Friday report

Telehealth

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Beckers Hospital Review reports,
    • “CMS said its enforcement efforts have resulted in blocking more than $1.6 billion in possibly improper Medicare lab payments throughout President Trump’s administration.
    • “An Aug. 28 CMS news release said these enforcement actions included savings of $732 million from 157 providers with revoked Medicare privileges, and a CMS investigation of 600 labs that resulted in 185 payment suspensions with more than $500 million in potentially fraudulent payments stopped. There were also 85 law enforcement referrals from a contractor that led to the prevention of $127 million in possibly fraudulent payments, and there was a recoupment of more than $276 million from 442 flagged overpayments to suspect labs.
    • “CMS had been using AI, among other analytics tools, to mine original Medicare claims. CMS focused on several kinds of lab fraud, such as labs billing for up-coded services. The news release said lab fraud can take place across services, including pathogen detection, high-complexity drug tests and genetic testing.
    • “Since the start of 2026, the CMS Fraud Defense Operations Center has been responsible for more than $371 million in Medicare suspended payments implicating 267 providers and suppliers.
    • “The news release comes amid CMS’ broader anti-fraud push across government programs, including Medicaid.”
  • FEHBlog observation — I find it hard to believe that these scoundrels would similarly attach FEHB plans for which private carriers hold the risk.
  • Beckers Payer Issues relates,
    • “The Labor Department is proposing a rule that would set criteria for employer associations to sponsor association health plans that qualify as employee welfare benefit and group health plans under the Employee Retirement Income Security Act.
    • “Received by the Office of Information and Regulatory Affairs Aug. 11, the rule is under review. ERISA outlines minimum standards for employee benefit plans.”
  • Beckers Behavioral Health adds,
    • “The Drug Enforcement Administration has submitted a final rule on telehealth prescribing of controlled substances to the White House for regulatory review.
    • “The DEA filed the rule Aug. 25 and listed it as “economically significant,” an Office of Management and Budget designation reserved for regulations expected to have an annual economic impact of at least $100 million.
    • “The rule would establish a long-promised special registration pathway allowing DEA-registered practitioners to prescribe controlled substances, including medications for opioid use disorder and attention-deficit/hyperactivity disorder, via telemedicine. It follows a proposed version of the rule that drew more than 6,400 public comments and would replace a series of temporary extensions the DEA has issued since pandemic-era flexibilities suspended the in-person visit requirement for such prescriptions. The agency’s latest extension of those temporary flexibilities runs through Dec. 31, 2026.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services’ six-month moratorium on the enrollment of new durable medical equipment, prosthetics, orthotics and supply companies in Medicare expired Aug. 27. CMS said that national provider enrollment contractors have resumed accepting initial enrollment applications from those suppliers. The agency said that suppliers should submit applications as soon as possible to allow contractors the maximum time for processing before the bidding window opens for the 2028 round of the DMEPOS Competitive Bidding Program.”
  • NCQA informs us,
    • “To align with the industry’s transition to digital quality measurement and the need for more streamlined data exchange, NCQA is creating a new HEDIS® measure for Transitions of Care (TRC) that uses the Electronic Clinical Data Systems (ECDS) reporting methodology.
    • “The current TRC measure assesses performance through a hybrid reporting methodology that combines administrative claims data and medical record review for a sample of eligible members. Because the hybrid TRC measure is included in the CMS Medicare Star Ratings, NCQA is coordinating this effort with CMS and other stakeholders.
    • “This measure is important because it evaluates care transitions, which present opportunities for missed connections that often require patients and families to fill in the gaps,” says Fern M., Director of Digital Quality Informatics at NCQA. “We know that health plans, technology vendors and policymakers are heavily invested in this measure, so we want to be as transparent as possible and allow organizations enough time to prepare for the changes.”
    • “The earliest implementation of the new ECDS TRC measure would be Measurement Year (MY) 2028, with the intention of retiring the hybrid version of the TRC measure in MY 2029.”

