Thursday report

Federal employment benefits

Thursday report

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

Simplicity is a virtue

From Washington, DC

  • Per a Department of Labor news release,
    • “The U.S. Department of Labor’s Employee Benefits Security Administration today finalized a landmark rule that will require pharmacy benefit managers and their affiliated brokers and consultants to disclose their fees and compensation to large employers’ self-insured group health plans. 
    • “In finalizing this rule, the Department has ensured that employers can see how much drug manufacturers, pharmacies, and others pay pharmacy benefit managers for the first time. Employers can use that information to negotiate contracts and seek lower prescription drug costs for workers and their families.” * * *
    • Issued under ERISA’s statutory service provider prohibited transaction exemption, the final rule requires PBMs to disclose the following information for the first time:
      • Rebates and other payments from drug manufacturers.
      • Compensation received when the price paid by the plan for a prescription drug exceeds the amount reimbursed to the pharmacy. 
      • Payments recouped from pharmacies in connection with prescription drugs dispensed to plan participants.   
    • “The final rule also allows plan fiduciaries to audit the accuracy of PBM disclosures and provides additional relief for plan fiduciaries if a PBM fails to meet its obligations.
    • This final rule is applicable to plan years beginning on or after July 1, 2027.
    • “Read the notice of the final rule on pharmacy benefit manager disclosures.”
  • The American Hospital Association News relates,
    • “A coalition of healthcare organizations, including the AHA, sent a letter Oct. 27 to the Center for Medicare and Medicaid Innovation recommending changes to its Ambulatory Specialty Model. The mandatory payment model, set to begin Jan. 1, 2027, focuses on specialty care for beneficiaries with heart failure or low back pain. The organizations recommended delaying the launch of the model and holding participants harmless from downside risk in the first year if the launch is not delayed. They also requested CMMI to maintain ongoing communications and support, including timely data, operational guidance, technical support and a single, consolidated help desk. Additionally, the organizations urged CMMI to share prospective performance thresholds for cost and quality performance categories prior to the model’s start date. CMMI was also asked to allow practice-level reporting of quality measures to align with other Centers for Medicare & Medicaid Services models and programs and minimize participant burden.”
  •  and
    • “Extending Medicaid coverage by 12 months following childbirth increased use of postpartum care among mothers with pregnancy complications such as diabetes and hypertension, according to a study published Oct. 14 by the Columbia University Mailman School of Public Health. The study analyzed Medicaid claims data on births from 2019-2023 in New York and Texas. Researchers found postpartum outpatient visits rose 28% for those with diabetes and 19% for those with hypertension in New York, and 58% and 51% in Texas, where baseline postpartum care rates were lower. Diabetes screening increased 5 percentage points in New York and 12 in Texas. Diabetes screening then declined in Texas after coverage ended during the unwinding of the continuous enrollment provision of the COVID-19 public health emergency.”
  • Modern Healthcare tells us,
    • “The Centers for Medicare and Medicaid Services is offering states mitigation strategies as they hustle to implement Medicaid work requirements by the Jan. 1 deadline. 
    • “CMS has created checklists of mitigation strategies states can choose to implement as they race to complete their work requirement verification systems. Starting next year, most working-age adults without disabilities must prove they work, volunteer or go to school for at least 80 hours a month to qualify for Medicaid.
    • “States seeking flexibility from CMS will need to identify actions that may not be complete before the deadline, explain how they intend to resolve those problems and offer alternative implementation timeframes, according to the memo CMS sent to states. CMS will conduct its own analyses and approve flexibilities or offer enforcement discretion.” 
  • Healthcare Dive discusses “Prior authorization in the real world: Takeaways from Epic ahead of looming API deadline.”
    • “As a Jan. 1 deadline looms for payers to adopt new prior authorization tech, Epic’s Vice President of Value-Based Care Ryan Bohochik breaks down the industry’s progress so far.”
    • “CMS-regulated payers, such as Medicare Advantage, Medicaid and marketplace insurers, are now confronting a Jan. 1 deadline to implement the three prior authorization application programming interfaces — sets of rules that enable computer programs to communicate directly with one another —  under a federal interoperability rule that was finalized in 2024.”

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

  • Fedweek reports,
    • “OPM has stressed to agencies the legal protections for federal supervisors and managers who take disciplinary actions against their subordinates and for federal employees who report issues with performance or conduct that can lead to such actions.
    • “OPM has received reports from some agencies that employees are reluctant to report a colleague’s misconduct or to serve as a witness — and supervisors and managers are reluctant to recommend or propose discipline — because they fear the subject of the report will respond with an equal employment opportunity (EEO) complaint, a grievance, an Inspector General (IG) complaint, or some other proceeding naming them personally,” says a memo.
    • “Some of the reluctance reported to OPM rests on an understandable but mistaken premise: that an EEO complaint, grievance, or appeal filed by the subject of a report is a proceeding against the official who made it. It is not,” it adds.”
  • FedSmith discusses “When an HDHP and HSA Make Sense—and When They Don’t.”
    • “Learn how FEHB High-Deductible Health Plans with HSAs can lower premiums, offer tax advantages, and build long-term healthcare savings.”
  • and points out
    • “Before federal managers call employees resistant to AI, they should find out what employees are resisting. The same hesitation may reflect fear of job loss, uncertainty about approved tools or a legitimate concern that AI-generated information could be wrong. The overhaul of federal employee surveys gives agencies an opportunity to ask.”
  • Tammy Flanagan, writing in Govexec, answers “more Medicare questions? Here’s what federal retirees need to know.”
    • “Got questions about HSA contributions, TRICARE For Life or keeping FEHB or PSHB when you enroll in Medicare? Here are answers to help you navigate the details of your federal health benefits.”

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

  • Bloomberg Law reports,
    • “Infant formula manufacturers face new requirements to change the amount of four nutrients they must include in products designed to replace or supplement breast milk under a proposed rule the FDA released Thursday. 
    • “A baby formula product’s level of iodine, Vitamin A, Vitamin D, and manganese would have to change under the Food and Drug Administration’s proposal, which estimates implementing the changes by reformulating and relabeling products will cost manufacturers between $8.4 million to $31.7 million annually. 
    • “The agency’s proposal comes after the Trump administration in 2025 launched the first comprehensive review in decades of nutrients FDA regulations require in baby formula products.” 
  • A Department of Health and Human Services news release adds, “While that process moves forward, the FDA is taking action now — releasing new chemical contaminant testing data showing that most infant formula samples had low or non-detectable levels of contaminants.”
  • The Pharmaletter relates,
    • “German drugmaker Stada said Thursday that the US regulator has approved Lucamzi (ranibizumab-blrz), a biosimilar to Lucentis (ranibizumab), providing another treatment option for wet age-related macular degeneration (wAMD) and other serious eye conditions.
    • “The company and its partners are finalizing preparations for a US commercial launch. Stada did not disclose a launch date or price in its announcement, although it said the product would offer a lower-cost option and help improve patient access.”
  • Reuters tells us,
    • “The US Food and Drug Administration on Thursday warned of safety ​risks associated with Medline (MDLN.O), opens new tab beds and accessories after ‌the company reported two deaths and 16 serious injuries linked to fire, entrapment and asphyxiation hazards.
    • “According to the regulator, Medline has ​told customers it is discontinuing and exiting the ​market for all Medline-branded beds and associated products, ⁠including homecare, bariatric and long-term care beds, as ​well as pendants, accessories and replacement parts.”
  • Cardiovascular Business tells us,
    • The U.S. Food and Drug Administration (FDA) has shared an update about an alert the agency first published in September about certain Automated Impella Controllers (AICs) from Johnson & Johnson MedTech. 
    • At the time, the FDA said these devices should be removed from where they are used or sold, but it was still investigating the issue to learn more. Now, with its investigation complete, the agency has officially ruled that this is a Class I recall, which means using the devices could cause “serious adverse health consequences or death.”
  • and
    • “Medtronic is recalling its CareLink SmartSync device manager due to a risk of inaccurate longevity estimates being displayed for the Micra AV2 leadless pacemaker or Micra VR2 leadless pacemaker. Unlike many recalls, no devices need to be returned to the manufacturer. Instead, customers can download a software update to resolve the issue going forward.
    • “The U.S. Food and Drug Administration (FDA) has ruled this a Class II recall, which means using the technology without a software update could cause “temporary or medically reversible adverse health consequences.” No adverse events have been reported at this time.
    • “Click here for additional details from the FDA.”

From the public health and medical / Rx research front,

  • Reuters reports,
    • “With wildfires becoming larger and more prevalent, ​today we report on a study that suggests a link between exposure during pregnancy to harmful particles in smoke from the ‌infernos and autism in the women’s children. Speaking of harmful particles, we also feature a study that may have discovered one way in which microplastics in our systems are causing health problems.”
  • Beckers Clinical Leadership adds,
    • “A PNAS analysis led by Stanford researchers suggests earlier estimates of long COVID’s effects may have been inflated by how studies selected their comparison groups, though the authors said the findings do not mean long-term symptoms are not real.”
  • Health Day relates,
    • “More people in the United States are vaping and at a higher frequency since 2013, according to a study published online Oct. 20 in Tobacco Control.
    • “Makenna N. Gomes, from the University of Waterloo in Ontario, Canada, and colleagues examined population-level patterns of e-cigarette use between 2013-2014 and 2022-2023 in both youth (aged 12 to 17 years) and adults. The total number of vaping days was determined using data from the Population Assessment of Tobacco and Health study.
    • “The researchers observed increases in total vaping days (+183 percent), past 30-day vaping (+45 percent), and daily vaping (+230 percent) over time. Among those under the minimum legal age of 21 years and those who vaped in the past 30 days, vaping days more than quadrupled (+337 percent) and accounted for 16 percent of all vaping days in the 2022-2023 wave. Since the pandemic, adult vaping days continued to increase due to increases in vaping frequency and population growth.”
  • and
    • “Suicidal thoughts and actions spiked among middle-aged and senior Americans in the years following the COVID-19 pandemic, a new study says.
    • “Suicidal thoughts increased by nearly 43% among Americans 50 and older, according to findings recently published in the Journal of Affective Disorders.
    • “Meanwhile, suicide planning and suicide attempts more than tripled, researchers found.
    • “These increases were concentrated among people without traditional risk factors for suicide, such as major depression or alcohol use disorder, researchers said.
    • “These findings suggest that many older adults who are struggling are not the ones our current screening approaches are designed to catch,” noted lead researcher Dr. Kevin Yang, a research fellow in psychiatry at the UCLA National Clinician Scholars Program.
    • “If a growing share of suicidal thoughts and plans is showing up in people without a depression diagnosis or recent substance use, we need to rethink how we identify risk and reach older adults before a crisis occurs,” Yang said in a university news release.”
  • STAT News tells us,
    • “For years, scientists have struggled to elucidate key biological differences between early onset colorectal cancer, typically in patients under the age of 50, and older patients. They’ve long believed that these cancers must be biologically distinct, since younger patients tend to be far more difficult to treat. They’re often diagnosed at later stages with tumors with more aggressive features.” * * *
    • On Thursday, Kimmie Ng, a colorectal cancer researcher and director of the Dana-Farber Cancer Institute Young-Onset Colorectal Cancer Center published a new study in Nature Medicine that may help illuminate critical differences between older and younger colorectal cancer patients. With 189 tumors, it’s the largest biological database — what researchers call a single cell atlas — of colorectal cancer tumors in patients ranging from their 20s to their 90s. The atlas, along with the technology Ng and her colleagues used, should help researchers control for variables that confounded studies in the past.
    • “It has the largest number of young onset tumors, 54 of them,” Ng said. “We intentionally designed our study to try to overcome these prior limitations in the published literature.”
    • “The atlas has enabled Ng and her team to see some characteristics  that may set early onset colorectal cancers apart. In particular, their analysis suggested that tumors in younger patients seem to be surrounded by a different cell environment that may make it more difficult for chemotherapies and immunotherapies to attack them. They also seem to have genetic differences that are associated with more aggressive and metastatic behavior.”
    • The article includes an interview with Dr. Ng.
  • Beckers Hospital Review informs us,
    • “A case report from researchers at the University of Colorado Anschutz Medical Campus in Aurora links tirzepatide, sold as Zepbound, to lithium toxicity in a 50-year-old woman with bipolar disorder. It is the fourth reported case of tirzepatide-associated lithium toxicity, MedPage Todayreported Oct. 26.
    • “Jay Davis, MD, and colleagues published the case in the Journal of Clinical Psychopharmacology. The patient’s serum lithium level was 0.7 mmol/L before she started weekly 2.5-milligram tirzepatide injections for weight management.
    • “Three weeks later, she arrived at a psychiatry appointment with a tremor in both hands, slurred speech and blurred vision. Her lithium level had climbed to 1.2 mmol/L. She had not changed her lithium dose or started other drugs, but said she was eating smaller meals and feeling full sooner.
    • “Her physicians cut her nightly lithium dose from 900 milligrams to 450 milligrams, and her symptoms resolved. Her lithium level measured 0.4 mmol/L 17 days later. She and her physician decided not to restart tirzepatide.
    • ‘Dr. Davis told MedPage that the leading explanation is that eating and drinking less causes the kidneys to reabsorb more lithium. He said incretin drugs will likely be prescribed more often to patients on lithium, and awareness of the interaction still needs to grow.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports on several quarterly financial reports from pharmaceutical manufacturers.
    • “Gilead Sciences raised its full-year product sales guidance to between $31 billion and $31.3 billion.
    • “The company’s third-quarter revenue grew to $8.3 billion, driven by strong sales in its HIV portfolio.
    • “The company’s third-quarter profit came in at $2.43 billion, down from $3.05 billion a year earlier.”
  • and
    • Merck’s third-quarter sales rose 5% to $18.09 billion, beating Wall Street expectations.
    • The cancer drug Keytruda generated $8.6 billion in sales, representing nearly half of Merck’s total worldwide sales in the quarter.
    • Merck raised its full-year adjusted earnings forecast to a range of $2.77 to $2.82 per share.
  • and
    • “Eli Lilly’s third-quarter revenue rose 39% to $24.4 billion, driven by high demand for its diabetes and obesity drugs Mounjaro and Zepbound.
    • “The pharmaceutical company raised its full-year revenue guidance to a range of $91 billion to $92 billion.
    • “Eli Lilly executives said a majority of new patients in Medicare’s Bridge coverage expansion program started on one of the company’s medicines.”
  • and
    • “Bristol Myers Squibb raised its full-year revenue outlook after third-quarter revenue increased 7% to $13.1 billion.
    • “The company’s third-quarter net income was $2.2 billion, or $1.05 a share, compared with $2.2 billion, or $1.08 a share, a year earlier.
    • “Bristol Myers Squibb cut its full-year adjusted earnings view to $6.35 to $6.55 a share due to charges and licensing impacts.”
  • Fierce Healthcare relates,
    • “Strong performance across its hospital and ambulatory businesses during the third quarter led Tenet Healthcare to raise its 2026 earnings guidance by 4%, with executives asserting that the core strength of operations will yield continued earnings growth in 2027 despite policy headwinds. 
    • “The for-profit this week reported $5.63 billion in net operating revenues for the quarter, not counting $646 million in contract termination revenue tied to its divorce with CommonSpirit Health that was recognized during the quarter. The tally was 6.5% above the same period last year and above the $5.47 billion consensus estimate, per Zacks Investment Research. 
    • The bigger standouts were its $6.64 adjusted earnings per share, well above the prior year’s $3.70 earnings per share and more than 40% above the consensus estimate of $4.60 per share. “Further, executives highlighted third-quarter adjusted EBITDA of $1.36 billion (about 16% above the street, per Stephens), about 10% year-over-year growth when excluding $147 million in one-time items stemming from the shifting timing of its CommonSpirit contract winddown.”
  • Beckers Hospital Review tells us,
    • “Seattle-based Fred Hutchinson Cancer Center recorded operating income of $25.7 million (1% margin) for fiscal year 2026, down from operating income of $82.8 million (3.3% margin) in fiscal 2025, according to its audited financial statements for the 12 months ended June 30. 
    • “Fred Hutch reported total revenue of $2.7 billion in fiscal 2026, a 6.4% increase year over year. Patient service revenue rose 17% to $1.9 billion, while research grants and contracts revenue decreased 1.4% to $493 million. Contributions decreased 27.1% to $141.8 million, and investment income and realized gains fell 44.3% to $76.9 million.
    • “Total expenses were $2.6 billion for fiscal 2026, a 9% increase year over year. Supplies and pharmaceuticals rose 21.7% to $891.1 million. Salaries, wages and benefits increased 5.4% to $902.7 million, and purchased services were flat at $349.2 million.”
  • and
    • “Salisbury, Md.-based TidalHealth reported a $49.1 million operating loss (-3.8% margin) in the fiscal year ending June 30, 2026, compared to a $33.9 million operating loss (-3.4% margin) in 2025, according to financial documents posted Oct. 28.”
  • Beckers Behavioral Health informs us
    • “Houston-based PsychPlus has acquired Precision Psychiatric Services, a California psychiatric group, adding more than 100 psychiatrists to its clinical network. PsychPlus announced the deal Oct. 23. Financial terms were not disclosed.
    • Precision, founded in 2018, is a physician-led organization with hospital partnerships across California. It provides psychiatric care in emergency departments, inpatient behavioral health facilities, medical-surgical units, outpatient clinics and addiction treatment settings. Its hybrid model pairs in-person psychiatry with telepsychiatry.
    • “PsychPlus plans to use the combined network to help hospitals and health systems manage psychiatric workforce shortages, expand clinical coverage and improve patient throughput.
    • “Precision has built an exceptional psychiatric organization with deep clinical expertise and strong hospital relationships throughout California,” said Faisal Tai, MD, founder and CEO of PsychPlus.”
  • Fierce Healthcare points out.
    • “Optum Rx is launching a new program that aims to integrate specialized care for women navigating menopause into the pharmacy benefit.
    • “The program is a virtual-first offering that connects eligible women with clinicians that have been certified with the Menopause Society. Through the program, they can access both hormonal and nonhormonal therapies, symptom tracking, education and one-on-one patient coaching.
    • “Tracy Spencer, senior vice president for product and strategy at Optum Rx, told Fierce Healthcare that 50 million women are currently experiencing symptoms related to either perimenopause, menopause and post-menopause. And 40% of those women say those symptoms impact their work performance.
    • “This is an area that remains one of the most underserved in healthcare, which is why we’re here today, because closing that gap for women’s health is really important,” Spencer said.”
  • and
    • “Blue Cross Blue Shield of Massachusetts is teaming up with precision medicine company Medzown to make it easier for members with complex conditions to participate in clinical trials.
    • “In the partnership, Medzown’s tech stack will identify the members that are most likely to benefit from a novel therapy for their condition and then match them with potential clinical trials. The company will then deploy a team of scientists, clinical trial experts and care navigators to work alongside the patient and their care team through the process.
    • “Jennifer Levin Carter, M.D., the CEO of Medzown, told Fierce Healthcare that there’s no shortage of new drugs and therapies coming through the pipeline for complex diseases like cancer, but access is a significant challenge.
    • “The next frontier for precision medicine is making sure that the right patient can actually get access,” Carter said.”
  • Healthcare Dive notes,
    • “When nine widely used AI models were prompted with questions about medication dosing, about 19.5 per 1,000 answers contained an error that was serious or potentially lethal, according to new research from health tech company Doximity.
    • “Doximity’s research, which was launched in tandem with the company’s new dose verification tool, claims other popular AI models got doses wrong in at least 2.3% of answers.
    • “It’s the company’s latest attempt to differentiate itself from major AI companies like OpenAI and Anthropic that are expanding their presence in healthcare.”

