From Washington, DC

• The Roll Call informs us,
  • “Appropriators could finish drafting a compromise version of a three-bill spending package for fiscal 2026 in “two or three days” once the partial government shutdown is over, House Appropriations Chairman Tom Cole, R-Okla., said last week.
  • “The shutdown has stalled work on full-year appropriations for more than three weeks, but Cole said lawmakers in both chambers are close to finishing compromise drafts of the Agriculture, Legislative Branch and Military Construction-VA bills. Those can’t move forward, however, until the government reopens, he said.”

• The Wall Street Journal adds,
  • “The nation’s largest federal workers’ union called for Congress to end the shutdown now in its fourth week, putting new pressure on Senate Democrats who have repeatedly blocked a Republican measure to reopen the government.
  • “It’s time to pass a clean continuing resolution and end this shutdown today,” said Everett Kelley, president of the American Federation of Government Employees, or AFGE, which represents more than 800,000 employees, referring to a short-term spending bill.
  • “Kelley called the situation an “avoidable crisis” that is harming families and communities. “Both political parties have made their point, and still there is no clear end in sight,” he said.
  • “The union’s demand—a clean continuing resolution—is the same approach the Republicans have urged Democrats to adopt for the past month, though AFGE didn’t mention either party by name. The union didn’t immediately reply to a request for comment.”

• The Hill notes,
  • “Speaker Mike Johnson (R-La.) on Monday said House Majority Leader Steve Scalise (R-La.) is working with the chairs of three House committees to compile a Republican health care plan as the government shutdown nears the one-month mark and Democrats demand action on expiring ObamaCare subsidies.” * * *
  • “The heads of those House committees of jurisdiction involved in the health care plans would be Ways and Means Chair Jason Smith (R-Mo.), Energy and Commerce Chair Brett Guthrie (R-Ky.), and Education and Workforce Chair Tim Walberg (R-Mich.).”
    
• The Defense Department issued a Federal Register notice describing TRICARE benefit changes for 2026.

• Per an ERISA Industry Committee news release,
  • “The ERISA Industry Committee (ERIC) and employee benefit industry groups today urged The U.S. Departments of Labor, Health and Human Services, and Treasury (the Tri-Departments) to take immediate action to address severe negative consequences of the Independent Dispute Resolution (IDR) process under the No Surprises Act. Despite the Act’s clear goals of protecting patients from surprise medical bills and fostering fair payment negotiations, employers warn that certain providers have increasingly exploited the IDR process.” * * *
  • “The employers called on the Tri-Departments to take three immediate steps to restore the legitimacy of the IDR system, including:
    • Strengthen enforcement to ensure only eligible claims are submitted to IDR.
    • Increase transparency in arbitration decisions and require clear rationale when awards deviate from the qualified payment amount (QPA).
    • Penalize abuse by providers who repeatedly submit ineligible claims.
  • Read the entire employer letter here

• Federal News Network tells us,
  • “Current and former federal employees affected by the massive 2015 Office of Personnel Management data breach may be losing their identity protection services in the coming year.
  • “IDX, the company providing these services since 2015, sent out emails earlier this month telling recipients of their identity protection services that they would have to renew on their own dime after receiving services for 10 years paid for by the government.
  • “IDX, which has held the identity protection and credit monitoring contract since 2015, sent at least three emails out over the last few weeks offering customers a discount to renew their subscriptions.”

• Fierce Pharma notes,
  • “More and more, as momentum builds for the soon-to-be-blockbuster Winrevair, Merck’s $11.5 billion buyout of Acceleron in 2021 is looking like a savvy move.
    The FDA has signed off on a label update for the first-in-class activin signaling inhibitor, which was the key piece of the acquisition. The new approval adds language to the medicine’s label about its ability to reduce patients’ risk of hospitalization for pulmonary arterial hypertension (PAH), lung transplantation and death.
  • “Paving the way for the label update were results from the phase 3 Zenith trial, which enrolled 172 PAH patients at the highest risk of mortality—those in the World Health Organization Functional Class (FC) III or IV—and achieved its primary endpoint of time to clinical worsening to first morbidity or mortality event.
  • “Winrevair, added to maximum background therapy, reduced the risk of these events by 76% versus placebo. Patients in the trial’s treatment cohort received a subcutaneous dose of Winrevair every three weeks, and the median follow-up with patients was 10.6 months.”

