“Simplicity is a great virtue but it requires hard work to achieve it and education to appreciate it. And to make matters worse: complexity sells better.”
– Edsger W. Dijkstra

From Washington, DC

• Per a Senate Committe news release,
  • “On Wednesday, November 18, [beginning at 9:45 am ET] the U.S Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on nominations for the U.S. Equal Employment Opportunity Commission (EEOC), Department of Education, Department of Health and Human Services (HHS), Occupational Safety and Health Review Commission, and the National Science Foundation.” * * *
  • “Click here to watch live.”

• STAT News adds,
  • :The Senate health committee has scheduled a pivotal vote for next week on the nomination of Heidi Overton to serve as commissioner of the Food and Drug Administration — despite lingering doubts from Republicans on the panel.
  • “The vote is set for Nov. 18, according to a committee release. If it passes, Overton’s nomination would then go to the full Senate, where Republicans are racing to confirm nominees before Democrats take power in January. The committee will also vote on James O’Neill’s nomination to serve as director of the National Science Foundation and three other nominations. 
  • “Even as he scheduled the vote, committee Chair Bill Cassidy (R-La.) remained undecided on Overton, he wrote in a post on X. It would take just one Republican on the committee to sink her nomination, assuming all Democrats vote against her.

• BioPharma Dive relates,
  • “Two months after China unveiled a five-year plan to accelerate the ascent of its fast-rising biotechnology sector, a prominent lobbying group is pitching a policy proposal designed to help the U.S. maintain an edge in the field.
  • “The “action plan” by the Biotechnology Innovation Organization unveiled Tuesday lays out seven priorities Congress and the Trump administration should act on to “ensure” the U.S. remains the sector’s “global leader.” Called “BioAdvance: Securing America’s Biotech Century,” it involves ways to speed up drug development, improve the nation’s clinical trial infrastructure, attract investment and better support biomedical research.
  • “BIO also calls on the U.S. to establish a “White House Office of Biotechnology” to help coordinate these plans and keep them on track. 
  • “This moment demands the ambition and determination that catalyzed the biotechnology revolution and made America the definitive global leader,” said BIO President and CEO John Crowley in a statement.”

From the judicial front,

• STAT News reports that PHI Health, a large air ambulance company, is directly suing self-funded employers of all different sizes for unpaid No Surprises Act arbitration awards,
  • PHI Health, a national chain, is arguably the most aggressive company suing employers, which it claims are not “passive” bystanders in insurers’ refusal to fully pay awards. Other regional physician practices have sued some employers as well. But PHI and its army of attorneys have filed lawsuits against hundreds of companies, demanding they collectively pay tens of millions of dollars in unpaid out-of-network claims that it won in the federal arbitration process. 
  • PHI isn’t just suing small, local firms like Hancock’s. It’s also taking legal action against some of the largest corporations — Amazon, Walmart, Eli Lilly, United Airlines, General Motors, PepsiCo, State Farm, and Toyota, to name a few — as well as unions, counties, cities, states, public school districts, and universities.
• FEHBlog observation: That’s a big bowl of wrong.

• Beckers Payer Issues relates,
  • “At least 11 health insurers have now sued CMS over their 2027 Medicare Advantage star ratings, claiming the agency used quality measures that were never formally adopted through the rulemaking process. Combined, the plans say the ratings will cost them nearly $4 billion.”
  • The article discusses the 11 lawsuits.

From the public health and medical / Rx research front,

• Beckers Hospital Review reports,
  • “Emergency physicians in Baltimore are seeing a rise in preventable ER visits tied to GLP-1 medications as more people buy them online and use them without medical supervision, according to a Nov. 10 report from WBAL-TV.
  • “Miriam Fischer, MD, an emergency medicine physician at Columbia, Md.-based MedStar Health, told the station that patients arrive at the ER every day with side effects from GLP-1s. “We see a lot of people come in with stomach upset, but even more severe,” she said, describing patients who can’t keep anything down, can’t tolerate food or drink and have severe dehydration. She said the drugs can also lead to complications such as biliary disease, including gallbladder problems and pancreatitis, and that dehydration raises the risk of kidney stones.
  • “Dr. Fischer said GLP-1s slow the digestive system, so mild nausea or stomach upset is normal, but the drugs should not cause severe pain. She called the medications “wonderful” but said patients need to be under a physician’s care.”
    