Midweek update

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

Simplicity is a virtue.

From Washington, DC,

  • The Wall Street Journal reports
    • “The Trump administration will require the companies that manage hundreds of billions of dollars of drug spending to disclose details on how they get paid.
    • “Under a new regulation from the Labor Department expected to be released Thursday, pharmacy-benefit managers will have to provide their employer clients with granular information about the prices they pay for pharmaceuticals, as well as payments they receive from drugmakers, according to people with knowledge of the matter.
    • “The new rule is an effort to lower healthcare costs, said a Labor Department official, in line with an executive order from April 2025 and the Trump administration’s promise to significantly reform PBMs.” * * *
    • “Under the new rule, PBMs will have to tell employers upfront about compensation they expect to receive from drug manufacturers and pharmacies and then provide updates every six months on their actual earnings, according to people familiar with the matter. Employers would also get the right to audit their PBMs.
    • “PBMs will have to disclose rebates and other types of payment from drugmakers, the people said, including any that might lead patients to be steered to certain drugs over others. The disclosure requirements also include group purchasing organizations tied to PBMs, which can collect rebate payments on their behalf.
    • “The PBMs also need to tell employers about “spread pricing” arrangements, under which an employer may pay more for a drug than a pharmacy is reimbursed for the same medication, leaving a margin that the PBM can keep.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “Combating kidney disease starts with prevention, early detection, and timely treatment to help protect kidney health and slow disease progression. For Americans who depend on dialysis, high-quality care is vital to their health and daily lives. The Centers for Medicare & Medicaid Services (CMS) is committed to improving how our kidney care system serves patients by supporting access to lifesaving treatment so more Americans can live longer, healthier lives.
    • “CMS is advancing its goals for dialysis access and quality through the calendar year (CY) 2027 Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) final rule. On Oct. 28, 2026, CMS issued a final rule to update payment rates and policies under the ESRD PPS for renal dialysis services furnished to Medicare beneficiaries on or after Jan. 1, 2027. This rule also finalizes updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2027 and updates requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2027, CMS will increase the ESRD PPS base rate to $297.52, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7%. This amount includes a $12.85 increase to account for the incorporation of phosphate binders into the ESRD PPS base rate. The CY 2027 ESRD PPS final rule also finalizes changes to the low-volume payment adjustment, changes to the payment adjustments for pediatric patients, an increase to the home and self-dialysis training add-on payment adjustment amount, and modifications to the transitional drug add-on payment adjustment (TDAPA), and modifications to the post-TDAPA add-on payment adjustment policies.” * * *
    • “The final rule can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection/current.”

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

  • Govexec reports,
    • “The Office of Personnel Management is hosting a virtual hiring fair on Thursday as part of Director Scott Kupor’s push to bring more early-career workers into the civil service. 
    • “I’ll call it a hire-palooza for lack of a better word,” Kupor said on The Charlie Kirk Show, a podcast that was previously hosted by the slain conservative activist. “We’re going to have 16 agencies who are literally going to use an online campaign and do online interviews with folks, and we’re going to make job offers on the spot on Oct. 29.” 
    • “In response to questions from Government Executive, an OPM spokesperson clarified that the event is only for applicants who are already going through the hiring process. 
    • “The purpose of the hiring fair is to coordinate across agencies to complete virtual interviews and initiate job offers for early career positions across the country,” they said in a statement.” 
  • FedSmith explains why “Your FEHB Premium Can Rise Faster Than Your Plan’s Price.”
    • The government pays exactly 75% of FEHB premiums in some plans and a fixed amount in others. Here is how the [statutory] formula works and why it matters for 2027.

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

  • The Wall Street Journal reports,
    • “Health Secretary Robert F. Kennedy Jr. is temporarily allowing six unapproved peptides on the market, despite warnings from government scientists that there is not enough evidence to prove they are safe or effective.
    • “In a policy released Wednesday, Kennedy said his department would no longer stop compounding pharmacies from distributing a handful of widely used peptides. The Food and Drug Administration is deciding whether to officially allow them to be compounded—a decision that could take months or even longer. The new policy could make it more difficult for the FDA to restrict peptides in the future.” * * *
    • “The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500, which are marketed for antiaging, boosting metabolism and improving memory, among other things. Earlier this year, the FDA’s Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on the peptides, despite warnings from career scientists. Many of the committee members were selected on Kennedy’s watch, and some had ties to peptide businesses.
    • “The interim policy is expected to lead to a boom in peptide sales, with major telehealth companies including Hims & Hers and Noom considering or planning to expand the list of peptides they offer. Leerink analysts have estimated that with legalization, the peptide business for telehealth companies could reach $2 billion a year.”
    • Note — The FEHBlog learned earlier this month that a peptide is a chain of amino acids.
  • Cardiovascular Business relates,
    • “Abbott has secured U.S. Food and Drug Administration (FDA) approval for its Amplatzer Paraclose PVL Occluder, a new transcatheter device specifically designed to treat paravalvular leak (PVL) following heart valve surgery.
    • “PVL is a known complication after valve replacement surgeries as well as transcatheter valve replacement procedures. It occurs when the new valve is implanted in a way that leaves a small gap that blood can then pass through.  
    • “The Amplatzer Paraclose PVL Occluder is the first device of its kind to ever receive FDA approval. It is delivered through an artery or vein in the leg, no additional open-heart surgery required, and it is positioned within the PVL to close the leak. 
    • “The FDA’s decision to approve the device was based on data from PARADIGM, a multicenter study of 200 patients who underwent an aortic or mitral valve replacement surgery.”

No Surprises Act News,

  • Healthcare Dive reports,
    • “Insurers and employers are asking the Trump administration to stop recertifying No Surprises Act arbiters until the law’s controversial dispute resolution process is reformed.
    • “The Coalition Against Surprise Medical Billing, a payer advocacy group, and the ERISA Industry Committee, which represents large employers, sent letters to top administration officials last week asking them to pause recertifications until they implement more rigorous standards for independent dispute resolution entities — third-party organizations responsible for mediating billing disagreements under the NSA.
    • “IDREs have contributed to “structural failures” in the arbitration process, which has generated billions of dollars in wasteful costs, the CASMB argued in its letter sent Oct. 22. The groups also want the CMS to allow more time for the public to comment on IDRE applicants.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “The cumulative flu hospitalization rate has climbed to the highest level for this point in the season in more than 15 years, according to CDC data.
    • “For the week ending Oct. 17, the cumulative flu hospitalization rate was 2.1 per 100,000 population — more than 10 times the rate seen during the same period last season. This marks the highest rate for this point in the season since at least the 2010-11 season, followed by the 2022-23 and 2023-24 seasons, historical CDC data shows. 
    • “The hospitalization rate comes as the U.S. sees an unusually early start to flu season, which researchers have linked to a single mutation in the circulating H1N1 influenza virus that may help it evade some pre-existing immunity.”
  • and
    • “States with lower breast cancer screening rates often report higher shares of breast cancers diagnosed at a regional or distant stage, according to U.S. Cancer Statistics data released in June by the CDC.
    • “The CDC classifies breast cancer stage at diagnosis based on how far the disease has spread: Localized cancers remain in the breast, regional cancers have spread to nearby tissue or lymph nodes and distant cancers have spread to other organs or distant lymph nodes. Regular breast cancer screening helps detect the disease before it spreads, when it is easier and less costly to treat, and reduces breast cancer deaths, according to the CDC.
    • “According to the National Cancer Institute, the five-year relative survival rate for breast cancer from 2016 to 2022 was 100% when the disease was localized, 87.5% when it was regional and 33.8% when it was distant.”
  • The American Hospital Association News adds,
    • “A study conducted by the University of Utah examined variations in risk behaviors for colorectal, cervical and breast cancer and trends in screening across rural and urban areas. The study, which used data from the Census Bureau and the Centers for Disease Control and Prevention, found that rural areas had greater socioeconomic disadvantages and more limited healthcare access, as well as higher smoking, physical inactivity and obesity prevalences than urban areas. The study found more variation in colorectal cancer screening rates (64.5% for urban vs. 61.2% for rural areas) than cervical and breast cancer screening rates (84.5% vs. 82.6% and 75.5% vs. 74.6%, respectively).”
  • Cardiovascular Business relates
    • “The Heart Failure Society of America (HFSA) has released a new scientific statement calling for right heart failure (RHF) to be recognized as its own distinct clinical syndrome instead of a secondary complication of left-sided heart disease.[1] The statement was published in full in the Journal of Cardiac Failure (JCF).[1]
    • By consolidating evidence and outlining clear knowledge gaps, the HFSA scientific statement aims to help clinicians apply a more consistent, pathophysiology-driven approach to RHF. Another goal is to lay the groundwork important research the writing group says is still needed to advance the field of heart failure care.
    • “The authors of the statement provided a structured framework to guide the earlier recognition of RHF and more consistent management in clinical practice. The group noted that RHF is growing more common as pulmonary vascular disease advances, which results in longer hospitalizations, heavier ICU use and frequent hospital readmissions that place substantial strain on the healthcare system.
    • “RHF has too often been treated as an afterthought of left heart disease,” Manreet K. Kanwar, MD, corresponding author of the statement and director of the heart failure and pulmonary hypertension program at the University of Chicago, said in a statement. “This statement makes the case that RHF should be recognized and managed as its own syndrome, with a diagnostic approach and treatment strategy tailored to right ventricular physiology.”
    • “Our hope is that this framework gives clinicians a structured way to recognize and manage right heart failure earlier, and gives the research community a foundation to close the gaps that have limited progress in this field,” added Ryan J. Tedford, MD, senior author of the statement and medical director of cardiac transplantation at the Medical University of South Carolina.
  • Health Day tells us,
    • “The pace of your daily stroll could show how close the Grim Reaper is behind you.
    • “In a new study, folks who walked at a brisker pace had a lower risk of an early death.
    • “Faster walking speed and more steps-per-minute are both associated with a lower risk of dying from any cause, researchers reported Oct. 23 in JAMA Network Open.
    • “Walking speed and step rate were “consistently associated with all-cause mortality, even after adjustment for daily step count,” the researchers wrote. The study was led by Rayane Haddadj, a fellow in public health and nursing at the Norwegian University of Science and Technology in Trondheim.”
  • and
    • “Showing teens how to better manage their emotions may help them maintain a healthier weight, a new study says.
    • “Teens engaged in a weight-loss program were less likely to regain weight if the program included training on how to understand and manage their moods, researchers reported Oct. 22 in JAMA Network Open.
    • “Doing so left teens less inclined to use snacking as a way to ease stress or boost mood, the research showed.
    • “Weight loss is only part of the story,” explained lead researcher Kerri Boutelle, a professor of pediatrics and psychiatry at the University of California-San Diego.”
  • BioPharma Dive informs us,
    • “Eli Lilly’s triple-acting metabolic drug retatrutide bested Novo’s Ozempic in a head-to-head Phase 3 trial, with the highest dose tested beating Novo’s drug on measures of blood sugar and weight loss, the company said Wednesday.
    • “After 80 weeks of treatment, a 12 milligram weekly dose of retatrutide lowered blood sugar by an average of 2.2 percentage points, significantly more than Ozempic’s 1.8 percentage points, Lilly said. A 9 mg dose of retatrutide also lowered blood sugar by 2.2 percentage points, but the difference when compared to Ozempic was statistically “nominal,” the company said.
    • “The results confirm earlier findings suggesting retatrutide — which acts on three metabolic pathways versus one for Ozempic — could be a differentiated diabetes and weight loss medicine. In an obesity trial, this “triple-G” drug stimulated weight loss that rivaled results seen in bariatric surgery.”
  • Medscape adds,
    • “The investigational weight-loss drug retatrutide (Eli Lilly) significantly reduced obstructive sleep apnea (OSA) severity in adults with overweight or obesity, with or without type 2 diabetes, in two phase 3 randomized trials.
    • “At 80 weeks, patients receiving once-weekly subcutaneous retatrutide had substantially greater reductions in breathing interruptions during sleep than those receiving placebo, along with marked weight loss.
    • “Retatrutide treatment enabled more participants to have remission of OSA or mild OSA without excessive daytime sleepiness,” reported the investigators, led by Ronald R. Grunstein, MD, PhD, of the Woolcock Institute of Medical Research and Macquarie University in Sydney, Australia.”
  • The Washington Post points out,
    • “At 80, he’s a top dementia expert. Here’s how he keeps his brain healthy.
      • “Researcher Ron Petersen says there are simple things we can all do for healthier cognitive aging.”

