Monday report

SCOTUS

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–Agentic & Generative AI, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, SCOTUS, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Both Houses of Congress have left Capitol Hill for the campaign trail.
  • SCOTUSblog reports,
    • The Supreme Court’s 2026-27 term will officially kick off on Monday [October 5]. The justices will hear argument that morning in two cases: Suncor Energy Inc. v. County Commissioners of Boulder County, on whether a lawsuit filed in Colorado state court seeking to hold energy companies responsible for their alleged role in climate change can go forward, or whether federal law instead bars such claims; and Johnson v. United States Congress, on whether a federal district court may hear a constitutional challenge to a law limiting disability benefits for certain incarcerated veterans.”
  • The Centers for Medicare and Medicaid Services announced last Thursday,
    • Medicare Improvement Fund Premium Rebate Frequently Asked Questions
    • Q: What will the Medicare Improvement Fund do for Medicare beneficiaries? 
    • A: The Administration is making a $90 Premium Rebate available for Part B premiums to certain Medicare beneficiaries because the best way to improve Medicare is to put healthcare dollars back where they belong – in the hands of our Medicare beneficiaries – and make coverage more affordable. 
    • Q: How much is the Medicare Improvement Fund Premium Rebate and when will beneficiaries receive it?
    • A: Eligible beneficiaries will receive one $90 rebate in October 2026. Most beneficiaries will receive a direct deposit for $90 on or around October 8th followed by an email or a letter from the President in mid-October. Some beneficiaries will receive a paper check for $90 from the U.S. Department of the Treasury later in October with the following accompanying message “Medicare Improvement Fund Payment; $90 Payment to Offset October Premium.” 
    • Q: Who will receive the Medicare Improvement Fund Premium Rebate?
    • A: The 20.8 million Americans in Original Medicare Part B who are: (1) Living in the United States, are (2) not receiving premium assistance from Medicaid; or, (3) not paying an Income-Related Monthly Adjustment Amount. Beneficiaries enrolled in Medicare Advantage are not eligible.
  • FEHBlog observation — While the FEHBlog is on Original Medicare Part B and lives in the U.S. he is ineligible for the rebate because he pays an IRMAA fee on top of his Part B premiums. It’s still a good deal.
  • 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 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.
    • “Members of the task force will include Vice President JD Vance, Defense Secretary Pete Hegseth, Richard Walters, White House deputy chief of staff, Bessent, Wiles and others. External participants will include venture capitalists David Sacks, co-chair of the president’s Council of Advisors on Science and Technology and Condoleezza Rice, former Secretary of State in the George W. Bush administration, who will provide advice on national security.”

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

  • My Federal Retirement considers whether “Fraud is driving your FEHB premium increase based on what OPM’s numbers reveal.
    • OPM’s numbers fail to consider that the proper payment rate for the carriers that cover the vast majority of FEHB and PSHB members is 99.9% according to paymentaccuracy.gov and what’s more OPM, not withstanding carrier requests, has not implemented the HIPAA 820 electronic roster transaction which would allow carriers to reconcile premiums with individual enrollee coverage. The HIPAA 820 has been around since 2012.
  • FedSmith reports,
    • “Seven months ago, the OPM retirement backlog stood at a record 65,237 claims. At the end of September 2026, it stood at just 8,814, the lowest total in data going back to January 2012.
    • “September also closed out fiscal year 2026 (FY 2026), which ran from October 2025 through September 2026. It was by far the busiest year in the data for both incoming and completed retirement claims.
    • “New claims received: 179,958, up 59% from FY 2025 (112,857) and well above the previous high of 116,463 in FY 2013
    • “Claims processed: 178,551, up 70% from FY 2025 (104,800)
    • “Backlog: began the year at 23,552, peaked at 65,237 in February, and ended at 8,814
    • “The wave of claims that defined the first half of the year followed the end of the deferred resignation period in September 2025 and broader reductions to the federal workforce. Monthly intake has since settled back toward more typical levels, with fewer than 9,000 new claims in three of the last four months.”
  • FEHBlog observation: The favorable change is attributable to the OPM Director’s implementation of a digital retirement claim system. The HIPAA 820 would similarly reduce the time needed to process premiums and for the first time allow carriers to reconcile premiums with individual enrollments.

No Surprises Act News,

  • The Centers for Medicare and Medicaid Services announced last Friday
    • “On November 1, 2026, the Notice of IDR Initiation web form will include new functionality to enforce certain batching provisions under the Federal IDR Operations Final Rule (final rule).
    • “The new functionality to be added to the Notice of IDR Initiation web form includes:
    • Any batched dispute submitted with an open negotiation period start date on or after November 1, 2026, will be limited to 50 dispute line items.
    • “System validations will enforce the timely initiation of a dispute after a 30-business-day cooling off period by preventing any dispute initiated after the cooling off period from being initiated before the end of the cooling off period or more than 4 business days after the end of the cooling off period.
    • “In addition to the Notice of Initiation web form changes, the payment determination letters will reflect the correct cooling off period based on the dispute type and open negotiation period start date.”
  • CMS Notes:
    • “Batched disputes with an open negotiation period start date before November 1, 2026, will continue to be subject to the 90-calendar-day cooling off period.
    • “Single and bundled disputes will also continue to be subject to the 90-calendar-day cooling off period regardless of the open negotiation period start date.
    • “For disputes subject to a 90-calendar-day cooling off period, disputing parties will continue to have 30 business days after the end of the cooling off period to submit a dispute to the Federal IDR process for any items or services whose open negotiation period expired during the cooling off period.
    • “System validations will continue to prevent any dispute from being initiated before the end of the 90-calendar-day cooling off period.
    • “Furthermore, system validations were added on September 24, 2026, to enforce timely initiation of disputes following a 90-calendar-day cooling off period, preventing any dispute initiated after the cooling off period from being initiated more than 30 business days after the end of the cooling off period.”‘

From the public health and medical research front,

  • The New York Times reports.
    • “The Food and Drug Administration said on Friday that it had found two samples of the cyclospora parasite during its investigation of Taylor Farms facilities in Mexico, strong new evidence that an outbreak that sickened thousands in the United States this summer came from lettuce produced by the company.” * * *
    • “Also on Friday, the F.D.A. announced a series of actions intended to prevent future cyclospora outbreaks. Those included greater surveillance of foods that have caused past outbreaks, which can include cilantro and raspberries, and outreach to growers about how to reduce the risk of produce contamination with the parasite.
    • “It is difficult to know whether those steps will be effective at preventing future outbreaks, since the F.D.A. has not yet determined how the lettuce at Taylor Farms was contaminated, said Jim Gorny, a produce safety expert who retired from the agency in 2024.
    • “Aside from that,” he said, “it’s just a recommitment to employ the same strategies and tactics over and over again hoping for a different outcome.”
    • “Bill Marler, a lawyer based in Washington State whose office represents about 500 people sickened in the outbreak, said there is still more to learn from additional analysis of the samples from the inspection and stool samples of those who fell ill.
    • “But before next growing season, he said, it would be ideal if federal officials could invest in the development of a water test to routinely surveil water for cyclospora, which does not currently exist. He would also like to see officials enforce a federal rule requiring food companies to hand over supply chain records in 24 hours after a product is implicated in an outbreak.
    • “The F.D.A. finalized such a rule but delayed its implementation last year, potentially slowing down the response to this outbreak, The New York Times found.”
  • The Independent relates,
    • “Florida is experiencing its largest dengue outbreak in decades, with 252 locally acquired cases reported as of late September, among the highest totals seen in the continental U.S. in several decades.
    • “The vast majority of cases have been reported in Hillsborough County, home toTampa, where officials are ramping up mosquito-control efforts, according to the latest numbers released by state health officials. Florida has also recorded 245 travel-associated cases this year, while at least 13 Hillsborough County cases involved people who had recently traveled.
    • “The surge has prompted Hillsborough, Pasco and Pinellas counties to declare local states of emergency and step up efforts to kill mosquitoes and eliminate standing water where they breed.” * * *
    • “Dengue is a viral infection spread primarily through bites from infected Aedes aegypti and Aedes albopictus mosquitoes, both of which are found in Florida. Some people have no symptoms, while others can develop a sudden fever, severe headache, pain behind the eyes, muscle and joint pain, nausea or vomiting.
    • “Most people recover, but dengue can sometimes become severe, causing bleeding, shock and death. Florida has reported one dengue-related death this year, involving an elderly Tampa woman who died on September 4.”
  • MedPage Today reminds us,
    • “It’s October and time for flu shots.
    • “Medical experts urge getting a flu vaccination soon, before influenza starts spreading widely — and to get up to date on protection against other fall respiratory viruses, too. Updated COVID-19 shots are available now, plus shots for people especially vulnerable to another winter risk, respiratory syncytial virus (RSV).
    • “While these infections make many people feel miserable for a few days before they recover, every year flu alone causes hundreds of thousands of hospitalizations in the U.S. and kills tens of thousands.”
  • Surprisingly, Health Day informs us,
    • “Colon cancer in U.S. adolescents is on the rise, experts say, and a new report finds it’s typically caught in its more deadly later stages.
    • “Colorectal cancer is, unfortunately, becoming more common in adolescents and young adults and represents a different disease than colorectal cancer diagnosed in older adults,” said study author Dr. Erica Arnold, a pediatric surgery research fellow at Nationwide Children’s Hospital in Columbus, Ohio.
    • “She said colon cancer diagnosed in adolescents “is often aggressive, presenting with late-stage disease and associated with high rates of disease relapse and mortality.” She spoke in a news release from the American Academy of Pediatrics (AAP).” * * *\
    • “The study said symptoms that could indicate colon cancer in young people include unexplained weight loss, rectal bleeding, back/abdominal pain and changes in bowel habits. 
    • “Because colon cancer is so unexpected in this age group, diagnosis is often delayed, the study group warned. 
    • “Children and adolescents without known colorectal cancer predisposition syndromes experience delays in diagnosis and the majority do not have a known family history,” the researchers noted in their study. 
    • “Routine colon cancer screening for people at average risk usually begins at age 45.
    • “The study authors urged physicians to consider this cancer in any young person presenting with symptoms such as abdominal pain or rectal bleeding. 
    • “Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal.”

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

  • The New York Times reports,
    • Starting Thursday [October 1], women across the United States will be able to find out their risk of developing breast cancer in the near future with the help of an A.I. tool that examines a single recent mammogram.
    • “Everlywell, a digital health company, announced it would now offer patients nationwide access to Clairity Breast, an A.I. tool approved by the Food and Drug Administration last year to predict a woman’s five-year risk of breast cancer based on imaging. The test, which was previously available only at select locations in Massachusetts and Colorado, will cost $249. It is not covered by insurance.
    • “Doctors use mammograms to detect the presence of cancer, sometimes with the help of A.I. models that can read the images. But Clairity’s software uses the scans for a different purpose: predicting the risk of developing cancer and providing a probability score that reports the patient’s future risk in the form of a percentage, from zero to 100.
    • “That score, which doctors should consider along with other clinical information like family and patient medical history and other risk factors, could aid in efforts to detect cancers earlier, when they are more treatable and more likely to have better outcomes, said Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in Paramus, N.J.”
  • BioEngineer relates,
    • “Sleep problems in children are far more than a nightly nuisance for exhausted families. According to a recent nationally representative study by Carney and colleagues published in the Journal of Clinical Sleep Medicine, sleep disorders among children and adolescents in the United States add an estimated 2.88 billion dollars in health care expenditures every year, a burden significantly higher than that carried by children without sleep disorders.
    • “The finding, highlighted in an open access commentary by pediatric sleep specialist Sally L. Davidson Ward of Children’s Hospital Los Angeles and the Keck School of Medicine of USC, reframes pediatric sleep health as a major economic and public health issue rather than a niche clinical concern. The commentary argues that recognizing, treating, and where possible curing sleep disorders in individual children could simultaneously reduce spending, improve quality of life, boost school attendance, and free parents to work and care for their families.
    • “The underlying evidence comes from the Medical Expenditure Panel Survey, administered by the US Agency for Healthcare Research and Quality, covering the years 2017 through 2022. This survey is unusual in that it captures data from households themselves as well as from their medical providers, including clinics, hospitals, home health agencies, and pharmacies, along with a sample of insurance plans offered by employers. Crucially, the analysis adjusted for covariates and comorbidities that either facilitate or impede access to health care, or that influence the perceived need for care. That methodological rigor matters, because the question of whether sleep disorders drive excess spending, or whether sicker children simply use more services of every kind, is exactly the kind of confounding that national datasets can help untangle when handled carefully.”
  • The Washington Post discusses how to use patient advocates at the time of a family health crisis.
  • Last but certainly not least, AHIP created an illuminating infographic breaking up a dollar bill based on prescription drug spending.
    • “Health plans and PBMs [combined] retain just over one cent of every dollar spent on prescription drugs as profits — compared to 6.5 cents brand manufactures take in profits.”

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • AHIP reports,
    • “The House Ways and Means Committee’s recent advancement of the Apples to Apples Comparison Act (H.R. 4093) signals policymakers recognize the growing need for more accurate data and assessments comparing Medicare Advantage (MA) and fee-for-service (FFS) Medicare. If enacted, this legislation would require Medicare to report more complete expenditure data and direct the Medicare Payment Advisory Commission (MedPAC) to compare MA and FFS using a more transparent and reliable methodology. 
    • “Key Context: Accurate and reliable analyses are essential to understanding how MA compares to FFS. It requires accounting for key differences between the programs – including the benefits provided within MA, different enrollment requirements, and demographics and health characteristics among MA enrollees. 
    • “A growing body of research points to significant questions and concerns with MedPAC’s current approach to comparing spending in MA and FFS, including its estimates of alleged favorable selection into MA and failure to account for the key programmatic, enrollment, and other differences.
    • “The Apples to Apples Comparison Act would address these concerns and ensure that policymakers have the information needed to accurately assess both programs.
    • “Why It Matters: Accurate comparisons between MA and FFS show that MA provides better care at lower costs than FFS. With 36 million American seniors and people living with disabilities choosing MA, policymakers should ensure they protect and strengthen MA for the seniors who count on it.”
  • Beckers Behavioral Health relates,
    • “HHS will provide $96 million over four years to eight communities through its new Safety Through Recovery, Engagement, and Evidence-based Treatment and Support program.
    • “The funding will help communities build coordinated systems of care for people who are homeless and have serious mental illness, substance use disorders or co-occurring disorders.
    • “The program combines street-based engagement and treatment with recovery supports, housing and other community services.
    • “The Substance Abuse and Mental Health Services Administration will administer the STREETS program, according to an Oct. 2 news release from HHS. Each selected community will receive $3 million a year for four years.”
  • and
    • “The 988 Suicide & Crisis Lifeline has brought back specialized crisis support for LGBTQ+ youth through its “Press 3” option, with the service available again starting Sept. 30, the Los Angeles Times reported Oct. 1.
    • “Launched in 2022 in partnership with the Trevor Project, the option connects callers and texters directly with counselors trained to support young LGBTQ+ people. The service was suspended in July 2025 after the Substance Abuse and Mental Health Services Administration said it would “no longer silo LGB+ youth services” from the general hotline.”
  • STAT News tells us,
    • “Finding information from the National Institutes of Health about human health, disease, and biomedical research is about to look a lot different. On Monday, the NIH will unveil a new version of its website that shifts attention away from individual institutes and centers and towards eight thematic hubs focused on health, research, data, clinical studies, rare diseases, technology, cancer, and grants.
    • “Agency officials say the redesign — which is part of an ambitious project to consolidate the NIH’s digital footprint — is intended to streamline what was a sprawling and fractured information ecosystem, requiring users to understand NIH’s organizational structure, into an intuitive experience that more closely reflects what type of information people seek out most often.
    • “The goal, said NIH deputy director for public affairs, Amanda Fine, is “to make trusted NIH information across the agency easier and faster to find.”
    • “The beta version, which was soft-launched this week, is still under development and will continue to evolve in the coming months, NIH officials told STAT. Some functions, including search, do not yet appear to be operational. During this transition period, NIH’s existing websites will continue to remain available, and they will sunset on a rolling basis “as critical and mandated content is verified and redirects are put in place,” Fine told STAT.” 

From the Medicare Advantage front,

  • Beckers Hospital Review reports,
    • “SCAN Health Plan and Costco shared Oct. 1 that their co-branded Medicare Advantage plans will go live in California and Nevada in 2027.
    • “The HMO will be available in 17 California counties and two Nevada counties on Jan. 1, a SCAN news release said. This is Costco’s first time offering MA.
    • “Entering Medicare Advantage is a natural extension of our commitment to delivering quality and value for our members,” Richard Stephens, Costco’s senior vice president of pharmacy, said.
    • “The plans do not include Costco memberships, but non-Costco plan members can use over-the-counter benefits and get hearing aids and eyewear elsewhere.”
  • “KFF Examines the 2027 Marketplace for Medicare Advantage and Part D Stand-Alone Drug Plans.”
    • “A companion analysis of the stand-alone Part D prescription drug plan (PDP) marketplace finds that the number of stand-alone plans available to the average beneficiary will fall for the fourth year in a row, from 11 in 2026 to 9 in 2027. It also finds that many PDP enrollees will see premium reductions or only modestly higher premiums in 2027 if they keep their current plan, while others will face substantially higher premiums unless they switch.
    • “Notably, there will be no zero premium PDPs available for Part D enrollees in 2027 (except low-income beneficiaries who receive extra financial help from the government.) That means that 4 million PDP enrollees who paid no monthly premium in 2026 will face higher premiums in 2027 if they keep PDP coverage.” 

