Midweek report

CMS

Midweek report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a Senate news release,
    • “On Wednesday, July 15, [beginning at 10 am ET], the U.S Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a confirmation hearing on the nomination of Sean Kaufman to be Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services and Erica Schwartz to be Director of the Centers for Disease Control and Prevention.”
  • The Wall Street Journal reports,
    • “Rates for many Affordable Care Act plans rose by double digits this year. Insurers want to do the same next year.
    • “Some of the biggest Obamacare companies are seeking hefty premium increases for 2027, often for the second year in a row. In Washington state, Centene is asking for a 28% hike, after boosting rates by 35% in 2026. Blue Cross and Blue Shield of Illinois wants 15%—on top of a 28% increase this year.
    • “It is a stunning jump” when you add both years together, said Cynthia Cox, senior vice president at KFF, a health-research nonprofit. At the request of The Wall Street Journal, KFF analyzed the rate requests for the largest ACA plans by enrollment in 15 states where insurers’ 2027 filings have already become public, as well as the District of Columbia.” * * *
    • “KFF calculated the median increase across 77 publicly available ACA rate filings for 2027: 14%. For 2026, the median final rise across all ACA plans was 20%.   
    • “Insurers’ 2027 ACA rates have to be reviewed by regulators, and the premiums finalized in late summer might be different from these early requests.”
  • Beckers Payer Issues reports,
    • “CMS has rescinded a decade-old “fast-track” review process for certain Medicaid Section 1115 demonstration waiver extensions as the agency prepares to implement new federal budget neutrality requirements that take effect in 2027.
    • “The July 7 informational bulletin formally withdraws 2015 guidance that allowed eligible states to use an expedited review process when renewing some Section 1115 demonstrations.
    • “CMS said the change is necessary because new statutory requirements will require the agency’s chief actuary to certify that Medicaid demonstrations will not increase federal spending before they can be approved, renewed or amended beginning Jan. 1, 2027.” * * *
    • “CMS previously notified state Medicaid directors that it intends to propose new budget neutrality policies and expects to issue additional implementation guidance. The agency said it remains committed to working with states to support Medicaid and CHIP innovation while complying with the new statutory requirements.”
  • Federal News Network relates,
    • “The Trump administration is looking to tweak the rules for federal employees’ paid administrative leave. Recently proposed regulations from the Office of Personnel Management would give agencies more leeway to use paid leave, including during workforce reduction efforts. During 2025, agencies used administrative leave to implement the deferred resignation program, choosing to paying thousands of employees for several months not to work, in exchange for them agreeing to quit their jobs.”
  • and
    • Federal News Network interviews Tammy Flanagan about early retirement for federal law enforcement officers.
      • [I]n law enforcement, typically, you’ve got to retire by the time you’re 57. And sometimes that’s hard because they really love that career for the most part, and that’s their identity. So leaving that early sometimes can be a tough transition, not only financially, but also emotionally.
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services and the Centers for Medicare & Medicaid Services July 8 launched  a voluntary pledge that hospitals can sign related to their efforts on healthy food. Among other actions, the pledge asks that hospitals prioritize food options in alignment with the 2025-2030 Dietary Guidelines for Americans; ensure that inpatient meals meet individual nutritional needs; provide accessible nutrition education and resources to sustain healthy habits following discharge; and provide community-based nutrition programs to support healthier communities.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “The top contenders to lead the Food and Drug Administration have been sent to the White House for a final review and decision, according to a person familiar with the process.
    • “The finalists include Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and health system executive; and Stephen Ferrara, a health affairs official at the Defense Department.” * * *
    • “The advancement of the finalists suggests the highly anticipated decision is on the horizon, though the timing remains unclear.”
  • Politico discusses the FDA’s 2026 regulatory agenda which was released on July 3.

From the judicial front,

  • HealthExec reports,
    • “Once scheduled for the fall, the federal murder trial against the man accused of killing UnitedHealthcare CEO Brian Thompson will now begin in January, a judge determined last week.
    • “At the conclusion of a June 29 hearing, U.S. District Judge Margaret Garnett agreed with attorneys representing Luigi Mangione who argued the original date of Oct. 13 left little time to prepare a defense.
    • “A trial in New York on state charges of second-degree murder is set to begin first, with jury selection pegged for a Sept. 8 start date, followed by opening arguments on Oct. 13—the same day the federal trial was initially scheduled to begin. With it now pushed back, Mangione’s attorneys need only worry about the looming prospect their client could be spending the rest of his life in prison as a result of the first trial.”
  • Per a Justice Department news release
    • “The founder and former Chief Executive Officer (CEO) Ruthia He of Done Global Inc., a California-based digital mental health company, was sentenced today to six years in prison and a fine of $1 million for orchestrating a scheme that used her company’s technology platform, compensation structure, and clinical protocols to unlawfully distribute over 37 million pills of Adderall, defraud insurers of over $12 million, and obstruct the federal investigation that followed.”

From the public health and medical / Rx research front,

  • The Hill reports,
    • “As of Monday [July 6], the parasitic illness has spread to at least 18 states, with the most cases reported in Illinois, Michigan, New York and Texas.
    • “While exact numbers are unknown, the Michigan Department of Health and Human Services has reported 572 cases of cyclosporiasis as of July 4, and New York has reported more than 100. No exact numbers have been released for Illinois or Texas. Current figures are most likely an undercount, as most people who are sick don’t report it or go to a doctor unless it’s severe.
    • “Other states linked to the outbreak include Alaska, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia and Wisconsin.”
  • Health Day relates,
    • “Exercise can boost a smoker’s odds of successfully quitting, a new evidence review says.
    • “Smokers taking part in exercise programs were more likely to either quit or cut back on cigarettes, researchers reported recently in the Journal of Sport and Health Science.
    • “In fact, a single bout of exercise immediately reduces nicotine cravings for up to a half hour afterward, researchers found.
    • “Quitting smoking is one of the best things a person can do for their health, but it’s also one of the hardest,” lead investigator Ben Singh, a research fellow at Adelaide University in Australia, said in a news release.
    • “Many smokers want to quit, but the current approaches don’t work for everyone,” Singh said. “That’s why we need more strategies that people can incorporate into their daily lives at little or no cost.”
  • The New York Times discusses the medical problems created by parents refusing to protect their infants with an injection that resolves the Vitamin K deficiency with which all of us are born. It’s worth a read.
  • STAT News tells us,
    • “Could a lifesaving lung transplant strategy that contained the Covid-19 virus also save patients whose advanced lung cancer hasn’t spread? 
    • “That’s the question that inspired surgeons and oncologists at Northwestern Medicine to offer double lung transplants to patients who had run out of treatment options but whose late-stage cancer hadn’t left their lungs. People with late-stage lung cancer have not been transplant candidates before for two reasons: rates were high for cancer recurrence and low for survival.
    • “There are ethical considerations to weigh, too, when deciding how to allot donated organs.
    • “On Wednesday, the Northwestern team reported in JAMA that the 17 patients who received lung transplants after advanced but limited cancer fared better than 81 similar patients who continued standard immunotherapy, chemotherapy, or radiation treatments. Overall, the study followed 404 patients with end-stage pulmonary disease, including 98 with stage 4 lung cancer.
    • “After one year, through June 2025, all the lung cancer transplant patients had survived compared to 88% of patients transplanted without cancer. Among those 17 patients, by January 2026, there were four recurrences of cancer and two deaths unrelated to cancer — one from an infection and one from a blood clot. Among the 81 cancer patients getting standard care, 74 saw their cancers progress.”
  • Genetic Engineering and Biotechnology News informs us,
    • “It has long been known that brain gray matter plays a key role in multiple sclerosis (MS) disease progression and cognitive impairment, but because magnetic resonance imaging (MRI) has only been able to detect lesions in white matter, neither clinicians nor researchers have had a way to detect or monitor gray matter (cortical) lesions. And while many new drugs developed in the past decade can slow disease progression significantly, they primarily work on reducing white matter lesions.
    • “A University at Buffalo (UB)-led team now reports that it has found a way to use artificial intelligence to reveal these otherwise invisible cortical lesions by reviewing existing MRI scans. The researchers say the significance of finally being able to see what has been known as one of the most important indicators in MS disease progression cannot be overstated.”
  • Healio points out,
    • “Public health messaging had a longer-lasting impact on parents’ intent to vaccinate their children against HPV than AI chatbot interactions.
    • “Strategies to make both modalities more effective are needed.”
  • Per Fierce Healthcare,
    • “After thriving in the market for more than a decade as the only treatment for Dupuytren’s contracture and Peyronie’s disease, Keenova Therapeutics’ Xiaflex has excelled in a phase 3 trial that could set up the injectable biologic enzyme for approval in a third indication.
    • “The study of 436 patients with plantar fibromatosis achieved its primary endpoint, showing statistically significant and clinically meaningful reductions in pain versus placebo as measured by the Average Daily Pain Intensity on the Numeric Rating Scale (NRS).” * * *
    • “Plantar fibromatosis, which is also known as Ledderhose disease, causes lumps composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot. It can cause pain, swelling, and difficulty walking. Based on claims data and projections, Keenova estimates that 300,000 people will see a healthcare provider for plantar fibromatosis in 2028.
    • “There is no medicine on the market specifically for plantar fibromatosis. Patients can get relief through radiation therapy or corticosteroid injections, with surgical interventions generally reserved as a last resort.” 
  • The Wall Street Journal reports,
    • “Some patients are using GLP-1 drugs to treat eating disorders like bulimia and binge-eating disorder.
    • “No major medical organization has endorsed GLP-1s for eating disorders, and drugmakers Novo Nordisk and Eli Lilly say they are not approved for this.
    • “Experts say widespread adoption is unlikely soon due to limited scientific data.”
  • Per MedTech Dive,
    • “Penumbra said Tuesday it has started a clinical trial that could support wider use of mechanical thrombectomy in a subset of stroke patients.
    • “The real-world prospective study is assessing Penumbra’s RED reperfusion catheter portfolio in patients with M2 occlusions.
    • “Penumbra, which Boston Scientific has agreed to buy for $14.5 billion, is assessing whether its computer-assisted vacuum thrombectomy and modulated aspiration tools improve outcomes.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “A newly released audit of UnitedHealth’s home visits for Medicare seniors found little evidence to support accusations that the program, called HouseCalls, drums up extra patient diagnoses to inflate UnitedHealth’s reimbursement from the federal government.
    • “UnitedHealth argued that the results vindicate HouseCalls, which has faced scrutiny from regulators and lawmakers focused on combating profiteering in Medicare Advantage, Medicare’s privatized sister program.
    • “About 96.6% of diagnoses that UnitedHealth found during the home visits were backed up by patients’ health records, according to the audit released Tuesday from FTI Consulting, which used the same review process as the government.
    • “That leaves 3.4% of diagnoses unsupported by medical information — three times lower than the error rate found by the CMS in its most recent audit of data in the privatized Medicare program.
    • “UnitedHealth said it reviewed FTI’s findings and that the lion’s share of diagnoses unsupported by medical records were backed up by other information like paid claims.”
  • and
    • “Data from consumer wearables are valuable in clinical care, and many physicians are using the information in their practice — but widespread adoption is hindered by limited workflow integration and other barriers, according to a survey published Wednesday by the American Medical Association. 
    • “Eighty-six percent of U.S. physicians reported they at least sometimes reviewed data from their patients’ wearables, like information on heart physiology, oxygen and breathing, and sleep, according to the report, which also interviewed doctors from Canada, France, Germany, Spain and the U.K.
    • “But only 6% of doctors in the U.S. said wearable data was integrated into clinical workflows, like the ability to import information into electronic health records. “We have all this data that’s available, but it’s actually not actionable because we don’t have a way to get it into clinical workflow,” AMA CEO Dr. John Whyte said in an interview.”
  • Modern Healthcare relates,
    • “Health insurance companies and third-party vendors offer arrangements to mitigate the costs of cell and gene therapies to employers.
    • “More than three-quarters of employers see gene therapies as a major challenge, yet 35% lack financial protection, a survey found.
    • “The Food and Drug Administration has approved cell and gene therapies for conditions such as blood cancers and neurodegenerative diseases.”
  • MedCity News adds,
    • “In Oncology, the Cost Problem Goes Beyond Predictability.
    • “Healthcare does not lack the data needed to better understand oncology costs. What it does lack is a consistent way to connect clinical progression with financial impact in a time frame that aligns with strategic planning.”
  • Beckers Payer Issues tells us,
    • “Memorial Hermann Health System plans to shut down its commercial health insurance business.
    • “The wind-down affects the Houston-based system’s HMO, PPO, and self-funded products for employers. On its website, the system said it would be difficult to reach the scale needed to sustainably provide value to members moving forward. The closure notice does not include the system’s Medicare Advantage business.
    • “This decision was made following a careful and comprehensive assessment of system assets and resources, including an evaluation of existing opportunities and future challenges amid sustained pressures on health system-owned health plans,” the system wrote.
    • “Current coverage will remain in effect, and providers can continue treating members through each plan’s termination date, which will vary by employer group. Groups whose plan year is set to renew before Dec. 1 will have the option to enroll in one additional year of coverage before the full closure.”
  • and
    • “Josh Michelson started serving as executive vice president and chief strategy and innovation officer for The Cigna Group, according to a recent LinkedIn post.
    • “A Cigna website said Mr. Michelson is responsible for steering the company’s long-term strategic direction, corporate innovation and The Cigna Group Ventures, the company’s venture capital branch.
    • “He joined Cigna in 2020 and was most recently a senior vice president and chief strategy and transformation officer for the company.”
  • Beckers Health IT notes,
    • “[The major electronic health records company] Epic named four executives who will take on expanded responsibilities following President Sumit Rana’s departure, according to a statement from Founder and CEO Judy Faulkner shared with Becker’s.
    • “Ms. Faulkner said Seth Howard, Mark Lipsky, Erv Walter and Garrett Adams are among a small group of leaders who will be adding to their responsibilities as the company moves forward without Mr. Rana.
    • “The statement did not detail the additional responsibilities these individuals would be taking on.” * * *
    • “Mr. Rana’s departure leaves a notable gap at the top of the nation’s largest EHR vendor. He was widely viewed as a potential successor to Ms. Faulkner, who is 82.”
  • Per Cardiovascular Business,
    • “Novo Nordisk is now working with Vivani Medical, a California-based biopharmaceutical company, to evaluate the potential of a long-lasting semaglutide implant. This is a non-exclusive agreement between the two companies. 
    • “Novo Nordisk, one of the world’s largest pharmaceutical companies, sells semaglutide under the brand name Wegovy. Vivani is known for its drug implants, which are designed to help patients benefit from life-changing medications without ever needing to inject or ingest them. 
    • “The goal of this partnership is to reduce the risk of non-adherence and ensure patients taking semaglutide can receive the care their physicians have determined they need. The implant in question, currently known as NPM-139, is being developed to help patients with chronic weight management. It utilizes Vivani’s proprietary NanoPortal technology and could help patients receive the maximum benefits of treatment with just one or two treatments per year.
    • “Vivani is also preparing the launch of a new first-in-human clinical trial that would randomize certain patients to either undergo treatment with an NPM-139 implant or receive semaglutide injections.”
  • Per MedTech Dive,
    • “Resmed has agreed to sell its MatrixCare software business for $490 million to private equity firm Frazier Healthcare Partners. The deal is meant to sharpen Resmed’s focus on sleep and breathing health devices and connected, home-based care.
    • “Divesting MatrixCare enables Resmed to reallocate capital and resources toward higher-growth opportunities and expansion of its digital health ecosystem, the company said Tuesday.
    • “The cash transaction is expected to close in the first quarter of Resmed’s fiscal 2027, which ends in September.”

Tuesday report

David Ermer–ACA, Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Roll Call reports,
    • “The sweltering Fourth of July weekend is over, but for both parties in House and Senate leadership, the heat is still cranked up.
    • “Both chambers are likely to return next Monday to the same sweat-inducing tangle of legislative problems that left them stumped as they headed out of town at the end of June.
    • “Speaker Mike Johnson, R-La., is looking for a solution so “irresistible” that his fellow Republicans will have to accept it — but the numbers are working against him.
    • “For one thing, August is fast approaching, leaving just a couple weeks in Washington before lawmakers depart for an even longer summer break. And as Senate Majority Leader John Thune, R-S.D., has said all along, mathematical realities can’t be changed in the Senate, even when it comes to the White House-backed voter ID bill dubbed the SAVE America Act.”
  • Beckers Hospital Review relates,
    • “CMS is proposing to create a new payment pathway for algorithm-driven diagnostic software, including AI tools, as part of its 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgery Center proposed rule, issued July 2. 
    • “The proposal marks CMS’ first attempt to build a standardized payment structure for what it calls “Software as a Medical Service” — clinical software that uses algorithms to analyze patient data and produce a diagnosis, risk score or treatment recommendation.”
  • and
    • “The planned July meeting for the U.S. Preventive Services Task Force has been postponed until late August, an HHS spokesperson told Becker’s.” * * *
    • “The HHS spokesperson said the July meeting was postponed due to an “unprecedented” number of nominations for task force membership, to allow more time for selection and onboarding of new members.”
  • Fierce Healthcare reports,
    • “The American Medical Association (AMA) updated maternity care coding Thursday, in what it says is the “most significant” move in decades to improve care delivery and data to advance maternal health.
    • “Beginning Jan. 1, 2027 (PDF), current procedural terminology (CPT) codes will reflect modern obstetric care, enable accurate and transparent reporting across the full pregnancy spectrum and create a data foundation for improved care throughout the entire patient journey.
    • ‘The update featured the deletion of 17 codes, the creation of six codes and the revision of six codes. It also includes new subsections, revised guidelines and relocation for some existing codes.
    • “Moreover, new CPT codes (PDF) will separately identify four phases of care: antepartum, labor management, delivery and postpartum.” * * *
    • “There is no expected impact on health plan benefits or an increase in cost-sharing, according to an AMA analysis using data from more than 650 physicians and certified nursing midwives.”
  • FEHBlog observation. We shall see.
  • KFF Health News explains how surprise Medicare Part D premiums can adversely affect Medicare Part D beneficiaries.

From the Food and Drug Administration front

  • Per a July 6, 2026, FDA announcement,
    • “The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of E. coli O145:H28 infections linked to frozen GreenWise brand-organic blueberries recalled by Frutas y Hortalizas del Sur S.A, of San Carlos, Chile.”
    • “Recalled frozen GreenWise-brand organic blueberries in 10-oz packages with printed lot code of 60401 and Best by Date of February 9, 2028.” * * *
    • “Recalled product was shipped to Publix retail stores throughout 8 states including Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia. Blueberries may have been distributed to other retailers, and FDA will update this advisory as more information becomes available.” 
  • Cardiovascular Business reports,
    • “Medtronic is recalling certain lots of the delivery catheter system for its Harmony Transcatheter Pulmonary Valve (TPV) System due to a significant safety risk. The U.S. Food and Drug Administration (FDA) has ruled this as a Class I recall, which means using the device could cause “serious adverse health consequences or death.”
    • “Medtronic initiated the recall after identifying an issue with the delivery system that could lead to distal tip detachment during implant procedures. More than 1,800 devices are included in this Class I recall.
    • ‘The Harmony TPV system is used to treat a native or surgically repaired right ventricular outflow tract (RVOT) in patients with severe pulmonary regurgitation. It has received FDA approval in addition to CE mark approval. Click here to read about a recent analysis of the device’s safety and effectiveness.”
  • Fierce Pharma relates,
    • “When Vera Therapeutics in-licensed atacicept from Merck KGaA about six years ago, patients with IgA nephropathy (IgAN) had no FDA-approved treatment options. Today, the dual-target drug has crossed the regulatory finish line but is entering a vastly different landscape as the sixth drug approved for the rare kidney disease.
    • “Atacicept, a recombinant fusion protein to be marketed under the brand name Trutakna, is now the first drug in the U.S. that inhibits both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), two cytokines involved in B-cell survival and the production of autoantibodies associated with IgAN.” 

From the judicial front,

  • Per a June 25, 2026, Justice Department news release,
    • “Julianna C. Lung pleaded guilty in federal court today to health care fraud, admitting she marketed and sold hearing protection devices to United States Border Patrol agents, other federal employees, and their family members, then falsely billed insurance providers for what she claimed were medically-necessary hearing aids.
    • “According to her plea agreement, Lung submitted approximately 385 fraudulent claims to health insurance plans participating in the Federal Employees Health Benefits (FEHB) program. The claims falsely represented that beneficiaries suffered from hearing loss or tinnitus that required treatment.
    • “In reality, Lung told customers the devices were intended to protect their hearing—not treat a medical condition—and assured them their insurance would cover the cost for that purpose.
    • “As a result of the scheme, FEHB plans paid approximately $2,500 per device, totaling about $962,500 in fraudulent reimbursements.”