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

  • Beckers Hospital Review reports,
    • “Franklin, Tenn.-based Community Health Systems reported an operating income of $146 million (5.3% margin) in the third quarter, down from a $243 million operating gain (7.9% margin) in the same quarter last year, according to financial results published Oct. 29. 
    • “After accounting for interest and income tax expenses, the 59-hospital, for-profit system posted a net loss of $86 million (-3.1% margin) in the third quarter, down from a $130 million net gain (4.2% margin) in the same period in 2025.  
    • “Hospital divestitures, an unfavorable payer mix and higher medical specialist costs weighed on the health system’ financial results.”
  • and
    • “For several large health systems, the selling phase is ending. In May, Becker’s reported that Dallas-based Tenet Healthcare, St. Louis-based Ascension and Franklin, Tenn.-based Community Health Systems were shedding hospitals and putting the proceeds into surgery centers.
    • “Five months later, the next phase is clearer. These systems are reporting improved margins and are treating that recovery as permission to grow again, carefully and close to home.
    • “[The article describes] four patterns emerging as systems move from defense to offense.”
  • and
    • “As many hospitals and health systems face margin pressure from rising expenses, growing bad debt and shifting payer mix, some have made operational decisions that keep them on solid financial footing, from squeezing more capacity out of operating rooms and imaging to holding department leaders accountable for monthly budget variances.
    • “For University Health, staying in the black has really come down to growing business without the associated expenses growing more,” said Ed Banos, president and CEO of the San Antonio-based system.
    • “About 43% of U.S. hospitals are operating at a loss, up from about 33% before the COVID-19 pandemic, according to Kaufman Hall’s August 2026 “National Hospital Flash Report.” Kaufman Hall pointed to three converging forces: rising expenses, growing bad debt and charity care, and payer mix erosion.
    • “University Health, Lincoln, Neb.-based Bryan Health and Rapid City, S.D.-based Monument Health have credit ratings of AA+, AA- and AA-, respectively, according to Fitch. Their CEOs shared the operational decisions and financial strategies they credit with helping maintain that stability.”
  • The American Hospital Association News relates,
    • “The AHA has released its latest downloadable Fast Facts infographic providing statistics on the number of behavioral health hospitals and hospital services in the U.S. It also includes trend data on hospitals providing psychiatric screenings and on hospitals that are consulting/liaising behavioral healthcare with acute inpatient care, emergency services, extended care or primary care services.”
  • Insurance Business tells us,
    • “Fewer providers name prior authorization as their biggest administrative headache than did a quarter ago, and the shift points to something benefits advisors evaluating health plan and third-party administrator relationships should track closely.
    • “The finding comes from Aetna’s Q3 2026 Provider Survey, which polled 727 US healthcare providers, including hospital system executives, physicians, nurses, pharmacists, and health IT leaders, via Morning Consult. The survey is self-commissioned by Aetna, a CVS Health company. The underlying data, however, reflects actual movement in the administrative burden conversation.” * * *
    • “Among providers who cited administrative burden as their top challenge, 27% pointed to prior authorization as the leading contributor, down from 31% in Q2 and representing a meaningful shift from the previous quarter. That movement coincides with active regulatory pressure on prior authorization processes.” * * *
    • “The decline in prior authorization complaints has not reduced the overall weight of administrative burden. It has changed its shape. Among providers who cited administrative burden as a top challenge, 58% now identify updating patient medical records as the biggest contributor, up five percentage points from Q2. Nearly one in three providers said providing real-time patient information is the single most important action payers could take, the top answer when providers were asked to prioritize.”
  • Healthcare Dive informs us,
    • “Online scheduling company Zocdoc is now letting AI agents search for providers and book appointments on behalf of patients. 
    • “Agents must register with Zocdoc to gain access and obtain patient consent before booking or canceling an appointment on its online platform, the company said Wednesday. Google Gemini, Amazon Health AI, and text- and call-based AI agent Instinct are already connected, and other agents can apply for access with or without a human’s help.
    • “Zocdoc is taking a bet on agentic AI at a time when the industry is split on how to move forward with the technology. “I would say that welcoming agents the way we are is a bit of a contrarian move,” said Dr. Oliver Kharraz, founder and CEO of Zocdoc.”
  • Modern Healthcare adds,
    • “Health insurance companies are wagering that sleek artificial intelligence tools and directed care will lower costs for members.
    • “UnitedHealthcare parent company UnitedHealth Group, Aetna parent company CVS Health and Cigna Healthcare parent company Cigna Group are among the companies that have touted AI’s potential to simplify care navigation and upgradethe customer experience, as Wall Street looks for assurances the investments will pay off.
    • “Already investing heavily in AI to process claims, identify fraud and connect with members, insurers are further developing customer-facing tools.
    • “The last year has really seen an explosion,” said Nate Holobinko, managing director, senior partner and North America sector leader for healthcare services at Boston Consulting Group. 
    • “Aetna and UnitedHealthcare lead rivals in overall website and mobile app experience, according to a report that Corporate Insight, a research firm that analyzes digital platforms, published in August. 
    • “This new generation of AI tools that we’re seeing is really a big leap forward,” said Stephanie Chan, healthcare research manager at Corporate Insight.”
  • Beckers Clinical Leadership notes,
    • “Internal medicine represents the largest primary care specialty, with 48% of all primary care physicians practicing in this field, according to new data from KFF.
    • “In contrast, obstetrics and gynecology represents 10.1% of the primary care workforce, underscoring a significant disparity in physician distribution as the U.S. population continues to age, driving demand for specialized care.
    • “For its analysis, KFF obtained information on the number of active, licensed primary care physicians in the U.S., as of this September from Redi-Data. Figures include both allopathic and osteopathic physicians.
    • “Nationwide, 576,793 professionally active primary care physicians were practicing in the U.S., as of September.”
  • Per the Wall Street Journal,
    • “Here’s Why Moderna’s CEO Isn’t Fazed by Its Cancer-Vaccine Selloff
      • “Stéphane Bancel defends his melanoma data and argues that rivals can’t easily copy the technology.”

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • Beckers Hospital Review reports,
    • “Thirteen Senate Democrats are demanding answers from the largest ACA marketplace insurers about their involvement in recent [ACA federal marketplace] coverage terminations that cut more than 760,000 people from their health plans.
    • “The Oct. 26 letters, led by Sen. Ron Wyden, D-Ore., and Sen. Bernie Sanders, I-Vt., accuse the insurers of “quietly colluding” with the Trump administration on what the lawmakers said was an improper process to terminate qualified enrollees without sufficient notice or compliance with consumer protections.”
    • It’s worth adding the Administration claims the 760,000 people were unauthorized enrollments.
  • and
    • “House Democrats introduced a bill Oct. 22 that would lower Medicare’s eligibility age to 50 from 65.
    • “The bill comes from Reps. Pramila Jayapal of Washington, Chris Deluzio of Pennsylvania, Debbie Dingell of Michigan and Pat Ryan of New York. Provisions would generally go into effect six months after enactment.
    • “Millions leave the workforce before 65, and with Trump’s cuts to healthcare, many are now left without any options as they wait, sometimes years, for Medicare enrollment,” Ms. Jayapal said in an Oct. 23 news release. “Expanding this program is a commonsense step towards ensuring that all Americans have the care they deserve.”
    • “If passed, the bill would sunset five years after most of its provisions go into effect.” 
  • The American Hospital Association News relates,
    • “The Department of Health and Human Services Oct. 27 announced a new initiative to improve breast cancer screening and detection efforts. The initiative, led by the Office on Women’s Health, the Agency for Healthcare Research and Quality, and DenseBreast-info.org, will coordinate actions that include expanding breast density education and improving diagnostic follow-up. HHS said more than 40 health systems will expand evidence-based practices and address delays in care under the program, called the OWH-AHRQ Breast Cancer Screening and Diagnostic Follow-up Initiative. The department said OWH and DenseBreast-info.org will also expand access to educational resources to improve breast density awareness, support informed discussions between women and healthcare providers, and promote understanding of breast cancer screening and diagnostic follow-up options.”
  • and
    • “The Department of Health and Human Services Oct. 26 announced that more than 250 hospitals have signed its voluntary pledge related to hospital efforts on healthy food. The pledge asks hospitals to align patient food services with the 2025-2030 Dietary Guidelines for Americans. It also asks hospitals to ensure inpatient meals meet individual nutritional needs and support healing, recovery and long-term health; and to provide accessible nutrition resources and education as part of discharge planning to help patients sustain healthy habits. The pledge was announced during the AHA Annual Membership meeting in April.”
  • Per an Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today released new analysis from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) examining America’s record-low overall age-adjusted death rate in 2025 and substantial progress in reducing prescription opioid exposure and expanding treatment. An article in Health Affairs Forefront and a new ASPE report highlight how actions across President Trump’s two terms to reduce unnecessary opioid prescribing, combat illicit fentanyl, and strengthen treatment and recovery have led opioid-related deaths in the United States to plummet to the lowest since President Trump declared a public health emergency in 2017. HHS Secretary Robert F. Kennedy, Jr. announced the findings at an event at Detroit Wayne Integrated Health Network in Detroit, Michigan.” * * *
    • “The ASPE report The U.S. Age-Adjusted Death Rate Reached a Record Low in 2025: What Drove the Decline? can be found here.
    • “The Health Affairs Forefront article can be found here.”
  • Beckers Clinical Leadership tells us,
    • “CDC deputy director and chief medical officer Jennifer Shuford, MD, is leaving the agency after six months, The Washington Post reported Oct. 26.
    • “Dr. Shuford, an infectious disease physician, previously served as Texas’ health commissioner and was hired in April as part of a new leadership team meant to increase trust in the agency. CDC scientists were optimistic about her hiring due to her public health background and willingness to speak out during Texas’ measles outbreak last year, the Post reported.
    • “She is expected to leave after the midterm elections Nov. 3.”

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

  • Federal News Network reports,
    • “Agencies now have explicit authority to put federal employees on paid administrative leave for “workforce realignment” reasons, according to final regulations the Office of Personnel Management published earlier this month.
    • “Paying federal employees not to work, after they agree to leave their jobs during workforce reduction efforts, is now an officially acceptable use of paid administrative leave under OPM’s final rule. The leave category is also permissible during reduction-in-force (RIF) notice periods, as well as physical fitness activities in limited cases. And agencies can now deny employees’ requests to withdraw their resignations while under a deferred resignation program (DRP).
    • “The regulations provide more transparency and accountability, provide a firmer legal foundation for allowing or prohibiting certain uses of administrative leave, promote consistency across agencies, clarify the authority of agencies and reduce potential disputes,” OPM wrote in its Oct. 19 final rule.”
  • Govexec relates,
    • “Americans’ satisfaction with public-facing services provided by the federal government has fallen for the first time in five years, according to new findings released by the American Customer Satisfaction Index.  
    • “ACSI reports that citizen satisfaction has fallen to a score of 68.6 out of 100 – a 2.6% decrease. 
    • “This marks the first decline tracked by the index since 2021, when many federal employees were put on mandatory work-from-home schedules at the height of the COVID-19 pandemic and agencies struggled to bring more of their public-facing services online.” 
  • FedSmith advises “Check your FEHB plan’s provider network before Open Season to ensure your trusted doctors, hospitals, and pharmacies are still covered.
  • OPM’s Inspector General has posted its Fiscal Year 2027 Oversight Plan, which is worth a gander.

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

  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Food and Drug Administration, today issued a draft guidance for industry to help sponsors develop and seek approval for personalized gene therapies designed to treat patients with rare genetic diseases.
    • “The guidance, Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management, provides a clear regulatory framework for submitting and managing Biologics License Applications (BLAs) for individualized genome editing (GE) products. The Trump Administration is committed to modernizing approaches to safely get more cures and meaningful treatments to all Americans, regardless of the size of the patient population.” * * *
    • “A recorded webinar, Individualized Human Genome Editing Products: Considerations for BLA and Postapproval Management, summarizing the key elements of the guidance is available on the FDA’s YouTube channel.
    • “The FDA is inviting public comment on the draft guidance. Comments may be submitted to the docket FDA-2026-D-11783 at regulations.gov within 30 days of publication in the Federal Register.”
  • Health tells us,
    • “A popular plant-based butter has been recalled in 10 states due to yeast, mold, and E. coli, the Food and Drug Administration (FDA) announced. The Miyoko’s butter was initially recalled on Sept. 11, and on Oct. 23, the FDA gave the recall the second-highest risk level, Class II. This means the butter is unlikely to cause permanent health issues, but may cause temporary or reversible effects.”
  • Cardiovascular Business adds,
    • “Medtronic is recalling certain OmniaSecure defibrillation leads due to an increased risk of implant issues. No adverse events have been reported, but clinicians did report experiencing difficulties that could potentially lead to “tissue trauma.” 
    • “The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall, which means using the devices “may cause temporary or medically reversible adverse health consequences.”
    • “Medtronic initiated the recall in September, notifying customers that they should “quarantine and return” any affected OmniaSecure defibrillation leads.
    • “Medtronic recently requested the retrieval of a subset of nonimplanted OmniaSecure defibrillation leads for an engineering evaluation,” a company spokesperson told Cardiovascular Business. “The notification request for retrieval was limited to a subset of leads that may have undergone a specific manufacturing sequence as identified by an internal quality process. There have been no reports of patient harm.”
    • “This recall covers more than 700 OmniaSecure defibrillation leads distributed throughout the United States. The two item numbers are 3930M74 or 3930M79. Only the leads specifically included in this recall are being recalled. Click here for a list serial numbers.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S lost a bid in a US court to temporarily block Eli Lilly & Co. from using advertisements that claim its drugs are more powerful, a setback to Novo as it battles to regain a larger share of the obesity and diabetes drug markets.
    • “US District Judge Zahid Quraishi ruled Monday that Lilly can continue to make the disputed claims in its ads while Novo proceeds with a lawsuit filed in July in federal court in Trenton, New Jersey. The judge said Novo’s case for a preliminary injunction was “less than persuasive” because it failed to show irreparable harm.”
  • Fierce Healthcare relates,
    • “CVS Heath’s Aetna is joining the ranks of insurers suing over its results in the 2027 Medicare Advantage star ratings.
    • “The insured filed suit Monday in Georgia’s Southern District Court, and argues that 28 measures used by the Centers for Medicare & Medicaid Services to calculate its scores were “unlawfully adopted” and should have been excluded.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “A single mutation in the H1N1 influenza virus — G155E — is emerging as the defining feature of a flu season that has arrived months ahead of schedule and may slip past some people’s immunity, researchers told Nature, CNN and Today. 
    • “Becker’s reported Oct. 5 that H1N1 had overtaken H3N2 in early West Coast surveillance. The mutation now drawing scrutiny helps explain why.” * * *
    • “Because this year’s shots were formulated in the spring, before G155E spread, the H1N1 component may not be well-matched if the mutation dominates, Dr. Bloom told Nature, though he cautioned it is too early to know. 
    • “Scott Hensley, PhD, a virologist at the University of Pennsylvania in Philadelphia told Nature the H3N2 and influenza B components appear well-matched. Experts stressed that a mismatch means reduced protection, not none. 
    • “This is one of those seasons where the key message is to go get vaccinated now,” Dr. Greninger told CNN. He added that a second, more conventional wave could follow once H1N1 peaks.”
  • and
    • “The CDC found four drug-resistant pathogens require urgent and aggressive action, according to its 2026 Antimicrobial Resistance Threats Report.
    • “The 2026 report, published Oct. 27, estimates the impact of 19 drug-resistant bacterial and fungal pathogens on human health in the U.S. They are categorized into three threat levels. Urgent threats require urgent and aggressive action. Serious threats require prompt and sustained action, and concerning threats require careful monitoring and prevention action, the report said. The CDC also included a watch list of pathogens being monitored because their full burden is not yet understood. 
    • “The CDC updated its methodologies and data sources to make the 2026 report the most comprehensive to date. As a result, direct comparisons to previous reports should not be made, the CDC said.”
  • and
    • “Older adults who received two weeks of home-delivered meals post-discharge were 69% less likely to be readmitted within 14 days, a Durham, N.C.-based Duke University study found.
    • “The study, published on Sept. 19 in Journal of Hospital Medicine, analyzed data from 368 adults 60 and older who were discharged from Duke hospitals between September 2022 and April 2024. All the adults were at risk of food insecurity or malnutrition and were referred to a state-funded Meals on Wheels hospital discharge pilot program that provided two weeks of home-delivered meals. 
    • “Meal recipients also had 54% lower odds of readmission at 21 days. Two weeks post-discharge, nearly 5% of patients who received meals were readmitted, compared with roughly 13% of those who did not.” 
  • Health Day relates,
    • “Ultra-processed foods appear to rewire kids’ brains so they crave more junk food, a new study says.
    • “Pictures of cookies or fries trigger a powerful reaction in the brain reward systems of children who eat more ultra-processed food, researchers reported Oct. 23 in JAMA Network Open.
    • Those children subsequently have higher odds of weight gain and more body fat, researchers found.
    • “Children’s brains are still developing, habits are still forming and food preferences are still being made,” senior researcher Dr. Kathleen Page, a professor of medicine and pediatrics at the Keck School of Medicine of USC, said in a news release. “It’s an important period where the brain is very sensitive to food and the food environment.”
  • and
    • “Nearly 1 in 5 young adults in the U.S. feel anxious every single day, a new study says.
    • “Just under 20% of Americans between 18 and 25 said they suffered from daily anxiety in 2024, up from 15% in 2020, researchers report in the American Journal of Public Health.
    • “The odds of receiving an anxiety diagnosis or a prescription for anxiety meds also rose by roughly a third during the same period, researchers found.
    • “This anxiety might stem from the COVID-19 pandemic and its lasting impact on the psyche of Americans, researchers said.”
  • Genetic Engineering and Biotechnology News tells us.
    • “A study by researchers at the Centre for Genomic Regulation (CRG) has identified six different genes that can help forecast survival of patients with acute myeloid leukemia (AML), a type of cancer that has very variable outcomes between patients.
    • “Headed by ICREA Research Professor Luciano Di Croce, PhD, a researcher at the CRG, the team created a scoring system by moving repeatedly between laboratory experiments with mice and patient records, crossing the two to look for genes that behaved consistently in both. * * *
    • “Findings from the study could point to new ways of helping to predict outcomes in patients with this type of blood cancer, contributing to the development of future prognostic tests, and may suggest new therapeutic targets. Patients suspected of having AML already give a bone marrow sample for laboratory analysis, and measuring six genes is simpler and cheaper than reading a broader genetic profile.”
  • The New York Times informs us,
    • “Millions Use Antidepressants. We Still Don’t Understand How They Work.
      • “Here’s how psychiatrists like me think about the most promising hypotheses.”
  • Fierce Pharma points out,
    • “Vanda Pharmaceutical’s Nereus may soon break out of its motion sickness niche to become a treatment option for the burgeoning GLP-1 market. 
    • “Topline results from the D.C.-based pharma’s phase 3 called “Study 3601” are in, and Nereus demonstrated a 27% reduction in vomiting among patients on GLP-1 receptor agonist therapy and a 35% reduction in severe nausea and vomiting.
    • “Nausea and vomiting are among the biggest obstacles to GLP-1 adherence. Roughly half of patients quit the treatments within their first year, and gastrointestinal challenges are among their cited reasons. Vanda believes Nereus has the potential to help more patients stay on their therapy. Data in hand, the drugmaker is now heading for the FDA in hopes of a label expansion.”
  • and
    • “Pfizer’s Elrexfio has taken another step on its path to potential commercial momentum: The drugmaker just announced another phase 3 win for the bispecific antibody, this time as a treatment for patients with relapsed or refractory multiple myeloma (RRMM) whose disease has progressed after first-line treatment.
    • “The topline readout, announced Tuesday, came by way of Pfizer’s MagnetisMM-32 trial, one of multiple ongoing phase 3 trials evaluating Elrexfio as an earlier-line option for RRMM. 
    • “According to Pfizer, patients who took Elrexfio after at least one prior line of treatment had a significantly lower risk of disease progression or death compared to an investigator’s choice regimen of BMS and AbbVie’s Empliciti (elotuzumab) with Bristol’s Pomalyst (pomalidomide), Pomalyst with Takeda’s Velcade (bortezomib), or Amgen’s Kyprolis (carfilzomib), all paired with the steroid dexamethasone.” 
  • MedTech Dive adds,
    • “Abbott on Monday launched a new version of its Oncodetect molecular residual disease test designed to better monitor for traces of cancer in the body after treatment.
    • “MRD tests look for tiny amounts of circulating tumor DNA, or ctDNA, in the blood to act as an early warning signal for cancer recurrence. The goal is to detect recurring disease earlier than traditional methods like imaging scans.
    • “Abbott’s new test, based on technology developed at the Broad Instituteof MIT and Harvard, uses whole-genome sequencing to track as many as 5,000 patient-specific cancer mutations, compared with up to 200 variants in the earlier Oncodetect test.”

