can really extract optimization out of AI to make us more efficient and effective, and then ultimately transition that off to our government sponsors and our critical infrastructure, so that they can take advantage of what we’ve learned.”

From the cybersecurity policy and law enforcement front

  • Cyberscoop reports,
    • “Members of Congress are pressing the Trump administration to expand the federal government’s role in securing artificial intelligence, wanting new safety standards and regulations, independent testing of models and more “aggressive” use of AI for defensive cybersecurity purposes.
    • “In a letter, Sens. Maria Cantwell, D-Wash., and Mike Rounds, R-S.D., said that multiple incidents of frontier AI models escaping sandbox protections and breaching real companies, organizations and governments necessitate a stronger federal role in regulating the technology.”
  • Security Boulevard informs us,
    • “The FBI has arrested Canadian cybersecurity expert Edward Dubrovsky, accusing him of conspiring with ShinyHunters in the breach of the agency’s systems.
    • “The attack exposed sensitive information of thousands of FBI employees, including job details, specializations, and medical records, after hackers exploited an unpatched Oracle PeopleSoft vulnerability.
    • “Dubrovsky’s arrest follows the detention of other alleged ShinyHunters associates as investigators pursue the prolific extortion group, which the FBI says has breached more than 140 organizations since 2025 and extorted $70 million.”
  • The American Hospital Association News tells us,
    • “Microsoft and Health-ISAC Oct. 15 announced that they disrupted three cybercriminal businesses that provided services to threat actors to attack more than 75,000 organizations worldwide, including healthcare. The businesses were found to be part of a wider, Chinese-language cybercriminal marketplace supplying malicious services to threat actors around the world. Investigators that included Microsoft, Health-ISAC, Japan’s National Police Agency and other organizations collaborated to seize and redirect domains for infrastructure operating the three criminal businesses — YAM Store, CoGUI and Iron Man. The businesses collectively enabled more than 1 billion malicious messages that targeted consumers, healthcare organizations, financial institutions and other entities in more than 150 countries, generating tens of millions of dollars.” 
  • Bleeping Computer adds,
    • “The U.S. Department of Justice (DoJ) has disrupted the Famous Chollima threat group’s operations by arresting two suspects, charging 14 individuals, and seizing nearly 187 laptops used in North Korean [(DPRK)] remote IT worker schemes.
    • “Famous Chollima (a.k.a. WageMole) is commonly tracked as a DPRK threat actor associated with fraudulent IT-worker schemes that generate revenue for the DPRK regime.” * * *
    • “Laptop farms are locations where facilitators host employer-issued computers that North Korean IT workers access remotely to appear based in the United States.
    • Law enforcement agents seized approximately 187 laptops and KVM input devices, which were used by Famous Chollima operatives that cybersecurity company CrowdStrike had been tracking since April 2025.
    • “CrowdStrike researchers say that DPRK IT workers used several methods to send the company-issued laptops to the “farm,” instead of the address in the provided identity documents: 
      • Submit fake theft reports to trigger replacement shipments to the farm’s address
      • Rotate through residential addresses to obscure the final destination
      • Claim last-minute relocations to divert devices mid-shipment
      • Abuse IT staffing roles they sometimes hold to covertly redirect shipments
    • “CrowdStrike says public exposure has pressured the operatives, leading them to rely more on spoofing device identifiers or even reusing identifiers across victim organizations.
    • “While CrowdStrike acknowledges that actions like Lonestar Roundup will likely have limited impact, the company called the operation “the beginning of a broader U.S. law enforcement effort to dismantle Famous Chollima’s U.S. infrastructure.”

From the cybersecurity breaches and vulnerabilities front

  • HIPAA Journal reports,
    • “In July 2026, 77 healthcare data breaches affecting 500 or more individuals were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights. July was the third consecutive month in which large healthcare data breaches increased, with a month-over-month increase of 10%.” * * *
    • “A majority of the data breaches reported in July were due to hacking and other IT-related incidents, including all but one of the 23 data breaches affecting 10,000 or more individuals. In July, 67 of the month’s data breaches (87%) were reported as hacking/IT-related incidents, involving the protected health information of 33,446,371 of the month’s affected individuals (99.9%). The average breach size was 499,200 individuals, and the median breach size was 4,851 individuals.” * * *
    • “In July, network servers were the most common location of breached protected health information, followed by email systems.”
  • and
    • “Cyberattacks on healthcare organizations are continuing to rise, are becoming costlier to resolve, and are increasingly negatively impacting patient care, according to a recent survey conducted on behalf of the cybersecurity firm Proofpoint. The findings were published in the 2026 Ponemon Healthcare Cybersecurity Report.
    • “The survey was conducted by the Ponemon Institute and included 705 responses from IT and IT security practitioners whose responsibilities include setting cybersecurity policies, selecting vendors and contractors, and managing security budgets. The respondents included public healthcare providers (22%), private healthcare providers (18%), healthcare insurers (18%), payers (11%), healthcare insurance companies (10%), with the remainder from life sciences, pharma, and biotechnology companies.” * * *
    • “While hacking incidents continue to increase, insider risk continues to be a problem in healthcare, with 97% of organizations experiencing at least two data loss or exfiltration incidents in the past 12 months, with an average of 21 incidents at each organization. More than half of respondents (54%) said these incidents impacted patient care, and 56% of respondents said these insider incidents resulted in an increase in mortality rates.
    • “Cybersecurity incidents are increasingly disrupting clinical operations, consuming organizational resources, and affecting care delivery,” explained Proofpoint.  “The healthcare organizations that will be most successful in the years ahead will be those that combine cyber resilience, identity security, human risk management, supply chain security, and AI governance into a unified strategy focused on protecting both operations and patient outcomes.”
  • Cybersecurity Dive relates,
    • “Days after a cyberattack targeting French supermarket refrigerators, thousands of controllers across the globe are visible online and at risk of compromise. 
    • “Hundreds of grocery stores in France were targeted in a sophisticated attack, in which hackers gained access to programmable controllers that regulate commercial refrigeration systems. 
    • ‘Hackers were able to manipulate controls inside the refrigerators, causing systems to overheat – and in some cases catch fire – leading to millions of dollars in damage. 
    • Hackers targeted vulnerabilities in Danfoss AK-SM, Danfoss AK-SC, Copeland xweb and Dixell xweb controllers, according to ANSSI, France’s national cybersecurity agency.” * * *
    • Security researchers say the problems begin in the design of these systems, where security is not a top priority. 
    • “People who design systems, people who build systems, they usually believe that people will be well behaved,” Aleksandr Yampolskiy, co-founder and CEO of Security Scorecard, told Cybersecurity Dive. “But hackers are not well behaved.”
    • “High-severity vulnerabilities in Danfoss controllers were publicly disclosed in an August report by Claroty, a firm that specializes in industrial cybersecurity. Researchers found high-severity flaws in the web management interface of Danfoss systems that could allow an attacker to take control of a device.
    • “The vulnerabilities were tracked as CVE-2025-41451 and CVE-2025-41452. Researchers originally alerted Danfoss to the flaws in 2025 before releasing the report under a coordinated disclosure process. The manufacturer patched the flaws and issued additional guidance. 
    • “The attacks impacted hundreds of supermarkets across multiple chains, including Carrefour, Monoprix, Cooperative U and Intermarche. 
    • “A spokesperson for Copeland confirmed that a vulnerability was found in discontinued end-of-life controllers. The company is actively working with impacted customers to mitigate the risk.”
  • CISA added nine known exploited vulnerabilites to its catalog this week.
    • October 13, 2026
      • CVE-2026-96951 Microsoft Windows Command Injection Vulnerability
      • CVE-2026-104935 Ivanti Connect Secure Authentication Bypass by Spoofing Vulnerability
        • CISA separately advises about the Ivanti KVE here.
        • SOC Prime discusses the Microsoft Windows KVE here.
    • October 14, 2026
      • CVE-2026-0322 Palo Alto Networks PAN-OS Code Injection Vulnerability 
      • CVE-2026-76519 Cisco Secure Email Gateway Relative Path Traversal Vulnerability
      • CVE-2026-105133 Ahsay AhsayCBS Improper Authentication Vulnerability 
      • CVE-2026-105134 Ahsay AhsayCBS Command Injection Vulnerability 
        • The Hacker News discusses the Palo Alto Networks KVE here.
        • SOC Prime discusssed the Cisco KVE here.
        • The Hacker News discusses the Ahsay KVEs here.
    • October 15, 2026
      • CVE-2026-21589 Atlassian Multiple Products Files or Directories Accessible to External Parties Vulnerability 
        • TechNadu discusses the Atlassian KVE here.
    • October 16, 2026
      • CVE-2025-61624. Fortinet Multiple Products Path Traversal Vulnerability
      • CVE-2026-102764 BeyondTrust Remote Support Authentication Bypass by Spoofing Vulnerability 
        • Cybersecurity Dive discusses the Beyond Trust KVE here.
        • CISA also gives separate advice on the Beyond Trust KVE here.
        • The Hacker News discusses the Fortinet KVE here.
  • SC Media lets us know,
    • “We had a lot of predictions in place at the start of 2026, most of which have come to fruition. But in several cases, reality moved even faster than we expected.
    • “The biggest change we have seen so far in 2026 was not a single new attack technique. It’s the way several trends have come together. AI now helps attackers move much faster than before, identities are becoming more important than malware, and legitimate tools and trusted platforms are increasingly becoming the attack path themselves.”

From the ransomware front

  • Beckers Health IT reports,
    • Ransomware attacks and unverified ransomware claims targeting U.S. healthcare organizations increased 64% in the third quarter of 2026 from the second quarter, an Oct. 15 report from cybersecurity research company Comparitech found. * * *
    • The U.S. accounted for 185 of the 306 healthcare ransomware incidents and claims tracked worldwide between July and September. Of those U.S. incidents, 26 were confirmed, including 23 involving healthcare providers.
    • Healthcare technology companies experienced the largest quarter-over-quarter increase among the healthcare business categories highlighted in the report. Comparitech identified 22 incidents and claims targeting those companies, up 175% from eight in the previous quarter. Medical manufacturers accounted for another 51 incidents and claims, a 28% increase from the second quarter.
    • “Saber Healthcare Group had the largest reported ransomware-related breach, affecting 427,084 people. The organization confirmed in July that a cyberattack had encrypted some files and disrupted services. In September, it began notifying individuals of a breach involving medical information, health insurance details and Social Security numbers. Other large breaches identified in the report involved Park Place Behavioral Healthcare, affecting 71,702 people; Hawaii Family Dental, affecting 45,853; WindRose Health Network, affecting 33,158; and Vernon & Waldrep OB-Gyn Associates, affecting 17,435.
    • “The median reported ransom demand was $300,000 for healthcare providers and $150,000 for healthcare businesses. No ransom payments were officially confirmed during the reporting period.
    • “The Gentlemen made the most claims against healthcare providers, with 18, followed by INC with 14. Qilin led claims against healthcare businesses with 15. Chaos had the most confirmed attacks in each category.”
  • The HIPAA Journal adds,
    • “The tactics of ransomware groups are constantly changing to increase pressure on victims to give in to their demands. Initially, file encryption alone was sufficient; however, as victims improved cyber resilience and were able to recover their encrypted files from backups, tactics had to evolve. Ransomware groups incorporated data theft into their attacks and started threatening to sell or leak the stolen data if the ransom was paid. This double extortion approach proved highly successful, with the threat of a data leak alone sufficient to prompt many victims to pay up.
    • “Encryption and data leak threats are no longer enough, as the percentage of victims paying ransoms continues to fall. According to a recent survey commissioned by the Identity Threat Detection and Response (ITDR) firm Semperis, the percentage of ransomware victims paying ransoms has fallen from 78% in 2024 to 69% in 2025, and 59% in 2026.
    • “Ransomware groups have responded by adopting more aggressive tactics, and a trend has emerged of ransomware groups issuing personal threats against company employees and their friends and family members. The survey revealed that 37% of ransomware attacks involved threats against friends or family members of staff members, and 41% of respondents to the survey said they had been a target of physical or psychological intimidation.
    • “While contacting individuals whose data was stolen in an attack has been adopted by several groups in the past, the threats have generally been limited to the publication of personal data, but threats are becoming more severe. Ransomware groups are now issuing threats of physical violence and are contacting employees and their friends and family members via text, email, or phone, confirming that they know where they live, work, and even where their children go to school.” * * *
    • “I’ve spoken with CISOs that had strong relationships with law enforcement,” said Courtney Guss, AVP of Crisis Management, Semperis. “They’ve found it to be a much faster route to information and resources than they would otherwise have found on their own, which can often help them recover more quickly. So, knowing those contacts and building those relationships in advance should be part of your crisis management plan.” Semperis also recommends strengthening identity resilience, preparing for identity system breaches, and practicing incident response procedures time and again against realistic scenarios, including tabletop exercises involving all team members involved in the ransomware response.”
  • BitSight offers a “DragonForce Ransomware Profile: From Affiliate Program to Cybercrime Cartel”

From the cybersecurity business and defenses front

  • The Wall Street Journal reports,
    • “Proofpoint has agreed to acquire data-security company Varonis Systems for about $6.3 billion, as artificial-intelligence security continues to drive deals and investment across the cybersecurity industry.
    • “Proofpoint will pay $49.75 a share in cash for Varonis, a 52% premium over the stock’s June 22 closing price, the final trading day before reports of a potential sale first surfaced. The transaction is expected to close in the first half of 2027, subject to approval from Varonis shareholders and regulatory bodies.
    • “The acquisition comes as cybersecurity vendors scramble to expand their AI capabilities, both to defend against threats that use the technology and to safeguard corporate systems increasingly accessed by autonomous AI tools.
    • “Varonis specializes in securing sensitive corporate data and managing access controls, while Proofpoint primarily focuses on email protection and user-level threat defense.”
  •  and
    • “Quantum-computing company IonQ IONQ struck an all-stock deal to buy Elisity in a transaction that values the cybersecurity firm at up to $1.3 billion, executives told The Wall Street Journal. 
    • It is a bet that cybersecurity will be even more critical for companies as quantum computing and AI systems become more powerful and advanced, said IonQ Chairman and Chief Executive Niccolo de Masi. 
    • “The bad guys are going to keep taking advantage of new technology,” he said in an interview. “Unfortunately, we are entering the most dangerous years, vis-à-vis cybersecurity risks.” * * *
    • “Founded in 2019, Elisity offers a platform that aims to prevent cyber attackers or ransomware from spreading across organizations. Some of its big customers include healthcare companies and hospitals.” * * *
    • “IonQ, which works closely with the U.S. Defense Department, has been on an acquisition spree to become a one-stop shop for its customers. Earlier this year, it struck its biggest deal yet, a $1.8 billion takeover of chip maker SkyWater Technology.”
  • Cybersecurity Dive relates,
    • “The open-source software community needs to understand several key lessons in order to improve its cybersecurity posture, according to IBM, which operates a clearinghouse for analyzing and disclosing open-source vulnerabilities.
    • “Finding a vulnerability is only the start,” IBM said in a report published on Thursday [October 15]. “Security teams must understand the risk, determine whether action is needed, find a usable fix, then get that fix to the software that needs it.”
    • “The new report — the first in a series collecting insights from IBM’s clearinghouse — is meant to help software maintainers and their customers, including businesses, better understand systemic risks in the open-source ecosystem.”
  • and
    • “Hackers could break into businesses by going after internet-exposed AI tools that often contain serious vulnerabilities, the internet monitoring firm Censys warned in a report published on Wednesday [October 14].
    • “The growing complexity of the AI ecosystem — in which public-facing services rely on a sprawling web of back-end products, many of them neglected by security teams — creates additional security risks, researchers said.
    • The Censys report also analyzed internet exposures of industrial control systems (ICS), finding that many of them ran traditional IT services that made them more hackable.
  • A human pentester considers when how AI pentesting stacks up against human pentesting.
    • “AI pentesting and human pentesting are different, and once you stop trying to rank them the comparison gets a lot more useful.
    • “The agents are finding serious issues in applications that human testers have already been through multiple times. They’ll read a whole codebase, work through every path in it, and write up every instance of what they find with the fix down to the line of code.
    • “And you can run one whenever you want. For what a single human engagement costs you can run four AI pentests, which means you can do deep testing on a regular basis rather than once a year.
    • “That’s a key thing that is missed by human pentesting, and often applications have undergone a lot of untested changes in between pentests.”
  • Per the Cybersecurity Hub Newsletter,
    • “Anthropic has launched OSS Scanner, a free service that uses its most capable AI models to search open-source software for security vulnerabilities, expanding its efforts to help developers identify weaknesses before attackers exploit them.
    • “The service offers participating projects periodic security scans. Its launch introduces a faster route for distributing findings to maintainers who want early access to potential vulnerabilities.
    • “The central trade-off is human review. Reports from the new service are generated and delivered without prior human triage, leaving participating projects to establish whether a reported issue is valid and warrants a fix. That could accelerate remediation for teams with sufficient expertise, but it also raises questions about how much additional assessment work maintainers can absorb.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

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

Simplicity is a virtue

From Washington, DC,

  • Radiology Business reports,
    • “A U.S. senator has introduced legislation that would slash $2 billion in imaging spending while also bolstering radiologist pay. 
    • “Sen. Roger Marshall, MD, R-Kan., recently proposed the Patients First Act of 2026 [(S. 5672)] in the upper chamber. A companion bill to a version introduced in the U.S. House in July, the legislation would tie physician reimbursement in the Medicare program to a measure of inflation. 
    • “The proposal also incorporates language from the Radiology Outpatient Ordering Transmission (ROOT) Act—which would revive the stalled imaging appropriate-use criteria program. If approved, it would require referring physicians to consult clinical decision support before ordering scans, hoping to root out unnecessary and wasteful imaging. 
    • The American College of Radiology—which supports the bill—estimates that the ROOT Act would reduce federal spending on medical imaging by about $2 billion over the next decade. In addition, it would save Medicare beneficiaries another $1.5 billion during the same timeframe. 
    • “The ROOT Act provisions would modernize implementation of Medicare’s Appropriate Use Criteria program for advanced diagnostic imaging,” ACR said in a news update touting its support for the bill on Oct. 15. “The Patients First Act also includes broader Medicare physician payment reforms, including annual payment updates tied to the Medicare Economic Index, changes to Medicare budget-neutrality policies and reforms to quality reporting requirements.”
  • The Government Accountability Office posted a report about private health insurance.
    • “Multiple companies may sell health insurance in a given market, but only a small number of these insurers will have the most enrollees, as we previously reported. Known as market concentration, this can leave enrollees with fewer choices of insurers and higher premiums because of less competition in the market.
    • “Market concentration generally increased from 2011 through 2024, with three or fewer insurers holding at least 80% market share for the individual and employer group markets in at least 36 states. However, concentration in the markets for individuals peaked in 2019 and has become slightly less concentrated since.”
  • The Wall Street Journal explains “How to Get All the Tax Benefits From Your Health-Savings Account.”
    • “An HSA can cushion the blow of medical expenses, but it’s also a tax-favored investment vehicle.” * * *
    • “In 2026, new provisions took effect that benefit individuals with ACA coverage. They enable HSAs to be paired with Bronze and Catastrophic plans, which have the highest deductibles.
    • “This change is good news for several groups. One is self-employed workers. Another is early retirees who use ACA coverage and aren’t yet eligible for Medicare. Still another is the fairly small group who opt only for the ACA’s catastrophic coverage.”