From the public health and medical / Rx research front,

  • Dr. Drew Altman, writing in KFF Health News, tells us,
    • Many of us in health care are deeply concerned about misinformation (and declining trust), so it seems important to underscore that while the American people may not always be as science-based as we might like them to be, they may also not be as anti-science as you may think they are—only a sliver of the public are hard-core refusniks who believe the lies, myths, misinformation or misbeliefs about vaccines. Occasionally, a lie breaks through when it’s amplified by someone influential and by the media. For example, 41% of the American people believed there were death panels in the ACA, but that’s the exception, not the norm.
    • In our most recent Tracking Poll on Health Information and Trust, we tested out who believed and didn’t believe each of four vaccine-related myths: “Getting the measles vaccine is more dangerous than becoming infected with measles;” “mRNA vaccines can change your DNA;” “measles, mumps, and rubella vaccines, also known as the MMR vaccines, have been proven to cause autism in children;” and, “more people have died from the COVID-19 vaccines than have died from the COVID-19 virus.” Here’s what stood out to me from these findings:
      The share of the public who believe these four myths is very small. Between 3% and 8% of the adult population believe these different vaccine myths are “definitely true.” By any standard, that’s a small, even tiny share of the overall adult population (for context, about a quarter of adults say they are MAGA). These are likely most of the folks you see in the spikes in social media engagement we sometimes observe when influencers or leaders like Secretary Kennedy amplify vaccine or
      other myths. 
    • Looked at another way, the hard-core group is even smaller: Just 1.3% believe all four false claims about vaccines are “definitely true.” 
    • By contrast, between 31% and 44% of the public think these claims are basically nonsense, meaning the share who don’t believe these things at all outnumber those who definitely do by almost 5-to-1 or more. That’s hardly the impression you get when you read reports about social media posts and views with characterizations like “engagement spiked” or “views tripled.” It’s important to track social media engagement to know how misinformation is spreading and who is spreading it, but it doesn’t give us a real picture of reach or impact. How many people believe it? How strongly? Who are they? Where did they get their information? Who do they trust and not trust when it comes to health information? That’s why we do our information and trust surveys. 
    • As I have written before and we have widely reported, most people are floundering around in a muddled middle uncertain what to believe. Take, for example, the slam dunk falsehood that “more people have died from the COVID-19 vaccines than from COVID-19 itself.” As you can see in the chart below, 53% of the American people are not certain about the answer to that question, with 34% saying that’s “probably false” and 19% “probably true,” Estimates are that the vaccine saved 2.5 million lives, and many more years of life. 
  • The Washington Post reports,
    • “The number of people injecting themselves with or taking an oral version of the new class of weight-loss drugs continues to rise dramatically.
    • “A Gallup poll released Tuesday based on a web survey of 5,065 U.S. adults says that 15 percent of U.S. adults reported using GLP-1 medications to lose weight at some point, while 11 percent say they currently are taking them.
    • “That’s up from a Gallup poll in 2024 that found 6 percent had ever taken them, and 3 percent were currently on the therapy.
    • “At the same time, respondents’ self-reported obesity rates have dipped, and diabetes rates have flattened. “The growing popularity of GLP-1 medications continues to point to broader health benefits for American adults as obesity levels curtail and the diabetes rate levels off after years of increases,” Gallup said.”
  • Beckers Payer Issues adds,
    • “The share of employers covering GLP-1s for both diabetes and weight loss has held steady at 36% year over year, according to a survey from the International Foundation of Employee Benefit Plans.
    • “The survey was conducted June 2 to June 12. The foundation represents more than 31,000 multiemployer, corporate and public sector members representing over 25 million lives.”
  • Radiology Business tells us,
    • “Experts are calling for greater integration of breast and lung cancer screening programs to help bolster monitoring for both diseases. 
    • “Researchers with Thomas Jefferson University, Philadelphia, made the case in a new analysis published July 3 by the Journal of the American College of Radiology. They noted that, despite the proven lifesaving benefits of mammography, completion rates remain as low as 55%, with worse screening adherence among socioeconomically disadvantaged patient populations. 
    • “Women eligible for lung cancer screening represent a unique population, they note, with elevated cancer risk and “substantial healthcare needs.” Previous studies have explored lung cancer screening among women already receiving mammography, but less is known about whether those actively engaged in LCS programs are up to date on their breast exams. 
    • “This represents an important gap in the literature because dual BCS/LCS-eligible women can be more efficiently identified from an [lung cancer screening] cohort than from a [breast cancer screening] cohort,” lead author Meghan Maceyko, MD, with the Department of Surgery at Thomas Jefferson, and colleagues wrote Friday. “Additionally, LCS participants may have access to highly structured LCS navigation pathways to facilitate BCS completion.”
  • The American Journal of Managed Care informs us,
    • “Adults with diabetes treated with insulin who were prescribed continuous glucose monitoring (CGM) by their primary care clinician were associated with meaningful and durable improvements in hemoglobin A1c (HbA1C), along with fewer hospitalizations and emergency department (ED) visits, according to a cohort study published in JAMA Network Open.”
      .
  • MedPage Today points out,
    • “Influenza vaccine effectiveness against death among U.S. kids and teens averaged 80% in recent years.
    • “Vaccine effectiveness against death was 77% among kids with underlying medical conditions and 87% among those without.
    • “The findings come against a backdrop of declining influenza vaccine uptake since 2021.”
  • and
    • “Roughly 22 high school students die each week from a fentanyl overdose.
    • “In a nationally representative survey study, less than half of 8th graders surveyed attributed great risk to experimental use of fentanyl.
    • “The study’s findings are a “call to action” to better educate children and teens about the synthetic opioid’s risks, a researcher said.”
  • Per Health Day,
    • “Artificial sweeteners may affect metabolism.
    • “Artificial and low-calorie sweeteners have been linked to higher fasting insulin, higher HbA1c and reduced insulin sensitivity.
    • “Alterations to the gut microbiome may help explain the observed metabolic changes.”
  • Cardiovascular Business notes,
    • “A polypill containing three different medications is associated with significant benefits for select heart failure patients, according to new findings published in Nature Medicine.[1]
    • “For the POLY-HF randomized trial, researchers explored data from 212 heart failure patients treated at two U.S. healthcare facilities. The median age was 54 years old, and 78% of patients were men. Nearly seven in 10 patients were either uninsured, or faced other barriers that can make it harder to receive optimal medical therapy.” * * *
    • “The study’s primary outcome, change in left ventricular ejection fraction after six months, was 3.3% higher for patients taking the polypill than it was for patients taking each medication separately. In addition, patients taking the polypill had a 60% lower rate of heart failure hospitalizations or ED visits.
    • “Adherence, evaluated by studying each participant’s blood for metoprolol and spironolactone, was also higher for patients taking the polypill than it was for patients taking each medication separately.”
  • Per STAT News,
    • “Compass Pathways said its investigational psilocybin treatment had lasting benefits on patients with severe depression out to six months.
    • “The biotech previously reported that 39% of patients who took two high doses in a Phase 3 trial achieved what Compass called a “clinically meaningful reduction” on a depression rating scale after six weeks. Today, it said that on average, those participants maintained the benefit through at least six months.
    • “In the trial, participants who didn’t achieve remission in the first six weeks were eligible to then get an additional dose. Compass said this morning that 28% of participants who had achieved a clinically meaningful response but not remission at six weeks did later go into remission after the additional dose. * * *
    • “Compass’ treatment is one of three psychedelic compounds the FDA has selected to review on an accelerated basis. It’s possible the drug could be approved as soon as this year.”

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

  • STAT New reports,
    • “It has never been more difficult for employers to offer health insurance for their workers. That’s especially true for America’s small businesses, the backbones of entire communities. More and more, they’re giving up entirely.
    • “America’s employer-based health insurance system — the dominant form of coverage for people younger than 65 — is crumbling. The percentage of working-age adults who get their health coverage from a job has declined from 67% in 1998 to about 60%. It’s also more expensive than ever.”
  • FEHBlog observation — To lower premiums, uncouple the employer market from the Affordable Care Act.
  • Modern Healthcare reports,
    • “Care navigators are helping health systems reduce unnecessary admissions and save money as chronically ill older adults and uninsured patients flood emergency departments. 
    • “Care navigators are typically nurses embedded in emergency departments who connect patients to less costly outpatient services to avoid hospitalizations. Providers, including St. Louis-based BJC Health System and Chicago-based Northwestern Medicine, have been growing care navigator programs.”
  • Healthcare Dive relates,
    • “Ascension has agreed to snap up a regional health system in a deal worth almost $1 billion as the Catholic nonprofit giant continues to beef up its portfolio.
    • “On Monday, Franklin, Tenn.-based Williamson Health announced it plans to sell to Ascension through the company’s Tennessee business Ascension Saint Thomas, after Williamson’s board voted unanimously in support of the change of ownership.
    • “The proposed transaction is still subject to approval by the Williamson County Board of Commissioners and other regulators. If the deal advances, the companies expect it to be finalized in 2027 or 2028.”
  • Beckers Hospital Review tells us,
    • “Jupiter (Fla.) Medical Center, an independent, nonprofit health system, broke ground June 24 on its second hospital, the “Jupiter Medical Center Neighborhood Hospital at The Health Park at Avenir.”
    • “The 53,000-square-foot facility will comprise 29 inpatient beds, four operating rooms, 24-hour emergency services, imaging services and a diagnostic laboratory, according to a news release. 
    • “Jupiter Medical Center Neighborhood Hospital at The Health Park at Avenir will be adjacent to a 47,000-square-foot, three-story medical office building for Jupiter Medical Center physicians. The building will feature cardiology, concierge medicine, gastroenterology, general surgery, primary care, pulmonary and orthopedics.
    • ‘Both the hospital and medical office building are expected to open in early 2028.” 
  • Fierce Healthcare informs us,
    • “Handspring Health offers a virtual mental health clinic for youth and families, purpose-built around evidence-based care and ongoing training and support for clinicians.
    • “The startup, which launched four years ago, picked up $19 million in series B funding to grow its clinician workforce, expand value-based care partnerships with payers and broaden its geographic reach.”
  • Fierce Pharma lets us know how “biosimilar experts size up US hurdles, opportunities ahead.”
  • Beckers Payers Issues explains “How 4 health plans are innovating with specialty pharmacy.”
  • MedCity News offers “The AI Playbook for Health Plans: 5 Steps for Leaders Who Don’t Know Where to Start.”
    • “It starts with a simple mindset shift, realizing that a successful AI journey begins with identifying a business problem, not with technology. The plans that make real progress embrace this mindset first then follow these five steps.” 

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “Clinical trial policy got caught up in the Trump administration’s attack on policies related to diversity, equity, and inclusion. Republicans in Congress would like to change that. 
    • “Days after Trump took office, the Health and Human Services Department began purging all references to DEI from the websites of its agencies. Those efforts were supposed to target DEI initiatives focused on hiring practices, communications, and social issues.
    • “But supporters of clinical trial diversity say the policy has nothing to do with DEI in that sense. Instead, it aims to ensure that clinical trials enroll people who are similar to the patients who would use the drugs and medical devices being tested. 
    • “Congressional Republicans seem to agree. Last month, the Republican-controlled House passed a bill, mostly along party lines, to fund the Food and Drug Administration. It was accompanied by a report that, while not legally binding, tells agency officials what congressional appropriators expected of them. 
    • “A section of that bill deals with trial diversity.
    • “The Committee encourages FDA to continue to implement legislation and policies requiring study sponsors to submit a diversity action plan for phase 3 studies of new drugs,” the report states.”
  • MedPage Today relates,
    • “I still have hope,” said Peggy Tighe, legislative counsel for the Regulatory Relief Coalition, a group of physician specialty organizations advocating for regulatory burden reduction in Medicare, when she was asked about the Improving Seniors’ Timely Access to Care Actopens in a new tab or window, which was approved last weekopens in a new tab or window by the House Energy and Commerce Health Subcommittee.
    • “The measure, which seeks more transparency and accountability from Medicare Advantage plans on their prior authorization decisions, must still be approved by the full Ways & Means and House Energy & Commerce committees before it hits the House floor for a vote.
    • “What’s different this year is that there is much more limited committee time and House floor time because of the … drama on the House floor and the paucity of votes,” Tighe said in a phone interview with MedPage Today. “So with everything else going on, I still have hope that we could pass this bill out of Energy & Commerce and Ways & Means before the August recess, but every day that Congress gets canceled, it makes it more difficult to find that time to accomplish what I think should be a very easy goal of passing legislation that is zero cost and widely supported.”
  • Per a HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced more than $281 million in funding opportunities for 15 grant programs.
    • “The investments will advance President Trump’s Great American Recovery Initiative by expanding access to a wide range of behavioral health services, including substance use disorder treatment, overdose prevention and response, mental health and suicide prevention, trauma-informed care, integrated care, recovery supports, first responder training, privacy education and workforce development.”
  • The American Hospital Association tells us,
    • “The AHA today sent a letter to the Office of the United States Trade Representative to ask that medications, medical devices and other healthcare equipment and supplies be exempted from proposed duties on goods from other nations. While “America’s hospitals and health systems support the administration’s goal of strengthening domestic manufacturing for drugs, medical devices, PPE and other essential medical supplies,” the AHA noted, “the U.S. healthcare system relies significantly on international sources for many drugs, devices, supplies, equipment and other products needed to both care for patients and protect our healthcare workers.”
  • Federal News Network informs us,
    • “An overhaul to the federal workforce’s performance management system is now set in stone, following a final rule the Office of Personnel Management released this week.
    • “Going forward, agencies will be limited in the share of employees they can rate highly in performance reviews. OPM’s final regulations, which are scheduled to publish Tuesday to the Federal Register, remove a previous ban on using forced distribution in the government’s performance management system.
    • “The final rule marks the largest overhaul of the government’s performance management system in decades. Agencies will have to be in compliance with OPM’s changes by Jan. 1, 2027. Once effective, the changes to performance management will apply across virtually the entire federal workforce.
    • “These changes are necessary to promote a culture of accountability and excellence across the federal workforce — one that reflects both the government’s evolving operational demands and its longstanding commitment to a merit-based civil service,” OPM said in the final rule.”
  • Other health plan related highlights from last Friday’s unified regulatory agenda.
    • A proposed rule [RIN 0938-AV95, to be published in December 2026] would propose requirements under the Mental Health Parity and Addiction Equity Act (MHPAEA) to clarify plans’ and issuers’ obligations, promote compliance, and reduce burden.
    • A long term plan [RIN 0945-AA22] to modify the Security Standards for the Protection of Electronic Protected Health Information (the Security Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications will improve cybersecurity in the health care sector by strengthening requirements for HIPAA regulated entities to safeguard electronic protected health information to prevent, detect, contain, mitigate, and recover from cybersecurity threats. A final rule is expected to be published in July 2027.

From the public health and medical / Rx research front

  • The Washington Post explains “Why U.S. measles outbreaks have grown harder to extinguish.”
    • The nation is already nearing last year’s record case total, and experts say the virus is forcing doctors to relearn a disease many thought had been consigned to history.”
  • Beckers Hospital Review tells us that “Clinical cases of the drug-resistant fungus Candida auris more than doubled in the U.S. from 2022 to 2024, highlighting ongoing transmission in healthcare settings, according to a CDC study published July 2.” 
    • “C. auris is frequently resistant to antifungal drugs, can persist on patients’ skin and surfaces, and spreads readily in healthcare settings. Bloodstream infections caused by the fungus are associated with high mortality.
    • “The CDC said sustained infection prevention and control measures, including transmission-based precautions, environmental disinfection and communication of patients’ Candida auris status during transfers, remain essential to limiting further spread.”
  • The AP informs us,
    • “Doctors and others are sounding an alarm: More U.S. children have been drowning in recent years.
    • “When drowning occurs, seconds matter,” said Dr. Rohit Shenoi, the lead author of a recent American Academy of Pediatrics warning. “Quick rescue and resuscitation can mean the difference between life, death and lifelong disability.”
    • “About 4,000 to 5,000 Americans drown each year. Most are adults who die in natural bodies of water, such as lakes, ponds or oceans.
    • “But statistically speaking, drowning is a much larger danger to children. It’s the No. 1 cause of death for kids ages 1 to 4, and one of the top killers of children ages 5 to 14. The drowning rate is higher for white kids in the younger group, but much higher for Black, American Indian and Alaska Native children in the older group.
    • “Drownings of very young children sometimes occur in bathtubs. But most, like Stewie Leonard’s, occur in swimming pools.”
  • The American Medical Association lets us know what doctors want their patients to know about sunburn.
    • “Sunburns cause lasting skin damage. Learn the difference from sun poisoning, how to prevent burns and treat symptoms safely, and when to seek medical care.”
  • Health Day points out,
    • “Many people with long COVID suffer from “brain fog,” finding it difficult to remember things, think on their feet or pay attention.
    • “But this symptom can be addressed by rehab, according to a new study.
    • “Ten weeks of cognitive rehabilitation helped long COVID patients lift much of their brain fog, allowing them to achieve goals they’d set in their work and home lives, researchers reported July 1 in JAMA Network Open.”
  • Beckers Hospital Review notes,
    • “Active drug shortages in the U.S. climbed to 223 in the first quarter of 2026, the second consecutive quarterly increase. Buried in that count are dozens of manufacturer-specific dates — extended-use deadlines, promised “next delivery” windows, backorder recovery targets — that pharmacy teams are tracking lot by lot. Several of those dates land this month.
    • “[The article identifies] six hospital-use drugs with a shortage-related deadline in July, according to the FDA’s drug shortage database and its list of extended use dates.”

From the U.S. healthcare business front,

  • Beckers Hospital Review discusses “Kaiser Permanente’s partnership strategy and what comes next” and identifies “15 maternity service closures in 2026.”
  • Fierce Healthcare reports,
    • “For a month now, weekly prescriptions for Eli Lilly’s Foundayo have been hovering at around 20,000. In other words, three months into its market debut, the non-peptide GLP-1 receptor agonist was still at the same script level that Novo Nordisk’s Wegovy pill had achieved in two to three weeks post-launch.
    • “For the week ended on June 26, Foundayo’s total scripts dipped about 4% sequentially to 19,830, according to IQVIA data cited by Jefferies. During the same period, scripts were also down about 2% for oral Wegovy, reaching about 149,000.
    • “In a July 4 report, Jefferies analysts modeled about $71 million in U.S. sales during Foundayo’s debut quarter from April to June, versus the team’s previous estimate of $85 million in a June 26 report. Wall Street’s consensus currently has the number at $130 million. To reach its estimate, Jefferies used an illustrative calculation based on the IQVIA data, with certain assumptions regarding pricing, dosing and stocking.
    • “While Lilly still lags Novo on the oral GLP-1 battlefield, the Indianapolis pharma has maintained a majority 59.5% share of the overall obesity market, according to IQVIA’s prescription data.” 
  • The Wall Street Journal informs us,
    • Vertex Pharmaceuticals VRTX has agreed to purchase Crinetics Pharmaceuticals CRNX for $10 billion, adding a biopharmaceutical company that specializes in treatments for endocrine diseases to its portfolio that mainly includes cystic fibrosis therapies.
    • Vertex, a Boston-based biotechnology company, said it would acquire Crinetics for $85 a share in cash. The company pegged the value at $8.8 billion when accounting for net estimated cash acquired.
  • and
    • Novartis NOVN said it agreed to pay up to $1.5 billion for Myricx Bio, in a bid to bolster its portfolio amid industry competition for oncology drugs.
    • “The Swiss pharmaceutical company said it would purchase the privately held U.K.-based biotechnology firm, which is developing a new class of antibody-drug conjugates. Myricx Bio’s approach delivers differentiated cancer-killing mechanisms directly to tumor cells, Novartis said.
    • “Novartis will pay $1.1 billion upfront, with up to $400 million in potential additional payments. The deal, expected to close in the second half of 2026, is subject to regulatory approvals. Myricx Bio has a pipeline of antibody-drug conjugates that show pre-clinical efficacy and tolerability across tumor-associated antigens and cancer cell types, it said.”
  • BioPharma Dive adds,
    • “Drug developers making new medicines to treat autoimmune conditions and cancer made up more than 40% of the venture funding rounds in the first half of 2026, BioPharma Dive data show.
    • “Of the more than $9 billion that poured into venture-backed biotechnology companies from 26 highly active investors tracked by BioPharma Dive, a little more than $3.9 billion went toward immune and cancer drugmakers. About $2.1 billion of that figure alone was dedicated to that former bucket, in which many startups are working on experimental therapies for conditions such as lupus, atopic dermatitis and inflammatory bowel disease. A handful are developing drugs in these two fields simultaneously (and have been included in the funding totals for each).
    • “While exits might be concentrated in other research areas like obesity and cardiometabolic disorders, venture funding is likely to continue pouring into cancer and immunology because of a lack of “a time-sensitive element,” said Ben Zercher, a senior analyst at PitchBook.”