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

  • The Wall Street Journal reports,
    • “Centene CNC raised its full-year outlook for the third time as the health insurer continued to control medical costs.
    • “However, its total at-risk membership fell to 25.7 million as of Sept. 30, down from 28 million a year earlier, primarily reflecting a contraction in its Health Insurance Marketplace enrollment.
    • “The company’s health-benefits ratio, a measure of how much was paid out to cover enrollees’ medical expenses, held steady at 92.7%, below the mean analyst estimate of 92.9%, based on FactSet. The company said the underlying performance in its Medicare Advantage and Prescription Drug Plans drove the stability, alongside improved pricing and risk transfer in Marketplace reflecting member acuity.”
  • and
    • “GSK expects to nearly double the number of cancer medicines it is testing in clinical trials next year, according to one of its top scientists, highlighting how the company’s dealmaking spree is filling its drug pipeline.
    • “Hesham Abdullah, head of oncology research and development at the U.K. drugmaker, said in an interview that the company is firing on all cylinders to speed up its return to the field of cancer medicine.
    • “Right now we have five approved [cancer] medicines, I think probably in a few weeks’ time there’ll be six,” Abdullah said. “We have a clinical-stage portfolio of about 15 assets that’s probably going to, I would say, close to double in 2027.”
  • Fierce Healthcare relates,
    • “HCA Healthcare’s earnings landed above internal and analyst expectations for the third quarter as accelerated volume growth and cost reductions blunted a weakening payer mix.
    • “On Tuesday morning, executives at the country’s largest for-profit health system said it’s now on track to land in the upper half of its 2026 estimated guidance ranges, and in an earnings call gave an early prediction that earnings performance next year “will be generally consistent with 2026” despite expected policy and macroeconomic headwinds. 
    • “I’ve often mentioned that HCA has strong staying power because of our scale, the important role we play in providing critical services to communities and our disciplined culture,” CEO Sam Hazen said during the call. “Despite the challenges this year brought about by federal policy changes, we have continued to move the company forward and believe we are positioned to end the year positively as we look ahead to 2027.”
  • Beckers Hospital Review tells us,
    • “King of Prussia, Pa.-based Universal Health Services reported an operating income of $454 million (9.6% margin) in the third quarter of 2026, down from a $522 million operating income (11.6% margin) during the same period last year, according to financial results published Oct. 27. 
    • “The news release comes after UHS completed its acquisition of Talkspace, a virtual behavioral health company, in mid-August for $835 million.” * * *
    • “UHS comprises 30 inpatient acute care facilities, 388 inpatient behavioral health facilities, 169 outpatient and other facilities, nationwide virtual behavioral health services, an insurance offering, a physician network and various related services with locations in 40 states, Washington, D.C., Puerto Rico, Ireland and the United Kingdom. It has more than 102,000 employees.”
  • and
    • “Healthgrades released its 2027 Specialty State Rankings Oct. 27, naming the top three or five hospitals in each of 19 specialties across 30 states.
    • “The rankings use Medicare inpatient data from 2023 to 2025 on 31 conditions and procedures. To be ranked, a hospital must have no one-star ratings and at least one five-star rating in the cohort being measured. States with six or fewer eligible hospitals in a specialty are not ranked in that specialty, states with seven to 10 eligible hospitals receive a top three and states with 11 or more receive a top five. This year’s ranked specialties include emergency hospitalization, which was not ranked last year and covers 12 common emergency conditions.
    • “The 30 states with rankings are Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.”
    • The article lists those hospitals by State.
  • and
    • “Pharmacist pay swings by tens of thousands of dollars depending on the state. Technician pay is lower and depends heavily on local cost of living. Meanwhile, the jobs themselves are shifting out of retail and into hospitals, where pay tends to be higher.
    • “[The article shows] what pharmacy pay looks like in 2026, based on the latest federal wage data.”
  • BioPharma Dive informs us,
    • “Ferring Pharmaceuticals has agreed to buy fertility treatment startup Gameto in a potentially $1.4 billion deal that boosts the Swiss drugmaker’s portfolio of reproductive medicines. 
    • “Ferring didn’t disclose exactly how much it’s paying up front for Gameto in its announcement Tuesday, only noting that the transaction involves payments tied to unspecified development, regulatory and sales milestones. The two entities will also continue to operate independently until the buyout closes. 
    • “Once completed, the acquisition will hand Ferring “Fertilo,” a novel technology the biotech developed to help simplify and shorten in vitro fertilization cycles.” 
  • and
    • “Artiva Biotherapeutics will lay off most of its staff and stop developing an experimental “natural killer” cell therapy for autoimmune conditions after reporting the deaths of two participants in a clinical trial. 
    • “Artiva made clear in a Tuesday statement that both of the deaths appear unrelated to its therapy, which is known as AlloNK and was being tested in inflammatory diseases like rheumatoid arthritis.” 
  • Beckers Health IT points out,
    • “Anthropic has acquired Mithril Medicine, a one-person startup developing treatments for two rare forms of muscular dystrophy. The AI company also released early results from Claude-assisted drug development work with six outside organizations, it said Oct. 27.
    • “The partners are BigHat Biosciences, Bristol Myers Squibb, Divergence Labs, Enveda, Generate Biomedicines and the Column Group. Most of the work is still preclinical, meaning most of the drug candidates have not yet been tested in humans.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • Beckers Health IT reports,
    • “The Department of Health and Human Services finalized a rule Oct. 26 eliminating 14 federal health IT certification criteria and scaling back AI transparency requirements, with the agency projecting more than $1.5 billion in regulatory cost savings.
    • “The final rule, known as Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity, or HTI-5, reduces compliance requirements for developers participating in the Office of the National Coordinator for Health Information Technology’s certification program.
    • “HHS initially proposed eliminating 34 of the program’s 60 certification criteria in December 2025. The final rule takes a narrower approach, removing 14 criteria and revising seven while leaving 39 unchanged.
    • “Among the changes is the elimination of AI model-card requirements within the decision support interventions certification criterion. Those requirements, established under the HTI-1 rule, were intended to give healthcare organizations information about predictive algorithms and other decision-support tools incorporated into certified health IT.
    • “The rule also removes or revises requirements involving care coordination, patient engagement and certain health data exchange capabilities, and formally removes a clinical decision support criterion that expired Jan. 1, 2025.”
  • More is information about the final rule can be found at healthit.gov/hti5, on LinkedIn, or by following @ONC_HealthIT on X.
  • Healthcare Dive adds,
    • “The healthcare industry is slowly but surely moving away from the old, fragmented and manual way of handling prior authorization toward a modernized electronic system.
    • “CMS-regulated payers, such as Medicare Advantage, Medicaid and marketplace insurers, are now confronting a Jan. 1 deadline to implement the three prior authorization application programming interfaces — sets of rules that enable computer programs to communicate directly with one another —  under a federal interoperability rule that was finalized in 2024.
  • Beckers Hospital Review considers five big questions as the 340B drug rebate pilot nears launch on January 1, 2027.
  • Beckers Payer Issues relates,
    • “Ghost networks have long been a point of frustration, with health plan members sometimes left scrambling to check if a provider is in network — or available at all.
    • “Several health insurers — including Elevance Health and Blue Shield of California, in recent months — have faced lawsuits concerning the accuracy of their provider directories. Some of these complaints said that seemingly bigger networks draw more customers, even if that appearance is ultimately misleading.
    • “But more recent developments have pointed to ongoing issues. One study published in October found more than half of secret-shopper calls made to psychiatrists and psychologists across six Blue Cross Blue Shield plans’ directories indicated errors. Separately, this fall, UnitedHealthcare mistakenly told members that eight clinicians had died before correcting the issue. 
    • “While the No Surprises Act, state laws and CMS rules have targeted ghost networks and network adequacy before, there has been a renewed focus on getting directories right.
    • “On Oct. 13, DataSpring, powered by CAQH, rolled out a new standard to measure provider directory data quality for individual clinicians. DataSpring convened major insurers, the American Medical Association and the National Committee for Quality Assurance to develop a framework rooted in the CMS quality foundation for provider directories.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. brought his “Take Back Your Health Tour” to Texas and Florida last week to advance President Trump’s Make America Healthy Again agenda. Across four days, Secretary Kennedy announced new actions on kidney disease and dementia, promoted stronger nutrition education for future doctors, and worked to expand access to women’s healthcare.
    • “From Tuesday through Friday, Secretary Kennedy met with healthcare providers, patient advocates, medical educators, and pharmaceutical manufacturers in Fort Worth, Texas, and Orange Park, Fort Lauderdale, and Miami, Florida.  At each stop, he advanced concrete actions to prevent chronic disease, improve patient care, and give Americans more information and choices to protect their health.
    • “President Trump has directed us to confront chronic disease and put patients first,” said HHS Secretary Robert F. Kennedy, Jr. “Across Texas and Florida, we put that mission into action — detecting kidney disease earlier, strengthening nutrition education for future doctors, advancing prevention and care for families facing dementia, and expanding access to women’s health treatments. HHS is moving prevention to the center of American health care and giving patients more control over their health.”
  • Bloomberg Law notes,
    • “One of the Department of Labor’s key policy advisers is departing the Employee Benefits Security Administration, following completion of the agency’s recent rulemaking on pharmacy benefit managers and healthcare price transparency.
    • “EBSA Senior Policy Advisor Caitlin Soto announced on LinkedIn that Friday would be her last day, calling her time at the DOL “the honor of my career.”
    • “Leading the Department’s PBM Fee Disclosure rulemaking, after nearly a decade of PBM transparency work, was the highlight,” she wrote in her post. “I’m also proud of our work on behalf of this administration to advance fertility benefits, transparency in coverage, and mental health parity. The list goes on.”
    • “The department is expected to release a rule in the coming days requiring PBMs — which negotiate drug prices for health plans — to disclose detailed compensation information to employers and other health plan sponsors. DOL also recently finalized a rule aimed at strengthening price transparency for medical services.”

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

  • Federal News Network reports,
    • “More details are emerging on the Trump administration’s revisions to paid administrative leave. Agencies’ ability to pay employees not to work during workforce reduction efforts has been formalized. Paid leave will also be allowed during reduction-in-force notice periods, the Office of Personnel Management said. OPM’s latest guidance comes after it finalized regulations to conform with the rules for the deferred resignation program. OPM is expected to soon update other online resources to reflect the new regulations. — Drew Friedman (Revised administrative leave regulations – Office of Personnel Management)”
  • and
    • “The White House is following a court’s order when it comes to reduction-in-force policies. The Office of Management and Budget and the Office of Personnel Management have formally rescinded two memos calling for reductions in force during shutdowns. The Trump administration agreed to terminate the two memos as part of its settlement in September to end a lawsuit by a coalition of federal employee unions including the American Federation of Government Employees, National Federation of Federal Employees and National Treasury Employees Union. Along with the removing the two memos, the Trump administration agreed to rescind every RIF notice issued during the 2026 shutdown and reinstate employees with back pay from the State Department, General Services Administration and Small Business Administration. Additionally, agencies must remove from their shutdown contingency plans any language authorizing RIFs, or RIF work, during a lapse in appropriations, unless a statute expressly permits it. — Jason Miller (OMB rescinds memo allowing RIFs during shutdowns – Office of Management and Budget)

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

  • Bloomberg Law reports,
    • “A recently launched FDA initiative targeting rare diseases is a top focus to carry out, the agency’s acting chief said ahead of a public meeting Wednesday to solicit feedback on the framework. 
    • “We’ve got to make sure that that process is in place. We’re working really hard to do it,” Kyle Diamantas, acting commissioner for the Food and Drug Administration, said Monday at the National Organization for Rare Disorders’ breakthrough summit. “It’s a top priority of mine.”
    • “Earlier this month, the agency introduced the Rare Disease Framework Initiative, which seeks to give patients more input and drug companies more transparency in the regulatory process for rare treatments. The initiative aims to develop a fit-for-purpose plan that considers the nuances of each disease and patient needs.”
  • Michigan Engineer relates,
    • “Conventional methods of pulling clots out through the blood vessels can damage fragile vessel walls.
    • “The newly FDA-cleared technology gently pulls on the clot with suction, stretches and thins it with an agitator, and vacuums it out of the body. 
    • “The device was designed by a team of neurosurgeons and engineers at the University of Michigan and is being commercialized by U-M startup Endovascular Engineering.”
  • Per a Pfizer news release,
    • “Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has expanded approval of TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (PC) with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations. mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC).
    • “This approval makes TALZENNA, an oral poly ADP-ribose polymerase (PARP inhibitor), plus XTANDI, an androgen receptor pathway inhibitor (ARPI), available in an earlier line, providing an opportunity to delay disease progression at a critical stage when more patients may experience greater benefit.”