From the U.S. Office of Personnel Management front

  • Bloomberg Law reports,
    • “The Trump administration has removed a mandatory waiting period for internal federal promotions, allowing employees to rise faster through the ranks.
    • “A final rule published Friday by the Office of Personnel Management removes a requirement that new hires remain in their current jobs for a set period before becoming eligible for a promotion. Many were required to stay at a given grade for a year before moving up the pay scale, which Trump administration officials said reinforced backward priorities.
    • “To me, it’s an anti-merit principle,” OPM Director Scott Kupor said in an interview last week. “If you’re doing awesome and we hired you three months ago, and it turns out you’re performing at a level that’s the next grade level relative to where we hired you, we should not have an arbitrary thing that slows us down from promoting you.”

From the U.S. Food and Drug Administration front

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about safety concerns associated with certain delivery systems sold with the Sapien M3 transcatheter mitral valve replacement (TMVR) system from Edwards Lifesciences. The affected devices should not be used for patient care. Any delivery systems that are not part of this recall can still be used like normal.
    • “The FDA announced this early alert due to issues with the Commander M delivery system that clinicians use to implant the Sapien M3 TMVR system during a minimally invasive procedure. Edwards Lifesciences has received multiple reports of balloons bursting during inflation.
    • “Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath, which may require additional intervention, including surgery,” according to the FDA’s advisory. “Because this patient population is deemed unsuitable for surgery, these interventions carry a high risk of serious adverse health consequences including death.”
    • “One death and one serious injury have been linked to this issue so far.”
  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration approved a new nonprescription eye drop treatment, Brytly, apraclonidine ophthalmic solution, 0.125%, for relief of eye redness due to minor irritations. This is the first nonprescription eye drop with apraclonidine.
    • “Expanding access to safe and effective nonprescription treatments is a priority for FDA,” said Mike Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research (CDER). “Today’s approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a healthcare provider.”
  • The AP relates,
    • “U.S. health officials are moving ahead with a plan to allow specialty pharmacies to produce certain peptides, a class of largely unregulated injections that have become popular among followers of Health Secretary Robert F. Kennedy Jr. and other wellness influencers.
    • “Kennedy’s Department of Health and Human Services submitted a peptides “interim access policy” to the White House for review, according to a posting Thursday on a government website. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations with the potential for significant economic impact.
    • “HHS officials did not immediately respond to requests for comment Thursday afternoon.
    • “Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.”

From the Medicare Advantage front,

  • Fierce Healthcare reports,
    • “CareCycle, a voice AI company serving Medicare agencies, has launched a free tool that helps Medicare beneficiaries compare plans.
    • “The tool, Match Your Medicare, coincides with Medicare’s Open Enrollment period and is set to be available indefinitely. It is free to use, takes no payments from payers or commissions and does not sell or share personal information. 
    • Based on information provided by users, the tool surfaces yearly cost estimates, including premiums, copays and drugs. It also shows what plans in a user’s area keep their docs in-network. Users can compare up to three plans side by side.
    • “MatchYourMedicare.com requires no account and makes no sales calls. Users only need to enter a ZIP code, date of birth and gender. They can also optionally submit their doctors’ prescriptions and health conditions. Additionally, the tool features a video guide that walks users through each step and can help them fill in forms by voice as users speak.”

From the fraud, waste and abuse front

  • Beckers Hospital Review reports,
    • “A top CMS official wants provider suspensions to quadruple in the next six months as part of a broader anti-fraud push that includes new exclusion authority and AI tools, Nextgov/FCW reported Oct. 15.
    • “CMS Deputy Administrator Kimberly Brandt discussed the agency’s enforcement efforts Oct. 15 at the ADAPT conference in Santa Fe, N.M. Ms. Brandt’s slideshow credited the anti-fraud effort with $41.9 billion in fiscal year 2025 savings, up 59% from the year before.
    • “My hope is that suspension number will quadruple over the course of the next six months,” Ms. Brandt said, according to Nextgov/FCW.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • “Seasonal flu activity is increasing in many parts of the country but remains low.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated nationally.”
  • ABC News reports,
    • “More than 4,400 measles cases have been reported in the U.S., according to an update on Friday from the Centers for Disease Control and Prevention (CDC).
    • “A total of 4,410 cases have been confirmed, with most reported by 45 states and Washington, D.C. Eighteen of this year’s total have been among international visitors to the U.S., according to the CDC.
    • “At least 1,200 of those cases have been reported in Pennsylvania alone by local health officials, as have six measles-related deaths.
    • “It comes as the CDC is planning to send a “disease detective” to Pennsylvania in response to the outbreak.” 
  • STAT News adds,
    • “About 40% of high school students reported binge eating in the past month in a large new government survey, putting a spotlight on how widespread this common form of disordered eating is among young people in the U.S. 
    • “This is the first time the biennial survey, conducted by the Centers for Disease Control and Prevention, has asked about binge eating, and the first data on disordered eating collected by the Youth Risk Behavior Survey in a decade. Among its other striking findings: 17% of nearly 7,000 students said they had engaged in binge eating within the last three days.  “It was extremely alarming seeing how high those numbers were,” said Ariel Beccia, a researcher in the adolescent and children’s medicine division of Boston Children’s Hospital.
    • “Binge eating was more prevalent among female than male students (19% versus 16%). It was also more common among Black (19%), Hispanic (20%), and multiracial (20%) students compared to white (15%) and Middle Eastern or North African students (10%).
    • “The finding that young people of color are largely more likely to report binge eating is important because it counters longstanding stereotypes that eating disorders and disordered eating primarily affect white girls and young women, said Beccia.”  
  • USA Today relates,
    • “Research has shown ultra-processed foods may be the culprit behind rising colon cancer rates − but a new study suggests the type makes a difference.
    • “In the study, published in the journal PLOS Medicine on Oct. 15, researchers found no association between overall ultra-processed food intake and colorectal cancer incidence. Findings differed, however, by type of food.
    • “Higher intake of whole grain and dairy products from ultra-processed food sources was associated with lower colorectal cancer incidence, whereas processed meat from ultra-processed food sources was associated with higher risk, according to the study.
    • “Our findings support current dietary guidance to consume whole grains, fiber, dairy and calcium and avoid processed meat for (colorectal cancer) prevention,” the authors wrote.”
  • Healio adds,
    • “Lower ultra-processed food consumption was associated with reductions in anxiety and depression. 
    • “The crossover pilot trial showed the intervention was feasible and can be expanded in future clinical trials.” 
  • The New York Times tells us,
    • “Doctors are growing increasingly concerned that weight-loss drugs are driving new cases of anorexia, and that few safeguards are in place to protect patients with eating disorders.
    • “Tens of millions of patients now take these medications, which can sometimes cause symptoms that mirror the effects of anorexia: hair loss, dizziness, gastrointestinal issues, extreme calorie deficits.
    • “At that point, it’s like, is that anorexia? Is that disordered eating? Or is that just a side effect of the medication?” said Dr. Katherine Kiley, a family and sports medicine physician in Long Beach, Calif.
    • “Citing an “urgent need” for guidance, an international coalition of obesity medicine specialists, eating disorder clinicians and other experts released new recommendations last month on GLP-1 prescribing and eating disorders. Among their ideas for physicians: Screen all patients for signs of eating disorders before starting a GLP-1, and routinely monitor anyone on the drugs for them.” * * *
    • “Further complicating matters is that many people get the drugs through telehealth services, with little to no oversight from a physician. In a recent study, researchers who tried purchasing weight-loss drugs from 49 websites found that only about one-third required direct interaction with a clinician before prescribing the medications, and only around half asked about eating disorders.”
  • MedScape informs us,
    • “Patients with non-erosive reflux disease (NERD) who took once-daily tegoprazan — a novel, fast-acting, oral potassium-competitive acid blocker (P-CAB) — had a significant reduction in heartburn frequency, a phase III trial showed.
    • “Among patients randomized to placebo or tegoprazan 50 mg or 100 mg, mean percentages of 24‑hour heartburn‑free days through week 4 were 17.3%, 26.2%, and 30.1%, respectively, translating into relative improvements of 51% (P=0.0006) and 74% (P<0.0001) with tegoprazan over placebo, reported Ronnie Fass, MD, of Case Western Reserve University School of Medicine in Cleveland.
    • “Key secondary endpoints of percentages of days without daytime and nighttime heartburn were also significantly improved with tegoprazan, he said at the American College of Gastroenterologyopens in a new tab or window annual meeting in Nashville, Tennessee.”

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

  • Healthcare Dive reports,
    • “The time to start planning for your company’s 2028 health benefits? January of 2027.
    • “That’s according to Marybeth Gray, senior VP of health and welfare benefits consulting with Marsh McLennan Agency. Speaking to a crowd of finance leaders at the CFO Leadership Council’s fall conference in Colorado this week, Gray urged attendees to start thinking about health benefits as soon as feasibly possible.
    • “What might have long been considered strictly an HR issue, Gray said, has firmly become a finance issue.
    • “We need to get on solid footing,” she said, citing data from the Business Group on Health showing that healthcare costs have ticked up as much as 76% over the last decade.”
  • Fierce Pharma relates,
    • “The previous week was rather uneventful for the two oral GLP-1 drugs as Americans geared up for another national holiday, Columbus Day.
    • “Total prescriptions for Novo’s Wegovy pill dipped about 3% sequentially to approximately 173.5K last week. Again, the script number was the result of a compromise between Citi’s reported 173K and Jefferies’ 174K, both referencing IQVIA.
    • “Meanwhile, Lilly’s Foundayo scripts ticked up about 4% to 60,151, still shy of the small molecule’s previous record of 64,268.
    • “In the broader obesity market, Lilly’s Zepbound remained the leader with about 801.8K total scripts, relatively flat week over week. All Wegovy scripts across its injectable and oral forms trended 2.5% downward and landed at about 492.6K, according to Citi.”
  • Beckers Clinical Leadership tells us,
    • “Academic health systems are opening their own longevity medicine programs amid growing demand for preventive care, The New York Times reported Oct. 16.
    • “Since last fall, Los Angeles-based Cedars-Sinai, Chicago-based Northwestern Medicine and New York City-based Weill Cornell Medicine have launched programs aimed at extending health span, or the years a person lives without chronic disease or disability. New York City-based Mount Sinai Health System also expects to open its program this month.
    • “The academic systems’ research entities are playing important roles in shaping these programs. For example, Northwestern’s clinic draws partly on the university’s Potocsnak Longevity Institute, which is studying biomarkers of aging. 
    • “The systems are betting that their research ties will set them apart from the hundreds of private U.S. longevity clinics. Some of those clinics charge thousands to tens of thousands of dollars a year, and many offer screenings and therapies that are not yet proven effective.
    • “The field is still developing, and health systems are drawing different lines on clinical evidence. Northwestern does not offer whole-body MRI, citing a lack of evidence that it lengthens life span, nor does it offer genome sequencing. Meanwhile, Mount Sinai will offer both after patients review the risks and benefits with their physician.”
  • Radiology Business informs us,
    • “Breast imaging startup BeSound is launching its flagship clinic location with plans to eventually scale nationally. 
    • “The company officially opened its newest imaging center in Manhattan on Thursday. Founded in 2023, BeSound offers scanner technology that combines ultrasound with FDA-approved, near-infrared photo-acoustic imaging. It’s focused on targeting the more than 40% of women with dense breasts, whose cancer cases may be missed by traditional mammography.
    • “BeSound is now accepting appointments at its Flatiron District location, with no referral required. The company charges $349 per exam and promises screening results in 48 hours, with pain-free imaging that avoid compression, radiation and contrast dye. 
    • “BeSound said its scans also use proprietary artificial intelligence “designed to help physicians read scans faster, surface findings earlier, and track how a woman’s breast tissue changes over time.”
  • MedTech Dive points out,
    • “MiniMed completed its separation from Medtronic, the companies said Thursday.
    • “The diabetes technology firm, which went public in March, is now independent from its former parent. 
    • “Medtronic began an exchange offer last month to split off a portion of its MiniMed shares. The agreement included a provision where Medtronic could choose to sell all of its remaining shares in MiniMed if the offer is oversubscribed.
    • “Because the offer was 5.4x subscribed, Medtronic chose to exchange all of its remaining interest in MiniMed for shares of Medtronic, the company said Thursday. It no longer holds a stake in MiniMed.”
    • “As an independent company, we have the freedom to make the decisions we believe are right for our business and the people we serve, and the responsibility to see those decisions through,” MiniMed CEO Que Dallara said in a statement. “Our focus now is to put that independence to work and continue advancing what is possible in diabetes care.” 
       
  • Beckers Health IT lets us know about Anthropic’s eight big healthcare moves.

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • “The Department of Justice has a warning for health care executives: Don’t be another Theranos. 
    • “As the Trump administration continues its fight against Medicare and Medicaid fraud, it is also expanding its investigations into corporate wrongdoing, DOJ officials announced this month.”
    • “A key part of that plan is making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing, Jacob Foster, deputy assistant attorney general in the National Fraud Enforcement division, said Thursday at the STAT Summit in Boston. Foster oversees the unit that investigates health care fraud.” * * *
    • “Going forward, companies in the health care sector looking to file voluntary self-disclosures will find a one-stop shop at the DOJ, Foster said. They previously would’ve had to navigate a separate process at the Department of Health and Human Services, but that is now being consolidated under the health care fraud section at the DOJ. 
    • “Under the new policy, companies that report potential criminal misconduct can reap the benefits — such as a limited cap on financial damages — from both agencies at once. 
    • :The health care fraud section at the DOJ brings a range of expertise under one roof to handle issues like the emerging field of digital health technology, Foster said. DOJ will make use of data analytics and artificial intelligence algorithms to try and suss out instances of corporate wrongdoing, like providers billing for unneeded services, companies fabricating patient records, or health tech companies adding redundant diagnoses. 
    • “The department will also design new programs that “appropriately incentivize” whistleblowers to report fraud, according to an Oct. 1 memo from Assistant Attorney General Colin M. McDonald. Health care investigators also look at social media, news reports, and other sources of information to learn about companies possibly breaking the law, Foster said.” 
       
  • This new Justice Department policy “making it easier for companies themselves to report potential criminal activity, and encouraging whistleblowing” is available here.
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention issued a reminder Oct. 14 that the declaration supporting the emergency use of COVID-19 in vitro diagnostics tests will end Dec. 26. The December end date marks the end of a 180-day transition period from the end of the COVID-19 emergency use authorization declarations announced June 30. The EUA declarations were issued in 2020 to accelerate access to medical products during the COVID-19 pandemic.”

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

  • Federal News Network reports,
    • “The Office of Personnel Management and the White House Task Force to Eliminate Fraud are partnering to hire the next cohort of the US Tech Force. The two-year program will place applicants across agencies, including the General Services Administration, the Social Security Administration, the Office of Personnel Management, the Department of Health and Human Services, the State and Treasury departments. Vice President JD Vance says the partnership will help the government identify fraud, waste and abuse and reduce reliance on foreign technological advancements. Tech Force positions are open to the public and federal employees through career transition and reinstatement programs. The job announcement closes October 23.”
  • FedSmith offers an approach that allows federal and postal employees and annuitants to compare health coverage without getting overwhelmed.
  • Tammy Flanagan, writing in Govexec, explains that “Federal retirees face more than a COLA change in 2027.”
    • “From Medicare premiums and Social Security earnings limits to a federal pay freeze, several changes could affect retirees’ finances and the benefits available to them next year.”

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

  • The AP reports,
    • “For the first time in more than a quarter-century, Americans have a new option when shopping for sunscreen: a skin-protecting chemical that’s long been a go-to option in Europe and other parts of the world.
    • “The U.S. Food and Drug Administration approved bemotrizinol — sometimes called BEMT — in June. The first sunscreens containing it are now hitting U.S. store shelves, including formulas from Neutrogena and other manufacturers.
    • “Dermatologists say the chemical fills an important market gap by offering broad protection, like the most well-established sunscreen ingredients, but without their cosmetic downsides, including white streaking.”
  • Fierce Pharma tells us,
    • “U.S.-based generic drugmaker Par Health has issued a voluntary recall of 22 lots of the direct thrombin inhibitor argatroban for IV injection that could be contaminated with cellulose, polystyrene, polyethylene terephthalate, stopper material, and potentially even stainless steel.
    • “The recall, which was published to the FDA’s website on Oct. 14th, is Par’s third in a matter of weeks.”
  • Targeted Oncology relates,
    • “The FDA will review FYB206, an investigational biosimilar candidate referencing pembrolizumab (Keytruda), after accepting its biologics license application (BLA), marking the first publicly announced acceptance of a filing for a pembrolizumab biosimilar, according to a news release from Zydus Lifesciences and Formycon.1
    • “The application was sent to the FDA in the third quarter of 2026. The Biosimilar User Fee Amendments (BsUFA) set a 12-month goal from submission to completed review, made up of a filing review lasting as long as 60 days followed by a 10-month substantive review. On that schedule, a regulatory decision could come in the third quarter of 2027, and a regulatory dossier has also been filed with Health Canada, according to the companies.”

From the Medicare Advantage front,

  • Beckers Hospital Review reports,
    • “Kaiser Permanente led the 2027 U.S. News & World Report ratings for the “best overall” Medicare Advantage companies.
    • “The ratings, published Oct. 14, are based on a five-point scale, assigning weights to more than 30 CMS quality measures. After calculating contract ratings, U.S. News determined enrollment-adjusted average ratings for carriers. U.S. News considered MA companies among the “best” if they had an overall rating of at least 3.8 once rounded and served at least 1,000 beneficiaries in December 2025 in each of 10 or more states or territories where they still offer 2027 coverage.
    • “These ratings looked at standalone MA contracts, as well as ones that also cover Part D. For the publication’s Medicare Part D ratings, the same two companies secured the “best overall” recognition in 2026 and 2027. In 2027, Humana scored 3.8, and Centene scored 3.5. To qualify as a top Part D company, insurers needed to have served at least 1,000 Part D beneficiaries in each of at least 10 jurisdictions where they still offer coverage for 2027. The threshold was an enrollment-weighted average rating of at least 3.5 after rounding.”

From the Affordable Care Act marketplace front,

  • Beckers Payer Issues relates,
    • “CMS has reinstated a small number of enrollees who lost coverage after the agency canceled ACA policies for more than 760,000 people, according to a KFF Health News report published Oct. 15 in NPR.
    • “KFF Health News learned of the reinstatements through insurance industry sources, finding that not all of those who lost coverage were fraudulently enrolled. 
    • “On Aug. 31, CMS canceled 315,000 policies for 2026 that covered more than 760,000 individuals. These enrollees signed up with agent or broker assistance but lacked citizenship or immigration documentation, and issuers were unable to find claims or did not have records of contact, according to a September rulemaking document. CMS told Becker’s on Oct. 15 that another criterion was whether premiums were fully covered by advance payments of the premium tax credit. CMS expected that these cuts would lead to a return of roughly $2.2 billion in subsidies.”