Pre-holiday weekend report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

Note — The FEHBlog will be writing his weekly cybersecurity report tomorrow and will resume regular FEHBlog posts on Sunday July 5. Happy Independence Day! We are so blessed to be Americans.

From Washington, DC,

  • Roll Call reports,
    • “As America gets ready to celebrate its 250th birthday, Congress is taking a road trip back to the place where it all began — Independence Hall in Philadelphia. 
    • “Led by Pennsylvania Democratic Rep. Brendan F. Boyle, members will gather for a ceremonial event Thursday in his hometown, an effort Boyle said was two years in the making. 
    • “This is going to be truly one of the highlights of my tenure in Congress, to be sitting there where our Founding Fathers sat exactly 250 years prior, to the exact day,” Boyle said, adding he hoped it could be a rare “unifying moment.” 
    • “While July 4 gets most of the fanfare, Boyle said its lesser-known neighbor, July 2, deserves more attention as the day the Second Continental Congress voted to declare independence from Great Britain in 1776. 
    • “It was always the date that John Adams thought would be celebrated as America’s birthday. Unfortunately, this was another instance in which Adams lost to [Thomas] Jefferson — because Americans came to, of course, celebrate two days later the Fourth of July, which is the date Congress adopted the Declaration of Independence,” he said.” 
  • OPM Director Scott Kupor added a third post (OPM.gov link) to his Secrets of OPM blog this week. In this post, Director Kupor commemorates the new paperless federal retirement system by spurning the altar of Michael Scott, the fictious paper czar of Scranton, PA.
  • Healthcare Dive reports,
    • “The CMS proposed a rule on Thursday that would slash Medicare payment rates for a program [known as 340B] that hospitals use to buy discounted drugs and implement site-neutral payments for some imaging services next year.
    • Reforming the 340B drug discount program and better equalizing payments between sites of care have been priorities in the second Trump administration. Thursday’s proposed rule builds upon those agendas, including by expanding the services subject to site-neutral payments and more aggressively tamping down on discounts given to hospitals in the 340B drug program, which regulators previously tried to overhaul before dialing down their efforts in the face of opposition from the industry.
    • Medicare officials said the proposed rule would control costs and ensure Medicare money is directed toward “clinically appropriate” care. * * *
    • “The 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center rule proposes to increase pay for outpatient care by 2.4%, slightly less generous than the 2.6% rate update finalized last year.
    • “The rule would request information from stakeholders about how hospitals post publicly available price data, an ongoing priority for the Trump administration. Additionally, if finalized, the rule would allow certain accrediting organizations to assess hospitals on their compliance with laws regarding emergency care.”
  • The American Hospital Association News tells us,
    • “The House Education and Workforce Subcommittee on Health, Employment, Labor and Pensions July 1 examined whether direct health care contracts between employers and providers could help address rising health care costs. During the hearing, lawmakers from both parties expressed interest in arrangements that bypass traditional insurers, with supporters citing lower costs, reduced administrative burdens and improved access to care. Witnesses highlighted advantages such as simplified billing, price transparency and direct primary care services, while lawmakers also discussed the need for greater insurer transparency and access to health plan data. The committee did not signal specific legislative proposals following the hearing.”
  • and
    • “The Trusted Exchange Framework and Common Agreement Recognized Coordinating Entity published updated standard operating procedures for the individual access services exchange protocol and new FAQs. The revised SOP removed references to “TEFCA IAS Consent” workflows and associated patient matching methodologies, retaining the ability for providers to verify requests for access and use of data. Updates were made based on recommendations that the AHA and other stakeholders provided to SOP proposals. The SOP will be effective Aug. 3, 2026.”

No Surprises Act news

  • Federal Hearings and Appeals Services, which is certified IDR entity, tells us about
    • “The Cooling Off Period: What Providers and Health Plans Need to Know
      • “What is actually changing with the cooling off period under the final rule for the federal IDR program? To help clarify both the ongoing rules, the coming changes, and their timing, FHAS is offering two new tools to support parties.
        • “First, a new guide to the cooling off period explains which claims are subject to the cooling off period, how long it lasts, what will change under the final rule, and when those changes are coming.
        • “Second, FHAS has launched a new Cooling-Off Calculator which parties can use today to determine cooling off period dates and new dispute initiation timeframes. FHAS can help your team understand, anticipate, and implement changes directed by the final rule.”

From the judicial front,

  • Healthcare Dive reports,
    • “Elevance is suing the CMS after the agency recalculated the Medicare Advantage star ratings of a competitor in a more favorable way than it did for other plans.
    • “After losing a lawsuit earlier this year, the CMS reran 2026 quality scores for Clover Health, dropping 20 measures that a judge ruled could not be factored in. Regulators then recalculated stars for other MA insurers last month, but cut out extra measures, too — measures that Elevance performed well on, the insurer argued in its complaint filed Wednesday in Georgia district court.
    • “Elevance says it lost out on $115 million in bonus payments as a result. The company is asking the court to force CMS to redo its own ratings using the same methodology as for Clover.”
  • STAT News relates,
    • “In a victory for the pharmaceutical industry, a federal judge blocked a Colorado state panel from placing a cap on the price of a blockbuster drug sold by Amgen after deciding the company is “likely to be significantly harmed.”
    • “The ruling pauses a controversial, first-in-the-nation move by the Colorado Prescription Drug Affordability Board, which was created four years ago in response to the rising cost of prescription medicines and is permitted to set upper payment limits on what most state residents will pay for selected drugs.” * * *
    • “Last October, the board then voted to limit what health plans in the state will pay for the drug. The board capped Enbrel prices at $600 for a ​50-milligram weekly dose, or $30,350 a year per person, effective on January 1, 2027. That compared with roughly $53,000 that the average plan in the state paid in 2023, according to a state claims database.
    • “The drugmaker then quickly filed a second lawsuit, reiterating its earlier arguments. Meanwhile, the company had until July 5 to decide whether to continue selling the treatment, which has a list price exceeding $100,000 a year and generated $2.23 billion in sales last year, in Colorado.
    • “But Judge Daniel Domenico of the U.S. District Court in Denver agreed with the company. In his ruling, which was issued on Wednesday, he noted that the state has a ​legitimate interest in helping patients afford Enbrel, but “capping the price of a patented drug” is not an ​option.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The U.S. overall death rate in 2025 fell to its lowest point on record, even as influenza and pneumonia are now among the nation’s top 10 causes of death for the first time in years, according to new data from the Centers for Disease Control and Prevention.
    • “The death rate fell 4.6% last year, to 689.2 deaths per 100,000 people, down from 722.1 in 2024, according to the CDC’s National Center for Health Statistics. The death rate declined across every age group and nearly every demographic group tracked in the provisional report.
    • “The main driver of the record low was a continued drop in drug overdose deaths, said Farida Ahmad, a health scientist at the CDC and one of the report’s co-authors. Another factor, she added, was that Covid-19 no longer contributed to as many deaths.
    • “Against that backdrop, influenza and pneumonia stood out—moving from 11th to eighth place in all age groups—with 56,511 deaths in 2025 compared with 48,139 in 2024. It is the first time the influenza category has cracked the top 10 since 2020.”
  • AAMC relates,
    • “Patients arrive in the emergency department (ED) doubled over in pain and retching uncontrollably, a brew of symptoms physicians have nicknamed “scromiting” — a combination of screaming and vomiting. The problem: an underrecognized consequence of cannabis use called cannabinoid hyperemesis syndrome (CHS), and emergency medicine physicians say few conditions leave patients more obviously miserable.
    • “My heart breaks for them,” says Kathleen Clem, MD, an emergency medicine physician at Dartmouth Health in Lebanon, New Hampshire, and interim associate dean for faculty affairs at the Geisel School of Medicine at Dartmouth. “They come in because they absolutely cannot keep anything down. They’re dehydrated and their belly is sore from vomiting so much. Sometimes they vomit so much, they’ll break little blood vessels in their esophagus, and little bits of blood come up with that.”
    • “The leading cause of marijuana-related ED visits, CHS is associated with the chronic and long-term use of marijuana products, and it is becoming more prevalent, likely due to the increased legalization of marijuana. Some 24 states have legalized recreational marijuana use since 2012, and 40 states allow its use as a medicinal treatment. An additional eight states allow “limited-access” medical cannabis, which refers to low-THC (tetrahydrocannabinol) products and CBD (cannabinoid) oil.
    • “In the United States, cannabis use has nearly doubled in the past decade, with 22.3% of individuals 12 years and older — 64.2 million people — reporting its use in the past year, up from 12.6% in 2013, according to data from the Substance Abuse and Mental Health Services Administration. And research shows a 15-fold increase in the number of people reporting daily or near daily cannabis use from 1992 to 2022.”
  • The Today Show adds,
    • “Cyclosporiasis, a nasty parasitic infection that causes “explosive” watery diarrhea, has sickened dozens of people in Michigan and other parts of the United States.
    • “Cases of the gastrointestinal illness, caused by a parasite that spreads through contaminated food, have been on the rise in multiple states since May, according to the U.S. Centers for Disease Control and Prevention. At least 20 people have been hospitalized nationwide so far. 
    • “The CDC is working to identify potential sources of the parasitic infection, which is commonly linked to fresh produce.” * * *
    • “The U.S. typically sees several hundred cases of cyclosporiasis annually. In recent years, the number of infections reported in the U.S. has increased significantly.” * * *
    • “The best way to prevent infection is to avoid consuming food or water that may be contaminated with feces, the CDC says. Following proper hand hygiene and safe food handling practices can also lower your risk of foodborne illness.”
  • The New York Times points out,
    • Habitual users of fentanyl have developed such a strong tolerance to the drug that standard doses of medications to manage withdrawal and initiate recovery are no longer working for many patients, a team of researchers in Los Angeles has found.
    • Their study, published in the journal Drug and Alcohol Dependence, presents a picture of the dangerous volatility of the city’s street supply and the capacity of users to tolerate ever greater amounts of pure fentanyl, which is at least 50 times more potent than heroin.
    • “In a summary of the findings, Morgan Godvin, one of the lead authors of the study and a health services researcher at the University of California, Los Angeles, said that a seasoned user’s daily street dose of fentanyl was roughly equivalent to 1,250 hospital doses of 100 micrograms of fentanyl given during and after surgery.
    • “In any other context, that would be unsurvivable,” she wrote. “Among people who use fentanyl every day, it is routine.”
    • “The study reinforces the belief among many addiction experts that, for high-tolerance patients, the standard treatment regimens for opioid addiction have become outdated. Doses of medications such as buprenorphine and methadone, opioids that help satisfy cravings without inducing a high, were calculated to treat addictions to heroin and prescription painkillers. The results of the new research, experts said, support a growing call by clinicians for treatment guidelines to be revised to keep pace with the convulsive drug market.”
  • MedPage Today tells us,
    • “A global study showed that body mass index-associated gaps in blood pressure and cholesterol have diminished from 1990 to 2024.
    • “With more medications being used, older people with obesity were metabolically similar to, and in some countries even lower risk than, people with a normal BMI.
    • “Young adults with obesity remain metabolically higher risk, however, and should be a focus of prevention and treatment, some say.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For nearly half a century, scientists have known that malaria parasites force their way into human red blood cells (RBCs) through a ring-shaped structure called the moving junction (MJ). What no one could work out was what it actually does. The structure assembles, does its job, and dissipates in the space of 60 seconds—gone before anyone can get a close look.
    • “A team at Columbia University has now finally caught the moving junction in the act. By freezing parasites at the onset of invasion and lifting the intact complex straight out of the cell, the researchers obtained the first high-resolution view of its three-dimensional structure. What they saw overturned a decades-old assumption about how the parasite gets in. Rather than a passive doorway, the moving junction turns out to be a molecular machine that actively remodels the host cell’s membrane to help the parasite force its way inside.
    • “The findings detail how the team obtained the structure and then used it as a blueprint to design a mini-protein, from scratch, that blocks invasion—a proof of concept for a new kind of antimalarial drug.”
  • The Washington Post lets us know,
    • “When it comes to dementia risk, certain factors, such as genetics, are out of your control. However, plenty of research suggests lifestyle behaviors— things you can change — may help improve your chances of staying sharp as you age. In a new study, people with an elevated risk of dementia were less likely to develop the condition if they followed a healthy dietary pattern, particularly a less inflammatory one.”
  • Per BioPharma Dive,
    • “Roche’s experimental medicine divarasib helped patients with a certain type of lung cancer live longer than two approved treatments in a new study.
    • “The Phase 3 trial compared divarasib with Amgen’s Lumakra and Bristol Myers Squibb’s Krazati in patients with KRAS G12C non-small cell lung cancer who had already received previous treatment. Researchers found significant improvements in both overall survival and progression-free survival for the group taking divarasib, Roche said Thursday.
    • “Roche did not release detailed data, saying the results would be presented at an upcoming medical meeting. There were no new safety findings of concern and most treatment-related side effects were “manageable and reversible,” the company said.”

From the U.S. healthcare business front,

  • Healthexec reports,
    • With Election Day only four months away, healthcare is again emerging as a major source of idealistic campaign promises. Many of these are driven by widespread public angst. What sorts of changes can U.S. healthcare stakeholders realistically expect once the results are in? 
    • “Professional prognosticators at the global accounting and consulting firm PricewaterhouseCoopers, aka PwC, have considered the policy possibilities and are sharing their thinking in writing. * * * PwC offers forward-looking insights and advice for organizations across healthcare’s four major subsectors. 
      • “PROVIDERS: Policy drivers are reshaping delivery and access. 
        Healthcare providers will do well to “examine their care delivery footprints, leverage automation and technology to reimagine the workforce and operations in order to mitigate economic strain,” PwC comments. 
        ‘This should include identifying opportunities to diversify revenue sources, partnerships or M&A with other stakeholders, and prioritizing investment in new technology to reduce impacts of the increase in uncompensated care and workforce constraints.’
      • “PAYERS: Policy drivers are reshaping cost structures. 
        “Healthcare payers will likely need to strengthen care management capabilities as they expand their holistic support to members, the analysts forecast. 
        ‘This will include, in the future, leveraging sophisticated data models and interactive real-time communications to understand and influence member behavior patterns, accelerate paths to appropriate cost-effective care, and drive financial savings for members and plans.’
      • “PHARMA: Policy drivers are reshaping pipeline decisions, regulatory strategy and market access. 
        “In the future, pharmaceutical manufacturers, propelled by accelerating science and shifting patient expectations, “should expand from drug manufacturers to ‘lifespan partners,’ requiring more agile operating models and greater collaboration across technology, and ecosystem players,” the authors write.  
        ‘In the interim, pharmaceutical manufacturers can embrace innovative approaches to access, affordability and evidence generation to meet the needs of today’s consumer and keep pace with pipeline and pricing pressures.’
      • “MEDTECH: Policy drivers are reducing federal oversight of AI-powered and wellness devices. 
        “Going forward, the subsector is expected to become a broader ecosystem player, building interoperable, intelligent systems that connect care across hospitals and the home, PwC remarks. 
        ‘MedTech should strengthen capabilities for post market surveillance as FDA shifts oversight focus from a premarket review paradigm to an emphasis on performance and safety once on the market, particularly for low risk, consumer devices.’
  • Cardiovascular News relates,
    • “The American College of Cardiology (ACC) reached a major milestone this summer; its highest honor, the HeartCARE Center National Distinction of Excellence, has officially been awarded to 100 U.S. hospitals [all of which are listed in the article]. 
    • “The ACC established the HeartCARE Center designation in 2018 to celebrate hospitals and health systems that “demonstrate ongoing excellence through comprehensive accreditation, data-driven performance measurement and continuous quality improvement initiatives.” Recipients must be “forward-thinking organizations” that participate in ACC Accreditation Services programs, NCDR registries and other quality improvement campaigns focused on cardiovascular health.
    • “Reaching 100 hospitals recognized as ACC HeartCARE Centers marks an important milestone in our ongoing effort to elevate the standard of cardiovascular care,” Steven B. Deitelzweig, MD, chair of the ACC Accreditation Oversight Committee, said in a statement. “Each of these institutions has demonstrated a deep commitment to evidence-based care, continuous quality improvement and measurable outcomes—ensuring that patients receive the highest level of cardiovascular care, no matter where they live.”
  • Beckers Hospital News tells us,
    • “The Kroger Co. will acquire supermarket chain Giant Eagle, Inc. for $1.65 billion, expanding its pharmacy footprint across northern Ohio, western Pennsylvania, West Virginia, Maryland and Indiana.
    • “Giant Eagle operates 11 standalone pharmacies, according to a July 1 news release. Kroger said the acquisition will strengthen its presence in adjacent markets and build on Giant Eagle’s pharmacy business, loyalty program and private label portfolio. 
    • “The deal adds to Kroger’s pharmacy footprint at a time when retail pharmacy access is contracting elsewhere in the industry, with Walgreens restructuring into five standalone companies following multibillion-dollar operating losses and Rite Aid’s footprint largely gone — a gap health systems have increasingly stepped in to fill by opening their own pharmacies.” 
  • MedTech Dive informs us,
    • “Guardant Health said Wednesday its Shield test for colorectal cancer is now covered by UnitedHealth, the first major private U.S. health insurer to reimburse for the screening.
    • “The decision by UnitedHealth, the largest private U.S. health insurer, expands access to the screening to about 100 million Americans, the company said.
    • “Canaccord Genuity analyst Kyle Mikson, in a note to clients, called the coverage decision a “watershed moment” for liquid biopsy-based cancer screening and for the category of blood-based cancer testing.”

Wednesday report

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

Simplicity is a virtue.

HAPPY NATIONAL POSTAL WORKERS DAY!

From Washington, DC,

Plenty of news from the U.S. Office of Personnel Management today.

