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.”