Weekend update

Telehealth

Weekend update

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medicare, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services (CMS) hosted health tech leaders at a Health Tech Ecosystem Connectathon event in Washington, D.C., Thursday [November 13, 2025] to showcase progress on its interoperability pledge.
    • “In late July, the CMS and the White House jointly announced a new focus on driving healthcare interoperability and getting health data into Medicare patients’ hands. The push for innovative products that ease health data transfer stems not from regulation, but from voluntary commitments made by industry to uphold new standards set out by the CMS. 
    • “The announcement was sprawling and included several spokes: a new CMS Interoperability Framework and a Health Tech Ecosystem that committed to working on conversational AI, modern digital identity verification and diabetes apps. 
    • “The CMS also committed to improving Medicare beneficiaries’ digital experience with CMS websites.” * * *
    • “The CMS debuted a beta prototype of its new national provider directory, multiple attendees said. The directory will allow Medicare beneficiaries to find providers that accept Medicare and will be available via a free FHIR API. 
    • “One participant noted that the CMS will update the public on its progress online and via a GitHub repository, an open-access cloud repository for projects that also tracks changes.  
    • Multiple companies also demonstrated products that meet the standards set out by the CMS in July for its so-called CMS Aligned Networks.”
  • Federal News Network shares OPM Associate Director for Healthcare and Insurance Shane Stevens views on the Open Season and the FEHB / PSHB program generally.

From the public health and medical / healthcare research front,

  • The Wall Street Journal offers women information about the Food and Drug Administration’s recent removal of a black box warning from all forms of menopausal hormone therapy.
  • Wired reports,
    • “GLP-1s are being studied for a wide range of conditions. Now, scientists will test whether their anti-inflammatory properties can help alleviate symptoms of long Covid.”
  • and
    • “The Aedes aegypti mosquito that can carry dengue, yellow fever, and Zika was thought to be too reliant on a hot and wet climate to survive in the Mountain West. But now, a population is thriving in Western Colorado.
  • The Washington Post adds,
    • “When Susan Akin first started injecting a coveted weight-loss drug early this year, the chaos in her brain quieted. The relentless cravings subsided — only they’d never been for food.
    • “The medication instead dulled her urges for the cocaine and alcohol that caused her to plow her car into a tree, spiral into psychosis and wind up admitted to a high-end addiction treatment center in Delray Beach, Florida.
    • “Doctors at Caron Treatment Centers tried a novel approach for the slender 41-year-old by prescribing her Zepbound, part of a blockbuster class of obesity and diabetes medications known as GLP-1s. Federal regulators have not approved the drugs for behavioral health, but doctors are already prescribing them off-label, encouraged by studies suggesting that they could reshape addiction treatment.
    • “Scientists caution that the research remains nascent. Health insurers do not cover the pricey drugs for that purpose. Addiction specialists say the medications might not be a cure but may work as a tool to quell addictive behaviors.”
  • MedPage Today informs us,
    • “Blood Test May Be a ‘Viable Alternative’ in Liver Cancer Surveillance. Investigational multi-target test more sensitive than ultrasound, but fell short in specificity.
  • The New York Times points out the best foods and drinks to resolve constipation.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health’s operations saw year-over-year improvement for the quarter ended September 30, but the nonprofit health system continues to be weighed down by rising expenses and reimbursement challenges.
    • “Despite strong volume, salary cost management, length-of-stay improvements and higher productivity, CommonSpirit’s financial performance continues to be impacted by expenses growing at a faster pace than revenue,” management said in a press release issued Friday.
    • “A significant impact to the organization’s revenue comes in the form of challenges with payers on denials and timely payments, and payment increases from both government and non-government payers that do not keep up with inflation,” management said.
    • “The 138-hospital system reported an as-recorded operating loss of $396 million (-4.0% operating margin) for the quarter ended September 30, its first fiscal quarter in 2026, as compared to the prior year’s $331 million operating loss (-3.5% operating margin).”
  • and
    • “Maven Clinic is expanding its maternity program to make pregnancy care more precise and personalized.
    • “The expansion includes remote monitoring to identify risks earlier and help address complications. Maven is also adding a NICU program to help get babies home faster through parent preparedness. New features begin rolling out this month.
    • “There’s no typical pregnancy; it’s not a thing. And it’s 2025, and it’s time to not have a cookie-cutter approach,” Neel Shah, M.D., chief medical officer at Maven, told Fierce Healthcare in an advanced interview.
    • “Maven clients trust the company to take care of an entire population, per Shah. That requires providing the right care for the right person, which is now being enabled by a new level of access to data. A year ago, Maven still relied on what members shared about themselves and claims data, Shah said. Now, Maven also has insights from wearables.”
  • Per a November 11, 2025, company news release,
    • “Doc.com, a pioneering healthcare technology company, proudly announces the launch of its new telemedicine platform and services. The platform combines artificial intelligence and blockchain-based technologies to enhance patient access, data security, and care coordination. Through a seamless mobile experience, patients can connect with licensed healthcare professionals within their state to receive quality care conveniently and securely. As part of its introductory rollout, new users may access up to 15 minutes of complimentary teleconsultation, available in eligible jurisdictions and subject to applicable regulations. These minutes may be used across one or multiple sessions as part of an initial trial experience. Subsequent consultations will be available at standard rates.
    • “Doc.com’s United States application rollout begins today with Phase 1 launching in West Virginia, followed by Virginia soon after. The company will then expand to the remaining U.S. states in three additional phases throughout 2026, concluding with full nationwide availability by early 2027. In addition to its United States rollout, Doc.com is introducing a blockchain component, designed to ensure secure, transparent, and efficient transactions across the healthcare ecosystem. This technology supports telemedicine consultations, medical record management, and AI-driven diagnostics, creating a fully integrated platform.”

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Politico reports,
    • “Republicans say they are close to finalizing a package of full-year funding measures for select federal agencies — a critical piece of bipartisan negotiations over the terms for ending the prolonged government shutdown.
    • “The mini-package should be nearing completion, and that will be the vehicle” for the stopgap spending bill to reopen the government, Senate Majority Leader John Thune said Wednesday after a closed-door GOP lunch.
    • “Thune met Tuesday night with Democratic negotiators on the shutdown, including Sen. Jeanne Shaheen of New Hampshire and Sen. Angus King (I-Maine), who caucuses with Democrats. Bipartisan negotiators want the Senate to stay in session through the weekend to finish a deal, according to two people granted anonymity to disclose private dynamics. 
    • “While Thune didn’t rule out staying past the Senate’s normal Thursday afternoon exit time, he said he’d need to first see how much progress was being made.”
  • The Wall Street Journal reports,
    • “The Federal Aviation Administration said it was ordering airline traffic to be reduced by 10% at 40 airports while air-traffic controllers work without pay during the government shutdown.
    • “Transportation Secretary Sean Duffy said starting Friday, the reduction would help keep air travel safe as flight delays and cancellations pile up. The shutdown, which began Oct. 1, has exacerbated staffing issues in the ranks of federal transportation employees, leading to flight delays and long lines at security checkpoints. 
    • “This is about where’s the pressure and how do we alleviate the pressure,” Duffy said Wednesday at a news briefing.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) today released new guidance to federal agencies on how to implement President Donald Trump’s Executive Order 14356, Ensuring Continued Accountability in Federal Hiring. In his first year in office, President Trump met and exceeded the ratio of four employee departures for each new hire, this guidance directs agencies on how to ensure federal hiring remains cost-effective, mission-focused, and aligned with administration priorities.
    • “This is about ensuring government works better for the American people,” OPM Director Scott Kupor said. “We’re bringing accountability and discipline to every hiring decision, making sure agencies are staffing for mission need, not bureaucratic habit.” * * *
    • “Read the memo here and Director Kupor’s blog on this here.”
  • Federal News Network points out,
    • “As Open Season approaches, one Republican is raising concerns about funding for the Federal Employees Health Benefits program. Sen. James Lankford (R-Okla.) is questioning the Office of Personnel Management on how it plans to avoid exhausting the FEHB’s trust fund. He said it’s a concern, since there aren’t any incoming contributions to the trust fund under the government shutdown. In response to Lankford’s questions, OPM said that if needed, it would be able to let health carriers request additional funding from contingency reserves. But for the time being, OPM said all FEHB plans have sufficient funds to pay claims.(Letter to OPM on FEHB program under shutdown – Sen. James Lankford (R-Okla.))”
  • and
    • “The Office of Personnel Management is hinting at some upcoming tech hiring initiatives. The specific timeline for launching the OPM initiatives is unclear, and many details of the tech hiring efforts are still in the works. But agencies should be focused on tech recruitment, particularly in artificial intelligence, according to OPM Director Scott Kupor. “I think the thing that government has to do is not be the last dinosaur. If we do that, there’s no amount of organizational structure or marketing or anything else that’s going to save us, we have to be willing to embrace these things,” Kupor said at a NAPA conference on Monday. (OPM’s Kupor wants more tech expertise in the federal workforce – Federal News Network)”

From the judicial front,

  • Per Fierce Biotech,
    • “Amid the rapidly unfolding saga revolving around Metsera, a judge has denied Pfizer’s request to block Novo Nordisk’s buyout bid for the biotech, Bloomberg reports.
    • Delaware Chancery Judge Morgan Zurn has refused to deliver a Pfizer-requested temporary restraining order, saying the pharma’s objections to the proposed deal weren’t a legitimate reason for stopping Novo’s offer, according to the publication.” * * *
    • “Meanwhile, Pfizer has said it remains “confident” in the merits of its claims and its belief that Metsera is breaching its contractual obligations.
    • “Today’s decision does not address the merits of the underlying legal issues raised, and Pfizer intends to continue to pursue its claims vigorously through the ongoing litigation process as well as in its parallel antitrust litigation pending in Delaware federal court,” the pharma said in a Nov. 5 statement in response to the ruling.”
  • STAT News reports,
    • “The Federal Trade Commission has raised concerns about Novo Nordisk’s attempt to outbid Pfizer to acquire obesity startup Metsera, the latest complication in a dramatic bidding war between two pharma giants.
    • “Companies normally have to seek FTC review for acquisitions under a law called the Hart-Scott-Rodino Premerger (HSR) Notification Act. The companies must wait a prescribed amount of time after the filings are submitted before concluding their transaction.
    • “Novo’s deal is structured so that it would first pay a large amount to acquire half of Metsera’s stock. If Novo does that before seeking regulators’ review, then it may violate the act, Daniel Guarnera, director of the bureau of competition at the FTC, wrote in a letter sent Tuesday to lawyers of Novo and Metsera.”

From the public health and medical / Rx research front,

  • The American Hospital Association News tells us,
    • “There have been 1,681 confirmed cases of measles in the U.S. so far this year, according to the latest Centers for Disease Control and Prevention data. Cases have been reported by 42 states and jurisdictions, and 12% of cases have been hospitalized. There have been 44 reported outbreaks, and 87% of all cases are outbreak-associated. The vaccination status of 92% of all confirmed cases is classified as “unvaccinated or unknown.” 
  • and
    • “An AHA blog examines how the Cleveland Clinic’s food-as-medicine strategy reaches far beyond clinical care by using a multi-angle approach to food access and nutrition. READ MORE” 
  • Health Day informs us,
    • “Tobacco remains the leading preventable cause of cancer death in the U.S., despite a dramatic decline in smoking, a new American Cancer Society report says.
    • “More than 80% of lung cancer deaths are linked to tobacco, according to data from the inaugural release of the American Heart Association’s U.S. Tobacco Atlas.
    • “That’s even though cigarette smoking among adults cratered from 42% in 1965 to just 11% in 2023, researchers said.
    • “Quit rates also have skyrocketed, with a record 62% of smokers trying to drop the habit in 2022, the reports say.
    • “However, smokers are shunning the low-dose CT chest scans that are recommended for lung cancer screening, results show.
    • “Only 18% of eligible current or former smokers were up to date with screening in 2022 — such screening can catch cancers early and improve survival odds.”
  • MedPage Today adds,
    • “Though the percentage of U.S. teenagers who vape nicotine has declined in recent years, daily vaping among those already doing so increased, as did unsuccessful quit attempts, a cross-sectional study suggested.
    • “In a pooled sample of more than 115,000 respondents from the Monitoring the Futureopens in a new tab or window survey, prevalence of past-30-day nicotine vaping declined from 17.8% in 2020 to 10.1% in 2024 (RR 0.88, 95% CI 0.86-0.89), reported Abbey Masonbrink, MD, MPH, of the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues.
    • “However, among more than 15,000 respondents who currently vape, prevalence of daily vaping increased from 15.4% in 2020 to 28.8% in 2024 (RR 1.14, 95%CI 1.11-1.18), they reported in JAMA Network Openopens in a new tab or window. And among more than 3,500 daily vapers, prevalence of unsuccessful quit attempts rose from 28.2% in 2020 to 53% in 2024 (RR 1.08, 95%CI 1.02-1.15).
    • “Despite recent trends in decreasing overall prevalence of nicotine vaping in youth, our research team was concerned about the potential for increasing hardening among current youth users,” Masonbrink told MedPage Today in an email. “As recently evolving nicotine vaping products allow for higher nicotine exposure and known treatment barriers for youth, we wanted to assess for increasing frequency of use and nicotine dependence in this population.”
    • “Ultimately, the study found a “concerning recent trend of increasing trends in daily use among youth who are current users by nearly double and increasing inability to successfully quit, a marker of nicotine dependence, in this population,” she said.”
  • The Wall Street Journal offers advice from Team USA’s doctor on how to avoid becoming ill during air travel.
  • The Washington Post discusses prospects for an experimental pancreatic cancer treatment pill.
    • “Based on early clinical trial results, the Food and Drug Administration in October awarded the drug’s sponsor, biotech company Revolution Medicines, a new and unconventional accelerated review designed to get promising drugs to patients faster than ever. The pancreatic cancer drug, and other medications selected under the “Commissioner’s National Priority Voucher” initiative, will test whether it can expedite novel treatments without compromising the rigor of agency reviews, experts say.” * * *
    • “The FDA’s selection of Revolution Medicines’ daraxonrasib appeared to cement its status as one of the most promising experimental cancer drugs. It also is being studied for treating lung and colorectal cancer.
    • One of the company’s first clinical trials gave daraxonrasib to 83 patients whose pancreatic cancer had spread after undergoing at least one earlier intervention, such as chemotherapy. Over more than 16 months, at least 29 percent of the participants saw their tumors shrink while more than 90 percent saw no tumor growth. The median overall survival was 15.6 months, according to the results, which by some measures is about twice as long as such patients typically fare with standard treatments. Results of its first major, randomized trial, with about 460 patients, are expected next year.”
  • Medscape adds,
    • “A blood-based biomarker test, PancreaSure, demonstrated high sensitivity and specificity in differentiating patients with early-stage pancreatic ductal adenocarcinoma (PDAC) from control individuals at high risk. The test outperformed CA19-9 alone, showing higher sensitivity across two independent clinical validation studies.”
  • Cancer Therapy Advisor notes,
    • “Beginning statin therapy within 36 months of breast cancer diagnosis is linked to improved survival for patients with early-stage disease, compared to patients who do not use statins, according to research published in JAMA Network Open.
    • “These findings highlight the potential of statins as an adjunctive therapy in [breast cancer] treatment, offering a promising avenue for enhancing clinical outcomes,” study researchers wrote.”
  • Per MedPage Today,
    • “Moderate to severe obstructive sleep apnea (OSA) independently correlated with development of cerebral microbleeds seen on brain MRI.
    • “Cerebral microbleeds are considered an early marker of cerebral vasculopathy and are associated with increased risk of developing symptomatic stroke and dementia.
    • “Moderate to severe OSA should be a potential target for early diagnosis and treatment to potentially prevent future strokes and dementia in aging populations, although the study did not assess those outcomes.”
  • and
    • “Survival rates of people with young-onset dementia — dementia diagnosed before age 65 — varied considerably by clinical type, a population-based cohort study in Finland showed.
    • “The median survival for young-onset dementia (also known as early-onset dementia) was 8.7 years, said Eino Solje, MD, PhD, of the University of Eastern Finland in Kuopio, and co-authors.
    • “The shortest survival was seen in people with young-onset frontotemporal dementia (6.9 years) or alpha-synucleinopathy (7.0 years). The longest survival was seen in people with young-onset Alzheimer’s disease (9.9 years) and those with mixed or other dementias (more than 10 years).”
  • Beckers Hospital Review identifies “14 recent drug shortages and discontinuations, according to FDA drug supply databases.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana is convinced that it can grow both the size and profitability of its Medicare Advantage business in 2026, despite concerns that the insurer’s plans are too generous and could saddle the company with undesired costs.
    • ‘Executives said they’re confident in their plan pricing and design on a call to discuss Humana’s third quarter results Wednesday morning — though, they noted there are steps Humana can take to manage membership growth if it starts looking like it may get out of hand as open enrollment continues.
    • “Humana said it’s still on track to double pre-tax margins in the privatized Medicare plans next year compared to 2025. But that forecast excludes the impact of quality or “star” ratings. The number of Humana members in highly rated plans dropped for 2026, complicating its path to profit recovery during a difficult time for payers in government programs.”
  • and
    • “Amwell is considering divesting some non-core assets as the telehealth vendor looks to narrow its business focus and improve financial performance, executives said on a third quarter earnings call Tuesday. 
    • “The company is mulling selling legacy assets that could be more easily separated from the rest of the business without creating challenges for customers, executives said. “These are distinct assets that have a certain profile of clients that we could, in fact, cordon off,” said Amwell CFO and COO Mark Hirschhorn.
    • “Amwell already sold its virtual psychiatric care business to fellow telehealth provider Avel eCare for about $21 million early this year.” 
  • and
    • “The fate of bankrupt Prospect Medical Holdings’ two Rhode Island hospitals hangs in a precarious balance this week, as the health system and the state’s attorney general clash in court over Prospect’s desire to close the facilities by year end. 
    • “Prospect sought court approval to close the two safety-net hospitals on Thursday, saying in court documents that the facilities are losing millions each month and that sale conditions imposed by state regulators make a deal untenable.
    • “The Centurion Foundation, the hospitals’ proposed buyer, and attorney general Peter Neronha opposed the motion in their own filings on Monday. Neronha warned closures would be “catastrophic” for patients.”
  • Fierce Healthcare relates,
    • “Hinge Health wrapped up another strong quarter—its second as a public company—as its results beat Wall Street expectations and the company boosted its 2025 outlook.
    • “The virtual physical therapy company, which went public in late May, brought in third-quarter revenue of $154 million, up 53% from the same period a year ago. Wall Street analysts expected revenue of $142 million.
    • “Hinge’s third-quarter revenue performance exceeded the high end of its guidance range of $141 million to $143 million “due to strong billings performance stemming from the continued strength of the company’s underlying fundamentals,” the company’s chief financial officer James Budge told investors and analysts on the company’s third-quarter earnings call Tuesday.”
  • and
    • “Medicare Advantage (MA)-focused insurtech Clover Health saw its revenue climb by 50% year over year in the third quarter, per its earnings report released late Tuesday.
    • “Clover reported $496.6 million in total revenue for the quarter, up from $331 million in the third quarter of 2024. Through the first nine months of the year, revenues were $1.4 billion, compared to the company’s haul of $1 billion through the first three quarters of 2024.
    • “The company also posted a $24.4 million net loss in the quarter, with its losses increasing from $9.2 million in the prior-year quarter. Clover has reported $36.2 million in losses through the first three quarters of the year, up from $20.9 million in losses a year ago.
    • “The company reported $2 million in earnings before interest, taxes, depreciation and amortization.
    • “Our model of care continues to perform well as we bring our technology-powered care to more Medicare Advantage seniors,” said Clover Health CEO Andrew Toy in the earnings release.”
  • and
    • “Carrum Health launched a substance use disorder treatment program for employers a year ago and has now expanded it to include cannabis, cocaine and methamphetamine as employer demand surges.
    • “It’s estimated that 29 million U.S. employees—1 in 6 working adults—are struggling with substance use disorder. Approximately 6.5% of full-time U.S. employees met the criteria for a cannabis use disorder in a 2021-22 study. Another study found that workplace cannabis consumption was highest among workers in states with “recreational” cannabis laws.
    • “This poses a major health challenge for employers, and there’s a critical unmet need for cost-effective prevention and treatment strategies.”
  • The American Journal of Managed Care tells us,
    • “Adequate outpatient follow-up within 30 days significantly reduces 30-day all-cause hospital readmissions, impacting hospital finances and patient care quality.
    • “The study analyzed 83 studies, primarily US-based, showing reduced readmission risks for heart failure and acute myocardial infarction with timely follow-up.
    • “Heterogeneity in study designs and US-centric data limit the generalizability of findings to other health systems.
    • “Authors emphasize considering patient-specific risk factors in prioritizing post-discharge follow-up to optimize outcomes.”
  • Per BioPharma Dive,
    • Novo Nordisk reined in expectations for full-year sales and profit amid expected price cuts and a disappointing third quarter for its obesity drug Wegovy.
    • The Danish drugmaker now expects sales growth of 8% to 11% for the year after previously predicting revenue might expand by as much as 14%. Operating profit will likely grow between 4% and 7%, down from an estimate of as much as 10%, Novo said Wednesday, a shift executives attributed on a conference call to “intensifying competition and pricing pressure.”
    • Sales of semaglutide, sold as Wegovy for obesity and Ozempic for diabetes, continued to rise in the third quarter and together brought in more than 51 billion Danish kroner, or about $7.9 billion. But analysts had been looking for more from Wegovy, and the combined total fell short of Eli Lilly’s rival Zepbound/Mounjaro drug, which became the world’s best-selling medicine in the third quarter with more than $10 billion in revenue.
  • Per Fierce Pharma,
    • “Madrigal’s Rezdiffra generated sales of $287 million in the third quarter for a 35% sequential jump from Q2. In just its fifth full quarter on the market, the world’s first treatment for metabolic dysfunction-associated steatohepatitis (MASH) is now annualizing at more than $1 billion.
    • “While the numbers are heady and a second MASH treatment has recently entered the market, Madrigal says there is significant room for growth. Because the disorder is underdiagnosed, the company figures that competition from Novo Nordisk’s GLP-1 Wegovy—which gained an FDA label expansion to treat MASH three months ago—will help increase the patient pool.
    • “We welcome new entrants to this evolving market. Wegovy’s recent approval in MASH adds momentum to a market that’s just starting to take shape,” Madrigal CEO Bill Sibold said on a quarterly conference call. “Novo is targeting a much larger population, which will raise awareness and drive more screening, diagnosis and treatment.”