  • Per an OPM news release,
    • “Today, the US Office of Personnel Management (OPM) announced the “Last Day of Paper,” officially ending paper retirement processing for more than 95 percent of federal retirement applications and completing the agency’s transition to a fully digital retirement process.
    • “For decades, federal retirement applications relied on a paper-based process that required physical documents to move between agencies, payroll providers, and OPM’s Retirement Operations Center in Boyers, Pennsylvania. As of yesterday, nearly all retirement applications will be submitted and processed electronically through OPM’s Online Retirement Application (ORA), eliminating paper from the process and significantly reducing processing times.
    • “The milestone follows rapid adoption of ORA, which has processed more than 155,000 retirement applications over the past year after serving only a few hundred users during its initial rollout.” * * *
      • “As part of today’s milestone, OPM is also launching new capabilities designed to accelerate retirement processing, including:
      • “A new pre-retirement application that allows employees and agency HR offices to complete much of the retirement process before an employee’s separation date.
      • “Earlier processing of retirement applications while final payroll information is still being finalized, reducing unnecessary delays.
      • “A commitment to issue a retiree’s first pension payment within seven days of retirement for applicants who submit a complete retirement package by their separation date.”
  • FEHBlog observation – While OPM deserves credit for this accomplishment, the agency has not announced implementing the HIPAA standard transaction 820 which is an electronic enrollment roster that would allow carriers to reconcile premiums to individual enrollments. The HIPAA 820 has been around since 2012. Carrier systems must accept the HIPAA 820. What is the sense in collecting family member eligibility documents when no one currently knows whether the enrollee is paying the proper premium?
  • Govexec adds,
    • “The federal government’s 401(k)-style retirement savings program posted mixed results in June, ending two straight months of consistent growth.
    • “The Thrift Savings Plan’s S Fund, which is made up of small- and mid-size businesses, saw the best performance, gaining 4.34% last month. Since January, the S Fund has grown 18.41%.
    • “The fixed income (F) fund increased 0.25% last month, bringing its 2026 performance to 0.74%. And the G Fund, which is made up of government securities, increased by its statutorily mandated rate of 0.37%. So far this year, the G Fund has swelled 2.18%.
    • “But the I Fund was virtually flat in June, losing 0.03%. That brings the I Fund’s 2026 performance to 16.53%. And the C Fund’s common stocks fell 0.95%, bringing its gains since January down to 10.20%.”
    • The performance of other funds can be found in the article.
  • Another OPM news release tells us,
    • “The US Office of Personnel Management (OPM) today proposed sweeping reforms to modernize how agencies address poor performance, streamline disciplinary and removal procedures, and strengthen accountability across the federal workforce.
    • The proposed rule would require agencies to better equip supervisors with training on employee accountability while making it easier to address employee performance issues. Among other reforms, the proposal establishes a default 30-day Performance Improvement Plan (PIP), eliminates pre-PIPs that unnecessarily delay action, standardizes employee response periods for adverse actions, and modernizes Merit Systems Protection Board review of adverse action appeals by replacing the current checklist-based approach (called “the Douglas factors”) with a totality-of-the-circumstances standard.
    • This proposal is part of the Trump Administration’s broader effort to build a high-performing federal workforce that rewards excellence, recognizes strong performance, and holds employees accountable when performance falls short.” * * *
    • “The proposed rule will be published in the Federal Register and will be open for public comment. Read Director Kupor’s blog post on this here.”
  • OPM Director Scott Kupor added a second post to this Secrets of OPM blog today. The second post is titled “Measure what matters.”
    • “Last year, we postponed the Federal Employee Viewpoint Survey (FEVS) and critics were quick to claim that we at OPM did not believe in employee engagement surveys. That couldn’t be farther from the truth. * * *
    • So, today we announced that OPM will no longer centrally administer FEVS. As a centrally-administered system, it’s costly, doesn’t serve as a valuable management tool and fails to enable actionable results. That serves nobody well.
    • Instead, we have provided detailed guidance to agencies on how best to design surveys that meet their specific needs. That guidance includes a common set of core questions that every agency will ask—ensuring we preserve the ability to track government-wide trends and maintain a coherent thread of data across the federal workforce. The goal isn’t fragmentation; it’s better ownership. Agencies will have the flexibility to go deeper where their missions demand it, while OPM retains the visibility to understand the broader landscape and identify where systemic challenges require government-wide attention.”
  • Federal News Network reports,
    • “President Donald Trump said Monday [June 29] he will nominate Keith Sonderling to be the secretary of labor, elevating him from the agency’s acting director two months after Lori Chavez-DeRemer resigned amid abuse-of-power allegations.
    • “Sonderling, a lawyer who has held a variety of acting positions and leadership roles across Trump’s government, was previously the deputy labor secretary and a Republican member of the Equal Employment Opportunity Commission.
    • “Throughout his career, Keith has proven his dedication to delivering strong results for the Hardworking People of our Country, and I know he will do an incredible job in his new role,” Trump wrote in a Truth Social postannouncing Sonderling’s nomination.
    • Sonderling’s nomination is subject to Senate confirmation.
  • Fierce Healthcare relates,
    • “The Trump administration has officially launched its new “bridge” model that brings GLP-1 coverage for weight loss to Medicare beneficiaries.
    • “Eligible people enrolled in Medicare Part D can secure certain GLP-1 medications for weight loss or management at $50 each month. The program will remain in place through the end of 2027, the Centers for Medicare & Medicaid Services said in an announcement.
    • ‘Under the GLP-1 bridge, the feds will cover the cost of expanded coverage. Alongside this model, the agency also proposed a second approach—called Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth, or BALANCE—in which it would negotiate lower GLP-1 prices in exchange for standardized coverage options.
    • “Plans balked at the model, and CMS indefinitely delayed from a planned January 2027 start date. A similar model was implemented in Medicaid in May 2026.
    • “In a CMS announcement commemorating the model’s launch, Administrator Mehmet Oz, M.D., urged beneficiaries to reach out to their doctors to see if they’re eligible.
    • “For too long, many Americans have been unable to access these treatments because of cost,” Oz said.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is proposing new safeguards to ensure taxpayers aren’t on the hook for noncompliant Medicare providers and suppliers, continuing its campaign to crush fraud, waste, and abuse throughout its programs and hold bad actors accountable. The Calendar Year (CY) 2027 Home Health Prospective Payment System (PPS) proposed rule would strengthen CMS’ ability to recover improper payments and remove non-compliant providers and suppliers from Medicare, actions estimated to save approximately $82 million in annual savings, while also expanding access for patients receiving care at home and improving the timeliness of publicly reported home health agency quality information.”
    • * * * “The proposed rule also would update Medicare home health payment rates for CY 2027. At the same time CMS is strengthening oversight and crushing fraud, waste, and abuse, the agency is proposing targeted payment updates that support access to care for beneficiaries who rely on home health services. CMS is also proposing to continue to fulfill its statutory obligation to transition the Home Health PPS to the Patient-Driven Groupings Model in a budget-neutral manner. CMS estimates total Medicare payments to home health agencies would increase by approximately 2.4%, or $420 million, compared to CY 2026.” * * *
    • “To view a fact sheet on the proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-home-health-prospective-payment-system-proposed-rule-fact-sheet-cms-1844-p. 
    • “The proposed rule can be viewed on the Federal Register at: https://www.federalregister.gov/d/2026-13602.” 
       
  • Per a GAO news release,
    • “A leading cause of death in the U.S., suicide resulted in more than 49,000 deaths in 2023. That’s up by 31% from 2003.
    • “To help those at risk, the federal government set up the 988 Suicide & Crisis Lifeline. It offers support via call, text, and chat.
    • “Since the Lifeline’s inception in July 2022 through September 2025, we found:
      • “Call, text, and chat contact volume increased
      • “Call answer rates increased, while text and chat answer rates varied
      • “Average time to answer calls, texts, and chats varied
    • “We also found that the federal government set goals for the Lifeline. It collected data related to those goals and used it to assess its performance.”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission rescinded its affirmative action guidelines Tuesday, eliminating an interpretation that had persisted for 40 years.
    • “According to a June 30 statement, the guide and a related compliance manual “ran afoul” of Title VII of the Civil Rights Act of 1964 and more recent U.S Supreme Court rulings in the eyes of the commissioner. Almost three years ago to the day, the high court issued its decision in Students for Fair Admissions, Inc. v. Harvard, holding that race-conscious admissions practices at two universities were unconstitutional.” * * *
    • “The takeaway from the new plan should not be to “abandon lawful EEO efforts, but to ensure policies do not use protected characteristics as selection criteria,” management-side attorney Randi Hyatt, a partner at Whiteford, Taylor & Preston, said in an analysis.”

No Surprises Act News

  • Fierce Healthcare reports,
    • “Healthcare technology company Zelis rolled out an AI-native solution to help health plans manage Independent Dispute Resolution complexity under the No Surprises Act.
    • “Independent Dispute Resolution (IDR) is the process for adjudicating out-of-network claims created by 2020’s No Surprises Act (NSA).
    • “Zelis’ solution uses AI to automate payers’ workflows, from claim repricing, open negotiation, dispute prevention, case management and IDR resolution. The company unveiled the new solution as dispute volume, compliance requirements and process deadlines pressure payer operations, executives said.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). This is the first gene therapy approved for patients aged 2 years and older with SCD.  
    • Casgevy has been previously approved for the treatment of patients aged 12 years and older with SCD with recurrent VOCs or TDT.  
    • “With today’s decision, pediatric patients as young as 2 years of age can now access a critical additional treatment option to treat these debilitating, life-threatening diseases,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “The FDA is committed to prioritizing and speeding up the review of products that address critical U.S health priorities through expedited review programs, including the FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program. These initiatives are designed to advance therapies for diseases with significant unmet medical needs, enabling faster access to innovative treatments while upholding the FDA’s rigorous gold-standard requirements for safety and effectiveness.”  
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today commended the Drug Enforcement Administration’s (DEA) issuance of two Notices of Intent to begin the temporary scheduling process for certain kratom-related substances.
    • ‘One Notice of Intent addresses temporary placement of 7-OH above a specified threshold in Schedule I, while the second would temporarily place three synthetic 7-OH derivatives into Schedule I of the Controlled Substances Act (CSA):
      • “Mitragynine pseudoindoxyl (MP)
      • “Dihydro-7-hydroxymitragynine (MGM-15)
      • “The 9-fluoro derivative of 7-hydroxymitragynine (MGM-16)
    • “Concurrent with DEA’s Notice of Intent addressing 7-OH, the Office of the Assistant Secretary for Health (OASH) issued a Request for Information (RFI) on seeking public comment on the proposed 7-OH threshold level in the NOI. The request is limited to obtaining comments on whether: 1) there is additional scientific data to support the proposed or an alternative threshold level – specifically, what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety; and 2) data exist supporting alternative measurement expressions for purposes of specifying the threshold level that is necessary to avoid an imminent harm to public safety.
    • “After the 30-day comment period for the RFI, OASH will provide comments submitted to the RFI public docket to the Attorney General for consideration. Once comments have been considered and at least 30 days have passed since the publication of the NOI, the Attorney General may then issue a temporary scheduling order placing 7-OH above a certain threshold in Schedule I. The CSA provides the Attorney General with the authority to issue a temporary scheduling order placing a substance in Schedule I of the CSA for two years, if such action is necessary to avoid an imminent hazard to public safety.”
  • Cardiovascular Business relates,
    • “Amgen is recalling nearly 935,000 bottles of ivabradine, a heart failure drug the company sells under the brand name Corlanor, due to the presence of a foreign substance. 
    • “The recall includes specifics lots of 5-mg and 7.5-mg Corlanor tablets manufactured in Italy and then distributed by Amgen throughout the United States. The drugs are packaged in 14- and 60-tablet bottles. Expiration dates range from July 2026 to December 2028.
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, which means taking the drugs in question could cause “temporary or medically reversible adverse health consequences.”
    • “Amgen first received FDA approval for ivabradine in April 2015. The agency’s decision was largely based on data from the SHIFT trial, which included more than 6,500 patients randomized patients treated with ivabradine or a placebo. In 2021, researchers found that ivabradine could be used to treat symptoms associated with postural orthostatic tachycardia syndrome in COVID-19 patients.”
  • MedTech Dive adds,
    • “The Food and Drug Administration has reported 252 injuries were associated with Hologic’s BioZorb radiographic markers implanted in the breast and other soft tissue sites during medical procedures. No deaths were reported.
    • “The update comes almost two years after Hologic told customers to stop using the devices due to reports of adverse events such as pain, infection and device migration. At the time, Hologic said it had received 188 complaints associated with adverse events.
    • “In its latest communication, the FDA repeated Hologic’s instructions advising healthcare providers not to use the BioZorb markers. Patients should be monitored for signs of adverse events, but Hologic said there is no need to have an implanted marker removed from the body.”
  • Beckers Hospital Review tells us,
    • “Cisplatin, carboplatin, oxaliplatin and ifosfamide remain in active shortage, and manufacturers’ latest estimates show full resupply of some formulations will not arrive until October, according to updates posted by the American Society of Health-System Pharmacists. 
    • “The four chemotherapy drugs form the backbone of treatment for breast, lung, ovarian, testicular, bladder, and head and neck cancers. Becker’s previously reported that hospitals and cancer clinics working with group purchasing organization Premier received only 38% of their ifosfamide orders and about two-thirds of their cisplatin orders in recent weeks, prompting some healthcare organizations to space out doses and prioritize patients most likely to benefit from treatment.”
  • BioPharma Dive identifies “5 FDA decisions to watch in the third quarter of 2026.”
    • “A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “West Nile virus activity is starting earlier than it has in years, with the CDC warning it is now seeing the highest number of human cases of the nasty mosquito-borne disease since 2004.
    • ‘At least 48 cases had been reported as of Tuesday, and 38 have involved serious illness affecting the brain or nervous system. 
    • “For comparison, by the end of June, the Centers for Disease Control and Prevention usually sees only about 10 human cases. The earlier start could be problematic, as it extends the amount of time people could be exposed to the disease before the season dies down in colder months.” * * *
    • “Arizona has reported the highest number of cases in the country at 32. Maricopa County, the state’s most populous county, has reported 29 cases, including four deaths, already more than half of the case total it reported in all of 2025.”
  • Drug Topics relates
    • “Surveillance through June 2026 shows widespread, outbreak-driven measles transmission, with 93% of cases in unvaccinated/unknown-status individuals and 6% requiring hospitalization. 
    • “Erosion of kindergarten MMR coverage from 95.2% to 92.5% leaves hundreds of thousands susceptible, while subregional coverage can fall near 50%, enabling explosive outbreaks. 
    • “Utah’s large outbreak prompted enhanced monitoring, including wastewater-based detection, and recommendations for earlier MMR dosing (from 6 months) to mitigate infant risk. 
    • “Persistent misinformation and vaccine hesitancy necessitate motivational interviewing techniques (OARS, readiness rulers) and proactive pharmacist-led community engagement to rebuild trust and uptake.”
  • Managed Health Executive points out,
    • “Physical inactivity and racial and ethnic minority status emerged as the two strongest predictors of diabetes prevalence across U.S. counties in a new machine-learning analysis published in Diabetes/Metabolism Research and Reviews.
    • “The cross-sectional study, led by Nicolaas P. Pronk, Ph.D., of the HealthPartners Institute, set out to capture what the authors call the “multilevel ecology” behind diabetes, defined as the mix of broad structural forces and individual-level behaviors that impact diabetes development.”
  • Beckers Clinical Leadership lets us know about “Lung cancer screening, mortality and incidence — by state.”
    • “At 11%, California had the lowest up-to-date lung cancer screening rate in 2024, while Connecticut, Massachusetts and Pennsylvania had the highest rate at 28%, according to American Cancer Society data. 
    • “The national median rate for up-to-date lung cancer screening in 2024 was 18%.
    • “Lung cancer mortality and incidence remain highest in Kentucky and West Virginia, despite having above-average lung cancer screening rates.” 
  • Health Day tells us,
    • “Stepped alcohol treatment (SAT) offered via telehealth helps people with chronic liver disease (CLD) reduce alcohol consumption, according to a study published online June 24 in Hepatology.
    • “Derek D. Satre, Ph.D., from the University of California, San Francisco (UCSF), and colleagues evaluated the efficacy of telehealth SAT, which consisted of three motivational interviewing sessions followed by addiction medicine referral if no drinking reduction at month 3. One hundred fifty-seven adults with CLD and unhealthy alcohol use (>7 drinks/week or ≥4/day for women; >14/week or ≥5/day for men; or heavy episodic drinking) were randomly assigned to SAT (81 participants) or usual care (76 participants). 
    • “The researchers found that SAT had no difference in percentage of alcohol use below moderate level (primary outcome) versus usual care. However, SAT had greater reduction in drinks/week from baseline to month 3 and month 6 (estimates, −0.66 and −0.67, respectively) (secondary outcome). Compared to usual care, the six-month effect of SAT on alcohol use reduction remained significant when controlling for covariates. The 30-day abstinence rates were 29 percent for SAT and 18 percent for usual care at month 6. There was a positive association between baseline motivation to reduce alcohol use and treatment response.”
  • The latest NIH Research Matter covers the following topics:
    • “Alzheimer’s proteins in blood linked to midlife cognition 
      • “A study found that people in midlife with more Alzheimer’s-related proteins in their blood had worse cognitive function.
      • “The results suggest blood tests could one day help identify people who may benefit from early efforts to delay Alzheimer’s symptoms.”
    • “Genetic testing may benefit more patients with melanoma 
      • “Researchers found people diagnosed with melanoma at a young age or with multiple melanomas were more likely to carry a genetic mutation.
      • “The findings suggest that certain patients with melanoma could benefit from genetic testing to identify mutations and potential risk for other types of cancer.”
    • “Senescent cells mapped in human body over the lifespan
      • “Scientists located and classified senescent cells, a hallmark of aging, to begin building an atlas of these non-dividing cells in the human body.
      • “The atlas could help track how senescent cells drive age-related conditions and may inform treatment strategies for age-related diseases.”
  • The University of Minnesota’s CIDRAP notes,
    • “Vaccine myths are not new. They have circulated for decades, surviving retracted studies and countless public health campaigns. Now, a new poll suggests that, while relatively few Americans fully believe those falsehoods, many remain uncertain about them—a finding that suggests opportunities to counter vaccine misinformation.” * * *
    • “The poll found a strong association between trust in healthcare providers and vaccine attitudes, with adults who have a provider they trust being less likely to believe vaccine myths.
    • “Just under half of adults (46%) who do not have a trusted healthcare provider to answer questions about their health said it was “probably” or “definitely true” that more people have died from COVID vaccines than from COVID itself. That’s almost twice as many as those who reported having a trusted provider (24%). 
    • “Researchers noted that the relationship remained significant even after accounting for factors such as age, race and ethnicity, education, political affiliation, and insurance status.”
  • Per BioPharma Dive,
    • “Shares of Paris-based biotechnology company Abivax surged nearly 40% Tuesday following the release of supplementary Phase 3 data on its inflammatory bowel disease drug that cleared away investors’ concerns about increased cancer risk.
    • “Abivax said cancer rates seen across enrollees in its Phase 2 and Phase 3 trials were no higher than the “background” one seen in people with ulcerative colitis, which is higher than the general population in certain types of malignancies.
    • “The update from the second part of that Phase 3 trial — which enrolled people who didn’t respond to the drug or relapsed during the trial — added safety data that “appropriately addresses the key overhang facing the stock,” wrote Jefferies analyst Faisal Khurshid in a client note. Abivax followed the share price increase with an $800 million sale of its U.S. listed shares.”