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

  • Govexec reports today,
    • “Federal employees and retirees will pay an additional 10.9% on average toward their health insurance premiums in 2026, the third straight year of double-digit increases, according to the Office of Personnel Management.
    • “The government’s share of Federal Employee Health Benefits Program premiums will increase by an average of 8.6% in 2026, making the overall cost increase 9.3%. This year, the increase in employees’ share of insurance premiums was 12.3%, and in 2025 that increase apexed at 13.5%.”
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *
    • As in past years, OPM encouraged federal workers to shop around from among the more than 100 insurance plan offerings and to take advantage of using pre-tax money to pay for out-of-pocket costs via a flexible spending account. New for next year is the availability of a debit card via FSAFEDS, reducing some of the administrative burden of needing to submit paperwork and receipts for reimbursement.
    • Kevin Moss, a senior editor with Consumers’ Checkbook’s Guide to Health Plans for Federal Employees, said it is more important than ever to actually follow that advice. That’s because hidden behind the average premium increase figures are a number of wide swings on the individual plan level.

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

  • Fierce Pharma reports,
    • “The FDA has approved Bristol Myers Squibb’s application to expand the label of its cardiac myosin inhibitor, Camzyos, to include pediatric patients.  
    • “Camzyos is used to treat symptoms and improve functionality in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), a genetic condition that causes the heart muscle to thicken. Camzyos was first approved to treat adults in 2022, and the new approval makes it the first oHCM treatment available to pediatric patients.” 
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has accepted CeleCor Therapeutics‘ new drug application (NDA) for zalunfiban (Disaggpro). The investigational drug was developed to treat ST-elevation myocardial infarction (STEMI) heart attacks to dissolve clots and reopen the coronary artery as soon as possible to prevent death or irreversible heart damage.
    • “Zalunfiban is a new type of small-molecule inhibitor of the platelet GPIIb/IIIa receptor that is designed to quickly prevent clotting during a heart attack.
    • “The company presented positive Phase 3 clinical trials results from its CeleBrate study at the 2025 American Heart Association (AHA) Scientific Sessions, and those findings were later published in The New England Journal of Medicine Evidence.[1] The multinational CeleBrate study found that rapid zalunfiban treatment for STEMI at the first point of medical contact reduced the risk of cardiovascular events over 30 days following treatment.”

No Surprises Act news,

  • Per a Centers for Medicare and Medicaid Services news release,
    • “On Thursday, October 1, 2026, the Centers for Medicare & Medicaid Services (CMS) convened leaders from across the federal government and from certified independent dispute resolution (IDR) entities to discuss issues impacting the federal IDR process. CMS Administrator Dr. Mehmet Oz, Department of Labor Assistant Secretary Daniel Aronowitz, and officials from the Departments of Health and Human Services, Labor, and the Treasury (the Departments) met with representatives from all certified IDR entities to address the increasingly high IDR-associated costs affecting the United States healthcare system. The ideas discussed in the meeting build on the system reforms that were a part of the Federal IDR Operations final rule as well as the fundamental technological evolution of the Federal IDR Portal into the IDR Gateway, which will launch in late 2026.” * * *
    • “The No Surprises Act has succeeded in its primary objective: protecting American consumers from surprise medical bills. The Departments and certified IDR entities expressed their shared responsibility to improve the federal IDR process. The participants, representing all active certified IDR entities, are committed to enhancing their processes in collaboration with the Departments. 
    • “The Departments will consider the insights offered by the certified IDR entities as they continue to explore all available regulatory and operational solutions.”

From the judicial front,

  • The SCOTUSblog reports today,
    • “On Thursday, the Supreme Court added three new cases to its oral argument docket for the 2026-27 term, including a case on the Trump administration’s policy of detaining noncitizens apprehended within the United States (as opposed to at the border) without the opportunity for a bond hearing and a dispute over the enforcement of zoning ordinances against religious institutions.” * * *
    • “Unlike past years, OPM did not provide reporters with the average premium increases for the three plan types—self, self plus one and family—on a per paycheck basis. When asked for the information, the agency sent a copy of its “Open Season Highlights” document, and then a collection of spreadsheets listing every FEHB plan’s premium increase.” * * *

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 low but is increasing.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.”
  • The University of Minnesota’s CIDRAP calls to our attention
    • “With three months left of 2026, the United States is closing in on a number of measles cases that would have been unheard of just a couple years ago. With 228 new cases logged this week, the country reached 3,886 infections, just 114 shy of 4,000, according to the Centers for Disease Control and Prevention’s (CDC’s) weekly update today.
    • “It could top that milestone next week. And US cases could be more than double the 2025 total this month.
    • “The national wave comes as Pennsylvania, the nation’s hot spot, adds more than 100 new cases in the past week to its total for the year. More than two-thirds of the cases in the state involve adults. * * *
    • “Cases in other states are also climbing. The Wisconsin Department of Health Services today added 72 infections to its total, which has now grown to 243. Kentucky added 27 new cases and has 94 for the year. And Ohio’s health department lists 206 measles cases, which is 17 more than last week. Utah lists 527 cases, nine of which are new.”
  • and
    • “Measles infections make people miserable for up to two long weeks, commonly causing dangerously high fevers, a painful sensitivity to light and, of course, a tell-tale red rash.
    • “Sufferers who escape without developing pneumonia, brain swelling, or other serious complications may believe the worst is over. 
    • “Yet the measles virus has only gotten started.
    • “The virus also damages the immune system, leaving people vulnerable to other infections for up to five years.
    • “The rash and the fever, that’s the tip of the iceberg,” Michael J. Mina, MD, PhD, coauthor of two seminal studies in Science on the effect of measles on the immune system, told CIDRAP News. “The majority of the damage being done is under the surface.”
  • The Wall Street Journal reports,
    • “Grip strength is increasingly being viewed as an important biomarker of our overall strength and fitness.
    • “While not used as widely as body-mass index, or BMI, as a screening tool for health, doctors and researchers say awareness of its value is growing. That’s happening as research shows that grip strength is associated with future health risks and even longevity. 
    • “At the University of Michigan Medical School, many clinics test patients’ grip strength, says Mark Peterson, a professor of physical medicine and rehabilitation. 
    • “We do it with our older populations but I have also gotten it pulled into clinics in our neurological population,” he says.
    • “Some doctors think grip strength should be used more routinely in wellness appointments. “I have really tried to encourage geriatricians to think about incorporating grip strength, it seems to trump almost every single measure including cardiovascular fitness training,” Peterson says.
    • “Even in children, studies have found grip strength to be associated with cardiometabolic health.” 
  • Nature relates,
    • “Armed with new tools and fresh optimism, researchers seeking to subdue pancreatic cancer — one of the world’s deadliest — are chasing a radical strategy: cancer interception.
    • “In this approach, tissues that are growing abnormally are treated to keep them from turning cancerous and spreading. Interception is already being trialled for breast and skin cancers, among others. But now the success of a new drug that quashes pancreatic tumours is raising scientists’ hopes that interception could succeed even for this recalcitrant cancer.
    • “Cancer interception was one of the main themes at September’s American Association for Cancer Research Conference (AACR) on Pancreatic Cancer in San Diego, California — the first such meeting since the US Food and Drug Administration approved the landmark pancreatic-cancer drug daraxonrasib (Rasonque) in August. Its success has renewed optimism that researchers can combine it or other emerging therapies with early-detection methods to revolutionize how pancreatic tumours are treated.
    • “A combination of early-detection techniques and interception is “going to be the breakthrough strategy that really changes survival”, says Diane Simeone, director of the Moores Cancer Center at University of California San Diego Health. At the AACR meeting, Simeone argued that such an approach could more than triple the proportion of people who survive for five years after being diagnosed with pancreatic cancer, from 13.7% to 50%.
    • “It’s a lofty aspiration, but other researchers are also eyeing interception. “We’re so excited that we are at this juncture now to even be considering this,” says Anirban Maitra, director of the Perlmutter Cancer Center at New York University Langone Health in New York City. “This wasn’t possible even a few years ago.”
  • CNN adds,
    • “Sugary foods combined with antibiotic treatment can damage the gut microbiome in ways that could leave people vulnerable to dangerous infections, a new study shows.
    • “The new research, published Wednesday in the journal Nature, took advantage of a natural experiment: It looked at what happened to gut bacteria in cancer patients who were hospitalized and treated with sustained antibiotics before receiving stem cell transplants. Because the patients only ate food prepared by the hospital, researchers knew exactly what and how much food they ate – a rarity in nutrition studies, which typically rely on participants to recall what they ate hours or days earlier, something people are notoriously bad at.
  • Health Day tells us,
    • “Functional decline begins many years before clinically apparent cardiovascular disease (CVD) events, according to a study published online Sept. 23 in JAMA Cardiology.
    • “Aung Zaw Zaw Phyo, Ph.D., from Monash University in Melbourne, Australia, and colleagues examined how functional performance trajectories change in the years preceding a CVD event. The analysis included data from 12,015 participants (2,403 cases and 9,612 matched controls) in the Aspirin in Reducing Events in the Elderly cohort.”
    • “Results of this nested case-control study show that declines in functional aging markers were prominent before clinically apparent CVD, suggesting that they may represent the culmination of progressive multisystem aging and indicating a prolonged window of opportunity for closer clinical evaluation and early intervention,” the authors write.”
  • and
    • “Isometric exercises like wall sits may help lower your blood pressure.
    • “And just one session a week could help you maintain those healthier numbers.
    • “A team led by Harry Swift of King’s College London studied 100 adults with an average age of 37 who had normal to high-normal blood pressure. Eighty were assigned to do wall sits three times a week.
    • “After four weeks, their systolic blood pressure — the top number in a blood pressure reading — had dropped by an average of about 9.5 points compared with the control group.
    • “For the next month, participants either kept the same schedule, cut back or stopped.
    • “Cutting back to once a week still left systolic pressure about 6.6 points lower than at the start.
    • “But three sessions a week delivered a much bigger benefit — down nearly 14 points.
    • “When participants stopped exercising, the improvements reversed.”
  • The American Medical Association lets us know how to do a wall sit.
  • Per BioPharma Dive,
    • “An experimental eczema drug from Pfizer met its primary goal in a mid-stage clinical trial, achieving stronger skin clearance in significantly more people at multiple doses compared to a placebo after 16 weeks.
    • “According to detailed data from an ongoing Phase 2 trial shared at a European medical meeting Thursday, a substantially higher percentage of patients given Pfizer’s three-pronged antibody drug, tilrekimig, as opposed to a placebo experienced a 75% reduction in the scope and severity of their disease. The trial enrolled participants with moderate to severe atopic dermatitis, and the latest results build on data previously announced in March.
    • “Analysts described the findings as “very strong” and indicative that Pfizer’s drug could compete with already approved therapies like Eli Lilly’s Ebglyss and Sanofi and Regeneron Pharmaceuticals’ market-leading Dupixent. In a statement Thursday, Pfizer said it has pushed tilrekimig into advanced testing for asthma, chronic obstructive pulmonary disease and atopic dermatitis — including a head-to-head trial against Dupixent.”

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

  • The Wall Street Journal reports,
    • “Bayer BAYN  said it plans to spend $2.2 billion to build a new manufacturing site in Ohio for its pharmaceutical business, becoming the latest European drugmaker to invest in the U.S.
    • “The German agricultural and pharmaceutical group said Friday that its new site in New Albany will create around 600 jobs, with plans to open a first module dedicated to drug substance manufacturing in 2031, followed by a second module for finished products in 2034.
    • “Bayer’s pharma business has been looking to expand in the U.S., betting that an enlarged presence in the world’s largest drug market can help it revive sales growth after two key products went off patent.
    • “With the move, the company joins a growing list of European pharma companies committing to invest in the U.S. Under pressure from the Trump administration’s tariff threats, big drugmakers like AstraZeneca, Novartisand Roche, as well as smaller rivals, pledged to make multibillion-dollar investments in the country and have started to execute their plans.
    • “The U.S. is our largest and fastest-growing market,” Bayer’s U.S. president, Sebastian Guth, said in an interview.”
  • and
    • “Novartis NOVN struck a deal valued at up to $7.8 billion to license a messenger RNA drug candidate from Abogen Biosciences and gain options over future therapies, turning to China to fill its pipeline.
    • “Many of the world’s biggest drugmakers have set their sights on China to look for new drug ideas, seeking to bolster their portfolios in preparation for older medicines going off patent. Novartis has sealed several tie-ups with emerging Chinese biotech players in recent years.
    • “Novartis is paying $575 million upfront and could make additional payments of up to $7.2 billion if options on all programs are exercised and targets are met, Abogen said Friday.
    • “Under the deal, Novartis will acquire worldwide rights over Abogen’s lead drug candidate, called ABO2203, which uses mRNA to boost the production of so-called T-cell engagers within the body to fight malignant cells. Abogen said its lead drug has potential to transform the treatment landscape for patients with autoimmune diseases—those in which the body’s immune system attacks healthy cells instead of protecting them.”
  • Modern Healthcare relates,
    • “HCA Healthcare has completed a deal to sell 31 home health and hospice locations in eight states to Deaconess Associations.
    • “The former HCA sites and their employees are now part of Deaconess subsidiary Central Pyramid, the Cincinnati-based provider announced in a news release Thursday. Neither Deaconess nor Nashville, Tennessee-based HCA disclosed the financial terms of the transaction.
    • “The home health and hospice locations are spread across Colorado, Florida, Kansas, Kentucky, Missouri, Tennessee, Texas and Virginia. The companies agreed to the transaction in June.”
  • Beckers Payer Issues tells us,
    • “San Francisco-based Dignity Health, part of Chicago-based CommonSpirit, reached an agreement to transfer its share of co-owned Arizona managed care health plan, Mercy Care, to CVS Health subsidiary Aetna.
    • “CommonSpirit had a 49.75% ownership interest in Mercy Care as of June 30, 2026, and June 30, 2025, according to CommonSpirit’s fiscal year 2026 report. 
    • “Dignity Health co-owns the plan with Ascension, which said it had also reached an agreement with Aetna to transfer its portion of Mercy Care to the company. 
    • “The transaction is expected to close in fiscal year 2027, subject to required regulatory reviews and approvals, a spokesperson for Aetna said in an Oct. 2 statement shared with Becker’s.” 
  • and
    • “New Jersey Democratic Gov. Mikie Sherrill launched the State Health Benefits Program Reform Working Group on Oct. 1 to review and advise on health coverage for public employees.
    • “Ms. Sherrill announced the working group following a Sept. 2 agreement with 17 state employee unions. Along with unions, participants include public employer organizations, legislative offices and healthcare groups, such as the New Jersey Association of Health Plans and New Jersey Hospital Association. Aetna, Horizon Blue Cross Blue Shield of New Jersey, and UnitedHealth Group’s pharmacy benefit manager, Optum Rx, are all vendors serving the benefits program. All three are also members of the working group.
    • “The working group will form advisory recommendations for the governor, focusing on benefits administration, provider network structures and payment, plan pricing and premium contributions, plan design, employer and member participation, and whether the program has resources to manage costs. The working group will have subcommittees targeting these areas.”
  • Fierce Healthcare adds,
    • “Tacoma, Wash.-based MultiCare Health System is set to launch its own health plan next year, the organization announced Thursday.
    • “The creation of the plan—dubbed the MultiCare Health Plan—is part of the organization’s continuing advancement from a traditional provider to an integrated organization, executives say. It will be a wholly owned subsidiary of the health system, with support from MultiCare’s population health partner, PSW.”
  • Beckers Hospital Review informs us,
    • “Chicago-based CommonSpirit Health has launched CommonSpirit Ambulatory Ventures, a new division aimed at organizing and expanding the health system’s ambulatory surgery center portfolio.
    • “The move is part of CommonSpirit’s broader effort to diversify beyond acute care and “accelerate growth” in ambulatory services, according to financial documents published Oct. 1. The system said the new division will establish an ASC vertical “from which to organize and enhance our current and future capability in the ASC space.” 
    • “CommonSpirit currently has 239 ambulatory joint ventures spanning dialysis, imaging, oncology and other services. That portfolio includes 80 ASCs, either wholly owned or operated through partnerships, along with six specialty surgical hospital partnerships.” 
  • Beckers Physician Leadership points out,
    • “After years of steady gains, compensation for registered nurses and licensed practical nurses (LPNs) showed no measurable growth in 2026 for the first time in the past 5 years, according to a report from Medscape. 
    • “The “Medscape RN/LPN Compensation Report 2026: Where Did the Growth Go?,” published Oct. 2, surveyed 3,253 registered nurses and 1,337 licensed practical nurses on compensation and pay trends.” 
  • Per Radiology Business,
    • “Patients grappling with medical debt appear more likely to face later-stage cancer diagnoses, according to new research published Thursday. 
    • “Such financial obligations are a pervasive challenge among U.S. households and a key social determinant of health, experts write in JAMA Network Open. About 1 in 6 individuals here report having at least some medical debt, with millions facing collections—a situation disproportionately impacting low-income households, minorities and the uninsured. 
    • “Researchers aimed to better understand how these IOUs impact patient outcomes, analyzing data spanning nearly 3,000 U.S. counties. They found that higher burden of medical debt was associated with significantly increased incidence of late-stage lung, colorectal, cervical, skin, kidney, bladder, and head/neck cancer. 
    • “These findings suggest that medical debt may be an area-level marker of structural and financial barriers associated with cancer detection and cancer outcomes at the population level,” study co-author Xin Hu, PhD, with the Department of Radiation Oncology at Emory University, Atlanta, and colleagues wrote Oct. 1.” 
  • Per Fierce Pharma,
    • “Eli Lilly’s Foundayo is showing clearer signs of acceleration. Total prescriptions for the oral GLP-1 receptor agonist surged about 21% to 64,268 during last week, according to IQVIA data cited by Citi. That haul came off a 13% sequential increase the week before that.
    • “We’re seeing early signs of growth in Q3 for Foundayo,” Jefferies analysts wrote in an Oct. 2 note.
    • “Recent expansion of Foundayo could be attributed to a direct-to-consumer ad first aired in late August featuring Martha Stewart, as well as the Medicare GLP-1 Bridge program which, as of July, offers eligible seniors GLP-1 obesity drugs at a $50 monthly copay.”
  • Cardiovascular Business adds,
    • “More and more young children are starting to be prescribed GLP-1 drugs to manage their weight, according to new research published in Pediatrics.
    • “The study’s authors focused exclusively on obese children without diabetes between the ages of 8 and 11. In 2019, just 0.03% of those children were on GLP-1 medications. However, that number skyrocketed to 9.3% in 2026. The group estimated that approximately 20,000 children between the ages of 8 and 11 have been prescribed GLP-1 drugs during that time. 
    • “Our study offers the first national overview in young children of the use of GLP-1 drugs to fight the obesity epidemic in the United States and shows that while the absolute numbers of children under the age of 12 receiving GLP-1 treatment is still low, GLP-1 use is accelerating rapidly,” first author Babak J. Orandi, MD, PhD, MSc, a transplant surgeon and obesity specialist with NYU Langone Health’s NYU Grossman School of Medicine, said in a statement. “The careful use of GLP-1s remains a valuable tool in confronting the obesity epidemic among young Americans.”
  • Beckers Payer Issues lets us know,
    • “Booking an appointment with a provider often means confirming they’re in network, working through an automated phone menu and trading available times with a receptionist. But for some UnitedHealthcare and Aetna members, an AI agent is now handling that work.
    • “Senior executives at both insurers have described their scheduling tools publicly in recent months as part of broader AI investments aimed at cutting administrative costs and simplifying how members get care.
    • “If I would usually schedule an appointment, I’d make a phone call, sit on hold, figure out my calendar, juggle my children. All that is gone, because Avery will do it for me,” Prianka Advani, senior vice president of AI delivery and telephony at UnitedHealth Group, said during a media event in June.”  