Friday Report

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

Happy Halloween!!

From Washington, DC

  • The Wall Street Journal reports,
    • “President Trump’s demand that Republican senators bypass Democrats to reopen the federal government risked upsetting delicate negotiations on Capitol Hill, where lawmakers were finally making progress toward a deal to end the monthlong impasse and head off more pain for American households. 
    • “Optimism had been growing among Republican and Democratic senators involved in talks over recent days, with hopes that a resolution could be reached in the week ahead, people familiar with discussions said. 
    • “But Trump’s new demand in a social-media message late Thursday to eliminate the Senate filibuster rule could complicate the path forward. Meanwhile, food aid is at risk of lapsing for millions of people, the nation’s airports are increasingly snarled, and Affordable Care Act health-plan enrollees are confronted with sharply higher premiums.”
  • Time will tell.
    • “In remarks Friday on his way to Florida, Trump didn’t mention his filibuster demand but reiterated that he was willing to talk with Democrats if they would provide votes to reopen the government. 
    • “Let them open up the country, and we’ll meet,” he said. “It’s so easily solved.” 
    • “A White House spokeswoman said that if Democrats don’t work with Republicans to reopen the government, then the “nuclear option” of ending the filibuster will need to be used.
    • “Senate Republicans are set to return to Washington on Monday night to face a loyalty test on whether they will side with Trump on killing the filibuster or try to seal the deal with bipartisan talks. 
    • “Senate Majority Leader John Thune (R., S.D.) has pledged to protect the longstanding rule. A spokesman said Friday that his position hadn’t changed.”
  • Tammy Flanagan, writing in Govexec, tells us “what federal employees need to know about Medicare enrollment.” She provides “an updated guide to timing, parts, costs and coordination so you don’t get stuck with penalties or surprises at 65.”
  • OPM announced on October 30, 2025,
    • “two new online tools designed to make retirement services faster, and easier for federal retirees. These improvements are part of OPM’s broader effort to modernize its Retirement Services operations and enhance the customer experience through expanded self-service options. Beginning today, retirees can:
      • “Securely download their 1099-R tax forms without logging into Retirement Services Online, offering a faster, paperless option for accessing tax documents.
      • “View current retirement processing times to better understand the expected timeline for the completion of their retirement benefit applications.
    • “These new self-service tools are another step toward delivering the efficient, transparent, and customer-focused experience federal retirees deserve,” OPM Director Scott Kupor said. “By expanding digital access and improving automation, we’re giving retirees more control over their information and freeing up our team to focus on complex cases that require extra care.”
  • Healthcare Dive informs us,
    • “Federal regulators have greenlit eight drugmaker proposals to enact rebates in 340B, upending how savings in the massive drug discount program are normally divvied out to providers.
    • “The approvals were disclosed by the Health Resources and Services Administration, the HHS agency that oversees 340B, on Thursday. They include frequently prescribed drugs manufactured by companies like Bristol Myers Squibb and Johnson & Johnson, two drugmakers that sued the government after it blocked them from implementing their own 340B rebate plans.
    • “Hospital groups slammed the model approvals as benefiting drugmakers at their expense, with America’s Essential Hospitals calling it a “clear case of the fox guarding the hen house.”
  • Roll Call adds,
    • “Lawmakers impatient with the lack of progress on a key health care issue — the long-debated need for changes to what’s known as the 340B drug pricing program — say they are closing in on legislation aimed at what they say are abuses in the program.” * * *
    • “Lawmakers argue the program incentivizes practices that drive up health care costs. A report released last month by the Congressional Budget Office found the program’s design encourages prescription of higher-cost drugs and promotes increased vertical integration among facilities.
    • “When 340B hospitals acquire or open new outpatient clinics, such as infusion centers or specialty medicine practices, those clinics also become eligible for the program. Critics say the hospitals collect discounts on drugs offered at those clinics and then sell them at full price to insured patients.
    • “Our goal is to make health care more affordable, but 340B is making employer-sponsored insurance, which pays for the health care for 150 million people, less affordable,” Senate HELP Chair Bill Cassidy, R-La., said.” * * *
    • The [rebate] pilot [mentioned above] could increase pressure on Congress to pass 340B legislation after debating it for several years, said Darbin Wofford, deputy director of health care for Third Way’s economic program. But action is doubtful with Congress in the throes of a government shutdown.
    • “It’s unlikely we see movement for any 340B policy in Congress this year, but there are opportunities next year and in the following Congress,” Wofford said.
  • The American Hospital Association News reminds us,
    • “Individuals and families can enroll in or change their health coverage options through the Health Insurance Marketplace beginning tomorrow through Jan. 15. The AHA offers resources to help people choose the best coverage for themselves and their families.”  
  • Beckers Payer Issues points out six things to know about this ACA marketplace open enrollment period.

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Seven new illnesses and two additional deaths have been reported multistate Listeria outbreak tied to prepared pasta meals, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said yesterday in updates.
    • “A total of 27 people in 18 states have been infected with the outbreak strain of Listeria monocytogenes, with 25 hospitalizations and 6 deaths. One pregnancy-associated infection resulted in fetal loss. Deaths have been reported in Hawaii, Illinois, Michigan, Oregon, Texas, and Utah.
    • “The illness-onset dates range from August 6, 2024, to October 16, 2025. Patient ages range from 4 to 92 years, with a median age of 74 years. Two thirds of patients are women.”
  • The Washington Post reports,
    • “Most children should not receive prescription fluoride, Food and Drug Administration officials said Friday as they announced measures to restrict sales of the cavity-fighting drug.
    • “The agency said children under 3 and older children not at high risk for tooth decay should avoid ingestible fluoride, which is often sold as tablets or drops. It sent letters to manufacturers warning them not to market the products to such children.
    • “Fluoride tablets are often prescribed to children who live in communities that do not put the tooth-strengthening mineral in its water supply. But Health Secretary Robert F. Kennedy Jr. has led the Trump administration’s efforts to crack down on fluoride, including revisiting the decades-old recommendation from the Centers for Disease Control and Prevention to fluoridate water.“ * * *
    • “The American Dental Association recommends prescription fluoride to children ages six months and older who are considered high risk for tooth decay and have little fluoride in their drinking water. 
    • “Scott Tomar, a spokesman for the ADA on community water fluoridation, said the FDA recommendations were not too different then the association’s guidance.”

From the judicial front,

  • Govexec relates
    • In a lawsuit filed in Delaware Chancery Court, Pfizer said Novo Nordisk’s offer can’t be considered superior because it isn’t reasonably likely to be completed on the terms proposed.,
    • “A federal judge in Boston ruled Friday that the U.S. Department of Agriculture’s plan to pause a food assistance program for 42 million people was illegal — but gave the Trump administration until Monday to respond to her finding before she decides on a motion to force the benefits be paid despite the ongoing government shutdown.
    • “At nearly the same time Friday, a Rhode Island federal judge in a similar case brought by cities and nonprofit groups ordered USDA to continue payments and granted a request for a temporary restraining order.
    • “In Massachusetts, in a Friday afternoon order, District Court of Massachusetts Judge Indira Talwani said she would continue to take “under advisement” a coalition of Democratic states’ request to force the release of funds from a contingency account holding about $6 billion.
    • “Her ruling came a day before a cutoff of Supplemental Nutrition Assistance Program, or SNAP, benefits to low-income households [due to the government shutdown].”
  • The Wall Street Journal reports,
    • “Drugmaker Pfizer on Friday sued obesity-drug developer Metsera and Novo Nordisk, seeking to block Metsera from terminating its multibillion-dollar merger deal with Pfizer after Novo Nordisk made an unsolicited takeover bid.
    • “In a lawsuit filed in Delaware Chancery Court, Pfizer said Novo Nordisk’s offer can’t be considered superior because it isn’t reasonably likely to be completed on the terms proposed.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership lets us know,
    • “Respiratory syncytial virus activity is starting to tick up across the country, marking the start of virus season, according to data tracked by epidemiologists and public health experts. 
    • “Routine CDC tracking on respiratory virus trends is on pause amid the federal government shutdown, now approaching its fifth week. However, data from the PopHIVE project at Yale School of Public Health in New Haven, Conn., shows that ED visits for RSV among children under 4 are on the rise.” 
  • Per Medscape,
    • “Impaired glymphatic function — the brain’s waste clearance system — could help explain how cardiovascular disease (CVD) risk factors may drive dementia. 
    • “In a large UK Biobank study, MRI markers of disrupted cerebrospinal fluid (CSF) and glymphatic flow predicted future dementia and were closely linked to vascular risk factors, including high blood pressure, diabetes, smoking, and arterial stiffness.
    • “Discovered just over a decade ago, the glymphatic system depends on the efficient circulation and drainage of CSF. When this process is impaired, the brain’s ability to clear amyloid, tau, and other toxins diminishes, potentially accelerating the development of dementia.
    • “The study shows, with very convincing data, that these markers predict dementia risk, and also that the markers relate to cardiovascular risk factors,” study author Hugh S. Markus, MD, professor of stroke medicine in the Department of Clinical Neurosciences, University of Cambridge, UK, told Medscape Medical News.
    • “This offers a novel way in which one might be able to target or treat dementia. If one could improve glymphatic flow, one could then reduce the risk of dementia.”
  • The Wall Street Journal reports,
    • “Parkinson’s disease is the fastest-growing neurodegenerative disease in the world. But it’s also one of the most preventable, according to Dr. Ray Dorsey, neurologist at Atria Health and Research Institute in New York and co-author of a new book, “The Parkinson’s Plan: A New Path to Prevention and Treatment.”
    • “A progressive nervous-system disorder, Parkinson’s primarily impacts movement. As dopamine-producing brain cells die, movement becomes affected, resulting in tremors, muscle stiffness, slowed movement and impaired balance.
    • “Some doctors like Dorsey say most cases appear to be caused by environmental factors. A study in the journal Brain last year found that only 13% of Americans carry a genetic risk factor for the disease. 
    • “The vast majority of Americans have no known genetic cause or risk factor for their disease,” says Dorsey. “So the principal cause of disease lies not with us, but outside of us, in our environment, in chemicals in our food, water and air.”
    • “Other doctors say conversations about preventing Parkinson are missing the mark.
    • “We’re very much oversimplifying if we say, ‘If we just get rid of that particular pollutant we are going to prevent Parkinson’s,’ ” says Dr. Brad Racette, chair of neurology and senior vice president at Barrow Neurological Institute in Phoenix. “We will probably have a measurable effect on the number of cases, but I think the key message is it’s not as simple as a single pollutant is causing an individual’s Parkinson’s.”
    • The article “offers some of the ways that doctors like Dorsey recommend to potentially reduce your risk of developing Parkinson’s disease.” For example
      • “Research the area near your home. Try not to move to an area near a golf course or Superfund site. A May JAMA Network Open study found that people who live within one mile of a golf course have a 126% increased risk of developing Parkinson’s.
      • “Superfund sites aren’t well marked, but you want to avoid living too close to one since toxic chemicals leak into the soil and eventually the surrounding air. The Environmental Protection Agency has a database to search for sites and environmental firms can test your air.”
  • Per MedPage Today,
    • “Moderate exercise of about 17 metabolic equivalent task (MET)-hours per week significantly reduced the risk of digestive system cancers (DSCs) and DSC mortality.
    • “Optimal risk reduction occurred at about 50 MET-hours per week.
    • “After factoring in consistency, physical activity equivalent to 16.9 MET-hours/week had the same effect on DSCs as 50 MET-hours/week.”
  • Here is a link to an MET calculator.
  • Per BioPharma Dive,
    • “Tucked into its latest earnings report, Eli Lilly disclosed that it has removed from its research pipeline an experimental drug for pain.
    • “The drug, which Lilly in-licensed several years ago, works by inhibiting a protein called P2X7. This protein helps regulate molecules that trigger inflammation and amplify pain signals. Blocking P2X7, Lilly had hoped, would be an effective way to treat conditions like osteoarthritis, chronic lower back pain and the nerve pain that often accompanies diabetes.
    • “However, data from mid-stage tests “did not meet our high internal bar for success,” according to Lilly spokesperson Ashley Hennessey. While the company is “assessing next steps for the program, including possible additional indications,” for now, the drug is out of its pain pipeline.
    • “It’s at least the second Lilly pain program to get axed this year. A drug named mazisotine, designed to boost a pain-relieving protein known as SSTR4, was shelved this summer.”