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

  • Modern Healthcare reports,
    • “Brian Evanko, Cigna Group’s new chief executive officer, said he aims to put patients at the center of the company’s strategy. He’ll have to convince people struggling with rising healthcare costs that he’s serious — and persuade Wall Street that this strategy can be profitable. 
    • “That’s been a difficult balancing act for Cigna. Last year the company announced that it would phase out rebate payments from drug companies in many of its prescription plans, pulling back from a “middleman” practice the Trump administration has criticized.
    • “Cigna said this would lower patient costs and only temporarily shrink profits. But investors punished Cigna with its worst selloff in 17 years. Its shares still haven’t recovered.”
    • “It’s a tension Evanko will have to navigate beginning Wednesday when he becomes the public face of Cigna, a giant in medical insurance, prescription drug benefits and specialized pharmacy services. Insurers are under fire in Washington for high costs. Employer clients are balking at premium hikes. Patients are frustrated with spending-control tactics like prior approvals. And investors are wary that addressing those concerns could erode profits.
    • “Evanko said he’s focused on making Cigna more responsive to the 185 million people who use its healthcare services, the bulk of whom have prescription drug coverage managed by the business.
    • “For me, coming into the role, importantly, we’re going to put the customer at the center of everything we do, so being patient-first,” Evanko, 50, said in a recent interview at Bloomberg’s New York headquarters. “We see that as actually a strategic choice.”
  • Beckers Payer Issues relates,
    • “Hospitals and insurers have been fighting an AI billing war for the better part of two years, with providers deploying the technology to optimize and defend their coding, and payers using it to audit and push back.
    • “AI is placing pressure on cost through RCM tools, and we have seen those patterns in terms of service intensity, and cost per encounter going up,” UnitedHealthcare CEO Tim Noel said at a June media event attended by Becker’s. “It clearly has occurred, and that is a source and driver of trend. I don’t think that that’s going to be persistent. That’s a moment that we’re in that will get to saturation.”
    • “Revenue cycle executives and physicians have described the ongoing dynamic as an “AI arms race,” that has been adding administrative cost and friction on both sides. This month, PwC projected that employers’ medical cost trend will reach its highest level in 17 years in 2027, pointing to provider adoption of AI documentation and coding tools as one of five primary inflators. Nearly 70% of surveyed health plans ranked it among their top three concerns, and roughly 20% named it the single largest driver.
    • “Mr. Noel said UnitedHealthcare is already working to move beyond paid-claims data to understand “more upstream where these hot spots are.” 
    • “The global trends are the global trends, and there are some opportunities to address those in the moment, and we are,” he added. “But we also have to look for new sources of affordability moving forward.”
  • and
    • “Sustainability has become less about cutting costs and more about redesigning how healthcare delivers value. Becker’s asked several health plan leaders how they’re thinking about long-term sustainability, and the responses point to a shared shift away from volume-driven models toward outcomes, accountability, and member-centered design. From shifting social health programs toward measurable, evidence-based interventions to redesigning the consumer experience around choice and transparency, leaders are converging on the idea that sustainability isn’t a single initiative — it’s a durable operating model built for the long haul.
    • “The answers below reflect a range of strategies, from strengthening payer-provider partnerships and embedding AI into clinical decision-making to balancing financial discipline with health equity and community trust. Common threads emerge around reducing low-value care, building data infrastructure that supports proactive rather than reactive management, and designing systems flexible enough to adapt as member needs evolve. [In the article], healthcare leaders share how they’re positioning their organizations for what’s next.
  • Vizient discusses “From scale to orchestration: The new requirements for payer success.”
    • “For executive and board consideration:
      • “Evaluate strategic pathways, including independence, partnership, affiliation, or acquisition.
      • “Assess strengths and gaps across products, member diversification, scale, and market positioning
      • “Identify partners that align across strategy, governance, economics, and long-term objectives.
      • “Execute transactions and integrations with rigor and discipline.”
  • MedCity News considers,
    • “Healthcare’s Most Avoided Question: “How Much Exactly Do You Need, and What Will America Get in Return?”
      • “Before policymakers, employers, insurers, or taxpayers commit ever-larger sums to the system, an uncomfortable question deserves attention: How much additional capacity does healthcare actually need and what measurable outcomes should society expect in return?”
  • Modern Healthcare tells us,
    • “Allegheny Health Network closed its acquisition of Heritage Valley Health despite pushback from the Pennsylvania attorney general. 
    • “The deal adds Heritage’s two hospitals, dozens of clinics and 500 employed and affiliated physicians to the 16-hospital provider division of Highmark Health.
    • “A final order Friday from a federal court paved the way for the transaction’s close, with conditions. Last Wednesday, Pennsylvania Attorney General Dave Sunday (R) sued to block the transaction over potential anticompetitive effects. He claimed the acquisition could allegedly increase hospital and radiation oncology prices in Beaver County and Allegheny County.
    • “The order from U.S. District Court for the Western District of Pennsylvania Judge Maureen Kelly requires Allegheny Health to provide current services at the rebranded AHN Beaver Hospital – Heritage Valley and AHN Sewickley Hospital – Heritage Valley for at least five years and maintain an existing joint venture between Heritage Valley and UPMC Cancer Centers.
    • “In addition, Allegheny cannot terminate automatic renewal clauses in its insurer contracts for at least a year and it must pay Sunday $75,000 in legal fees, among other provisions.”
  • The Wall Street Journal informs us,
    • “Ipsen IPN said it agreed to buy Swiss biotechnology company Memo Therapeutics in a deal that could exceed 700 million euros ($799.6 million) and that seeks to expand the French drugmaker’s rare-disease portfolio.
    • “The move marks Ipsen’s second acquisition this week after its agreement to take over Kartos Therapeutics, a company developing a drug to treat a rare blood cancer, for up to $1.75 billion.
    • “Ipsen said it would pay 200 million euros initially and make deferred payments subject to certain development, regulatory approval and sales-based targets that could take the total price above 700 million euros.
    • “The deal focuses on Memo’s experimental drug potravitug for the treatment of nephropathy associated with BK polyomavirus, a complication in kidney transplant recipients, Ipsen said. The drug—which was granted fast-track designation from the U.S. Food and Drug Administration in 2023—is due to move to a mid- and late-stage clinical trial later this year, the company added.”
  • Fierce Healthcare points out,
    • “Patients are taking charge of their healthcare with artificial intelligence and other solutions, with 58% of U.S. patients researching symptoms before deciding whether to book an appointment, according to a new report from ZS Impact Institute. 
    • “The recent report drew insights from nearly 10,000 healthcare consumers and providers across the U.S., Germany and China. Researchers note the shift is consistent across healthcare systems, which they say points to a “broader breakdown in how patients seek and experience care globally.”
    • “Thirty-seven percent of U.S. respondents report using search engines for health information—94% of which find it helpful—and 18% report using AI. Eighty-nine percent of those using AI to find information report it being helpful.”
  • and
    • “Evernorth has unveiled a new specialty pharmacy program that leans on AI to support a better experience for patients with complex conditions.
    • “Called Pharmacy Forward, the program aims to use technology to drive more coordinated, connected care and to offer personalized supports in real time. Evernorth plans to launch the program first for Accredo Specialty Pharmacy customers, investing $100 million through 2028 in the project.
    • “The goal, according to an announcement from the company, is to allow care teams to spend more time on clinical and patient care, while also accelerating prescription processing and service responsiveness.
    • “Patients navigating complex health conditions need comprehensive, expert support, often during some of the most difficult moments in their lives,” said Matt Perlberg, president of the Evernorth Health Services pharmacy and care delivery businesses, including Accredo, and executive vice president of Customer Innovation for The Cigna Group, in the announcement.”
  • Beckers Health IT notes,
    • “Anthropic is launching an internal drug discovery program with a focus on neglected diseases that traditional pharmaceutical companies would not consider commercially attractive, CNBC reported June 30.
    • “At a June 30 event in San Francisco, Eric Kauderer-Abrams, Anthropic’s life sciences head, said the effort is designed to give the company firsthand experience in drug development as it builds AI tools for biopharma customers. Anthropic leaders framed the drug discovery program as a way to build credibility with the biopharma companies it hopes to win as Claude Science customers.
    • “Jonah Cool, Anthropic’s head of life sciences partnerships, said the focus on neglected diseases will run alongside the company’s broader push to create and sell AI tools to life sciences companies.”
  • Genetic Engineering and Biotechnology News adds,
    • “Anthropic has released Claude Science, an AI workbench for scientists that consolidates fragmented research tools, including over 60 scientific databases and connectors pre-configured for genomics, proteomics, structural biology, and more, into a single reasoning layer. The platform joins an increasingly crowded ecosystem of tech platforms specialized for biology and aims to accelerate scientific discovery by making domain expertise more accessible.
    • “Anthropic’s life science partners are delivering applications. Basecamp Research is targeting global public health, where drug-resistant infections play a role in nearly five million deaths per year. The London-based team has announced that its antibiotic design and vaccine target prediction EDEN models will now be available through Claude Science.
    • “A metagenomic foundation model, EDEN demonstrated a 97% success rate when designing functional peptides with high potency against World Health Organization (WHO) critical-priority and multidrug-resistant pathogens. The work was done in collaboration with César de la Fuente, PhD, presidential associate professor at the University of Pennsylvania.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

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

No Surprises Act news

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Midweek update

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Healthcare Dive reports,
    • “U.S. healthcare spending spiked 7.3% last year to reach $5.7 trillion, driven by soaring spending on hospital services and pricey prescription drugs like GLP-1s, according to new government data.
    • “The sharp spending growth isn’t primarily caused by increasing prices. Cost growth has been moderate. Instead, Americans are consuming more healthcare after a lag during the coronavirus pandemic, CMS actuaries said. It’s the same trend they called out in the national health expenditures report for 2024.
    • “But the high rate of growth last year was still surprising, according to Jacqueline Fiore, an economist with the CMS’ Office of the Actuary.
    • “Spending growth continuted to grow more rapidly for 2025 than we had expected,” Fiore said on a call with press Wednesday to discuss the projections, which the CMS released in the journal Health Affairs.
    • “The forces accelerating spending, however, are no surprise. Retail prescription drug spending is forecast to grow at the fastest clip over the next decade, but especially in 2025 and 2026 due to more Americans utilizing expensive drugs for conditions like cancer — and rabid demand for GLP-1s.”
  • Modern Healthcare adds,
    • “National health expenditures will rise to nearly $9 trillion and comprise 20.6% of gross domestic product by 2034, according to a federal report released Wednesday. * * *
    • “Health expenditures are forecast to rise an average 5.4% per year through 2034, when they will reach $8.97 trillion, the study found. Healthcare spending will continue to outpace the economy, which the actuaries anticipate will grow an average 4.1% annually over that time. * * *
    • “Hospital spending is projected to have risen 8.2% to $1.8 trillion in 2025, below the 8.9% rate in 2024. Spending on physician and clinical services is projected to have increased 6.2% to $1.2 trillion, down from an 8.1% growth rate in the prior year.”
  • NPR relates,
    • “Helped by pausing payments to worker retirement funds, the U.S. Postal Service is no longer on track to run out of money and stop deliveries next year, Postmaster General David Steiner confirmed to Congress on Wednesday.
    • “But with people and businesses still sending a lot less mail compared to decades ago, the self-funded federal agency remains close to a financial cliff as it struggles to continue delivering mail six days a week to just about every address in the country.
    • “A cash crisis at USPS may now come sometime between 2031 and 2034, according to the agency’s latest projections.
    • “What we are doing right now is we’re basically borrowing money from our retirement plans to fund current operations,” Steiner told lawmakers at a hearing before the Senate Homeland Security and Governmental Affairs Committee. “I’m not particularly comfortable with that. I promise you our employees are not particularly comfortable with that. You all shouldn’t be comfortable with that. None of us should be comfortable with that. To me, that’s why we have to have this discussion of how we fix this broken business model.”
  • Beckers Hospital Review tells us,
    • “A bipartisan group of senators led by Senator Brian Schatz, a Democrat from Hawaii, introduced the Ensuring Access to General Surgery Act of 2026, legislation that would create the first formal federal shortage designation for general surgeons and direct the Health Resources and Services Administration to map gaps in surgical care access nationwide.
    • “According to a June 23 news release by The American College of Surgeons, who also backed the bill, the proposal would require HRSA to study and define general surgery workforce shortage areas and collect data on the adequacy of surgical services across the country. It would also authorize the HHS secretary to establish a formal general surgery shortage area designation — a tool that currently exists for primary care and other specialties but has never been applied to general surgery.”
  • Per an HHS news release dated June 23,
    • “The U.S. Department of Health and Human Services (HHS) today announced the successful conclusion of the federal public health response to the Hantavirus exposure event associated with the M/V Hondius cruise ship. The final 42-day monitoring period ended on June 21 at 2 p.m. EDT. No individuals in the United States remain under public health monitoring for Hantavirus exposure.
    • “Under the leadership of Secretary Robert F. Kennedy, Jr., HHS worked closely with federal, state, and local public health partners to identify potentially exposed individuals, conduct monitoring, provide clinical guidance, and ensure readiness across the United States healthcare system. As a result of these efforts, no sustained transmission of Hantavirus occurred in the United States, and all monitoring activities related to the event have been completed.
    • “Proponents argue the absence of that designation has left policymakers without a standardized mechanism to identify underserved communities, recruit surgeons to those areas, or direct federal resources toward access gaps. The legislation is the Senate companion to House bill HR 7198, introduced earlier this year.”
  • Per a CMS fact sheet,
    • “On June 24, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies under the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2027. This rule also proposes updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2027 and proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2027, CMS is proposing to increase the ESRD PPS base rate to $299.55, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 1.1%. This amount includes a proposed $15.96 increase to account for the incorporation of phosphate binders into the ESRD PPS base rate. The CY 2027 ESRD PPS proposed rule also proposes changes to the low-volume payment adjustment, changes to the payment adjustments for pediatric patients, an increase to the home and self-dialysis training add-on amount and technical modifications to the transitional drug add-on payment adjustment (TDAPA), and a post-TDAPA add-on payment adjustment.” * * *
    • The proposed rule can be downloaded from the Federal Register at: https://www.federalregister.gov/d/2026-12925.
  • Fierce Healthcare unpacks for us “CMS’ decision to recalculate 2026 MA star ratings after Clover Health ruling.”
  • Healthcare Dive notes,
    • “The Rural Health Transformation Program is beginning to reshape how hospitals in rural America deliver care. But with nearly a trillion dollars in Medicaid cuts looming and pressure to show results or risk losing funding, many states are pursuing the safest path available: paying hospitals to downsize.” * * *
    • “Framing the program as incentivizing hospitals to shrink is misleading, said Robert Parris, a managing director who leads government-focused healthcare advisory work at consulting firm Huron. What’s actually happening, he said, is that communities are getting more of what they need and less of what they don’t.
    • “It’s more about reallocation as opposed to taking away,” Parris said.
    • “The program is also shifting how leaders think — from what services a facility can provide within its own walls to what care the surrounding population actually has access to, said Paul Johnson, a managing director who works directly with rural hospital clients at Huron.
    • “Many hospitals had these changes on their wish lists for years, but they couldn’t justify the investment because they were focused on surviving the next budget cycle.
    • “It’s almost like a license for them to pivot into things that they know they’ve had to do,” Johnson said.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The game is on for TROP2 antibody-drug conjugates in first-line triple-negative breast cancer.
    • “Less than a month after an approval for Daiichi Sankyo and AstraZeneca’s Datroway for front-line TNBC patients who are not candidates for PD-1/L1 inhibitors, the FDA has handed Gilead Sciences’ Trodelvy a rivaling approval that allows the drug to be used regardless of patients’ PD-L1 status.
    • “The new FDA approval for Trodelvy in first-line TNBC now allows the first-in-class TROP2 ADC to be used either alone for patients who aren’t eligible for PD-1/L1 inhibitors or in combination with Merck & Co.’s Keytruda for those with PD-L1-positive tumors, defined as a combined positive score of at least 10.”
  • and
    • “It’s been seven years since Pfizer scored an expansion for its breast cancer blockbuster Ibrance, and during that time, the drug has started to lag sales of two others in its class—Eli Lilly’s Verzenio and Novartis’ Kisqali.
    • “But on Wednesday, the FDA gave the CDK4/6 inhibitor a shot in the arm, signing off on Ibrance as a maintenance option for patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer after induction treatment.
    • “CDK4/6 inhibitors such as Ibrance are well-established treatments for HR-positive, HER2-negative breast cancer, but the HR+/HER2+ indication represents a new frontier. 
    • “With today’s FDA approval, Ibrance becomes the first and only CDK4/6 inhibitor indicated for patients with HR+ metastatic breast cancer regardless of HER2 status, extending its impact to patients who continue to face challenges with treatment resistance,” Aamir Malik, Pfizer’s U.S. commercial chief, said in a Jun. 24 statement.” 
  • Cardiovascular Business relates,
    • “GuideAI Health, a Boston-based medtech company founded by radiologists, has secured U.S. Food and Drug Administration (FDA) clearance for artificial intelligence (AI)-powered software that flags early warning signs of peripheral artery disease (PAD).
    • “VascularAssist Occlusion Triage (VAOT) alerts clinicians when it detects a suspected vascular occlusion, ensuring the patient receives a prioritized review. The newly approved software has been linked to high patient-level sensitivities for both 2D and 3D analyses of medical imaging exams of the lower extremities.
    • “Receiving FDA 510(k) clearance for VAOT is a defining milestone for GuideAI and for the patients we ultimately aim to serve,” Raj Shah, MD, MBA, CEO of GuideAI Health, said in a prepared statement. “Peripheral vascular disease is too often missed or detected late, with devastating consequences. VAOT brings AI-powered triage directly into the radiology workflow, helping clinicians identify vascular disease sooner so patients can be directed to the right care faster. This clearance marks the first step in our broader vision to set a new standard in AI-driven vascular care.”
  • and
    • “Pathway Labs, a New York-based artificial intelligence (AI) company founded by a cardiologist, has received U.S. Food and Drug Administration (FDA) clearance for its EchoNext screening tool that detects signs of structural heart disease in electrocardiograms (ECGs).
    • “We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease,” Pierre Elias, MD, Pathway Labs founder and CEO, medical director for artificial intelligence at NewYork-Presbyterian and assistant professor of medicine and biomedical informatics at Columbia University Vagelos College of Physicians and Surgeons, said in a statement. “Through EchoNext, we are able to diagnose critical, high-risk conditions that the human eye can’t, and potentially deliver lifesaving treatment earlier.”
    • EchoNext was cleared to identify a total of six different types of heart disease, flagging ECG results when a follow-up echocardiogram is recommended. The advanced algorithm was trained on more than 700,000 ECG-echo pairs. Recent studies have found that it can identify structural heart disease with a greater accuracy than trained cardiologists.
    • “Pathway Labs celebrated these clearances by officially launching EchoNext. The company has also partnered OpenEvidence to help expand access to the algorithm throughout the United States.” 
  • MedTech Dive tells us,
    • “The Food and Drug Administration has dropped a warning letter against wearable device firm Whoop following changes the company made to its blood pressure feature.
    • “In a closeout letter posted Tuesday, the FDA said it does not intend to enforce device requirements on the modified version of Whoop’s feature, consistent with guidance the agency issued earlier this year that would exempt more wearable features from oversight.
    • “Whoop CEO Will Ahmed said in a Wednesday LinkedIn post that the regulatory update was a “major development” and praised the updated wellness guidance.”
  • Healio informs us,
    • “The FDA announced approval of generic Priftin tablets to treat two types of tuberculosis caused by Mycobacterium tuberculosis, marking the first generic of this drug, according to an agency notice.
    • “The FDA outlined that the generic of Priftin (rifapentine) is for patients aged 12 years and older with active pulmonary TB and for patients aged 2 years and older with latent tuberculosis infection at high risk for progression to TB disease.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Cancer death rates in the U.S. have dropped dramatically in the past 35 years, falling by 35%, according to a report from the American Association for Cancer Research published Wednesday. The decline, which translates to nearly 5 million fewer cancer deaths since 1991, has been driven in large part by increased screening and advances in cancer treatments.
    • But the progress has not been seen equally across the country. 
    • “African American communities and American Indian and Alaska Native populations have the highest overall cancer death rates of any U.S. racial or ethnic group, and this means higher incidence and mortality for multiple cancers,” said the chair of the report, Mariana Stern, a professor of clinical population and public health sciences and urology at the Keck School of Medicine of the University of Southern California.
    • “Black people in the U.S. have long had higher cancer death rates than white people, though the gap has narrowed in recent years. Still, Black people are about twice as likely to die from multiple myeloma and cancers of the stomach, prostate and gallbladder as white people. For breast cancer, mortality rates are 35% higher among Black women than among white women. 
    • “Colorectal cancer — which is rising in people under 50 — also has higher mortality rates among Black and American Indian/Alaska Native populations, compared with white people.” 
    • “Increased screening has contributed to 79% of the colorectal cancer deaths averted, according to the AACR report. During a colonoscopy, doctors remove precancerous polyps before they have the chance to turn into cancer. People at average risk are advised to begin screening at age 45.
    • “But screening rates are lower among non-white populations, the report found.”
  • Following up on the Fierce Pharma articles above, the Wall Street Journal reports,
    • “Drug companies have found promising new options for one of the most aggressive and hardest-to-treat forms of breast cancer after decades with few breakthroughs.
    • “Gilead Sciences won Food and Drug Administration approval Wednesday to sell its drug Trodelvy as a first treatment for newly diagnosed patients with the advanced form of a type of breast cancer known as “triple negative” because it has characteristics that render common treatments ineffective. 
    • “It is the second such approval in about a month: AstraZeneca and Daiichi Sankyo’s rival drug, Datroway, was approved for a similar group of patients in May.
    • “Both of the drugs are antibody-drug conjugates—a type of targeted therapy that uses an antibody to identify a protein found on most triple-negative tumor cells and then delivers a concentrated dose of chemotherapy directly into the cancer. 
    • “The aim is to spare more healthy tissue than standard chemotherapy, which attacks growing cells throughout the body. These drugs both reduced the risk of progression of the disease by around 40% when compared with chemo.
    • “The progress is a lot more palpable right now and bringing us a greater deal of hope and excitement,” said Dr. Carmen Calfa, a breast medical oncologist at the Sylvester Comprehensive Cancer Center in Miami who wasn’t involved in either study.”
  • STAT News adds,
    • “It is one of the oldest mysteries in medicine: Why do fundamentally healthy people drop dead? Sudden cardiac arrest kills upward of 350,000 people a year in the U.S., a fate that is particularly tragic because it’s preventable with an implantable defibrillator.
    • “The challenge is figuring out who needs one.
    • “A study published in Nature on Wednesday uses artificial intelligence to identify those people, and pinpoints a possible reason why they so often evade detection. It reports that a culprit once considered relatively benign — cardiac fibrosis, or scar tissue scattered throughout the heart — is commonly present in people with the highest risk of sudden death.
    • “In a nice normal heart, everything happens at the same time, things are synchronized,” said Ziad Obermeyer, a University of California, Berkeley, scientist and lead author of the paper. “When you have fibrosis, you have these little dead areas that cause a breakdown of order.”
    • “The resulting disorganization, and its deadly implications, can be detected by AI on widely available electrocardiogram, or EKG, tracings, opening up the possibility that the technology could help direct lifesaving treatment to exactly the people who need it, the study found. Currently, about two-thirds of the defibrillators implanted in patients based on medical guidelines never deliver a lifesaving shock, a gap that exposes patients to risks of complications and imposes significant costs on the health care system.”
  • Fierce Pharma informs us,
    • A Nature Medicine paper landed on Feb. 2 like a stone in a pond, sending out ripples that quickly turned into tidal waves across biomedical circles. By midday, renowned physician-scientist Eric Topol, M.D., had signaled its importance to his more than 700K followers on X, then hailing it as “probably the best proof of the importance of timing of therapy that we’ve seen in medicine to date.” By the time the Super Bowl kicked off on Feb. 8, the study’s 3 p.m. threshold has become a punchline, as longtime biotech investor and TV host Brad Loncar jested that the Patriots’ sluggish offense was “like immunotherapy administered after 3:00 PM.”
    • “However, by Feb. 19, the journal would put up an editor’s note, alerting readers to several concerns around the article, titled “Time-of-day immunotherapy in non-small cell lung cancer: a randomized phase 3 trial.” Topol apparently deleted his comment at some point as well.  
    • “At the time, concerns raised against the article ran the gamut from major revisions to trial design and inconsistent trial protocol, to unusual efficacy and safety data patterns.
    • “Now, after a four-month investigation, Nature has decided to pull the study.”
  • Side note – Beckers Clinical Leadership identifies “The top 25 U.S. healthcare institutions for research in 2025 were, according to Nature.” “Boston-based Massachusetts General Hospital was the highest-performing U.S. healthcare institution on Nature‘s 2026 Research Leaders ranking.” 
  • The National Institute of Standards and Technology lets us know about its test of seven “At-Home Gut Microbiome Test Kits.”
  • Health Day points out,
    • “That juice box you hand your child as a daily treat could be setting them up for poor heart health later on, a new study says.
    • “Drinking fruit juice or sugary sodas throughout childhood may be linked to an increased risk of high blood pressure in adulthood, researchers reported June 22 in the journal Circulation.
    • “Kids who drank 12 ounces or more of fruit juice every day had a 35% higher risk of developing high blood pressure in adulthood, researchers found.
    • “Likewise, those who drank 24 ounces or more of sugary sodas or sports drinks had a 52% higher risk.
    • “The study also found that substituting either with a piece of whole fruit lowered a child’s future risk of high blood pressure.”