Monday report

David Ermer–ACA, Agentic & Generative AI, CMS, COVID-19 vaccine, Electronic health records, Medical / Rx research, Medicare, No Surprises Act, OPM, SCOTUS, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Per a House of Representatives news release,
    • “Health care providers that deliver high-quality, cost-effective care to American patients will be able to operate more efficiently thanks to bipartisan legislation approved by the U.S. House of Representatives. The Health Care Efficiency Through Flexibility Act (H.R. 5347), introduced by Ways and Means Health Subcommittee Chairman Vern Buchanan (FL-16) and fellow Committee member Representative Jimmy Panetta (CA-19), recognizes the benefits Accountable Care Organizations (ACOs) provide to patients in the way of value-based care, but also that current reporting processes required by the Centers for Medicare & Medicaid Services (CMS) are onerous and costly. As more ACOs deploy sophisticated electronic health records (EHRs) to streamline data reporting to CMS, the legislation provides ACOs with certainty and flexibility to help make the transition to digital quality measure reporting successful.” * * *
    • “Read a fact sheet on the bill here.
    • “The bill passed the Committee with a vote of 43-0.
    • “The bill was approved by the U.S. House of Representatives with unanimous consent.”
  • Bloomberg Government adds,
    • “Senators’ search for affordability wins to boast about on the campaign trail is leading back to capping the cost of insulin at $35 in the private insurance market and for the uninsured.
    • “The proposal is modeled on a similar measure Democrats included in their 2022 tax-and-healthcare law designed to curb costs for the diabetes drug in the federal health insurance program for seniors. 
    • “This time, the private-market insulin cap is being pushed by Sen. Susan Collins (R-Maine), who is facing a tough reelection battle this fall. She said last week that she added two more co-sponsors to her bill. 
    • ‘Fourteen Republican senators are now signed on, including Sens. Dave McCormick(R-Pa.), Tommy Tuberville (R-Ala.), Lisa Murkowski (R-Alaska), Jim Banks (R-Ind.), Chuck Grassley (R-Iowa), and Cindy Hyde-Smith (R-Miss.), as well as 12 Democrats.
    • ‘The measure, which previously earned the support of seven Republicans the last time a version of the idea was considered, could serve as a rare bipartisan triumph for lawmakers in what’s been a divisive Congress. 
    • “Every day we’re gaining momentum,” said Collins of her growing number of supporters on the bill. “There’s a hole here that we want to plug, and that is for people on employer plans and people who are uninsured.”
  • KFF reports,
    • “A new KFF analysis finds that 3.8 million Medicare beneficiaries met the criteria to be eligible for the new Medicare GLP-1 Bridge, based on claims data from 2023.
    • “The temporary 18-month program, launching on July 1 and running through December 2027, will provide coverage of three GLP-1s (Wegovy, Zepbound, and Foundayo) used for weight reduction and weight management to eligible beneficiaries who are enrolled in Medicare Part D.
    • “The total cost to the federal government of the program will depend in part on what share of eligible beneficiaries participate, how quickly they take up coverage, and how many prescriptions each participating beneficiary fills during the 18-month period.” * * *
    • “The clinical criteria for determining a Part D enrollee’s eligibility for Bridge include having a BMI of 35 or more; or having a BMI of 27 or more along with certain comorbid conditions. In addition, eligibility is limited to Part D enrollees who don’t have conditions treated by GLP-1 drugs that are currently covered under Part D, such as type 2 diabetes, and who have not filled a GLP-1 prescription in their Part D plan in 2026.”
  • Healthcare Dive relates,
    • “Enrollment in Affordable Care Act health plans declined by nearly 3 million people this year as policy turbulence continues to roil the exchanges, according to federal data released Friday. 
    • “About 19.2 million people were enrolled in ACA marketplace plans in February, down about 13% from the same time in 2025. 
    • “The Trump administration attributed the decline to efforts to prevent improper and fraudulent enrollment. But more generous financial assistance for ACA plans also expired at the end of last year, pushing more Americans to drop their plans due to rising costs, experts say.” 
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today finalized a rule strengthening the federal government’s ability to address serious misconduct and ensure federal employees continue to meet high standards of integrity throughout their careers. 
    • “The rule advances President Trump’s efforts to build a high-performing federal workforce that serves the American people with professionalism, integrity, and accountability. By modernizing federal suitability regulations, the rule provides agencies and OPM with additional tools to address serious misconduct, protect public trust in government, and support a more consistent approach to accountability across the federal workforce. 
    • “For too long, the federal government has had stronger tools to prevent someone with serious misconduct from entering public service than to address the same misconduct once that individual is already employed,” OPM Director Scott Kupor said. “This rule closes that gap, strengthens accountability, and helps ensure the federal workforce continues to earn the trust of the American people.” * * *
    • “Read the final rule here.” 
  • Federal News Network adds,
    • “The Office of Personnel Management is giving many employees in its healthcare and insurance division another chance to accept voluntary incentives and leave their jobs, ahead of their busy season.
    • “OPM told employees in its healthcare and insurance (H&I) division on Monday that most of them will have another shot at opting into the deferred resignation program. Employees who apply and are accepted by OPM will go on paid administrative leave for six months before separating from the agency.
    • “Most of OPM’s healthcare and insurance division employees will also be eligible for early retirement. Federal employees are eligible for early retirement if they have 20 years of service at age 50, or 25 years of service at any age. Eligible employees are allowed to voluntarily retire and earn an immediate annuity.
    • “Eligible employees have until 5 p.m. Eastern on July 13 to accept the DRP or Voluntary Early Retirement Authority (VERA) offers. OPM employees approved for the DRP program will go on paid administrative leave starting Aug. 31, 2026, and will officially separate from the agency on March 1, 2027.”
  • Fierce Healthcare tells us,
    • “The Health Resources and Services Administration highlighted on Monday $140 million in newly opened grant funding opportunities focused on rural health priorities like substance use treatment, workforce development and telehealth. 
    • “Applications for the slew of grants opened over the last few weeks and are set to close throughout July. 
    • “HRSA and its administrator Tom Engels, who promoted the funding opportunities during a Monday event at an Iowa critical access hospital, said the programs build on the administration’s priorities of addressing opioid addiction as well as rural healthcare sustainability, the latter of which includes the ongoing $50 billion Rural Health Transformation Program.”
  • and
    • “The Trump administration unveiled new efforts to strengthen oversight of the Trusted Exchange Framework and Common Agreement (TEFCA), including hiring a federal IT contractor to provide audit, review and compliance support.
    • “TEFCA is the government-backed health data-sharing initiative that allows patients, providers and payers to share health records. It was mandated by the 21st Century Cures Act back in 2016 and went live in December 2023.” * * *
    • “Alliance Global Tech Inc., a company specializing in federal IT services including cybersecurity, cloud solutions and data analytics, was awarded a five-year contract to provide TEFCA audit, review and compliance support for HHS, according to a new USASpending.gov listing. USASpending.gov is an official open data source of federal spending information, including information about federal awards such as contracts, grants and loans.
    • “The five-year contract is worth up to $5.62 million, structured as a one-year baseline, around $1.28 million, with annual renewal options through June 2031.”

No Surprises Act news

  • STAT News reports,
    • “For the past 40 years, it’s been illegal in the U.S. for emergency departments to turn away patients because of an inability to pay. But that only applies to hospitals that contract with Medicare. Houston-based Nutex Health, which runs the hospital Behounek visited, has opted not to at most of its hospitals, so it’s not bound by that law. Nutex claims it complies voluntarily, screening every patient to ensure they’re not dying before demanding payment. But some patients say they were never screened. 
    • “In this way, Nutex is able to have the best of both worlds: It charges emergency department prices while avoiding the responsibilities that usually come with being an ER; namely, taking all comers. It’s just one way Nutex has enriched itself and its investors through exploiting loopholes in laws meant to protect patients. In recent years, that’s meant funneling most of its bills through a surprise billing ban’s arbitration process, even though it’s meant to be a last resort. It’s been a gold mine, quadrupling its revenue. 
    • “There is a growing for-profit business model that is exploiting the benefits and higher revenue that comes with providing emergency care without taking on the risks or obligations of being an emergency department,” said Amber Sabbatini, an associate professor of emergency medicine at the University of Washington. Nutex is one of several companies running microhospitals and freestanding emergency departments, although many are run as satellites of traditional hospitals. They tend to open in wealthier areas where people are likely to have insurance.
    • “The federal arbitration process set up under the No Surprises Act has been a stunning success for providers. Not only are they winning in over 80% of cases, they’re securing payments that are three to nine times in-network rates. The program, known as independent dispute resolution, has also been slammed with far more disputes than federal officials had expected. Because of that, it cost at least $5 billion between 2022 and 2024 alone, potentially wiping out the savings Congress expected it to generate. 
    • “For Nutex, this arbitration process has generated eye-popping returns. In less than a year, the company more than tripled its revenue and profit soared nearly twelvefold. The numbers are so dramatic, in fact, that some investors view the money-making strategy as a house of cards. Several are suing Nutex over what they say is an unsustainable reliance on arbitration wins and a precarious alignment with HaloMD, a middleman whose tactics are the subject of multiple lawsuits.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has identified a Class I recall of North American Rescue first aid kits containing TRUE METRIX Blood Glucose Monitoring Systems by Trividia, which have also been recalled. The FDA said the Trividia recall is due to an issue with an E-5 error code. Trividia has reported 114 serious injuries and one death associated with its recall. The FDA notice said that North American Rescue has not reported any serious injuries or deaths associated with its issue as of March 27.” 
  • Fierce Pharma relates,
    • “The FDA has accepted two Abbreviated New Drug Applications from generics powerhouse Sandoz for its copycat versions of Eli Lilly’s tirzepatide.The applications are for generic versions of Mounjaro and Zepbound, which help treat patients with type 2 diabetes and obesity, respectively. If Sandoz wins the approvals, the company believes it could launch “one of the first generic tirzepatide products” in the U.S., according to a June 29 release.The company noted that it developed its generic tirzepatide in-house.” 
  • and
    • “Viridian Therapeutics has scored FDA approval for Lumvoa to treat thyroid eye disease (TED), triggering competition with Amgen’s blockbuster Tepezza, the only other medicine on the market for the eye-bulging autoimmune condition.
    • “The FDA nod applies to adults with active or chronic TED, making it the first approved therapy in its anti-insulin-like growth Factor 1 receptor (IGF-1R) class to carry labeling that includes data in both active and chronic TED, the company pointed out.
    • “In addition to this advantage, Viridian hopes to count on a convenience edge over Amgen’s IGF-1R Tepezza.”
  • BioPharma Dive tells us,
    • “On Friday, [June 26] Replimune said that the Food and Drug Administration has accepted the resubmission for its cancer drug RP1, with a decision expected by Aug. 2 and an advisory committee set to convene in July to discuss the twice-rejected application. The latest move is another signal of the changing attitude of the FDA, which was accused of moving the goal post or providing conflicting feedback to companies, leading to delayed or rejected applications under the now-exited leaders Marty Makary and Vinay Prasad. Multiple other companies that faced hurdles under the prior leadership are now gaining new chances for their applications.
  • MedTech Dive informs us,
    • “Edwards Lifesciences on Friday received Food and Drug Administration clearance for the Ecliptis left atrial appendage exclusion system, an entry in the FDA’s 510(k) database shows.
    • “The implantable clip is intended to close the left atrial appendage, or LAA, a small pouch-like structure in the heart’s left atrium, to prevent blood clots from forming that can lead to stroke.
    • “The Edwards device is positioned to compete directly with AtriCure’s AtriClip platform and Medtronic’s Penditure system, BTIG analyst Marie Thibault told clients in a note Monday. Boston Scientific and Abbott sell LAA occlusion devices that are implanted in minimally invasive procedures.”
  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.
    • “The FDA launched the PreCheck Pilot Program on February 1, 2026, in response to Executive Order 14293 signed by President Trump in May 2025 and following a public meeting on challenges and opportunities to facilitate domestic manufacturing. The pilot program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway for companies that plan to manufacture drugs for the U.S. market, helping support greater access to critical medicines for Americans.” * * *
    • “For more information visit the FDA PreCheck Pilot Program webpage.”

From the judicial front,

  • Federal News Network reports,
    • “The Supreme Court on Monday dramatically expanded presidential power, upholding President Donald Trump’s firings of the heads of independent federal agencies with one important exception: the Federal Reserve.
    • “The justices allowed Fed governor Lisa Cook to stay in her job while she fights the Republican president’s effort to fire her over allegations of mortgage fraud, which she has denied.
    • ‘But other than at the nation’s central bank, with its role of setting interest rates, the court held that presidents have free rein to fire agency heads at will, despite federal laws that require a cause for such dismissals and a 91-year-old decision that had limited executive authority.
    • “With the six conservative justices in the majority, the nine-member court jettisoned its unanimous [1932] decision in Humphrey’s Executor that had limited when presidents can fire agencies’ board members — in part to try to ensure decision-making free of political influence.
    • “We hold that such protection from removal is contrary to the separation of powers enshrined in the Constitution,” Chief Justice John Roberts wrote for the court.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Getting a COVID and flu shot on the same day was not associated with an increased risk of adverse events, according to a target trial emulation using electronic health data from the VA.
    • “Compared with influenza vaccination alone, coadministration of COVID and influenza vaccines was not associated with an increased risk for any of the three composite outcomes of serious or life-threatening, clinically significant, or less severe or self-limiting adverse events, reported Ziyad Al-Aly, MD, of Washington University in St. Louis, and colleagues in the Annals of Internal Medicineopens in a new tab or window.
    • “Of the 46 individual adverse events assessed, two less severe or self-limiting adverse events had “nominal statistical significance” with coadministration — a slightly higher risk of syncope (risk ratio [RR] 1.09, 95% CI 1.02-1.17) and a slightly lower risk for tinnitus (RR 0.95, 95% CI 0.92-0.99) — but no risks were statistically significant after correcting for multiple comparisons.
    • “Even in today’s world, where people have been exposed to multiple prior COVID-19 vaccines and their immune systems have been shaped by at least one COVID-19 infection, vaccines have a reassuring record of safety,” Al-Aly told MedPage Today. “We looked at 46 different outcomes — literally leaving no stone unturned — and we came up empty-handed.”
  • and
    • “Lung cancer screening criteria based on the duration of smoking appeared to be a better option for determining individuals at highest risk for lung cancer in an observational study.
    • “Compared with USPSTF recommendations, criteria based on the minimum number of years smoked (20, 30, or 40 years) identified more individuals most expected to benefit from screening.
    • “A threshold of at least 40 years of smoking was also more effective than the USPSTF in excluding people least expected to benefit from screening.”
  • Health Day relates,
    • “Brain imaging could help doctors use magnetic stimulation to better treat depression.
    • “Brain imaging helps find specific targets for stimulation.
    • “People treated using brain imaging had lower symptoms and better response rates.
  • and
    • “Women with preeclampsia have increased risk of developing hypertension and chronic kidney disease (CKD) later in life, according to a study published online May 19 in BJOG: An International Journal of Obstetrics and Gynaecology.” * * *
    • “The most surprising finding was how clearly the amount of protein in the urine during preeclampsia was linked to the risk of later high blood pressure and chronic kidney disease,” Dr. Vestergaard said in a statement. “Women with moderate to severe protein excretion had a higher risk of both conditions compared with women with low or no protein excretion.”
  • MedTech Dive informs us,
    • ‘Johnson & Johnson said last week that it has started pivotal development of a Shockwave Medical device for treating calcified carotid arteries.
    • “J&J designed the investigational device, called SkyRunner, to repurpose Shockwave’s intravascular lithotripsy technology for breaking up calcium in the carotid artery.
    • “A physician in Michigan recently treated the first patient in the investigational device exemption clinical program for SkyRunner.”