From the U.S. healthcare business front,

  • Per Fierce Pharma,
    • “For the third straight quarter, AbbVie has jacked up its revenue forecast for 2025. The Illinois drugmaker has raised its guidance by $400 million, now expecting sales to reach $60.9 billion.
    • “The estimate is $1.9 billion higher than AbbVie’s projection from the start of the year, another indication that the company continues to be surprised by the performance of immunology stalwarts Skyrizi and Rinvoq and that it has rebounded from the 2023 loss of patent protection in the United States for Humira, the first drug ever to generate more than $20 billion in annual sales.
    • “Clearly, the momentum is there,” AbbVie CEO Rob Michael said on a Friday conference call. “We’ve beaten and raised in every quarter in 2025.”
    • “The new forecast reflects expectations that Skyrizi sales will reach $17.3 billion in 2025, which is a $200 million increase from AbbVie’s previous estimate based on the drug’s market share gains in psoriasis and inflammatory bowel disease (IBD), chief financial officer Scott Reents said.”
  • and
    • “For the last several quarters, Gilead Sciences’ earnings calls have been colored by anticipation for the launch of the California drugmaker’s long-acting HIV pre-exposure prophylaxis (PrEP) option. This week, Gilead had a chance to share some early returns on the med’s market debut after its FDA approval five months ago.
    • “Since Yeztugo’s U.S. launch in June, the drug has garnered $54 million in sales, Gilead reported on Thursday, with $39 million generated specifically during the third quarter. The company has already secured 75% U.S. payer access for Yeztugo, some three months ahead of its original targeted timeframe of six months post-launch, with 90% expected by the end of the first half of 2026, Gilead said in its third-quarter earnings presentation (PDF). 
    • “Gilead expects $150 million to come from Yeztugo this year, but Citi analysts call this guidance “conservative,” citing broad update and rapid payer coverage as “hallmarks of a strong launch” that the drug has already demonstrated, the analysts wrote in a note to clients. 
    • “On the flip side, Mizuho analysts note that the Yeztugo’s quarterly haul was a “slight miss.”
  • Radiology Business reports,
    • “Hospital giant Intermountain Health has reached a deal to acquire a nearly 40-year-old private radiology practice in Las Vegas, the two announced Thursday. 
    • “The Salt Lake City-headquartered nonprofit is buying Steinberg Diagnostic Medical Imaging for an undisclosed sum, with the integration taking place sometime after Jan. 1. SDMI opened its first office in 1988 and today commands a team of over 550 employees and affiliates, including approximately 30 radiologists. 
    • “Intermountain is growing in southern Nevada and believes adding SDMI and its 12 outpatient imaging centers will help “enhance patient access to high-quality, cost-effective care.” Acquiring the practice also will allow the hospital system to provide more “coordinated and integrated imaging,” said Eric Liston, chief clinical shared services officer. 
    • “As the number of people with chronic and complex health conditions continues to grow, ease of access to high-quality imaging services is more important than ever,” he said in a statement Oct. 30.”
  • Per Fierce Healthcare,
    • “Elevance Health’s Anthem plans are cracking down on hospitals or outpatient facilities that offer services using out-of-network providers.
    • “Beginning Jan. 1 in 11 states, Anthem will impose an administrative penalty equal to 10% of the allowed amount on a facility’s claims that include out-of-network providers. These facilities will also be at risk of termination from Anthem’s provider network, per a notice from the insurer sent out earlier this month.
    • “Ariel Bayewitz, vice president of health economics at Elevance Health, told Fierce Healthcare in an interview that the policy was designed in response to provider behavior under the No Surprises Act (NSA) independent dispute resolution (IDR) process. He said the insurer has seen a consistent pattern of IDR being used as a “back-door payment channel” for pricey, nonemergent procedures.” FEHBlog note — Smart move.
  • and
    • “Online therapy provider Talkspace reported another strong quarter with 25% revenue growth, driven by its expanding payer business, with net income of $3.3 million, up 73% from the same period in 2024.
    • “The company brought in $59.4 million in revenue in Q3, driven by a 42% year-over-year increase in payer revenue, or insurance-covered sessions, to reach $45 million. Talkspace’s direct-to-consumer business, however, continued to decline, with $4.6 million in revenue, down 23% year-over-year. The company’s direct-to-enterprise revenue was $9.3 million, down 1% year-on-year.
    • “The company reported adjusted EBITDA of $5 million, an improvement from $2.4 million adjusted EBITDA in the third quarter of 2024.
    • “The company completed 432,000 insurance-covered mental health sessions in Q3, up 37% year-over-year, and active payer members increased 29% in Q3 to 129,000, Ian Harris, Talkspace’s chief financial officer, said during the company’s third-quarter earnings call.“
  • Per Healthcare Dive,
    • “Healthcare executives see digital health and virtual care as key technologies to improve patient experience, but determining returns from these investments is unclear, according to a survey published this week by healthcare consultancy Sage Growth Partners.
    • “Nearly 60% of respondents said their health system offered virtual primary care and remote patient monitoring. Additionally, half said they offered telehealth for stroke care. 
    • “But fewer than 30% earned significant ROI from most of their virtual care offerings, according to the survey. Plus, many executives said they would need to invest funds to shift to a new virtual care platform in the next few years.” 

Weekend Update

David Ermer–Congress, Congress, COVID-19 vaccine, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • On Thursday, the Senate Committee on Aging will hold a hearing at 3:30 pm ET “to examine modernizing health care, focusing on how shoppable services improve outcomes and lower costs.”
  • The Wall Street Journal reports that “Congress Is running out of time to decide the fate of Obamacare subsidies. Republicans decry the ‘Biden bonuses’ of enhanced ACA, while Democrats say pressure will rise on GOP to extend subsidies.”
    • “Enhanced Affordable Care Act subsidies, benefiting more than 20 million people, are set to expire this year, prompting a political standoff.
    • “Republicans seek major changes to the ACA, including addressing alleged fraud.
    • “ACA sign-ups have more than doubled since 2021. More than three-quarters of policyholders now reside in states that voted for President Trump.”
  • Roll Call adds,
    • “President Donald Trump is expected to host Senate Republicans for a Rose Garden lunch Tuesday, while the ongoing partial government shutdown continues to have no end in sight.
    • “A GOP source confirmed the plan for the White House visit, which comes as the Senate majority will also try this week to call up a bill that would pay federal workers who are on the job during the shutdown. The Senate this week is also expected to continue to confirm Trump’s judicial nominees.”

From the 2025 European Society for Medical Oncology congress in Berlin,

  • STAT News reports,
    • “Patients with a highly aggressive form of breast cancer will likely have new treatment options for the first time in years after AstraZeneca and Gilead Sciences both presented successful trial results here Sunday, dual achievements that will also leave clinicians having to figure out which drug to choose when treating triple-negative tumors. 
    • “Both studies tested what’s known as an antibody-drug conjugate — essentially, a next-generation type of chemotherapy — compared to traditional chemotherapy regimens as a first-line medicine in patients with metastatic triple-negative breast cancer who couldn’t receive an immunotherapy. The women largely weren’t eligible for treatments like checkpoint inhibitors because their tumors did not express the protein that the drugs target. For these patients, there hasn’t been a new first-line drug approved in over a decade.
    • “Researchers were already going to be comparing the results of the two Phase 3 studies in the difficult-to-treat tumors, but the stakes were upped with the trials being presented back-to-back here at the European Society for Medical Oncology’s annual conference. A single discussant also analyzed the results together, parsing the outcomes for Gilead’s Trodelvy as well as for Datroway, made by AstraZeneca and its partner Daiichi Sankyo.” 
  • and
    • “mRNA-based Covid vaccines from Pfizer-BioNTech or Moderna may have an unexpected benefit for cancer patients who undergo immunotherapy. 
    • “A new study suggests that these vaccines might boost the effects of immunotherapy drugs, perhaps by alerting the immune system and helping direct immune cells to attack tumors. That’s in addition to helping protect against Covid, which can be particularly important for cancer patients who can sometimes have weakened immune systems. 
    • “The study found that advanced cancer patients who received a Covid vaccine within 100 days before taking an immunotherapy drug during the pandemic lived longer than patients who did not, in a retrospective analysis. Researchers from MD Anderson Cancer Center presented the study at the European Society for Medical Oncology conference in Berlin on Sunday. 
    • ‘The results are intriguing cancer immunologists and oncologists, who reacted with both excitement and caution.” 
  • Fierce Pharma adds,
    • “Novartis has shared detailed data showing its radioligand therapy Pluvicto could slow the progression of certain hormone-sensitive prostate cancers ahead of a planned application with the FDA.
    • “Pluvicto plus standard of care significantly reduced the risk of radiographic progression or death by 28% versus standard of care alone in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), according to Novartis. The standard of care includes androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) such as Pfizer and Astellas’ Xtandi.
    • “Details from the phase 3 PSMAddition trial will be presented Sunday at the 2025 European Society for Medical Oncology congress in Berlin.”
  • and
    • “The standing ovation for Keytruda and Padcev in metastatic bladder cancer at the 2023 European Society for Medical Oncology (ESMO) Congress still echoes, and, now, the pair from Merck & Co., Pfizer and Astellas has pulled off similarly showstopping results in certain patients with muscle-invasive bladder cancer (MIBC).
    • “The combination of Merck’s Keytruda and Pfizer and Astellas’ Padcev reduced patients’ risk of death by a whopping 50% when used before and after bladder removal surgery in those with MIBC who are not eligible for or declined cisplatin-based chemotherapy compared with surgery alone, according to results to be presented at the 2025 ESMO Congress.
    • “The PD-1/antibody-drug conjugate combo also significantly improved event-free survival (EFS) by 60% versus surgery alone. A negative event includes progression of disease that precludes surgery or failure to undergo surgery, gross residual disease left behind during surgery, cancer recurrence or death.”
  • and
    • “Merck’s efforts to make headway in a cancer type that was an elusive target for its superstar oncology med Keytruda prove to be fruitful, as demonstrated through its Keynote-B96 trial in ovarian cancer. 
    • “The latest data drop is a more detailed look at a win from previously reported positive analyses of the phase 3 study, which tested Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer who have tried one or two prior lines of therapy, including at least one platinum-based chemotherapy.”

From the public health and medical / Rx research front,

  • The Washington Posts offers expert advice on when to obtain Covid and flu boosters for this coming, winter infection season. Both infectious disease physicians encouraged getting the shots in October.
    • “[Dr.] Pavia encourages getting a shot whenever you have an easy opportunity. If you’re getting groceries and the pharmacy is offering flu shots, take five minutes to get one, because you are less likely to follow through by scheduling an appointment, Pavia said.
    • “The Centers for Disease Control and Prevention now recommends that people consult a clinician before receiving a coronavirus shot, but that process can be as simple as a brief conversation with a pharmacist. The Post previously published a guide to getting covid shots under these new conditions.
    • “By now, many people know how they react to flu and coronavirus shots. The coronavirus shot can give some people quite a sore arm. If that’s the case, avoid getting both shots in the same arm, they said. [Dr.] Rivers got her shots in two different arms during the same visit, but the rest of her family got them in the same arm. For people who don’t have much a reaction, there is no disadvantage to getting two shots at the same time, [Dr.] Pavia said. He got his shots at different times because that’s when it was convenient for him.”
  • The American Medical Association offers healthcare providers advice on how to answer patients’ questions about vaccinations.
  • The New York Times explains why more older adults have turned to cochlear implants after Medicare expanded eligibility for the devices.
    • “Twenty-five years ago, “it was a novelty to implant people over 80,” said Dr. Charles C. Della Santina, director of the Johns Hopkins Cochlear Implant Center. “Now, it’s pretty routine practice.”
    • “In fact, a study published in 2023 in the journal Otology & Neurotology reported that cochlear implantation was increasing at a higher rate in patients over 80 than in any other age group.
    • “Until recently, Medicare covered the procedure for only those with extremely limited hearing who could correctly repeat less than 40 percent of the words on a word recognition test. Without insurance — cochlear implantation can cost $100,000 or more for the device, surgery, counseling and follow-up — many older people don’t have the option.
    • “It was incredibly frustrating, because patients on Medicare were being excluded,” Dr. Della Santina said. (Similarly, traditional Medicare doesn’t cover hearing aids, and Medicare Advantage plans with hearing benefits still leave patients paying most of the tab.)
    • “Then, in 2022, Medicare expanded cochlear implant coverage to include older adults who could identify up to 60 percent of words on a speech recognition test, increasing the pool of eligible patients.”

From the U.S. healthcare business front,

  • Medscape considers whether the obesity drug battleground is offering wins for clinicians and patients?
  • TechTarget reports,
    • “Teladoc Health has launched new AI capabilities that enable care teams to monitor and mitigate violence in healthcare workplace settings.
    • “The virtual care provider has integrated the new AI features into its Clarity monitoring solution. The AI technology utilizes video and audio cues to assess facial expressions, gestures and language to determine threats. If a situation is deemed potentially aggressive and appears to be escalating, the solution will notify the appropriate care teams and staff. For example, it will identify safety risks, such as a person aggressively tampering with medical equipment.”
  • The Wall Street Journal relates,
    • “Provalus, an outsourcing company, is expanding revenue by 35% to 40% annually as it invests in rural American towns.
    • “The company recruits and trains individuals from small towns, offering jobs in IT and professional services with competitive benefits.
    • “Provalus aims to create middle-class jobs in overlooked areas.”
  • Per HR Dive,
    • “While 7 in 10 U.S. hiring managers say they typically consider overqualified candidates, many also express concerns about low engagement and quick exits, according to an Oct. 8 report from Express Employment Professionals and The Harris Poll.
    • “In fact, three-quarters of employers said they believe overqualified hires struggle to stay motivated in lower-level roles, and they worry these hires will leave as soon as a better opportunity comes along. In response, 58% said they’d rather train someone new than risk disengagement.”