From the judicial front,

  • Bloomberg Law reports,
    • “Eli Lilly & Co. is forming a new battlefront over a weight loss treatment that has yet to secure FDA approval, intensifying a legal drive to protect its blockbuster obesity franchise.
    • “The pharmaceutical giant has filed at least 11 federal lawsuits against a range of online vendors and wellness clinics making copycat versions of its experimental drug retatrutide, accusing them of illegally selling or facilitating access to a product not approved by any regulator in the world.
    • “The crackdown escalates the company’s broader legal campaign against businesses making copies of its powerful therapies, establishing a new wave of aggressive challenges over a drug predicted to outperform currently marketed weight loss treatments. Retatrutide is still in clinical trials for obesity, type 2 diabetes, and other related conditions.” * * *
    • “Lilly’s endeavor to protect retatrutide is also focusing on the FDA, as it plans to submit an application to the regulator in the first quarter of next year. 
    • “The drugmaker is simultaneously in a legal battle with the regulator after the agency determined a few years ago that retatrutide is a drug and not a biologic — a crucial designation that shapes its market exclusivity and when Medicare can negotiate its price.
    • “A biologic designation would grant retatrutide 12 years of protection from competitors, while small molecule drugs get five. Significant for Lilly, a biologic classification would prohibit compounded versions. 
    • “The FDA earlier this month doubled down on retatrutide’s drug label after a federal court sent the determination back to the agency for review, concluding the product doesn’t meet an amino acid length threshold that would count it as a biologic.
    • “An appeals court is now weighing whether it has jurisdiction to review the battle.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Nearly 1 in 10 adults hospitalized with respiratory syncytial virus infection died in the hospital or within 30 days of discharge, according to preliminary CDC data.
    • “Researchers analyzed RSV hospitalization data from the CDC’s Respiratory Virus Hospitalization Surveillance Network, which tracks hospitalizations with lab-confirmed influenza, COVID-19 or RSV in 14 states and more than 300 hospitals. The analysis included 18,301 RSV hospitalizations among adults across eight seasons from 2014 to 2024.” 
  • MedPage Today lets us know,
    • “Obesity in young adulthood was associated with significantly increased likelihood of early-onset cancers in an observational study, a risk that persisted into middle age.
    • “Men had a higher cancer risk than women, and abdominal fat further increased cancer risk beyond BMI alone.
    • “Cancer rates were highest for thyroid, endometrial, and ovarian cancers.”
  • STAT News relates,
    • “Women’s hearts are different from men’s. Research from clinical trials that have required female participants only since 1993 have repeatedly drummed home that message, from varying chromosomes in heart muscle cells to different heart attack symptoms and causes. Yet wide gaps remain in heart health care for girls and women across specialties. 
    • “Recognizing that clinical fragmentation and the resulting harm to women’s health, four medical societies — the American Heart Association, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists — have issued a framework intended to unite clinicians and patients over a lifetime of care, all aimed at dethroning cardiovascular disease as the leading cause of death in women. In that spirit, three articles offering guidance across the course of a woman’s life were published Monday in Circulation.
    • “Their message: Because female-specific biology affects girls’ and women’s hearts throughout their lives, it requires connected, holistic care starting in adolescence to reflect transitions not found in the male models that have dominated health care: periods, pregnancy, perimenopause, and menopause.” 
  • Radiology Business points out,
    • “The performance of digital breast tomosynthesis—commonly referred to as 3D mammography—improves steadily with patient age, underlying the effectiveness of screening in an elderly population. 
    • “That’s according to new large-scale research from Massachusetts General Hospital, published Friday in RSNA’s Radiology Imaging Cancer. 
    • Current mammography guidelines remain largely age-based, with the influential U.S. Preventive Services Task Force’s last update in 2024 advocating for screening starting at 40. However, USPSTF claimed current evidence was insufficient to weigh the benefit of screening for women 75 and older. 
    • “Researchers with the Harvard University-affiliated institution recently sought to address this knowledge gap, analyzing data from over 300,000 mammograms. They found screening to be increasingly effective, particularly among the elderly, based on common quality benchmarks. 
    • “Cancer detection and sensitivity increased, false-positive rates declined, and specificity improved, resulting in particularly strong performance among female individuals aged 70 years and older,” lead author Leslie R. Lamb, MD, MSc, with Boston-based Mass General’s Department of Radiology, and colleagues wrote Oct. 23. “These findings provide a contemporary benchmark for screening DBT performance across age groups and contribute to the ongoing reassessment of age-based screening guidelines,” they added later. 
  • Healio notes,
    • “Most U.S. women know physical activity reduces breast cancer risk, but only one-quarter meet recommended levels.
    • “A majority know alcohol raises cancer risk, but two-thirds consume alcohol to some extent.”
  • Health Day adds,
    • Marijuana legalization may be landing more people in the hospital with heart problems, a new study suggests.
    • For the study, researchers analyzed more than 50 million hospital discharge records spanning 2012 to 2018. They compared Western states, where recreational marijuana sales began in 2014, with other U.S. regions.
    • The study — led by Dr. Samuel Slavin, of the Boston University Chobanian & Avedisian School of Medicine — found that hospital admissions for several serious heart conditions rose faster after legalization.
    • For each year of sales, admission rates were nearly 4% higher for heart failure, 3% higher for heart attacks and just over 2% higher for atrial fibrillation — an abnormal heart rhythm.
    • Rates for stroke, deep vein blood clots and tachycardia — a fast heartbeat — were also higher, but not statistically significant.
    • While the study cannot prove cause and effect, researchers said their findings “point to potential adverse effects of recreation legalization on population health.”
  • The Washington Post tells us about “the most important things to do to stay healthy while traveling.
    • “An infectious-diseases doctor shares essential tips to prepare for any health issues while traveling in another country.”
  • Beckers Behavioral Health informs us,
    • “Nearly 1 in 3 young adults in the U.S. reported using generative AI to seek substance-related information, with higher rates of use among Black and male respondents, according to a study published Oct. 19 in JMIR Formative Research.
    • “Researchers at Rutgers, the State University of New Jersey in New Brunswick, surveyed 995 U.S. adults ages 18-29 in April 2026 through the online research platform Prolific. The cross-sectional study examined the prevalence and frequency of, and reasons for, substance-related AI use, along with demographic differences and perceptions of the technology.”
  • and
    • “Researchers have identified evidence supporting a potential subtype of clinical depression, known as “circadian depression,” defined by disrupted sleep-wake patterns and associated with more severe symptoms and poorer responses to commonly prescribed antidepressants, according to a study published Oct. 20 in The British Journal of Psychiatry.
    • “The study, led by researchers from the University of Sydney’s Brain and Mind Centre, analyzed data from 11,380 adults with depression in the Australian Genetics of Depression Study. Researchers classified participants as having a circadian subtype if they met at least three of six criteria related to sleep and circadian disruption: social jetlag, seasonality, delayed sleep midpoint, evening chronotype, morning tiredness and hypersomnia. They compared clinical characteristics, self-reported antidepressant responses and genetic risk profiles between groups.”
  • Physicians’ Weekly informs us,
    • “Compared with patients with normal weight or overweight, the odds of death after emergency general surgery increase 92% for patients with underweight and 59% for patients with frailty, according to findings presented at the American College of Surgeons (ACS) Clinical Congress 2026 in Washington, DC.
    • “Our study shows that patients who are both underweight and frail have the worst outcomes,” said lead study author Ellen Cohn, MD, MPH, of the University of Chicago, in a news release. “We also saw that frailty reduces the positive impact of the obesity paradox — the finding that patients who are overweight, but not at the extremes of obesity, tend to have better outcomes. That protective effect is lost if a patient is frail.”   
  • Per Fierce Pharma,
    • “Fresh off the excitement of Rasonque’s big splash in pancreatic cancer, the oncology community has another impressive clinical win to celebrate. Amgen’s T-cell engager Imdelltra has posted a massive survival benefit in small cell lung cancer, delivering what Chief Medical Officer Paul Burton, M.D., Ph.D., called a “watershed moment” for the field.
    • “When added on top of AstraZeneca’s Imfinzi, Imdelltra reduced the risk of death by 58% as a first-line maintenance therapy for patients with extensive-stage SCLC who had not progressed following initial treatment with Imfinzi and chemotherapy.
    • “The result came from the phase 3 DeLLphi-305 study, which showed that, compared with Imfinzi alone, Imdelltra plus Imfinzi improved median overall survival by 8.4 months to 21.1 months. These data are being presented during a presidential symposium at the European Society for Medical Oncology Congress 2026 and simultaneously published in The New England Journal of Medicine.”
  • and
    • “As a cornerstone of Merck & Co.’s post-Keytruda oncology strategy, sac-TMT has cleared a clinical milestone. In its first global phase 3 win, the TROP2 antibody-drug conjugate delivered results that are “pretty consistent” with earlier China data, according to Marjorie Green, M.D., Merck’s head of oncology clinical development.
    • “Sac-TMT, partnered with China’s Kelun-Biotech, reduced the risk of death by 32%—and the risk of disease progression or death by 41%—compared with chemotherapy in patients with previously treated endometrial cancer. The patients had received prior treatment with platinum-base chemo and PD-(L)1 inhibitor therapy.
    • “Derived from the TroFuse-005 trial and presented at the European Society for Medical Oncology 2026 Congress, the data gave sac-TMT its first positive global phase 3 report out of 18 trials that Merck has launched in one of the industry’s broadest clinical development programs for a single drug.” 
  • and
    • “Novartis lifted the veil on its phase 3 wins in relapsing multiple sclerosis (RMS), announced in early September. 
    • “Not only did the company’s BTK inhibitor Rhapsido reduce relapses and disease progression compared to Aubagio, an older RMS treatment from Sanofi, but it did so without inciting any liver issues, a side effect that has proven to be an ongoing barrier to success of the drug class in this indication. 
    • “Novartis said it plans to seek regulatory approval globally in RMS. Its applications will be backed by data from the Remodel-1 and Remodel-2 trials presented at MSToronto last week and simultaneously published in The Lancet.”
  • BioPharma Dive adds,
    • “An antibody-drug conjugate from BioNTech and DualityBio met its main goal in a Phase 3 study in breast cancer, but may only have a “limited” impact in people with the condition, the companies said Monday.
    • “The treatment, known as trastuzumab pamirtecan, successfully delayed tumor progression in a trial of people whose breast tumors express low, but still detectable levels of the HER2 protein. The improvement on that measure was “modest,” though, and treatment was also associated with higher rates of interstitial lung disease — a potentially deadly kind of lung inflammation — than the companies had seen in earlier testing.” 
  • The Wall Street Journal reports,
    • “Roche Holding ROP said it expects a pill it is developing to become the new standard treatment for an advanced form of lung cancer, and the company’s first shot at an emerging field within the oncology market.
    • “The Swiss drugmaker is working on several drugs that target a driver of cancers that long eluded the industry. A breakthrough in pancreatic cancer from U.S. biotech Revolution Medicines put the field on investors’ radar, and Roche aims to venture into it with lung-cancer medicine divarasib.
    • “In study results presented Sunday at the annual congress of the European Society for Medical Oncology in Madrid, Roche said its drug lowered the risk of death by 44% compared with available treatments from Amgen and Bristol-Myers Squibb. The late-stage clinical trial compared the effects of the drugs on patients with a specific type of lung cancer who had been previously treated.
    • “Fewer participants who took divarasib dropped out of the trial due to side effects than those who received the existing drugs, Roche said.
    • “The data are practice-changing,” Roche’s Deputy Chief Medical Officer, Stefan Frings, said in an interview.”

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

  • Fierce Healthcare reports,
    • “Earlier this year, UnitedHealthcare unveiled Avery, a generative AI companion aimed at supporting care coordination for its members.
    • “At the time, the tool was available to about 6.5 million of its members in employer plans and 160,000 people enrolled in Medicare Advantage. Now, the insurer is expanding access to 21 million of its members, growing the tool’s reach at a faster clip than was initially expected.
    • “To date, the company has found that Avery has resolved 90% of its member interactions, and in the remaining 10% of cases, can complete a handoff to a human advocate to offer member support. 
    • “As we’re seeing some of the statistics and some of the feedback that we’re getting from users around the success we’ve had within the early phases of Avery, it’s just making sense to open up that application into more and more of the population,” Craig Kurtzweil, chief data and analytics officer at UnitedHealthcare, told Fierce Healthcare.”
  • and
    • “Building stronger bridges between payers and providers will prove critical in addressing the biggest challenges facing healthcare: affordability and access.
    • “It’s with that backdrop that Aetna is releasing its latest provider survey, a quarterly poll that seeks to better understand providers’ perspective on their insurer counterparts and where there’s room to continue developing trust between the two. In the third quarter survey, provided first to Fierce Healthcare, Aetna found a trust score of 6 out of 10, on par with the 6.1 score seen in Q2.
    • “The tally makes for a significant increase from the first quarter, where the trust score was 5.4.
    • Steve Nelson, president of Aetna, told Fierce that “trust is at an all-time low,” so the insurer has been putting an emphasis on addressing some of the biggest pain points that erode that trust, including administrative burdens like prior authorization and increasing transparency.
    • “It’s not just a hope and a prayer here,” he said. “We’re actually making progress.” 
  • and
    • “Doximity inked a partnership with Wolters Kluwer Health to embed UpToDate’s evidence-based clinical content directly within Doximity Ask, the company’s AI clinical decision support tool.
    • “In the coming weeks, at health systems that use both products, clinicians will see an answer based on UpToDate’s 13,000 clinical topics and best practice guides alongside Doximity Ask’s response, without leaving the Ask workflow.
    • “Doximity is a digital platform for U.S. medical professionals that offers workflow tools such as a telehealth solution, a clinician-to-patient dialer tool and digital faxing capabilities.
    • “The company aims to become a leading AI platform for doctors with plans to scale its clinical AI suite, including its ambient note-taking tool Scribe and clinical AI assistant and medical search engine Ask. A year ago, Doximity acquired clinical AI company Pathway and then integrated Pathway’s datasets and its AI into its free Doximity GPT product to offer DoxGPT (now Ask).”
  • Beckers ASC Review relates,
    • “On Oct. 26, Cincinnati-based Bon Secours Mercy Health agreed to acquire Brentwood, Tenn.-based Surgery Partners through its affiliate HealthSpan Partners in a take-private deal valued at about $5.7 billion including debt. 
    • “The transaction would add more than 200 ASCs, surgical hospitals and physician practices across 30 states, along with about 5,000 affiliated physicians, to a 47-hospital system — making the latest in a growing group of health systems that have shifted ambulatory care from a nice-to-have to a strategic imperative.
    • “It most recently follows St. Louis-based Ascension’s $3.9 billion acquisition of Nashville, Tenn.-based Amsurg, which closed earlier this year, and comes as Dallas-based Tenet Healthcare keeps adding to United Surgical Partners International, its surgical arm and the nation’s largest ASC portfolio.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • The Wall Street Journal reports,
    • “A top ally of Health Secretary Robert F. Kennedy Jr. is departing the Trump administration after frustrations with White House delays on Kennedy’s food agenda. 
    • “Calley Means, a senior adviser to Kennedy who also worked in the White House to further “Make America Healthy Again” policies, quit his role on Thursday, he told The Wall Street Journal.
    • “I leave with tremendous respect for President Trump and Robert F. Kennedy Jr.,” he said. “This movement is in the first inning and just getting started.” Means said he would continue working to further Kennedy’s MAHA agenda.”
  • Per a Health and Human Services Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the 2026 Update to the National Plan to Address Alzheimer’s Disease and Related Dementias, taking Department-wide actions to guide coordinated federal action on dementia risk reduction, research and innovation, care, and support for people living with dementia and their families. Secretary Kennedy made the announcement at the Broward Health Medical Center in Fort Lauderdale, Florida.
    • “Millions of American families have seen the devastating toll of Alzheimer’s disease and related dementias,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump, HHS is shifting the national strategy toward prevention, earlier detection, and faster development of better diagnostics and treatments. We are advancing gold-standard science, reducing risk where we can, improving care, and giving patients and families stronger support at every stage of the disease.”
    • “The updated plan puts greater emphasis on reducing dementia risk across the lifespan and translating scientific discoveries into better prevention, diagnosis, treatment, and care. It also formally recognizes related dementias in the plan’s title, reflecting public input and the shared challenges that patients and families face across different forms of dementia.” * * *
    • “Details on the National Plan and participating agencies’ initiatives are available at hhs.gov/aging/adrd.”
  • The New York Times adds,
    • “Alzheimer’s Researchers Look at an Unusual Data Point: Head Shape.
      • “Could the geometry of our brains increase the risk of Alzheimer’s disease? It’s a provocative question, but one that some scientists are beginning to explore.”
  • Beckers Health IT relates,
    • “HHS plans to award Anthropic a sole-source contract to keep its workforce on the company’s Claude AI tools without an open competition.
    • “The agency posted a notice of intent Oct. 19 on SAM.gov for a “limited continuity of services award.” The award would run until the department completes a competitive multiple-award blanket purchase agreement for enterprise frontier AI models. The notice did not list a contract value or projected award date.
    • “HHS argued that only Anthropic can meet the requirement because Claude is the company’s proprietary model family and is already integrated into department infrastructure. Covered capabilities include chat, drafting and summarization, coding assistance, agentic features, connectors, and administrative controls such as single sign-on and audit export.” * * *
    • “The notice comes as Anthropic’s discounted General Services Administration OneGov deal is set to expire Oct. 31, FedScoop reported. HHS rolled out Claude across the department in December 2025 after Anthropic offered its services to agencies for $1 a year.”
  • Beckers Hospital Review tells us,
    • “Under the Healthcare False Claims Act Self-Disclosure Pilot Program, companies that meet the requirements can settle disclosed conduct through a coordinated civil release that covers the False Claims Act and certain HHS administrative authorities, according to an Oct. 22 news release shared with Becker’s. 
    • “To qualify, healthcare companies must:
      • “Reveal all relevant details of the potential violations;
      • “Provide documents that show the full nature and scope of the conduct;
      • “Detail remedial steps taken;
      • “Repay the government under the protocol, which applies a multiplier of 1.25 to 1.6
    • “The multiplier depends on various factors, including how quickly the company provided disclosure, and the scope and duration of the misconduct, whether senior leadership was involved, the company’s financial benefit, and whether the company inherited the liability via a transaction but fixed the issue promptly.
    • “In return, companies will get a Justice Department release for disclosing the conduct. As part of the resolution, the HHS Office of Inspector General will not impose exclusion or require a corporate integrity agreement. CMS will also not revoke billing or enrollment privileges, and neither CMS nor OIG will impose civil monetary penalties.”

From the U.S. Office of Personnel Management front

  • Tammy Flanagan, writing in Govexec, considers
    • “If you already have FEHB, should you sign up for Medicare B?
      • “Pairing your federal health plan with Medicare can lower out-of-pocket costs, but monthly premiums and income-based surcharges add up. Here’s what to consider before deciding whether the extra coverage is worth the price.”
  • FedWeek tells us,
    • “Several key figures are increasing for 2027 in the Social Security program affecting both current employees and retirees.
    • “For the former group, the 6.2 percent Social Security payroll tax will apply on up to $192,300 of earnings, up from $184,500. For FERS employees, that tax cuts off at that threshold and from there on they pay only the civil service retirement contribution (which is 0.8, 3.1 or 4.4 percent, depending on when they were hired).
    • “Above the cutoff CSRS Offset employees continue to pay 6.2 percent into Social Security and their pertinent percentage into the federal retirement fund, but all the money after that point goes into the federal retirement fund instead. Employees under “pure” CSRS don’t pay the Social Security payroll tax.
    • “For those drawing Social Security benefits, the earnings test applying to beneficiaries aged 62 through their “full” retirement age (65-67, depending on year of birth; 67 for those born in 1960 and after), will rise from $24,480 to $25,56v0. Those beneficiaries lose $1 in Social Security benefits for every $2 in earnings through employment or self-employment earnings above the limit.
    • “A separate earnings test applies only to earnings for months in the year an individual reaches full retirement age but prior to the individual attaining that age. One dollar in benefits will be withheld for every $3 in earnings above $67,920, up from $65,160. There is no limit on earnings beginning the month an individual attains full retirement age.”