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

  • Fierce Healthcare reports,
    • “As drug costs and spending continue to rise, the demand for solutions opens the door to closer collaboration between payers and manufacturers.
    • “Brian Evanko, president and chief operating officer for the Cigna Group, and Miguel Fernández Alcalde, president of EMD Serono, spoke at a keynote session at AHIP 2026 earlier this month, discussing the delicate balance between promoting innovation and ensuring affordability.
    • “The two companies are longtime partners and most recently worked alongside one another on the cost of fertility treatments. Evernorth operates Freedom Fertility, the largest provider of fertility specialty pharmacy services in the U.S., while EMD Serono is a leader in fertility on the manufacturer side.
    • “Evanko said the partnership deepened last year, when both worked with the Trump administration to drive down the cost of certain fertility treatments. Patients can sign up for Trump Rx and find treatments at a cash-pay price of between $1,000 and $1,500, depending on the number of doses in a course of treatment, he said.”
  • and
    • “AI startup Doctronic is partnering with Simple HealthKit, an at-home health screening platform, to offer consumers end-to-end diagnostic screening integrated with virtual clinical care.” * * *
    • “Simple HealthKit offers at-home screening kits directly to consumers through its website and retail partners and also works with health plans, providers and public health programs.
    • “Through this partnership [with Doctronic], we are initially focused on the conditions where we can deliver the greatest immediate impact across our national health plan and retail partnerships, with plans to expand across our broader portfolio over time. Our vision is to make high-quality healthcare accessible for all,” Simple HealthKit co-founder and CEO Sheena Menezes, Ph.D., told Fierce Healthcare.
    • “Doctronic touts that it’s the first AI system legally authorized to practice medicine in the U.S. The startup offers a free personal AI doctor via chatbot to help navigate symptoms and answer medical questions and can connect users with a licensed physician through a virtual visit. Doctronic, available in all 50 states, is being tested by the state of Utah to refill prescriptions as part of a pilot program.”
  • Beckers Hospital Review relates,
    • “Provider compensation continued to rise in 2025, but a new survey suggests health systems may be nearing the limits of what they can sustainably support.
    • “According to the “AMGA 2026 Medical Group Compensation and Productivity Survey,” overall clinical compensation increased 4.3% in 2025. The survey includes data from 451 medical groups and health systems representing nearly 188,000 providers across more than 190 specialties.
    • ‘The increase comes as reimbursement growth remains largely stagnant, creating a widening gap between provider pay and collections.
    • “Over the past several years, provider compensation has increased, but approximately half of the increases have been supported by ongoing growth in wRVU production,” Fred Horton, president of American Medical Group Association Consulting, said in a June 24 news release shared with Becker’s. “In a marketplace with stagnant reimbursement, this is necessary to afford the increases in total cash compensation, but it is not sustainable. At some point productivity will top out, and providers are already adjusting their FTE and seeking alternative work arrangements in response to increased workloads.”
    • “Primary care compensation increased 3.7% in 2025, while medical specialties saw a 4.3% increase and surgical specialties experienced a 3.2% increase. Compensation for radiology, anesthesiology and pathology providers grew 5.7%, the highest increase among specialty categories tracked by the survey.”
  • Fierce Pharma tells us,
    • “Likely thanks to the Juneteenth federal holiday, prescriptions for both Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo were lower compared with their highest. For the week ended on June 19, Foundayo logged 20,594 total scripts, down from 21,648 the prior week, according to IQVIA data cited by Jefferies. 
    • “For oral Wegovy, the numbers were about 152,000 for the June 19 week, a roughly 9,500 (5.9%) decrease from the prior week. 
    • As Jefferies’ analysts noted, most GLP-1 scripts were down or rather flat in their weekly comparisons. Injectable Wegovy added about 1,000 (0.3%) scripts, landing at 315,000. Mounjaro essentially saw no change, at 804,000.
    • Lilly has previously noted that it takes time to build awareness for Foundayo as a new brand, whereas Novo benefits from familiarity with the Wegovy moniker.” 
  • The Wall Street Journal informs us,
    • “Ipsen IPN said it agreed to buy Kartos Therapeutics in a deal valued at up to $1.75 billion that seeks to strengthen the French drugmaker’s pipeline of cancer medicines.
    • “Through the acquisition, Ipsen adds a late-stage drug candidate for myelofibrosis–a rare blood cancer–to expand its portfolio in oncology, it said Monday. Ipsen is paying $450 million upfront to take over Kartos, with additional payments of up to $1.3 billion subject to regulatory and sales targets.
    • “The deal builds on Ipsen’s acquisition of oncology specialist ImCheck Therapeutics for up to 1 billion euros ($1.14 billion) last year after Somatuline, the company’s top-selling medicine, faced generic competition in recent years.
    • “Redwood City, Calif.-based Kartos is a privately held pharmaceutical company that was founded after the licensing from Amgen of an experimental cancer drug. It is developing the drug, navtemadlin, as an add-on therapy to the standard-of-care treatment for patients with myelofibrosis.”
  • BioPharma Dive points out,
    • Royalty management company Zymeworks is buying Theravance Biopharma, announcing Monday a $929 million deal that gives it partial rights to Theravance’s COPD drug Yupelri, along with payouts due from its co-development of Trelegy with GSK and an antibiotic for hospital-acquired infections.
    • Per deal terms, Zymeworks will pay $17 a share, along with a second potential payout should Zymeworks license or sell a drug called ampreloxetine that Theravance has developed for a type of low blood pressure. Zymeworks is partially financing the deal by borrowing $350 million from Omers Life Sciences, which will be paid off with Yupelri’s cash flow.
    • Theravance initiated a strategic review of its business in 2024, which accelerated earlier this year when ampreloxetine missed the primary goal of a Phase 3 trial in nervous-system driven low blood pressure in people with the rare disease multiple system atrophy. In a statement, independent Board Chair Susannah Gray said “this transaction achieves the greatest value for Theravance Biopharma shareholders.”
  • OptumRx, writing in LinkedIn, discusses the “Top 5 ways Optum Rx is putting AI into action.”

Weekend update

David Ermer–CDC, Congress, Electronic health records, Medical / Rx research, Medicare, SCOTUS, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington DC,

  • The House of Representatives remains in session through July 1 for floor voting and Committee business. The Senate left Capitol Hill last Thursday and will not return until July 13.
  • MedCity News reports,
    • “A group of Democratic senators introduced a new bill on Thursday that would create a $5,000 cap on out-of-pocket costs for traditional Medicare beneficiaries.
    • “The Medicare Cost Cap Act was introduced by Senator Lisa Blunt Rochester (D-Delaware), Senate Finance Committee Ranking Member Ron Wyden (D-Oregon) and Senate Democratic Leader Chuck Schumer (D-New York).
    • “The bill seeks to “level the playing field” between traditional Medicare and Medicare Advantage, which has annual out-of-pocket spending caps (as do employer-sponsored insurance and coverage bought on the marketplace).” 
  • Healio notes,
    • “It has been nearly a year since the U.S. Preventive Services Task Force released new recommendations, and experts remain concerned about its future.
    • “HHS removed the chair and vice chair of USPSTF last month, which came after three task force meetings were canceled under HHS Secretary Robert F. Kennedy Jr.’s tenure.

From the judicial front,

  • Healthcare Finance reports,
    • “CareFirst of Maryland has filed a federal racketeering lawsuit against two former Maryland insurance brokers, alleging they used fake residences, false identities and an international referral network to enroll out-of-state and overseas clients in CareFirst health plans reserved for Maryland residents.
    • “The complaint, filed June 15 in the U.S. District Court for the District of Maryland, names Avraham Rappaport, a former licensed insurance broker based in Olney, Maryland, and his brother Eliezer Rappaport, a financial advisor and former licensed broker. It also names John Does 1-20 as alleged co-conspirators.
    • “CareFirst described itself in the filing as the victim of a “health insurance fraud conspiracy of breathtaking scale and audacity.” The insurer alleges the brothers coordinated an “international insurance-fraud machine” that allowed people who did not live in Maryland to obtain coverage through CareFirst policies intended for state residents.”

From the public health and medical / Rx research front,

  • NPR lets us know “8 things to know about the gut microbiome and keeping yours healthy.”
  • Health Day reports,
    • “A next-generation blood test could improve early detection of the most dangerous forms of prostate cancer.
    • “The major challenge in prostate cancer screening is not just to find more cancer cases, but to identify the cancers that are truly dangerous,” said first author Thorgerdur Palsdottir, a researcher at the Karolinska Institute in Stockholm. 
    • “Our results show that Stockholm3 identifies significantly more aggressive cancer cases than PSA [prostate-specific antigen], without increasing the number of unnecessary follow-ups,” she added in a news release.” * * *
    • “Unlike the standard PSA test, which measures a single blood protein, the Stockholm3 test combines multiple protein and genetic markers with factors like age and family history to better assess the risk of aggressive prostate cancer.
    • “The study — published June 23 in the Annals of Internal Medicine — showed that Stockholm3 detected 90% of prostate cancers, compared with 74% for PSA, without subjecting more men to unnecessary testing.”
  • Medscape relates,
    • GLP-1 receptor agonists (GLP-1 RAs) are associated with reduced incidence of breast cancer among women with overweight or obesity, according to two observational studies.
    • One found that GLP-1 RA users had a roughly 30% lower incidence of breast cancer than was seen in matched nonusers. The smaller of the two, which followed more than 80,000 women at high risk for breast cancer, found a more modest 16% reduction.
    • Using GLP-1 drugs to prevent cancer is “an exciting new frontier that will likely revolutionize the field of oncology, but like any new exciting therapy we need [randomized] clinical trials to understand how to optimally” use them, said Neil M. Iyengar, MD, a breast medical oncologist who was not involved in either study.
  • Cardiovascular Business tells us,
    • “Transcatheter aortic valve replacement (TAVR) is associated with certain early benefits for women not seen with surgical aortic valve replacement (SAVR), according to a new meta-analysis published in JACC: Advances.[1] These benefits were primarily seen in intermediate- and high-risk patients—and they weren’t seen at all when treating men.
    • “As TAVR expands to younger and lower-risk populations, clarifying sex-specific and time-dependent outcomes is critical for individualized valve selection,” wrote first author Hendrianus Hendrianus, MD, a researcher with Chung-Ang University in South Korea, and colleagues.
    • “The group explored data from nine different randomized controlled trials (RCTs) comparing TAVR and SAVR. Studies were required to include sex-stratified outcomes to be counted as part of this meta-analysis. The nine RCTs included more than 9,500 patients with severe aortic stenosis who were randomized to undergo TAVR or SAVR. Approximately 44% of all patients were women. The primary outcomes for these trials were slightly different from one another, but they all included all-cause mortality as a key component.
    • “After one year, TAVR was linked to a 33% relative reduction in the risk of the trial-defined endpoint for women. This was largely driven by improvements for intermediate- and high-risk patients. This trend was not seen in men.” 

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

  • BioPharma Dive reports,
    • “A surge in licensing deals involving drugs from Chinese pharmaceutical firms has triggered alarms in U.S. biotech circles, setting off arguments over what it means for national security and market competition.
    • “Nearly 100 agreements between Chinese and U.S. biotechnology firms have been publicly announced since the start of 2025, according to BioPharma Dive data. Lawmakers on Capitol Hill have signaled intentions to try and disincentivize those investments. Among recent efforts are a push to add the biotechnology sector to the list of industries where investments in China will be scrutinized by U.S. regulators.
    • “The issue featured prominently [last] week at the annual meeting of the Biotechnology Innovation Organization, the industry’s top lobbying group. Multiple panels were geared towards the way licensing deals are affecting the business development landscape and early venture investment. And during a brief meeting with reporters, BIO CEO John Crowley acknowledged the tough spot the U.S. biotech ecosystem is in as well as the pros and cons of Congressional intervention.
    • “Protecting U.S. biotech is a “national security imperative,” and “we need to maintain our lead here,” he said.”  
  • Fierce Healthcare offers a ranked list of the most expensive EHR projects underway in 2026, and relates,
    • “Innovaccer and Amazon Web Services (AWS) signed a multi-year strategic collaboration agreement to help health systems and payers deploy agentic AI solutions at scale. 
    • ‘The collaboration aims to bridge the gap between working AI pilots and deployments that meet security, compliance and scale requirements. Under the agreement, Innovaccer will scale agentic AI workloads using AWS services while expanding its go-to-market through the AWS marketplace.
    • “Innovaccer CEO and co-founder Abhinav Shashank said in a statement AI in healthcare, “has a production problem, not an innovation problem.”
    • “The organizations we work with are not short on ambition,” Shashank said. “What they need is the infrastructure to run AI agents reliably, securely, and at the scale their operations demand. AWS gives us exactly that, and what we bring is a decade of healthcare-native context that makes those agents actually work in the environments health systems and payers operate in every day. This agreement is about closing the gap between what AI can do for healthcare and what healthcare is currently getting from it.”
    • The collaboration also includes co-investment in customer success programs, the companies say.”
  • Health Day tells us,
    • “People are becoming more comfortable communicating with their doctor through clinics’ patient portals.
    • “Folks use the portals to ask their doc questions and even to review the results of recent medical tests.
    • “But there are some matters that still require a face-to-face interaction between doctor and patient, a new study says.
    • “In all, 3 of 4 patients want to hear about a cancer diagnosis directly from their doctor, rather than through a portal message or report, researchers reported June 24 in JAMA Network Open.
    • “While most patients in the general population appreciate rapid electronic access to test results, the situation for patients with cancer is much more nuanced,” lead researcher Dr. Sheena Bhalla said in a news release. She’s a medical oncologist at the Harold C. Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center in Dallas.”
  • Per Medical Economics,
    • “People enjoy healthier lives when their physicians work with community partnerships, sharing the goal of improving social and behavioral factors that treat or worsen chronic disease.
    • “Using Community Partnerships to Inform the Prevention Strategy of the Center for Medicare and Medicaid Innovation” is a new consensus study report published this spring by the National Academies of Sciences, Engineering, and Medicine. Its Standing Committee on Primary Care drafted it as a detailed road map for building effective partnerships between physicians’ practices, health care organizations, and community organizations. The committee examined what makes these partnerships work, where they fail, and what the federal government should do to fund and sustain them at scale. Drawing on real-world models from Massachusetts to Alaska, it delivers three concrete recommendations for the Centers for Medicare & Medicaid Services.
    • “This slideshow summarizes the report’s key findings. All data points come from the report, which is available free online.”