Friday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, HSA, Medical / Rx research, No Surprises Act, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital News lets us know,
    • “The Senate Oct. 16 failed for a 10th time to advance the continuing resolution to extend government funding and end the ongoing shutdown. The chamber adjourned until Oct. 20, pushing the shutdown into next week. The House continues to remain out of session with no plans to return. Lawmakers remain at an impasse, and no formal negotiations have resumed.”
  • Govexec informs us,
    • “President Trump on Wednesday signed a new executive order effectively indefinitely extending the ongoing hiring freeze, albeit while creating new requirements for federal agencies to obtain exceptions as well as new opportunities to politicize the federal workforce.
    • “Trump’s hiring freeze, first implemented on Jan. 20, was set to expire Wednesday. The new order, entitled Ensuring Continued Accountability in Federal Hiring, requires agencies to create a strategic hiring committee, whose membership should include the deputy agency head and the agency head’s chief of staff, to approve “the creation or filling” of each vacancy within the organization. It also requires the creation and submission to both the Office of Personnel Management and the Office of Management and Budget of an annual staffing plan.
    • “In these plans, agencies shall seek to improve operational efficiency; eliminate duplicative or unnecessary functions and positions; reduce unnecessary or low-value contractor positions; promote employee accountability; enhance delivery of essential service; appropriately prioritize hiring for national security, homeland security and public safety positions; and implement the recruitment initiatives described in the merit hiring plan,” the order states. “Going forward, agencies shall prepare, in coordination with OPM and OMB, annual staffing plans to implement at the start of each new fiscal year.”
  • OPM Director Scott Kupor discusses the new executive order in this week’s post in his Secrets of OPM blog.
    • “The goal of this exercise is not for OPM nor OMB to question the judgment of our very capable agency heads; without a doubt, the “CEOs” of these organizations know their agencies far better than do we. Rather, the goal is to provide a level of pan-government visibility across resourcing in furtherance of the key initiatives that the president has laid out. And, in doing so, we can look for ways to maximize efficiency and deliver the best possible set of services to the American people.
    • “For example, if we learn that collectively across agencies we are looking to hire 10,000 engineers this year, then OPM can help design an x-government process to facilitate more centralized hiring. Or, if we see that there are core personnel resources that are being duplicated across agencies that could be more effectively done via specialization and centralization, OPM can help drive that as well. And this list goes on.
    • “None of this is rocket science. But President Trump rightfully recognizes that the federal government needs to operate on the same fundamental practices that do all modern organizations writ large.
    • “Rationality prevails – at least for now – in DC.”   
  • 401k Specialist points out,
    • “Assets in health savings accounts (HSAs) climbed to $146 billion in 2024, with an 18% year-over-year increase, according to new data out today from Morningstar.
    • “The investment analyst’s latest Health Savings Account Landscape Report notes that the tax benefits associated with HSAs, along with widespread adoption of high-deductible health plans (HDHPs), has accelerated growth among the savings vehicles.
    • “Growing adoption of HDHPs has coincided with HSA asset growth, Morningstar reports. According to the findings, the percentage of workers in employer-sponsored medical insurance plans that have elected HDHPs increased from 7% in 2006 to 32% by the end of 2024. In that same timeframe, HSA assets rose to $146 billion from close to $5 billion about 20 years ago.
    • “In nearly a decade of research, we’ve seen the HSA industry mature considerably as more individuals take advantage of the powerful tax advantages and long-term savings potential these accounts offer,” said Greg Carlson, senior manager research analyst at Morningstar, in a statement.”
  • Fierce Healthcare relates,
    • “A new evidence-based framework aims to establish a U.S. industry standard for measuring health equity efforts.
    • “Put out by the Institute for Healthcare Improvement (IHI), the white paper has been in the works for two years. It offers a four-step approach to help healthcare teams across settings identify health disparities. Advancing health equity is defined in the paper as reducing and eliminating health disparities that adversely affect historically underserved groups.
    • “We’re hoping that this will be a standardized approach to data and measurement,” Nikki Tennermann, IHI senior project director and an author of the white paper, told Fierce Healthcare. “We wanted to make sure that this framework was accessible to big large integrated health systems but also maybe it’s a small local mental health alliance.”
    • “In healthcare, there is no single standard to identify, quantify, track and report health equity gaps in patients, per the paper. The framework aims to address that. More than 35 subject-matter experts representing clinical, quality, payer, academic and administrative roles contributed to the framework.”  
  • Fierce Pharma notes,
    • “Six years since the FDA blessed Sanofi and Regeneron’s Dupixent as the first biologic to treat chronic rhinosinusitis with nasal polyps (CRSwNP), a second biologic therapy has broken through with a nod in the indication.
    • The U.S. regulator has endorsed Amgen and AstraZeneca’s Tezspire as an add-on maintenance treatment for patients age 12 and older. The first-in-class monoclonal antibody, which is injected monthly, inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine which triggers inflammation.
    • It’s this novel mechanism of action that keys the effectiveness of Tezspire, which has produced clinical results that suggest it could become the top product on the market for CRSwNP.”

From the judicial front,

  • Govexec reports,
    • “The Trump administration on Friday vowed to comply with a judge’s order to halt any layoffs caught up in a court-ordered pause on such reductions, though it left the door open to cuts of personnel not currently party to the lawsuit.” * * *
    • “The plaintiffs on Friday filed an amended complaint seeking to add the National Federation of Federal Employees, the National Association of Government Employees and the Service Employees International Union to the case to ensure protection for those workers as well. In an emergency an emergency hearing for Friday evening, the judge on the case agreed to expand her order to include those employees.”  
  • Beckers Payer Issues relates,
    • “Wellmark Blue Cross and Blue Shield has filed a lawsuit against Iowa’s insurance commissioner, challenging the enforcement of a newly enacted state law that regulates pharmacy benefit managers and the administration of prescription drug benefits.
    • “The lawsuit, filed on Oct. 14 in an Iowa federal court, claims that the legislation violates the First Amendment and the Employee Retirement Income Security Act. The lawsuit stems from the Iowa court’s previous ruling in a case involving the Iowa Association of Business and Industry, which had sought to block the bill, and a ruling in July that partially found the law to be invalid.
    • “While the court granted a preliminary injunction in that case and blocked the law’s enforcement against certain plaintiffs, Wellmark argues that the injunction does not extend to other entities like itself, which were not part of the previous lawsuit. Wellmark claims that the enforcement of the new law would harm its business and members by imposing significant costs and regulatory burdens, especially those tied to provisions the court previously found unconstitutional, including anti-referral and anti-promotion requirements for pharmacies and PBMs.
    • “The complaint also argues that many provisions of the law violate ERISA’s preemption provisions and impose regulations that interfere with the administration of ERISA plans. Wellmark has requested an injunction to block enforcement of the provisions that have been enjoined in the other lawsuit, as well as additional provisions that affect its role in administering ERISA-covered plans.” 
  • The Miller & Chevalier law firm observes,
    • “Air ambulance providers Guardian Flight, LLC, and Med-Trans Corporation, both of whom lost their bids to sue payors in court for payment of No Surprises Act (NSA) Independent Dispute Resolution (IDR) determinations, petitioned the U.S. Supreme Court on October 8, 2025, seeking to overturn a Fifth Circuit decision finding no private right of action under the NSA. Guardian Flight, L.L.C., et al. v Health Care Service Corporation, No. 25-441 (U.S.).” * * *
    • “The majority of federal courts that have addressed the issue of whether the NSA provides a private right of action have decided it does not and the Fifth Circuit is the only federal appellate court to rule on this issue. Without a circuit split, it will be surprising if the Court takes up this issue at this time.” 

From the public health and medical / Rx research front,

  • Per the University of Minnesota’s CIDRAP,
    • “In a precursor to what we might expect in the coming flu season in the United States and across the Northern Hemisphere, a new study shows flu vaccine effectiveness (VE) to be around 50% for both clinic visits and hospital stays for influenza during the 2025 Southern Hemisphere flu season.
    • “The findings, which demonstrate that the vaccine cuts the rate of medical care for flu in half, were published recently in Morbidity and Mortality Weekly Report by researchers with the US Centers for Disease Control and Prevention (CDC), the Pan American Health Organization, and their collaborators in Southern Hemisphere nations.
    • “CDC recommends that all eligible persons aged ≥6 months receive the seasonal influenza vaccine,” the authors note. “The 2025–26 Northern Hemisphere seasonal influenza vaccine composition is the same as that used during the 2025 Southern Hemisphere influenza season and might be similarly effective if the same viruses circulate in the coming season.”
  • Beckers Clinical Leadership tells us,
    • “U.S. adult obesity prevalence has dipped slightly year over year, with fewer states reporting obesity rates at or above 35%. However, the nation continues to face a high overall obesity rate.
    • “That’s according to a new report released Oct. 16 by Trust for America’s Health.
    • “Nineteen states had adult obesity rates at or above 35% last year, down from 23 in 2023, according to “The State of Obesity: 2025,” which is based in part on TFAH’s analysis of 2024 CDC data, and recent data from the 2021-2023 “National Health and Nutrition Examination Survey.”
    • “Still, the analysis found that slightly more than 4 in 10 U.S. adults have obesity, and rates are rising among children and adolescents, with more than 21% of those ages 2 to 19 affected.”
  • Health Day adds,
    • “A new definition of obesity could dramatically increase the number of Americans considered obese.
    • “Under the new definition, the prevalence of obesity rose from around 40% to nearly 70% among more than 300,000 people participating in a long-term health study, researchers reported Oct. 15 in JAMA Network Open.
    • “The new definition takes into account additional measures of excess body fat rather than just relying on body mass index (BMI). BMI is an estimate of body fat based on height and weight.
    • “We already thought we had an obesity epidemic, but this is astounding,” said co-lead researcher Dr. Lindsay Fourman, an endocrinologist at Mass General Brigham in Boston.
    • “With potentially 70% of the adult population now considered to have excess fat, we need to better understand what treatment approaches to prioritize,” she said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “The gut microbiome has been increasingly connected to a myriad of conditions, in part due to the metabolic output of the microbes in the gut. Studies have suggested that exposure to carcinogens or toxins can have a broader impact on health. The brain-gut microbiome connection has also been under investigation. How the gut microbiome impacts the brain’s response to and preference for alcohol has not yet been thoroughly explored.
    • “Researchers at Tufts University have found a connection between a gut fungus, Candida albicans, and the dopamine pathway in the brain. Their paper titled, “Candida albicans colonization modulates murine ethanol consumption and behavioral responses through elevation of serum prostaglandin E2 and impact on the striatal dopamine system,” was published in mBio.” * * *
    • “While many treatments for alcohol use disorder hinge on behavioral modifications, exploration of alternative approaches, including therapies involving the gut microbiome, may be a promising path. “We are excited to learn more about the mechanisms that allow microbes to affect host behavior,” shared [the researchers] Kumamoto and Day with GEN.” 
  • and
    • “Faulty brain circuits seen in Down syndrome may be caused by the lack of a particular molecule essential for the development and function of the nervous system, according to a new study in lab mice. Restoring the molecule, called pleiotrophin, could improve brain function in Down syndrome and other neurological diseases, possibly even in adults, the researchers say.
    • “The scientists conducted their work in mice, rather than in people, so the approach is far from being available as a treatment. But the researchers found that administering pleiotrophin improved brain function in adult mice long after the brain was fully formed. That suggests that the approach could offer major advantages over prior attempts to enhance Down syndrome brain circuits that would have required intervention at extremely precise, and brief, times during pregnancy.
    • “This study is exciting because it serves as proof-of-concept that we can target astrocytes, a cell type in the brain specialized for secreting synapse-modulating molecules, to rewire the brain circuity at adult ages,” said researcher Ashley N. Brandebura, PhD, who was part of the research team while at the Salk Institute for Biological Studies and is now part of the University of Virginia School of Medicine. “This is still far off from use in humans, but it gives us hope that secreted molecules can be delivered with effective gene therapies or potentially protein infusions to improve quality of life in Down syndrome.”
  • The Wall Street Journal reports on human longevity research focused on people living beyond 110 years.
    • “Supercentenarians, a rare group of people older than 110, are tracked and their ages validated by an international nonprofit known as the Gerontology Research Group. Two hundred or so are alive today, the eldest now being a 116-year-old British woman.”
  • Per Radiology Business,
    • “One New York organization recently detailed how it was able to more than double the number of eligible patients who complete lung cancer screenings. 
    • “Over a decade after the U.S. Preventive Services Task Force (USPSTF) recommended lung cancer screening (LCS) in high-risk individuals via low-dose CT scans, utilization of the exam has continued to lag. Less than 20% of eligible patients in the U.S. adhere to LCS recommendations, despite numerous studies highlighting the exam’s ability to spot cancer at its earliest stages. 
    • “A group of providers from the University of Rochester Medical Center (URMC) were able to overcome this statistic, increasing their organization’s LCS rates from 33% in 2022 to 72% in 2025, sharing their findings in the New England Journal of Medicine Catalyst.   
    • “Our biggest success was not only screening a high percentage of eligible patients, but also enrolling those patients in the comprehensive program to ensure they receive the necessary annual follow-up screenings,” noted lead author Robert Fortuna, MD, MPH, professor of primary care and pediatrics at URMC.”

From the U.S. healthcare business front,

  • Beckers Clinical Leadership reports,
    • “Productivity, rather than quality, is gaining prominence in physician bonus structures, according to a recent report from recruiting firm AMN Healthcare. 
    • “Last year, 62% of physician contracts featured a production bonus, the report found. That figure has grown to 66%. In comparison, 16% of contracts included a quality metric in its bonus structure, down from 26% in 2024 and 31% in 2023. 
    • “Productivity metrics include relative value units, net collections, gross billings and patient encounters. Quality ranges from patient satisfaction scores to readmission rates, according to the report. 
    • “Despite initiatives “to steer physician payments toward quality metrics and away from volume-based formulas,” according to the report, “finding the right compensation formula … has been elusive.”
    • “Other industry reports have found a similar trend, with base salary and work RVU productivity remaining the most common aspect of physician compensation plans.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical introduced a pay-per-visit telehealth service for common pediatric conditions like pink eye, skin rashes and asthma prescription medication renewals.
    • “The service offers parents and guardians virtual consultations and expert medical advice for select children’s care needs, Amazon executives said in a blog post.
    • “The telehealth service, available for children ages 2 to 11, can help treat pink eye, lice and more than 10 common skin-related issues such as eczema; bug bites; contact dermatitis; impetigo; fungal rashes (e.g., ringworm); hand, foot and mouth disease; fifth disease; roseola; poison ivy; and diaper rash. This service also covers EpiPen and asthma medication renewals. For any prescriptions that are needed, customers can fulfill those orders through Amazon Pharmacy or the pharmacy of their choice. 
    • “Message-based visits start at $29, and video consultations cost $49. Insurance, Prime memberships or Amazon One Medical memberships are not required to use the service.”
  • and
    • “With the launch of its first direct-to-patient (DTP) program, Genentech is joining the wave of drugmakers setting up direct-to-consumer sales of popular products at steep discounts for cash-paying patients.
    • “The Roche subsidiary’s inaugural DTP program will center on Xofluza, its prescription influenza treatment, according to Thursday’s announcement. The single-dose oral antiviral med will be available to eligible uninsured, underinsured and self-pay patients for $50, down about 70% from its list price, per Genentech.
    • “The program will fulfill Xofluza prescriptions via partnerships with a trio of online pharmacies: Alto Pharmacy, Amazon Pharmacy and Mark Cuban Cost Plus Drug Company. Same-day delivery will be available in some U.S. markets through Alto Pharmacy and Amazon Pharmacy.
    • “The new DTC approach to Xofluza sales “will allow us to reach more patients where they are increasingly interested in seeking their medicines,” Genentech CEO Ashley Magargee said in the announcement.”

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports.
    • “As the government shutdown entered its second week, Democratic lawmakers insisted the tide is shifting toward a deal as some hard-line Republicans express support for extending health insurance subsidies, despite blanket opposition from Republican leadership to any agreement in advance of reopening the government. 
    • “Ending the standoff appears unlikely in the short term — votes aimed at doing so Wednesday yielded similar results as before, with the GOP’s continuing resolution going down for a sixth time, 54-45. The same three Democratic caucus members — Catherine Cortez Masto of Nevada, Angus King of Maine and John Fetterman of Pennsylvania — voted in favor. The Democrats’ continuing resolution was also blocked.
    • “As for the parameters of a potential deal, House Minority Leader Hakeem Jeffries, D-N.Y., once again ruled out a one-year extension of the subsidies. Democrats have called for a permanent extension of the premium tax credits but asked by reporters if a two-year extension was possible, Jeffries didn’t rule it out.”
  • The Wall Street Journal explains who currently gets subsidies in return for receiving coverage under the Affordable Care Act.
  • Because the 2019 shutdown ended due to an air traffic controller walkout, Govexec observes,
    • “The Federal Aviation Administration reported no travel delays due to staffing levels at U.S. air traffic control facilities Wednesday, following a day of some delays related to above-average absences at a handful of facilities.
    • “An FAA operational plan posted about noon Eastern Time on Wednesday, the eighth day of the federal government shutdown, showed no facilities impacted by “staffing triggers.” A day earlier, the same memo showed staffing levels affected operations at major hub airports in Phoenix and Denver, as well as a smaller airport in Burbank, California.
    • “Air traffic controllers are essential to the functioning of the nation’s air transportation system and must continue to work during a shutdown, though they are not paid while it is ongoing.
    • “The group has not yet missed a paycheck during the current lapse in federal funding. The first impact most federal employees will see on their pay will be Friday, when electronic funding transfers are made for the pay period from Sept. 24 to Oct. 7. 
    • “Because Congress has not appropriated money beyond Sept. 30, they would only receive a partial paycheck. Future paychecks would not be allocated until the government reopens.”
  • Per Fierce Healthcare,
    • “The top senator on healthcare policy is taking a hard look at the American Medical Association’s “anti-patient and anti-doctor” handling of the healthcare system’s near-ubiquitous billing and claims processing codes.
    • “Bill Cassidy, M.D., R-Louisiana, who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee, chastised the nation’s leading physician association for “abusing” the Current Procedural Terminology (CPT) coding system and said he will be “actively reviewing” the issue.
    • “In a letter sent Monday but made public Wednesday, he accused the AMA of “charging exorbitant fees to anyone using the CPT code set, including doctors, hospitals, health plans and health IT vendors. These fees inevitably are passed on by CPT users to patients in the form of higher healthcare costs.”
    • “The letter includes requests for the AMA to detail how it incorporates provider feedback into its process for finalizing codes, and for specific details on revenues and spending related to CPT codes.”
  • The Wall Street Journal relates,
    • “The country’s top drugmakers are set to meet in early December at the Four Seasons hotel in Georgetown with Donald Trump Jr. and senior Trump administration officials that regulate the pharmaceutical industry.
    • “The host: BlinkRx, an online prescription drug delivery company that this year installed Trump Jr. as a board member. The summit will conclude with a dinner at the Executive Branch, the exclusive new club founded by Trump Jr. and his close friends, according to people with knowledge of the event and a copy of the invitation viewed by The Wall Street Journal. 
    • “BlinkRx stands to benefit from a shake-up of how patients buy drugs after President Trump urged pharmaceutical companies to sell their medicines directly to consumers. BlinkRx helps drugmakers do exactly that with a service that promises to set up direct-to-patient sales programs in as little as three weeks. TrumpRx, a new government website set to launch in early 2026, would funnel patients to direct-sale sites.”
  • Healthcare Dive informs us,
    • “The top lobby for pharmacy benefit managers has named Adam Kautzner, the head of major PBM Express Scripts, as chair of its board.
    • “As board chair, Kautzner will oversee the Pharmaceutical Care Management Association’s strategy, including defense of the drug middlemen amid growing scrutiny of their role in rising drug costs. 
    • “The PCMA has also created a new council to represent its mid-market clients, a segment of its membership that’s been growing, the lobby said Tuesday. The council will be represented by a new seat on the PCMA’s board to be held by Jeff Park, president of drug pricing platform Waltz Health.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “More than 10 years after bringing one of the first idiopathic pulmonary fibrosis (IPF) drugs to market, Boehringer Ingelheim is freshening up its leadership in the rare lung disease space with a newly approved treatment option.
    • “Jascayd’s Oct. 7 FDA approval makes it the first new therapy for IPF in more than a decade, following in the footsteps of the company’s own Ofev and Roche’s Esbriet, which won their respective FDA nods back in 2014. Together, those two medicines make up the current therapeutic market for IPF in the U.S. 
    • “With a tolerability edge over the older treatments and proven benefits in lung function, Boehringer’s new option could “shape the future of IPF treatment,” Martin Beck, head of the company’s inflammation disease area, told Fierce Pharma in an interview.”
  • BioPharma Dive adds,
    • “Lexeo Therapeutics on Tuesday said the Food and Drug Administration appears willing to review, and potentially approve, its experimental rare disease gene therapy more quickly than previously anticipated.
    • “According to the company, the agency has “indicated openness” to an accelerated approval filing for its treatment — a gene therapy called LX2006 for the neurodegenerative condition Friedreich’s ataxia — that’s based on pooled data from ongoing studies as well as results from a planned pivotal trial.”