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

  • The Washington Post reports,
    • “Federal health officials are investigating a multistate salmonella outbreak that has been linked to raw oysters and sickened 27 people across a dozen states. 
    • “Five of the cases have involved hospitalizations, health officials said. 
    • “The Centers for Disease Control and Prevention said an investigation is underway of infections linked to raw oysters harvested by the Little Wicomico Oyster Co. from the Little Wicomico River’s harvest area in Virginia. 
    • “The company recalled oysters harvested from that area from Sept. 18 through Oct. 8. People are advised not to eat, sell or serve them, officials said.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program aligned with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments. NAIN is designed to advance the science, tools, and regulatory approaches needed to support the development of medical products for conditions affecting the brain and nervous system. NAIN’s inaugural initiative, the Alzheimer’s Prevention Accelerator, will focus on advancing medical products that help delay or prevent Alzheimer’s disease. Both efforts support the National Alzheimer’s Project Act (NAPA), the federal government’s comprehensive roadmap for coordinated action on Alzheimer’s and related dementias.”
  • Beckers Hospital Review tells us,
    • “The FDA has granted accelerated approval to Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression, making it the first and only C5 complement inhibitor approved for this use.
    • “The approval followed Priority Review and was based on a prespecified interim analysis of the I CAN phase 3 trial, according to an Oct. 21 news release. Ultomiris demonstrated a 43.4% reduction in proteinuria compared with placebo at 34 weeks.
    • “Ultomiris is administered intravenously every eight weeks in adults, based on body weight, following a loading dose. The trial’s safety profile was consistent with the known profile of Ultomiris, with no new safety concerns identified.”
  • BioPharma Dive informs us,
    • “Compounding pharmacy Apothecary Pharma has issued a voluntary recall of its copycat version of Eli Lilly’s obesity drug Zepbound, stating in a notice that it couldn’t definitively guarantee the medication’s safety.
    • “The recall, of which Apothecary notified the Food and Drug Administration in September, covers 22 lots of compounded tirzepatide, the active ingredient in Lilly’s medicine. Those lots have beyond-use dates ranging from Oct. 8 to Nov. 26.
    • “Apothecary’s recall comes as Lilly and Novo, the only makers of FDA-licensed GLP-1 obesity medications, have sought to stop companies from selling compounded counterparts. The recall could help bolster Lilly and Novo’s claims that the knockoff versions don’t have the same quality, safety or efficacy as the FDA-approved ones.”
  • STAT News adds,
    • “For the popular diabetes and obesity medications known as GLP-1s, addiction medicine is one of many possible promising next acts.
    • “Eli Lilly is investigating a new drug, brenipatide, and testing it in alcohol use disorder. A new company called Baseline Therapeutics is studying a GLP-1 receptor agonist in alcohol, cocaine, and methamphetamine use disorders; Altimmune is testing one called pemvidutide for alcohol. Addiction medicine specialists are hopeful that the Food and Drug Administration may soon approve a new medication for alcohol use disorder — the first in two decades. 
    • “But some telehealth platforms that specialize in treating addiction aren’t waiting. In the last year, a few companies have begun to market off-label prescriptions of GLP-1s, both branded and compounded, to treat alcohol use disorder and other addictions. 
    • “Trying to drink less but your doctor won’t prescribe a GLP-1?” reads a Facebook ad from a telehealth brand called Livelyhood, which started offering the drugs in April. “Livelyhood can.” 
    • “Another, called Quel, launched in September as an online extension of the off-label prescribing at a Pennsylvania-based addiction treatment center.” * * *
    • “Telehealth companies recognized the potential for opportunism in prescribing GLP-1s for addiction ahead of FDA approval, while maintaining that their platforms are the exception. And it’s not necessarily lucrative: “Economically, GLP-1 for alcohol use disorder is much tougher than pretty much any other GLP-1 indication,” said Lively. 
    • “If that’s the case, Witkiewitz wonders: Why not wait for an FDA approval? Klein and Lira said they look forward to prescribing new drugs if they are approved. But Witkiewitz worries that if early adopters see bad outcomes, patients could be deterred from seeking approved treatments in the future. “We’re so close to having this done right and well, or having it done in a way that protects patients to the best of our abilities,” she said. “Caution is warranted, and some patience is warranted.”

From the fraud, waste and abuse front,

  • Beckers ASC Review reports,
    • “Five physicians are among 15 defendants charged in a Los Angeles healthcare fraud takedown involving $2 billion in alleged fraudulent claims, according to an Oct. 22 news release from the U.S. Attorney’s Office for the Central District of California. 
    • “Most of that total comes from a $1.6 billion substance abuse treatment scheme that DOJ calls the largest of its kind it has ever prosecuted. The physicians’ cases make up a smaller share.”
  • The Wall Street Journal adds,
    • “A Southern California drug-rehab operator allegedly engaged in an elaborate scheme that involved providing recovering addicts with illegal drugs in order to keep billing their insurers for treatment, according to federal prosecutors. 
    • “Facilities associated with Nathan Young submitted more than $1.6 billion in claims to major health insurers and were paid over $210 million between 2020 and 2026, including billings for “non-existent and woefully inadequate ‘therapy’ sessions,” prosecutors said in a recently filed criminal complaint.
    • “Young and his father, David Young, were arrested last week. Lawyers representing the Youngs didn’t respond to requests for comment. The Youngs were charged with healthcare fraud and violating an anti-kickback statute, according to federal prosecutors.” 

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Forty-three percent of on-duty firefighter fatalities over the last 35 years were attributed to cardiac causes, according to a new study published in JACC: Advances.[1] These findings call into question the types of screenings firefighters should undergo to detect potential heart problems.
    • “Researchers at Cedars-Sinai Health Sciences University explored autopsy findings from more than 3,000 on-duty firefighter deaths. The group said the proportion of cardiac-related fatalities has steadily increased over the years However, cardiac related deaths have been on the decline for the general U.S. population over the same time period.  
    • “These findings might indicate the need to change annual health screenings for firefighters. Current national screening recommendations rely on exercise stress testing, which can identify ischemic issues with blood flow, but may miss hidden structural remodeling of the heart that could lead to sudden cardiac arrest.
    • “Our research shows there may be a blind spot when it comes to routine heart screenings for firefighters in the U.S.,” senior author Alan Kwan, MD, assistant professor of cardiology in the Smidt Heart Institute at Cedars-Sinai, said in a statement. “Identifying heart conditions when they can be treated is key to addressing these new findings.”
  • Health Day relates,
    • “Newly eligible younger adults are less likely to have discussed colorectal cancer (CRC) screening with their clinician compared with their older counterparts, according to a study published online Oct. 18 in the Journal of General Internal Medicine to coincide with the American Association for Cancer Research Conference on The Science of Cancer Health Disparities, held from Oct. 18 to 21 in Atlanta.” * * *
    • “This finding strongly suggests that patients who are newly age-eligible for screening are not receiving adequate information about their screening options from a health professional, and that could be contributing to low screening rates in this age group,” [lead researcher] Jordan Baeker Bispo, Ph.D., M.P.H. said in a statement.
  • and
    • “Smartphones are costing teenagers a good night’s sleep, a new study says.
    • “Teens who use their phones late into the evening suffer from delays in falling asleep, shorter total sleep time, and sleep that’s more restless and broken, researchers reported Oct. 19 in JAMA Pediatrics.
    • “These findings suggest that reducing evening smartphone use, particularly after 10 p.m. and immediately before bedtime, may help improve sleep health in adolescents,” concluded a team led by Dr. Dimitri Christakis, a professor of general pediatrics at Seattle Children’s Research Institute.”
  • Nature adds,
    • “The speed at which regions of the brain mature during early adolescence can forecast the emergence of mental-health conditions up to four years before symptoms develop, according to a study of nearly 12,000 young people in the United States.
    • “By tracking the brains of adolescents over six years in nearly 30,000 scans, researchers mapped how the brain’s outer layer, the cerebral cortex, thins as children grow into teenagers. The team observed that sensory areas of the cortex thinned, or matured, first, followed by the regions responsible for complex thought.
    • “The findings, posted on 11 October on the preprint server bioRxiv1 ahead of peer review, challenge the theory that psychiatric disorders are caused by defects in specific brain circuits. Instead, they indicate that vulnerability to mental-health symptoms could involve disruption of the brain’s developmental timeline and could be set in motion by genes that are active before birth.
    • “The work “provides one of the clearest pictures yet of how the cortex develops from childhood into adolescence”, says Avram Holmes, a systems neuroscientist at Rutgers University in New Brunswick, New Jersey, who was not involved in the study. “It makes you think about the timing of brain development, not just the location [in the brain], when we look at psychiatric symptoms,” he says.
  • Beckers Clinical Leadership informs us,
    • “Receiving a personalized mRNA-based cancer vaccine alongside immunotherapy lowered the risk of recurrence or death by 42% versus immunotherapy alone in a phase 3 clinical trial of patients with surgically resected stage 2B to 4 melanoma.
    • “The vaccine, called intismeran autogene and jointly developed by Merck and Moderna, was tested in combination with Merck’s immunotherapy Keytruda after surgery as part of the phase 3 INTerpath-001 trial, according to an Oct. 22 news release from the companies. 
    • “The trial results were leaked online Oct. 22, The Wall Street Journal reported, two days before Merck and Moderna were expected to present the data at the European Society for Medical Oncology conference in Madrid.” * * *
    • “Read the latest trial results from Merck and Moderna here.”  
  • Fierce Pharma points out,
    • “Delaying the use of subcutaneous Parkinson’s disease treatments by one year increases annual medical costs by 59.1%, AbbVie-sponsored research found.
    • “The study, which researchers will present (PDF) at the AMCP Nexus Conference this month, modeled the impact of delaying the initiation of two subcutaneous therapies by one year. One therapy comprised foslevodopa and foscarbidopa, the combination that AbbVie sells as Vyalev. The other therapy featured apomorphine, the active ingredient in Supernus Pharmaceuticals’ Onapgo.” 

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

  • The Wall Street Journal reports,
    • “A KFF survey shows the average cost of a family health plan rose 5% this year, while workers’ contributions increased 9% to $7,471.
    • “Employers are facing healthcare cost increases driven by high-cost drugs and hospitals raising prices and using AI tools to boost billing.
    • “To manage rising costs, some employers are increasing workers’ premium contributions, raising deductibles and dropping coverage for GLP-1 drugs.”
  • Beckers Payer Issues relates,
    • “Molina Healthcare reported $38 million in net income for the third quarter of 2026, a 52% year-over-year drop from $79 million.
    • “The insurer attributed the decline mainly to a higher consolidated medical loss ratio, which was  92.9% in Q3, up from 92.6% a year earlier. Total revenue for the quarter was $11.1 billion, down 3.4% year over year. Premium revenue fell approximately 4% to $10.5 billion, reflecting lower membership in Medicaid and the ACA marketplace, partially offset by rate updates.
    • “With the apparent plateauing of medical cost trend, which remains at elevated levels, and the strength of recent rate updates for 2027, we believe we are likely observing the beginning of the turn in Medicaid margins,” President and CEO Joseph Zubretsky said in an Oct. 21 news release.”
  • and
    • “Medicare Advantage annual enrollment kicked off Oct. 15, and the ACA open enrollment period is around the corner. Employers are also navigating cost pressures, opening the door to innovative plans.
    • “Insurers have been primed to consider new health plans across commercial and government programs, and many are biting.
    • “Not every organization rolling out health plans in the coming years is a traditional insurer, however. For example, Tacoma, Wash.-based MultiCare Health System and the Muscogee (Creek) Nation are entering the MA market.
    • “The trend has extended to the employer space. Tech-enabled healthcare company Included Health said it will introduce health plans for self-insured employers Jan. 1, 2028, following its acquisition of Firefly Health, a clinically integrated health plan and advanced primary care company. Health technology and benefits administration platform Judi Health is launching a Medicare Part D Employer Group Waiver Plan, as well.”
  • Fierce Healthcare tells us,
    • “Redesign Health is making a major push deeper into health system-led innovation, merging with Sheba Medical Center’s innovation arm ARC Global.
    • “Together, the organizations want to create an end-to-end platform that helps health systems turn ideas originating with their own clinicians and operators into technology products and standalone companies that can then be scaled across a global network, company executives said. The deal was announced Thursday.
    • “The combined company is valued at approximately $2 billion, according to a source with knowledge of the deal.”
  •  and
    • “Talkiatry is expanding virtual therapy services nationwide as part of a broader push to provide comprehensive behavioral health services across the acuity spectrum, from low to high.
    • “As a national mental health practice that provides in-network psychiatry and therapy, the expansion also positions the company to offer broader behavioral health services to health systems, payers and employers.
    • “The company initially built its scale around telepsychiatry, with more than 800 employed psychiatrists and a large national insurance footprint. Talkiatry claims to be the nation’s largest private employer of psychiatrists as well as the preferred in-network psychiatry partner for more than 70 U.S. health systems.”
  • Per MedTech Dive,
    • “Labcorp said Tuesday that it has agreed to acquire Myriad Genetics’ prenatal health testing business for $210 million.
    • “The deal covers tests for assessing fetal risk of certain conditions and other aspects of prenatal care. Labcorp expects the tests to add about $160 million in revenue in year one. 
    • “Evercore ISI analysts see room for Labcorp to improve the economics of the acquired business using its infrastructure and to broaden access to the tests through its provider relationships.”
  • SmartBrief informs us,
    • “AI is making medical information easier to access.  According to a recent KFF poll, nearly a third of US adults have used AI for health information or advice in the past year, and nearly 1 in 5 have used it to compare treatment options.
    • “The appeal is clear. People can ask health questions in their own words and get answers almost immediately. But receiving an answer and knowing how and when to use it—and whether they can rely on it—are different things.
    • “Health plans will see an increasing number of members using AI to evaluate their care options. That reality creates a need for plans to fill in the gaps of today’s AI capabilities.”
    • The article identifies pathways.
  • Beckers Health IT adds,
    • “Microsoft’s AI diagnostic system correctly diagnosed 83.2% of complex New England Journal of Medicine cases, compared with 36.1% for generalist physicians, according to a study published Oct. 22 in Science.
    • “The system, called Diagnostic Orchestrator, or DxO, simulates a panel of physicians. It starts from a brief clinical presentation, then asks questions, orders tests and revises the differential diagnosis step by step. Microsoft researchers tested it on 304 NEJM clinicopathological conference cases and 325 emergency department admissions from the MIMIC-IV-ED dataset.
    • “On the emergency cases, DxO running OpenAI’s GPT-5 reached 80.3% accuracy, compared with 46.8% for physicians.
    • “The researchers also tracked estimated testing costs, using the chargemaster of Kaiser Permanente Washington’s Central Hospital in Seattle. With no budget limits, DxO averaged $5,431 per complex case. With budget constraints, it hit 80.9% accuracy at $2,241. Physicians using search and reference tools averaged $4,725.” * * *
    • “Microsoft plans to evaluate DxO in real-world settings through a partnership with Beth Israel Deaconess Medical Center in Boston, TechCrunch reported Oct. 22.”

Midweek update

David Ermer–ACA, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Mental health care, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Oct. 21 announced that Amazon, Axon Enterprise, Inc., Google, Meta and Oracle Corp. are in support of its prior authorization pledge announced last year. The pledge involves streamlining prior authorization processes and increasing transparency for patients and providers by 2027. The AHA recently launched a new website on prior authorization, containing prior authorization news and resources. The website will be updated with additional resources and guidance as they become available.”
  • and 
    • “The AHA submitted comments to the Centers for Medicare & Medicaid Services Oct. 21 on its preliminary calendar year 2027 Medicare clinical laboratory fee schedule rates. The AHA said the preliminary rates highlight the need for substantial reforms to CMS’ methodology, saying they are based on incomplete data. The AHA discussed the requirement under the Protecting Access to Medicare Act that called for hospital outreach laboratories and other clinical laboratories to report their private payer data to CMS between May 1 and July 31, 2026. Only 2% of laboratories paid under Medicare Part B reported any information at all to CMS. The AHA noted there was widespread confusion among laboratories that did report their data regarding whether they were suitably qualified as “applicable laboratories” and what data they needed to report. The AHA expressed concerns that the underreporting means CMS’ preliminary 2027 rates do not reflect the “market-based payments” that Congress mandated under PAMA, resulting in substantial proposed cuts to Medicare CLFS reimbursement for hundreds of codes. The AHA said these cuts threaten seniors’ access to essential clinical laboratory testing and continued investment in diagnostic innovation.
    • “The AHA also said it was concerned that CMS’ approach to collecting applicable private payer information directly from clinical laboratories is inadequate for setting fully “market-based” rates. To help address these concerns, the AHA urged CMS to provide support and technical assistance to Congress as it considers the Reforming and Enhancing Sustainable Updates for Laboratory Testing Services (RESULTS) Act of 2025, which consists of efforts designed to improve private payer data collection by CMS to set Medicare Part B CLFS rates.” 
  • Healthcare Dive relates
    • “Some major insurers in the Affordable Care Act exchanges are expanding into new counties for 2027, even as many of their peers run for the exit amid ongoing cost and policy turbulence.
    • Centene, the largest ACA insurer in the U.S., is expanding into 55 additional counties in Alabama, Iowa, Illinois, Louisiana, Michigan, New Jersey and Texas next year; while Oscar Health, one of the fastest-growing carriers in the exchanges, is adding 140 new counties, including by entering South Carolina for the first time.
    • “The changes, announced in press releases Tuesday, show a continued bet on the ACA among some major participants in the exchanges, which may see a growth opportunity as their competitors downsize and leave their members looking for new carriers.”

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

  • FedSmith explains “Prescription Drug Coverage: What Every Federal Employee Should Check.”
    • Learn how to save on FEHB prescription costs by reviewing your medications, checking formularies, and comparing mail-order and retail pharmacy options.
  • FedWeek reports,
    • “More than a year after creating the deferred resignation program—and enticing some 140,000 persons to leave federal employment under those offers last year—the Trump administration has formally put it into regulation.
    • “A notice in the October 19 Federal Register finalizes rules proposed in June giving agencies broad authority to use extended periods of administrative leave, formerly typically limited to only a few days or even hours, for that purpose. The rules also authorize putting employees on that form of paid leave—also called excused absence—between receiving a RIF notice and the RIF separation date, and “to facilitate the voluntary resignation of employees with documented poor performance or misconduct” under a settlement agreement.
    • “They also clarify certain technical aspects of deferred resignation offers, including specifying that agencies have sole authority over whether to grant an employee’s request to withdraw acceptance of such an offer.”