Thursday Report

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

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “The chair of the Senate health committee introduced a bill to restrict a federal drug discount program known as 340B that has been lucrative for nonprofit hospitals.
    • “The bill by Sen. Bill Cassidy (R-La.) comes as hospitals face attacks on their bottom lines, especially in Medicaid. The tax bill that Republicans passed last summer significantly decreased the federal government’s share of Medicaid costs and is expected to reduce the number of people on Medicaid. Hospitals also face the prospect of legislation that would lower hospital payments to levels charged by doctor offices, an idea known as site-neutral payments.” * * *
    • “Cassidy’s bill would implement many pharmaceutical-industry backed restrictions on the program. It would allow drugmakers to give hospitals retroactive rebates, instead of the upfront discounts that hospitals prefer. Hospitals could insist on receiving upfront discounts, but only if they pass them on to patients. They’d also need to establish a sliding-fee scale for prescription drugs, effectively sharing some of the discounts with low-income and uninsured patients.” * * *
    • “Similarly, the bill would place restrictions on the contract pharmacies that hospitals use to administer the discounts. Hospitals would be limited to five contract pharmacies, which would be required to be located in a 340B entity’s service area. The bill also would define conditions for contract pharmacies to participate in the 340B program.” * * *
    • “There are also transparency measures in the bill. Hospitals would have to annually report profits from the drug discount program, the number and types of patients who received 340B drugs, and details of charity care they offer.”
  • The Whistleblower Network News relates,
    • “Sen. Chuck Grassley (R-Iowa) is calling on the Office of Personnel Management (OPM) to revise a proposed government-wide nondisclosure agreement, warning that the draft form could discourage federal employees from reporting waste, fraud, and abuse.
    • “On May 27, OPM, the federal government’s chief human resources agency and personnel policy manager, published a notice seeking public comment on a proposed nondisclosure agreement for use by federal agencies with new and existing employees. According to OPM, the proposed form is intended to standardize confidentiality obligations across the federal government and protect non-public, confidential and proprietary information obtained through official duties.
    • “Grassley, who chairs the Senate Judiciary Committee and co-founded the Senate Whistleblower Protection Caucus, warned that the draft does not go far enough to ensure federal employees understand that the agreement cannot override their whistleblower rights. In a letter to OPM Director Scott Kupor, Grassley urged the agency to update the draft NDA to include the full anti-gag provision required by federal law. Grassley also framed the issue as one implicating federal employees’ constitutional rights.”
  • The Wall Street Journal tells us “What to Know About the Government’s $6.5 Billion Healthcare Fraud Crackdown.”
    • “An $865,000 Bulgari necklace, $600,000 spent on vehicles and more are detailed in documents.”
  • The American Hospital Association News tells us,
    • “The House Energy and Commerce Subcommittee on Health June 25 held a markup session on bills regarding healthcare price transparency, illicit drugs and prior authorization. Bills considered by the subcommittee included the Lower Costs, More Transparency Act (H.R. 9393), legislation that would codify existing price transparency regulations for hospitals and health plans; the Prices on the Wall Act (H.R. 9390), a bill that would require hospitals to post pricing physically on their walls; and the Improving Seniors’ Timely Access to Care Act (H.R. 3514), an AHA-supported measure that would reduce variation in prior authorization methods used for Medicare Advantage plans. 
    • “The AHA provided comments to the subcommittee June 10 for a hearing discussing some of the proposals from today’s markup. All of the bills considered June 25 were advanced to the full committee for consideration.”
  • Bloomberg Law informs us,
    • “Out-of-network doctors are winning drastically higher arbitration payouts for planned procedures under a law protecting patients from unexpected emergency bills, according to data from insurer Elevance Health Inc.
    • “Over the last two years, median arbitration awards won by out-of-network doctors for the most common billing codes for planned procedures are 53 times the in-network rate, the insurer said in a paper shared with Bloomberg Law. Elevance said doctors are exploiting a loophole under the No Surprises Act meant to exclude procedures where patients knowingly consent to paying for out-of-network care.” * * *
    • “The No Surprises Act is largely intended to protect patients when they need emergency care at out-of-network hospitals. But it also allows doctors to file arbitration disputes for in-network procedures where the secondary physician, such as an anesthesiologist, is out-of-network. Doctors are prohibited from balance-billing in those situations unless the patient signs a specific waiver acknowledging the additional costs.
    • “Planned procedures made up around 60% of Elevance’s “independent dispute resolution” awards, and the amounts dwarfed those won for emergency care. Overall, arbitration awards for provider groups filing the most disputes are three to nine times higher than in-network benchmarks. Elevance’s data, by contrast, show that doctors performing planned procedures were winning awards 53 times the in-network benchmark rate.”
  • The FEHBlog who represents a payer (not Elevance) in these No Surprises Act cases seconds Elevance’s contention. What’s more an out-of-network primary surgeon can use the No Suprises Act process as long as the surgery occurs in an in-network facility.
  • Per an AHIP news release,
    • “Recent polls show that rising healthcare costs are a top concern for Americans across the political spectrum and voters strongly support common-sense policy solutions to address the root causes driving the healthcare affordability crisis.
    • “New polling data from the Century Foundation underscores the breadth of bipartisan support for policy solutions: 
      • “Two-thirds of voters said that the federal government should make “stop[ping] hospitals from charging excessive prices” their top priority – more than any other policy proposal.
      • “Support for reining in hospitals’ ever-higher prices is decisive across partisan and demographic lines, including 71% of Democrats, 66% of Republicans and 75% of rural voters.
      • “Six in 10 voters said reining in surprise medical billing by providers should be a top priority – the second-highest priority of all proposals tested.
    • “Voters’ bipartisan concerns are well-grounded in the data. Healthcare costs are rising faster than inflation, driven by unchecked growth in the price of hospital care, physician services and prescription drugs. Americans’ premiums and out-of-pocket costs directly reflect these rising costs.”
  • Tammy Flanagan, writing in Govexec, points out, at the conclusion of a longer article
    • “Even as Medicare and FEHB premiums continue to rise, many retirees still find the combination worthwhile when plans include cost-sharing waivers, rebates or Medicare Advantage structures that shift more costs away from point-of-care spending. Higher-income retirees subject to IRMAA face a sharper calculation: higher fixed premiums today versus potential exposure to higher out-of-pocket costs later. For many, the decision is less about optimization than risk tolerance over time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Doctors treating cancer patients nationwide are facing a shortage of essential generic chemotherapy drugs, a situation that many fear could lead to widespread rationing.
    • “The shortages stem from manufacturing problems, shipping delays and decisions by some companies to stop producing the medications, according to the Food and Drug Administration.
    • “The decades-old medicines are challenging to make in sterile plants and command a very low price in the United States. But they are considered among the most effective treatments for some cancers without more targeted options, including some breast, lung, and head and neck cancers. * * *
    • “From a systemwide policy change, not a single thing has changed,” said Laura Bray, the executive director of Angels for Change, a nonprofit that works to alleviate drug shortages. “It’s time for Washington to get involved and help the citizens of the United States ensure that we have lifesaving medicine.”
  • Fierce Pharma relates,
    • “After 35 years of research and development in pharmaceutical products, Ionis began marketing its drugs for the first time in 2024.
    • “While the company’s maiden voyage into commercialization has progressed “remarkably smoothly,” according to CEO Brett Monia, Ph.D., those efforts will now ratchet up to a new level with the FDA approval of Tryngolza to treat severe hypertriglyceridemia (sHTG).
    • “With the nod, Ionis advances from selling two rare disease drugs to marketing a product that could be used by millions of potential patients.
    • There is no other drug on the market designed specifically to treat sHTG or to combat its accompanying bouts with pancreatitis, which can land patients in the hospital for extended stays and be life-threatening.” * * *
    • “In anticipation of the approval, Ionis’ launch team has been in place since February, promoting Tryngolza to endocrinologists, cardiologists and lipid specialists for FCS while also educating them on sHTG.   
    • “The physicians are just chomping at the bit, waiting to prescribe Tryngolza for their sHTG patients since they manage so many of them,” Monia said.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “The [U.S.] Supreme Court on Thursday ruled for Bayer in its fight against claims that it failed to warn consumers that Roundup causes cancer, boosting the company’s efforts to resolve costly litigation over its popular weedkiller. 
    • “In a 7-2 decision, the court said the pharmaceutical and agriculture company can’t be held liable under state law for failing to warn about the alleged risk when a federal regulator—the Environmental Protection Agency—didn’t require the product to carry a warning label.” * * *
    • “In a statement, a Bayer spokesperson said Thursday’s decision was “good for science, farmers, and industries that depend on regulatory clarity for innovation. It should help significantly contain the Roundup litigation after nearly a decade of legal battles.”
    • “It is a significant victory for Bayer Chief Executive Bill Anderson, who took over the German conglomerate in 2023 with a mandate to help steer it through the litigation. Securing a win at the Supreme Court, along with its proposed settlement, are crucial parts of the company’s strategy to finally move past the long-running Roundup litigation woes.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Here’s another reason to cover up in the thick of tick season this summer: There is a bite that can leave you allergic to burgers, bacon and steak.
    • “That’s right—Lyme disease isn’t the only health threat ticks can pose. More people are learning about alpha-gal syndrome, a potentially life-changing allergy linked to the lone-star tick.
    • “The condition triggers a red-meat allergy. In some cases, it also causes an allergy to dairy and other products or medication derived from mammals (think gelatin).
    • “And lone-star ticks are on the move, thanks to climate change and burgeoning white-tailed deer populations. They are moving beyond their traditional base in the Southeast and south-central U.S., pushing farther north and west. 
    • “The ticks are especially common in coastal areas, such as Martha’s Vineyard off the coast of Massachusetts and Suffolk County in New York. And no, despite their name, the ticks didn’t originate in Texas. They are called that because of a single white dot on their backs that looks like a single star.” * * *
    • “An added problem: Some doctors believe cases are still being missed. After all, until recently many healthcare providers knew little about the condition caused by lone-star tick bites.
    • “A 2023 CDC report found that 42% of healthcare providers had limited knowledge of alpha-gal syndrome and 35% weren’t confident in their ability to diagnose it. 
    • “Patients say misdiagnosis of the syndrome is common and diagnoses can be delayed. That’s because allergic reactions often take place three to six hours after eating the culprit. Among common misdiagnoses: irritable bowel syndrome.”
  • Contemporary Pediatrics tells us,
    • “Researchers found evidence that childhood influences may contribute to 85 adult health diagnoses, including tobacco use disorder, heart disease, digestive disorders, and urinary conditions.
    • “Later age at menarche may serve as a marker of childhood environmental or acquired factors that affect long-term health outcomes.
    • “Findings support the need for greater research into childhood determinants of adult disease and potential prevention strategies across the lifespan.”
  • MedPage Today informs us,
    • “Most in-vitro fertilization (IVF) add-on treatments have little to no evidence of benefit.
    • “Many patients rely on social media and IVF clinic websites for information about them, which may be overhyped.
    • “Better information for patients, and trials of benefits and harms of add-ons are needed.”
    • * * * For example, “[f]our add-ons seemed to have no effect on live birth rates:
      • “EmbryoGlue: OR 1.12, 95% CI 0.91-1.37, P=0.29; seven RCTs; low-certainty evidence
      • “Preimplantation genetic testing for aneuploidy: OR 1.16, 95% CI 0.91-1.47, P=0.23; five trials; moderate certainty
      • “Endometrial receptivity testing: three trials; meta-analysis not undertaken; moderate certainty
      • “Corticosteroids: OR 0.95, 95% CI 0.70-1.27, P=0.71; two trials; moderate certainty.”
  • and
    • “Use and misuse of GLP-1 receptor agonists were common in people with eating disorders, interim results of an ongoing cross-sectional study suggested.
    • “Among over 400 people with eating disorders, 32.1% said they have used GLP-1 drugs, and 22% reported current use, wrote Nicholas C. Peiper, PhD, MPH, of the University of Louisville in Kentucky, and co-authors in a research letter in JAMA Psychiatry.opens in a new tab or window
    • “Notably, 10.1% said they have misused the medications, and 9.9% reported using noncommercial compounded products.”
  • Healio notes,
    • “Omega-3 fatty acids may not deliver benefits for cognitive function on their own, according to a study published in eBioMedicine.
    • “The results show the need for a multimodal approach to preventing dementia in older adults, one that simultaneously addresses physical inactivity, vascular health and other risk factors, Hussein Yassine, MD, director of the USC Center for Personalized Brain Health, and colleagues wrote.”
  • Cardiovascular Business lets us know,
    • “Oral nicorandil can reduce the risk of contrast-associated acute kidney injury (CA-AKI) when patients with renal dysfunction undergo percutaneous coronary intervention (PCI), according to new research published in Circulation: Cardiovascular Interventions.[1] The greatest impact was seen in patients receiving three high doses of the medication per day.
    • “Nicorandil is currently indicated for the treatment of angina. Because it is associated with improved hemodynamics in addition to anti-oxidant and anti-apoptotic benefits, the team behind this study hoped to learn more about its potential effect on high-risk PCI patients who present with renal dysfunction.
    • “Researchers focused on more than 600 patients with renal dysfunction who underwent PCI from 2022 to 2025. While approximately one-third of those patients received 5 mg of nicorandil three times per day, another one-third received 10 mg of nicorandil three times per day. The remaining patients received no nicorandil and served as the study’s control group.
    • “Overall, the rates of CA-AKI within 72 hours were 8.7% for the high-dose group, 10.9% for the conventional dose group and 19.8% for the control group. High-dose nicorandil was linked to a 61% relative risk reduction without significantly increasing the risk of adverse events.”
  • Per BioPharma Dive,
    • “Biotechnology startup RQ Bio has snagged a nine-figure funding round to support development of a drug it believes to be capable of providing broad, long-lasting protection against seasonal influenza.
    • “The London-based biotech said Wednesday it raised 85.5 million pounds, or $115 million, to advance a program known as RQB01. Currently in preclinical testing, the therapy has an undisclosed “differentiated dual mechanism” targeting parts of the virus that remain unchanged even after mutations. RQ Bio claims this approach could help ward off flu-related illness from a variety of different strains, with a single dose providing protective effects that persist for a full season.
    • “The financing round was led by Frazier Life Sciences, included participation from founding investor LifeArc Ventures, and involved other well-known firms such as Forbion and EQT Life Sciences.”

From the U.S. healthcare business front,

  • HealthLeaders reports,
    • “PwC projects a 9.0% commercial medical cost trend for group plans in 2027, driven by structural inflators like AI-enabled documentation tools, rising specialty pharmacy costs, and IDR payments. 
    • “As payers aggressively deploy AI-driven pre-payment reviews to combat rising costs, providers are automating their defenses, creating an expensive administrative arms race that fails to lower systemic costs for the consumer.
    • “To navigate this financial squeeze without alienating their communities, health systems must shift away from back-end collections and prioritize transparent, empathetic pre-service financial clearance.”
  • Beckers Payer Issues relates,
    • “Optum is speaking with multiple large New York health systems to sell some specialties in the state, the company confirmed to Becker’s June 24.
    • “The UnitedHealth Group subsidiary is considering the sale of certain specialties, including orthopedics, general surgery and urology. The specialties are affiliated with Optum Medical Care and Crystal Run Healthcare, which Optum purchased in 2023.
    • “We are in discussions with several large health systems across New York regarding the transition of certain specialty services with the goal to keep that care local,” Jon Nasser, MD, CEO of Optum New York and New Jersey, said in a statement shared with Becker’s. 
    • ‘Optum has already signed or is negotiating letters of intent with the interested health systems. The company aims to reach agreements and close sales by the end of 2026.”
  • and
    • “Walgreens will begin supporting eligible Medicare beneficiaries through the new Medicare GLP-1 Bridge program at about 8,000 pharmacies when the initiative launches July 1.
    • “More than 56 million patients in the Medicare network may be eligible for the program, according to a June 25 news release. Walgreens pharmacists will help patients navigate eligibility requirements, answer questions about participating medications and provide ongoing support during treatment. Free delivery will be available in most states for select oral GLP-1 tablets, as well.
    • “Walgreens joins CVS Health, Walmart and Sam’s Club in supporting the Medicare GLP-1 Bridge program. CVS said it will offer expanded pharmacist support, a $49 MinuteClinic virtual weight management visit and a $50 monthly copay option for eligible Medicare beneficiaries. Walmart and Sam’s Club said they will provide pharmacist consultations and educational resources through nearly 5,000 pharmacy locations.”
  • Beckers Hospital Review tells us,
    • “Orlando Health Watson Clinic Lakeland (Fla.) Highlands Hospital is scheduled to open July 8 after more than six years of construction and planning.
    • “The more than $500 million facility is the first hospital opening in Lakeland in over a century, and Orlando Health’s 50th facility in Florida, including clinics, freestanding emergency departments, hospitals, and institutes, according to a June 25 news release shared with Becker’s. 
    • “Orlando Health Watson Clinic Lakeland Highlands Hospital has hired 1,500 employees, and is offering full scholarship programs to full- and part-time staff. The 558,233-square-foot facility has seven floors, 206 patient beds, 49 emergency room beds and sits on nearly 80 acres.
    • “The hospital has eight labor and delivery beds, 28 postpartum rooms and two cesarean section operating rooms. In the next few months, it will open a neonatal intensive care unit that comprises 12 beds for babies who need specialized postbirth care.”
  • Radiology Business adds,
    • “The University of Pittsburgh Medical Center recently held a ribbon cutting for an $8 million new interventional radiology suite. 
    • “UPMC Williamsport, a 224-bed acute care hospital, said the relocated IR facility seeks to bring minimally invasive care closer to home for patients in north central Pennsylvania. The upgraded suite now includes two state-of-the-art labs, equipped with next-generation imaging systems. 
    • “UPMC said the scanners will allow radiologists to visualize blood vessels and internal structures in real time. There, they’ll deliver procedures including stent placements and balloon angioplasties with “greater accuracy and control.” 
    • “This investment reflects UPMC’s ongoing commitment to expanding access to advanced, high-quality care across north central Pennsylvania,” Luke Klingler, director of the health system’s Heart and Vascular Institute, said in an announcement June 17. “The new interventional radiology suite strengthens our ability to meet the evolving needs of our communities by enhancing clinical capabilities, supporting multidisciplinary collaboration, and ensuring patients can receive leading-edge, minimally invasive care close to home.”
  • MedCity News informs us,
    • “Michigan-based insurer Priority Health has teamed up with Garner Health, a digital platform that steers patients to high-performing doctors to lower costs, the companies announced on Wednesday.
    • “Priority Health serves 1.4 million members in Michigan, Indiana, Ohio and Wisconsin. The new partnership will support both self-funded and fully funded employer groups, and will become available starting August 1.
    • ‘The partnership seeks to make it easier for Priority Health’s members to find high-quality physicians in their area. Garner Health has a dataset of over 60 billion medical records that helps identify the best quality doctors. When members choose high-performing providers through Garner’s dataset, their employer then covers most or all of their out-of-pocket costs. This incentivizes employees to choose better doctors and lowers costs for employers by avoiding unnecessary procedures.”
  • Per Fierce Healthcare,
    • “Virtual care platform First Stop Health unveiled an expansion of its Healthy Weight Program amid increasing GLP-1 demand and subsequent healthcare plan costs.
    • “The program integrates weight management, including GLP-1 prescriptions when appropriate, directly into its primary care model. New to the program is a cash-pay access option for employers who do not currently cover GLP-1 prescriptions and a managed coverage program for those who do offer coverage. 
    • “The goal isn’t simply weight loss — it’s improving metabolic health and reducing long-term health risk,” said Cole Barfield, M.D., First Stop Health chief medical officer, in an emailed statement to Fierce Healthcare. 
    • “Barfield said the virtual care platform aids “employers on either side of the coverage decision” by “combining clinically appropriate prescribing with primary care, dietitians, health coaches, and diabetes educators who support sustainable behavior change.” 
    • “Medication can be transformative, but it works best when it’s part of a real care relationship focused on the whole person,” Barfield said.”