From the public health and medical / Rx research front,

• MedPage Today points out,
  • Hormel Foods is recalling nearly 4.9 million pounds of frozen boneless chicken it sold to restaurants, cafeterias, and other outlets after customers reported finding metal in the products, the U.S. Department of Agriculture (USDA) announced. (AP)
  • And a South Dakota company is recalling more than 2.2 million pounds of Korean barbecue pork jerky sold at Costco and Sam’s Club stores, again because the product may be contaminated with pieces of metal, USDA said. (AP)

• The Hill relates,
  • “More than two years after the mpox outbreak in the U.S. was declared over, a new crop of cases in California has infectious disease experts on edge. 
  • “The mpox outbreak that spread through men who have sex with men was declared over at the start of 2023, though low-level transmission has persisted since then.” * * * 
  • “A collection of three unrelated mpox cases recently detected in California is raising concerns, as they were caused by a more infectious, more dangerous strain of the virus called clade I mpox.”
  • “Joseph Cherabie, a member of the HIV Medicine Association board of directors and assistant professor of infectious diseases at Washington University St. Louis, said it was “only a matter of time” before clade I mpox was detected in the U.S.” * * *
  • “If we learned anything from the 2022 outbreak, casual contact, and, you know, transmission through things like clothing, shared clothing, or sitting on the same seat in a subway or anything like that — that did not occur,” Cherabie said. “You need very close, intimate contact with these lesions. So that is why the predominant means of transmission previously was through sexual contact.”  

• Your Local Epidemiologist writes in her Substack blog to which the FEHBlog subscribes,
  • “After an unusually quiet October for respiratory viruses, an RSV wave is starting to take hold. Flu remains remarkably low, and Covid-19 transmission is at one of the lowest points we’ve seen in months.
  • “Although CDC data remain paused because of the federal government shutdown, emergency department records compiled by PopHIVE show RSV activity is starting to climb, especially among children under four. This follows a familiar pattern: the virus first hits the youngest children (particularly those under one year) before spreading to adults, often about a month later.”

• The American Medical Association tells us what doctors wish their patients knew about ovarian cancer prevention. “What is known about risk factors has not translated into practical ways to prevent most cases of ovarian cancer. Three ob-gyns share what to keep in mind.”

• The New York Times reports,
  • “Surgeons removed a genetically modified pig kidney from a 67-year-old man last week, nearly nine months after he received the pioneering procedure at Massachusetts General Hospital in Boston, officials said on Monday. The kidney was removed “after a period of decreasing kidney function,” according to a statement from the hospital.
  • “The patient, Tim Andrews, lived with the pig kidney for a record-setting 271 days. He was the fourth person in the United States to receive a genetically modified pig kidney. The first two patients died shortly after their transplants; the third had her kidney removed after 130 days, when her body rejected the organ.
  • “Tim set a new bar in xenotransplantation,” the Mass General Brigham statement said, referring to the process of transplanting organs from one species into another.
  • “Mr. Andrews “will now resume dialysis and remain on the list for a human donor kidney,” the hospital added.
  • “The nation faces an acute shortage of human organs. More than 100,000 people are on waiting lists to receive an organ transplant; roughly 90,000 of them are awaiting kidneys.
  • “The shortage has prompted an effort to genetically modify pigs so that their organs can be safely transplanted into humans.”

• Per MedPage Today,
  • “Surgery alone offered improved survival and a potential cure for select pancreatic cancer patients.
  • “Clear surgical margins and negative lymph node status were essential to better survival.
  • “The findings came from a registry database, not a randomized clinical trial.”
• and
  • “Estetrol (E4) — one of four natural estrogens — significantly reduced the weighted weekly score of moderate-to-severe vasomotor symptoms in postmenopausal women, according to an analysis of two phase III trials.
  • “Among more than 1,200 women included in E4COMFORT I and E4COMFORT II, the weekly weighted score (WWS) of vasomotor symptoms (VMS), which combined the number and severity of hot flashes, decreased in all treatment arms, including placebo, reported Ekta Kapoor, MBBS, of the Mayo Clinic in Rochester, Minnesota, at the Menopause Society annual meeting
  • “Both examined doses of once-daily oral E4, 15 mg and 20 mg, resulted in greater and statistically significant reductions compared with placebo, and the 20-mg dose demonstrated the largest and earliest reductions, Kapoor reported.”