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

  • Fox 10 News in Mobile, Alabama, reports,
    • “The FDA issued its highest-risk warning for a California-based company amid concerns over a multistate cheese E. coli outbreak.
    • “The Class I classification applied to all affected Graziers raw milk cheese products manufactured by California-based Sierra Nevada Cheese Company, including Monterey Jack, jalapeño jack, medium cheddar and sharp cheddar varieties, according to a press release. 
    • “The affected products were distributed in Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, New Jersey, Oregon, Texas, Washington and Wisconsin.
    • “Investigators said 13 people in nine states became sick. More than half of those infected were children age 5 and younger.”
  • Health lets us know,
    • “Check your medicine cabinet: More than 4 million tubes of toothpaste have been recalled nationwide. According to the Food and Drug Administration (FDA), the toothpaste was initially recalled on Sept. 10 over deviations from Current Good Manufacturing Practice (CGMP), which ensures the identity, strength, quality, and purity of drugs. On Monday, the FDA gave the recall the second-highest risk level, Class II, for the possibility of temporary or reversible health effects.”
  • Per a company news release,
    •  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for use of the oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg ORLADEYO pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. 
    • With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered ORLADEYO for prophylaxis to prevent attacks of HAE [hereditary angioedema] in either capsule or pellet formulation. The ORLADEYO pellet formulation is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.
  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has cleared Elucid’s FFR-IQ software for the noninvasive estimation of fractional flow reserve from coronary CT angiography (FFR-CT). The artificial intelligence (AI)-based technology incorporates coronary anatomy and plaque composition into its estimation of coronary physiology to provide more accuracy.
    • “Plaque composition, coronary anatomy and physiology are closely connected,” Amir Ahmadi, MD, clinical associate professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai and Elucid’s lead scientific advisor, said in a statement. “BioIntegrated FFR-CT incorporates anatomy and plaque characteristics into the physiological estimate itself. Together with plaque assessment, this approach can help physicians evaluate the significance of an individual lesion while also addressing the patient’s broader atherosclerotic disease and need for preventive treatment.”
    • “Elucid said physicians told the company they want a more accurate FFR-CT algorithm that considered other factors that could impact hemodynamics; this newly approved algorithm does just that.
    • “Elucid is now the third vendor to offer FFR-CT commercially in the U.S., following prior approvals by Heartflow in 2016 and KeyaMed in 2022. Other vendors are also developing their own versions of FFR-CT. Interest in the technology has also increased rapidly recently as coronary CT angiography (CCTA) continues to rapidly gain momentum among care teams.”

From the judicial front,

  • The American Hospital News reports,
    • “The U.S. District Court for the District of Maine should deny motions by several drug companies and Pharmaceutical Research and Manufacturers of America to intervene in the lawsuit challenging the administration’s revised 340B rebate model, the AHA and its co-plaintiffs argued in a filing submitted Oct. 21.
    • “The AHA and plaintiffs noted that the court previously rejected similar intervention requests in litigation over an earlier version of the 340B rebate model, finding that the federal government could adequately defend its own policy.
    • “The AHA, Maine Hospital Association and four safety-net hospitals filed suit Oct. 9 to stop the revised rebate program, arguing that it would impose more than $1 billion in annual administrative costs on hospitals and divert resources away from patient care. The lawsuit seeks to prevent implementation of the program, which is scheduled to take effect Jan. 1, 2027.” 

From the fraud, waste, and abuse front,

  • The AP reports,
    • “President Donald Trump and Vice President JD Vance on Tuesday announced a $25 million program to encourage the public to blow the whistle on suspected fraud in the U.S. government as they ramp up efforts to end the abuse of federal programs and dollars.
    • “The White House said that under the Fraud Whistleblower Incentive Program, anyone who submits a tip that leads to a fraud conviction or a significant federal enforcement action is eligible to receive up to $30,000, and that the Justice Department will administer the program.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “[S]ome experts in health communication believe the time has come to reconsider the way government agencies communicate to the public about the [measles] virus. Yes, measles can be deadly, they say, but counterintuitively, health officials would have more success if their messaging clearly confirmed what many parents already know: Most children will survive.
    • “Public health agencies and experts should say forthrightly that for most healthy children measles is an unpleasant, self-limited illness from which they recover completely,” Peter Sandman, a retired risk communication expert formerly at Rutgers University, said in an email. “It has to be said repeatedly and emphatically.” 
    • “Public health experts STAT spoke to emphasized that there are many downstream health issues that could befall children who are infected with measles, and that vaccines are crucial and safer than trying to build immunity through exposure to the disease. But saying most children recover could ultimately build trust.”
  • NBC News adds,
    • “The Pennsylvania Department of Health issued an alert Monday to doctors about an increase in measles infections in pregnant women, as well as a concerning rise in congenital measles — a disease that’s rarely, if ever, seen in the U.S. 
    • “The department said that 66 pregnant women in Pennsylvania had been diagnosed with measles since the state’s outbreak began in April. “Getting measles while pregnant increases the risk of miscarriage, early labor, and low birth weight,” a department spokesperson said in an email.” 
  • Per MedPage Today,
    • “Children who started the two-dose human papillomavirus (HPV) vaccine series at age 9 or 10 years were more than twice as likely to get both shots versus those who began later, a cluster randomized trial showed.
    • “Across 31 U.S. pediatric practices, kids who were recommended to receive HPV vaccination starting at age 9 or 10 had better initiation and completion rates by age 13 versus those who received vaccination starting at age 11 or 12:
      • Initiation rates: 77.1% vs 67% (adjusted HR 2.52, 95% CI 1.93-3.27)
      • Completion rates: 61.6% vs 45.1% (aHR 2.85, 95% CI 2.12-3.83)
    • “What our data show is that the age at which families first hear about the HPV vaccine recommendation changes how many children are protected, and how soon,” said Sean O’Leary, MD, MPH, of the Children’s Hospital Colorado Anschutz Medical Campus in Aurora, during a press briefing ahead of the IDWeek annual meeting. “For clinicians who now start at 11 or older, we would suggest at least considering earlier introduction in their offices.”
  • The New York Times relates,
    • “In the United States, rabies can seem like a disease of the past, a remote risk caused by a mostly vanquished virus. But in recent months, this ancient foe has returned to the spotlight.
    • “A handful of unusual outbreaks have made headlines: rabid beavers at a Maryland state park, a cluster of goat cases at a North Carolina petting zoo. Officials in several states, including Idaho and Alabama, flagged surges in animal cases; California set an annual record for rabid bats.
    • “And last month, the Centers for Disease Control and Prevention issued a national health advisory, citing reports of “local increases in human rabies exposures.” The agency reported an uptick in the use of medical interventions — antibody treatments and vaccines — designed to protect people exposed to potentially rabid animals.
    • “So far, no human rabies cases have been reported in 2026. And it’s unclear whether the reported surges reflect a real increase in rabies risk. But they are worth keeping a close eye on, experts said, and highlight the persistence of rabies as a complex, ever-evolving threat.”
  • Beckers Clinical Leadership points out how this season’s flu cases compare to past seasons.
    • “As of early October, the rate of outpatient visits for flu-like illness was tracking as the third-highest since 2010. In the week ending Oct. 10, about 2.1% of outpatient visits were for respiratory illness — up from 1.6% during the same week last season, CDC data shows. This marks the third highest weekly rate behind the 2022-23 season (2.5%) and the 2023-24 season (2.4%). The CDC classified both of these seasons as moderately severe.”
  • Beckers Behavioral Health notes,
    • “States that legalized online sports betting saw increases in antidepressant and anti-anxiety medication use, along with outpatient diagnoses of depression and anxiety, a study published Oct. 14 in JAMA Psychiatry found.
    • “Researchers at the Baltimore-based Johns Hopkins Bloomberg School of Public Health analyzed employer-sponsored health insurance claims from January 2016 to December 2023. The study compared 22 states that legalized online sports betting between 2018 and 2022 with 13 states that had not legalized it by the end of 2023.
  • Health Day tells us,
    • “More teen girls are vaping than boys.
    • “About 7.8% of teen girls vape compared to 4.6% of boys.
    • “Less than half of 1% of all teens smoke cigarettes.”
  • and
    • “Black children’s race may put them at greater risk for a more severe form of asthma.
    • “Black kids are nearly three times as likely to suffer from T2-high asthma as white kids.
    • “This increased risk comes regardless of environmental or social factors like neighborhood air quality or family income, researchers say.”
  • Per BioPharma Dive,
    • “A Roivant subsidiary will ask regulators to approve a new indication for its anti-inflammatory medicine brepocitinib after posting successful results in two Phase 3 studies in an eye condition called non-infectious uveitis that can lead to blindness.
    • “In the trials, known as Clarity-1 and Clarity-2, patients were able to last for a median of more than 48 weeks before “treatment failure,” a measure of eye inflammation and other markers, compared with 12 weeks for those on a placebo. The brepocitinib patients also went 40 weeks without needing immunosuppressive steroids, setting a new bar in treating the disease. And the drug succeeded on every secondary endpoint, including resolving macular edema, the company said Wednesday.
    • “The Roivant unit, Priovant Therapeutics, already has Food and Drug Administration approval to sell brepocitinib under the brand name Lisraya to treat adults with the skin disease dermatomyositis. Priovant now plans to submit a supplemental application to expand the medicine’s use in the first half of next year.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Elevance Health ELV lifted its guidance for the year again after higher premium yields and pharmacy growth drove profit and revenue higher, offsetting a drop in membership.
    • “The health-insurance company on Wednesday said it now expects earnings per share of at least $22 for 2026, up from the prior $20.10. Adjusted earnings per share is now seen at $29 or higher, up from previous guidance of at least $27 a share.
    • “Analysts expect adjusted earnings of $27.26 a share for the year, according to FactSet.” * * *
    • “The company said it benefited from higher premium yields, increased product revenue from its pharmacy benefit manager CarelonRx, and growth in service fees.
    • “The benefit-expense ratio, a closely watched metric that compares health costs with premium revenue, improved by 70 basis points to 90.6%, driven by better performance in Medicare Advantage and individual Affordable Care Act plans.”
  • Beckers Payer Issues adds,
    • “Newly enabled competition between Blue Cross Blue Shield plans is continuing to contribute to Elevance Health’s commercial insurance business, leadership said on the company’s quarterly earnings call Oct. 21.
    • “Dubbed the “second blue bid,” the provision stems from a $2.67 billion settlement that resolved class action allegations dating back to 2012 that BCBS plans conspired to divide up markets to avoid competing with one another. The settlement eliminated a rule that required large employers to work with the BCBS plan covering their headquarters’ geography, thereby allowing certain national accounts to solicit bids from a competing Blues plan.
    • “Elevance, which owns 14 BCBS companies, said in January that it won nine of 11 second blue bid accounts in its first year competing under the provision. Morgan Kendrick, the company’s president of commercial and specialty health benefits, said on the third quarter earnings call that second blue bid opportunities have also been a component of its 1.7 million-member national accounts pipeline for 2027. 
  • and
    • “Elevance named Jeff Park as president of healthcare services subsidiary Carelon, effective Dec. 1. Mr. Park was most recently president of health technology company Waltz Health. Along with other healthcare leadership roles, he previously served as COO of pharmacy benefit manager Optum Rx, according to his LinkedIn profile.” * * *
    • “Carelon revenue grew 5.4% year over year, reaching $19.3 billion for the third quarter. This was spurred by CarelonRx product revenue and further expansion of Carelon Services risk-based solutions. Carelon’s operating margin was 4.7%, up from 4.2% in third-quarter 2025.
    • “CarelonRx’s operating gain was $616 million for the quarter, up 10.8% year over year. Its operating margin grew to 5.3%, up 20 basis points from the same period last year.”
  • and
    • “Horizon Blue Cross Blue Shield of New Jersey has agreed to acquire multispecialty physician group Summit Health’s New Jersey operations, including CityMD urgent care sites in the state, the insurer confirmed to Becker’s.
    • “We are excited by the opportunity to preserve access to high quality care for all of Summit Health’s patients, improve healthcare quality and affordability for our members, and to support the continued independence of Summit Health’s physicians and clinicians for the benefit of New Jerseyans,” a Horizon spokesperson said Oct. 21.
    • “The deal is subject to regulatory review and financial terms were not disclosed. Summit operates more than 120 locations across New Jersey, New York and Connecticut, while CityMD operates more than 180 urgent care centers across the three states.” 
  • Fierce Healthcare relates,
    • “Kaiser Permanente’s Risant Health has tapped Oklahoma’s largest nonprofit provider as the next to join its growing cadre of regional health systems.
    • “Integris Health and the nonprofit value-based care platform announced Wednesday their signed definitive agreement, which is subject to regulatory review but could close in early 2027. Financial terms were not disclosed. 
    • “The deal would make Integris the third regional health system to join Risant, following Pennsylvania’s Geisinger Health and North Carolina’s Cone Health, both deals that closed in 2024.”
  • and
    • “Alcon—the eye-focused pharma spun out of Novartis—is handing over $550 million to buy outNeurotech Pharmaceuticals, its encapsulated cell therapy platform and commercial medicine Encelto.
    • “Encelto, greenlit in March of 2025, is the first and only FDA approved therapy for macular telangiectasia type 2, a rare and progressive type of central vision loss. So far, the drug is only available in the U.S., where Neurotech estimates there are 25,000 MacTel patients and 2,000 to 3,000 new diagnoses each year. Through the merger, Alcon will now endeavor give the drug-device combo a more global reach, the pharma said in a statement. 
    • “Neurotech will also bring the tech behind Encelto to Alcon. The biotech’s encapsulated cell therapy approach pairs a surgically placed implant with cells that have been genetically engineered to produce therapeutic proteins. In the case of Encelto, the implant continuously releases recombinant human ciliary neurotrophic factor (rhCNTF), a protein that can travel to the retina and protect the photoreceptors—cells that are implicated in MacTel vision loss.” 
  • The Wall Street Journal informs us,
    • “Abbott ABT Laboratories plans to separate its nutrition business into an independent company by the end of next year, distancing itself from an embattled unit that has dragged down earnings and been the subject of years of litigation.
    • “The newly created company, set to house brands including Pedialyte electrolyte beverages and Similac infant formula, is expected to generate about $8.5 billion in annual sales.
    • “Chief Executive Robert Ford said the separation will allow both companies to sharpen focus and direct resources more effectively. Abbott will dial in on its core portfolio, which includes higher-growth categories such as medical devices and diagnostics, while the nutrition company will aim to capitalize on growing demand in the global nutrition market.
    • “We believe both businesses will be better positioned for the future as independent organizations,” Ford said on a call with analysts.”
  • Beckers Hospital Review lets us know,
    • “There are more than 400 birth centers in the U.S., and the number varies widely by state, from 92 in Texas to none in 10 states, according to Oct. 15 data the American Association of Birth Centers shared with Becker’s. Six states and the District of Columbia have one birth center.
    • “The count includes all birth centers known to the association, said Kate Bauer, executive director of AABC. She said state differences stem from factors such as state regulations, the midwifery workforce, insurance reimbursement and other elements that affect sustainability.
    • “An Oct. 20 Commonwealth Fund report on freestanding birth centers found that birth center births accounted for 0.62% of U.S. births in 2024, up from 0.23% in 2004, though access varies widely by state.”
  • Per Radiology Business,
    • “Capitol Imaging Services is expanding in South Florida with the acquisition of four outpatient centers. 
    • “The private equity-backed, Houston-based radiology group is buying Impression Imaging for an undisclosed sum, the two announced Tuesday. Capitol said the move establishes a strong presence in the Sunshine State and “marks an important step” as the group expands into molecular imaging and theranostics. 
    • “Founded in 2012 by physicians, Impression Imaging operates Florida locations in the communities of Tamarac, Pembroke Pines, Boca Raton and Coral Springs. 
    • “The addition of Impression Imaging to the Capitol Imaging Services network aligns perfectly with our mission to provide patients and physicians with the highest quality screening and advanced diagnostic imaging services,” John Stagg, CEO of Capitol Imaging, said in an announcement Oct. 20. “This acquisition expands our presence in Florida while strengthening our commitment to bringing cutting-edge imaging technology, precision diagnostics and greater patient access to every medical community we serve.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
  • Simplicity is a virtue.