From the judicial front,

  • Reuters reports,
    • “A federal appeals court on Monday rejected Novo Nordisk’s (NOVOb.CO) challenge to the U.S. government’s program that gives its Medicare health insurance plan the power to negotiate lower drug prices, the latest in a barrage of lawsuits brought by drugmakers to fail.
    • “The Philadelphia-based 3rd U.S. Circuit Court of Appeals affirmed a lower court’s ruling dismissing the Danish drugmaker’s challenge to the program and the Centers for Medicare and Medicaid Services’ selection of six of its insulin products for price negotiations.
    • “A unanimous three-judge panel rejected Novo’s constitutional challenges to the program, which was part of Democratic former President Joe Biden’s Inflation Reduction Act, and said the law specifically bars courts from reviewing the drugs selected.
    • “A Novo Nordisk spokesperson said the company was assessing its options to appeal the ruling.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “Today the Centers for Disease Control and Prevention (CDC) updated its measles data for the country, showing a total of 1,563 cases in 2025, an increase in 19 cases since last week. This is the most cases seen in the United States since 2000, the year measles was officially declared eliminated. 
    • “Twenty-seven percent of cases have been in children under the age of 5, and 92% of patients are unvaccinated or have an unknown vaccination status. CDC officials have confirmed 44 outbreaks, which account for 87% of confirmed infections.”
  • and
    • “An international team of researchers today reported promising results from a phase 1 trial of a novel vaccine designed to protect against typhoid fever and non-typhoidal Salmonella infections.
    • “The team, led by investigators from the University of Maryland (UM) School of Medicine, reported that the trivalent (three-strain) Salmonella conjugate vaccine (TSVC) produced a strong immune response, and was safe and well-tolerated, in a small group of healthy US adults. The findings from the trial were published today in Nature Medicine.
    • “The investigators say the findings are encouraging and provide a strong foundation for evaluating the vaccine in children. Typhoid fever and invasive non-typhoidal Salmonella (iNTS), which causes severe bloodstream infections, are leading causes of illness and death in children in Africa.
    • “A single vaccine that protects against both could be a game-changer for global pediatric health,” UM School of Medicine Dean Mark Gladwin, MD, said in a university press release.”
  • MedPage Today notes,
    • “Receipt of the 2024-2025 COVID-19 vaccine was associated with decreased risks of severe outcomes, according to an observational cohort study of U.S. veterans.
    • “Looking at COVID-associated outcomes in nearly 300,000 veterans at 6 months, the estimated vaccine effectiveness was 29.3% against emergency department visits, 39.2% against hospitalizations, and 64% against deaths, reported Ziyad Al-Aly, MD, of the VA St. Louis Health Care System, and colleagues.
    • “Overall, vaccine effectiveness for a composite of the three outcomes was 28.3%, with a risk difference per 10,000 people of 18.2 (95% CI 10.7-27.5), they noted in the New England Journal of Medicine.
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
  • The Washington Post lets us know how to stop the No. 1 killer of Americans long before any symptoms. Cardiovascular disease experts propose a new approach to treating heart disease, focusing on atherosclerosis prevention and early detection.
    • To improve your heart health, consider following the American Heart Association’s checklist, said Neha Pagidipati, a cardiovascular disease prevention expert with the American College of Cardiology.
    • The AHA’s “Life’s Essential 8” include:
      • Eating better. Recommendations include whole foods, lots of fruits and vegetables, lean protein, nuts, seeds, and using olive or canola oil for cooking.
      • Staying active.
      • Quitting tobacco and vaping.
      • Getting healthy sleep. For most adults, this is seven to nine hours of sleep each night.
      • Managing weight.
      • Controlling cholesterol. LDL, or “bad” cholesterol, should be 100 milligrams per deciliter or lower, Nissen said.
      • Managing blood sugar. If you have diabetes, pay attention to your hemoglobin A1C levels, which should be below 5.7 percent.
      • Managing blood pressure. For most people, blood pressure should be below 120/80, Nissen said.
  • Medscape adds,
    • “Many people with obesity have chronic pain due to joint stress and inflammation. Speaking to these patients about modifiable lifestyle factors — like diet and exercise — can help improve their pain severity and quality of life.
    • “In a new study published in the European Journal of Nutrition, patients with overweight or obesity who followed a 3-month weight-loss dietary intervention cut chronic musculoskeletal pain scores in half — independent of adiposity changes.”
  • NBC News reports,
    • “Short bursts of purposeful activity — such as walking around the block or lifting small weights — may be the best way to get in the habit of exercising. Bite-sized bits of exercise also improve heart and muscle fitness, a study published Tuesday in BMJ Sports Medicine found.
    • “Less than half of adults in the United States get enough aerobic activity and less than a quarter get the recommended amount of both aerobic and muscle-strengthening exercise. 
    • “When people are asked why they don’t exercise, the answers are almost always the same, no time and no motivation,” Miguel Ángel Rodríguez, a doctoral student in clinical research at the University of Oviedo in Spain, who led the study, said in an email.”
  • Per Health Day,
    • “Memantine improves social impairments in youth with autism spectrum disorder (ASD), according to a study published online Oct. 1 in JAMA Network Open.
    • “Gagan Joshi, M.D., from Massachusetts General Hospital in Boston, and colleagues examined the safety and efficacy of memantine for treating social impairments in youths with ASD in a 12-week placebo-controlled randomized clinical trial. The study population included 42 youths aged 8 to 17 years with ASD without intellectual disability who initiated treatment. The intention-to-treat efficacy analysis included 35 youths (16 treated with memantine and 19 with placebo).”
  • and
    • “More women are choosing to freeze their eggs, but fewer are returning to use them, according to a study published online Aug. 29 in the American Journal of Obstetrics & Gynecology.
    • “Mabel B. Lee, M.D., from the University of California, Los Angeles, and colleagues assessed national trends in planned oocyte cryopreservation, subsequent oocyte utilization, and outcomes of oocyte warming cycles. The analysis included data from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (2014 to 2021).”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Medical practice network OneOncology has acquired GenesisCare USA of Florida and is relaunching the practice as SunState Medical Specialists.
    • “The deal adds more than 100 physicians, including urologists, oncologists and surgeons, at 104 clinics throughout Florida to OneOncology’s portfolio, according to a Wednesday news release.
    • “GenesisCare USA of Florida was part of GenesisCare, an Australia-based cancer treatment provider that filed for Chapter 11 bankruptcy protection in 2023. The company, which was backed by private equity firm KKR and China Resources Capital, entered the U.S. in 2020 when it acquired 21st Century Oncology.
    • “As part of bankruptcy proceedings, GenesisCare sought to restructure with about $1.7 billion in debt and separate U.S. operations from those in Australia and Europe. It emerged from the bankruptcy process in 2024 and trimmed its U.S. footprint to Florida and North Carolina markets. 
    • “OneOncology, which is majority owned by TPG Capital, said the latest Florida deal builds on the company’s previous investments in urology. It plans to invest in upgraded technology at SunState Medical and expand access to clinical services such as advanced radiation therapies and interventional radiology, according to the release.”
  • BioPharma Dive tells us,
    • “Having closed a nine-figure fundraising round, a newly launched biotechnology company hopes to rewire the immune system with drugs aimed at a special kind of nerve cell.
    • “Nilo Therapeutics debuted Wednesday, equipped with $101 million from a Series A financing that was co-led by the venture capital firms DCVC Bio, Lux Capital and The Column Group. Alexandria Venture Investments and the Gates Foundation also contributed to the round.
    • “The fresh money, according to Nilo, will go toward growing the biotech’s research and development team, advancing its preclinical drug programs, and establishing laboratories in New York City. Nilo formed through a collaboration between The Column Group and three Ivy League scientists — Charles Zuker, of Columbia University; Ruslan Medzhitov, of Yale University; and Stephen Liberles, of Harvard University.”
  • Per Fierce Healthcare
    • “As pharma giant Eli Lilly builds out its direct-to-consumer care site, LillyDirect, the company has tapped virtual primary care company HealthTap to join its small lineup of independent care providers.
    • “Consumers who come to LillyDirect in search of specific treatments or Lilly-manufactured medications, such as GLP-1s, can find educational materials on common health conditions and access recommendations for in-person or virtual care. 
    • “LillyDirect has been building out its network of independent care providers for a slew of healthcare conditions and specialities, including diabetes, obesity, cancer, dermatology, autoimmune, sleep apnea and migraine.
    • “HealthTap will be listed as a provider for treating type 1 and type 2 diabetes on the LillyDirect site.”
  • and
    • “Allara Health, a virtual women’s health provider, has expanded to all 50 states. 
    • “The provider, specializing in women’s hormonal, metabolic and reproductive health, was in 30 states at the start of the year. Alongside news of the expansion, Allara has also published clinical outcomes data that demonstrate improvements in patient health in a health impact report.
    • “The retrospective analysis included nearly 1,500 patients who either had a PCOS diagnosis or were being seen for other hormonal or metabolic care. It found that in the first nine months of care, patients with a body mass index (BMI) in the obese range (equal to or greater than 30) achieved a 5% mean BMI reduction. A 5% weight reduction is considered clinically significant, the report said.
    • “The analysis also found that after 10 months, two-thirds of prediabetic patients had normalized their A1C levels, and 77% of diabetics reduced their A1C levels out of the diabetic range. Patients with a high level of insulin resistance saw a 12% reduction in those levels.” 
  • and
    • “Amazon Pharmacy is rolling out kiosks stocked with prescription medications to help patients get their meds immediately after appointments. 
    • “The kiosks will launch across One Medical locations in Los Angeles starting December 2025. Expansion to additional One Medical offices is expected soon after. The kiosks will contain commonly prescribed meds like antibiotics, inhalers and blood pressure medications. Controlled substances and medications requiring refrigeration are not available.” 

Tuesday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “The guarantee of back pay for furloughed federal employees is now in limbo, as the White House weighs a different interpretation of the 2019 law that ensures federal employees get compensated following a government shutdown.
    • “A new draft legal opinion from the Office of Management and Budget, as first reported by Axios, argues that whatever funding legislation Congress ultimately passes to end the current shutdown must explicitly include appropriations to provide back pay for furloughed federal employees. And if it’s not expressly written in the spending legislation, the OMB memo argues that furloughed workers cannot receive any retroactive compensation.
    • “A copy of the OMB document, which a senior White House official shared with Federal News Network, appears to contradict OMB’s previous interpretation of the Government Employee Fair Treatment Act, or GEFTA, which President Donald Trump signed into law in 2019 during the last government shutdown. Both OMB and the Office of Personnel Management previously affirmed that under GEFTA, excepted and furloughed employees would be given back pay as soon as possible, once any current or future shutdown ends.”
  • In the FEHBlog’s opinion, this draft OMB opinion is a lead balloon.
  • Healthcare Dive shares six takeaways from CMS Administrator Mehmet Oz’s appearance on Monday before a Washington D.C. think tank audience.
  • Modern Healthcare reports,
    • “Federal regulators say they have made inroads into speeding up the process to resolve out-of-network billing disputes. It’s not enough for frustrated providers and health insurance companies.
    • “The No Surprises Act’s Independent Dispute Resolution, or IDR, process has been a punching bag for both camps since it launched in 2022, and a backlog of cases had piled up by the beginning of this year.
    • “But the share of IDR cases unsettled after 30 business days fell from 69% in January to 34% in July, the most recent month for which data are available, according to the Health and Human Services, Labor and Treasury departments. Likewise, 96.5% of disputes submitted since 2022 are either resolved or are less than 30 business days old, the departments wrote in a notice published Sept. 19.
    • “The departments’ efforts have delivered remarkable improvements in the throughput of cases compared to prior years,” the notice says. “IDR entities are now resolving disputes faster than they are submitted.”
  • STAT News informs us,
    • “The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.
    • “Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.”
    • “They have to now,” said one lobbyist of their clients’ thinking, noting the “anger”with Pfizer for effectively adding to their pressure to come to an agreement with the administration.
    • “The people cautioned that negotiations remain unfinished and several variables, including the government shutdown, could delay any announcements.
    • “The growing chatter around potential announcements signals the Trump administration’s pressure campaign may be paying off. But whether the deals will actually accomplish the administration’s objective — lowering prescription drug prices — remains unknown.”
  • Fierce Healthcare points out,
    • “The current state of the Medicare Part D market is a mixed bag, with premiums declining but many payers scaling back options, according to a new analysis from KFF.
    • “The report noted that the Centers for Medicare & Medicaid Services put an emphasis on “stability” in Part D when it announced premium estimates in late September, but KFF found that the total number of stand-alone Part D plans available will decrease in 2026, marking the third straight year of shrinking plan options.
    • “Some payers are trimming down their offerings, per the report. For example, Centene is ending three drug plans offered through WellCare and Health Care Service Corporation is discontinuing one of Cigna’s three Part D plans and pulling back from certain regions.
    • “Other insurers, such as Elevance Health, are exiting the stand-alone Part D plan market entirely.
    • “For 2026, beneficiaries in each state will be able to select from between eight and 12 stand-alone Part D plans, in addition to Medicare Advantage prescription drug coverage. Across the 34 Part D plan markets, a total of 360 plans will be made available by 17 parent organizations—a decrease of 22% from 2025.”
  • “As many major insurers scale back on Medicare Advantage,” Beckers Payer Issues takes a “look at the insurers that are fully backing out.”
  • NextGov/FCW explains how OPM Director Scott Kupor plans “to attract tech talent [to federal government employment] after months of workforce cuts.”
  • Per HR Dive,
    • “The U.S. Senate confirmed Brittany Panuccio, an assistant U.S. attorney for the Justice Department in Florida, as a commissioner for the U.S. Equal Employment Opportunity Commission in a 51-47 vote Tuesday. Panuccio’s confirmation was part of an en bloc vote on several nominations.
    • “Panuccio fills the seat vacated in December by Keith Sonderling, who was named deputy labor secretary in March, and gives Republicans a majority. Her term expires July 1, 2029. 
    • “Panuccio’s confirmation restores a quorum to EEOC, which has operated with only two commissioners since January, when President Donald Trump fired Democratic commissioners Charlotte Burrows and Jocelyn Samuels before the expiration of their terms.”