• The Washington Post reports,
  • “A sweeping study found thousands of stillbirths occur without clear warning signs
  • “A study led by researchers at Harvard and Mass General Brigham shows stark socioeconomic divides and thousands of unexplained losses, even in seemingly healthy pregnancies.
  • “The study published Monday shows that nearly 30 percent of stillbirths occur in pregnancies that did not appear linked to any previously identified health or clinical risks. The study also found that stillbirth continues to fall unevenly along racial and socioeconomic lines, with Black families and poorer communities being hit hardest.”
  • “Mark Clapp, an obstetrician and maternal-fetal medicine specialist at Massachusetts General Hospital and one of the study authors, said better screening and monitoring are urgently needed.”
    
• Per Health Day,
  • Lousy sleep might be an early warning sign for suicide risk among teenagers, a new study says.
  • Teenagers who didn’t get enough sleep on school nights or suffered from interrupted sleep had a significantly higher risk of suicide, researchers reported Oct. 23 in the journal Sleep Advances.
  • “Adolescents who experience difficulties maintaining and obtaining sufficient sleep are more likely to report a suicide attempt several years later,” said lead researcher Michaela Pawley, a doctoral candidate in psychology at the University of Warwick in the U.K.
  • “Poor sleep is not just a symptom of wider difficulties, but a significant risk factor in its own right,” Pawley said in a news release. “Addressing sleep problems could form a vital part of suicide prevention strategies.”

• Per STAT News,
  • “Experimental CAR-T therapies from Cabaletta Bio and Bristol Myers Squibb have induced complete remissions in patients living with a severe inflammatory muscle disease, results from dual clinical trials being presented this week show. 
  • “The new data, while still preliminary, add to evidence reported over the past several years that personalized cell therapies — already used to treat blood cancers — may be curative for patients with serious autoimmune disorders.
  • “These are patients who take three-to-five medicines every day, every week, every month, at great cost both healthwise and financially,” said Steven Nichtberger, CEO of Cabaletta. With a one-time CAR-T treatment, “We’re showing we can eliminate all of those drugs, giving them the opportunity to no longer be patients. We are freeing them from their disease.” 

• BioPharma Dive relates,
  • “Shares of Intellia Therapeutics lost nearly half their value Monday a serious safety event led the company to temporarily pause a pair of Phase 3 trials testing its gene-editing drug against the rare disease transthyretin amyloidosis.
  • “Intellia said it has stopped enrollment and dosing in both late-stage studies of the therapy, codenamed nexiguran ziclumeran or nex-z, while it works on new measures to ensure patient safety. The company plans to consult with regulators and independent experts to “develop a strategy to resume enrollment as soon as appropriate,” CEO John Leonard said in the statement.
  • “The enrollee, a man in his 80s and treated on Sept. 30, on Friday experienced a “grade 4” spike in liver enzymes that were concerning enough to require hospitalization. Prior to the stoppage, Intellia had already enrolled more than 650 people with the cardiomyopathy form of transthyretin amyloidosis in one trial and 47 with the polyneuropathy form in its other study.”
• and
  • “An experimental medicine from BridgeBio Pharma succeeded in a late-stage study in a form of limb-girdle muscular dystrophy, positioning the company to engage U.S. regulators about a potential approval filing. 
  • “Study volunteers with that “type 2I/R9” form of limb-girdle and treated with the drug, BBP-418, had a roughly 17% improvement after three months in “αDG glycosylation,” an important marker of muscle stability and the trial’s main objective. That increase was sustained after 12 months, compared to no change on this measure among placebo-treated participants. No new or “unexpected” safety findings were observed, the company said Monday. 
  • “BridgeBio also said drug recipients had “statistically significant” and “clinically meaningful” improvements after a year in all key trial endpoints studied, including measures of walking ability and lung function. The company will discuss the results with the FDA later this year and intends to submit an approval application in the first half of 2026.” 