From Washington, DC

  • The American Hospital Association News reports,
    • “The AHA Oct. 20 expressed support for the Addressing Boarding and Crowding in the Emergency Department (ABC-ED) Act (S. 1974), bipartisan legislation designed to improve data collection on hospital capacity and ED boarding. The bill is sponsored by Sens. Chris Coons, D-Del., and David McCormick, R-Pa. In its letter to the bill’s sponsors, the AHA emphasized that the causes of ED boarding and crowding are complex and have become persistent and growing challenges for hospitals and health systems nationwide.”
  • Beckers Payer Issues relates,
    • “A newly introduced House bill is targeting the methodology behind Medicare Advantage star ratings, adding more pressure to a program that has seen years of litigation from insurers.
    • “The Medicare Advantage Strengthening Transparency and Accountability in Rating Systems Act, or MA STARS Act, was introduced Sept. 21 by Rep. Mike Kelly, R-Pa., and would direct the federal government to rewrite star ratings policy beginning with the 2031 contract year.
    • ‘Under the bill, CMS would have to exclude any measure that is unrelated to clinical quality, outcomes or experience, or is not reasonably attributable to the actions of the plan and its delegated entities, such as contracted providers and subcontractors. Measures built on enrollee surveys would also be excluded if the survey has more than 10 questions, fails to draw responses from a diverse group, or misses minimum response and sampling standards set by HHS.
    • “Measures that no longer distinguish performance among most contracts would also come out of the calculations, while new measures could be added only if they relate to clinical quality, outcomes or experience.”
  • and
    • “As Medicare Advantage faces concerns regarding plan oversight, possible overpayments and care access, RAND researchers assembled experts to unpack potential reforms.
    • “Published in Health Affairs Oct. 5, the study consisted of two rounds with nearly 40 panelists. They rated 15 policy reform ideas on a nine-point scale. These ideas had high-level framing and were drawn from panelist suggestions and published research. The policy list was updated between the two rounds.
    • “While none of the proposed policies were found to simultaneously benefit all stakeholders — beneficiaries, plans and the government — the researchers identified the three “most feasible near-term reforms” that would benefit beneficiaries while not harming health plans and the government. These are standardizing supplemental benefits, limiting the number of plans an insurer can offer and reforming agent commissions.”
  • Medical Daily tells us,
    • “A senior federal health official has acknowledged that Medicare’s experiment with AI-assisted prior authorization is falling short. “There are a lot of things about WISeR that are not working,” Centers for Medicare & Medicaid Services (CMS) Deputy Administrator Kimberly Brandt said Oct. 15 at a conference in Santa Fe, New Mexico, Nextgov/FCW reported.
    • “The admission matters most for people with Original Medicare in the six states where the test runs: Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington.
    • “For older adults and their caregivers, the main issue is time. When a needed procedure waits on approval, pain, wound healing, and mobility can all suffer. Knowing how the system works can help families push for faster answers.”
  • Per Health and Human Services Department news releases,
    • “The U.S. Department of Health and Human Services (HHS) today launched the Kidney Care National Plan, a coordinated department-wide strategy focused on revitalizing American kidney care.
    • “As part of the Make America Healthy Again initiative, the new Kidney Care National Plan will address the root cause of disease and implement better treatments for Americans at every stage of kidney disease. The Plan identifies where federal action can improve kidney care across the entire spectrum of kidney disease, eliminate regulatory barriers to support innovation and a well-functioning kidney market, and deliver greater choice and superior outcomes to Americans.
    • “President Trump changed the course of kidney care in 2019 by challenging a system that waited for patients to reach kidney failure,” said HHS Secretary Robert F. Kennedy, Jr. “Now HHS is building on that work by detecting kidney disease earlier, expanding treatment and home-care options, removing barriers to innovation and transplantation, and strengthening safety across the transplant system. Our goal is simple: preserve kidney health, give patients more choices, and help more Americans avoid kidney failure and live longer, healthier lives.”
    • Link to the Kidney Care National Plan Fact Sheet
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced seven awards through its new Sickle Cell Disease Regional Care Excellence (SoRCE) Program. The awards establish Regional Coordinating Hubs to help people with sickle cell disease access high-quality care and community services closer to home.
    • “Americans living with sickle cell disease should not have to travel long distances or overcome unnecessary barriers to receive effective care,” said HHS Secretary Robert F. Kennedy, Jr. “Early treatment can prevent serious complications and help patients live healthier lives. The Trump Administration is expanding access to proven treatments and specialized care so more patients can get the support they need in the communities they call home.”
    • “Approximately 100,000 people in the United States live with sickle cell disease. Early and ongoing treatment can prevent or reduce serious complications, yet many people face barriers to preventive care, specialty services, and disease-modifying therapies. The SoRCE Program aims to improve access and quality of care while tracking indicators of quality of life.” * * *
    • “See the FY 2026 SoRCE Program award recipients.”

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

  • FedScoop has named OPM Director Scott Kupor one on its 11 FedScoop 50 2026 Golden Gov: Federal Executives of the Year. Congratulations Director Kupor.
  • Director Kupor added to his Secrets of OPM blog a post titled Free is Good which concerns open source software and super intelligence efforts.
  • The ABA Banking Journal reports,
    • “As the Office of Personnel Management considers possible changes to federal employee health benefits, it should create more opportunities for employees to select health savings account-qualified, high-deductible health plans, the American Bankers Association HSA Council said in a letter to the agency.”

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

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance ends longstanding uncertainty by providing recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug’s official label, and what companies should submit to the agency.
    • “Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Captain Chris Wheeler, Pharm.D., Director of the Division of Medical Policy Programs within FDA’s Center for Drug Evaluation and Research. “This guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers.”
    • “The guidance addresses three key questions for industry: when app content is treated as FDA-required labeling versus promotional labeling, when an app should be referenced in a drug’s official prescribing information, and what companies should submit to FDA when they distribute app content to users.”
  • and
    • “The U.S. Food and Drug Administration yesterday approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week. The approval aligns with FDA’s Public Health Pillar: Increasing Access to Affordable Medicines & Medical Products.
    • “Menopause is a universal experience for women, and it can greatly affect a person’s quality of life. This approval makes effective treatment more accessible,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Approvals like this reflect FDA’s ongoing commitment to expanding American patient access to safe, affordable, high-quality medications.”
    • “The generic estradiol and levonorgestrel transdermal system is therapeutically equivalent to Climara Pro, which is indicated for use in women with an intact uterus for:
      • “Treatment of moderate to severe vasomotor symptoms due to menopause
      • “Prevention of postmenopausal osteoporosis.”
  • and
    • “The U.S. Food and Drug Administration today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis. Hibsago is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B. Hibsago is approved for certain adults without cirrhosis who have been taking HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test. 
    • “For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, Acting Director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research. “Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 20 published two qualifying payment amount audits under the No Surprises Act. The audits were of CareSource in Indiana and the School Employees Retirement Systemin Ohio, with both required to complete corrective actions following the audits. The CareSource audit focused on almost 25,000 claims, primarily concerning emergency and non-emergency services, while the School Employees Retirement System audit focused on six air ambulance claims. Both audits were conducted between Jan. 1, 2022, and May 31, 2023.”

From the fraud, waste and abuse front,

  • The Oklahoma Voice reports.
    • “Oklahoma’s Medicaid payment error rate is well below the national average, according to the agency that administers the program. 
    • “Oklahoma’s “improper payment rate” for Medicaid, also known as SoonerCare, was 0.15% in 2025 compared to the national average of 6.12%, according to the Oklahoma Health Care Authority.” * * *
    • “Oklahomans expect every taxpayer dollar to be spent the right way, and we hold ourselves to that standard,” said Aaron Morris, interim CEO of the Health Care Authority, in a statement. “We are continuously enhancing our tools to ensure Medicaid dollars are preserved and available to fund services for Oklahomans in need.”
    • “In 2022 Oklahoma’s Medicaid program had not yet made the switch to managed care, but overall, the state’s Medicaid error rate was 1.95%, the second lowest rate in the nation. * * *
    • “In the three years since the last review, the agency worked on “rigorous staff quality control and enhanced data integrity,” said Rebecca Sheppard, a spokesperson for the Health Care Authority. 
    • “The Health Care Authority is “continually adapting its strategy” to combat fraud through firewalls, automated application screenings and data validation exchanges with partners like Equifax, according to a news release. 
    • “OHCA’s broader plan to protect program integrity combines strict provider credentialing and revalidations of high-risk providers with targeted post-payment audits that verify medical necessity and proper documentation,” according to a news release.” 

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Flu season is off to an unusually early start, with wastewater surveillance, emergency department data and local health departments from Virginia to California all indicating increased virus activity. 
    • “An earlier-than-usual rise does not guarantee a worse season, but on nearly every surveillance measure — and in a growing list of states — the virus is proliferating.
    • “Thirty-eight states are seeing a “high” level of influenza A in wastewater, according to Wastewater SCAN, a dashboard developed by Stanford (Calif.) University. The 12 states still at a “low” level are clustered in the Midwest: Kansas, Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, Nebraska, North Dakota, South Dakota and Wisconsin.” * * *
    • “Officials across states are urging residents to get vaccinated by the end of October, noting the shot takes about two weeks to take full effect. El Paso County, Colo., is “seeing an earlier rise in higher numbers of flu,” public health official Haley Zachary told CBS affiliate KKTV, after the state reported its first pediatric flu death of the season. In Kentucky, where cases are running above last year’s level, EDs are already treating flu-like illness earlier than usual, CBS and The CW affiliate WKYT reported.”
  • Health Day relates,
    • “Food sensitivity appears to change as a child ages
    • “More kids become sensitive to food allergens as they grow older
    • “Peanut is an early and persistent allergen, but others become prominent by age five.”
  • and
    • “Epilepsy is strongly associated with young-onset dementia (YOD; age younger than 65 years), according to a study published online Oct. 14 in Neurology.”
  • Radiology Business tells us,
    • “Despite anxiety pertaining to the exam, many breast cancer survivors report high confidence in contrast-enhanced mammography (CEM) and would recommend it to other survivors as part of their post-treatment surveillance plan. 
    • “Survey findings published in Insights Into Imaging are offering new insight into how patients feel about having to complete CEM exams for monitoring purposes after cancer treatment. In recent years, the exam has emerged as a promising alternative to digital mammography, which has limited sensitivity in post-op patients.” 
  • Cardiovascular Business informs us,
    • “Researchers with NYU Langone Health may have identified a new way to predict heart transplant rejection without the need for an invasive biopsy. Their findings were recently published in the Journal of Heart and Lung Transplantation.[1]
    • “The study combined blood biomarkers with electrocardiogram (ECG) heart rhythm recordings into an artificial intelligence (AI) model and then compared the results directly against the gold-standard myocardial biopsy results. The team found the AI accurately identified when a transplant patient’s body starts attacking a donated heart.”
  • and
    • “Advanced artificial intelligence (AI) models can anticipate when older heart failure patients may start to experience functional decline, according to new findings published in the Journal of Cardiac Failure.[1]
    • “Researchers explored data from more than 6,000 patients 65 years old or older who were hospitalized for heart failure and prescribed rehabilitation. The median age of the cohort was 82 years old. An advanced machine learning model was then developed capable of evaluating a patient’s one-year risk of experiencing functional maintenance, functional decline or death. Functional decline was specifically defined as anyone who transitions to a housebound/ bedridden lifestyle due to their health.” 
  • Healthcare IT News adds,
    • “The relationship between clinicians and clinical knowledge is changing, according to a new JAMA study that suggests a “growing share of knowledge access is shifting from recall to retrieval.” 
    • “Researchers also say by characterizing the scale, distribution and clinical content of clinician-AI interactions, their findings fill an evidence gap needed to further frameworks that properly evaluate and guide AI use in clinical practice.” * * *
    • A significant number of medical practitioners are using AI in the clinic to explore treatment options for their patients in areas outside their clinical specialty, said Harvard in announcing the findings of what it’s calling the “first large-scale study of how often clinicians use artificial intelligence tools in patient care.”
    • “Harvard Medical School and Brigham and Women’s Hospital – along with researchers from Seattle Children’s Hospital, New York University’s Grossman School of Medicine, Massachusetts General Hospital and the National Bureau of Economic Research in Cambridge, Massachusetts – analyzed two-and-a-half years of OpenEvidence usage data. 
    • “The goal was to understand what types of clinicians are making queries, and how they are using the AI-driven findings. 
    • “Among 950,000 clinicians who submitted more than 270 million queries of artificial intelligence over a two-and-a-half-year period, queries were highest for nurse practitioners, followed by physician assistants and physician residents and fellows, according to the report, published Oct. 15.
    • “Use of clinical AI was also higher among physicians in oncology/hematology, internal medicine and family medicine and lower among those in ophthalmology, radiology, orthopedics and anesthesiology, said researchers from Boston-based Mass General Brigham in an email to Healthcare IT News.” 
  • BioPharma Dive points out,
    • “An experimental pill from Boston-based Rapport Therapeutics narrowly succeeded in a mid-stage study focused on bipolar mania, an outcome that analysts described as unexpected and a potential stepping stone to a billion-dollar-plus market.
    • “Rapport’s study enrolled around 250 adults with bipolar mania, who, once a day for three weeks, were given either a placebo or the company’s drug, “RAP-219.” Researchers then evaluated participants on several health measures, with the most important being how they fared on a 0 to 60-point clinical scale where higher scores reflect more severe bipolar symptoms. According to Rapport, those on its drug improved an average of 15.4 points by the third week, versus 12.3 points among the placebo group.
    • “That 3.1-point difference was just enough for the results to be statistically significant. Rapport said that, compared to the control arm, drug-treated patients showed improvements across all 11 components of the scale, which evaluates things like mood, speech, irritability and aggression. RAP-219 also beat the placebo on a “secondary” measure that used a different mania severity scale.
    • “The drug was well-tolerated, according to Rapport, with all so-called treatment-emergent adverse events being mild to moderate.” 
  • The New York Times calls attention to “5 Common Medications That Can Mess With Your Sleep.”
    • “Certain prescription and over-the-counter drugs are known to keep people awake. We asked experts for some of the biggest offenders.” * * *
    • “Any sleep disruptions that result from taking a medication should be discussed with a doctor, Dr. Neubauer said.
    • “Adopting healthy sleep habits could also help counter the medication’s side effects, Dr. White added. Try to avoid consuming caffeine after around 2 p.m., don’t drink alcohol just before bed, keep your bedroom dark and cool and maintain a consistent sleep schedule.”

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

  • STAT News reports,
    • “Officials at Dana-Farber Cancer Institute and Beth Israel Lahey Health celebrated on Monday the start of work on their new $1.68 billion Boston hospital to treat cancer patients, the only medical center of its kind in New England.
    • “The clanking of cranes slated to descend over the Longwood site also brings the impending divorce of Dana-Farber and its longtime partner, Brigham and Women’s Hospital, one step closer. Meanwhile, Brigham’s parent, Mass General Brigham, has launched its own rival cancer institute and is constructing new buildings and renovating other spaces to compete.”
  • Fierce Healthcare relates,
    • “Hackensack Meridian Health has signed a definitive agreement to pick up Central New Jersey’s Hunterdon Health, a $230 million deal that would grow the state’s largest health system to 19 total hospitals. 
    • “The pair had signed a letter of intent to merge in June and are now pursuing state and federal regulatory reviews. The announcement did not outline a potential timeline for the merger’s close.
    • “The agreement does outline a $200 million capital investment on behalf of Hackensack Meridian, which the nonprofits said would go toward facilities, programs and Central New Jersey communities Hunterdon serves.” 
  • Beckers Hospital Review tells us,
    • “Tampa, Fla.-based Moffitt Cancer Center recorded operating income of $238.4 million (6.9% operating margin) for fiscal year 2026, up from operating income of $127.5 million (4.2% margin) in fiscal 2025, according to its financial report for the 12 months ended June 30.  
    • “Moffitt reported total revenue of $3.4 billion in fiscal 2026, a 14.3% increase year over year. Patient service revenue rose 14% to $3 billion. Other revenue, which includes state appropriations and grants, increased 14% to $345 million.
    • “Total expenses were $3.2 billion for fiscal 2026, an 11.1% increase year over year. Salaries, wages, benefits and faculty fees totaled $1.5 billion, a 12.7% increase. Supplies rose 8.1% to $1.2 billion. Purchased services increased 21% to $276 million.”
  • and
    • offers a “nonexhaustive” list of “87 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • The Wall Street Journal informs us,
    • “Front-line nurses are leaving bedside roles in droves due to burnout, understaffing, verbal abuse and workplace violence.
    • “The annual turnover rate for bedside registered nurses hit 18% last year, according to NSI Nursing Solutions.
    • “Losing a nurse is expensive for hospitals, with research at Emory Healthcare showing it costs the system around $78,000 anytime a nurse leaves.”
  • and
    • “AstraZeneca is partnering with Oracle to use artificial intelligence, cloud and data capabilities to refine clinical research.
    • “The collaboration will initially explore clinical-trial recruitment, earlier diagnosis and drug-safety monitoring.
    • “The first program under the partnership will focus on hypertension care and clinical research in Abu Dhabi.”
  • Beckers Health IT adds,
    • “OpenAI has acquired Orchestra Bio, an AI-powered platform that helps biopharma teams coordinate the drug development process.
    • “OpenAI announced the deal Oct. 20 and did not disclose financial terms. The company plans to combine Orchestra’s team and technology with Rosalind, its suite of AI models and tools for life sciences research, which includes the GPT-Rosalind reasoning model and Rosalind Workbench.
    • “Orchestra Bio’s platform lets scientists and program leaders hand off the monitoring and tracking of studies to AI agents. When a problem hits one part of a drug program, such as a failed manufacturing batch that could delay the start of a clinical trial, the agents identify which activities and timelines are affected, gather relevant information and compare response options. Scientists and program leaders then decide how to proceed.
    • “OpenAI said the combined effort aims to build agents that connect scientific findings to the studies, decisions and next steps needed to advance a potential medicine.”
  • Medical Economics discusses “how unbundled maternity care codes could change OB/GYN pay in 2027.”
  • Per the American Hospital Association News,
    • “The median annual net launch price for new prescription drugs increased 35% from 2022 to 2025, to $257,000, according to a report released by the Institute for Clinical and Economic Review and West Health. Nearly 25% of drugs in 2025 launched above $500,000 and 34% launched between $200,000 and $500,000. The groups found that even if drug characteristics impacting launch prices remain constant, such as product type, therapeutic class, and orphan or ultra-rare status, launch prices may continue to increase.”

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.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC

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

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

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

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

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

From the Medicare Advantage front,

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

From the Affordable Care Act marketplace front,

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

No Surprises Act News

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Midweek report

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

Simplicity is a virtue.

From Washington, DC

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

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

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

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

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

No Surprises Act News

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

From the Medicare Advantage front,

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

From the Affordable Care Act marketplace front,

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

From the public health and medical / Rx research front,

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

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

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