From the Food and Drug Administration front,

  • Healio adds,
    • “The FDA approved Zoryve cream 0.05% for the treatment of children aged 2 to 5 years with mild to moderate atopic dermatitis, according to a press release. 
    • “Currently, there are approximately 1.8 million children aged 2 to 5 years being treated with a topical therapy for AD. Zoryve (roflumilast, Arcutis) cream 0.05% is a once-daily, next-generation phosphodiesterase-4 inhibitor that offers a nonsteroidal option for children and their caregivers.
    • “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and vice chair of the department of dermatology at University of California San Diego, said in the release. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reassuringly explains how to get a Covid booster vaccination under the CDC’s newly approved guidelines.
  • MedPage Today reports
    • “To prevent measles outbreaks, public health systems and clinicians should look below the 35,000-foot view of state- and county-level vaccination rates against measles, mumps, and rubella (MMR) and instead aim their focus on at-risk school districts and schools, according to a statewide analysis of Texas counties.”
  • and
    • “The pre-cooked pasta Listeria recall broadened to include pasta salads and prepared dishes at Kroger, Trader Joe’s, and more grocery stores.
    • “Some Hello Fresh meals may contain Listeria-tainted spinach, USDA’s Food Safety and Inspection Service warned.
    • “Chicken corn dog products from Foster Poultry Farms also were recalled after wood was found in the batter causing at least five injuries. (NBC News)”
  • Per Healio,
    • “Changing trajectories of heart health markers during young adulthood were associated with potentially increased risk for cardiovascular disease later in life, researchers reported.
    • “In addition, individuals who maintained higher levels of CV health through young adulthood had lower risk for incident CVD vs. those whose CV health was maintained at lower levels or declined, according to data published in JAMA Network Open.”
  • and
    • “Acupuncture needling greatly improved pain-related disability in older adults with low chronic back pain compared with usual care, a randomized controlled trial demonstrated.
    • “Acupuncture may be an effective and safe pain management tool for many older adult patients,” Lynn L. DeBar, PhD, MPH, a researcher at Kaiser Permanente Center for Health Research, told Healio. “While it is unlikely to take away all the pain, this study suggests that it can decrease pain-related disability substantively.”
  • The New York Times considers that “He was expected to get Alzheimer’s 25 years ago. Why hasn’t he? Scientists are searching for the secret in [76-year-old] Doug Whitney’s biology that has protected him from dementia, hoping it could lead to ways to treat or prevent Alzheimer’s for many other people.”
  • Per Health Day,
    • “Preschoolers who regularly overeat are likely swallowing their emotions as well, a new study says.
    • “Girls who overeat as preschoolers are more likely to develop anxiety, impulsivity and hyperactivity when they grow into teenagers, researchers reported in the journal BMC Pediatrics.
    • “The results indicate that children’s eating patterns could be early signs of mental health challenges, researchers said.
    • “Occasional overeating is normal, but if a child frequently overeats, it can be a sign of emotional struggles,” senior researcher Linda Booij, a professor of psychiatry at McGill University in Quebec, Canada, said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “A research team co-led by scientists at Institute for Bioengineering of Catalonia (IBEC) and West China Hospital Sichuan University (WCHSU), working with partners in the U.K., has developed a nanoparticle technology that studies showed can reverse Alzheimer’s disease (AD) in mice. Unlike other types of nanomedicine that rely on nanoparticles as carriers for therapeutic molecules, this approach employs nanoparticles that are bioactive in their own right, and which the team refers to as “supramolecular drugs.”
    • “Instead of targeting neurons directly, the therapy restores proper function of the blood-brain barrier (BBB), the vascular gatekeeper that regulates the brain’s environment. The BBB is a cellular and physiological barrier that separates the brain from the blood flow to protect it from external dangers such as pathogens or toxins. Through their newly reported research the investigators demonstrated that targeting a specific mechanism enables undesirable “waste proteins” produced in the brain to pass through this barrier and be eliminated in the circulation. In Alzheimer’s disease, the main waste protein is amyloid-β (Aβ), the accumulation of which impairs normal neuronal function.
    • “By repairing this critical interface, the researchers observed a significant reduction in brain amyloid-β (Aβ) levels and a reversal of Alzheimer’s pathology in the animal models, with cognitive benefits lasting up to six months following treatment.
    • “Study lead Giuseppe Battaglia, PhD, ICREA research professor at IBEC, principal investigator of the Molecular Bionics Group, and colleagues reported on their findings in Signal Transduction and Targeted Therapy, in a paper titled “Rapid amyloid-β clearance and cognitive recovery through multivalent modulation of blood–brain barrier transport,” in which they stated, “This innovative therapeutic paradigm offers a promising pathway for developing effective clinical interventions, addressing vascular contributions to AD, and ultimately enhancing patient outcomes…The therapeutic trilogy achieved—amyloid clearance, barrier restoration, and sustained cognitive recovery—establishes a blueprint for precision neurovascular medicine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “It was a repeat performance for all 10 children’s hospitals named as the nation’s best in this year’s iteration of U.S. News & World Report’s ranking.
    • “The highly watched list, now in its 19th year, reviewed outcomes, practices and surveyed opinions for 198 children’s hospitals.
    • “Of these, 86 hospitals were named in some respect, whether that be a top-10 ranking for 10 different pediatric specialties and/or as one of 50 unranked facilities named as a high performer on pediatric and adolescent behavioral health.
    • “Among these, 10 children’s hospitals were named to the list’s honor roll for scoring well across multiple specialties. That unranked collection is identical to last year’s honorees.
      • “Boston Children’s Hospital
      • “Children’s Hospital Colorado, Aurora
      • “Children’s Hospital Los Angeles
      • “Children’s Hospital of Philadelphia
      • “Children’s National Hospital, Washington, D.C.
      • “Cincinnati Children’s
      • “Nationwide Children’s Hospital, Columbus, Ohio
      • “Rady Children’s Hospital, San Diego
      • “Seattle Children’s Hospital
      • “Texas Children’s Hospital, Houston”
  • and
    • “Providers are betting on artificial intelligence to ease the pain point of prior authorization, a new survey shows.
    • “Cohere Health, which provides clinical intelligence to insurers and risk-bearing providers, polled 200 clinicians and office administrators and found that 99% of clinicians report confidence in using AI to back prior authorization. Most (96%) office administrators said the same.
    • “Two-thirds of those surveyed said a completely digital prior authorization process would significantly improve their workflows. Across the board, the respondents said the process should have real-time tracking baked into the experience, allowing them to track the status of key requests.
    • “Providers are speaking loud and clear: they want and deserve a prior authorization process that is smarter, simpler and more transparent,” said Brian Covino, M.D., chief medical officer of Cohere Health, in an announcement.”
  • Healthcare Dive relates,
    • “Saint Peter’s Healthcare System and Atlantic Health abandoned plans to merge on Monday, citing impacts of the “rapidly evolving healthcare landscape nationally.”
    • “The New Jersey-based health systems first announced plans to combine in January last year and signed a definitive agreement to merge in June 2024. 
    • “The systems shared scant details about why the deal fell apart. However, in a joint statement issued Monday both Atlantic President and CEO Saad Ehtisham and Saint Peter’s President and CEO Leslie Hirsch called the deal’s end disappointing.”
  • STAT News informs us,
    • “Just a decade ago, a doctor with multiple medical licenses was an anomaly. Sometimes physicians would apply for credentials from a few states if they lived near a border and wanted the flexibility to practice on either side, since a doctor needs to be licensed where their patient is physically located. In-demand specialists might get a few more if they wanted to see patients virtually. But in the years since Covid began driving patients online, the number of physicians seeking multi-state licensure has ballooned to support the growing field of telehealth.
    • “Within that group, a STAT analysis of physician licenses shows that a small but powerful cohort of physicians is accumulating licenses in all 50 states, plus the nation’s capital and its territories. These physicians don’t max out on licenses just to practice across state lines. Often, they own the medical groups that are affiliated with nationwide telehealth companies. A doctor’s full roster of medical licenses can be leveraged for online businesses that provide specialty care, build patient funnels for pharma companies seeking to sell drugs directly to consumers, prescribe compounded meds — or sometimes, all of the above. 
    • “In 2016, just nine physicians in the U.S. held active licenses in all 50 states, according to data from the Federation of State Medical Boards. By 2024, 172 doctors had filled out their bingo card, and another 356 doctors had acquired at least 45 licenses — significantly outpacing the profession’s overall growth.”
  • As we approach Open Season, the American Diabetes Association offers “Health Insurance Aid for Diabetes. Access to medical care is key to managing your diabetes. Get more information on resources available to people living with diabetes.”

Monday report

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, FDA, Government Contracting, Medical / Rx research, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump signaled a willingness to strike a deal on funding healthcare subsidies demanded by Democrats, as the government shutdown entered its second week. 
    • “We have a negotiation going on right now with the Democrats that could lead to very good things,” Trump told reporters in the Oval Office on Monday. 
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) said formal talks hadn’t commenced. “Trump’s claim isn’t true. But if he’s finally ready to work with Democrats, we’ll be at the table,” he said in a statement.” * * *
    • “After Trump’s comments on Monday, Sen. Markwayne Mullin (R., Okla.) said he had spoken with Democrats and the president in an informal way about healthcare, but funding the government must come first. “Once they reopen the government, we’ll be happy to talk about the way we make healthcare better for the American people,” he said.” * * *
    • “At a press conference late Monday, House Minority Leader Hakeem Jeffries (D., N.Y.) said he hadn’t heard from Trump, but it was “an interesting statement that the president has made.” He said that he would be willing to talk with Trump or White House officials at any time.” 
       
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations by the Advisory Committee on Immunization Practices. Patients are now advised to consult their health care provider if they want to receive a COVID-19 vaccine, which would be covered by health insurance like other routine vaccines. In addition, it is now recommended that children through age 3 receive a standalone chickenpox vaccine rather than the combined measles, mumps, rubella and varicella vaccine.”
  • The Washington Post adds,
    • “What does it mean to consult a clinician [/ their health care provider?
    • “The CDC website lists health care providers who can be involved in discussing vaccines with patients. They include anyone else who provides or administers vaccines, including primary care physicians, specialists, pharmacists, physician assistants, nurse practitioners and registered nurses.
    • “That means a person doesn’t necessarily need to make a doctor’s appointment to get a vaccine.
    • “Pharmacists are trained to discuss pros and cons of all medications with patients, including coronavirus vaccines.”
  • Per Health Day,
    • “The U.S. Food and Drug Administration is considering changes to a 20-year-old warning on menopause hormone therapy
    • “Experts say the warning has discouraged safe use of treatment for hot flashes, poor sleep and other symptoms
    • “Research suggests hormone therapy can be safer and more effective when started earlier in menopause.”
  • Bloomberg Law points out,
    • “A new regulatory pilot project from the US Centers for Medicare and Medicaid Services is under review at the White House budget office, suggesting that the Trump administration is seeking to take regulatory action against drugmakers even as it strikes deals with individual companies.
    • “There are no details about the policy CMS plans to test, titled the “Guarding US Medicare Against Rising Drug Costs” pilot, including what drugs or companies could be impacted. Regulatory pilot projects help the government determine if a new regulation will save money, allowing it to experiment with rules before implementing them widely.
    • “The proposed regulation is the agency’s second recent move toward new rules on drug prices; another posted on Sept. 25.”
  • Healthcare Dive informs us,
    • “Arbitration of surprise billing disputes between insurers and providers will continue despite the government shutdown, the CMS said on Friday.
    • “Parties that disagree over how much an out-of-network claim should be reimbursed can still submit disputes via the federal independent dispute resolution portal, and arbiters will continue to process disputes, according to the agency.
    • “However, a prolonged shutdown could throw a wrench in other processes that underlie the implementation of the No Surprises Act, which was passed in 2020 to protect consumers from unexpected out-of-network bills. Since congressional appropriations lapsed last week, Congress has made no progress on a deal to reopen the government.”
  • The Healthcare Financial Management Association lets us know that “No Surprises Act arbitration has been a bonanza for a few provider groups. For-profit provider companies have fared well in the NSA’s independent dispute resolution portal even as the process remains a frequent subject of litigation.”
    • “In a span of 2.5 years through 2024, providers reaped more than $2.2 billion from the No Surprises Act’s arbitration process, relative to the applicable in-network payment rates for the disputed care episodes.
    • “The awards received through the NSA’s independent dispute resolution (IDR) process largely arise from “disputes that are primarily initiated and won by private-equity-backed providers,” said Kennah Watts, research fellow at the Center on Health Insurance Reforms at Georgetown University.
    • “Driven by that handful of groups, the volume of IDR disputes “continues to surpass agency estimates by millions,” Watts said during a webinar presented by Health Affairs.”
    • “Although the involvement of private equity (PE) frequently raises questions in healthcare, some smaller providers might struggle to effectively engage with the IDR process if not for that support, panelists noted during a discussion as part of the webinar.”
  • Per Govexec,
    • “Dr. Kevin Rhodes has received Senate confirmation to lead the White House’s Office of Federal Procurement Policy, a move that designates him as the first permanent leader of that component in six years.
    • “Senate lawmakers approved the nomination of Rhodes on Thursday, five months after the White House announced him as President Trump’s choice for the role.
    • “Rhodes has been acting as a senior adviser to OFPP’s parent agency, the Office of Management and Budget, since February with the responsibility of leading the Trump administration’s push to restructure federal procurement.
    • “All but one section of the Federal Acquisition Regulation has been overhauled since then. OFPP and the FAR Council have collaborated on the effort and gradually rolled out the changes.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Immunologists Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi were awarded the Nobel Prize in Physiology or Medicine for uncovering a process that prevents the immune system from attacking our own tissues, called peripheral immune tolerance. The work unlocked a new field of research and potential therapies.
    • “The trio identified a core feature of how the immune system functions and keeps itself in-check: regulatory T-cells. They prevent other immune cells from harming our own bodies and developing autoimmune conditions including Type 1 diabetes and rheumatoid arthritis. Based on this fundamental knowledge, clinical trials are ongoing to test therapies for autoimmune diseases, cancer and post-organ transplantation.
    • “Their discoveries have been decisive for our understanding of how the immune system functions and why we do not all develop serious autoimmune diseases,” said Olle Kämpe, chair of the Nobel Committee on Monday.
    • “Brunkow is now based at the Institute for Systems Biology in Seattle, Ramsdell at the San Francisco and Seattle-based Sonoma Biotherapeutics, while Sakaguchi is a distinguished professor at Japan’s Osaka University. The group will share the 11 million Swedish kronor, or roughly $1.1 million, prize.”
  • Heath Day reports,
    • “An alarming trend is emerging on America’s roads.
    • “More drivers killed in crashes are testing positive for THC, the active ingredient in marijuana.
    • Researchers in Ohio reviewed autopsy records from 246 drivers killed in crashes between 2019 and 2024.
    • “They found that 41.9% had THC in their system — at levels far above what most states consider impairment.
    • “The average blood level was 30.7 nanograms per milliliter. By comparison, many states set legal limits between just 2 and 5.
    • “The researchers say that means the drivers likely used marijuana close to the time of the crash. The study also found the high rate of THC positivity stayed consistent over six years and didn’t change when recreational pot became legal in Ohio in 2023.
    • “The lead author says from a public health standpoint, there hasn’t been enough attention on the dangers of legalization.”
  • and
    • “When someone has whooping cough, the sound can be unmistakable: A deep, gasping “whoop” as they struggle to catch their breath between fits of coughing. 
    • “Now, this once-rare illness, also known as pertussis, is making a comeback across the United States.
    • “Cases have now surpassed pre-pandemic levels, and while the disease can be exhausting for adults, experts warn it can be life-threatening for newborns and infants, especially those under two months old.
    • “Most babies in this age group who contract pertussis are hospitalized, according to a report published Oct. 3 in the journal Pediatrics.”
    • “Pertussis symptoms are different in infants,” said lead author Dr. Caitlin Li, an infectious diseases specialist at Ann & Robert H. Lurie Children’s Hospital of Chicago and assistant professor of pediatrics at Northwestern University Feinberg School of Medicine. “The characteristic whooping cough may be absent, but apnea, or breathing interruption, is common.” * * *
    • “Given that infants are at high risk for complications, pertussis vaccination of mothers during pregnancy is critical, as it protects newborns against this potentially fatal illness,” Li explained in a news release. “Widespread vaccination is also an important tool to protect everyone.”
  • The American Cancer Society lets health plans know “how to address cancer care gaps to improve cost and clinical outcomes at every step.”
  • Genetic Engineering and Biotechnology News discusses the largest genetic map of human metabolism ever created.
    • “The contribution of genetics to the variability in people’s metabolism has remained largely unknown. This is, in part, because genetic studies of human metabolism have been limited in scale and allelic breadth. Now, the largest genetic map of human metabolism has been created, revealing new insights on the role of metabolites in health and disease and creating a blueprint for further research.
    • “This work is published in Nature Genetics in the paper, “A genetic map of human metabolism across the allele frequency spectrum.”
  • Per Healio,
    • “Adults with obesity who reported more intense tastes while receiving semaglutide or tirzepatide had a higher likelihood for increased satiety and decreased appetite and food cravings, according to a presenter.
    • “In a cross-sectional study presented at the European Association for the Study of Diabetes annual meeting and published in Diabetes, Obesity and Metabolism, researchers surveyed adults with obesity who were using semaglutide (Ozempic/Wegovy, Novo Nordisk) or tirzepatide (Mounjaro, Eli Lilly) and asked about changes in their appetite, satiety and sensory perception after starting an incretin-based therapy. Researchers found some adults reported increased intensity of sweet and salty tastes, and increased intensity of both types of tastes were tied with greater odds for increased satiety. However, change in taste did not affect weight-related outcomes.
    • “This means that taste perception changes may serve as markers of appetite response rather than predictors of treatment success,” Othmar Moser, PhD, professor in the division of endocrinology and diabetology in the department of internal medicine at Medical University of Graz in Austria and in the division of exercise physiology and metabolism at the Institute for Sports Science at University of Bayreuth in Germany, told Healio. “The findings highlight the nuanced ways incretin therapies act beyond pure metabolic regulation.”
  • BioPharma Dive relates,
    • “An experimental weight loss drug from Skye Bioscience failed a mid-stage clinical trial, wiping out most of the San Diego biotechnology company’s market value.
    • “Skye said Monday its therapy, an obesity medicine targeting a kind of cannabinoid receptor, didn’t significantly lower weight loss compared to a placebo after 26 weeks of treatment. Patients who received Skye’s drug, nimacimab, achieved only 1.5% weight loss, compared to less than 0.3% for placebo recipients. In a statement, Skye blamed the findings on the dose it chose for the study, arguing an analysis found that a 200 milligram weekly injection is “suboptimal as a monotherapy.”
    • “Nimacimab fared better when paired with semaglutide, the active ingredient in Novo Nordisk’s Wegovy, and tested against semaglutide alone. In that study cohort, patients on the combination lost just over 13% of their body weight, compared to more than 10% for those only on semaglutide. Skye said the findings support the potential for future studies evaluating combinations of nimacimab and other so-called incretin-based therapies widely used for weight loss.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Physician pay is increasing, largely through sign-on bonuses, but higher salaries alone often aren’t enough to retain physicians or attract top-tier talent.
    • “Advanced technology, paid time off and compensation for on-call requirements are just a few of the demands incoming physicians have for potential employers, according to respondents to Modern Healthcare’s 2025 Physician Compensation Survey. This year’s results reflect data from nine staffing and consulting firms, indicating that the trend of rising physician compensation isn’t likely to slow down anytime soon.
    • “If you’re employing physicians or any staff, you’re probably going to have to pay higher wages, particularly now,” said Chad Stutelberg, a managing director at consulting firm Gallagher. “The physicians have more leverage.”
  • Beckers Hospital Review notes,
    • “Rite Aid has closed its final 89 stores, bringing an end to operations after decades as one of the largest pharmacy chains in the U.S.
    • “All Rite Aid stores have now closed. We thank our loyal customers for their many years of support,” the company said on its website.
    • “The company filed for Chapter 11 bankruptcy protection in October 2023 and shuttered 154 stores. It filed again in May after failing to recover. 
    • “The pharmacy chain once operated more than 5,000 stores at its peak and employed about 45,000 people in 2023, including 6,100 pharmacists.”
  • The Washington Post reports,
    • “Popular weight-loss drugs Ozempic and Wegovy are now being sold at below sticker prices at Costco pharmacies across the United States, as rising obesity levels boost demand for the drugs and cheaper copycat versions.
    • “Novo Nordisk’s U.S. president, David Moore, told NBC News that the drugmaker’s push into Costco is a way to “offer the real, authentic Wegovy and Ozempic where patients seek care.”
    • “It comes as the Danish pharmaceutical giant seeks to head off competition from rival manufacturers, after sales of copycat drugs from compound pharmacies soared amid national shortages.
    • “The drugs, which mimic a natural hormone to curb hunger and make people feel full for longer, will be available on prescription to Costco members for an out-of-pocket price of $499 a month.
    • “The current list price of Ozempic is nearly $1,000 per injectable pen while Wegovy is around $1,350.”
  • Beckers Payer Issues tells us nine things to know about confusion among older adults before Medicare open enrollment.
  • Per Fierce Healthcare,
    • “Online therapy provider Talkspace acquired Wisdo Health to integrate peer support and coaching into its mental health services.
    • “Wisdo is an artificial-intelligence-powered coaching and peer-to-peer support platform that gives users 24/7 access to trained peers, moderated communities and group coaching to help combat social isolation and loneliness.
    • “The acquisition will enhance Talkspace’s service line, offering lower-acuity options and complementing existing therapy and psychiatry services. 
    • “Financial terms of the acquisition were not disclosed.”
  • and
    • “Health data company CertifyOS has unveiled its new Provider Hub platform, technology that allows insurers greater insight into key data across their provider network.
    • “Through Provider Hub, payers can tap into unified and real-time provider data that are critical to operations. The company said in an announcement that these data have traditionally been managed in siloed systems, spreadsheets and outdated tools that hinder effective use.
    • “When payers lack access to complete or usable provider data, it can have a negative impact on a slew of key business functions, Certify said, including compliance with key regulations, member experience and claims processing. 
    • “The Provider Hub takes in and cleanses, normalizes and validates key provider data from multiple sources, including credentialing, directories, claims and other internal systems. The platform leans on artificial intelligence to support this effort, according to the announcement.”
  • Per Beckers Health IT,
    • “AI-powered customer engagement company Qualtrics has agreed to acquire healthcare market research firm Press Ganey for $6.75 billion, the Financial Times reported Oct. 6.
    • “Press Ganey, currently owned by investor Ares Management and private equity firm Leonard Green & Partners, conducts surveys on behalf of over 41,000 health systems and other healthcare organizations.
    • “The deal would give Qualtrics, which deploys AI for such uses as ordering food online and rescheduling hotel stays and flights, a foothold in healthcare alongside other tech players including Oracle and Palantir, the Times reported.”