Thursday report

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, NIH, OPM, SCOTUS, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republican senators stopped short of using their political leverage to kill President Trump’s $1.8 billion “anti-weaponization” fund, approving a critical immigration-enforcement bill without adding language reining in the controversial program.
    • “Passage of the $70 billion package funding Immigration and Customs Enforcement and Border Patrol through the end of Trump’s second term came after a more than 19-hour session of amendment votes and intraparty negotiations. The GOP-backed measure passed 52 to 47 shortly before 5 a.m., with Republican Sen. Lisa Murkowski of Alaska voting with Democrats against the bill.
    • “The session’s votes allowed GOP senators in competitive election fights this fall—including Susan Collins of Maine, Dan Sullivan of Alaska, Jon Husted of Ohio and Ashley Moody of Florida—to register their objections to the fund without derailing a bill that is a priority for Trump and the party.
    • “The House is expected to take up the immigration-enforcement measure next week.”
  • The No Surprises Act’s final independent dispute resolution (IDR) rule was published in the Federal Register today. Federal Hearings and Appeals Services, which a certified IDR entity, offers its summary of the rule with helpful charts!
  • Federal News Network reports
    • The Postal Service, on the verge of running out of cash early next year, is pricing out a wide range of possible reforms that, if passed by Congress, could address the agency’s long-term financial problems.
    • Postmaster General David Steiner told House lawmakers in March that USPS is set to run out of cash in early 2027 and that lawmakers need to act soon to keep the agency running.
    • The agency’s wish-list of possible legislative reforms, outlined in a document titled “Accelerating Progress: Elements of Postal Reform,” includes several longstanding proposals supported by postal watchdogs and unions. The document also considers more controversial options, such as closing post offices and reducing delivery days to save USPS billions of dollars each year.
  • Per a House of Representatives Oversight and Government Reform news release,
    • “Subcommittee on Government Operations Chairman Pete Sessions (R-Texas) delivered his opening statement at today’s hearing with the Commissioners of the Postal Regulatory Commission. In his opening remarks, Subcommittee Chairman Sessions highlighted the financial crisis the U.S. Postal Service (USPS) is facing and how actions to reform the agency have fallen short of expectations. He also emphasized that Congress and the American people have to decide what they want out of USPS to help resolve procedural and financial issues in the agency.” 
  • The OPM Director Scott Kupor added to his Secrets of OPM blog (available on LinkedIn and Substack) concerning a Presidential Memorandum approving the use of critical position pay to support investment programs related to national security.
  • Tammy Flangan, writing in Govexec, discusses whether a record number of new retirees this year will slow your retirement claim.
    • “New OPM data offers clues about processing times, potential delays and why retiring employees may need a larger financial cushion than expected.” 
  • Per a National Institutes of Health news release,
    • “National Institutes of Health Director Jay Bhattacharya, M.D., today announced the selection of Steven Schiff, M.D., Ph.D., as the next director of the Fogarty International Center (FIC) and NIH associate director for international research. Schiff began his role on June 4, 2026. 
    • “A pediatric neurosurgeon and global health researcher, Schiff currently serves as the Harvey and Kate Cushing Professor of Neurosurgery, vice chair for global health in the Department of Neurosurgery, and professor of epidemiology and of electrical and computer engineering at Yale University in New Haven, Connecticut.” * * *
    • “As director of FIC, Schiff will lead NIH’s global health research efforts by supporting collaborations between U.S. and international investigators, strengthening partnerships among research institutions worldwide, and training future global health scientists. He will oversee the center’s approximately $95 million annual budget, most of which supports research grants and training programs.” 
  • Beckers Health IT lets us know,
    • “The White House is backing a push for AI to take over more of the duties of physicians, The Washington Post reported.
    • “The Trump administration supports an experiment in Utah where AI is writing prescriptions, plans to offer over $50 million in research awards to developers of conversational AI for cardiovascular care, has created an expedited approval process for digital health products like AI chatbots, and is working on a regulatory pathway for independent AI physicians, according to the June 4 story.
    • “People are seeing the difference the AI is bringing,” Amy Gleason, the administrator of the Department of Government Efficiency who is now a healthcare AI advisor at HHS, told the news outlet. “And it’s like the genie is out of the bottle.”
  • and
    • “HHS, under Secretary Robert F. Kennedy Jr., has sought access to detailed patient records held by state health information exchange systems as part of an effort to research a potential link between vaccines and autism, KFF Health News reported June 4.
    • “Federal officials met with leaders of state-run health information exchanges several times over the past year, asking how the medical records they maintain from hospitals and health systems could be used for vaccine research, according to seven people familiar with the meetings.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Leaders at the Food and Drug Administration on Thursday listened to criticisms and recommendations for how to move forward with a speedy drug review program put in place by former FDA commissioner Marty Makary. 
    • “The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, particularly those whose drugs have already been approved through the program. But most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback.” 
  • Per a corporate news release,
    • “Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis® (Genentech).”
  • Reuters relates,
    • “The U.S. FDA’s Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for ​an artificial intelligence-based drug development tool designed to ‌help predict drug-induced liver injury.
    • ‘Drug-induced liver damage is a major cause of trial failures, and current methods do not reliably ​predict human risk. The U.S. Food and Drug Administration said ​the tool could potentially help improve early safety assessments, reduce reliance ⁠on animal testing and support more informed decisions before human trials ​begin.’

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court raised the bar for branded pharmaceutical companies seeking to sue over a competitor’s generic versions of their drugs that are marketed using what’s called a skinny label.
    • “The justices unanimously concluded that a district court judge was right to dismiss Amarin Pharma Inc.’s infringement suit over claims that Hikma Pharmaceuticals USA Inc. was encouraging doctors to prescribe its generic version of Amarin’s Vascepa heart health drug for a still-patented treatment method.
    • “Drugmakers frequently obtain patents not just on chemical compounds they discover for novel drugs, but separately for methods of using such drugs to treat various medical conditions. When some uses are covered by active patents while others aren’t, generics can get government approval of a “skinny label” that carves out the patented uses.
    • “Thursday’s ruling ramps up the evidence that branded drugmakers need in order to sue when they think the generic label in combination with a generic company’s marketing statements or other communications cross a line into actively inducing patent infringement.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Scientists have made a discovery that may help prevent some people from developing lung cancer, which kills more people worldwide than any other cancer. 
    • “A team of more than 80 researchers working across four continents have identified a set of proteins in the blood that accurately predict lung cancers more than five years before diagnosis. The scientists also found early evidence that an existing anti-inflammatory drug could significantly reduce lung cancer risk in people with elevated concentrations of these proteins, which they linked to inflammation.
    • “More research is needed before a test based on these proteins could be ready for use in patients. And scientists would still need to run a randomized trial to determine whether the drug prevents lung cancers. Still, outside experts said the findings, which were published on Thursday in the journal Cell, offer a promising starting point toward a long-held public health goal.”
  • The Washington Post adds,
    • “The story of GLP-1 drugs keeps getting bigger.
    • “First they transformed the treatment of diabetes. Then they upended the science — and culture — of weight loss. Now a growing body of research is raising another possibility: that these drugs may help protect against cancer.
    • “At this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago, more than 40 studies, abstracts, oral presentations and poster presentations examined the relationship between GLP-1-based drugs and cancer. The results were strikingly consistent. Taken together, they suggest that people taking medications such as Ozempic, Wegovy and Mounjaro may develop certain cancers at lower rates than comparable patients who are not taking the drugs — and that those already diagnosed may experience a slower decline and better outcomes.
    • “For oncologists, the accumulation of evidence is hard to dismiss. The findings are “super promising,” said Mark Orland, a cancer researcher at the Cleveland Clinic. “We’re really excited to be on the forefront of looking at the effects of these drugs.”
  • Health Day relates,
    • “A simple urine test might help identify children who are likely to have autism earlier than the best assessment tools now available, a new study says.
    • “Autistic children appear to have specific gut microbe profiles that can be used to distinguish them from neurotypical (or typically developing) children, researchers reported May 26 in the journal Molecular Psychiatry.
    • “A urine test based on these profiles correctly identified 90% of autistic children and did not misidentify any children without autism, researchers found.
    • “What’s really striking about the bacteria is that they make metabolites that are basically altered versions of serotonin and dopamine,” said researcher James Adams, a professor of engineering at the Biodesign Center for Health Through Microbiomes at Arizona State University (ASU) in Tempe.”
  • and
    • “Mailed fecal immunochemical tests (FITs) can significantly increase colorectal cancer (CRC) screening across racial and ethnic groups, according to a study published in the May/June issue of the Annals of Family Medicine.
    • “Anisha P. Ganguly, M.D., from the University of North Carolina at Chapel Hill, and colleagues compared the effects of a CRC intervention (mailed FIT for screening-eligible patients plus patient navigation for positive results) across race/ethnicity. The analysis included 3,734 patients at federally qualified health centers.” * * *
    • “This analysis showed that mailed colorectal cancer screening tests have the power to improve screening rates for diverse populations,” Ganguly said in a statement. “This is really important, because we want these innovations in screening to improve outcomes among the hardest to reach populations and move the needle on colorectal cancer disparities.”
  • The American Journal of Managed Care tells us,
    • “Sudden death has long been considered an abrupt and unpredictable event in patients with heart failure
       (HF). But a new post hoc analysis of the FINEARTS-HF randomized clinical trial challenges that assumption, finding that most sudden deaths in patients with HF with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) are preceded by measurable clinical deterioration in the months before death.”
  • According to Infectious Diseases Advisor,
    • “Maternal SARS-CoV-2 mRNA vaccination during the third trimester reduces risk for infection and related hospitalization in infants through 6 months of age, highlighting the importance of maternal vaccine timing.”
  • STAT News informs us,
    • “Otsuka’s Voyxact slowed the loss of kidney function after one year in patients with a chronic autoimmune kidney disease, but the benefit was less than expected and left room for competing treatments to perform better. 
    • “In a Phase 3 study, patients with IgA nephropathy, or IgAN, who received injections of Voyxact saw their kidneys lose function at an annualized rate of 3 points over one year compared to an annualized function loss of 7.6 points over one year for patients receiving a placebo, the Japanese drugmaker reported Thursday.” * * *
    • “While the relative improvement in kidney function was positive, the result was also less robust than what was seen in an earlier Otsuka study. The data left open the possibility that competing drugs from Vera Therapeutics and Vertex Pharmaceuticals may be able to show a larger effect on kidney function when their respective studies read out results.” 

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

  • Beckers Payers Issues reports,
    • “UnitedHealth Group and CVS Health, Aetna’s parent company, are among the top 10 companies on the Fortune 500 this year.
    • “Fortune‘s June 3 list ranks the top 500 U.S. companies by revenue. Nine health payers [which are listed in the article] made the cut, with 2025 revenues ranging from $11.7 billion to $447.6 billion.
    • “UnitedHealth Group held its third-place standing from 2025. Amazon topped the list, ending Walmart’s 13-year tenure in the top spot.”
  • Beckers Hospital Review relates,
    • “Brentwood, Tenn.-based Lifepoint Health has completed its acquisition of eight community hospitals from Louisville, Ky.-based ScionHealth.
    • “The hospitals are spread across six states, according to a June 2 news release. Lifepoint acquired:
      • “Bolivar Medical Center in Cleveland, Miss.
      • “Ennis (Texas) Regional Medical Center
      • “Livingston (Tenn.) Regional Hospital
      • “Logan (W.Va.) Regional Medical Center
      • “Palestine (Texas) Regional Medical Center
      • “Parkview Regional Hospital in Mexia, Texas
      • “St. Joseph Regional Medical Center in Lewiston, Idaho
      • “Watertown (Wis.) Regional Medical Center
    • “Lifepoint originally signed an agreement to acquire the hospitals in March.
    • “ScionHealth said the eight hospitals will keep their current employees, providers and services. The company described the divestiture as part of a broader effort to strengthen its capital structure and focus on core operations.”
  • Healthcare Dive adds,
    • “West Virginia University Health System has solidified the next phase in its plan to acquire Greensburg, Pennsylvania-based nonprofit Independence Health System, announcing this week the two parties had signed a definitive agreement to combine.
    • “As part of the deal, which was announced last year, WVU Health System will invest $800 million into Independence’s five hospitals in order to install a new electronic health record and upgrade the facilities.
    • “The health systems now expect the acquisition will close in September or October, pending regulatory approval.”
  • Fierce Healthcare tells us,
    • “Due to advances in cancer treatment and early detection, the population of cancer survivors continues to grow, reaching more than 18 million individuals in the U.S. By 2035, that number is projected to exceed 22 million.
    • “But many cancer survivors have ongoing medical and mental health needs after cancer treatment ends. Faced with long-term side effects, behavioral health challenges and hormone therapies, many survivors are left to manage these healthcare challenges on their own.
    • “Value-based cancer care navigation company Thyme Care has expanded its cancer survivorship program, called Next Chapter Care, to provide a personalized, longitudinal approach to survivorship support. That program provides coordinated oncology support beyond active treatment for the more than 15,000 Thyme Care members who have completed cancer treatment.
    • “Rather than treating survivorship as a disconnected phase of care, the program extends the existing relationship Thyme Care already has with members across diagnosis, treatment and recovery, according to the company.”
  • and
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. 
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. “
  • Beckers Hospital Review points out,
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to the American Society of Health-System Pharmacists — and the FDA’s database continues to reflect new discontinuations weekly. The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also lists eight recent additions to the shortage list.

Monday report

David Ermer–CDC, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “President Donald Trump on Monday announced that about 600 low-cost generic drugs would be available through TrumpRx.gov, a government website aimed at helping Americans purchase medications at discounted prices. 
    • “By incorporating this massive catalog of low-cost generics at TrumpRx.gov, consumers will now have one source to ensure that they’re getting the lowest possible cost on their prescription,” Trump said in a presentation at the Eisenhower Executive Office Building.”
  • Federal News Network relates
    • “HHS sends RIF notices to dozens of staff it missed during office-wide layoffs last year.
    • “Meanwhile, HHS is looking to convert hundreds of senior positions to a rebranded version of the “Schedule F” classification for federal employees.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a reorganization of its Office for Civil Rights (OCR), the Department’s law enforcement agency charged with enforcing laws protecting civil rights, conscience and religious freedom, and health information privacy and security. The reorganization returns OCR to a program-based structure that aligns OCR’s three critical substantive areas with three distinct subject-matter divisions: the Conscience and Religious Freedom Division, the Civil Rights Division, and the Health Information Privacy, Data, and Cybersecurity Division.
    • “This reorganization restores the HHS Civil Rights Division and the Conscience and Religious Freedom Division and strengthens the Office for Civil Rights’ ability to defend religious liberty, enforce conscience protections, and combat unlawful discrimination,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “Under President Trump’s leadership, HHS will defend these rights with clarity, accountability, and resolve.”
    • “This reorganization reinstitutes a structure that rightly prioritizes civil rights and conscience and religious freedom alongside health information privacy and security,” said HHS Office for Civil Rights Director Paula M. Stannard. “All three areas are deserving of subject-matter expertise and distinct senior executive leadership for OCR to best serve the American people.”
  • The American Hospital Association News adds,
    • “Most hospital outreach laboratories must report private payer clinical diagnostic laboratory data for services furnished during the first six months of 2025 to the Centers for Medicare & Medicaid Services by July 31, the agency announced. This includes Healthcare Common Procedure Coding System codes, associated private payer rates and volume data. CMS previously sent letters to hospitals, which the agency believes have outreach laboratories that are likely required to report their data. CMS also has a guide and other resources for hospital outreach laboratories to determine whether and how they must report.” 