No Surprises Act News

  • Beckers Payer Issues relates,
    • “Arbitration awards under the No Surprises Act can reach nearly 6% of total commercial medical spend in some regions, UnitedHealthcare CEO Tim Noel said during an Oct. 13 earnings call. 
    • “The medical cost trend for UnitedHealthcare’s commercial business is “exceeding” an initial expectation of 11%, Mr. Noel said. While Mr. Noel pointed to clinician cost intensity and expensive specialty drugs as part of that, he also said there has been “an acceleration of costs related to the No Surprises Act.” He cited “ongoing abuse” driven by “a relatively small number of clinician groups and third-party organizations.”
    • “Mr. Noel said this translates to billions of dollars in additional costs that hit consumers and employers.” 

From the judicial front,

  • Per a Justice Department news release,
    • “A Kansas CEO and owner of an internet platform was sentenced yesterday to 19 years in prison for his role in operating a platform that generated false doctors’ orders and prescriptions to defraud Medicare and other federal health care benefit programs out of more than $1 billion.
    • “The Department of Justice and our agency partners dismantled one of the largest telemedicine fraud schemes ever, and yesterday’s lengthy prison sentence holds the orchestrator of that scheme accountable,” said Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division. “The defendant’s fraud scheme lured hundreds of thousands of elderly and disabled Americans into a sophisticated international telemarketing system with one goal: stealing as much as possible from the Medicare trust fund. The Fraud Division will continue to leverage its resources to take down complex fraud operations like Blackman’s DMERx.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Pediatric infectious disease specialists in Pennsylvania, home to the nation’s largest measles outbreak in more than three decades, are treating an influx of children with severe complications from a virus many physicians have little experience with, NBC News reported Oct. 14.
    • “Patrick Gavigan, MD, a pediatric infectious disease physician at Penn State Health Golisano Children’s Hospital in Hershey, said he expected measles to behave like COVID-19 in children, mainly manifesting as respiratory illness and hitting those with underlying conditions hardest. Instead, the virus is causing serious complications beyond the lungs in many previously healthy children, including in the gut, liver and brain, according to the report.
    • For example, some children are developing encephalitis, or brain inflammation, in response to the virus, according to Dr. Gavigan.
    • “They go from walking and talking one day to the next having significant neurologic dysfunction,” he told NBC News. Dr. Gavigan added that these patients recover slowly and often aren’t back to normal by the time they leave the hospital.”
  • and
    • “New dementia cases worldwide are projected to more than double by 2050, from an estimated 11.4 million in 2023 to 24.7 million, according to a meta-analysis published Oct. 12 in JAMA Neurology.
    • “Researchers led by the University of New South Wales in Sydney analyzed participant-level data from 22 population-based cohorts. The cohorts included 38,418 adults aged 60 and older without dementia at baseline, across 18 countries and territories on six continents. Approximately 3,001 participants developed dementia as of 2021. 
    • “The projection assumes age- and sex-specific dementia rates stay constant. That means the growth reflects an aging global population, not an increase in individual risk.”
  • MedScape relates,
    • “The combination of a low-calorie diet with a supervised exercise regimen induced nonpharmacologic remission of early-onset type 2 diabetes (T2D) in more than half of participants in a new study, with low drop-out rates and preservation of lean mass.
    • “The take-home message is that in early-onset type 2 diabetes, people should ideally have a potent nondrug option to tackle [the disease],” first author Kaberi Dasgupta, MD, a professor of medicine and director of the Division of General Internal Medicine at McGill University in Montréal, Quebec, Canada, told Medscape Medical News.
    • “In addition to inducing diabetes remission, the diet/supervised exercise intervention “shifts weight loss where we want it to be — from the fat compartment — and also increased muscle health, strength, and fitness, improving mood, lowering distress related to diabetes, and enhancing quality of life,” she said.”
  • MedPage Today tells us,
    • “Continuous glucose monitors (CGMs) are recommended for patients with type 1 diabetes and insulin-treated type 2 diabetes, but evidence has been limited in those with non-insulin-treated type 2 diabetes.
    • “Compared with routine care, adults with non-insulin-treated type 2 diabetes using CGMs had a significantly lower HbA1c level and more time spent in the target glucose range in a 26-week trial.
    • “Adherence to the device was high, and no cases of severe hypoglycemia or hyperglycemia-related serious adverse events were observed.”
  • The Washington Post informs us,
    • “About 12 percent of new cancer cases worldwide in 2024 were caused by infectious agents such as viruses and bacteria, according to a recent study by the International Agency for Research on Cancer.
    • “That means a sizable share of the cancer burden around the world is preventable with tools we already have, including vaccines and other preventative measures, researchers said.
    • “We have very actionable targets,” said Gary Clifford, a cancer epidemiologist and one of the authors of the study that published in the Lancet Oncology. “We have very many tools against these viruses already.” * * *
    • “Existing measures like condoms, vaccines for HPV and cervical cancer screening can prevent infection and cancers associated with infectious diseases, experts said.”
  • and
    • “A woman’s ovaries bring center-stage energy for decades of her life: governing fertility and interacting with organs from the brain to the heart, from the skeleton to the immune system. Because of that, they have attracted scads of scientific research.
    • “But after menopause, around age 50, the spotlight on the ovary has historically gone dark. A study published Wednesday in the journal Aging Cell shows that an ovary continues to play an important role even in its retirement years, with functions that do not diminish and may still affect the rest of the body.
    • “Above all, the study underscores why the postmenopausal ovary is worthy of attention.
    • “Women are living three [more] decades with this organ in their body, and we have no idea what it’s doing,” Francesca Duncan, an associate professor of obstetrics and gynecology at Northwestern University said. “We really owe it to half our population to understand what’s happening.”
  • Contemporary OB/GYN adds,
    • “The American College of Obstetricians and Gynecologists (ACOG) has issued its most comprehensive guidance to date on managing menopause, with a new clinical practice guideline covering menopausal hormone therapy (MHT), nonhormonal medications, and nonpharmacologic treatment of vasomotor symptoms (VMS), sleep disturbance, and mood symptoms. Clinical Practice Guideline No. 13, published online October 15, 2026, in Obstetrics & Gynecology, replaces Practice Bulletin No. 141 from January 2014.
    • “According to the guidance, 50% to 92% of women in menopause report VMS, 16% to 66% of women in the United States report menopause-related sleep disruption, and more than one-third of perimenopausal and postmenopausal women worldwide report depressive symptoms. ACOG is also developing companion guidance on genitourinary syndrome of menopause, expected in 2027.” * * *
    • “View the complete and full guidance via Obstetrics & Gynecology, here.”
      .
  • Beckers Hospital Review notes,
    • “An Oct. 13 analysis from the Health Transformation Alliance examined linked claims and EHR data for 12.7 million patients from 2018 through 2025 to identify who is most and least likely to respond to GLP-1 therapy.”
  • Beckers Behavioral Health points out,
    • “Adults with schizophrenia and Type 2 diabetes who started a glucagon-like peptide-1 receptor agonist were less likely to be hospitalized or seen in the emergency department for psychiatric reasons than peers who started a dipeptidyl peptidase-4 inhibitor, a sodium-glucose cotransporter-2 inhibitor or none of the three drug classes, according to a study published in The Lancet Psychiatry.
    • “The results point to a possible psychiatric upside to GLP-1 therapy beyond blood sugar and weight control, though the study’s observational design means it cannot show the drugs caused the lower risk.”
  • and
    • “The rate of opioid use disorder diagnoses among commercially insured patients rose 32.7% nationwide between 2022 and 2025, FAIR Health found in its latest analysis of commercial health claims.
    • “The national rate reached 596 patients with an opioid use disorder diagnosis per 100,000 commercially insured patients receiving medical services in 2025, up from 449 in 2022. The findings were published as part of FAIR Health’s annual Opioid Tracker update, according to an Oct. 14 news release from the organization.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of two new treatments: nomlabofusp (Larimar Therapeutics, Inc.) and omaveloxolone (Skyclarys®, Biogen Inc.) for Friedreich’s Ataxia, a rare, genetic disorder. 
    • “Downloads: Draft Evidence Report | Draft Voting Questions
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

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

  • The Wall Street Journal reports,
    • “Pharmaceutical companies are investing billions of dollars into protein degraders, a new class of drugs designed to target disease-driving proteins.
    • “These drugs work by using a cell’s recycling system to destroy smooth proteins that traditional medicines can’t easily latch on to.
    • “While the FDA has approved a handful of these drugs, scientists are still working to ensure they don’t accidentally destroy healthy proteins.”
  • and
    • “AstraZeneca is partnering with Insitro to use artificial intelligence to find new treatments for cardiometabolic diseases.
    • “AstraZeneca will pay Insitro $40 million upfront and up to $1.46 billion if development and commercial targets are met.
    • “Insitro will use its AI platform to identify disease causes, while AstraZeneca will lead clinical development and commercialization.”
  • Beckers Health IT relates,
    • “Epic is working with Amazon Pharmacy, Mark Cuban Cost Plus Drugs and other pharmacy companies to develop a tool that will allow clinicians and patients to compare prescription drug prices directly within its EHR system.
    • “The new feature, called Prescription Marketplace, will allow clinicians and patients at health systems using Epic to compare medication prices across pharmacies before a prescription is sent, according to an Oct. 15 news release from the EHR vendor.
    • “The tool will display pharmacies’ cash prices alongside what patients would pay through their insurance plans, allowing them to determine whether paying cash could be less expensive.
    • “Amazon Pharmacy has worked with Epic since early 2025 to help develop the feature. Mark Cuban Cost Plus Drugs is also working with the company on its development, and executives from Costco and Eli Lilly’s LillyDirect voiced support for the tool in the release.”
  • Cardiovascular Business informs us,
    • “U.S. healthcare payment policies are accelerating physician consolidation and driving up the cost of care, according to Rick Snyder, MD, president of HeartPlace and chief physician executive at U.S. Heart and Vascular. He is also the vice president of the American Independent Medical Practice Association (AIMPA) and a former president of the Texas Medical Association. In addition, Snyder has held policy-focused positions with the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.
    • “In his role with AIMPA, he testified before Congress during this year’s House Energy and Commerce Committee hearings focused on healthcare affordability. He argued that the nation’s healthcare system spends more than any other country of healthcare, but has lower life expectance and poorer outcomes than other Western nations. According to Snyder, this is not due to a lack of spending, but a lack of cost efficiency.” 
  • MedTech Dive points out,
    • “Labcorp has agreed to buy certain laboratory testing businesses from Opko Health subsidiary BioReference Health for $722 million, plus an additional sum of up to $150 million tied to revenue from a prostate cancer blood test. The final purchase price could be adjusted based on closing revenues, the companies said Thursday.
    • “Labcorp is acquiring businesses focused on clinical and women’s health testing services, urology and diagnostic services provided to correctional institutions. The deal also adds more than 80 patient service centers to Labcorp’s network.
    • “In addition, the lab services provider is gaining BioReference Health’s 4Kscore test, which has Food and Drug Administration approval to help predict the likelihood of finding aggressive prostate cancer before a biopsy decision.”
  • and
    • “Zimmer Biomet said Tuesday it has inked a multi-year extension to its exclusive distribution agreement with Think Surgical.
    • “The deal, which extends an agreement signed in 2024, positions Zimmer to continue distributing an exclusive version of Think’s TMINI wireless handheld miniature robotic system. 
    • “Zimmer’s exclusive version of TMINI is compatible with its Persona knee system, a personalized product used in total knee replacements.”
  • Per Fierce Healthcare,
    • “The Elevance Health Foundation has launched a new prize program aimed at supporting solutions aimed at improving patient safety, with the first crop of winners targeting challenges like health literacy, fall prevention and medication errors.
    • “Elevance will dispense $4 million in prizes to four organizations through the first round of the program. The goal is to identify scalable, community-based solutions to tackle critical patient safety risks. The Patient Safety Prize falls under the foundation’s Community Action Leadership umbrella, and the team saw an opportunity to move beyond its core focus areas with these programs.
    • “The winners include: Care Synergy’s CAPABLE, or Community Aging in Place—Advancing Better Living for Elders, program; NYU Grossman School of Medicine; the Public Health Institute’s Population Health Innovation Lab; and the Parkland Center for Clinical Evaluation.”
  • Per Beckers Health IT,
    • “OpenEvidence drew 271 million queries from 952,008 U.S. clinicians between January 2024 and June 2026, according to a study published Oct. 15 in JAMA.
    • “Researchers from Somerville, Mass.-based Mass General Brigham and Boston-based Harvard Medical School analyzed query logs from OpenEvidence users with verified National Provider Identifiers. Vishal Patel, MD, and Samuel Finlayson, MD, PhD, contributed equally as lead authors, and Anupam Jena, MD, PhD, oversaw the study.
    • “Dr. Finlayson and two other co-authors, including OpenEvidence’s chief medical officer, were OpenEvidence employees during the study. The company provided the data and contributed to the analysis.
    • “Monthly active users grew from 355 in January 2024 to 703,265 in June 2026. Average monthly queries per active user rose from 18 to 39.5, and month-over-month retention climbed from about 70% to 90%.
    • “Physicians accounted for 556,200 users. Nurse practitioners and physician assistants used the platform most intensively, at 44.5 queries per active user-month, compared with 37.1 for physicians. Physicians within a decade of medical school graduation made up 24.3% of the physician workforce but submitted 61.8% of physician queries.”

Midweek report

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

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • “The Trump administration is delaying by 90 days a federal rule that could prevent Americans from obtaining prescription drugs from licensed international pharmacies.
    • “The move follows growing criticism that the rule, which was initially slated to go into effect on Oct. 22, could drastically reduce the flow of medicines from Canada and other countries. In recent weeks, patient advocacy groups and dozens of congressional lawmakers urged the administration to rethink its approach.” * * *
    • “This gives the FDA time to work with CBP to ensure a pathway for patients to continue importing more affordable prescription drugs for personal use when the rule is implement, based on identifiable safety criteria,” said Gabriel Levitt, who heads Prescription Justice, an advocacy group. “That’s what members of Congress have called for and that’s what the law says FDA should do.”
  • Per Department of Health and Human Services news releases,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. yesterday determined that public health emergencies exist in Florida and Alabama as a result of Hurricane Isaias. The determinations follow President Trump’s October 9 emergency declarations for both states (Florida, Alabama).
    • “The President’s declarations and the Secretary’s determination allow HHS to authorize temporary waivers and modifications of certain requirements. These flexibilities help the Centers for Medicare & Medicaid Services (CMS) support healthcare providers and suppliers serving people enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) in the covered emergency areas.” * * *
    • “Prior to landfall, ASPR pre-positioned regional staff in areas at risk from the storm to monitor the impacts on public health and healthcare systems and provide technical assistance in anticipation of state requests. Healthcare System Assessment Teams also deployed to evaluate the storm’s impact on healthcare facilities.
    • “In addition, ASPR shared HHS emPOWER datasets with states in the storm’s path. These data can help responders identify, by geographic area, the number of Medicare beneficiaries relying on electricity-dependent medical equipment or certain essential healthcare services, including facility-based dialysis and home healthcare.”
    • In declaring the public health emergency and authorizing flexibilities for CMS providers, suppliers, and beneficiaries, Secretary Kennedy acted within his authority under the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to October 6, 2026, in the state of Florida and October 7, 2026, in the state of Alabama.
  • and
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., joined by Health Resources and Services Administration (HRSA) Administrator Tom Engels, today launched the HHS Health Center Healthy Lifestyle Commitment, a voluntary initiative that encourages health centers nationwide to put nutrition, prevention, and healthy living at the center of patient care.
    • “Secretary Kennedy announced the initiative during a visit to Piedmont Access to Health Services (PATHS) health center in Chatham, Virginia, where he highlighted the role health centers play in preventing chronic disease and helping patients build healthier lives.”
  • PBS News tells us,
    • “Social Security checks will increase by roughly $76 per month for the average retired worker in 2027, the federal government announced Wednesday.
    • “The payment jump is due to the Social Security Administration’s annual COLA, or cost-of-living adjustment, which has been determined each fall for decades. Next year’s increase is 3.6%, based on inflation data, amounting to a little more than $900 next year.”
  • Govexec adds,
    • Because “[t]he Social Security Administration announced Wednesday that Social Security beneficiaries will receive a 3.6% cost-of-living adjustment next year, Federal retirees in the Civil Service Retirement System will therefore receive a 3.6% increase to their annuities next year, but former feds who are part of the Federal Employees Retirement System, launched in the 1980s alongside 401(k)-style Thrift Savings Plan, will see only a 2.6% adjustment.
    • “That’s because FERS’ annual cost-of-living adjustment is based on an extrapolation of the CSRS and Social Security increase. Each year, if CSRS sees an increase of less than 2%, FERS retirees receives the full COLA. But if the figure falls between 2% and 3%, FERS participants receive only a 2% increase, while if the COLA is 3% or more, like this year, FERS enrollees receive that adjustment, minus 1 percentage point.”

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

  • OPM posted in the Federal Register a direct final rule amending OPM’s Family and Medical Leave Act (FMLA) regulations in subpart L of part 630 of title 5, Code of Federal Regulations (CFR) to reflect statutory changes enacted in January 2021 and December 2023.
  • Per a U.S. Office of Personnel Management news release.
    • “U.S. Office of Personnel Management (OPM) Director Scott Kupor, Vice Chair of the Super Intelligence Task Force, joined Kayleigh McEnany on Fox News’ Saturday in America to discuss the task force’s work, the importance of U.S. leadership in SI, and the responsibility of technology companies to develop and release safe products.”
  • Govexec reports,
    • “The federal government’s human resources agency is revamping one of the most heavily trafficked tools on its website: annual pay tables for federal employees. 
    • “The Office of Personnel Management is planning to launch a new version of the online tables that agencies and employees use to look up federal pay rates each year.
    • “Adam Starr, the agency’s chief information officer, said on Wednesday that the agency’s pay rates website gets about 14 million visits each year, but hasn’t changed much since 2011. 
    • “I always like to remember that ‘OPM’ really stands for ‘other peoples’ money.’ And in this case, it is your money. People come to OPM pay tables, asking us to show them the money, and for years these have been legacy, clunky sites,” Starr said Wednesday at the SAP Public Sector Summit sponsored by GovExec. “It’s not the experience that a federal employee deserves.” 
    • “Starr said the revamped OPM pay tables will launch “later this calendar year,” in the first quarter of fiscal 2027.” 
  • A FedWeek article provides “a detailed explanation by OPM of changes in coverage terms for the 2027 plan year in the FEHB and PSHB programs, ahead of the open season that will run November 9 – December 14 (brochures with specifics by plan are to be released in early November).
    • FEHBlog observation: Historically the FEHB and PSHB plan carriers have posted their brochure on their websites before OPM does in early November.