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

  • Beckers Payers Issues reports that “A year after promising ‘change and reform,’ UnitedHealth opens its doors.”
    • “It’s not every day the country’s largest healthcare company provides on-the-record access to its senior leadership team, no topics barred. But that is exactly what UnitedHealth Group has done, inviting reporters and social media influencers to its corporate headquarters in June for a daylong showcase of where the company is heading.
    • “Staged across sleek suburban-Minneapolis campuses, the day felt closer to a Silicon Valley product keynote than an insurer’s media event, complete with live software demos, an AI assistant making medical appointments, and a walk through of the company’s intelligence center it uses to triage member and patient issues across the country. 
    • “Across nearly every session, UnitedHealth presented itself as a technology and data company, one that can build tools for its tens of millions of members, patients and customers – and also sell solutions to the rest of the industry. Coming about two years after the Change Healthcare cyberattack laid bare how much of the nation’s claims plumbing already runs through Optum, the ambition is notable.” 
  • Beckers Hospital Review relates,
    • “New York City-based Memorial Sloan Kettering Cancer Center has broken ground on a $2.3 billion inpatient facility, the Kenneth C. Griffin Pavilion.
    • “The new facility will be connected to the cancer center’s main hospital by a dedicated patient bridge, according to a Memorial Sloan Kettering news release shared with Becker’s.
    • “Memorial Sloan Kettering expects to start serving patients at the new facility in 2030.”
  • and
    • “Houston Methodist has received a $110 million gift, its largest single commitment in the system’s more than 100-year history.” * * *
    • “The funding will establish a new innovation fund supporting research and care within the Houston Methodist Academic Institute and Neurological Institute, as well as an excellence fund for women’s health initiatives in the department of obstetrics and gynecology.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare has agreed to sell 31 home health and hospice agencies across eight states to Deaconess Associations Incorporated, a Cincinnati-based company that manages a diversified portfolio of $1 billion in healthcare services, programs, investments and community grant initiatives.
    • “Upon closing, the agencies will become part of Central Pyramid, one of Deaconess Associations Incorporated’s four owned subsidiaries and a home health and hospice operator with nearly four decades of experience. The agreement expands Central Pyramid’s geographic footprint and positions it to serve patients across more communities.
    • “Deaconess framed the deal as part of a strategy to invest in organizations that strengthen its existing operations and expand access to care as services move beyond traditional clinical settings.”
  • Fierce Healthcare points out,
    • “The past several years have seen strong growth in life insurance, in part thanks to the COVID-19 pandemic, with half of Americans owning a policy today. 
    • “While life insurance has traditionally been seen as a death benefit—something that offers families financial assurance after a loved one has passed—part of the industry is expanding into wellness benefits for the living. 
    • “This reflects burgeoning demand: a third of consumers are interested in free mental health and wellness services to go along with their life insurance, trade group LIMRA finds. Nearly a quarter are also interested in gym memberships, health coaching and diet planning. 
    • “John Hancock has been leading the way for over a decade. In 2015, it launched its Vitality program with the idea of encouraging healthy living. Discounts on fresh produce, wearables and various health memberships are just one part of the array of offerings.
    • ‘John Hancock CEO Brooks Tingle is honest about the business incentive. Life insurers make money by investing their customers’ premiums. That means the longer they live, the more money the company stands to make.” 
  • The American Hospital Association News notes,
    • “Results from a KFF poll published June 17 found that 31% of adults use social media at least monthly to seek health information and advice, similar to 29% who said they use artificial intelligence for the same purposes. Most adults said they either “never” or “occasionally” use AI (71%) or social media (69%) to find health information. Among adults who use social media for health information, 36% said learning from people with the same health condition or who share similar experiences was a “major reason.” A smaller share (17%) said that not having a regular healthcare provider or not being able to afford the cost of seeing a provider was a “major reason” for turning to social media.”

Thursday report

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

Simplicity is a virtue.

In recognition of Juneteenth, a Friday report will not be posted tomorrow. The FEHBlog will return on Saturday with the latest Cybersecurity Saturday post.

From Washington, DC.

  • Healthcare Dive reports,
    • The CMS is recalculating 2026 Medicare Advantage stars for insurers after the agency lost a court case over its methodology.
    • Only plans that see their stars increase will have their ratings updated and be able to resubmit bids for next year, regulators said in a memo to plans Wednesday. It could be a major boon for insurers, given the stars are linked to lucrative bonuses and competitive advantages in the privatized Medicare program.
    • Still, the recalculation basically results in no change in average star ratings for other insurers besides Clover Health, which brought the lawsuit against the CMS, according to TD Cowen analysts. Some insurers may choose to sue over the approach.
  • STAT News relates,
    • “Making good on its threat, Eli Lilly has begun eliminating mandated price breaks to a few dozen hospitals that participate in a federal drug discount program after failing to receive comprehensive claims data.
    • “The move comes after the company warned earlier this month it would take such a step as part of a policy announced in January in order to reduce what it calls duplicate discounts paid to the hospitals. Trade groups representing hospitals, however, argue the move is unlawful and want Congress to intervene.
    • “At the time, Lilly maintained that more than 2,300 hospitals had complied with its demand, but some larger hospitals systems around the U.S. refused to do so, despite recent follow-up letters regarding the policy, which went into effect Feb. 1. Up to 1,000 had so far not complied, and Lilly indicated it was pressing about 50 larger hospitals to provide data.
    • “A Lilly spokesperson declined to say how many hospitals are now being denied the mandated discounts but sent us a statement saying, “Lilly is collecting claims data to stop the rampant fraud, waste, and abuse in the 340B program that is harming employers, state and federal governments, and patients.”
  • The American Hospital Association News tells us,
    • “The Health Resources and Services Administration Maternal and Child Health Bureau has announced grant opportunities available supporting maternal and child health initiatives. The Maternal Produce Prescription Program, or MP3, will provide grants for the development and implementation of community-based produce prescription programs and related nutrition education for maternal populations at risk of poor health outcomes due to nutrition insecurity and other health-related factors. Grants are also available for the Regional Pediatric Prevention Network, which will provide funding to hospitals working on advancing pediatric emergency and disaster preparedness locally, regionally and nationally, including for children with special healthcare needs and behavioral health concerns, children living in poverty, and children in rural, remote and tribal areas. The network will include at least 10 children’s hospitals, or their university pediatric partners, as well as community partners. The application deadline is July 17 for the MP3 and RPPN programs. 
    • “Funding is also available for the Maternal Health Emergency Management Training program, which seeks to increase capacity and improve the quality of care provided by clinicians and first responders who encounter pregnant and postpartum women in nondelivery and/or low-resource clinical settings. The deadline to apply for the MHEMT program is July 20.” 
  • Federal News Network inteviews Tammy Flanagan about the Federal Employees Group Life Insurance Program.
  • JAMA discusses original research concerning the Inflation Reduction Act.
    • “Question  How did prescription drug use change after the Inflation Reduction Act implemented annual out-of-pocket spending caps in Medicare starting in 2024?
    • “Findings  In this cohort study using a difference-in-differences framework of 3053 medications covering 92.9% of gross Medicare Part D spending in 2023, prescriptions for medications paid by Medicare increased after the out-of-pocket cap was implemented in 2024 compared with those paid by commercial insurance; this change was most pronounced among the highest-cost medications, with a 22.7% increase in 2024-2025.
    • “Meaning  Results of this study suggest that implementing annual out-of-pocket caps in Medicare was associated with higher use of medications and that the policy improved Medicare-insured patients’ access to costly medications.”
  • Fierce Pharma notes,
    • “Before Indian drugmaker Aurobindo can complete its acquisition of Pennsylvania generics specialist Lannet, it will have to divest four drugs from the proposed $250 million buyout to resolve anticompetitive concerns, the Federal Trade Commission said.
    • “Aurobindo’s acquisition of Lannett would combine two of a limited number of competitors in the markets for four different generic pharmaceutical products that provide critical relief for patients,” the FTC wrote of its proposed consent order (PDF).
    • “The U.S. regulator has specified that Aurobindo must sell the products to New Jersey generics maker Quagen Pharmaceuticals.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration advisory committee voted that the benefits of a seasonal flu vaccine from Moderna MRNA outweigh its risks, part of the agency’s review of a potential new treatment.
    • “Moderna said Thursday the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of the vaccine, mRNA-1010, exceed the risks for the prevention of flu in adults 50 through 64 years old, and in adults 65 years of age and older.
    • “The FDA plans to consider the committee’s recommendations as part of its ongoing review of Moderna’s biologics license application for mRNA-1010, the company said. Advisory committee recommendations are nonbinding, and the FDA is responsible for making final approval.”
  • Fierce Pharma relates,
    • “With FDA acceptance of its application, Roche has moved a step closer to gaining a thumbs up for its potential combination treatment of Polivy and subcutaneous Lunsumiofor adults with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy.
    • “The U.S. regulator says it’s aiming to decide whether to approve the application by Feb. 9, 2027.
    • “The application is backed by results from a phase 3 study, which showed that after a median follow-up of 23 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to Rituxan plus the chemotherapies gemcitabine and oxaliplatin.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), announced today that it is requesting updates to the prescribing information for testosterone replacement therapy products following a comprehensive review of new clinical data and existing scientific evidence.
    • “The proposed changes would:
      • “Remove the limitation of use stating that the safety and effectiveness of testosterone replacement therapy in men with age-related hypogonadism have not been established.
      • “Update information related to prostate cancer risk.
      • “Revise warnings regarding benign prostatic hyperplasia, also known as enlarged prostate.
    • “During Men’s Health Month, we are putting science back at the center of men’s healthcare,” said HHS Secretary Robert F. Kennedy, Jr. “By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men.”
  • Cardiovascular Business informs us,
    • “More than 11,000 bottles of a popular blood pressure medication have been recalled due to a failed test. The voluntary recall was initiated on June 5, according to key details provided by the U.S. Food and Drug Administration (FDA).
    • “This recall includes 11,460 bottles of Chlorthalidone Tablets manufactured by India-based Inventia Healthcare Limitedand distributed by New Jersey-based Rising Pharma Holdings. Chlorthalidone is a diuretic or “water pill” used to treat hypertension and reduce excess fluid caused by heart, kidney or liver disease. 
    • “These drugs have been recalled due to “failed dissolution specifications.” This means tablets tested by a regulatory body did not break down correctly, creating a risk of the drug being less effective than intended.
    • “The recalled bottles include either 100 or 1,000 of these tablets. They all have an expiration date of April 2027.
    • “Click here for additional details about this recall from the FDA. The incident has not yet been classified as a Class I or II recall.”

From the judicial front,

  • Healthcare Dive reports,
    • “Pharmacy benefit managers want to make sure that an Illinois law creating drug pricing transparency and reforming health benefits administration doesn’t apply to them.
    • “On Tuesday, powerful PBM lobby the Pharmaceutical Care Management Association filed a complaint in federal court against the Illinois Department of Insurance, arguing that the Prescription Drug Affordability Act signed into law last summer clashes with federal oversight of employee benefit plans and that PBMs should be carved out from its provisions.”
  • Beckers Hospital Review relates,
    • “A federal judge has denied The Leapfrog Group’s attempt to reverse a ruling that found its hospital safety grades violated Florida consumer protection law, and separately put a $10.5 million fee dispute on hold, pending appeal.
    • “On June 17, U.S. District Judge Donald Middlebrooks rejected Leapfrog’s motion to reconsider his March 6 ruling, which found the organization violated Florida’s Deceptive and Unfair Trade Practices Act by penalizing hospitals that declined to participate in its voluntary survey with artificially low safety grades.”
  • The Wall Street Journal informs us,
    • “Luigi Mangione’s defense team said Thursday they no longer intended to present a psychiatric defense at his coming New York state-court murder trial, abruptly reversing course after a judge made public the unusual strategy a day earlier.
    • ‘In a single-sentence letter to the presiding judge, the lawyers wrote that, at this time, they were withdrawing a defense in which Mangione would have argued he killed UnitedHealthcare Chief Executive Brian Thompson due to an emotional disturbance.
    • “Mangione’s defense team and a spokesman for the Manhattan district attorney’s office declined to comment.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “While infant formula in the U.S. has a good overall safety record, the stakes are incredibly high if something goes wrong. Food safety experts who spoke with STAT say they want regulators and the industry to take even stronger measures to prevent disease outbreaks that put babies’ lives at risk. And they want consumers to be wary of marketing from newer, high-end formula companies like ByHeart and Nara that position their products as safer than other options.
    • “I think a lot of parents can be confused and think that if they spend more money on a formula, it’s safer,” said Steven Abrams, a professor of pediatrics at Dell Medical School at the University of Texas at Austin. In fact, formulas are remarkably similar to one another because they’re required to use a blend of 30 ingredients necessary to give babies the nutrition they need. All formulas are also subject to annual FDA inspections and requirements to test for the pathogens salmonella and Cronobacter.
    • “Of designations like organic, GMO-free, or added probiotics and prebiotics, Abrams said, there’s no evidence that such features “have the slightest health effect on babies.”
    • “Nara and ByHeart were both manufacturers “claiming to produce a healthier type of infant formula because they were using whole milk,” said Frank Yiannas, a former deputy commissioner for food policy and response at the FDA. The fact that both brands have been linked with infant botulism, he said, suggests that “reformulating powdered infant formula should be done with extreme due diligence and caution.”
  • and
    • “If you’re an older adult, getting vaccinated against shingles could lower your risk of developing dementia.
    • “A new study found that elderly nursing home residents who received at least one dose of the shingles vaccine known as Shingrix, the only shot of its kind available in the United States, were 24 percent less likely to develop dementia over a four-year period compared to those who were not vaccinated, according to results published this week in the peer-reviewed journal Annals of Internal Medicine.
    • The research adds to the growing body of evidence showing a connection between the viral infection and cognitive decline.
    • “The fact that this is a super high-risk population for dementia and we’re still seeing a potential benefit is really remarkable and important evidence for this population,” said Kaleen Hayes, the study’s lead author and an assistant professor at Brown University who studies the use of medications for chronic conditions in older adults.”
  • and
    • “Fentanyl is by far the biggest opioid killer in the U.S. With more than a quarter of a million deaths since 2021 and about 200 fatalities a day, fentanyl is one of the country’s most urgent public health crises. But drug experts warn that nitazenes can be even more potent and are being mixed with fentanyl and other substances, creating increasingly lethal combinations.
    • “We’re always concerned about fentanyl being mixed in with other drugs — cocaine, meth, heroin,” said Frank Tarentino, associate chief of operations for the DEA’s northeast region. “You add nitazenes to that and it makes it exponentially more dangerous and frightening for drug law enforcement, parents, caregivers, educators, and the young.”
    • “Data obtained from the DEA’s National Forensic Laboratory Information System (NFLIS) show reports of confirmed seizures from nitazenes rising sharply — from 43 positive tests in 2019 to almost 2,000 in 2024 (the most recent year for which data are available). By March this year, more than 8,000 nitazene reports had been recorded since 2019. But experts said that not all laboratories can test for nitazenes — which come in many forms including powders, pills, and sprays — and many don’t feed into the NFLIS system, meaning these numbers are almost certainly an underestimate.” * * *
    • “Nitazenes are predominantly sold online, both on the clear web and dark web, and are often laced into other substances to increase their potency. Experts say this puts unsuspecting users seeking more common drugs, such as oxycodone, fentanyl, or stimulants like cocaine, at risk of fatal overdoses.”
  • The Washington Post tells us “7 unexpected takeaways from the newest research on cannabis and brain effects.”
    • “Whether it’s used in adolescence, midlife or older age may make a big difference.”
  • The American Medical Association lets us know “What doctors want patients to know about summer skin safety.”
    • “Too much sun exposure can have damaging effects on skin, but following proper precautions can help. Follow these summer sun safety tips.”
  • Health Day points out,
    • “Pregnant women are exposed to dozens of common chemicals linked to early delivery and low birth weight, according to a new study.
    • “Researchers tested urine samples from more than 5,000 women who gave birth between 2000 and 2021, and compared the findings with pregnancy outcomes.
    • “They screened for 113 chemicals commonly found in food, water, air pollution, personal care products, fragrances and other household items.
    • “On average, the tests detected 45 chemicals in each sample, with as many as 64 found in some participants.
    • “Among them were phthalates used to make plastics more flexible, as well as some newer plasticizers.
    • “Some of these compounds were consistently associated with earlier delivery and lower birth weight, according to the results.” * * *
    • “The researchers are calling on governments and companies to do more to reduce harmful chemicals in everyday products and ensure new ones are safe.”
  • MedPage Today informs us,
    • “In a cohort study, U.S. women logging at least 2 hours a week of resistance training had a 20% lower risk of incident major cardiovascular disease (CVD) over nearly 15 years.
    • “The benefit of resistance training persisted even if women also engaged in aerobic activity and limited sedentary time.
    • “A lower risk of major CVD could also be observed in those who reached ≥1 hour of weekly resistance training and were consistent about it over the years.”