• Medscape adds,
  • “The investigational triple incretin agonist drug retatrutide was associated with significant improvement in knee osteoarthritis (OA) pain and physical function along with weight loss in people with painful knee osteoarthritis and obesity, data from two phase 3 trials showed. 
  • “We saw very exciting amounts of pain reduction and function improvement over time. I think this is a big advance… Osteoarthritis has lacked effective therapies for so long,” study investigator Philip Conaghan, MBBS, PhD, director of the NIHR Biomedical Research Centre in Leeds and professor of musculoskeletal medicine at the University of Leeds, United Kingdom, told Medscape Medical News.” 

• The American Hospital Association News relates,
  • “A study on substance-related emergency department visits and hospitalizations published Nov. 4 by The American Journal of Psychiatry found that cannabis was involved in most visits by adolescents and young adults, while alcohol made up the majority for older adults. The study examined more than 1.3 million individuals aged 16-64 with at least one substance-related ED visit between January 2016 and December 2023. The data included visits related to opioids, alcohol, cannabis, stimulants and other substances. Researchers found that 84% of adolescents aged 16-18 with a substance-related ED visit or hospitalization had at least one encounter involving cannabis, the highest of any age group. Visits involving cannabis were at 19% for adults aged 55-64, the lowest for any age group. The study found that 33% of adolescents had an emergency encounter involving alcohol, a percentage that rose steadily the higher the age group. For the oldest group, ages 55-64, 70% had an alcohol-related encounter.

• The Wall Street Journal tells us,
  • “Timothy Ketchum was interested in natural supplements, not drugs. But somehow he ended up with an opioid-like addiction that stole two years of his life, cost him tens of thousands of dollars, and left him unable to go more than 12 hours without taking another dose.
  • “The culprit: 7-hydroxymitragynine, or 7-OH, a potent kratom derivative sold in concentrated forms at convenience stores and vape shops across the country.” * * *
  • “Some addiction specialists say they are seeing a growing number of patients dependent on 7-OH, even more than other opioids like fentanyl. Many consumers don’t realize what they are taking or how addictive it can be. The Food and Drug Administration has said 7-OH can cause dependence and withdrawal symptoms similar to those associated with opioids like fentanyl, and that it produces respiratory depression with more than three times the potency of morphine.
  • “With federal regulators moving to restrict the products, doctors say medications used to treat opioid addiction, particularly buprenorphine, can help people dependent on 7-OH, although there are no established treatment guidelines. 
  • “We need to be advertising that buprenorphine can be helpful for people who are struggling,” says Dr. Eliza Hutchinson, medical director of addiction services at Packard Health in Michigan.
  • “Treatment doses and duration of buprenorphine vary widely. Some patients may need months or even years of buprenorphine to prevent relapse. Doctors speculate that people who have used 7-OH longer or have a history of opioid addiction may need longer treatment.”

• The New York Times adds,
  • “A new meta-analysis found that certain antidepressants worked better on average than Prozac at helping people with depression feel better and stick with their treatment over the long term.
  • “The analysis looked at 21 different drugs across 115 studies to identify which drugs were most likely to help patients who planned to use antidepressants for more than three months. The study authors compared each drug to Prozac, also known as fluoxetine, because it’s a well-known drug that has been commonly prescribed, researchers said.
  • “While most of the antidepressants were comparable in terms of how well they worked or how long patients stayed on them, there were some subtle differences. People taking escitalopram (Lexapro), duloxetine (Cymbalta) or agomelatine (Thymanax), were more likely than those taking fluoxetine to see their symptoms improve and stay better.
  • “And there were two medications that performed worse than multiple other antidepressants: bupropion (known as Wellbutrin or Zyban) and reboxetine (Edronax).”

• The American Medical Association lets us know “5 things patients should know about microplastics”
  • “How concerned should you be about microplastics’ health impact, and what steps can you take? Philip Kuriakose, MD, explores on the latest “Health vs Hype” AMA podcast episode.”