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

  • Fox Business reports,
    • “More than 112,000 bottles of Amazon-branded extra-strength acetaminophen are being recalled after consumers reported discolored pills, according to the Food and Drug Administration (FDA).
    • “Aurobindo Pharma USA, a New Jersey-based pharmaceutical company, initiated the voluntary recall on Sept. 18, affecting three bottle sizes of Amazon Extra Strength Acetaminophen 500 mg caplets.
    • “The recall remains ongoing, according to the FDA.”
  • Cardiovascular Business adds,
    • “This voluntary recall includes 22 different lots of Argatroban Injection, a direct thrombin inhibitor used for prophylaxis or to treat blood clots in adult patients with heparin-induced thrombocytopenia (HIT). It can also work as an anticoagulant in adult patients with or at risk of HIT who are undergoing percutaneous coronary intervention (PCI) procedures. 
    • “According to new details shared by the U.S. Food and Drug Administration (FDA), the particulate matter in question has been identified as cellulose, polystyrene, polyethylene, terephthalate and stopper material. Some of it may also be stainless steel. The Argatroban Injection being recalled is delivered to a patient intravenously. If patients were treated with the contaminated drug, they would face a risk “life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels and/or inflammation of the wall of veins, which may lead to clotting.
    • “Par Health did emphasize that there have been no reports of adverse events related to this issue. 
    • “The drugs included in this recall were distributed by Par Pharmaceutical or Endo USA from December to May 2026. The lots are all set to expire as early as October 2026 and as late as September 2027.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to include adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG treatment. Anktiva is the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease. 
    • “The approval marks a new FDA approach to evaluating treatments for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The agency based its decision on evidence supporting an earlier approval of Anktiva for adults with another form of NMIBC, carcinoma in situ (CIS), with or without papillary tumors, and scientific similarities between CIS and high-grade papillary-only disease.
    • “We listen to patients, clinicians, and researchers, and we act when the science supports a new approach,” said R. Angelo de Claro, M.D., Director of the FDA’s Oncology Center of Excellence. “For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone. This approach may also help guide the development of future treatments.”
  • Beckers Behavioral Health points out,
    • “The FDA has taken a string of actions in recent months that could reshape how substance use disorders, ADHD and other behavioral health conditions are treated in the years ahead. 
    • “From clearing a novel alcohol use disorder drug for trials to approaching the first new ADHD medication class in decades and backing psychedelic research under a White House directive, the agency’s recent moves point to accelerating momentum in behavioral health drug development.” 
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases. As outlined in a new white paper, the Initiative will develop an optimized, fit-for-purpose framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type and the evidence that can be realistically generated in small patient populations.
    • “To solicit feedback on the Rare Disease Framework Initiative from patients and disease advocates, industry, and others, the FDA will host an October 28 meeting at the FDA’s White Oak campus. The meeting will be facilitated by the Reagan-Udall Foundation for the FDA.”

No Surprises Act News

  • CMS announced
    • “Beginning November 13, 2026, organizations with IDR Gateway accounts can submit “Notice of IDR Initiation,” “Notice of IDR Initiation Response,” “Notice of Certified IDR Entity Selection,” and “Notice of Offer” web forms in the Independent Dispute Resolution (IDR) Gateway.
    • “IDR Gateway users can also view reports and access dispute records for disputes started within the IDR Gateway, as well as disputes started outside the IDR Gateway that were successfully mapped to an organization using the dispute mapping process.”

From the Medicare Advantage front,

  • The New York Times discusses CMS’s upgraded Medicare Plan Finder website.
    • “For the first time, beneficiaries and those who help them can type in the name of any licensed health care provider — not just doctors, which was the case last year — and find which Advantage plans they accept.”

From the Affordable Care Act marketplace front,

  • Modern Healthcare reports,
    • “A new draft regulation would tighten access to health insurance exchange subsidies as federal agencies continue implementing President Donald Trump’s tax law.
    • “The IRS issued a proposed rule Wednesday that would set stricter definitions of who qualifies for tax credit subsidies, toughen eligibility verification requirements and narrow access to financial assistance for noncitizens.
    • “This regulation would complement pending rules from the Health and Human Services Department and the Centers for Medicare and Medicaid Services.
    • “The IRS and the Treasury Department characterized the policies as part of broader Trump administration efforts to reduce fraudulent activity on the exchanges, such as removing enrollees from the rolls and freezing broker enrollment.
    • “The proposed rules protect eligible taxpayers while strengthening the integrity of the premium tax credit,” IRS CEO Frank Bisignano said in a news release. “The enhanced verification measures are designed to curb improper claims, ensuring these vital tax benefits go strictly to the hardworking Americans who qualify for them.”
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $1.5 billion over the next year.
    • “In 2026, CMS identified 189,000 people who had subsidized Obamacare coverage through the Federal Marketplace and either had duplicate Medicare, Medicaid or Children’s Health Insurance Program (CHIP) coverage or were deceased. CMS took swift action to remove Obamacare subsidies for these people to save taxpayer dollars.”

From the public health and medical / Rx research front,

  • Reuters reports,
    • “The US CDC said on Tuesday it would deploy additional support to Pennsylvania to help investigate the ongoing measles ​outbreak, as the state formally requested federal assistance through the ‌agency’s Epi-Aid emergency response program.” * * *
    • “The agency said it would work with local health officials to investigate the outbreak, strengthen response efforts and prevent spread.
    • “Texas, South Carolina, Virginia, Kansas, New ​Mexico, and Wisconsin requested CDC Epi-Aids and worked alongside federal teams to ​help bring their outbreaks rapidly and successfully under control,” the agency said in a ‌statement.”
  • The New York Times relates,
    • “Pope Leo XIV had a “good” second night in the hospital after surgery to remove a cancerous nodule on his lung, the Vatican said on Thursday.
    • “The pope had a good night in the hospital. He got up and had breakfast,” the Vatican said on Thursday morning.
    • “Leo’s lung cancer diagnosis has cast uncertainty over his agenda and raises questions about succession about a year and a half into his papacy.
    • “The Vatican said that doctors operating on the pope in Rome on Tuesday confirmed he has ​lung adenocarcinoma, a common form of lung cancer that can be highly treatable when caught early. Surgeons removed the lower lobe of his right lung.”
  • Healio tells us,
    • “In 2023, the age-standardized mortality rate for asthma was lower than that of 1990 by 50.94%, whereas the 2023 rate for COPD was higher than the 1990 rate by 8.9%, according to data published in The Lancet Respiratory Medicine.” * * *
    • Between 1990 and 2023, the estimated number of people living with chronic respiratory disease in the U.S. rose from 33.28 million to 54.5 million.
    • “Increases between these years were also observed in the age-standardized prevalence rate (+10.24%) and the age-standardized mortality rate (31.19 per 100,000 population to 34.56 per 100,000 population). According to researchers, the modest increase in the mortality rate signals “persistent gaps in disease control.”
    • “When broken down by disease type, the study found that the age-standardized mortality rate in 2023 was higher than that of 1990 for COPD (+8.9%) and ILD and pulmonary sarcoidosis (+87.47%), whereas the 2023 rate was lower than the 1990 rate for asthma (–50.94%) and pneumoconiosis (–75.19%).” * * *
    • “Integrating tobacco control measures, equitable vaccination programs and targeted health-system investments could help to address the uneven burden of chronic respiratory diseases across U.S. states and the growing mortality gap despite stable prevalence, although further research is needed to clarify which specific policy determinants underlie these associations,” Yon and colleagues wrote.”
  • and
    • “Women with polycystic ovary syndrome, now known as polyendocrine metabolic ovarian syndrome, may have elevated risk for Alzheimer’s disease and related dementias, a review article stated.
    • “However, the higher risk may be mediated by metabolic disorders, the researchers wrote. 
    • “In findings published in the Journal of the Endocrine Society, researchers identified multiple studies that reported people with PCOS/PMOS have increased risk for Alzheimer’s disease and dementia. However, there remain several unanswered questions, including whether PCOS/PMOS independently raises Alzheimer’s disease risk and if any interventions may reduce the elevated risk in the PCOS/PMOS population. 
    • “The data indicate that it is critical to further assess the possible link between PMOS, metabolic dysfunction and Alzheimer’s disease, but we should recognize that according to the information we reviewed, this link is still hypothetical and much more research is needed,” Ricardo Azziz, MD, MPH, MBA, executive director at the Foundation for Research & Education Excellence and professor in the School of Medicine and School of Public Health at University of Alabama at Birmingham, told Healio.”
  • Radiology Business tells us,
    • “Researchers have developed a way of adapting adult radiology artificial intelligence models for the pediatric population. 
    • “Currently, only about 17% of U.S. Food and Drug Administration-authorized AI medical devices are labeled for use with children. That’s because most models are trained on adult data and do not translate well for infants and kids, experts write Tuesday in Nature Biomedical Engineering. 
    • “One key impediment is that medical records in pediatrics are subject to strict privacy regulations, with data tending to remain at the institution where treatment occurred. Currently, kids represent less than 1% of public medical imaging datasets. 
    • “Because it’s so much harder to get data for children, this transformative technology is disproportionately being developed to help adults,” lead author Vishwanatha Rao, a MD-PhD student with the University of Pennsylvania and research fellow at Harvard, said in a statement Oct. 13. “Children are being left behind.”
    • “To address this, Rao and colleagues championed a way of adapting one model, trained on adult X-rays, for the pediatric population. Their approach used data from multiple hospitals without sensitive information ever leaving each institution. “The model travels, but the data stays in-house,” experts noted.” 
  • Genetic Engineering and Biotechnology News notes,
    • “Researchers at Baylor College of Medicine, the Duncan Neurological Research Institute (Duncan NRI) at Texas Children’s Hospital, and collaborating institutions have identified new genetic candidates that help explain why autism is diagnosed about four times more often in boys than it is in girls. The study, involving tests in induced pluripotent stem cell (iPSC)-derived neurons (iNeurons), revealed that small changes in the gene MECP2 on the X chromosome might help explain part of this difference.
    • “Huda Zoghbi, MD, Distinguished Service Professor at Baylor, director of Duncan NRI, and a Howard Hughes Medical Institute investigator, is senior and corresponding author of the team’s published paper in The American Journal of Human Genetics, titled “A massively parallel reporter assay of MECP2 cis-regulatory elements reveals genetic candidates for male-biased autism.” In their paper, the team concluded, “These findings suggest noncoding MECP2variants can cause idiopathic, male-biased autism and provide a framework for uncovering regulatory variants in other X chromosome neurodevelopmental genes that may contribute to autism’s missing heritability.”
  • MedPage Today informs us,
    • “There are no licensed vaccines targeting invasive E. coli disease, an acute illness that can lead to sepsis and death.
    • “In a phase III trial of older adults, the nine-valent ExPEC9V vaccine’s efficacy rate of 14.6% indicated no protective effect against invasive E. coli disease.
    • “The results led to an early termination of the trial, and development of the vaccine has been discontinued.”
  • Per Bio-Pharma Dive,
    • “An experimental RNA interference drug developed by Arrowhead Pharmaceuticals lowered levels of an Alzheimer’s-linked protein in an early trial in healthy volunteers, signaling the medicine might be helpful in treating the memory-robbing condition.
    • “Arrowhead said the highest dose of its drug, administered in two injections spaced two weeks apart, dropped levels of that protein, “tau,” by an average of 73% after 105 days. The findings suggest the medicine, called ARO-MAPT, could be injected once every three months.
    • “The news comes as developers of RNA-modulating medicines have been increasingly exploring ways to overcome a longstanding research limitation by aiming their treatments at targets outside the liver. Arrowhead said the results from this early-stage trial “provide clinical validation” of a development platform that enables its drugs to reach cells elsewhere, including those in the central nervous system protected by the “blood-brain barrier.”
  • and
    • “Verastem Oncology shares rose 18% Wednesday after the company released highly anticipated early data suggesting its experimental cancer drug could help certain patients with three different types of tumors.
    • “The drug, VS-7375, targets the most prevalent of the “KRAS” mutations that drive cancer, one known as G12D. The medicine is designed to bind to both the “on” and “off” states of the mutation, which may allow it to hold back tumor growth more completely than rival treatments that only target one or the other, Verastem said.
    • “The small study included patients with metastatic pancreatic ductal adenocarcinoma, metastatic colorectal cancer and advanced non-small cell lung cancer. Based on the results, the company plans to kick off a trio of late-stage trials before the end of June.”

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

  • Human Resource Director reports,
    • “Employer health costs are on track to rise 8.2 percent per employee in 2027, the steepest increase since 2003, and many employers say they cannot get the claims data needed to explain why.
    • “Marsh, the benefits consultancy formerly known as Mercer, reached that figure in its 2026 National Survey of Employer-Sponsored Health Plans, which collected responses from more than 1,800 US employers between June 10 and August 10, 2026. Employers said costs would climb 11 percent if they took no action, and 59 percent plan cost-cutting changes such as higher deductibles. A separate Marsh survey found that about two-thirds of employers with 500 or more workers expect to raise employees’ share of premiums, so many workers will see paycheck deductions rise by more than the average. Aon and Business Group on Health have published similar pre-mitigation forecasts of 9.5 percent and 9.2 percent for 2027.
    • “Our report on Marsh’s 2027 health benefit cost projections covers the three newer drivers. Marsh’s actuaries attribute roughly one percentage point each to glucagon-like peptide-1 (GLP-1) weight loss drugs, artificial intelligence (AI)-enabled claims submission software and disputes under the No Surprises Act’s Independent Dispute Resolution (IDR) process.”
  • Beckers Hospital Review relates,
    • “Chicago-based Rush University System for Health and Evanston, Ill.-based Endeavor Health announced plans to merge Oct. 14. The transaction is expected to close in early 2027.
    • “Endeavor plans to fund a $1 billion investment as part of the deal, including $300 million to broaden community impact, $500 million for academics and research, and $200 million for quality care and innovation, according to a joint press release. The investment will also fund community partnerships focused supporting social determinants of health and underserved members of the community.
    • “Together, Rush and Endeavor Health have an opportunity to create a stronger, more connected health system that sets a new standard for how care is delivered and experienced across our communities,” said Gerald “J.P.” Gallagher, president and CEO of Endeavor. “Patients and communities will benefit from improved access, advanced research and nationally recognized, high-quality care close to home.”
    • “When the deal is finalized, the system will operate under the Rush brand based on the brand’s “strong national reputation and position as a leading academic institution,” according to the press release, with a commitment to academics, care quality and innovation.”
  • and
    • “Greensboro, N.C.-based Cone Health is sunsetting its Hospital at Home program, according to an Oct. 14 statement from the health system shared with Becker’s. 
    • “Cone Health made the decision following a comprehensive review of its priorities and the model’s sustainability. 
    • “The statement noted that health systems across the U.S. continue to evaluate hospital-at-home programs as they navigate evolving reimbursement models, operational complexity and long-term sustainability. 
    • “The program, which launched in April 2025, reported strong first-year results on June 1, including no patient deaths or healthcare-acquired infections. Cone Health had limited the program to six patients at a time and had planned to expand it once more payers covered the model.” 
  • Healthcare Dive adds,
    • “Nonprofit health systems MultiCare and Samaritan Health Services will merge on Nov. 1 after gaining approval from state regulators, the companies announced Monday.
    • “As part of the deal, MultiCare – which operates 13 hospitals –  will begin an affiliation with Samaritan and its network of five hospitals. MultiCare, which is based in Tacoma, Washington, will also invest $700 million over 10 years into Oregon-based Samaritan. Samaritan will continue to use its name, alongside MultiCare’s branding, the health system said.
    • “This milestone brings us closer to putting the investment and resources of our partnership to work for the people we serve.” said Marty Cahill, Samaritan president and CEO, in a statement.”
  • Modern Healthcare tells us,
    • “Elevance Health is distinguishing itself from other insurers by proactively, and publicly, railing against high costs it says are driven by providers. 
    • “The insurer announced last year that its Anthem Blue Cross Blue Shield commercial plans would penalize healthcare facilities with a fee up to 10% if out-of-network clinicians are deployed for elective surgeries. That policy was soon expanded to additional states.
    • Last month, Elevance Health tightened the screws again by becoming the first insurer to require that hospitals identify and charge correct rates for off-campus care.
    • “Elevance Health’s site-of-care policy represents a “relatively consumer-protective attempt at reducing spending,” said Christine Monahan, an associate research professor at the Georgetown University Center on Health Insurance Reforms.
    • “Hospitals, however, have already begun to challenge the restrictions, which they deem as unilaterally imposed on them in spite of their contracts with the insurer. It’s possible more health systems will sue, said John Barnes, a partner at law firm Davis Wright Tremaine who represents providers on issues concerning insurance contracts.”
  • and
    • “Zocdoc, a virtual marketplace for booking providers, has acquired insurance technology company Sohar Health.
    • “The deal marks Zocdoc’s first acquisition since launching in 2007, according to a Wednesday press release. Zocdoc declined to disclose the financial terms of the acquisition, which closed on Oct. 2.
    • “Sohar’s platform automates insurance benefits eligibility checks.”
  • MedTech Dive informs us,
    • “Steris said Monday it struck a $2.1 billion deal to acquire Xodus Medical for its portfolio of consumable healthcare products. 
    • “Xodus’ portfolio includes Pink Pad patient-positioning products and the See Sharp laparoscopic cleaning and defogging device. The company expects annual sales to hit $245 million this year.
    • “Buying Xodus “makes sense” for Steris because it expands the company’s healthcare consumables offering with high-growth, high-margin products, Needham analysts said in a note to investors.”
  •  and
    • “Agilent said Tuesday that it has agreed to buy digital pathology software provider Proscia for $240 million upfront.
    • “The deal, which includes up to $30 million in milestones, will give Agilent control of technology that connects slide scanners, laboratory information systems and other parts of the pathology workflow.
    • “Agilent’s deal comes months after Roche agreed to buy PathAI for up to $1.05 billion. Evercore ISI analysts noted that Agilent “got the rights to play in this market at a lower price point.”
  • Beckers Health IT points out,
    • “The American Hospital Association, American Medical Association, Anthropic and Elevance Health are participating in a national workgroup developing recommendations for how state medical boards should oversee AI in medical practice, a spokesperson for the Federation of State Medical Boards confirmed to Becker’s.
    • “FSMB announced the workgroup in May to develop recommendations and/or model guidelines for state medical boards, particularly regarding AI systems that perform clinical functions with limited or no direct physician supervision. The effort comes as companies test how AI can be used in diagnosis, prescribing and other clinical functions, and as states propose and implement regulatory sandbox frameworks, according to FSMB’s news release.
    • “The group met in Washington in early October, the FSMB spokesperson confirmed to Becker’s.”
  • Fierce Healthcare adds,
    • “Johns Hopkins Medicine is teaming up with OpenEvidence to advance the use of artificial intelligence in medical education and clinical care.
    • “OpenEvidence and Johns Hopkins executives provided Fierce Healthcare with a first look at the partnership news.
    • “The health system and academic institution will partner with OpenEvidence to develop what they describe as “human-first AI systems” that combine the best available evidence with a patient’s medical history and Johns Hopkins’ clinical best practices to support care delivery. Sophisticated AI will help clinicians reason through that information more quickly, contextualize it, and make the best decisions for their patients, executives said.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a DataSpring news release,
    • “The Provider Data Collective, convened by DataSpring, powered by CAQH, today announced a new standard to improve the measurement of provider directory data quality for individual clinicians. It is the first solution from the industry-led coalition bringing together health plans, a health professional organization and an accreditation body to tackle challenges no organization can solve alone. The Collective’s mission is to improve the accuracy and reliability of provider information — clinician data that underpins directories, network operations and other essential health care workflows — so patients, clinicians and health plans can rely on information they trust.
    • Founding organizations of the Collective include Aetna, the American Medical Association, Centene, The Cigna Group, DataSpring, Elevance Health, Horizon Healthcare Services, Inc., Humana, the National Committee for Quality Assurance (NCQA) and UnitedHealthcare. * * *
    • “Inaccurate provider data can create real barriers across healthcare. Patients struggle to confirm whether a clinician is in-network, providers face delays joining networks and seeing patients, and care teams often lack the reliable information needed to coordinate care,” said Tim Kaja, executive vice president of UnitedHealth Group Enterprise Services and board chair of DataSpring. “While CMS established a method to measure provider data accuracy, inconsistent application made it difficult to establish a common baseline for improvement of provider data quality across the industry. The Collective aligned the industry around a shared framework — a more consistent way to measure data quality, identify gaps and track progress.”
    • “The data quality measurement standard creates a foundation for tracking and improving provider data quality across the ecosystem. It also allows this industry-led work to inform regulatory activity as policymakers seek to modernize provider data infrastructures. With that foundation in place, the Collective will next focus on other industry challenges, including how accepting-new-patients status is determined, updated and reflected in directories to improve accuracy and patient access.”
  • Modern Healthcare reports,
    • “The Centers for Medicare and Medicaid Services has gained unprecedented authority to remove providers, insurers and suppliers from federal health programs over fraud concerns.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. published a notice Tuesday announcing he is officially delegating those powers, which had been solely held by the HHS Office of Inspector General, to CMS.”
    • “The two-page document formalizes remarks Kennedy made at a news conference in July. “Both CMS and the Office of Inspector General will be able to use that authority to remove bad actors from federal healthcare programs and, in many cases, permanently ban them from returning,” Kennedy said at the time.
    • “The policy shift gives CMS a significant enforcement tool as the agency toughens up its oversight and fraud detection strategy.”
  • Bloomberg Law adds,
    • “US Health Secretary Robert F. Kennedy Jr.’s proposal to pay doctors to collect information about vaccine injuries drew criticism from medical groups over concerns it would create perverse incentives and a perception of causality not based on evidence.
    • “The idea is one pillar of the Department of Health and Human Services’ new vaccine injury research project formally announced on Thursday, three days after agency leaders secretly met at the National Institutes of Health to pitch it. 
    • “The proposal to compensate Medicare providers was tucked into a wide-ranging physician payment rule expected to be finalized next month as part of an annual rulemaking process.”
  • Beckers Hospital Review relates,
    • “Four House lawmakers, Reps. Rob Bresnahan, R-Pa., Debbie Dingell, D-Mich., Tracey Mann, R-Kan., and Lois Frankel, D-Fla., have introduced bipartisan legislation that would pause HRSA’s 340B rebate model pilot.” * * *
    • “The bill, the 340B Rebate Model Delay Act, would require drugmakers to provide 340B discounts upfront at the time of purchase from Jan. 1, 2027, through Dec. 31, 2028. It would also bar the use of federal funds to implement the rebate pilot or a substantially similar program during that period.
    • “The pause would give Congress time to consider broader 340B reform, including the SECURE 340B Act in the House and the SUSTAIN 340B Act in the Senate, according to an Oct. 9 statementfrom Advocates for Community Health. The group said health centers could be forced to cut services if they have to absorb full drug costs while awaiting rebates.”
  • Per a HRSA news release,
    • “The Health Resources and Services Administration (HRSA) today announced $12.7 million in Fiscal Year 2026 awards through the Maternal Produce Prescription Program (MP3) to help pregnant and postpartum women and their families in low-income and medically underserved communities access healthy foods.
    • “MP3 provides produce prescriptions or vouchers and nutrition education to help pregnant and postpartum women and their families access fruits and vegetables. The program strengthens partnerships among healthcare providers, community-based organizations, and local food systems and aims to increase fruit and vegetable consumption, improve household food security, and improve maternal and birth outcomes.”