From the Food and Drug Administration,

  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it received U.S. approval for a new hypertension treatment, getting the green light to launch a drug the U.K. pharmaceutical company expects to generate multibillion-dollar annual sales at its peak.
    • “The drug, known until now as baxdrostat, will be marketed under the brand name Baxfendy, the company said Monday. The approval expands AstraZeneca’s cardiovascular, renal and metabolism portfolio shortly after diabetes drug Farxiga—its biggest product in that therapeutic area and the bestselling medicine in the company’s history—went off patent in the U.S.
    • “AstraZeneca said that Baxfendy treats hypertension in a new way by targeting aldosterone, a hormone that raises blood pressure.
    • “Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, said the approval brings a new treatment to a disease that has had little therapeutic progress for the past two decades.”
  • Fierce Pharma relates,
    • “Enhertu’s market conquest is continuing apace. Already tracking at $5 billion in annual sales, the star antibody-drug conjugate from Daiichi Sankyo and AstraZeneca has secured FDA approval to treat early breast cancer, further encroaching on Roche’s Kadcyla territory.
    • “The FDA has simultaneously greenlighted Enhertu for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer, the two companies said Friday [July 15, 2026]. The adjuvant nod came nearly two months ahead of schedule, as the FDA had originally targeted a decision by July 7.”
  • The New York Times tells us,
    • “A California dairy company has issued a recall for five ice cream flavors, warning customers that some tubs may be contaminated with metal.
    • “The company, Straus Family Creamery, recalled some of its organic ice cream, which was sold in 17 states since May 4. It said it ordered the recall because of “the potential presence of metal foreign material,” without giving further details.
    • “The warning applies to its vanilla bean, strawberry, cookie dough, Dutch chocolate and mint chip flavors with specific “best-by” dates in late December 2026.
    • “It did not say how many tubs were affected but said the issue was with a “small number of production runs.”
  • Health Day informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved an AI-powered early warning system to detect sepsis, one of the deadliest infections for hospital patients.
    • “The tool, developed at Johns Hopkins University (JHU), detects sepsis hours faster than doctors. It has already reduced deaths by nearly 20% in dozens of hospitals across the United States, JHU reports.
    • “Pre-suspicion screening is what creates lead time, and lead time is what changes outcomes in sepsis,” said Suchi Saria, director of JHU’s AI & Healthcare Lab. “Once a clinician already suspects sepsis, the clock has been running — often for hours or even days.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court turned away appeals from six pharmaceutical companies seeking to topple the Medicare drug price negotiation program that’s led to billions of dollars in discounts on top-selling treatments.
    • “Making no comment, the justices on Monday refused to hear a variety of constitutional arguments against a program created in 2022 by President Joe Biden’s Inflation Reduction Act. The court rejected separate appeals from units of AstraZeneca Plc, Johnson & Johnson, Bristol Myers Squibb Co., Novartis AG, Novo Nordisk A/S and Boehringer Ingelheim Pharmaceuticals Inc.
    • “The rebuffs leave in force a program the US government said in November will produce a 71% discount on Novo Nordisk’s blockbuster Ozempic and Wegovy drugs for Medicare patients starting in 2027. The Trump administration said that round of discounts, covering 15 drugs, will mean $12 billion in savings compared with 2024 list prices.
    • “The cases at the high court involved the previous year’s negotiated discounts, which covered 10 drugs and took effect in January. The Centers for Medicare and Medicaid Services said in 2024 that the deals would reduce out-of-pocket costs by $1.5 billion this year.”
  • Per a Justice Department news release,
    • “A New York man was sentenced today to 37 months in prison for conspiring to launder nearly $1.5 million in illicit health care fraud proceeds through multiple domestic and global banks on behalf of a Transnational Criminal Organization (Organization).
    • “According to court documents, Elnar Zarbailov, 42, of Staten Island, New York, and dual citizen of the United States and Azerbaijan, was a fixer and money launderer for the foreign-based  Organization that spearheaded the largest health care fraud case ever prosecuted by the Department of Justice, as uncovered by Operation Gold Rush. The Organization, based in Russia and elsewhere, orchestrated a multi-billion-dollar health care fraud and money laundering scheme to target, exploit, and steal from Medicare and private health insurance companies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The CDC announced Monday that an American tested positive for Ebola this weekend while working in Congo and is being transported to Germany for treatment along with six other Americans who are high-risk contacts. 
    • “The Centers for Disease Control and Prevention also is enhancing public health screening and traveler monitoring amid a growing Ebola outbreak, and non-U.S. passport holders face entry restrictions if they have been to Uganda, the Democratic Republic of Congo or South Sudan in the previous 21 days.
    • “To the American public, the risk to the United States remains low,” said Satish Pillai, CDC Ebola response incident manager. “Travelers to the region should avoid contact with sick people, report symptoms immediately, and follow our travel guidance.”
  • Health Exec points out,
    • “A healthcare research firm that provides trend analysis to stakeholders released a new report that examined usage of behavioral health services post-COVID, showing that demand and utilization for mental healthcare and addiction mitigation have intensified since the pandemic.
    • “According to the data from Trilliant Health, while the utilization of care related to emotional health, mental health, autism, and alcohol and drug dependency stand at new highs since the COVID lockdowns, outcomes may not be improving.
    • “Using publicly available data on utilization, provider numbers and demand, Trilliant’s data paints a picture of a mental healthcare system that is overburdened. From 2018 to 2024, the group reports that the number of behavioral health visits jumped 62.6%, standing at 1,346 visits per 1,000 people.
    • “People seeking care for anxiety led the trend, accounting for 89.3% of growth. Women aged 18-44 made up the majority of that cohort. However, Trilliant noted that childhood developmental disorders—autism, attention deficit disorder, speech problems and other issues including anxiety—including attempted self-harm, have risen nearly 48% over 20 years, from 2004-2024.”
  • Health Day adds,
    • Many older adults see cannabis as a more effective or nonpharmaceutical option to manage sleep, pain, or mental health, according to a study published online May 8 in JAMA Network Open.
    • Rebecca K. Delaney, Ph.D., from the University of Utah Intermountain Health Department of Population Health Sciences in Salt Lake City, and colleagues explored the motivations of older adults in Colorado interested in purchasing edible cannabis products to improve sleep, pain, or mental health concerns, as well as the perceived benefits and drawbacks of different cannabinoid profiles. The analysis included 169 interview participants aged 60 years and older.
  • The New York Times relates,
    • “A study of insurance claims for 1.8 million children found that the number of families raising mental health issues at visits to general practitioners rose sharply over a decade, with anxiety by far the fastest-growing complaint.
    • “The study, which was published on Monday in the journal JAMA Network Open, found that the number of pediatric visits rose to 9.7 percent in 2023 from 5.7 percent in 2014.
    • “The study included all insurance claims for children from ages 1 to 18 in Massachusetts, for a total of more than 1.8 million children. Visits were counted as mental health visits if a diagnostic code was included in the claim, either because the child or the family raised the issue or because the child screened positive for mental health symptoms during the visit.
    • “Visits for anxiety rose by more than 250 percent during that period, to 6.1 percent in 2023 from 1.7 percent in 2014.”
  • The American Medical Association lets us know “nine things patients should know about taking creatine.”
    • “The ‘Health vs. Hype’ AMA podcast explores what creatine is, its association with bodybuilders, and whether it’s safe for the general public.”
  • Medpage Today tells us,
    • “A course of azithromycin for preschoolers who presented to the emergency department (ED) with wheezing didn’t improve their symptoms, the AZ-SWED trial showed.
    • :Among children, ages 18-59 months, the 5-day sum of scores on the Asthma Flare-up Diary for Young Children (ADYC) did not differ significantly compared with placebo in either those who initially tested positive for pathogenic bacteria (median 9.59 vs 9.72, P=0.70) or those who tested negative (9.30 vs 9.10, P=0.69). ADYC scores range from 5-35 points, with higher scores indicating more severe symptoms.
    • “While the trial was stopped early for futility — reducing the statistical power of the trial — it was sufficient to show that “a moderate or large true effect is implausible,” Richard M. Ruddy, MD, of the University of Cincinnati College of Medicine, reported at the American Thoracic Societyannual meeting in Orlando. The findings were published simultaneously in the New England Journal of Medicine.”
  • and
    • “The 2025/2026 seasonal COVID vaccination was associated with a roughly 50% reduced risk for illness up to 9 weeks post-vaccination, especially in older Canadian adults, according to an interim analysis by the Canadian Sentinel Practitioner Surveillance Network. The seasonal vaccine, which was specifically formulated to target the LP.8.1 variant, also appeared to offer protection from other strains.
    • “An important aspect of the 2025/2026 season was the simultaneous circulation of influenza and other respiratory viruses, which suggested the need to consider the role that respiratory virus co-circulation might play in estimating vaccine effectiveness (VE).
    • “This year, we were especially interested to check the effects of co-circulating respiratory viruses (eg, influenza and respiratory syncytial virus [RSV]) since COVID circulated at only low levels through the current season,” lead author Danuta M. Skowronski, MD, epidemiology lead for influenza and emerging respiratory pathogens at the BC Centre for Disease Control in Vancouver, told Medscape News Canada.”
  • The American Journal of Managed Care points out,
    • “A retrospective VA cohort (2006–2019) compared ≥75-year-olds with adenoma vs no adenoma at ages 65–75 using registry and National Death Index outcomes. 
    • “Ten-year CRC incidence and CRC death were statistically higher with prior adenoma, but absolute differences were small and clinically overshadowed by competing non-CRC mortality. 
    • “Frailty stratification showed progressively lower CRC incidence and sharply higher non-CRC death, with severe frailty demonstrating <1% CRC versus 82% non-CRC death. 
    • “Advanced adenoma status did not significantly alter CRC risk, and follow-up colonoscopy rates after 75 were not higher among patients later developing CRC. 
    • “Generalizability is limited by a 98% male veteran population, reinforcing the need for confirmatory analyses in cohorts with greater female representation.”
  • Per BioPharma Dive
    • “An experimental cancer immunotherapy from Regeneron failed a late-stage study in melanoma in a surprise setback for the big biotechnology company’s oncology business.
    • “A regimen involving the prospect, fianlimab, and Regeneron’s marketed medicine Libtayo didn’t significantly delay cancer progression compared to Merck & Co.’s Keytruda in patients with unresectable metastatic melanoma. A high-dose combination held tumors in check for a median of 11.5 months, compared to 6.4 months for Keytruda recipients, a difference that narrowly missed statistical significance.
    • “Regeneron didn’t provide additional details but will present them at a future medical meeting. Another Phase 3 study testing fianlimab against Opdualag, a similar cancer immunotherapy sold by Bristol Myers Squibb, is ongoing. Company shares fell by double digits early Monday, erasing billions of dollars in market value.”

From the U.S. healthcare business front

  • Kauffman Hall reports,
    • Key Takeaways
      • March was the best month for hospitals in 2026 so far, despite mixed volumes. Month-over month discharges rose while patient days fell, indicating increased focus on improving average length of stay and a continued shift to outpatient care.
      • Operating margins improved month-over-month but remain below 2025. While bad debt and charity care declined month-over-month, gross revenue continues to outpace net, highlighting eroding payor mix.
      • Expenses declined in March, yet remain elevated year-over-year. Favorable improvements across the board are likely correlated to the decrease in average length of stay. However, drug expenses remain a primary driver of expense growth year-to-date.
      • Two notable outliers emerged in otherwise steady regional trends. The Northeast saw margin improvement, despite historical underperformance, while the West experienced the most dramatic increase in drug expense.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Massachusetts reported a net income of $59.6 million in the first quarter of 2026, a return to profitability after back-to-back annual losses in 2024 and 2025.
    • “The insurer posted revenue of $2.6 billion in the first quarter, reflecting a 2% net margin. Operating and other income came in at $17.4 million (0.6% operating margin), with investment income contributing $42.2 million.
    • “The company attributed the improved results to disciplined cost management, a milder-than-expected flu season and changes to its coverage of GLP-1 medications.
    • “Our first-quarter results reflect the challenging but necessary actions we’ve taken over the past year, including pricing our benefit plans to their true cost, identifying medical and pharmacy spending that doesn’t add value for our members, and keeping rate increases to our provider network at or below the state benchmark,” CFO Ruby Kam said May 15.”
  • Fierce Healthcare relates,
    • “Now three quarters into its fiscal year, Ascension has chopped down its operating losses by more than half and more than tripled its bottom-line gain. 
    • “The nonprofit system reported Friday a $203 million operating loss (-1.1% operating margin) for the nine months ended March 31, 2026, improving on the $466 million operating loss (-2.3%) for the prior fiscal year. 
    • “Both its total operating revenue and operating expenses dipped from the prior year due to a slew of divestitures. The former declined by 7.2% to $18.1 billion while the latter fell by 8.1% to $18.3 billion; on a same-facility basis, total operating revenue grew 9.3% while expenses increased 5.7%.” 
  • Healthcare IT News explains “How one practice combines in-clinic, telehealth and in-home care.”
    • “Dr. Payam Zamani is a practicing family medicine physician and founder and CEO of My Dr Now, one of the largest primary care providers in the Southwest. It’s designed as a hybrid in-person/telehealth/in-home health system.”
    • “When patients engage earlier and follow through consistently, the health system operates more efficiently, My Dr Now’s physician CEO reports: “This is not about technology for its own sake, it’s about designing care delivery around real life.”
  • Modern Healthcare tells us,
    • “Oregon gave the green light for Compassus to acquire a 50% stake in Providence’s home health and hospice operations across the state.
    • “After more than a year of review, Oregon Health Authority’s Health Care Market Oversight program said in a Friday news release it approved the joint venture with conditions.
    • “The Oregon deal is expected to close in the fall, Providence said in an email.”
  • and
    • “RWJBarnabas Health has opened a $7 million food-is-medicine hub to take on chronic disease, making it a potential standard bearer in the Make America Healthy Again movement.
    • “Last week, the New Jersey academic health system opened Harvest — an 8,000-square-foot facility in Newark that is a combination food bank, commercial kitchen and classroom. The center is designed to teach people living in nearby food deserts how to eat healthier and provide them with the food to do it.”
  • Health System CIO informs us,
    • “Epic added 77 acute care hospitals in 2025 while Oracle Health shed 56, according to the new KLAS report, “US Acute Care EHR Market Share 2026.” The five-year picture is even starker. Epic has gained a net 568 hospitals since 2021 while Oracle Health has lost 173. In total, the report covers EHR contracts executed from January through December 2025. Epic now holds 43.7% of acute care hospital market share and 56.9% of beds. Oracle Health, meanwhile, sits second at 21.9% of hospitals and 20.4% of beds, followed by Meditech at 14.7% and 12.5%.” * * *
    • “Hospitals impacted by EHR decisions fell about 40% from 2024 as buyers shifted investment toward AI and operational efficiency tools.”
  • Per MedTech Dive,
    • “Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.
    • “The agreement gives Boston Scientific an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain clinical and regulatory milestones. Boston Scientific said it may opt to acquire the rest of the TAVR business for additional cash payments totaling $3 billion.
    • “The deal comes about a year after Boston Scientific stopped selling its Acurate Neo2 and Acurate Prime TAVR devices, which were CE-marked in Europe, and ended plans to pursue approvals in the U.S. and other locations.”

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medicare, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Roll Call offers an overview of this week’s anticipated activities on Capitol Hill.
  • STAT News reports,
    • “Bill Cassidy, a key Republican health care leader in the Senate, will lose his seat, as Louisiana’s Senate primary heads for a runoff between state treasurer John Fleming and Rep. Julia Letlow, who won President Trump’s endorsement.” * * *
    • “Cassidy’s defeat is a win for President Trump and his allies, who have criticized the senator for voting in 2021 to convict the president for inciting the January 6 insurrection.” * * *
    • “Cassidy will likely remain chair of his committee until his term ends at the start of next year, potentially setting up roadblocks for Kennedy as he attempts to fill several vacancies across his department. That includes a new Food and Drug Administration commissioner, and nominees for surgeon general and Centers for Disease Control and Prevention director.”
  • Federal News Network points out four benefits bills in Congress for federal employees, retirees to watch. “Potential adjustments to short-term disability insurance and credit protection for feds during government shutdowns are on the table through new legislation.
  • Per a May 15, 2026, Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) issued a sweeping rule to strengthen oversight of the Affordable Care Act (ACA) Exchanges for plan year 2027 by lowering user fees, tightening eligibility verification, and giving states greater authority over plan oversight.
    • The final rule, “Notice of Benefit and Payment Parameters for 2027; Basic Health Program” (the 2027 Payment Notice final rule) reduces federal Exchange user fees to help lower premiums, establishes new safeguards to prevent improper enrollments, ensures subsidies go only to eligible individuals, increases consumer choice, affordability, access and protections, and expands state flexibility to manage Exchange operations.
    • “The rule strengthens program integrity, expands consumer protections, promotes plan innovation and consumer choice, and restores greater authority to states. 
    • “American taxpayers deserve to know their dollars are going only to people who truly qualify,” said CMS Administrator Dr. Mehmet Oz. “This rule strengthens eligibility checks, cracks down on abuse, and gives insurers more flexibility to offer affordable, consumer-focused coverage options.”
  • Here is a link to the CMS fact sheet on this final rule.
  • Kevin Moss writes in Govexec,
    • “CMS is launching the Medicare GLP-1 Bridge program, which will extend coverage of certain GLP-1 medications for weight loss to eligible Medicare beneficiaries, regardless of whether they have an underlying medical condition” effective July 1, 2026. 
    • “For [FEHB and PSHB} annuitants enrolled in Part D, this program could expand your options. Here’s [in the article] what it covers, who qualifies, and what it means for you.”
  • The U.S. Supreme Court will be releasing opinions at 10 am every Thursday morning until the end of next month.

From the public health and medical / Rx research front

  • The Wall Street Journal considers whether “the Weight-Loss Drug Revolution Causing a Frailty Epidemic? As millions flock to GLP-1s, doctors warn the drugs can cause rapid and significant muscle loss” and assesses “What Science Tells Us About the Risks of Hantavirus. Rare virus has high fatality rate and can spread through the air, research shows, though it is easier to contain than Covid-19.”
  • Health Day reports,
    • “A major women’s health condition is getting a new name—and experts say it could change how millions are diagnosed and treated worldwide.
    • “Polycystic ovary syndrome, or PCOS, will now be known as polyendocrine metabolic ovarian syndrome, or PMOS.
    • “The condition affects more than 170 million women worldwide and is linked to hormone imbalances, weight and metabolic issues, mental health symptoms, skin changes and fertility challenges.
    • “Experts said the old name was misleading because the condition is not actually defined by ovarian cysts.
    • “What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” said Helena Teede, director of the Monash Center for Health Research & Implementation in Australia and an endocrinologist at Monash Health.”
  • BioPharma Dive relates,
    • “A year after Vertex’s big launch, pain drug research faces a pivotal moment.
    • “Journavx started to revive area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?”