• Health Day informs us,
  • “Patients with stable heart disease who received a stent implant or bypass surgery early in their treatment did not live longer than those who received more conservative treatment, a new study found.
  • “Conservative treatment involved prescription drugs and lifestyle changes aimed at lowering cholesterol and blood pressure.
  • “Our analyses make clear that while managing stable coronary artery disease with early heart procedures helps relieve chest pain and improves quality of life in those with chest pain, it is unlikely to help patients live longer,” lead researcher Dr. Judith Hochman, a professor of cardiology at NYU Grossman School of Medicine, said in a news release.
  • “Researchers reported their findings Nov. 7 in JAMA.
  • “This research contradicts decades of advice from cardiologists, who have commonly recommended that people with clogged arteries receive stents or bypass surgery even if they were stable and had no symptoms, researchers said.”

• Cardiovascular Business adds,
  • “An artificial intelligence-derived measure of inflammation from noncontrast CT shows promise for cardiovascular risk prediction that goes beyond traditional coronary artery calcium (CAC) scoring. 
  • “A new analysis in JAMA suggests that these AI-assessed scores could help identify patients at elevated cardiovascular risk even when their calcium levels are low or absent on imaging. The study’s findings indicate that the scores’ prognostic performance is comparable to the established CCTA measures and could offer a way to assess coronary inflammation without requiring contrast-enhanced imaging.” 

• STAT News points out,
  • “A study of nearly 100,000 Americans identified thousands of new variants in a set of genes that influence our responses to prescription drugs, thanks to the inclusion of participants from a more diverse set of ancestries than previous studies of these so-called pharmacogenes.
  • “Using data from the National Institute of Health’s All of Us program, the researchers found that every participant carried at least one variant in the 16 pharmacogenes they studied, and that one in four participants had taken a medication that could be affected by these variants.
  • “The new paper, published Wednesday in Science Translational Medicine, advances efforts to use genetic data to personalize drug treatments, and should make this area of research useful to a broader population. 
  • “This really furthers the emerging evidence of how genetically guided clinical care adds benefit across a diverse population,” said Loren Saulsberry, a health policy researcher who has done work on equity and pharmacogenomics but was not involved in the new paper.” 

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

• The Wall Street Journal points out,
  • “Blackstone Life Sciences agreed to pay up to $1.5 billion to help Pfizer PFE develop a GLP-1 receptor.
  • The investment is set to cover development costs for berobenatide, an investigational drug being studied for chronic weight management and obesity-related conditions.
  • In exchange for the funding, Blackstone would be eligible to receive milestone-based payments, the companies said Wednesday. Pfizer still needs U.S. regulatory approval of the drug to achieve the commercial sales milestones.
  • Any milestone payments, if earned, would be payable to Blackstone over a multi-year period. Blackstone hasn’t acquired any rights or ownership to the drug, and Pfizer retains full control over operations and decision-making.
  • Pfizer plans to advance 20 or more trials for obesity and related conditions in 2026. That includes 10 continuing and planned Phase 3 trials for berobenatide.

• Beckers Hospital Review reports,
  • “Humana has launched a cancer care model aimed at easing the prior authorization process for oncology providers. 
  • “The model was developed in partnership with the American Oncology Network and specialty care management company Evolent, according to a Nov. 10 news release from Humana.
  • “The American Oncology Network — which spans more than 350 providers across 21 states — has rolled out Humana’s model at its clinics in eight states. Under the model, practices that meet quality and evidence-based treatment standards can bypass the traditional prior authorization process for most anticancer drugs.
  • “Participating practices also have access to an analytics platform that draws on real-time EHR data to inform individualized treatment plans, the release said.”
• and
  • “Becker’s compiled a list of the 180 hospitals across 39 states that have a five-star rating in both nurse and physician communication.
  • “CMS shares 10 HCAHPS star ratings based on publicly reported Hospital Consumer Assessment of Healthcare Providers and Systems measures. The physician communication star rating combinesdata from three HCAHPS survey questions and summarizes how well patients feel that their physicians explained things clearly, listened carefully to them, and treated them with courtesy and respect. The star rating is based on survey data collected from hospital patients October 2024 through September 2025. The figures are from CMS’ Provider Data Catalog and were released Aug. 13. 
  • “Across both metrics, 197 hospitals received a five-star physician communication rating and 586 hospitals received five-stars in nurse communication.
  • “Wisconsin had the most facilities with a dual five-star rating with 15 hospitals, followed by West Virginia with 12, and Iowa and Pennsylvania with nine each. 
  • “[The article lists] the hospitals who rank highest in both physician and nurse communication by state.”