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

  • Federal News Network discusses “FEHB and Medicare: Understanding how they work together in retirement.”
  • FedScoop adds, “OPM updates terms of service for USAJobs data following user confusion.
    • “The human capital agency again updated terms for its USAJobs application programming interface to reflect that the data is public and expressly allow analysis.” * * *
    • “In new updated terms released Friday, the agency enshrined its clarifications into its policy.
    • “The terms now state that information from the API is public data and as such, can be “copied, stored, reformatted, adapted, analyzed, published, redistributed, and used for lawful commercial or noncommercial purposes” without prior approval from OPM. 
    • “They also include language protecting analysis, while making it clearer that fraudsters are the target. Under the terms, API users can “modify, summarize, analyze, or combine” the public data, but may not falsely represent the information. ” * * *
    • “In response, the user community cheered the update.”

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

  • CBS News reports,
    • “The Food and Drug Administration received reports in recent months that two people died after taking bootleg versions of an experimental weight-loss drug, according to documents reviewed by CBS News.
    • “The reports link the deaths to products claiming to be retatrutide, a drug being developed by Eli Lilly that hasn’t been approved by the FDA. Federal law prohibits the commercial sale of unapproved drugs, but that hasn’t stopped vendors from selling imitation versions of the experimental drug online at a scale with no modern precedent. 
    • “The cases appear to be the first public accounts in the U.S. alleging that unauthorized use of retatrutide — or products claiming to contain it — played a role in a patient’s death, though the details aren’t verified and it is unclear whether the drug was to blame.” * * *
    • “CBS News was not able to independently verify the information included in the reports, which were obtained under the U.S. Freedom of Information Act and redacted by the agency to remove details that could identify the people mentioned in them. They are part of an emerging picture of potential side effects from a drug that many people are obtaining from unregulated sellers and with minimal to no medical supervision.
    • “America’s Poison Centers, a nonprofit, has tallied a steady increase in reported exposures to retatrutide since it began tracking them late last year, which is common for a newly monitored drug. The centers logged 862 exposures to retatrutide in the three months ending in September, up from 460 in the three months prior and 249 in the first three months of 2026.” * * *
    • “In a statement, Eli Lilly said that the reported deaths “make clear the two individuals were taking black-market retatrutide.” The company said it has found suspect products “with too much, too little, or the wrong active ingredient,” along with contaminants that “can put patients at serious risk.”
    • “Eli Lilly is taking legal action against companies selling bootleg versions of retatrutide, claiming that people will associate bad reactions to them with its product, “poisoning the well for the future of retatrutide medicines.” 
  • DI Cardiology tells us,
    •  “Endovascular Engineering (E2) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for both the Hēlo Thrombectomy System and Hēlo Return (Blood Return System).
    • “Hēlo, which is a physician-inspired, purpose-built thrombectomy platform for treating pulmonary embolism, leverages a unique design that consistently led to efficient single-pass procedures in the Engulf IDE study. The platform showcased the highest reported clot reduction and the lowest estimated blood loss across all PE Thrombectomy IDE studies.1 
    • “While Engulf provided important clinical validation of the platform’s capabilities, the FDA clearances represent a significant step forward as E2 brings its innovative platform to a broad range of physicians and patients. PE remains a leading cause of cardiovascular death and disability, and there is growing demand for mechanical solutions that support clot removal while reducing procedural complexity and right heart strain.”
  • MassDevice adds,
    • “BridgeSource Medical obtained de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify a patient’s hardware brand.
    • “According to the Austin, Texas–based company, about half the time a patient enters the ER they don’t know, can’t communicate or aren’t carrying the wallet card listing the specific brand of their pacemaker or implanted defibrillator. This causes delays in triage and treatment — with different approaches being needed for each manufacturer — and clinicians often have to resort to an X-ray to determine the type of device.
    • “BridgeSource’s SmartRead system can be used by frontline healthcare workers to identify an implant within 20 seconds. It works by mimicking the initial communication pings sent by the programming wands from each major implant manufacturer and waiting for a response, including devices from Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort.”

From the public health and medical / Rx research front,

  • JACC offers information about “Cardiovascular Disease Mortality [CVD] by County, Race and/or Ethnic Population, United States, 2000-2019.”
    • “While declining CVD mortality reflects meaningful clinical and public health progress, persistent and pervasive disparities demand solutions-oriented, place-informed research to drive further progress. Critically, these pre-Covid data establish a baseline essential for isolating Covid-era–attributable shifts from preexisting trends. These granular county-level data stratified by CVD cause, race, and/or ethnicity offer a scalable, repeatable framework for agencies to tailor health interventions and rigorously track disparities over time.”
  • Health Day adds,
    • “Monitoring blood pressure at home could help prevent a life-altering injury for some seniors, a new study warns.
    • “Seniors older than 78 with “masked” high blood pressure have a 70% higher risk of falls than those who’ve been properly diagnosed, according to results presented at the American Heart Association’s annual meeting on hypertension.
    • “Researchers said masked high blood pressure involves seniors’ readings appearing normal at a doctor’s office but consistently high at home.
    • “These findings highlight that, in addition to office blood pressure measurement, home blood pressure readings can be an important way to identify hidden home high blood pressure and risk of falls in older adults,” lead investigator Frances Wang said in a news release. She is a researcher at Beth Israel Deaconess Medical Center in Boston.
    • “Changes in blood pressure can increase fall risk by causing dizziness or fainting, according to the American Heart Association (AHA).”
  • Per a National Institutes of Health news release,
    • “A scientific team funded by the National Institutes of Health (NIH) has built a super intelligence (SI)-based interface that enables real-time communication between patients and epilepsy monitoring devices. As part of a small clinical study at the University of Pennsylvania, Philadelphia, patients used a smart-phone application to inquire about their own physiological data and received accurate information in response. Conversely, the system learned from patient feedback to improve seizure detection, ultimately reducing its false alarms by about 80%. 
    • “This proof-of-concept showcases a technology with the exciting potential to shift management of epilepsy and possibly other diseases in a more adaptive direction that puts patients in the driver’s seat,” said Amy Bany Adams, Ph.D., acting director of the NIH’s National Institute of Neurological Disorders and Stroke (NINDS).” 
  • Radiology Business reports,
    • “Alterations in brain connectivity may be associated with anxiety in adolescents, according to new research. 
    • “Published in Imaging Neuroscience, the findings implicate brain circuits connecting the cerebellum, amygdala and thalamus in adolescent anxiety. Experts involved in the study are hopeful that their research could help guide personalized approaches to youth mental health care in the future. 
    • “Precision psychiatry is likely to play an important role in future mental health care,” noted study leader Caterina Stamoulis, PhD, principal investigator in Boston Children’s Computational Neuroscience Laboratory. “In this study, we have identified specific circuits that are implicated in anxiety, which could become the targets of precision interventions to improve short- and longer-term mental health outcomes in youth.” * * *
    • “While the findings are promising and offer scientists a deeper level of understanding of the underlying mechanisms of anxiety disorders in adolescents, additional research will be needed to determine whether the imaging markers can predict individual outcomes or help clinicians select and evaluate targeted interventions. 
    • “Read more here.” 
  • BioPharma Dive relates,
    • “An experimental mRNA cancer immunotherapy from BioNTech failed to delay tumor progression in a late-stage study in a form of head and neck cancer, the company said Tuesday.
    • “According to BioNTech, a combination of its treatment BNT 113 and the widely used drug Keytruda didn’t extend progression-free survival at an interim data check. The trial is testing the dual regimen against Keytruda alone as a first-line treatment in head and neck squamous cell carcinoma that’s driven by a high-risk strain of human papillomavirus. 
    • “A data monitoring committee encouraged BioNTech to continue the trial to determine whether the BNT 113-Keytruda regimen can meet the study’s other main objective by extending survival. Should it do so, BioNTech could still claim success. The early results “support continued evaluation” and show the drug combination is “engaging its intended therapeutic mechanism,” said co-founder and Chief Medical Officer Özlem Türeci.”
  • and
    • “Bristol Myers Squibb said Monday that its experimental lung disease drug admilparant succeeded in a Phase 3 trial in idiopathic pulmonary fibrosis, significantly slowing the decline of study participants’ breathing capacity when compared to a placebo over the course of a year.
    • “However, trial investigators only found a clear benefit among those who received a 60 milligram dose of admilparant. A 120 milligram dose was associated with an impact on disease progression, but the difference didn’t meet the threshold for statistical significance, the company said.
    • “The failure of the high-dose arm is “confounding and requires further explanation,” RBC Capital Markets analyst Trung Huynh wrote in a client note. Bristol Myers previously made certain trial revisions that sparked liver-related safety concerns about admilparant, too, although the company said Monday that the drug “demonstrated a well-tolerated safety profile” and treatment-related study discontinuations were similar between study groups.”

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

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group reported earnings that came in above analysts’ expectations and again raised its projection for the year, as the healthcare company continued charting a financial turnaround.
    • “The announcement comes more than a year after Chief Executive Stephen Hemsley returned to the top job, promising major changes after a meltdown that cut the company’s valuation by hundreds of billions of dollars.
    • “For the third quarter of 2026, UnitedHealth reported net income of $4.11 billion, or $4.56 a share. That compared with net income of $2.35 billion, or $2.59 a share, a year earlier.” * * *
    • “UnitedHealthcare, the insurance arm, reported a medical-loss ratio of 88.4%, a closely watched number that represents the share of premiums spent on medical costs. The FactSet consensus projection was 89.7%.”
  • and
    • “Johnson & Johnson JNJ is “leaning” toward spinning out the hips-and-knees business that the company has been looking to hive off, Chief Financial Officer Joseph Wolk said.
    • “We think the best value creation at this moment in time for J&J shareholders is to spin it straight out,” Wolk said in an interview. The company talked with private-equity firm Apollo Global Management about a roughly $20 billion sale, The Wall Street Journal has reported.
    • “Wolk made the remarks as J&J said its sales grew a healthy 5.9% in the recent quarter to $25.4 billion, and the company raised its forecast for full-year performance.
    • “Sales of prescription drugs powered J&J’s quarterly results. The company’s medical-device business didn’t grow as much. While acknowledging the medical-device unit needed work, the company said it was on track to surpass $100 billion in yearly sales.
    • “J&J is considered a bellwether for the healthcare industry because its portfolio spans so many different products. Its results show the enduring demand for medical treatment, as other industries grapple with consumers tightening spending because of higher fuel and other costs.”
  • and
    • “Roche ROP Holding struck a deal with China’s Rona Therapeutics to license worldwide rights to an experimental therapy for obesity and metabolic diseases for up to $1.16 billion, moving to bolster its portfolio with a new weight-loss approach.
    • “Under the agreement, Shanghai-based Rona will get upfront and near-term payments of up to $100 million and be eligible to receive an extra $1.06 billion subject to reaching development, regulatory and commercial goals, as well as royalties on potential sales, Rona said Tuesday.
    • “Roche has sought to build and expand a portfolio of weight-loss drugs in recent years, joining a growing group of drugmakers vying to challenge Eli Lilly and Novo Nordisk. It completed in 2024 its $2.7 billion purchase of U.S. obesity drug developer Carmot Therapeutics and entered into an up to $5.3 billion licensing deal with Denmark’s Zealand Pharma to jointly develop a different kind of weight-loss medicine last year.”
  • Beckers Payer Issues relates,
    • “Humana has agreed to form a new joint venture with investment management firm BlackRock to own and operate nearly 150 CenterWell Senior Primary Care clinics, replacing CenterWell’s existing joint ventures with private equity firm Welsh, Carson, Anderson & Stowe. 
    • “Funds and accounts managed by HPS Investment Partners, part of BlackRock, will acquire Welsh Carson’s equity stake, valued at about $2.8 billion, according to an Oct. 13 Humana news release. BlackRock will hold majority ownership, while CenterWell will retain a minority stake and continue managing the clinics.
    • “Unlike the previous agreements, the new deal does not give BlackRock the right to force Humana to buy out its stake. Humana said removing that obligation will significantly reduce liabilities on its balance sheet and lower its cost of capital.
    • “Beginning in 2028, CenterWell can buy clinics from the joint venture, according to the release. If CenterWell has not acquired all of them by the end of 2033, BlackRock can exit through a sale of the remaining clinics, with CenterWell holding the right to make the first offer.”
  • and
    • “Centene will launch its National Performance-Based Gold Card Program in November.
    • “Gold carding aims to streamline prior authorization, reducing requirements for trusted providers. The program will first be available to more than 160,000 qualifying providers across the country for some outpatient services. Eligibility is determined by approval history, documentation quality, medical policy compliance and adherence to regulatory requirements. The insurer anticipates expanding the program to other service types and providers in the future.
    • “Centene COO Susan Smith said the program “was shaped through deep collaboration with providers, ensuring its review process is grounded in the real-world needs of those delivering care every day.” Providers spanning 24 states anonymously contributed feedback to inform the program, according to an Oct. 13 news release.” * * *
    • “In recent years, UnitedHealthcare and Humana have also announced gold card programs. Centene’s update comes as prior authorization reforms pick up steam.”
  • Per a Healthcare Cost Institute news release,
    • “Health care spending for people with employer-sponsored insurance reached $6,743 per person in 2023, according to the nonprofit Health Care Cost Institute’s latest Health
    • “Care Cost and Utilization Report. Per-person spending rose 18.8% from 2019 to 2023, with higher prices, not greater use of care, driving most of the increase.
    • “From 2022 to 2023, spending per person grew 6.5% while utilization was essentially flat. Average prices rose 6.7% that year, continuing a five-year pattern of annual price growth.
    • “Prices are the primary force behind high health care costs,” said Katie Martin, HCCI president and CEO. “Employers, policymakers and other decisionmakers need to focus on price growth to make care more affordable for people and families with job-based coverage.”
  • Beckers Hospital Review tells us,
    • “Hospital margins fell in August as financial pressures mounted and the share of hospitals operating at a loss is growing, according to Kaufman Hall’s [Augut 2026] “National Hospital Flash Report,” released Oct. 13.
    • “The report is based on August 2026 financial performance data from 1,300 hospitals, provided by Strata Decision Technology. The hospitals represent all regions of the country and range from small to large institutions.
    • “The average hospital margin has declined steadily since hitting 5.6% in June. The average fell to 1.8% in August, down from 3.8% in July. The year-to-date average operating margin dropped from 3.8% in July to 2.5% in August.
    • “Mounting financial challenges from increasing bad debt and charity care, payer mix erosion and rising expenses may prompt hospitals to strengthen enterprise margin preservation efforts,” the report said.
    • “About 43% of hospitals are operating in the red, up from 33% before the COVID-19 pandemic. Hospitals have experienced many challenges in the last six years, including staffing shortages, supply cost increases, tech and AI spend and more.”
  • Per a Vizient news release,
    • “The sustained momentum in hospital and health system M&A activity has shown that health systems continue to advance active positioning and portfolio management, with 16 hospital and health system transactions announced in Q3 2026. The 16 announced transactions in Q3 2026 (Figure 1) are on par with what we saw in Q3 2025. As deal volume continued, mega mergers also continued to make waves across the industry. For the third consecutive quarter, multiple mega mergers—transactions in which the smaller party had annual revenue exceeding $1 billion—were announced, along with several transactions that fell just shy of the $1 billion threshold.
    • “The size of these transactions kept the average seller size elevated relative to recent year-end figures, continuing to suggest that M&A activity is increasingly involving larger organizations opting to partner with even larger ones.
    • “Divestitures of specific health system assets represented five of the 16 announced transactions in Q3 2026.”
  • Beckers Payer Issues notes,
    • “CMS’ 2.5% efficiency adjustment cut work relative value units on about 7,700 non-time-based codes starting Jan. 1. It was a percentage cut that came with a conversion factor increase, so the dollar effect is easy to miss. For physicians paid per wRVU, it runs from nothing to more than $13,000 a year, depending on specialty.” * * *
    • “The Medical Group Management Association and consulting firm PYA have flagged procedural and imaging-heavy groups on formula-based wRVU incentives as the most exposed. MGMA also noted exposure for groups whose commercial contracts or benchmarks are tied to wRVU counts.”
  • MedCity News informs us,
    • “Outro, a neuroscience-based platform, announced last week that it raised $7 million in pre-seed and seed funding.
    • “The New York-based company helps patients discontinue psychiatric medications. Patients visit with clinicians trained in safe deprescribing and receive access to personalized tapering plans. They also gain access to compounded medication doses.
    • “Roughly 1 in 6 Americans take antidepressants. There are tens of millions of people on these drugs, yet no science-based way to get off safely. … Outro is the off-ramp that should have been built from the beginning. We want getting off a medication to be as supported as getting on it – arguably even more,” said Brandon Goode, co-founder and CEO of Outro.”
  • Beckers Health IT points out,
    • “The American Medical Association released a governance framework Oct. 13 for agentic AI that takes on clinical functions. The framework says an AI system’s clinical authority must be earned through evidence and maintained through ongoing performance.
    • “The AMA said an AI system’s authority and oversight can change as its evidence, performance, risk or underlying technology changes.”