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

  • The American Hospital Association News reports,
    • “Hospital and health system leaders gathered June 17 and 18 in Washington, D.C., for U.S. News & World Report’s Healthcare of Tomorrow Conference, focusing on the future of healthcare delivery. AHA Chair-elect Bill Gassen, president and CEO of Sanford Health in Sioux Falls, S.D., participated in a panel titled “Reimagining Healthcare: The Hospital and Health System of Tomorrow.” The session included discussion on challenges and opportunities shaping the future of hospitals and health systems, and involved topics such as artificial intelligence and digital transformation, care delivery models, community partnerships and sustainable financial performance.  
    • “When I think about the future of health care, I believe success will be defined by how well organizations can connect care across settings, specialties and communities to better serve patients,” said Gassen. “The organizations that will be best positioned for the future are those that can combine deep local relationships and community trust with the capabilities needed to deliver increasingly complex care, invest in innovation, develop the workforce and keep care accessible and affordable over the long term.” Former AHA Board Member Warner Thomas, president and CEO of Sutter Health, and Redonda Miller, M.D., president and CEO of The Johns Hopkins Hospital, also participated on the panel.” 
  • Kaufmann Hall relates,
    • The latest issue [April 2026] of the National Hospital Flash Report covers these and other key performance metrics.
    • Key Takeaways:
      • Hospital performance remains under pressure in 2026. Mixed performance on key volume indicators, staffing challenges, and expense growth continue to pressure hospital operations, reinforcing the need for focused prioritization and strategic planning.
      • Expense growth continues to outpace inflation. Drug and labor expense remains a key contributor to expense growth, driven by both cost and utilization as the population ages, underscoring the importance of strategic spend management across the board.
      • Payer mix continues to erode. Year-over-year climbs in bad debt and charity care reflect broader shifts in payer mix, shifts in coverage, and growth in uninsured populations, requiring hospitals to proactively adapt and manage long-term revenue risks.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Hospital Review ranks 81 health systems by annual revenue and identifies four hospital closures that have happened in 2026.
  • Bloomberg tells us,
    • “Johnson & Johnson has no plans to enter the booming obesity market, opting instead to focus on diseases such as cancer, Chief Executive Officer Joaquin Duato said in an interview for an upcoming episode of The David Rubenstein Show: Peer to Peer Conversations.
    • “The comments set J&J apart from many of its rivals trying to develop or acquire obesity medicines following blockbuster weight-loss drugs from Eli Lilly & Co. and Novo Nordisk A/S.“
  • Fierce Pharma informs us,
    • “What’s been Novo Nordisk’s secret weapon to turn the tables on Eli Lilly and win the current market battle over their oral GLP-1 obesity drugs? Name recognition.
    • “That’s according to Jim Hickey, an analyst with Spherix Global Insights, who has studied the competition by surveying 50 primary care physicians (PCPs) and 50 endocrinologists in the United States, as well as writing monthly reports on the uptake of the drugs, both of which debuted on the market earlier this year. 
    • “It’s interesting to see how strongly Novo Nordisk has come out of the gate,” Hickey said in an interview with Fierce. “It’s a very strong launch from what we can see. That lines up with the data Novo Nordisk has shared. I think a big difference between the two really comes down to familiarity. We see the familiarity ratings for the Wegovy pill as being much stronger than what we can see for Foundayo.”
  • Fierce Healthcare points out,
    • “Lantern and Marathon Health are joining forces to launch an integrated model that brings together primary and specialty care, a key concern for employers as costs rise.
    • “The partnership combines Marathon’s advanced primary care model with Lantern’s specialty care platform, simplifying the patient care journey, better managing costs and reducing unnecessary procedures. Marathon clients that do not currently work with Lantern can purchase its services through Marathon, making the process easier for employers, too.
    • “The two initially collaborated on a pilot program with early adopters, focused on orthopedic care, and found between a 37% and 100% increase in referrals to Lantern. Referrals from Marathon led to a 47% increase in either completed or averted surgical procedures, the companies said.”
  • Per BioPharma Dive,
    • “Biogen plans to buy startup RayThera to gain access to a portfolio of immunology drug candidates, including one slated to enter the clinic in the third quarter. 
    • “Founded in 2023, RayThera says its mission is to develop safer, more effective therapies for immunological diseases. But the company has said little publicly about what it’s doing. RayThera’s website doesn’t detail what it’s been working on, instead touting the company’s “nimble and adaptable approach” and containing a pipeline page with three prospects listed only as “anti-inflammatory.”
    • “The deal with Biogen is also rather opaque, per a statement released Wednesday. RayThera investors will get an undisclosed upfront payment and could reap as much as $1 billion if unspecified clinical and regulatory goals are met.”
  • and
    • “An emerging area of drug development got more crowded Wednesday, with the debut of a biotechnology startup trying to create new migraine prevention therapies.
    • “Vedana Therapeutics formed in response to an earlier class of migraine-thwarting medicines that first hit the market toward the end of the last decade. These medicines inhibit specific proteins, “CGRPs,” that play a key role in migraines by transmitting pain signals, widening blood vessels and triggering inflammation in the tissues around the brain. While effective for many, a large portion of patients — more than half, by some estimates — don’t respond to, or stop taking, CGRP-blocking therapies.”
  • McKinsey & Co. discusses “The health system CEO imperative: Turning AI’s promise into performance.”
  • The Wall Street Journal reports,
    • “The clash over AI doctors has begun, and its front line is in Utah.
    • “It started with technology from the startup Doctronic. The state launched a project in January that will allow the service to renew prescriptions for patients. The hope is it will improve medication access.
    • “Any Utah adult can log in to get a refill on cholesterol medications or antidepressants, among other prescriptions. When fully implemented, the project will break new ground by letting an artificial-intelligence product, acting on its own, perform this job typically done by physicians.
    • “Doctors aren’t happy about it.
    • “People can have life and death reactions to medications,” said Dr. Alan Smith, a family physician who chairs the Utah medical board but said he wasn’t speaking for the group. “And then I worry about liability. Who is actually liable for problems that may occur because of a refill of a medication?”
    • “Most of the state’s medical licensing board, including Smith, signed a letter calling for the project to be suspended on safety grounds. They said Doctronic’s tool hasn’t been vetted enough, and prescribing can create risks because drugs cause side effects or might not be appropriate to continue. The Utah Medical Association said it agreed with the letter.
    • “State officials overseeing the pilot program said that the medical board has no authority over the project but that they will consult with it.
    • “The debate over AI doctors extends far beyond Utah’s borders.” 

Tuesday Report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

Fron Washington, DC,

  • Beckers Hospital Review reports,
    • “Senate Finance Committee minority staff has released a request for information outlining three policy options aimed at lowering prescription drug prices, reducing patient out-of-pocket costs and supporting biopharmaceutical innovation. 
    • “The proposal, released June 16, builds on a February plan led by Sen. Ron Wyden, D-Ore., and several Senate Democrats and is the latest in a string of Democratic actions targeting drug pricing under the Trump administration. Most recently, Mr. Wyden and 18 fellow Senate Democrats introduced the Drug Deal Disclosure Act in April, which would require HHS to release contracts and communications tied to the administration’s drug pricing agreements with major pharmaceutical companies and direct the Congressional Budget Office and Government Accountability Office to analyze their impact on Medicare, Medicaid and patient costs.” * * *
    • “Stakeholders have until Aug. 17 to submit comments.”
  • Avalere Health adds,
    • The US Pharmacopeia Convention (USP) is a nonprofit organization that disseminates public compendial quality standards for medicines and maintains two drug classification systems: the Medicare Model Guidelines (MMG) for Part D plans and the Drug Classification (DC) for non-Part D plans.
    • “Statute required Part D plan formularies to include at least two drugs per class. The Centers for Medicare and Medicaid Services (CMS) determines the categories and classes of clinical concern—commonly known as the six protected classes¹—and requires Part D plans to cover “all or substantially all drugs” within each class in their formularies.
    • Under a cooperative agreement with CMS, USP updates these drug categories and classes “every three years in the MMG. These updates, made in consultation with manufacturers and other stakeholders, adjust for the market entrance of new Part D eligible drugs and for drugs with newly approved indications.
    • “On June 1, USP released the draft MMG version 10.0 (v.10.0) for public comment. The finalized v.10.0 is expected in September.”
  • MedTech Dive informs us,
    • “The Centers for Medicare and Medicaid Services on Monday proposed an updated national coverage determination for transcatheter aortic valve replacement that could expand the treatment to more patients, benefiting Edwards Lifesciences.
    • “The proposed NCD adds Medicare coverage for beneficiaries with asymptomatic severe aortic valve stenosis who are enrolled in a CMS-approved study.
    • “We are encouraged the draft coverage policy has the potential to improve timely access to lifesaving TAVR therapy for Medicare beneficiaries,” an Edwards spokesperson wrote in an email.”
  • Moreover, the Centers for Medicare and Medicaid Services issued a
    • “request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers (“PBMs”) and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative requirements that are effective beginning calendar year 2028: restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs; and data reporting requirements.”
    • The public comment period will expire on July 20, 2026.
  • Fierce Healthcare tells us,
    • “Beneficiaries face a series of complex decisions in enrolling in Medicare coverage, and a key federal panel outlines some of the pain points.
    • “The Medicare Payment Advisory Commission (MedPAC) released its June report to Congress on Monday, where it notes that when an individual becomes Medicare eligible, they have to immediately make a series of decisions about coverage that may be confusing.
    • “Eligible individuals are also tasked with similar decision points at other times in the year, which adds to the complexity, per MedPAC.” * * *
    • “The advisory group’s report undercuts a key argument often cited by providers seeking additional support from policymakers: that the increased penetration of Medicare Advantage plans, particularly in rural markets, is dangerously dragging providers’ financial stability.”
    • * * * “MedPAC’s report also included familiar recommendations for Congress regarding Medicare payment system incentives.
    • “For instance, “to bring [fee-for-service] Medicare’s overall payment levels closer in line with provider costs,” the group reiterated its support for “slightly” higher hospital outpatient and inpatient payments and physician payments compared to current law. MedPAC also recommends Medicare adopt site-neutral payment rates “for certain services that can be safely provided in more than one ambulatory setting,” and called for various new data sources and formulas to more accurately set relative payments.” 
  • The Congressional Budget Office made a “Call for New Research on the No Surprises Act.”
    • “CBO will continue to monitor evidence about outcomes of the No Surprises Act as it prepares cost estimates and projections for Congress. The agency could benefit from additional research that relies on more-recent data to understand trends related to network participation, prices, and ownership structure. The claims data used in existing studies end in 2023, when patterns from arbitration were only beginning to develop.
    • “Additionally, determining whether trends in prices are causally related to the No Surprises Act is difficult because prices for some specialties affected by the law may have been trending downward before it was enacted and because the rollout of the law coincided with a period of historic inflation. Quasi-experimental evidence could isolate the effects of the law from other trends in prices. Evidence that helps determine whether changes in prices or network participation vary with the degree to which the IDR system is used in a particular market might also help identify changes attributable to the law instead of other factors.
    • “CBO would welcome additional quantitative or qualitative research on the arbitrators’ decision-making process and any incentives they face. Because of the lawsuits challenging the use of the QPA as a guideline, the alternative benchmarks that are being used to determine outcomes from arbitration are unclear.
    • “And finally, CBO would welcome research about how health care markets continue to evolve in the wake of the law. Early evidence suggests that large organizations dominate arbitration activity, potentially disadvantaging smaller providers and encouraging consolidation (Adler, Fiedler, and Agarwal 2026; Hoadley and Watts 2025). Continued analysis of market structure and competition will be critical for understanding the law’s long-term effects.”
  • The American Hospital Association relates,
    • “The Administration for Strategic Preparedness and Response June 16 announced the launch of the Digital Stockpile and Manufacturing Response Network Challenge, a three-phase competition to improve the rapid domestic production of key medical supplies for emergencies. ASPR will award up to $2.04 million to participants from industry, academia, nonprofit organizations and the government for concepts for the network. The agency said it will host a series of virtual information sessions on the challenge beginning in July.” 
  • and
    • “The Health Resources and Services Administration announced June 16 that it will award a total of $2.8 million in grants through its Delta Rural Integrated Health Network Program. The program supports the development of integrated health networks among rural hospitals, primary care clinics, behavioral health providers and other essential services. HRSA will issue eight awards of $350,000 per year for two years. Applications are due by July 17. A recording of a technical assistance webinar on the program is also available.” 

From the Food and Drug Administration front,

  • Bloomberg reports,
    • “Nara Organics recalled all of its whole milk infant formula after three babies were hospitalized with confirmed or suspected botulism, the second total recall of a baby formula brand after it was linked to the deadly illness. 
    • “The US Centers for Disease Control and Prevention warned parents not to use Nara’s formula, which is sold on the company’s website and at Target, on Saturday after three babies confirmed to have consumed it contracted botulism. They are from California, Pennsylvania and Washington, the CDC said. No deaths have been reported.”
  • Cardiovascular Business points out,
    • “Medline, the Illinois-based medical supplier that went public in December 2025, has recalled nearly 50,000 procedure kits used in the cardiac cath lab and other parts of the hospital. 
    • “The recall was put in place due to a risk of issues with the Mastisol Liquid Adhesive included in these procedure kits. Developed by Ferndale Laboratories, Mastisol is commonly used to secure dressings, tapes and medical devices for long periods of time.
    • “Medline has identified a risk of the adhesive’s packaging cracking, which renders it “unusable for application.”
    • “No kits need to be returned. However, a warning label should be added that tells clinicians to use an alternative adhesive.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. This action aligns with President Trump’s Great American Recovery Initiative, a federal effort to address the U.S.’ addiction and substance use disorder crisis and coordinate the government’s approach to prevention, treatment, and long-term recovery.” * * *
    • “The number of overdose deaths has dramatically decreased since the first FDA approval of an OTC naloxone nasal spray in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl. In the 12-month period ending in August 2023, 111,451 overdose deaths were reported; in the 12-month period ending in December 2025, 68,632 overdose deaths were reported.” * * *
    • “The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.”
  • BioPharma Dive relates,
    • “Food and Drug Administration scientists evaluating a potentially new messenger RNA flu vaccine from Moderna have expressed skepticism about the evidence supporting its benefits, according to documents filed days before a crucial advisory committee meeting. 
    • “On Thursday, the FDA will convene a panel of experts to discuss use of the shot, dubbed mFlusiva and in development for seasonal influenza. Panelists are set to vote on whether the benefits of vaccination outweigh the risks in people either between the ages of 50 and 64, or those who are 65 and older. Moderna hopes the discussion will set the stage for approval of a vaccine U.S. regulators controversially refused to review earlier this year before abruptly changing course.” 
  • Genetic Engineering and Biotechnology News adds
    • “Flu shots reduce hospitalizations and deaths for the roughly one billion people worldwide that get the flu each year. But they are less effective when the vaccine strains don’t closely match the viruses circulating in the community. Today’s vaccines are made months in advance of the flu season due to a long manufacturing process. When projections are off, strain mismatch can reduce the efficacy of the flu vaccines from about 60% (in a good year) down to 19%. A broader immune response could translate to a more effective vaccine even when the virus is changing faster than vaccine makers can update their shots.
    • “Now, an investigational mRNA influenza vaccine, developed by Moderna, helps the immune system recognize a wider range of influenza viruses than today’s standard flu shot, offering stronger and potentially longer-lasting protection. The vaccine is currently under review by the U.S. Food and Drug Administration and, if approved, would be the first mRNA vaccine against influenza.
    • The findings are published in Nature Immunology in the paper, “mRNA-based influenza vaccine expands the breadth of the B cell response in humans.”

From the judicial front,

  • HR Dive reports,
    • “A federal judge agreed to dismiss an LGBTQ+ advocacy organization’s lawsuit claiming that the U.S. Equal Employment Opportunity Commission “abdicated” its duty to enforce federal workplace protections for transgender workers because the plaintiffs lacked standing, according to a decision issued Friday.
    • “FreeState Justice filed the lawsuit last July, alleging that EEOC unlawfully denied transgender workers access to its charge-investigation process and other enforcement protections as part of a “Trans Exclusion Policy.” But courts lack authority to review such discretionary agency decisions, Judge George Russell III held, quoting the November 2025 decision of a separate court in a lawsuit challenging alleged nonenforcement by EEOC.
    • “Russell dismissed the case without prejudice, writing that the EEOC’s decision to alter investigations of gender identity discrimination claims was “deeply troubling” but nonetheless unreviewable. FreeState did not immediately respond to a request for comment.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Cybele Maylone, 46, has been hearing about hormone therapy nonstop. Whether it is her friends going through menopause or posts from influencers on her social media feed, the subject has seemed unavoidable: who was on it, which doctor finally took their symptoms seriously and, most importantly, how good it felt to be on the medication. The hot flashes waning. Brain fog lifting. Sleep returning.
    • “To Ms. Maylone, it sounds like a miracle drug. But for her and millions of other women, it is not an option.
    • “She was diagnosed in 2023 with a type of breast cancer fed by estrogen, and now takes a drug that suppresses the hormone to reduce her risk of recurrence. While breast cancer is the most widely recognized reason women may not be able take hormone therapy, which delivers estrogen or progesterone through pills and patches, the list also includes endometrial cancer, certain cardiovascular issues, severe liver disease and blood clotting disorders.
    • “Ms. Maylone and other women said they feel deeply frustrated that they can’t take a drug that so many women around them seem to have benefited from.” * * *
    • “Ms. Maylone said that when she tried to raise the subject with her providers, she hit a wall. “Through no fault of their own, they’re like, ‘We’re trying to have you not have cancer,’” she said. “It just feels like you hit a dead end.”
    • “There is a “humongous provider knowledge gap” when it comes to menopause care, said Dr. Rajita Patil, director of the Comprehensive Menopause Program at UCLA. While demand has exploded, many clinicians are still not up to speed on the full range of treatments, including nonhormonal options, she said.”
  • The American Hospital Association News relates,
    • “A report issued by the Centers for Disease Control and Prevention June 11 found that 15.2% of pregnant women in the U.S. reported current alcohol consumption. The report, which examined 2021-2024 data from the Behavioral Risk Factor Surveillance System, also found that 4.9% of pregnant women reported binge drinking, and 2.2% reported heavy drinking during the past 30 days.” 
  • On the bright side, STAT News tells us,
    • “Infant mortality in the U.S. dropped to a new all-time low in 2025, according to preliminary government data.
    • There were slightly fewer than 5.4 infant deaths per 1,000 live births in 2025, according to the Centers for Disease Control and Prevention.
    • “While that appears to be a small decline from about 5.5 in 2024 and 5.6 in the two years preceding, researchers say it is statistically meaningful and translates to hundreds of fewer infant deaths per year.
    • “It’s difficult to pinpoint what’s driving the recent developments, but “this is an encouraging data point, and we hope that this trend will continue,” said Dr. Michael Warren, chief medical and health officer for the March of Dimes.”
  • The Wall Street Journal informs us,
    • “For years, doctors relied only on written memory tests, invasive spinal taps and expensive imaging to diagnose Alzheimer’s disease. Now, two Food and Drug Administration-cleared blood tests are simplifying the diagnosis.
    • “The tests, from manufacturers Fujirebio Diagnostics and Roche Holding, were cleared last year and look for different versions of tau, a protein that forms into tangles in the brain and can lead to memory loss. Fujirebio’s test also measures a protein called beta-amyloid, which can form sticky plaques that are a hallmark of Alzheimer’s disease and the target of recently approved drugs for the condition. 
    • “These tests, which use different methods and report results in different ways, can help evaluate patients with early signs of cognitive decline, neurologists say, but they aren’t designed to predict Alzheimer’s risk in healthy people. Even if they could, there are no approved treatments to prevent the onset of the disease yet.”
  • Per BioPharma Dive,
    • “Edgewise Therapeutics said its experimental heart disease drug hit the goals of a Phase 2 clinical trial, reducing signs of disease and biological markers in two types of cardiomyopathy and supporting advancement of the medicine into pivotal studies.
    • “The Colorado-based biotechnology company is testing its pill, called EDG-7500, in both the obstructive and non-obstructive forms of cardiomyopathy, seeking to improve blood flow and relieve heart failure symptoms in people whose hearts have thickened and weakened as their disease progressed.
    • “The trial data come two weeks after Edgewise wagered the company’s future on cardiovascular disease by selling off its experimental muscular dystrophy pipeline. In cardiomyopathy, Edgewise will have hefty competition, however, as it would face Bristol Myers Squibb’s Camzyos and Cytokinetics’ Myqorzo in the obstructive form of the disease.”
  • and
    • “Shares of Neumora Therapeutics lost half their value after one of the company’s drugs failed a pair of Phase 3 trials in major depressive disorder. Neumora’s drug navacaprant is part of a class of medicines that target kappa opioid receptors and have been hailed as potential blockbusters. But two prospects — navacaprant and J&J’s aticaprant— have now missed key goals in depression studies, and Neumora said Monday that it plans to end development of its drug altogether. The latest findings are “disappointing but not unexpected,” wrote William Blair analyst Myles Minter in a Monday note to investors. Minter referred to the setback as a “clearing event” that shifts focus to a pipeline that now includes drugs for obesity, schizophrenia and Alzheimer’s disease agitation. Neumora has lost most of its value since going public in 2023.” 