• Fierce Healthcare relates,
  • “Missouri-based BJC Health and St. Luke’s Hospital are planning a merger.
  • “The providers announced on Wednesday that they have signed a letter of intent to come together, bringing the community hospital into the fold with the Show Me State’s largest health system. The pair expects the deal to improve access and improve local care in the St. Louis region.
  • “St. Luke’s said in the announcement that the letter “follows a deliberate and thorough evaluation process,” conducted by its board of directors and leaders “to identify the best path forward for St. Luke’s and the communities it serves.”
  • “The providers said they intend to spend the next several months building a definitive agreement to merge and complete the needed regulatory approval process. In the interim, St. Luke’s patients can continue to see their regular physicians.”
• and
  • “Maven Clinic, a virtual provider for women’s and family health, is making its new DTC vertical in-network with over 475 commercial health plans.
  • “The first program to be in-network, starting now, is hormone care. Starting on Jan. 1, 2027, its GLP-1 program will also be covered. The fee-for-service contracts represent about 80% of commercially insured lives, according to the company. It is able to tap into the vast network through direct contracts and a third-party partner that it can’t name on the record. Coverage and applicable copays will vary by plan.
  • “We’re really doing this because of access [gaps] … the in-network coverage removes that barrier,” Alex Kubal, general manager of Maven’s Consumer Division, told Fierce Healthcare.
  • “Also in 2027, Maven plans to roll out in its DTC vertical, several additional specialties, including OBGYN care, maternal-fetal medicine, nurse practitioners for general women’s health and nutrition. Employees can use their health plan to get care for PMOS, endometriosis, hormonal, sexual or metabolic health, regardless of whether or not their employer sponsors a Maven program. Cash pay will also remain available.” 

• Modern Healthcare tells us,
  • “Health systems are using financial incentives, physician education and other strategies to drive hospital-at-home enrollment.
  • “Tampa General Hospital now receives roughly 80% of its hospital-at-home referrals from physicians.
  • “A University of Pennsylvania researcher says admission scorecards could encourage physicians to refer more patients to hospital at home.”

• Health Leaders adds,
  • “Urban hospitals had a 9.1% closure rate from 2010 to 2025, compared with 8.3% among rural hospitals.
  • “Safety-net hospitals face greater financial vulnerability, with 13.7% closing during the study period compared with 8.6% of other hospitals.
  • “Federal Medicaid cuts and changes to provider payments could add financial strain to urban safety-net hospitals, which lack a dedicated federal support program comparable to the Rural Health Transformation Program.”

• Healthcare Dive informs us,
  • “Bon Secours Mercy Health’s affiliate HealthSpan Partners has sweetened its deal to buy Surgery Partners after the outpatient facility chain received a competing offer.
  • “Under the new terms announced Monday, Surgery Partners’ shareholders would receive $25.00 per share in cash — up from $23.50 in the original agreement last month – in a deal worth $6 billion.
  • “Although the deal is expected to close in the first quarter of next year, shareholders — excluding those linked to Surgery Partners’ largest stakeholder Bain Capital Private Equity — would receive extra monthly payments if the close date is delayed after March 1, and could get up to $26.61 per share if the deal isn’t complete by Oct. 23.”

• STAT News points out,
  • “MDCalc, a medical reference tool site, on Wednesday launched CrossCover, a tool the company said is meant to help clinicians trust the answers of medical artificial intelligence chatbots while preserving patient and provider privacy.
  • “Graham Walker, head of AI at MDCalc, said the company sees the tool as an accelerator for clinical generative AI. “We can take away some of the challenges and risks and problems with the technology so that physicians can feel more confident in using it,” he said.
  • “CrossCover takes an approach that contradicts that of medical AI tools from OpenEvidence, Abridge, and electronic health record company Epic, which are trying to incorporate an ever-widening repertoire of patient, provider, and payer information into their recommendations. Rather than requiring clinicians to register with their national identification numbers or trying to mitigate risk by brokering privacy agreements that allow clinicians to enter protected patient health information, MDCalc’s tool focuses on stripping out those types of information from clinicians’ queries.
  • “The tool acts as an intermediary between the user and the AI chatbot. Once the clinician enters information into the AI model, the tool checks for protected, private information that could identify a patient, and confirms with the user its decision to redact the information. It also masks the metadata from the clinician’s query, such as the user’s IP address — MDCalc fears that non-health related information, such as where a clinician practices or what kind of population a hospital serves may unduly affect the chatbot’s answers.”