Tuesday report

David Ermer–AHRQ, CMS, Generative AI, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SDOH, Telehealth, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Many seniors enjoy the perks that come with Medicare Advantage. But those extras—like dental coverage and free gym memberships—are being scaled back.
    • “Insurers are cutting benefits and exiting from unprofitable markets, and Wall Street is cheering them on. Once rewarded by investors for rapid expansion in the lucrative privatized Medicare program, companies are now being applauded for showing restraint amid rising medical costs and lower government payments.” * * *
    • “To be clear, major insurers aren’t exiting Medicare Advantage. Apart from Cigna, which sold its Medicare business last year, the big players are still betting on the program—some are likely to take advantage of the turmoil to increase their market share. And the market is arguably still well served and competitive, especially in densely populated areas. Even after some moderation last year, the average beneficiary this year had 42 plan options from which to choose, according to health-research nonprofit KFF. 
    • “As the industry pivots to leaner operations, Wall Street may regain confidence. But the era of red-hot Medicare Advantage growth is over, at least for now. While Democrats have led efforts to cut overpayments, Republicans also face mounting pressure to curb spending—especially after recent tax cuts, notes Deutsche’s [George] Hill. He warns that more regulatory shifts may be coming, including a potential overhaul of the star ratings system, which governs billions in bonus payments tied to plan quality and patient satisfaction.
    • “Until that picture clears, investors will continue to reward restraint and tightly managed risk. In today’s Medicare Advantage market, and across government insurance programs, growth is taking a back seat to profitability.
  • BiioPharma Dive tells us,
    • “The U.S. plans to put tariffs of up to 250% on pharmaceutical imports over the next year and a half, President Donald Trump said in a Tuesday interview with CNBC.
    • “Trump said he would put a “small tariff” on such imports initially but added that he would raise the duties to 150% and then 250% in “one and a half years maximum.” The president indicated that announcements of pharmaceutical tariffs, as well as duties on semiconductors, would be announced “within the next week or so.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the beginning of a coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA), including the cancellation and de-scoping of various contracts and solicitations. The decision follows a comprehensive review of mRNA-related investments initiated during the COVID-19 public health emergency.
    • “We reviewed the science, listened to the experts, and acted,” said HHS Secretary Robert F. Kennedy, Jr. “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.” * * *
    • “While some final-stage contracts (e.g., Arcturus and Amplitude) will be allowed to run their course to preserve prior taxpayer investment, no new mRNA-based projects will be initiated. HHS has also instructed its partner, Global Health Investment Corporation (GHIC), which manages BARDA Ventures, to cease all mRNA-based equity investments. In total, this affects 22 projects worth nearly $500 million. Other uses of mRNA technology within the department are not impacted by this announcement.” * * *
    • “The move signals a broader shift in federal vaccine development priorities. Going forward, BARDA will focus on platforms with stronger safety records and transparent clinical and manufacturing data practices. Technologies that were funded during the emergency phase but failed to meet current scientific standards will be phased out in favor of evidence-based, ethically grounded solutions – like whole-virus vaccines and novel platforms.”
  • Roll Call lets us know,
    • “The Trump administration is escalating its push against what has become a key part of the way states, localities and communities respond to the overdose epidemic: harm reduction. 
    • “A public health approach aimed at mitigating the negative health effects associated with drug use, harm reduction aims to prevent overdoses and infectious disease transmission.
    • “Methods can involve the use of opioid overdose reversal medications such as naloxone, providing sterile needles to limit the transmission of infectious diseases, test strips that detect fentanyl in drugs, and “safe consumption sites,” where people can use drugs under supervision in case they need intervention.” * * *
    • “In a “Dear Colleague” letter sent to states last week, Art Kleinschmidt, principal deputy assistant secretary at SAMHSA, said he doesn’t consider naloxone a harm reduction method and as such it would continue to be funded by the government. Kleinschmidt said test kits and other services can also be funded through grants.
    • “But the letter stated that federal funding can’t be used to “purchase pipes or other supplies for safer smoking kits nor syringes or needles used to inject illicit drugs” or “any other supplies to promote or facilitate drug use.” 
    • “Moving forward, SAMHSA funds will no longer be used to support poorly defined so-called “harm reduction” activities; rather, SAMHSA is providing guidance to state agency leadership and to grantees through new award terms and conditions that provide clarity on what supplies and services previously defined under the umbrella of harm reduction can be supported with SAMHSA funding,” Kleinschmidt wrote.” 

From the public health and medical research front,

  • The American Hospital Association News informs us,
    • “Patients in the hospital for surgeries had better outcomes in 2024 than they did in 2019, according to a new report released today by the AHA and Vizient. 
    • “The significant improvement aligned not only with better performance on patient safety metrics — such as reductions in infections and falls — but also with marked declines in three major surgical patient safety indicators: severe bleeding, sepsis and respiratory failure. * * *
    • “The new findings build on a report AHA released in collaboration with Vizient last year showing that hospitals and health systems performed better on key patient safety and quality measures in the first quarter of 2024 than they did before the COVID-19 pandemic. In fact, hospitals’ efforts to improve safety led to 200,000 Americans hospitalized between April 2023 and March 2024 surviving episodes of care they wouldn’t have in 2019.” 
  • MedPage Today reports,
    • “Unhealthy alcohol use is a leading cause of death and serious illness among U.S. adults.
    • “In new draft guidance, the USPSTF reaffirmed that all adults should be screened for unhealthy alcohol use and [newly] recommended brief behavioral counseling interventions when appropriate.
    • “The task force found insufficient evidence to make the same recommendation in adolescents.”
    • The public comment period ends on September 2, 2025.
  • Healio adds,
    • “Testing for hepatitis C virus infection every 6 to 12 months — or even more frequently — among people who inject drugs could be a beneficial, cost-effective strategy, according to a study published in JAMA Health Forum.“
    • USPSTF recommends hepatitis c screening for adults aged 18 to 79 without known liver disease.
      • “Most adults need to be screened only once. Persons with continued risk for HCV infection (e.g., PWID) should be screened periodically. There is limited information about the specific screening interval that should occur in persons who continue to be at risk for new HCV infection or how pregnancy changes the need for additional screening.”
        • The JAMA Health Forum study fills in the screening interval information gap.
  • Per STAT News,
    • “Nathan Young, a community neurologist at the Mayo Clinic, recently saw a patient whose diagnosis he couldn’t quite nail down. Parkinson’s seemed a likely possibility, but Young was concerned she might instead have a rare neurological disorder called progressive supranuclear palsy, or PSP, which can progress much more rapidly. 
    • “I opened a can of worms,” said Young: He ordered a PET scan of the patient’s brain, but the radiology report only confused matters. Instead of ruling out PSP, it suggested yet a third diagnosis: Alzheimer’s. 
    • “Normally at this point, Young would call in other specialists as reinforcements, including Mayo’s renowned experts. But this time he had something different to help: a new AI tool called StateViewer.”
    • “Developed by Mayo’s Neurology AI program, StateViewer takes scans like the one Young ordered — they’re called FDG-PET scans, named for the radioactive tracer they use — and spits out a report of similar brains that have been scanned in Mayo’s clinical and research networks. The output: a differential diagnosis of nine potential types of dementia. In development over the last several years, StateViewer hit the rails at all three Mayo campuses four months ago, and it’s been run thousands of times on patients’ brain scans.”
  • and
    • “Vertex Pharmaceuticals said Monday afternoon that its next-generation non-opioid pain reliever failed to significantly outperform placebo in a Phase 2 trial.
    • “The experimental drug, codenamed VX-993, is similar to the company’s recently approved pill Journavx but could potentially be given at higher doses and formulated as an IV infusion. The hope is that it could thus provide superior relief or offer an alternative to IV opioids. But after Monday’s results, the company said it would discontinue efforts to develop the drug as a single-agent medicine for acute pain.”
    • “We do not plan to advance VX-993 as monotherapy in acute pain, because we do not expect that it will be superior to our [existing] NaV1.8 inhibitors,” said CEO Reshma Kewalramani during a Monday afternoon earnings call with investors, using a scientific shorthand for the class of drugs. She noted that the company will continue a trial testing the drug in patients with diabetes who have chronic nerve pain.”
  • Cardiovascular Business points out,
    • “A surgeon at Cleveland Clinic has performed the world’s first robotic-assisted heart surgery of its kind, using CardioPrecision’s CoreVista Robot Enabling Platform to implant Corcym’s Perceval Plus aortic heart valve through a small incision in the patient’s neck.
    • “The successful operation, known as AVATAR (Advanced Videoscopic Aortic valve surgery by Transcervical Approach using Robot assistance), was performed by Marijan Koprivanac, MD, a cardiovascular surgeon with Cleveland Clinic’s Heart, Vascular and Thoracic Institute. Other robotic techniques for aortic valve replacement have already been in use, including the robotic aortic valve replacement procedures developed at the WVU Heart and Vascular Institute, what sets this approach apart is the fact that everything is done through that small incision in the neck. 
    • “Combining the artificial heart valve with this new surgical technology means patients should experience less pain and time in the hospital following heart surgery,” Koprivanac said in a statement. “In fact, we believe that this may be one of the least invasive surgical heart valve replacement options now available.”
  • Per Genetic Engineering and Biotechnology News,
    • “Amyotrophic lateral sclerosis (ALS) is an incurable neurological disorder affecting motor neurons (MNs), which are nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing. Many ALS clinical trials, including those testing promising drugs, have fallen short of expectations, commonly because the extent of the disease can vary, and not all patients respond the same way to medications.
    • “Scientists at Case Western Reserve University now report new insights into one type of ALS, that may point towards a therapeutic approach for different types of the disorder. The team studied inducible pluripotent stem cell (iPSC)-motor neurons (MNs) carrying the P56S mutation in a protein called vesicle-associated membrane protein-associated protein-B (VAPB), which is responsible for a familial form of ALS. Their findings provided evidence that the mutation activates integrated stress response (ISR) via mitochondrial dysfunction in motor neurons and also indicated that pharmacological inhibition of ISR using ISRIB helped to rescue ALS-associated phenotypes in both VAPB P56S and patient-derived IPSC-MNs.
    • “Although the research centered on this rare form type of ALS, the investigators are optimistic the positive results could provide clues for potentially treating the devastating disorder more broadly. Study lead Helen Cristina Miranda, PhD, an associate professor of genetics and genome sciences at Case Western Reserve’s School of Medicine, suggested, “This work could help lay the foundation for genetically informed clinical trials.”
    • “Miranda and colleagues reported on their study in EMBO Molecular Medicine, in a paper titled “Convergent activation of the integrated stress response and ER–mitochondria uncoupling in VAPB-associated ALS,” concluding, “This is the first study to mechanistically connect a known ALS mutation with ISR activation, highlighting the potential for mutation-specific therapeutic targeting and patient stratification in ISR-modulating clinical trials.”
  • The National Institutes of Health announced a “new study to test if mothers’ diet prevents early sign of food allergy in babies. NIH trial to assess if eating peanuts, eggs during pregnancy, breastfeeding protects infants.”
    • “The study, called Expecting Mother’s Study of Consumption or Avoidance of Peanut and Egg (ESCAPE), will be led by Kirsi Järvinen-Seppo, M.D., Ph.D., chief of Pediatric Allergy and Immunology and Founders’ Distinguished Professor in Pediatric Allergy at University of Rochester Medicine. Results are expected in 2029. 
    • “More information about the trial, including contacts for people who are interested in participating, is available at ClinicalTrials.gov under study identifier NCT06260956.”
  • NIH Research Matters covers the following topics this week: “Treating CoQ10 deficiency | Specialized blood vessels in organoids | Fat-fueled neurons.”
  • Beckers Hospital Review identifies “seven new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • CIGNA, writing in LinkedIn, discusses the importance of access to mental health services.
    • “Virtual care appointments have emerged as a valuable tool in providing mental health services, particularly in remote or underserved areas. Connecting with mental health professionals via telephone, video calls, and even smart phone apps, make it easier to access care without the need for travel. Additionally, virtual care often reduces wait times, providing quicker access to necessary care.
    • “Community-based mental health programs are another effective approach. These programs use the strengths and resources of local communities to provide support and care. Community health workers, peer support groups, and local organizations can play a vital role in delivering mental health services and promoting mental well-being.
    • “Integrating mental health services into primary care is also promising. By training primary care providers to recognize and address mental health issues, individuals can receive holistic care that addresses both their physical and mental health needs. This integration can help improve overall health outcomes.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that drugmakers make more of their medicines available direct to consumers in the U.S. at lower cost, Pfizer CEO Albert Bourla said Tuesday.
    • “We have serious discussions in the industry,” Bourla told investors on a conference call Pfizer held to discuss its earnings for the second quarter. “I’m connected very often individually with all the major companies, and they are all ready to roll up their sleeves and execute something like that.”
  • MedTech Dive relates,
    • “Alcon has agreed to buy implantable lens maker STAAR Surgical for about $1.5 billion in total equity value, the companies said Tuesday.
    • “Alcon, which will purchase all outstanding shares of STAAR for $28 per share in cash, expects STAAR’s refractive surgery offerings to complement Alcon’s laser vision correction business.
    • “BTIG analyst Ryan Zimmerman said Alcon is getting “a solid deal” given STAAR’s setbacks in the China market. The company is betting on a recovery in China and the longer-term health of lens-based refractive surgery, said the analyst.”
  • Per Fierce Healthcare,
    • “Shares of Hims & Hers tumbled 12% in after-hours trading Monday after the company’s second-quarter revenue missed Wall Street analysts’ expectations.
    • “The company faces headwinds in its compounded GLP-1 drug business after pharma giant Novo Nordisk pulled the plug on a monthlong collaboration to make its weight loss drug Wegovy available on the telehealth company’s platform. The company had to off-board GLP-1 subscribers from the branded version of the drug, executives said.
    • “Hims & Hers continues to sell compounded semaglutide, the active ingredient in Novo’s Wegovy and Ozempic drugs, and these generic versions are more affordable than the branded drugs.
    • “Analysts, however, seem pleased by what they see as strong results and the online health and wellness company’s growth plans, including international expansion, new hormone health offerings and building out standalone lab testing.”
  • and
    • “Online therapy provider Talkspace continues to make big investments in artificial intelligence, seeing opportunities to improve the experience for patients and cut down on paperwork for providers.
    • “Talkspace connects people via an app with therapists who provide counseling remotely, either over the phone, by video chat or by text.
    • “The company is building out foundational large language models specifically for behavioral health using its internal, de-identified clinical data sets, as it claims to have the “largest behavioral health datasets in the industry,” consisting of millions of therapeutic interactions on the Talkspace platform over the past 12 years.
    • “Unlike existing, horizontal, general-purpose LLMs, we are working closely with mental health clinicians experienced with evidence-based therapeutic frameworks,” CEO Jon Cohen, M.D., told investors during the company’s second-quarter earnings call Tuesday. “Talkspace behavioral health LLMs are being developed specifically to understand the language complexity and workflows of mental health delivery. Once up and running, these behavioral health LLMs will be an integral part of how we provide higher-quality care to our Talkspace members.”
  • Modern Healthcare reports,
    • “Virtual behavioral health provider Cerebral announced Tuesday it had acquired Resilience Lab, which offers therapy and medication management through its online platform. The deal, which closed last week, includes Resilience’s clinician development program aimed at training and supporting early-career therapists. 
    • “The combined organization will be led by Cerebral CEO Brian Reinken under the Cerebral brand, with Resilence Lab Co-founder Marc Goldberg holding the president role, according to a spokesperson. Dr. Carl Marci will join the company as chief medical officer, and Resilience Lab Co-founder Christine Carville will serve as chief clinical officer. Cerebral representatives declined to disclose financial details of the deal.”
  • and
    • “Quest Diagnostics has completed its acquisition of some clinical testing assets from Spectra Laboratories, a subsidiary of dialysis company Fresenius Medical Care.
    • “Under the agreement, Quest will provide dialysis-related clinical testing to independent clinics formerly served by Spectra Laboratories.
    • “As part of a separate deal with Fresenius, Quest said in a Tuesday news release it expects to complete the acquisition of select dialysis-related water testing assets by the end of the year. It also said it plans to start providing comprehensive dialysis-related laboratory services for centers operated by Fresenius in the U.S. The transition of services is slated to be completed by early next year.”