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

  • Beckers Payer Issues reports,
    • “When Katerina Guerraz, Aetna’s COO, stepped into her role in mid-2024, the company was having, by her own admission, a really tough year. Rather than look for incremental fixes, she and her team decided to set a new direction entirely — one focused on fundamentally redesigning how Aetna operates, not just for the company, but for the providers and members it serves.
    • “We completely need a different north star — figure out how do we work differently with providers, how do we really design around the member experience, and then where can, how fast can we accelerate and apply technology for automation, and just have more smart workflows and streamline the work, not just for our constituents, but also for our colleagues,” Ms. Guerraz told Becker’s. “That’s the big difference — how you apply this, so it actually makes the healthcare system better, simpler, and you take a lot of the friction out.”
    • “The result is a sweeping operational push tackling claims processing, workforce training, provider relationships and member navigation — all connected by a single goal: taking friction out of the healthcare system.
    • “The push for real-time claims.”
  • and
    • “ICHRA, reference-based pricing, narrow networks, direct contracting, cash pay — it seems you can’t escape these terms today in the employer health benefits market. Each is traceable back to the same gradual shift happening among the leverage structures that have defined the payer-provider relationship for decades.
    • “Much of that shift is because of a departure from fully insured coverage, in which an employer pays an insurer to take on risk, to self-funded plans, where the employer pays claims directly and hires an insurer to handle the back-end administrative functions. From 2015 to 2025, self-funding among large employers stayed flat at roughly 80%, while the real movement came from small firms, according to KFF. Among small employers, fully self-funded enrollment rose from 17% to 27% over the decade and level-funded coverage (a self-funded variant paired with stop-loss coverage) surged from 7% in 2019 to 37% in 2025.
    • “As employers have taken on more risk and gained more visibility into what their plans actually pay (or at least try to), more scrutiny is arising around the value of insurers’ provider networks and their ability to actually negotiate lower prices.
    • “I don’t think provider networks are disappearing. I think they’re being questioned in ways they weren’t five years ago,” Stacy Mays, a former senior health insurance executive, told Becker’s. Since her time at organizations such as UnitedHealth and Capital Blue Cross, Ms. Mays has gone on to start her own consulting firm, Copeland Road Health Ventures.
    • “Before federal price transparency rules took effect, she said, most employers had little visibility into the rates their plans actually paid and were told that discounts were broadly similar across carriers. The data has since shown otherwise, revealing wide variation across networks and, in some cases, cash prices below contracted rates. If a network’s main value was negotiating better prices, she said, employers and providers are now positioned to see when that may not be the case.
    • “If you look at networks from the employer perspective, you have to ask whether employers are really getting value from a network or whether the network is simply the accepted way that healthcare is organized,” Ms. Mays said.”
  • Beckers Hospital Review lets us know the “days of cash on hand figures for 50 health systems as of March 31, according to their most recent financial reports.”
  • Fierce Healthcare relates,
    • “Telehealth utilization increased 10.1% across the U.S. from the fourth quarter of 2025 to the first three months of 2026, a new report from Fair Health found.
    • “Telehealth utilization, measured as a percentage of medical claim lines, increased from 5.01% of medical claim lines in the fourth quarter of 2025 to 5.51% in Q1 2026. The relative increase was 12% in the Midwest, 11.8% in the Northeast, 9% in the South and 8.1% in the West, Fair Health data indicated.
    • “The percentage of patients with a telehealth claim also increased nationally and in all four regions from the fourth quarter of 2025 to the first quarter of 2026. Nationally, that percentage increased from 17.3% in the fourth quarter to 18.4% in the first quarter, a 6.3% rise. The largest relative increase was in the Northeast, at 7.3%.
    • “The data is part of Fair Health’s newly launched Quarterly Telehealth Regional Tracker, building on data from the non-profit’s National Private Insurance Claims database. The database is built on commercial medical and dental claims from more than 75 contributors nationwide, the company says.”
  • BioPharma Dive tells us,
    • “Continuing a string of acquisitions this year, Eli Lilly said Tuesday it will buy non-opioid pain drug developer 4E Therapeutics.
    • “The deal hands Lilly a pipeline full of experimental pain treatments that 4E says are designed to be non-addictive. The biotechnology company specializes in MNK inhibitors, which go after a variant of enzymes involved in a signaling pathway that translates information outside of the cell to its interior. Its lead asset, “4ET1103,” is in development for nerve damage-related pain and has completed an early trial in humans demonstrating safety.
    • “Other drugs in 4E’s portfolio include experimental treatments for migraines and acute pain. The Austin, Texas-based startup raised just under $10 million across private funding and grants from the National Institutes of Health to advance its drug.
    • “The companies did not disclose the financial terms of the deal.”
  • MedCity News informs us,
    • “AI is rapidly gaining traction in the health insurance industry. But according to one health insurance executive, AI shouldn’t be used for the “sake of AI,” but to empower what the health insurer is trying to accomplish.
    • “During an interview at AHIP 2026 last week, Elevance Health Chief Digital Information Officer Ratnakar Lavu shared the company’s three key priorities for AI:
      • Simplifying and personalizing the member experience
      • Simplifying the provider experience, and
      • Making sure employees have the right information at the right time.
  • STAT News points out,
    • “A biotech is doing something that doesn’t happen enough: Talking about its failure.
    • “Verge Labs, formerly known as Verge Genomics, recently announced that its Phase 1b trial for an ALS drug failed. Now it’s trying to explain why, actually, this was a good thing. The company tells Brittany Trang it used the learnings to develop an artificial intelligence neurology model that predicts which patients are more likely to respond to treatment. The tech could help the company recruit candidates for clinical trials in the future. The new model reflects Verge’s “frontier AI lab” pivot  announced at the end of May.
    • “Read more here.”
  • and
    • “For decades, brain-computer interface research has been confined to small, tightly-controlled experiments in the lab. That era may be coming to a close.
    • “Casey Harrell, a man with ALS whose speech is very difficult to understand,  used a BCI system to communicate at home for more than 3,800 hours over the course of nearly two years. He operated it independently at an average speed of 56 words per minute, according to a study published Monday in Nature Medicine.
    • “Harrell is part of the BrainGate clinical trials, which includes researchers from several institutions and which STAT has written about in the past. His BCI system was developed by University of California, Davis researchers.
    • “Harrell’s not the first person to have a long-term brain implant, and other studies have demonstrated communication rates that more accurately reflect speaking. But experts suggest this study reflects where the field should go, if it wants to ensure the technology will be embraced by both users and regulators.”

Monday Report

David Ermer–ACA, CMS, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NIH, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“In her 1789 book The Female Reader, writer and philosopher Mary Wollstonecraft wrote: “Simplicity and sincerity generally go hand in hand, as both proceed from a love of truth.” (Source: https://tinyurl.com/4fzesrp4)

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. launched GetActive.gov, a new national resource to help Americans improve their health through movement, fitness, outdoor recreation, and active living, during a series of “Take Back Your Health” tour stops across Colorado.
    • “Secretary Kennedy joined Secretary of the Interior Doug Burgum in Grand Junction to announce the initiative and highlight the Trump Administration’s efforts to expand access to public lands and outdoor recreation opportunities. He then visited Fort Carson to see firsthand how the Army is improving nutrition for servicemembers through its campus-style dining modernization program. The Secretary also toured InnovAge in Thornton, where he met with caregivers and seniors participating in the Program of All-Inclusive Care for the Elderly (PACE).
    • “The key to reversing America’s chronic disease epidemic is empowering people to take back their health,” Secretary Kennedy said. “We are helping people Get Active, Eat Real Food, and Live Real Life. From our public lands to our military bases to our senior care centers, these Colorado visits show how we are putting Make America Healthy Again into action.”
  • The American Hospital Association News reports,
    • “The Medicaid and CHIP Payment and Access Commission June 15 released its June 2026 report to Congress. Among the topics discussed, chapter two focuses on automation in Medicaid prior authorization and makes recommendations to improve oversight and increase disclosure and transparency of managed care plans’ use of automation in PA. The third chapter includes recommendations to improve managed care plan accountability. Chapter seven examines Medicaid provider enrollment and managed care credentialing processes and highlights challenges that have effects on provider participation and state administrative burden.”
  • and
    • “The Centers for Medicare & Medicaid Services and the Department of Health and Human Services issued a request for information June 12 seeking input on CMS’ review of the Affordable Care Act’s Essential Health Benefits framework and the requirement that the scope of EHBs is equal to the scope of benefits provided under a standard employer plan. Specifically, CMS is seeking comments on current interpretations of EHBs, state approaches to selecting and updating EHB-benchmark plans, methodologies to determine the scope of benefits included as EHBs, and how those approaches relate to access and market stability under the ACA. The agencies said the information will impact CMS’ evaluation on whether revisions or additions to current EHB regulations would be appropriate. Comments are due by July 15.”
  • BioPharma Dive relates,
    • “New under-the-skin injections of the cancer immunotherapies Keytruda and Opdivo would be subject to Medicare price negotiations at the same time as their intravenous counterparts under a proposed federal rule published Friday.
    • “The Centers for Medicare and Medicaid Services said the rule would close a “loophole” that allows drugmakers to extend the patent-protected life of blockbuster drugs, commonly called “evergreening.” However, Medicare could exempt the newer formulation from its price ceiling should biosimilars of the IV version enter the market and compete on price.
    • “The rule could most immediately affect Keytruda maker Merck & Co. and Opdivo developer Bristol Myers Squibb, along with Halozyme, which developed the delivery technology that helped Opdivo and Johnson & Johnson’s Darzalex transition from IV to subcutaneous shots. Halozyme, however, said it forecasts “zero to minimal impact to its royalty revenues through at least 2035.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration said Monday that it will allow Colorado to import certain prescription drugs from Canada in an effort to bring prices down for residents, making it the second U.S. state to be granted such authorization. 
    • “For more than a quarter of a century, Americans have sought drugs from Canada for relief from the ever-rising costs of medicines, sometimes taking widely publicized bus trips across the border. It wasn’t until 2020, though, that the first Trump administration officially endorsed the practice, when it published a regulationallowing states and Indian tribes to propose import plans. The Biden administration affirmed this rule with an executive order in 2021. And Florida became the first state to earn FDA approval in 2024. 
    • “But state importation programs have proved extremely difficult to carry out, even with bipartisan support. Florida has yet to actually import any drugs from Canada, in part due to pushback from the Canadian pharmaceutical industry and fears the program will affect Canada’s drug supply. In May, the FDA extended its approval by six months to give the state more time to get its program up and running.”
  • Fierce Pharma relates,
    • “Despite prior concerns from the FDA, a regimen involving AstraZeneca’s AKT inhibitor Truqap (capivasertib) has passed muster in a specific population of prostate cancer patients. 
    • “Late last week, the U.S. regulator signed off on Truqap plus Johnson & Johnson’s Zytiga (abiraterone) and prednisone to treat adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer—the indication previously known as metastatic hormone-sensitive prostate cancer—that is determined to be PTEN-deficient.
  • and
    • Merck & Co.’s first-in-class HIF-2 alpha inhibitor Welireg is touching down in the clear cell renal cell carcinoma (ccRCC) treatment space, notching a Keytruda combination nod that stands to pad the landing for the company’s post-Keytruda outlook. 
    • The June 12 FDA approval is the first for a PD-1 and HIF-2a inhibitor combo, stipulating the regimen’s use as an adjuvant treatment for adults with ccRCC who are at intermediate-high or high risk of recurrence following kidney removal surgery. Welireg can be used in the disease setting with standard Keytruda or subcutaneous Keytruda Qlex. 
    • With that, Welireg can reach earlier-stage ccRCC for the first time following its 2023 clearance in advanced RCC, marking an “important step in addressing the needs of patients with earlier-stage renal cell carcinoma,” kidney cancer advocacy group KidneyCan’s CEO and co-founder Bryan Lewis noted in a Merck press release. 
  • Cardiovascular Busines tells us,
    • “Penumbra, a California-based medtech company known for its vascular technologies, has received U.S. Food and Drug Administration (FDA) clearance for a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.
    • “According to Penumbra, Thunderbolt represents the first CAVT device approved in the United States for the treatment of stroke. It is powered by Penumbra’s Engine technology and uses modulated aspiration to “detect, fatigue and completely ingest” blood clots at the site of occlusion. Thunderbolt will be sent to customers prepackaged with one of the company’s catheters.”
  • MedPage Today tells us,
    • “The FDA cleared medical-grade Australian sheep blowfly (Lucilia cuprina) larvae in what maker Cuprina Holdingsopens in a new tab or window believes marks the first debridement product to use this particular species.
    • “Dubbed Medifly Maggots, the product is indicated for removing dead or infected tissue from non-healing necrotic skin and soft tissue wounds — such as pressure or neuropathic foot ulcers — and non-healing traumatic or post-surgical wounds.
    • “A healthcare worker is required to oversee the application of the prescription maggot product, which was cleared based on demonstration of equivalence to the previously cleared medical-grade green bottle blowfly larvae — Lucilia sericata (Medical Maggots).”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has struck down key provisions in a CMS rule overhauling the Affordable Care Act, in a setback for the Trump administration’s push to combat fraud that critics argue is a smokescreen for weakening the exchanges set up by the Obama-era law.
    • “On Friday, Judge Brendan Hurson of the Maryland District Court vacated eight of the rule’s most consequential provisions, including the creation of a $5 premium penalty for individuals who automatically reenroll in coverage and a policy disqualifying people who fail to reconcile tax credits with their income from receiving subsidies.
    • “The decision is not a surprise after Hurson stayed most of the provisions last year. Still, officially tossing them out is a victory for proponents of expanded ACA coverage — though a short-term one, given many of the changes were codified in the GOP’s “Big Beautiful Bill” passed last summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A pregnant woman in rural Arizona with syphillis could have been treated fairly easily with an injection of penicillin. But the drug, Bicillin L-A, is manufactured only by Pfizer, and has been in short supply for a year now — which meant the drug arrived too late to prevent probable congenital syphilis in her newborn.
    • “The syphilis epidemic is worsening, congenital syphilis cases are up roughly 800% since 2012 — and this Bicillin shortage is expected to continue through 2027. Public health officials say Pfizer’s emergency allocation system is confusing and may disadvantage health departments serving low-income patients.
    • “A box of 10 syringes can cost around $8,000, and the drug is manufactured at only one Pfizer plant in Michigan to supply the whole country.
    • “Most shortages are of not-very-profitable drugs,” said Erin Fox, associate chief pharmacy officer at University of Utah Health.”
  • The American Medical Association lets us know what doctors want patientsto know about allergic rhinitis
    • “Allergic rhinitis, or hay fever, is more than just the sniffles. Understanding triggers and when to talk to a physician are key to managing allergic rhinitis.”
  • Per an National Institutes of Health news release,
    • “A clinical trial supported by the National Institutes of Health (NIH) found that adults with prediabetes assigned to a lifestyle intervention had a significantly lower risk of developing multiple chronic health conditions (known as multimorbidity) over time than those assigned to a placebo. This study, which followed participants for over two decades, also found that participants assigned to receive metformin did not experience a statistically significant reduction in multimorbidity risk. The findings, published in JAMA, highlight the lasting benefits of lifestyle programs that may lower risk of the development of chronic conditions.
    • “Multimorbidity is a common issue, and few interventions have been found to prevent or delay developing multiple chronic conditions,” said Marcel Salive, M.D., first author of the study, from NIH’s National Institute on Aging (NIA). “Our work showing that healthy lifestyle intervention can significantly lower the burden of multimorbidity is a step forward in addressing this growing problem.”
  • MedPage Today relates,
    • “COVID-19 vaccines were associated with a lower risk of major adverse cardiovascular events in “a cohort study of veterans.
    • “The 2024-2025 vaccines also demonstrated effectiveness against COVID-associated emergent care, hospitalization, and critical illness among adults.
    • “Among older adults who received a 2025-2026 vaccine, overall COVID vaccine effectiveness against symptomatic disease was 59%.
  • Healio tells us,
    • “Less than a quarter of patients with stroke and fewer than one in seven with traumatic brain injury were discharged to inpatient rehabilitation.
    • “Clinicians should plan for rehabilitation early and make it an intentional part of care.”
  • and
    • “The American College of Physicians (ACP) has published living clinical guidance to help physicians select medications for patients with overweight or obesity.
    • “Unhealthy weight remains a significant public health issue globally, with 68.5% of American adults and 59% of adults worldwide having overweight or obesity, according to Amir Qaseem, MD, PhD, MHA, MGIN, MRCP, FACP, ACP chief science officer and senior vice president of clinical policy at the Centers for Evidence Reviews, and colleagues.
    • “They wrote in Annals of Internal Medicine that first-line treatments for obesity and overweight include physical activity and nutrition, but the new guidance “addresses additional management using pharmacologic treatments when lifestyle modifications alone do not result in optimal weight loss or weight maintenance for a person.”
  • Pharmacy Times informs us,
    • “Pooling ATTAIN-1/2 female participants, menopausal stage–stratified outcomes at 72 weeks included weight, waist circumference, waist-to-height ratio, and categorical weight-loss thresholds using an efficacy estimand. 
    • “Orforglipron [Lilly’s oral GLP-1 drug] achieved statistically significant placebo-adjusted reductions across premenopause, perimenopause, and postmenopause, reaching approximately 14% body-weight loss and up to 11 cm waist reduction (P<.001). 
    • “Clinically meaningful responder rates favored orforglipron, with up to 83% achieving ≥5% weight loss vs 23% on placebo, and higher rates across ≥10%, ≥15%, and ≥20% thresholds. 
    • “More participants shifted to lower waist-to-height ratio categories on active therapy, supporting potential visceral adiposity and cardiometabolic risk mitigation in menopause-associated fat redistribution. 
    • “Unrestricted oral administration (no food/water requirements) may reduce adherence barriers in midlife women with polypharmacy, strengthening pharmacist-led counseling and referral pathways in obesity care.”
  • BioPharma Dive points out,
    • “An experimental drug that Eli Lilly recently picked up through a potentially multibillion-dollar acquisition appears to have passed its first major test, scoring positive results in a small study of patients with hard-to-treat blood cancer.
    • “Originally developed by Ajax Therapeutics, the drug inhibits an enzyme that spurs blood cell production. Several medicines that block this “JAK2” enzyme, including Incyte’s Jakafi, are already on the market, where they’re mostly used in rare, chronic blood cancers like myelofibrosis. While these medicines can be quite effective at treating symptoms, many patients either don’t respond or stop taking them because their disease progresses or they can’t tolerate the side effects, which range from nausea and fatigue to anemia and increased stroke risk.
    • “Lilly’s pill is designed to work in a slightly different way than its approved counterparts, binding to JAK2 in the “inactive” state. Researchers hypothesize this change should make for a superior therapy that also overcomes drug resistance challenges.
    • That idea now has more support thanks to data presented over the weekend at a major medical meeting in Europe.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. will launch a new line of commercial health plans called Edge across all five of its Blue Cross Blue Shield states beginning in 2027.
    • “The plans, powered by a proprietary plan design called Easify, have no deductibles and no coinsurance for in-network care, leaving members with fixed copays, according to a June 11 news release. 
    • “HCSC said the PPO plans aim to let employees in Illinois, Texas, Oklahoma, Montana and New Mexico anticipate out-of-pocket costs more easily and help employers better manage total medical spend. HCSC also said the new product will steer members toward “high-value” care using behavioral incentives.” 
  • Beckers Hospital Review relates
    • “Middle-age adults who use GLP-1 medications for obesity could save an average of $192,735 in lifetime medical costs, according to a study published in June by the National Bureau of Economic Research. 
    • “Researchers from Los Angeles-based University of Southern California simulated health and economic outcomes for U.S. adults ages 25 and older, comparing lifetime trajectories for people who used GLP-1s for obesity with those who did not. Obesity was defined as a body mass index higher than 30.”
  • and
    • “Virtual nursing for hospital discharge was associated with sharply lower 30-day emergency department readmissions across nine hospitals in a major Southeastern U.S. health system, according to a study published in npj Digital Medicine.
    • “Researchers at the University of North Carolina at Chapel Hill compared 4,662 discharges handled by remotely located virtual nurses with 4,662 traditional in-person discharges, matched on patient and hospital characteristics. Patients discharged through virtual nursing returned to the ED within 30 days at a rate of 3.7%, versus 13.3% for in-person discharge — a 72% relative reduction, or a risk ratio of 0.28. That works out to roughly 1 readmission in 27 virtual-nursing patients, compared with 1 in 8 receiving standard discharge.
    • “The effect held in both settings, with the gap widest in rural hospitals: 3.1% versus 17.9% rural, and 4.1% versus 10.7% urban.
    • “Virtual nurses delivered structured, uninterrupted discharge education — medication reconciliation, teach-back, and care-plan review — from an off-site center operating 7 a.m. to 7 p.m., seven days a week. The health system rolled out the model across the nine hospitals between 2022 and 2024.”
  • MedTech Dive informs us,
    • “Medtronic said Friday it has completed the $550 million takeover of neurovascular technology company Scientia Vascular.
    • “The deal, which Medtronic disclosed in March, covers guidewire technologies for stroke that are designed to equip physicians to access hard-to-reach parts of the brain.
    • “Buying Scientia will enable “every neurovascular procedure to start with Medtronic,” CEO Geoff Martha said on an earnings call with investors this month.”
  • Medical News Today points out,
    • Three AI-based mammography systems were able to identify subtle signs of future breast cancer years before diagnosis, with elevated cancer prediction scores seen in those who later developed the disease. 
    • In the study, approximately 20% of breast cancer cases showed AI-detectable mammographic changes as early as 6 years before diagnosis. 
    • At 90% specificity, the AI systems flagged potential future cancers in up to 19.7% of women 6 years before diagnosis, 25.2% 4 years before diagnosis, and 39.3% 2 years before diagnosis. 
    • The findings suggest AI could support earlier breast cancer detection and help enable more personalized screening strategies by identifying females who may benefit from closer monitoring or earlier intervention.
  • FYI, The Blue Cross Blue Shield Association has a job opening on its Legal Team supporting FEP.