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

  • The Wall Street Journal reports,
    • “Nurse practitioners and physician assistants are increasingly filling healthcare gaps, with NP ranks growing 60% to 461,000 between 2019 and 2025.
    • “Doctors’ groups express concern that non-MD providers practicing without physician oversight may pose risks to patients.
    • “A 2023 study found that allowing nurse practitioners to work without physician supervision reduced deaths that could have been prevented through healthcare by 2%”
  • Fierce Healthcare relates,
    • “Even without counting the multi-billion hit tied to the early termination of a major joint venture and outsourcing arrangement, CommonSpirit Health’s operations took a bruising during the three months ended March 31.
    • “The major Catholic nonprofit system reported Friday a $578 million operating loss (-5.8% operating margin) during the third quarter of its fiscal year. That’s after two key adjustments: normalization for delayed income received through California’s provider fee program; and removing the nearly $2.5 billion of “special charges” the system recorded on paper for the quarter that include contract termination and intangible asset impairment stemming from its breakup with Tenet Healthcare’s revenue cycle services business. 
    • “For comparison, CommonSpirit had logged an $85 million operating loss (-0.9% operating margin) a year prior with the California provider fee program adjustment. Across the first nine months of the fiscal year, the system is looking at a $743 million operating loss (-2.4% operating margin) for 2026 and a $282 million operating loss (-1.0% operating margin) in 2025, with the same adjustments.” 
  • Health Exec tells us,
    • “The days when most doctors worked in independent practice settings are fading from memory like old photoprints in a musty scrapbook.
    • “Taking their place is an era dominated by physician employment. And the employers are not only hospitals but also a “vast array of corporate entities with various financial incentives for employing physicians.”
    • “The quote is from the authors of a new report compiled by Avalere Health for the Physicians Advocacy Institute, also known as PAI.
    • “The shift towards corporatization of physician practice, the PAI analysts add, has “significant implications for costs, patient care and the future practice of medicine.”
    • “The report looks at trends in practice acquisitions as well as physician employment over the eight-year stretch from January 2018 to January 2026.”
  • MedCity News informs us,
    • “Anomaly Insights, an AI-powered payer intelligence company, announcedWednesday that it raised $17 million in funding.
    • “The company’s platform analyzes healthcare transactions to identify payer behavior patterns, policy changes and adjudication deviations. It helps predict at-risk payments so providers can proactively ensure claims are paid accurately. It also detects new denial patterns and identifies revenue opportunities. Currently, Anomaly is being used across more than 20 health systems.
    • “Specifically, the company seeks to solve the issue of “not knowing whether a healthcare encounter will be paid for or not before it happens,” said Mike Desjadon, CEO of Anomaly.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Oklahoma Republican Gov. Kevin Stitt on Tuesday selected Alan Armstrong, an energy executive, to fill the seat being vacated by Sen. Markwayne Mullinuntil a new election takes place in November.
    • “The announcement came a day after Mullin was confirmed Monday by the Senate as secretary of the Department of Homeland Security. The appointment of Armstrong as a temporary seat holder keeps the Senate’s GOP majority at 53-47.
    • “Armstrong, the chairman of Williams Companies, focused in remarks Tuesday morning on permitting reform, the cost of energy and infrastructure.” * * *
    • “President Trump has endorsed Oklahoma Rep. Kevin Hern for the Senate seat in the coming election, calling him a “true friend of MAGA.” The Republican primary in the deep-red state is scheduled for June 16.
    • “Armstrong said he had a positive meeting with Trump before his selection. Oklahoma state law prohibits Senate appointees from running for the seat in a subsequent election.” 
  • and
    • “Senate Republicans offered Tuesday to fund all of the Department of Homeland Security except for the unit that carries out immigrant arrests and deportations, moving to end a nearly six-week funding standoff that has caused security snarls at airports nationwide. 
    • “Democrats reacted coolly to the proposal, which didn’t include the new restrictions on immigration enforcement practices they have demanded, but said that they were engaged in negotiations. President Trump indicated he wasn’t pleased with the direction of the talks, muddying the prospects of a quick resolution.”
  • The Hill adds,
    • “House Republicans are pushing back stiffly against the idea of splitting up legislation to fund the Department of Homeland Security (DHS), despite the White House and Senate Republicans saying President Trump is open to doing just that.”
  • Roll Call notes,
    • “As a deadline arrives this week to nominate a Centers for Disease Control and Prevention director, some Republicans are skeptical the administration will find someone who can check all the boxes necessary for confirmation.
    • “The candidate will need the “Make America Healthy Again” mindset of Secretary Robert F. Kennedy Jr.’s Health and Human Services Department, while also appeasing a set of stick-to-science senators increasingly unhappy with Kennedy’s direction.” * * *
    • “HHS senior adviser Chris Klomp, in an interview last week with Stat News, said the agency has interviewed “dozens” of potential candidates. Though there is a structured process to name top candidates, Kennedy will ultimately make the final decision.
    • “Klomp also said that if the White House hasn’t named a nominee Wednesday, HHS would shift to delegate responsibilities, but getting a qualified nominee “is a top priority.”
  • The Washington Post points out,
    • “The nascent Make America Healthy Again movement got one of its biggest wins last spring: Casey Means was selected to be the nation’s top doctor.
    • :But more than 10 months later, the controversial surgeon general pickhas yet to assume the position advising Americans on how to improve their health. Her nomination has stalled as some Republicans question her stance on vaccines, her medical credentials and her pushes against the medical establishment.
    • “Means probably cannot afford to lose the support of a single Republican on the Senate health committee, which has yet to schedule a vote to advance her nomination to the full Senate. The panel’s chairman, Sen. Bill Cassidy (R-Louisiana), repeatedly pressed Means on her views on immunizations during a late February hearing — questions she largely dodged — and Sens. Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska) afterward publicly said they still have questions.”
  • The New York Times relates,
    • “Dr. Robert Malone, vice chair of the federal committee that recommends vaccines to Americans, angrily resigned his position on Tuesday.
    • “The panel, called the Advisory Committee on Immunization Practices, or ACIP, is currently in judicial limbo. A federal judge ruled last week that the advisers, appointed by Health Secretary “Robert F. Kennedy Jr., did not have the expertise needed to make vaccine recommendations and prevented them from meeting as planned this month.
    • “The judge also blocked all of the committee’s actions to date, including decisions to rescind recommendations for some childhood vaccines.
    • “The Department of Health and Human Services has indicated that it will appeal the ruling but has not said when. Dr. Malone indicated that he would not rejoin the committee even if the ruling were to be overturned or if Mr. Kennedy announced a new slate of advisers.”
  • FedManager observes,
    • “With the cancellation of the Federal Employee Viewpoint Survey (FEVS) for 2025, the Partnership for Public Service conducted its own version of FEVS. The goal: check the pulse of the workforce in a year of major workforce changes, including deferred resignations, returns to office, the cancellation of union contracts, and other changes. 
    • “The revamped survey was modeled after FEVS but was developed and deployed by the Partnership. While it’s not directly comparable, it contained similar questions. The survey was conducted on a smaller scale with 11,000 feds responding, compared to the 500,000 or so who respond to the official FEVS. Responses were collected in November and December 2025.
    • As for the results, employee engagement and satisfaction governmentwide was measured at a score of 32 out of 100, with 58 percent of respondents saying engagement has gotten worse since 2024. 
    • “We have every red light blinking across the federal government,” said Partnership President and CEO Max Stier. “Morale is as low as imaginable.”
  • Govexec informs us,
    • “As the U.S. Postal Service contemplates service cuts due to the prospect of running out of money as soon as fall 2026, President Donald Trump recently nominated three additional individuals to the postal agency’s Board of Governors. Several unions and other stakeholders, however, reported that they are largely unfamiliar with his picks. 
    • “[The National Association of Letter Carriers] is closely monitoring these unknown nominees and will actively work to ensure they have the best interests of the employees and the network before they are confirmed,” the union said in a press release responding to the nominations announcement. 
    • “The postal board nominees are: Robert Steffens of Texas, Jeffrey Brodsky and William Gallo, both of Florida.” * * *
    • “There are currently four governors on the USPS board — two Democrats, one Republican, one independent — leaving five vacancies. No more than five of them can be from the same political party. 
    • “NALC noted that the Senate has traditionally advanced postal nominees in bipartisan pairs, but all of Trump’s picks, so far, have been Republicans. The president has attempted to remove Democratic members of several bipartisan agency boards, prompting legal challenges that have reached the Supreme Court.” 
  • Modern Healthcare lets us know,
    • “The Accelerating State Pediatric Innovation Readiness and Effectiveness, or ASPIRE, Model is designed for children and young adults with complex physical and behavioral health needs.
    • “The demonstration will test wraparound Medicaid and Children’s Health Insurance Program payments to promote care coordination.
    • “CMS will distribute $125 million to up to five states over 10 years.”
  • KFF analyzes the BALANCE Model for GLP-1s in Medicare and Medicaid.
    • “GLP-1s, a class of drugs used to treat type 2 diabetes, obesity, cardiovascular disease, and other conditions, have exploded in popularity in recent years due to their demonstrated effectiveness, but are often not covered by insurance, particularly for the treatment of obesity. According to KFF polling, about half (56%) of GLP-1 users say these drugs were difficult to afford, including one in four who say they were “very difficult” to afford.
    • “The Trump administration is pursuing various approaches to lowering the cost and expanding coverage of these medications. These approaches include striking “most-favored nation” deals with GLP-1 manufacturers Novo Nordisk and Eli Lilly, providing access to discounted prices for GLP-1s through TrumpRx, and implementing a new demonstration program called the BALANCE (Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth) Model to expand Medicare and Medicaid coverage of GLPs for obesity, which is currently subject to statutory limitations (prohibited in Medicare, permissible but not required in Medicaid). In addition, the GLP-1 drug semaglutide (branded as Ozempic, Wegovy, and Rybelsus) was selected for Medicare drug price negotiation in 2025, with a negotiated price set to take effect in 2027.
    • “This brief describes current coverage of GLP-1s in Medicare and Medicaid, the Centers for Medicare & Medicaid Services’ (CMS) efforts to expand access and lower costs for GLP-1s through temporary demonstration programs including the BALANCE Model, and potential impacts on beneficiaries and program budgets.”
  • The American Hospital Association tells us,
    • “The Administration for Strategic Preparedness and Response March 24 announced an investment to expand the domestic manufacturing of propofol and metoprolol. Propofol is a sedative used for anesthesia and intensive care unit sedation, while metoprolol is a medication used to treat cardiovascular conditions such as arrhythmias and hypertension, and can also reduce lung inflammation in ICU settings. ASPR said the API Innovation Center, based in St. Louis, was awarded $8.3 million to produce both ingredients. The investment is the latest in a series of projects by ASPR and the Department of Health and Human Services to reduce reliance on foreign resources and increase the domestic production of essential medications and their active pharmaceutical ingredients.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “GE HealthCare has received 510(k) clearance for its spectral photon-counting CT technology, the company said Monday.
    • “The Food and Drug Administration clearance positions GE HealthCare to compete with Siemens Healthineers’ Naeotom Alpha, the first photon-counting CT machine to reach the U.S. market.
    • “Citi Research analysts said in a note to investors that GE HealthCare’s Photonova Spectra is differentiated by its use of a detector designed to produce high-contrast spectral images with detailed visualization.”
  • Cardiovascular Business adds,
    • “Medtronic has received an expanded U.S. Food and Drug Administration (FDA) approval for its OmniaSecure defibrillation lead. 
    • “The lead was originally approved for placement in the right ventricle in April 2025. This expanded indication covers the left bundle branch (LBB) area, meaning it can now be used for conduction system pacing and even LBB optimized cardiac resynchronization therapy (LOT-CRT). This is the first time the FDA has approved a defibrillation lead for placement in the LBB area.
    • “Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker,” Trevor Cook, vice president and general manager of Medtronic’s defibrillation solutions business, said in a statement. “Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy and activate the heart’s natural electrical system to enable a more synchronous, physiologic pattern. This approval underscores the versatility of the OmniaSecure defibrillation lead and supports its use across a variety of implant approaches to best serve a broad range of patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “CVS Health has reached a proposed settlement with the Federal Trade Commission in the agency’s sweeping case against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “The proposed consent agreement was disclosed Monday in a joint motion from the FTC and CVS for the company’s subsidiaries, PBM Caremark and group purchasing organization Zinc, to withdraw from the case while antitrust regulators consider the deal.
    • “The filing did not include the terms of the potential settlement, but analysts expect it would be similar to the deal the FTC secured with Cigna’s PBM Express Scripts earlier this year. If CVS reaches a settlement, that would leave UnitedHealth as the lone holdout in the high-profile suit.”

From the public health, medical research and Rx research front,

  • The AP reports,
    • “Whether they’re using weekly shots or daily pills, more Americans than ever are turning to anti-obesity drugs to lose weight and boost health.
    • “About 1 in 8 U.S. adults say they are taking a GLP-1 drug, according to a recent surveyby the health research group KFF.
    • “Just since January, more than 600,000 prescriptions have been written for Novo Nordisk’s new Wegovy pill, the company said. Early analysis suggests that more than a third of users are new to the drugs, according to Truveta, a health care data company. 
    • “But medication alone isn’t the answer, experts caution. It also takes lifestyle changes — healthy diet, exercise, adequate sleep and stress management — to reap the biggest benefits from the drugs known as GLP-1s.
    • “The biggest mistake people make with GLP-1 medications is thinking the prescription is the treatment,” said Dr. Katherine Saunders, an obesity medicine expert at Weill Cornell Medicine and co-founder of FlyteHealth, a weight-loss treatment company.
    • “GLP-1s can spur weight loss and health benefits on their own, but the effects are larger and last longer when the drugs are combined with lifestyle changes, a recent review of nearly three dozen studies found.”
  • Beckers Clinical Leadership relates,
    • “The CDC is tracking a new SARS-CoV-2 variant — BA.3.2 — that has been identified in 23 countries, including the U.S.
    • “Here are [four] things to know:
      • “1. The variant was first identified in South Africa in November 2024. Detections began increasing in September 2025, with the highest number reported during the week of Dec. 7, 2025.
      • “2. BA.3.2 was first detected in the U.S. in June 2025 at San Francisco International Airport through traveler-based surveillance. As of mid-February, it had been found in clinical samples from five patients across four states and 132 wastewater samples from 25 states. Prevalence among sequenced specimens remains low at 0.19%. Two of the five patients were hospitalized older adults with comorbidities, and all five survived.
      • “3. BA.3.2 carries about 70 to 75 mutations in its spike protein compared to JN.1 and its descendant LP.8.1, the antigens used in the most current COVID-19 vaccine. Lab studies show BA.3.2 evades antibodies more effectively than other circulating variants. The 2025–26 COVID-19 vaccine demonstrated the lowest antibody neutralization against BA.3.2 among seven variants tested. The CDC said real-world vaccine effectiveness data is still needed and that current vaccines continue to protect against the predominant circulating strains.
      • “4. Data from several European countries show BA.3.2 has not rapidly overtaken other strains. Instead, the strain has cocirculated with other JN.1 descendent lineages at 10% to 40% prevalence. Two lab studies also found BA.3.2 had reduced lung cell entry compared with other variants, potentially limiting its ability to become dominant. However, further evolution or seasonal transmission increases could enable broader circulation, the CDC noted.”
  • The American Journal of Managed Care tells us,
    • “AMD [Age related macular degeneration] affected more men than women and was higher in White vs Black individuals; Rhode Island reached ~7214 per 100,000. 
    • “Diabetic retinopathy clustered in Black and Hispanic populations and in southern states, with Mississippi ~3607 per 100,000 and marked male predominance. 
    • “DME [diabetic macular edema] prevalence remained low overall yet disproportionately higher in Black individuals (712 per 100,000) than Hispanic (578) and White (155), supporting targeted screening within diabetes care. 
    • “RVO [retinal vein occlusion] was least prevalent but showed higher rates in White individuals and in Rhode Island; analyses assumed age-related increases, potentially influencing estimates. 
    • “Specialist access and costs were substantial: California had 918 retina specialists vs 3 in Wyoming; annual payer costs were ~$13.4B AMD, $6.2B DR, $4.4B DME, $6.4B RVO.”
  • Cardiovascular Business informs us,
    • “Exercise and using medications to reduce a patient’s cardiovascular risk factors are not associated with significant improvements in cognitive function, according to new findings published in JAMA Neurology. The study’s authors focused on older patients with a family history of dementia and/or self-reported signs of possible cognitive decline. 
    • “Exercise combined with pharmacological management of cardiovascular risk factors is the evidence-based strategy for maintaining cardiovascular health,” wrote first author Rong Zhang, PhD, a researcher with the University of Texas Southwestern Medical Center and Texas Health Presbyterian Hospital Dallas, and colleagues. “However, its effects on cognitive function remain unknown.”
  • “Today’s issue of Research Matters from the National Institutes of Health discusses Treating addiction.”
    • “Alcohol and drug addiction can cause many harms. This Research in Context feature looks at research into the causes of addiction and new ways to treat it.”
  • Per Health Day,
    • “Higher combined consumption of fruits, vegetables, legumes, and potatoes may reduce the risk for Crohn disease (CD), according to a study published in the March issue of the American Journal of Gastroenterology.
    • “Antoine Meyer, M.D., Ph.D., from Université Paris-Saclay in France, and colleagues assessed the risk for developing CD and ulcerative colitis (UC) based on intake of individual fruits, vegetables, legumes, and potatoes. The analysis included 341,519 individuals completing food frequency questionnaires who were followed for a median 13.4 years.”

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

  • Plan Advisor reports,
    • “Rising health care costs are reshaping how employees choose workplace benefits, even when those selections expose workers to significant future financial risk.
    • “Nearly two-thirds of employees reported cost as their top priority during open enrollment, according to Securian Financial’s annual workplace benefits study, “The Affordability Trap: Why Cheaper Choices Cost Employees More.” The focus on cost leads many employees to choose lower-premium plans with higher deductibles; skip supplemental coverage; or scale back voluntary benefits, a pattern identified by the report as an “affordability trap.”
    • “While these decisions may reduce payroll deductions in the short term, the study found they often leave employees vulnerable to sizable out-of-pocket expenses when medical events occur.”
  • Per Healthcare Dive,
    • “Cencora has agreed to acquire EyeSouth Partners’ retina business for $1.1 billion as the drug distributor continues to expand its specialty medical arm.
    • “Once the transaction closes, EyeSouth’s physicians will join Cencora’s management services organization Retina Consultants of America, according to the Monday announcement.
    • “Cencora expects the deal to close after the company’s fiscal year ends on Sept. 30 and be slightly accretive to Cencora’s earnings.”
  • Fierce Healthcare relates,
    • “Highmark posted a $175 million net loss in 2025 as its insurance arm weathered cost pressures that strained the industry nationwide.
    • “The company said Tuesday morning that full-year revenue $32.4 billion, up 11%. Revenues were up across business units, with Highmark Health Plans posting a 12% increase, Allegheny Health Network reporting an 11% increase in revenue and the diversified business unit—which includes United Concordia Dental and its stop-loss business, HM Insurance Group—seeing revenue up 7%.
    • “The insurance division posted a $609 million operating loss in 2025, and executives told reporters during a briefing that the performance of other businesses helped to offset some of that downturn. Allegheny Health Network, the company’s provider arm, posted $90 million in operating income, up from $237 million in 2024.”
    • “We are not immune to the strong headwinds experienced across the entire insurance industry,” Carl Daley, Highmark’s chief financial officer, said during the briefing. “About half of the industry has had credit ratings or outlooks downgraded, including some of the largest players.”
  • BioPharma Dive tells us,
    • “Gilead Sciences will acquire autoimmune drugmaker Ouro Medicines, the companies said Monday afternoon, spending nearly $1.7 billion on the young startup and a T cell engager it licensed from a Chinese biotechnology firm.
    • “Ouro launched in early 2025, backed by GSK and Monograph Capital. Its bispecific antibody, called OM336 or gamgertamig, is designed to bind to a pair of immune cell proteins, BCMA and CD3, that have been popular targets for drugmakers.
    • “Many bispecific antibodies have been approved for cancers, but over the past decade, a flurry of research has shown these treatments hold promise in autoimmune diseases as well. The multipronged drugs eliminate B cells much like cell therapies, but cost less to manufacture, don’t require harsh chemotherapy conditioning and can be dosed multiple times.”
  • Fierce Pharma informs us,
    • “UCB plans to build a $2 billion manufacturing facility near its U.S. headquarters in Atlanta, Georgia. It will become the first plant in the U.S. for the Belgium-based company and will produce biologics.  
    • “The 460,000-square-foot factory will sit on a 79-acre plot of land in the Rowen innovation district, a mixed-use development designed to attract corporate investment. The project is modeled after North Carolina’s Research Triangle Park (RTP). 
    • “Officials from Gwinnett County signed off on UCB’s application on Tuesday afternoon. It becomes the largest investment a company has made in county history, according to the Atlanta Journal-Constitution. The site is near Dacula, Georgia, which is 35 miles northeast of downtown Atlanta. UCB’s U.S. headquarters is in Smyrna, which is in Atlanta’s northwest suburbs, about 45 minutes away.”
  • The Wall Street Journal lets us know,
    • “Finance chiefs once questioned the returns on investing in artificial intelligence. Those days are gone.
    • “Speaking at The Wall Street Journal’s CFO Council Summit in Palo Alto, Calif., finance chiefs from the tech, retail and financial services sectors said their companies are seeing big gains in efficiency and productivity—in some cases worth millions of dollars—from their investments in generative AI. Nudging employees to embrace AI also has yielded new ideas about how to accomplish time-consuming tasks, CFOs said.
    • “Finance chiefs say they are playing a leading role in their company’s AI transformation efforts, evaluating performance, pushing for productivity gains and clearly articulating the value to reluctant employees.”