Holiday Weekend update

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

Happy Columbus Day!

From Washington, DC

  • Congress remains on the campaign trail this week.
  • The Social Security Cost of Living Adjustment will be announced on Wednesday, October 14,
  • Beckers Hospital Review reports,
    • “Health systems told CMS in public comment letters how much its proposed cut to 340B drug payments would cost them, with estimates ranging from about $7 million to $109 million a year [as detailed on the article].
    • “The 2027 outpatient payment rule, proposed July 2, would pay hospitals for drugs bought through the 340B program at average sales price minus 33.4%, down from average sales price plus 6%. CMS estimates the change would cut Original Medicare drug payments by $4.55 billion in the first year. Because the rule must be budget neutral, CMS would raise payments for nondrug outpatient services by 8.44% for all hospitals, including those that do not participate in 340B.

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

  • David Setia, writing in Federal News Network, breaks down why federal employees “should consider retiring after 62, why it just got even more compelling, and how you can make this decision slightly less painful.”
  • FedSmith explains ‘how federal employees can build a financial cushion before the next shutdown.
    • “Federal shutdowns are unpredictable, but financial preparedness isn’t. Here’s how to build a savings cushion before the next funding lapse.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Alignment Healthcare sued federal regulators, alleging that its 2027 Medicare Advantage star ratings were determined “in flagrant violation” of statute.
    • “In the lawsuit filed Friday in District of Columbia federal court, the insurer says that the Centers for Medicare & Medicaid Services “has completely departed from Congress’s vision of leveraging predictable, valid measures developed with input from providers, plans, and the public” in establishing the methodology for the star ratings.
    • “The company argues that rather than establish “consistent, stable specifications” for metrics through the traditional rulemaking process, the agency instead detailed key measures through a series of “technical notes.” This violates the Administrative Procedure Act, per the lawsuit.”
  • Modern Healthcare adds,
    • “The Centers for Medicare and Medicaid Services excluded 20 measures from its 2027 Medicare Advantage star ratings methodology for Clover Health PPOs.
    • “Clover Health successfully sued CMS to get those metrics excluded from its 2026 scores.
    • “Other Medicare Advantage insurers were evaluated on different metrics than Clover Health.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “A 39-year-old unvaccinated woman from Franklin County, Pennsylvania, who had been diagnosed with measles has died, according to the local coroner’s office, marking the sixth such death reported since the state’s outbreak began this year.
    • “The woman’s primary cause of death was a “probable acute cardiac event due to possible complications of the measles,” the coroner’s office said in an emailed statement.
    • “The patient had “a recent history” of having contracted the highly contagious disease, the coroner’s office wrote in a Facebook post, adding that it meets the state health department’s definition of a measles-associated death. The woman had several underlying health conditions and had a “past diagnosis of measles with treatment.”
  • Beckers Clinical Leadership relates,
    • Flu season is off to an early start, with weekly lab-confirmed flu hospitalizations nearly tripling between early September and early October, according to CDC data. 
    • Hospitals reported 3,334 flu admissions in the week ending Oct. 3. That’s up from 2,572 the week before and 1,133 in the week ending Sept. 5. The national admission rate rose to 1.0 per 100,000 people, up from 0.3 in early September.
    • The West is furthest ahead. “California has a full-on flu epidemic right now,” Scott Gottlieb, MD, a former FDA commissioner, said in an interview with CNBC.
  • and
    • “Hospital and health system leaders are grappling with the balance between keeping patients safe and what to do when aging physicians continue to practice amid declining abilities, The Washington Post reported Oct. 12. 
    • “Nearly 47% of the active physician workforce is 55 or older, up from 38% in 2007, and in 2025, 22.4% of physicians are over 65. At older ages, reaction times slow, knowledge can become outdated and some can experience cognitive decline. Mild cognitive impairment increases with age, going from 8.4% in adults 65 to 69, up to 25.3% in adults 80 to 84, according to the American Academy of Neurology.
    • “Studies from Yale New Haven Hospital and Hartford (Conn.) Healthcare found 12.7% to 14.4% of physicians over 70 who were screened showed some degree of cognitive impairment.  
    • “It’s becoming a bigger issue with each passing year,” clinical neuropsychologist Victor Del Bene,PhD, of the University of Alabama at Birmingham, told the Post.”
  • The American Medical Association lets us know “what doctors want patients to know about the common cold.”
    • “Nearly everyone will experience a cold, most often caused by rhinovirus. While there is no cure, there are several ways to manage your symptoms.”
  • Health Day tells us,
    • “Late-night snack may be doing more than affecting your waistline — it could be hurting your liver health.
    • “A few studies have hinted at this idea but this is among the first long-term analyses to explicitly draw the connection to fatty liver disease,” lead author Dr. Robert Wilechansky said in a news release. He’s a hepatologist at Oregon Health & Science University in Portland who specializes in liver transplantation.
    • “Researchers analyzed diet and lifestyle data from nearly 200,000 healthy people who were monitored for about 16 years.
    • “Those who reported eating after dinner or after bedtime had a 36% higher risk of developing non-alcoholic fatty liver disease and a 28% higher risk of cirrhosis.
    • “The results were consistent even after adjusting for factors like age, diabetes status, physical activity and body mass index (BMI), an estimate of body fat based on height and weight.”
  • The Washington Post offers an interview with an oncologist who tells us what to know about DCIS or Stage 0 breast cancer.
    • Experts are starting to question whether identifying ductal carcinoma in situ as cancer leads to unnecessary interventions such as radiation and surgery.
  • The New York Times explains “why ketamine immobilizes some users.”
    • “Potent powders can produce a nearly catatonic state, particularly in those who have not tried the drug before.”
  • and
    • considers whether we ever will understand dementia.
      • “Today dementia is estimated to affect more than 55 million people worldwide, and nearly 10 million cases are added every year. By 2050 — as populations age and the power of diagnosis improves — that number is projected to rise as high as 139 million. We’re already on our way to becoming a society of caregivers, looking after an aging population unable to support itself.
      • “And yet, in a sense, we understand little more about the plaques and tangles of Alzheimer’s disease than we did 120 years ago, when Alois Alzheimer first noticed them. In recent years, we may have even lost ground. A decades-long consensus about the meaning of those plaques and tangles has collapsed as treatments built on those theories have failed, reopening what now must be understood as one of the most urgent unsolved problems in medical science: What is dementia, and how can we possibly slow its advance and reduce its terrible toll?” * * *
      • “A recent overview of the Alzheimer’s literature in the journal Cell offers “hope for a future where AD is not only treatable but also preventable,” while still acknowledging the condition’s “complex pathologic underpinnings.”
      • “This, after all, was Arnold Pick’s insight: that dementia is many things. What if we could nip these complex problems in the bud genetically, before the crippling health care costs and heartbreaking losses — before the ones we love lose much of what makes them who they are?
      • “With the gene carriers, you can get in very early, maybe even before any age-related change is happening, any pathology is present at all,” Dr. Miller said. “I think it’s going to be a really huge decade. We’re just beginning.”
  • Per Genetic Engineering and Biotechnology News,
    • “Domestic dogs offer a useful model for understanding the biology of aging because their lifespans vary dramatically with body size. Large dogs tend to be shorter lived than their smaller counterparts, but why? Headed by a team at Arizona State University, a study of nearly 900 dogs now suggests that the answer may be written into the animals’ epigenomes.
    • “Research professor Noah Snyder-Mackler, PhD, at Arizona State University School of Life Sciences, and colleagues developed an epigenetic clock that predicted mortality in dogs and showed that epigenetic aging is fastest early in life. The study results indicated that male dogs and larger dogs undergo accelerated molecular aging, with male dogs exhibiting pronounced DNA methylation (DNAm) changes on the X chromosome, and larger animals exhibiting methylation changes at transposable elements (TEs), stretches of DNA that can influence genome stability and gene regulation.”
    • “Snyder-Mackler is senior and corresponding author of the researchers’ published paper in Science (“Epigenetic aging and transposon dysregulation reflect size-related lifespan compression in dogs,”) in which they concluded, “Our findings broadly establish companion dogs as a translational model for uncovering molecular mechanisms of lifespan variation, epigenomic instability, and age-related disease.”
  • Per Fierce Pharma,
    • “Mirum pharmaceutical is on a hot streak. On the heels of an FDA approval and a phase 3 win in hepatitis delta, the rare disease company just announced another phase 3 victory for Livmarli, its ileal bile acid transporter (IBAT) inhibitor.
    • “Mirum’s Expand trial tested Livmarli in patients aged 6 months or older with cholestatic pruritus, an intense itch caused by an ultra-rare cholestatic liver disease. The topline readout showed the trial met its primary endpoint achieved significance across all five secondary endpoints.

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “More GLP-1 prescriptions are being filled without ever touching a patient’s insurance, and pharmacists say the shift is accelerating.
    • “Nearly seven in 10 pharmacists (68%) have seen cash-pay GLP-1 transactions increase over the past year, according to a Buzz Health survey of 256 U.S. pharmacists conducted in July 2026. The trend shows up weekly at the pharmacy counter, where patients often pay cash for a GLP-1 while still running their other prescriptions through insurance.
    • “Price isn’t the only factor. More than half of pharmacists say patients have paid cash even when a cheaper or equivalent option was covered by their plan, which suggests convenience and product preference play a role. Pharmacists credit manufacturer direct-to-consumer programs, telehealth pricing and new oral GLP-1s with pulling patients away from their benefits. That is the same growing mix of channels physicians already navigate when patients can’t access the GLP-1 they prescribe.
    • “The shift also creates a data problem. Cash purchases don’t always appear in the claims records that health plans and PBMs use to track utilization and adherence, and most patients don’t realize their insurer can’t see those fills. As online GLP-1 options continue to multiply, that blind spot could make it harder to know what patients are actually taking.”
  • Beckers Hospital Review relates,
    • “Durham, N.C.-based Duke University Health System recorded operating income of $453.1 million (5.4% margin) for fiscal year 2026, compared with operating income of $179 million (2.5% margin) in fiscal 2025, according to its Oct. 5 financial report.”
  • and 
    • “Many large health system layoffs in 2026 feature a common theme: Leadership is cutting corporate and administrative support roles while protecting positions that focus on patient care. It’s a pattern that shows how organizations are deciding what to cut as costs rise and federal policy changes reshape the industry.” * * *
    • “Even while administrative ranks thin, systems are still spending to retain workers. Becker’s has reported that 49 hospitals and health systems have announced plans to raise workers’ pay since December 2025. For example, Hartford (Conn.) HealthCare shared in late September that it will raise its minimum wage to $20 an hour Dec. 27, affecting about 4,000 employees. An additional 4,000 employees will receive pay adjustments to address wage compression resulting from the increase.”
  • Radiology Business tells us,
    • “Siemens Healthineers has officially ceased all sales of its general imaging ultrasound systems. The healthcare giant announced the shift in strategy on Monday, Oct. 12, saying it will now increase its focus on procedural imaging and image-guided therapies. The goal is to build on its strength in cardiovascular imaging, specifically in the areas of intracardiac echocardiography (ICE) and AI, and help care teams perform more complex procedures than ever as technologies continue to evolve. 
    • “Going forward, Siemens Healthineers remains focused on technologies used by electrophysiologists and interventional cardiologists for the detection and management of cardiovascular disease. The company’s Acuson Origin, for example, is a cardiovascular ultrasound system with advanced artificial intelligence (AI) capabilities that first gained U.S. Food and Drug Administration clearance in 2024. The Acuson P500 and Acuson Freestyle systems are also still part of the Siemens Healthineers portfolio.
    • “On the other hand, the company will no longer be selling its Acuson Sequoia, Acuson Redwood, Acuson Juniper or Acuson Maple systems.”
  • Beckers Payer Issues explains why payers have invested in ambulatory surgical centers and lets us know that
    • “Former UnitedHealth Group CEO Sir Andrew Witty has been named chairman of Hatteras Venture Partners, a venture capital firm focused on healthcare innovation, investing across biopharmaceuticals, medical devices and health technology.
    • “Mr. Witty is returning to Hatteras, where he served as a venture partner from 2017 to 2019, according to a Sept. 30 news release from the company.” 
  • Beckers Physician Leadership considers whether any physician can be truly independent.
    • “Independent” has become one of the most loaded words in physician practice. As hospitals, health systems and private equity firms have absorbed practices over the past two decades, the label has come to signal a practice that has stayed outside all three.
    • “Siddharth Tambar, MD, a rheumatologist and physician owner of Chicago Arthritis and Regenerative Medicine, questions how much that label actually describes.
    • “I understand what people mean when they say independent practice, right? That you’re not part of a large either group system, hospital system, PE-owned system,” Dr. Tambar told Becker’s. “So I get that, but realistically, if you are part of the American healthcare system, if you accept insurance, you’re part of these large networks. You’re part of these flows of how patients get to you, and so I don’t think any of us are truly independent in that regard.”
    • “Physicians have little leverage inside those networks. Only 5% of physicians report significant negotiating leverage in private-payer contract talks, and more than 40% report none, according to a Medscape‘s report, “Private-Payer and Government Insurance Report 2026: Medicare, Medicaid, and More,” published Oct. 2.” * * *
    • “Despite continuous shifts in the structures and regulations shaping the physician practice space, Dr. Tambar maintains that strong patient relationships and a desire to stay connected to them is what will keep practices growing in the future — regardless of their independence. 
    • “Long term, obviously, if you’re offering good care to patients, ethical care, that’s how you maintain, right?” he said. “As a physician or as an owner, you have to keep on finding ways to offer value to patients, and whatever treatments are new that can be helpful for the patients, you have to find a way to somehow introduce them and stay relevant and stay present in their minds.”

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the frontier artificial intelligence front

  • The Wall Street Journal reports,
    • “Rogue AI models have hacked companies and tried to break into government websites. Now one has submitted a fake tip for an unsolved crime.
    • “Police in Philadelphia say Anthropic alerted them this week that one of its artificial-intelligence models submitted a false homicide tip through PhillyUnsolvedMurders.com. 
    • In a blog post, Anthropic said the fake tip was among a group of rogue actions the company uncovered recently. The rogue activity also involved websites run by U.S. government agencies at the federal, state and local levels. The company said it has briefed the White House on these cases and notified each agency involved, and plans to report new instances of unintended AI behavior as it uncovers them.
    • “While these cases had minimal impact, we do not want to diminish the findings, because the same behaviors could do far more harm as models become more powerful,” Anthropic said in the blog post.
    • “The false-report incident happened in July. Anthropic didn’t realize it until September.”
  • and
    • “Anthropic edged to the front of the AI race earlier this year with cutting-edge models and a coding tool that corporate America loved. By some measures, OpenAI is now hot on its heels.
    • Demand for Anthropic’s Claude Code was so strong in the spring that the company faced frequent outages and a computing crunch. 
    • “But businesses grappling with mounting costs as more employees experimented with artificial intelligence realized they didn’t always need the most advanced options for most tasks. Companies, which now use a variety of models, increasingly turned to low-cost, open-weight models from China for some tasks. And some Claude users balked at guardrails Anthropic put on its powerful Fable 5 model when it was released in early June.
    • “OpenAI stoked the price war this summer with the release of its GPT-5.6 lineup—Sol, Terra and Luna—giving customers access to models with varying capabilities, including some that are less expensive to run. Its Codex coding product and other business tools are now gaining ground, and it has released additional iterations of its cost-efficient models.
    • “An analysis from OpenRouter, a startup that allows developers to access different models, found that among some 120,000 companies that use Anthropic and OpenAI tools, the share of spending was roughly even between the two AI giants in September. At the beginning of the year, Anthropic commanded three-quarters of that total. OpenRouter said its data largely represents spending by AI-native startups as well as some slightly older tech companies and large enterprises.”
  • and
    • “Mistral said it would soon release a new open-weight AI model that it claimed would rank among the best globally, part of efforts to grow its appeal, lock in more customers and better compete with U.S. rivals.
    • “The French artificial-intelligence startup said it was launching a public preview of Mistral Large 4, dubbed Le Chonk, on Tuesday so it could work with developers, cybersecurity experts and state authorities to evaluate how the model behaves. It plans to release the weights, or the trained parameters of the model, on Oct. 27.
    • “Since its early days, Mistral has been a staunch advocate of open-weight models that are publicly available for anyone to download and modify, saying they give users the flexibility to tailor them to their needs while protecting their data and intellectual property.”