Friday report

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s second weekly blog post which is titled “Rightsizing with a purpose.”
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. is planning to remove all the members of an advisory panel that determines what cancer screenings and other preventive health measures insurers must cover, people familiar with the matter said.
    • “Kennedy plans to dismiss all 16 panel members of the U.S. Preventive Services Task Force because he views them as too “woke,” the people said.
    • “The White House has made a priority of targeting initiatives that promote diversity equity and inclusion, or DEI, in everything from artificial intelligence to health research grants.
    • “The task force has advised the federal government on preventive health matters since 1984. The Affordable Care Act in 2010 gave it the power to determine which screenings, counseling and preventive medications most insurers are required to cover at no cost to patients. The group, made up of volunteers with medical expertise who are vetted for conflicts of interest, combs through scientific evidence to determine which interventions are proven to work.
    • “The Supreme Court decided a case in June that centered on a task-force recommendation to cover HIV-prevention drugs. The employer plaintiffs in the case had argued that requiring them to cover such drugs for employees violated their religious rights and that the task-force members weren’t properly appointed. The high court ruled that the task- force appointments were constitutional, while highlighting that the Health and Human Services Secretary has the authority to remove the members of the panel at will.”
  • Per a Senate news release,
    • Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Maggie Hassan (D-NH), and Roger Marshall, M.D. (R-KS) highlighted the importance of fully implementing the No Surprises Act, which protects patients from surprise medical bills and ensures they know the cost of care before receiving it. This bipartisan legislation was signed into law by President Trump in 2020 as part of his efforts to improve price transparency and lower health costs for American patients.
    • “Nearly five years ago, President Trump signed the No Surprises Act (P.L. 116-260) into law. This historic, bipartisan legislation protects patients from surprise medical bills and ensures that they know the cost of care before receiving it,” wrote the senators. “Ensuring that patients have transparent, personalized cost estimates for their health care is a bipartisan priority. Full implementation of both the good faith estimate and advanced explanation of benefits are critical to providing patients with the entirety of protections enacted under the No Surprises Act…We commend President Trump’s commitment to price transparency and stand ready to assist to ensure a successful and complete implementation of the No Surprises Act.”
    • Since the bipartisan legislation led by Senators Cassidy and Hassan was signed into law by President Trump in 2020, the No Surprises Act has protected American patients from more than 25 million surprise medical bills. This would not be possible without the work of the Departments of Health and Human Services, Labor, and the Treasury.
    • To build on this success, the senators are requesting rules to implement provisions in the law to give covered patients clear cost estimates before their scheduled medical care. To date, the good-faith estimate has been implemented for uninsured and self-pay patients. Additional rulemaking is needed to implement the good-faith estimate and the advanced explanation of benefits for covered patients. For a patient with insurance, providers and facilities are required to provide the good-faith estimate to the individual’s health plan or issuer of coverage, which in turn, must use the estimate to give the patient an advanced explanation of benefits outlining what the plan will cover and what the individual will owe out of pocket.
    • Read the letter here 
  • If Congress wants to improve the No Surprises Act, it should refine the dispute resolution process.
  • Healthcare Dive tells us,
    • “More than 200 telehealth and provider organizations are asking the Trump administration to hammer out regulation governing telehealth prescriptions of controlled substances before pandemic-era flexibilities expire at the end of the year. 
    • “In a letter sent to Terry Cole, the newly confirmed administrator of the Drug Enforcement Administration, the groups urged the administration to ensure a plan is in place by fall so patients can continue to receive remote prescriptions of controlled substances.
    • “The Biden administration proposed a framework for telehealth prescriptions just before President Joe Biden left office in January, but some industry groups have panned the proposed rule as too onerous for providers.”

From the public health and medical research front,

  • The U.S. Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among young children 0-4 years old. COVID-19 model-based epidemic trends (Rt) and wastewater activity levels indicate that COVID-19 activity is increasing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota’s CIDRAP adds,
    • “Emergency department visits rose 4.8% compared to the week before, mainly in children up to 4 years old. Test positivity rose slightly and is now at 5.3% nationally, with levels highest in the Southwest, followed by the South.
    • Wastewater SARS-CoV-2 detections remained at the low level and are highest in the West, with other regional hot spots, including Louisiana with very high activity and Florida with high activity.
    • “The CDC has not updated its variant proportion estimates since the middle of June owing to low numbers of sequences reported when the NB.1.8.1 subvariant was the most common. Variant proportions predicted from testing in international travelers during the same period suggested the XFG variant—one of many JN .1 offshoots— was most common. Both are considered variants under monitoring by the World Health Organization, which in late June said XFG seems to have a moderate growth advantage and a low risk of immune escape, though it added that confidence in its assessments were low because of recent expansion and low sequencing levels.”
  • The CDC also reports,
    • “Tetrahydrocannabinol (THC), a psychoactive substance found in Cannabis sativa plants, including varieties such as hemp, is increasingly being used in consumer products.
    • “During October 22–24, 2024, at least 85 persons, ranging from age 1–91 years, ate food from a restaurant in Wisconsin and experienced symptoms consistent with THC intoxication. The restaurant was in a building with a cooperative (i.e., shared) kitchen used by a state-licensed vendor who produced edible THC products. The restaurant mistakenly used THC-infused oil from the cooperative kitchen to prepare dough.
    • “Clinicians and public health practitioners should be alert to the possibility of mass THC intoxication events via food.
  • Doug Corley, MD, PhD, of The Permanente Medical Group, tells us why rising colon cancer rates—up 2% yearly in younger patients—demand earlier screening.
    • “Younger people are at increased risk compared to what they were,” said Doug Corley, MD, PhD, chief research officer for The Permanente Medical Group. Colorectal cancer “is a substantial problem, and it causes a lot of mortality … and morbidity.”
    • “The Permanente Medical Group is a part of the AMA Health System Member Program, which provides enterprise solutions to equip leadership, physicians and care teams with resources to help drive the future of medicine.
    • “Dr. Corley discussed the growing concerns about colon cancer in younger people, as well as how The Permanente Medical Group is helping these populations in a recent episode of “AMA Update.”
  • The American Hospital News lets us know,
    • “A report from AARP and the National Alliance for Caregiving released today found nearly 1 in 4 U.S. adults (63 million) are caring for an adult or child with a complex medical condition or disability. Over half of the caretakers are managing complex medical and nursing tasks like injections, wound care or medication management, though only 20% have training to do so.”
  • Per Medscape,
    • “Urgent care visits frequently result in inappropriate prescribing, with 12.4% leading to antibiotic fills, 9.1% to glucocorticoid fills, and 1.3% to opioid fills. Analysis of over 22.4 million urgent care visits revealed concerning patterns, including 40.8% of acute bronchitis visits resulting in inappropriate glucocorticoid prescriptions.” * * *
    • “Inappropriate prescribing in urgent care is influenced by clinician knowledge, patient demands, and lack of decision support. Antibiotic, glucocorticoid, and opioid stewardship programs are needed to reduce inappropriate urgent care prescribing and support long-term glucocorticoid and opioid deprescribing efforts,” wrote the authors of the study.”
    • “The study was led by Shirley Cohen-Mekelburg, MD, MS, Division of Gastroenterology and Hepatology and Institute for Healthcare Policy and Innovation, University of Michigan in Ann Arbor, Michigan. It was published online on July 21 in Annals of Internal Medicine.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Centene swung to a loss in the second quarter and offered a drastically reduced projection for full-year earnings, delivering a result even worse than Wall Street feared amid growing signs of a financial meltdown across the health-insurance industry.
    • “The managed-care company, which focuses on Medicaid, Affordable Care Act plans and Medicare, withdrew its earnings guidance for 2025 earlier this month, citing rising costs in Medicaid and problems in the ACA business. 
    • “Centene’s latest woes come after smaller competitor Molina Healthcare reduced its 2025 earnings projection for the second time in a month, and larger Elevance Health reported cost pressures as well. Industry bellwether UnitedHealth Group is set to report earnings next Tuesday, after earlier this year withdrawing its own guidance and replacing its chief executive. 
    • “The entire industry is contending with rising costs as well as a shifting membership and regulatory landscape across various lines of business that appear to have weakened insurers’ ability to predict the risks of the populations they enroll—a fundamental function.
    • Centene said in a conference call with analysts on Friday that it expects results to improve next year as it seeks higher payments and tightens its operations.” 
  • STAT News adds,
    • “Hospitals’ finances are strongly influenced by two factors: the prices they negotiate with insurers and how many patients they treat in their facilities. Right now, the latter does not appear to be the main driver of their strong profits. Inpatient and outpatient surgeries, which tend to be hospitals’ profit centers, were down slightly at both companies. Admissions barely budged. Another hospital chain, Community Health Systems, reported similarly underwhelming patient numbers this week. 
    • “It’s a different story among insurers, who say they’re being forced to shell out more money than usual for their members’ medical costs, particularly those who rely on Medicaid and Affordable Care Act plans. Elevance’s finance chief described what’s happening as a “market-wide morbidity shift,” meaning patients are sicker than the companies had expected when they priced their policies.
    • “One number may help explain why hospitals are faring well as insurers struggle: the amount of money hospitals make on each patient. In Tenet’s outpatient surgery business, revenue per case was up 8.3% year-over-year on a same-facility basis. In its hospital segment, that metric grew 5.2%. Tenet chalked that up to charging insurers higher prices — framed as patients having better-paying insurance — and its focus on offering higher-acuity services like cardiac care and orthopedics. At HCA, revenue per admission grew 4% year-over-year on a same-facility basis.”
    • “And consider which services are at issue for insurers. On the Medicaid front, Elevance said its members are using more home health, transportation, adult day care, and services to help them with daily activities like bathing and dressing. They’re also getting more behavioral health services and inpatient surgeries. As for people on ACA plans, the increase in care is concentrated among emergency room visits, behavioral health services, and high-cost drugs. 
    • “But on Friday, HCA said it’s seeing less demand for services among Medicaid patients.”
  • Here’s a link to a Beckers Hospital Review story about HCA’s second quarter earnings announcement.
    • “Nashville, Tenn.-based HCA Healthcare has reported “16 consecutive quarters of volume growth,” highlighting the strength of its diversified network of markets and services, CEO Sam Hazen said July 25 during the company’s second-quarter earnings call.
    • “The for-profit health system reported a 1.7% year-over-year increase in equivalent admissions for the second quarter and a 2.3% rise year-to-date. YTD managed care equivalent admissions — including the exchanges — increased 4%, in line with HCA’s expectations, according to CFO Mike Marks. Medicare grew 3%, slightly below the company’s expectations.
  • Per Beckers Payer Issues,
    • “With GLP-1 medication costs being a top concern for employers heading into 2026, UnitedHealthcare is addressing the challenge through its Total Weight Support program, aimed at improving weight loss outcomes for employees while managing the costs of medication adherence. 
    • “In our conversations and consultations with employers, they are all looking for solutions for their employees who are dealing with obesity and metabolic conditions that bring better value,” Rhonda Randall, DO, chief medical officer for UnitedHealthcare’s commercial business, told Becker’s. “Total Weight Support was put into the marketplace as a comprehensive solution for employers who are looking for that full-person approach to care for their beneficiaries and employees dealing with obesity.”
  • Mercer consulting offers detailed compliance consideration for GLP-1 drug coverage.