From the U.S. healthcare business front,

• Fierce Healthcare reports,
  • “Cigna’s Evernorth division is rolling out a rebate-free model for its pharmacy benefit manager, Express Scripts—meaning one of the industry’s “Big Three” is moving away from the oft-criticized approach.
  • “Cigna announced Monday morning that what it’s calling a “new era” for its PBM unit is built on three core elements: transparency, a better patient experience and greater support for community pharmacies. The company said that Evernorth will shift to a pass-through model, where discounts are available upfront to members.
  • “Cigna’s insurance arm, Cigna Healthcare, will adopt this model for its fully insured plans in 2027, and the more transparent model will be the standard offering for all of Express Scripts’ customers beginning in 2028.
  • “Pharmacy benefit managers have successfully driven down costs for Americans with generics and now with biosimilars,” said Adam Kautzner, president of Evernorth Care Management and Express Scripts, in the release. “In this new era of pharmacy benefits, we’re creating more choice for Americans by lowering the costs of expensive brand-name drugs while driving accelerated adoption of generics and biosimilars.”
  • “Our innovative model is a win-win for Americans and their employers—lower costs for Americans, real-time transparency for employers and renewed trust in pharmacy benefits for all,” Kautzner said.
  • Per the announcements, Evernorth estimates that the new model will save members an average of 30% each month on brand-name medications. It will lean on technology to compare pricing options for the patient and ensure they see the lowest cost when they pick up a prescription.
• Brilliant.

• Beckers Payer Issues lets us know,
  • “Blue Cross Blue Shield of Massachusetts is expanding its claims review process to address what it is describing as potential overcoding among physicians who routinely bill for high-complexity visits.
  • “The new policy takes effect for dates of service on or after Nov. 3 and applies to a small subset of clinicians whose billing patterns stand out from peers, BCBSMA told Becker’s.
  • “Under the program, BCBSMA will review evaluation and management claims from providers who consistently bill visits at the highest complexity levels (4 and 5) to ensure that the services billed match the severity of the conditions reported. Reimbursement may be reduced if the insurer decides that overcoding has occurred.
  • “BCBSMA estimates that 1% to 2% of primary care physicians and 3% to 4% of specialists in its network will be subject to the expanded process. Clinicians can submit additional documentation and appeal to have claims reinstated as originally billed.”

• Per Medical Economics,
  • “Sites of care, price transparency, competition and consolidation all play a role in U.S. health care in 2025, and likely will in coming years.
  • “There also could be changes in store — and there should be, if the nation wants to improve the value of a vital service now accounting for almost 20% of America’s gross domestic produce, according to health care economic analyst Trilliant Health.
  • “The new report, “2025 Trends Shaping the Health Economy,” posits that the health care system is at a crossroads with a choice to make: find ways to improve outcomes and value from within, or face new external regulation that might not be what the sector wants.”
• and
  • “A new KFF/Washington Post survey offers a detailed look at how American parents view their children’s health — and who they trust most for medical guidance. Conducted in summer 2025, the survey shows a nation largely united in concern over issues like mental health and diet, but deeply divided on vaccines, public health institutions and the balance between personal freedom and medical authority.
  • “For physicians, the results underscore a growing need to rebuild and reinforce trust at the point of care, as families increasingly navigate conflicting messages from social media, politics and federal agencies.
  • “Find an in-depth analysis of the survey’s findings here.”

• Per Fierce Healthcare,
  • “Community Health Systems (CHS) announced Friday evening a new definitive agreement to sell three Pennsylvania hospitals to affiliates of Tenor Health Foundation, a recently formed nonprofit. 
  • “Early discussions on the deal and a signed letter of intent had been reported during the summer and confirmed at the time by company representatives. The deal is a second attempt for CHS to sell off its Commonwealth Health system after a prior purchase agreement with WoodBridge Healthcare was called off last year. 
  • “Involved in the transaction are the 186-bed Regional Hospital of Scranton, the 122-bed Moses Taylor Hospital and the 369-bed Wilkes-Barre General Hospital, as well as their affiliate sites.
  • “Financial terms of the deal are not being disclosed. CHS said in its announcement that a close is contingent on Tenor finalizing its funding, as well as on customary regulatory approvals.”   

• Per Beckers Hospital Review,
  • “Nearly 75% of active drug shortages in the U.S. began in 2022 or earlier, with some persisting for more than five years.
  • “According to a report from the American Society of Health-System Pharmacists released in September, the number of active shortages declined to 214 in the third quarter of 2025 — the lowest since early 2018 and a steep drop from the record 323 reported in the first quarter of 2024. While the trend is improving, the ASHP warned that persistent shortages of commonly used medications, including lorazepam and triamcinolone injections, continue to disrupt care.
  • “Long-term shortages now account for most active disruptions, with the ASHP noting that nearly 75% began in 2022 or earlier. These prolonged gaps in supply often require health systems to modify treatment plans, locate alternatives and update clinical workflows.”