From the cybersecurity policy and law enforcement front

  • The Wall Street Journal reports,
    • “A new White House task force will have 120 days to report on the risks and opportunities of artificial intelligence—and determine the federal government’s responsibility—according to Jay Clayton, the director of national intelligence who effectively becomes the administration’s AI czar.
    • “The president asked that a group be put together that was going to ensure exactly what he said,” Clayton said, that “we stay the leaders in superintelligence, and that the interests of the American people are put first.” 
    • “Clayton will chair the “Super Intelligence Force” which takes President Trump’s preferred name for AI: super intelligence or SI.
    • “The risk of not being first is high,” Clayton said. “Not being first increases the identified, and unidentified, risks, particularly from our adversaries. Being first will better enable us to address those risks on behalf of the American people,” he added.” * * *
    • “The task force will have three vice chairs: Emil Michael, undersecretary of war for Research and Engineering, who will be responsible for coordination with AI companies; Scott Kupor, director of the Office of Personnel Management, who will be responsible for coordination with critical infrastructure providers and other industry stakeholders; and Andrew Ferguson, chairman of the Federal Trade Commission, who will oversee consumer interests and groups advocating for people of faith, children, privacy, freedom of speech, freedom of expression, and freedom of association.”
  • Cyberscoop relates,
    • “Federal government contractors that handle sensitive information could soon face a “sea change” in rules about how they protect that information and report when it has been part of a breach.
    • “Pending federal regulations on the handling of “controlled unclassified information,” or CUI, a category of sensitive data that falls short of classified — including people’s personal information such as Social Security numbers, information that could expose vulnerabilities in critical infrastructure and more — could arrive as soon as the end of this year, but likely no later than the end of President Donald Trump’s term, attorneys who specialize in federal procurement rules said. The changes are part of a larger overhaul of federal contracting rules.
    • As currently written, the proposed CUI rules mandate that unauthorized access of such data, including as a result of a cyberattack, would have to be reported to the federal government within 72 hours of discovery. The rules are a companion for most federal agencies to existing  Defense Department rules that cover the same subject. The 72-hour notice also is deliberately aligned with forthcoming rules from the Cybersecurity and Infrastructure Security Agency (CISA) for critical infrastructure owners and operators to report major cyber incidents under the Cybersecurity Incident Reporting for Critical Infrastructure Act (CIRCIA).” * * *
    • The other major aspect of the proposed rule is that contractors handling CUI would have to abide by certain cybersecurity standards set by the National Institute of Standards and Technology known as SP 800-171, which [Trayce] Howard and her Wiley [Rein] coauthors said would be imposed “on a broader group of contractors than ever before.” Some contractors might also have to meet other cybersecurity requirements, too.
    • “Another thing that will affect contractors is they’re going to have to flow down these requirements to their subcontractors,” she said. “So they’re going to have to identify what CUI am I giving to my subcontractors, and do some sort of oversight to make sure that their subcontractors are appropriately handling CUI.”
  • Cybersecurity Dive tells us,
    • “U.S. government agencies are failing to prepare for the transition to post-quantum encryption, creating the risk that their sensitive data will still be vulnerable to decryption by quantum computers whenever those machines are deployed, according to the Government Accountability Office.
    • Experts are divided over when the advent of cryptographically relevant quantum computers (CRQC) will occur, but GAO bluntly declared in a report published Tuesday [October 6]  that “threats from a CRQC could have devastating impacts to federal systems reliant on vulnerable cryptography.” * * *
    • “In a version of the report not publicly released, GAO recommended 89 actions that CISA and other agencies could take to increase their preparedness. Of the 23 agencies to which GAO assigned recommendations, only 12 fully agreed to implement them. “We continue to believe that all of the recommendations made in the sensitive report are warranted,” GAO said.”
  • The Wall Street Journal notes,
    • A bipartisan group of federal lawmakers is pressing Congress to increase mental-health funding for personnel at U.S. Cyber Command in the wake of several suicides this summer at the command and the National Security Agency. In separate letters, members of the House Armed Services cyber subcommittee and Maryland lawmakers urged leaders of the House and Senate Appropriations panels to back an $11 million request for “High Performance Team Training” at the command. (The Baltimore Banner)
  • and
    • German officials said they infiltrated ransomware group Qilin and detained a 28-year-old Russian national believed to be one of the group’s leaders. The arrest follows months of covert monitoring of Qilin’s activities, the official said. The group is alleged to have demanded more than $3 billion in ransom payments over the past two years from targets around the world. (LIGA)
  • The New York Times adds,
    • “The F.B.I. has arrested a Canadian cybersecurity expert in Pennsylvania on suspicion of carrying out the computer hack that stole sensitive information about thousands of F.B.I. employees, according to two people familiar with the matter.
    • “The theft of reams of personal data last month by a criminal hacking group that calls itself ShinyHunters left the nation’s premier law enforcement agency racing to respond to the investigators and the victims of one of the worst breaches of government data in recent years.
    • “The arrested man is Edward Dubrovsky, who has helped firms victimized by hackers and is now considered by federal authorities to be a primary co-conspirator in the ShinyHunters attack on F.B.I. data, the people said.
    • “Mr. Dubrovsky is the author of a book published last month titled “Cyber Extortion Strategic Response.” While the details of the charges against Mr. Dubrovsky remain under seal in Texas, federal court records in Philadelphia show that he was charged with conspiracy to commit extortion. Mr. Dubrovsky is expected to be transported to Texas to face the charges.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) today announced a settlement with Linda L. Shen d/b/a Shen Smiles, P.C. (Shen Smiles), a Pennsylvania-based healthcare provider that offers dental services, for potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The settlement resolves an investigation of a complaint alleging a failure to provide timely access to an individual’s protected health information (PHI).”
    • “The Notice of Proposed Determination may be found here.
    • “The Resolution Agreement may be found here [PDF, 161 KB].”

From the cybersecurity breaches and vulnerabilities front

  • HIPAA Journal reports,
    • “The scale of a 2025 data breach involving electronic protected health information stored on Oracle Health’s legacy Cerner servers is becoming clearer. While not independently verified, Bloomberg reports that the Texas Attorney General released information suggesting that the protected health information of almost 20 million individuals was compromised in the incident. Oracle Health has not publicly disclosed how many Cerner clients were affected, or the total number of individuals affected.”
  • Security Week relates,
    • “Healthcare organizations Clover Health Investments and AngMar Management Services are notifying more than 250,000 people that their information was stolen in separate data breaches.
    • “Jersey City, New Jersey-based Clover Health Investments was hacked in early July, after attackers used social engineering to compromise three non-managerial health plan employee accounts.
    • “The incident resulted in the theft of personally identifiable information (PII) and protected health information (PHI), the company said in an SEC filing in July.
    • “The potentially affected information included names, dates of birth, insurance identifiers, and account identification numbers, the company revealed.
    • “In mid-September, Clover Health Investments told the US Department of Health and Human Services (HHS) that 138,677 people were affected. HHS added the company to its data breaches portal last week.
    • “Mansfield, Texas-based AngMar Management Services identified suspicious activity on its systems in mid-July and confirmed in early September that hackers stole patient PII and PHI.
    • “AngMar Management Services provides business operations, administration, and support network management for home health and hospice care providers.”
  • The American Hospital Association News tells us,
    • “The FBI and Secret Service released an advisory Oct. 6 warning of ongoing activities by FortiBleed, a global credential-compromise campaign used by threat actors to target internet-facing Fortinet FortiGate firewalls and virtual private network gateways at critical infrastructure organizations. The agencies said the campaign exploits reused or leaked credentials and legacy password storages, allowing threat actors to harvest and decode authentication data at scale. Impacted organizations could be locked out of their systems if threat actors disable accounts or change passwords and would require remediation actions beyond typical patching and password resets. The advisory includes indicators of compromise and mitigation actions to defend against potential attacks.”
  • and
    • “A joint advisory released Oct. 8 by U.S. and international agencies warns of Chinese government-linked cyber threat actors using automated and hands-on hacking tools to steal sensitive data from critical infrastructure organizations, including healthcare, across the U.S. and abroad. The advisory said that the threat actors are enabled by the Integrity Technology Group, a China-based company with links to the Chinese government. The agencies said the threat actors are using automated scanning tools, large-scale botnets and hands-on exploitation techniques to attack Microsoft Exchange servers and virtual private network software. The advisory includes recommendations to help mitigate risk from potential attacks.” 
  • Cyberscoop adds.
    • “The Justice Department and FBI announced that they had seized two hacking tools connected to the Chinese government-linked group Flax Typhoon and a China-based company that the U.S. government has repeatedly taken action against, including with a new multi-agency advisory Thursday.
    • “The domain name seizures were meant to deny hackers access to the vulnerability scanning tool Microscan and the spearphishing tool FishHub created by the Chinese firm Integrity Technology Group, which the United States sanctioned last year. The U.S. government in 2024 also made the company the focus of a takedown operation, saying it was behind a massive botnet.
    • “U.S. agencies paired the announcement of the seizures with an Oct. 8 advisory from the FBI, Cybersecurity and Infrastructure Security Agency and National Security Agency.”
  • CISA added one known exploited vulnerability to its catalog this week.
    • October 4, 2026
      • CVE-2026-88779 Citrix NetScaler Improper Restriction of Operations within the Bounds of a Memory Buffer Vulnerability
        • Cyber Press discusses this KVE here.
  • Bleeping Computer notes,
    • “Attackers are exploiting a maximum-severity vulnerability in SonicWall SMA1000 appliances (CVE-2026-102255) that was patched on Tuesday, three days ago.
    • “Tracked as CVE-2026-102255, the flaw affects the Appliance WorkPlace interface on SMA1000 6210, 7210, and 8200v models, but does not affect the SMA 100 Series product line or SSL-VPN running on SonicWall firewalls.
    • “By abusing this path, a remote unauthenticated attacker could potentially exploit this vulnerability to direct the appliance to issue requests on their behalf and reach internal functionality and perform unauthorized operations,” SonicWall explained.”
  • and
    • “Citrix has warned IT administrators to patch systems immediately against a new critical vulnerability affecting NetScaler ADC networking appliances and NetScaler Gateway secure remote access solutions.
    • “Tracked as CVE-2026-107406, this flaw stems from a memory overflow weakness that attackers can exploit to gain remote code execution (RCE) on targeted devices or trigger a denial-of-service state that can cause crashes.
    • “To be vulnerable, NetScaler ADC and NetScaler Gateway appliances must be configured as a Security Assertion Markup Language (SAML) Identity Provider (IdP) or Service Provider (SP).
    • “We strongly urge affected customers to review the advisory and upgrade impacted NetScaler instances to the recommended versions as soon as possible,” the company said. “As of the publication of the bulletin, Citrix is not aware of any unmitigated exploits of this vulnerability.”
  • Per Cybersecurity Dive,
    • “Hackers may be using AI more frequently and in more ways, but their top priority is still subverting identity controls, the identity-security firm Okta said in a report published on Wednesday.
    • “The report included data about the frequency of different kinds of account takeovers and a reality check to enterprises that AI shouldn’t fundamentally change their calculus when it comes to identity management.
    • “In a separate report also published on Wednesday, Okta detailed how hackers are trying to bypass strong authentication controls to sneak into accounts, underscoring the need for vigilance among both system administrators and regular employees.”
  • Security Boulevard adds,
    • “An analysis of 150 billion transactions flowing through Domain Name System (DNS) servers published today by EfficientIP finds that malware has overtaken phishing as the threat vector now being detected most.
    • “The latest DNS Threat Intelligence Report from EfficientIP finds malware has climbed from fourth place in the second half of 2025 to first in daily activity, having roughly quadrupled between a January and an April peak of 32.6 million instances.
    • “Yaelle Harel, principal security market strategist for EfficientIP, said that while there is no conclusive evidence, that level of increase suggests cybercriminals may now be leveraging artificial intelligence (AI) tools to both create malware and launch attacks faster using newly acquired IT infrastructure resources.”

From the ransomware front

  • Info Security Magazine reports,
    • “Ransomware attacks reached their highest ever quarterly volume in the third quarter of 2026, according to an analysis by Comparitech.
    • “The firm identified a total of 2627 claimed attacks during the three-month period from July to September 2026. This is a 27% increase on the previous quarter, Q2 2026, and a 61% rise compared to Q3 2025.
    • “The finance and technology sectors experienced the biggest growth in ransomware incidents in Q3 compared to Q2 2026, up by 72% and 70%, respectively.
    • “Other critical sectors faced a significant rise in attacks, including education (up 50%), healthcare (39%), government (36%) and utilities (32%).
    • Of the 2627 attacks claimed by ransomware groups in Q3, 247 have been confirmed by the entity involved, Comparitech found.
    • “Rebecca Moody, head of data research at Comparitech, said that the figures are highly unusual, and represent a significant cause for concern.: * * *
    • “A possible explanation for the surge is developments in AI technology, which is enabling ransomware attackers to increase the scale and speed of campaigns, as well as their effectiveness.” * * *
    • “The report highlighted an increase in attackers using triple extortion tactics on victim organizations. In this model, in addition to encrypting systems and exfiltrating data, threat actors also target individuals impacted in the attack.
    • Moody added that this tactic further demonstrates that paying a ransom is no guarantee that the attacker will keep to their word regarding deleting stolen data.
  • Recorded Future News relates,
    • “The University of Illinois Chicago (UIC) recently discovered a ransomware attack that limited access to some systems at its College of Medicine.  
    • “A spokesperson for the university told Recorded Future News the hackers were able to steal some information held on the college’s servers and an investigation is underway to determine whether “any personal, research or academic information was compromised.” 
    • “As a result of this ransomware event, some College of Medicine systems were temporarily unavailable,” the spokesperson said. “However, all affected systems have since been restored. The university’s main network was not affected, and there was no impact on patient care delivery at UI Health.” * * *
    • “The attack was claimed last week by a ransomware gang known as Booba, which claimed to have stolen 344 gigabytes of data. The group emerged at the end of July and has already claimed 49 attacks. 
    • “SentinelOne’s Brett Williams said the group appears to be a rebrand of the Frag ransomware based on the leak site’s style and negotiation flow. Encrypted files are renamed with the .booba extension and there appears to be variants for Linux as well as Windows.  
    • “The group has targeted several companies and small county governments, including Merrimack County, New Hampshire.” 
  • Cyberscoop tells us,
    • “Authorities accuse the owner of a so-called ransomware remediation company of swindling clients victimized by ransomware attacks into paying the company inflated fees under false pretenses.
    • “Zohar Pinhasi, owner and operator of MonsterCloud, claimed he could decrypt and recover victims’ data with specialized, proprietary tools and avoid paying cybercriminals. Yet, no such tool existed, the Justice Department said Wednesday [October 7]. 
    • “Pinhasi allegedly used MonsterCloud clients’ fees to pay off cybercriminals and recover encrypted data without telling clients ransom payments were made on their behalf. The dual “U.S.-Israeli national is accused of charging hundreds of clients more than $19 million and paying more than $8 million in ransom payments during a five-year period ending in 2023.
    • “It baffles me that companies fall for this,” Jon DiMaggio, principal researcher at Arkem Cyber, told CyberScoop. “I mean, they just got hacked and they go straight to a shady source.”

From the cybersecurity business and defenses front,

  • Cybersecurity Dive discusses what the C-suite needs to know about AI governance
    • “As AI adoption surges, executives are learning tough lessons about security, oversight and accountability.”
  • The American Hospital Association News tells us,
    • The National Security Agency Oct. 8 released guidance for critical infrastructure organizations that recommends adopting high-impact zero trust strategies to improve cybersecurity for operational technology. For healthcare, such technology includes tools that manage energy control, HVAC, life-safety systems, door access controls, physical security systems, alarms and medical gasses. Zero trust is a security principle that assumes a compromise is possible or already present and continuously verifies users and devices. The guidance also highlights recent nation-state attacks, including the People’s Republic of China’s prepositioning of disruptive malware known as Volt Typhoon on critical infrastructure entities that healthcare depends on, such as energy. The guidance also explains how threat actors’ use of artificial intelligence is making cyberattacks more sophisticated and potentially more severe.
  • Security Week points out,
    • “All enterprises conduct security awareness training for their employees. But whether this has tangible benefits is debatable.
    • “Empirical evidence suggests that security awareness training isn’t working – successful attacks keep increasing. But opinions on the efficacy of awareness training range from it doesn’t work to it does work, with sometimes, perhaps and depends between the two extremes.
    • “Awareness training focuses on two tasks: to reduce the effect of bad judgment turning an employee into an insider threat; and to harden employees against falling to malicious social engineering. We focus on social engineering.” * * *
    • “Sanny Liao, co-founder and CPO at Fable Security, says bluntly, “For the most part, security awareness training as done today does not work. Social engineering continues to succeed because attackers exploit context, timing, and psychology, while most training remains generic, infrequent, and removed from the moments when employees are actually making decisions.”
    • “She hints at a novel approach. “One place the industry can look for inspiration is adtech. Marketers have gotten remarkably good at changing behavior by delivering the right message at the right time based on context. Security awareness has largely done the opposite by giving everyone the same training at the same time, regardless of the decisions they’re making or the risks they face. When organizations change behavior instead of simply raising awareness, employees stop being viewed as the weakest link and start becoming an active part of the organization’s security defenses.”
  • Per a NIST news release,
    • “For small businesses who are often confronted with limited resources, knowing how to get started and where to find support with planning, implementing, or evaluating a cybersecurity risk management strategy can be challenging — sometimes making cybersecurity feel like an insurmountable hurdle. However, there is good news.
    • “Many non-profit organizations across the United States have created programs for their local small business communities (in addition to local schools, municipal governments, and non-profits) that often extend beyond general cybersecurity education to include services like conducting risk assessments and penetration tests, performing compliance consulting services, helping with incident preparedness and response measures, and more.
    • “The NIST Small Business Cybersecurity Support Program Finder brings these programs together into one tool, connecting small businesses with local non-profit community partners who help with cybersecurity risk management.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

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

Simplicity is a virtue.

From Washington, D.C.,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 9 released its first report on how states are implementing funds from the Rural Health Transformation Program, which will distribute $50 billion to rural providers from fiscal year 2026 to FY 2030. The report covers the period from Dec. 29, 2025, to July 31, 2026. The report details how much each state has allocated for the first year of the program, which would be spent by September 2027.”
  • Over the past week, CMS has issued news releases about contributions to the following State rural health programs:
  • Per Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS) today launched the Newborn Essentials Support Toolkit (NEST) Program at West Virginia University Medicine Golisano Children’s Hospital in Morgantown, West Virginia, marking the next phase of a federal initiative designed to support mothers and babies during the critical first days and weeks after birth.
    • “Led by HHS through the Office of Intergovernmental and External Affairs (IEA) in coordination with the Health Resources and Services Administration (HRSA), NEST provides families with a one-time kit of essential newborn and postpartum supplies, maternal health items, and trusted information and resources around the time of birth.” * * *
    • “NEST Kits are distributed through hospitals, federally qualified health centers, and other organizations providing maternity care to mothers late in pregnancy or around the time of birth. Through these trusted partners, HHS is working to reach families in communities across the country while prioritizing areas where mothers and babies face greater barriers to care and resources.
    • “Through NEST, HHS is building on what families and healthcare providers said worked: providing useful, high-quality supplies at a moment when families need them most, while connecting mothers with trusted information to help care for themselves and their newborns.
    • “For more information, visit hhs.gov/newbaby.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), today announced the recipients of three falls prevention initiatives totaling up to $27.8 million over three years. The funding will expand proven programs, strengthen connections between health care providers and community organizations, and help states and local partners reach more older adults before a fall leads to injury or loss of independence.
    • “Falls are the leading cause of injury for people 65 and older. One in four older adults falls every year, and a fall is rarely just a fall. It can result in an injury or hospital stay, and non-fatal falls account for an estimated $80 billion in healthcare spending per year. A fall can also shake a person’s confidence and make everyday activities — from walking and shopping to visiting friends — more difficult. Healthcare and aging network providers can help prevent many falls by identifying risks early. They can then connect older adults with programs and support that build strength, improve balance, and make their homes safer.
    • “The three initiatives put prevention first and advance the Trump Administration’s Make America Healthy Again agenda. They will connect screening with community support, expand proven programs statewide, and help organizations deliver and sustain them.” * * *
    • “Learn more about ACL’s Falls Prevention Program here.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) provided a new recommendation to the Drug Enforcement Administration (DEA) that establishes science-based thresholds for 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI), potent opioid compounds associated with products marketed as kratom.
    • “The Department of Justice today announced that DEA issued new Notices of Intent reflecting HHS’ updated scientific analysis and recommendations, including a new Notice of Intent for 7-OH and MGPI incorporating HHS’ recommended concentration and ratio thresholds.
    • Following a review of available scientific data and comments, HHS Assistant Secretary for Health Admiral Brian Christine, M.D., recommended that DEA use concentration or ratio-based thresholds to determine which products containing 7-OH and MGPI are subject to Schedule I control for purposes of temporary scheduling of these substances under the Controlled Substances Act.
    • “The recommendation is designed to target concentrated or chemically altered products while distinguishing them from natural botanical kratom products, which may contain trace amounts of 7-OH and MGPI.”
  • Beckers Clinical Leadership adds,
    • “The National Institutes of Health plans to launch a public-private partnership in December to speed development of personalized cancer vaccines, according to an Oct. 9 New York Times report.”
  • NCQA, writing in LinkedIn, tells us,
    • “At the opening of the 2026 Health Innovation Summit in Atlanta, NCQA President and CEO Dr. Vivek Garg, MD, MBA reflected on his first year leading the organization, honored the legacy of healthcare quality pioneers and invited attendees to help shape what comes next. Addressing a room filled with health plans, clinicians, policymakers, researchers, employers, technology leaders and patient advocates, he framed the Summit theme, Quality’s Next Chapter, as both a moment of reflection and a call to action.
    • “A year ago, many of you met me for the first time on this stage, when Peggy O’Kane handed off an organization she spent more than three decades building,” Dr. Garg said. “I’ve spent the year since mostly listening.”
    • That year of listening, he said, clarified NCQA’s mission and reinforced a central belief: “we cannot write quality’s next chapter alone.”

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

  • Bloomberg Law reports,
    • “Food manufacturers can now use salt substitutes in common foods including bread, canned peas, and sour cream under a federal rule regulators updated in an effort to reduce Americans’ sodium intake.
    • “A final rule published Friday in the Federal Register under public inspection loosens requirements that certain foods contain salt under the Food and Drug Administration’s standards of identity, which regulate what a product must contain to be marketed as a specific food.
    • “The regulatory update allowing food makers to use salt substitutes actualizes a proposal from the Biden administration to improve consumers’ diets, as officials raised concern that the average American consumes a level of sodium that’s 50% above the limit recommended by scientists.” 
  • Reuters relates,
    • “Teva (TEVA.TA), opens new tab ​said on Friday it had received approval ‌from the US Food and Drug Administration for Weltruza, a once-monthly injection for adults with ​schizophrenia.
    • “Weltruza is the second US-approved product ​from Israel-based Teva’s partnership with French ⁠biotech company Medincell (MEDCL.PA), opens new tab after Uzedy, a long-acting ​injectable form of antipsychotic drug risperidone, which ​the FDA approved in 2023.”
  • Medical Life Sciences News tells us,
    • “The Alliance for Clinical Trials in Oncology (Alliance) today announced that the U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq®) in combination with fluoropyrimidine and oxaliplatin chemotherapy, for the adjuvant treatment of patients with stage III colon cancer with deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR).
    • “The approval is based on findings from the phase III Alliance ATOMIC (A021502) trial, sponsored by the National Cancer Institute (NCI) and conducted in partnership with Genentech, a member of the Roche Group, and the German group Arbeitsgemeinschaft Internistische Onkologie (AIO). The study demonstrated that patients with stage III colon cancer whose tumors had mismatch repair deficiency (dMMR) experienced significantly improved disease-free survival, a surrogate for overall survival, when atezolizumab was added to standard adjuvant chemotherapy following surgery.”
  • Healio adds,
    • “Medicare coverage is now available for the Fsyx ocular pressure adjusting pump, a device indicated to lower IOP in patients with glaucoma while they are sleeping.
    • “The device consists of pressure-sensing goggles connected to a compact pump that counteracts IOP overnight using negative pressure. CMS reimbursement for the Fsyx ocular pressure adjusting pump (Balance Ophthalmics) became effective on Oct. 1.”

From the Medicare Advantage front,

  • Healthcare Dive reports,
    • “Medicare Advantage star ratings are slipping in 2027, though one major insurer clinched an extreme upgrade.
    • “Humana, which suffered a major ratings collapse two years ago, saw the percentage of its members in 4+ star plans rocket from 41% in 2026 to 93% in 2027, according to a Healthcare Dive analysis of stars data released Thursday by the CMS.” * * *
    • “Alignment Healthcare, which covers some 280,000 members in five states, was one of the biggest losers, after its largest contract slipped below 4 stars for 2027.
    • “It’s a serious setback for the California-based insurer, given the contract covers around three-fourths of its total membership. Next year, Alignment will only have 25% of members in plans rated above that threshold, down from 98% currently.”
  • Beckers Payer Issues delves into Humana’s star rating turnaround.

From the judicial front

  • The American Hospital Association News reports,
    • “The AHA, the Maine Hospital Association and four safety-net hospitals Oct. 9 filed a lawsuit in the U.S. District Court for the District of Maine challenging changes by the Department of Health and Human Services to the 340B Drug Pricing Program that would expand the use of a proposed rebate model previously halted by the courts.  
    • The lawsuit seeks to prevent implementation of the new program, which is scheduled to take effect on Jan. 1, 2027. The rebate program would impose significant new financial and administrative burdens on hospitals that participate in the 340B program. Estimates show the new program could impose more than $1 billion in annual administrative costs on already-strapped hospitals. 
    • “When the government makes a change of this magnitude, it must fully consider what it will mean for the patients and communities that rely on 340B hospitals every day,” said Steve Walsh, president and CEO of the AHA. “The AHA and its member hospitals provided detailed evidence showing that the Rebate Program would impose massive new costs and divert resources that support care for millions of patients. We also proposed viable alternatives that would address concerns about transparency and program integrity without imposing the same financial price tag. For the sake of our shared goal of protecting patients and expanding access to care, those costs, consequences and alternatives cannot be treated as afterthoughts. It’s unfortunate that we are back in court challenging the same flawed program.” 
    • “Following HHS’ attempt to launch a similar rebate program in 2025, both the U.S. District Court for the District of Maine and the 1st U.S. Circuit Court of Appeals faulted HHS for moving forward with a rebate mechanism without adequately accounting for what it would cost the hospitals required to operate it. Shortly thereafter, HHS moved forward with a revised version of the same Rebate Program — only twice as large and even more expensive. 
    • “The AHA and Maine Hospital Association are joined in this action by Eastern Maine Medical Center, Unity Medical Center in North Dakota, Dallas County Medical Center in Arkansas, and Nathan Littauer Hospital and Nursing Home in New York — all community-based healthcare providers that participate in the 340B program.  
    • “See the press release for more details.  

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity.
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country.
    • “COVID-19 activity remains elevated in some regions but is declining nationally.
    • Seasonal flu activity is increasing in many parts of the country but remains low.
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • The American Hospital Association News adds,
    • “There are now 1,136 confirmed measles cases in Pennsylvania this year amid the state’s outbreak, the Pennsylvania Department of Health announced Oct. 9. Of those, 219 individuals have been hospitalized and five people have died. Nationally, there have been 4,080 confirmed cases of measles this year, according to the latest update by the Centers for Disease Control and Prevention. Of those, the vaccination status of 95% of cases is unvaccinated or unknown.”
  • and
    • “A study by the University of Minnesota Rural Health Research Center found that between 2007 and 2023, the percentage of midwife-attended births rose in both rural and urban settings and was higher in states that had full midwifery practice authority policies. The study, supported by the Federal Office of Rural Health Policy, used data from the Centers for Disease Control and Prevention and the American College of Nurse-Midwives. In 2007, 13 states and Washington, D.C., had full practice authority policies. From 2008 to 2023, 20 more states passed such policies. Overall, there was growth during the study period among states without full practice authority policies, states that passed policies in 2007 or earlier, and states that passed policies during the study period.”
  • Beckers Clinical Leadership breaks down the measles cases by State and tells us,
    • “Flu season is arriving weeks earlier than usual this year, with health system, retail pharmacy and federal surveillance data all showing activity rising ahead of schedule.”
  • Health Day informs us,
    • “HPV vaccination may reduce pregnancy complications.
    • “Women vaccinated against HPV had lower risks of preterm birth, early rupture of the amniotic sac and having a very small baby.
    • “Women vaccinated before age 17 showed stronger benefits.”
  • and
    • “Exercise might help slow the mental and physical problems associated with Parkinson’s disease.
    • “Patients who got the most exercise had slower declines in movement, thinking and memory.
    • “More than eight hours of physical activity weekly produced the greatest benefits.
  • and
    • “Among patients with cancer with a genetic variant that increases the risk for hereditary cancers, personalized support significantly increases the likelihood that their first-degree relatives complete genetic testing as well, according to a study published online Sept. 29 in the Journal of Clinical Oncology.”
  • Per NewsNation,
    • “The American Society of Hematology (ASH) has adjusted the standards for diagnosing iron deficiency in order to address the underdiagnosis of the condition.
    • “Iron deficiency impacts about two billion people worldwide and about 10 million American adults, according to a statement published by ASH. If left untreated, the condition can progress to iron deficiency anemia. One of the most common types of anemia. 
    • “It occurs when there’s a lack of iron in the blood, preventing the body from making hemoglobin. This is the molecule that carries oxygen throughout your body, according to the Cleveland Clinic.“
  • Medical Economics notes,
    • “Adding a brief safety reminder to the instructions given to artificial intelligence (AI) models reduced potentially harmful clinical choices in 19 of 20 models tested, according to a new study from researchers at the Icahn School of Medicine at Mount Sinai.
    • “The study, published September 26 in Communications Medicine, a Nature Portfolio journal, evaluated more than 10 million responses from 20 large language models (LLMs). Without a safety reminder, potentially harmful choices made up 16.6% of model responses. With a brief reminder added, that rate fell to 10.1%.
    • “Across all responses, the models made about 1.18 million potentially harmful clinical choices, the researchers reported.
    • “The researchers said the findings suggest that how AI systems are prompted and guided remains an important consideration in building safe and reliable clinical applications, even as newer models and AI agents become better at understanding a user’s intent without lengthy or detailed instructions.”
  • The New York Times points out,
    • “Last year, nearly 100 people tried a new form of medical care at Beth Israel Deaconess Medical Center in Boston. After scheduling a visit with the hospital’s urgent care facility, they discussed their ailments with a Google chatbot before meeting with their doctors.
    • “The bot explored their symptoms, the possible causes of their maladies and the potential treatments, before generating a summary of each conversation. Doctors could then review the bot’s summary in preparation for a patient’s visit.
    • “These patients were part of an eight-month clinical trial that explored whether this specialized chatbot could assist primary care physicians without providing misleading or otherwise harmful information.
    • “In the first-of-its-kind study, published on Thursday in the medical journal The Lancet, the hospital’s primary care physicians said that the bot was helpful in about 75 percent of patient cases, and that the technology may have changed the way they handled more than half of those cases. “They compared it to a high-performing medical student or resident,” said Peter Brodeur, a resident physician at Beth Israel.”

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

  • Fierce Pharma reports,
    • “As GSK works on a nearly $1 billion expansion at one wing of its Pennsylvania operations, the U.K.-headquartered Big Pharma is unveiling a similarly sized outlay to soup up another site across the state. 
    • “All told, GSK is plugging more than $800 million into an overhaul of its facilities in Upper Merion Township, where construction is slated to kick off next year, according to an Oct. 9 release from the office of Pennsylvania Governor Josh Shapiro. 
    • “The goal is to set up a biopharma “innovation and manufacturing hub,” per the Governor’s release, which will ultimately wed commercial production and R&D activities at a single site with the aid of digital technologies.”
  • and
    • “Prescriptions for Lilly’s Foundayo and Novo’s Wegovy pill pulled back a little during the last week. In its 26th week of launch, Foundayo achieved 57,920 total scripts, down 9.9% sequentially, according to IQVIA data cited by Citi. 
    • “For oral Wegovy, Citi said IQVIA recorded roughly 179K scripts, while Jefferies quoted 180K. To reconcile the discrepancy between the two numbers, we used 179.5K, which translates into a 1.4% weekly decline.
    • “In fact, scripts for all major GLP-1s declined last week across diabetes and obesity care, save for Lilly’s Zepbound KwikPen, a prefilled injection pen that delivers four fixed weekly doses of tirzepatide, according to Jefferies. Overall Zepbound scripts dipped below 800K in a 0.8% decrease sequentially, just as Novo’s total Wegovy scripts fell 2.7% to 505.5K, according to Citi.
    • “Based on the numbers, Jefferies now models $208 million for Foundayo sales in the third quarter, which the team noted is in line with consensus.” 
  • Beckers Payer Issues relates,
    • “Fortune recognized five healthcare companies on its 2026 “AIQ 75” ranking.
    • “Fortune partnered with Enterprise Technology Research and pulled from ServiceNow’s Enterprise AI Maturity Index. The team assessed how Fortune 500 companies, the largest U.S. companies by revenue, deploy AI and value those investments. Fortune released its first inaugural AIQ ranking in 2025.” * * *
      Here is where the five healthcare companies landed:
      • 30. UnitedHealth Group (No. 3 on Fortune 500)
      • 31. Elevance Health (No. 18 on Fortune 500)
      • 36. DaVita (No. 331 on Fortune 500)
      • 48. Pfizer (No. 73 on Fortune 500)
      • 75. Thermo Fisher Scientific (No. 106 on Fortune 500)
  • and
    • “The Blue Cross Blue Shield Association is bringing its data and analytics work “under one internal umbrella,” the organization confirmed to Becker’s Oct. 9.
    • “The former CEO of Blue Health Intelligence, an analytics company that has been a BCBSA licensee, said he wrapped up his work with the association in September after “supporting the integration of Blue Health Intelligence back into BCBSA.”
    • “I’m excited about the opportunity for the combined team to have an even greater impact on healthcare quality and affordability,” former BHI CEO Bob Darin said in an Oct. 8 LinkedIn post.
    • “A BCBSA spokesperson said the integration will help the association “better leverage data-driven insights to identify how we can lower costs, reduce friction and improve the healthcare experience for patients, employers and providers.”
  • Beckers Hospital Review tells us,
    • “Revised federal price transparency rules have made hospital price data clearer, but several issues still complicate price comparisons, according to an Oct. 7 analysis from the Peterson-KFF Health System Tracker.
    • “The revisions to the 2021 hospital price transparency rule took effect in January, and CMS began enforcing them in April. Hospitals must now post a negotiated rate as a dollar amount whenever the final payment can be known before care is delivered. When a rate is a percentage or a formula, hospitals must also report “allowed amount” data: the median, the 10th and 90th percentile payment amounts, and the number of payments.
    • “The researchers reviewed machine-readable files compiled by Turquoise Health and downloaded between July 17 and Aug. 2. They examined two common inpatient admission codes, MS-DRGs 280 and 807, in several local markets and reviewed national patterns across 6,445 hospitals.
    • “These complications reflect the complexity of payment arrangements between hospitals and payers,” the report stated.”
  • and
    • “Fifty-seven hospitals across 22 states have converted to rural emergency facilities since the law that created the designation took effect in January 2023, according to data from CMS.
    • [The article identifies] the hospitals that have converted to rural emergency status, by state.
  • and
    • “A $75,000 donation from Covenant Presbyterian Church in Austin, Texas, has helped erase $14 million in medical debt for 10,865 residents through a partnership with nonprofit Undue Medical Debt, The Austin American-Statesman reported Oct. 9.
    • “The church used part of a $200,000 budget surplus to fund the relief, targeting residents in an area of Travis County with significant financial need, according to the report. Recipients are being notified by mail the week of Oct. 9 and do not need to take any action to receive the relief.”
  • Beckers ASC Review points out,
    • “Cardiology is shaping up to be the next big ASC specialty, following the path GI took in the 1990s and orthopedics in the 2010s. Medicare’s 2026 decision to pay for cardiac ablation in ASCs, a proposed 2027 rule that keeps widening the door and payer pressure on site-of-care have pushed cath and EP labs onto ASC leaders’ agendas.”
  • Beckers Physician Leadership notes,
    • “Health systems want physicians to be more productive, and physicians want to be paid fairly for the work they do. 
    • “Somewhere between those two goals, many compensation models break down — either rewarding volume at the expense of everything else or offering so much guaranteed pay that productivity has no meaning.
    • “Westchester Medical Center Health Network, based in Valhalla, N.Y., is working through that tension now. The system is building a new physician compensation structure as it expands its medical group, which includes roughly 1,100 to 1,200 academic and community practitioners, and shifts from an inpatient-centric mix close to 80/20 toward something nearer 50/50 or 60/40 ambulatory.” * * *
    • “The risk in any productivity-based model, Dr. Tedjarati said that physicians start to feel like a cog in a machine. The structure has to signal that the organization still values them for who they are and what they bring, and that they remain part of a larger mission. Because institutions are constantly competing for the same physicians, he said, getting that balance wrong carries a real cost.
    • “It’s really about agility. It’s about agility and creating comp models that people can understand,” he said.
    • “When those pieces are in place, Dr. Tedjarati said, the incentive structure becomes something physicians can see themselves succeeding in rather than something imposed on them.
    • “I think people do well when they know where they’re starting and where they’re going to, and that if they happen to be more productive and more efficient, maintaining the quality that is required, then they should be appropriately rewarded and compensated,” he said.”