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

  • Govexec reports,
    • “Most federal employees would see their pay frozen at 2026 levels next year under an alternative pay plan issued by President Trump this week, though for the second straight year, federal law enforcement officers would receive a 3.8% increase.
    • “Trump first proposed the pay freeze as part of his fiscal 2027 budget proposal. Though the document was silent on federal employee compensation, officials with the Office of Management and Budget quickly clarified that its omission equated to a planned freeze for 2027.
    • “In a letter to House Speaker Mike Johnson, dated Thursday, Trump said increasing most federal employees’ pay would be “unacceptable and unfair” given the inflation that occurred under the Biden administration. Inflation actually has risen from 2.8% when former President Biden left office to 3.3% as of last month.
    • “I have therefore decided to set at zero the pay adjustment to be made for the 2027 pay year,” Trump wrote. “This decision will maintain fiscal responsibility without harming the government’s ability to recruit and retain well qualified employees.”
    • “But in the next paragraph, Trump said that for the second straight year, he instructed the Office of Personnel Management to issue a 3.8% increase in basic pay to federal law enforcement personnel next year, “to increase recruitment and retention” in those roles.”
  • Federal News Network adds,
    • “Up to 400 federal positions can now earn salaries of $400,000. A new final rule from the Office of Personnel Management allows the higher pay rates for hundreds of workers under an authority known as “critical position pay.” The authority is meant to help agencies recruit and retain highly qualified and specialized government workers in mission-critical roles. OPM’s final rule this week aligns with President Donald Trump’s orders earlier this year to use the pay authority for up to 400 national security roles.(Final rule on critical position pay authority – Office of Personnel Management)”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Squawk Box on CNBC to discuss the Trump Administration’s efforts to recruit top tech talent and advance his vision for a more tech-driven federal government.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about an ongoing safety issue with certain intravascular catheters manufactured by Boston Scientific. These devices are being removed from the market, and Boston Scientific has officially decided to discontinue them going forward.
    • “The devices in question are Boston Scientific’s single-use Imager II Angiographic Catheters, which interventional cardiologists, vascular surgeons and interventional radiologists use to capture images of a patient’s peripheral vasculature. They are available in a variety of shapes and lengths. 
    • “This warning, which covers all Imagers II Angiographic Catheters, was put in place due to a manufacturing defect that can cause the catheter tip to degrade or detach from the rest of the device.”
  • MedTech Dive adds,
    • “Medtronic has recalled a pH monitoring capsule over a risk linked to 184 serious injuries, the Food and Drug Administration said Thursday.
    • “The recall, which the FDA communicated in an early alert notice, affects Bravo CF capsules that pose risks including perforation of the esophagus, obstruction of the airway and blood loss.
    • “Medtronic withdrew a subset of the newly recalled Bravo CF lots last year. The FDA said the same failures triggered both recalls, but the underlying causes of the problems are different.”
  • Fierce Pharma relates,
    • “In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk.
    • “On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of adverse cardiovascular events in at-risk patients.
    • “The label expansions came on similar timelines for the rivals. While Novo achieved its heart-helping endorsement three years after the FDA originally approved Ozempic, Lilly gained its expansion four years after the FDA first signed off on Mounjaro.”
  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.
    • “Mimrylo offers a new treatment approach for patients whose disease has not been adequately controlled with existing therapies. It is the first approved treatment for polycythemia vera that mimics hepcidin, a hormone that naturally regulates iron in the body. By limiting the iron available to make new red blood cells, Mimrylo helps reduce their overproduction and keep red blood cell levels under control. This novel approach offers a new option for patients who have not achieved adequate control with existing therapies.

From the judicial front,

  • Per a Department of Justice news release,
    • “The Justice Department, together with the Drug Enforcement Administration (DEA), today announced a $50 million settlement with Walmart Inc. (Walmart) to resolve allegations that Walmart pharmacies illegally filled thousands of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA).” * * *
    • “The government’s complaint — filed on Dec. 22, 2020, and amended in 2022 in the U.S. District Court for the District of Delaware — alleged that since June 26, 2013, Walmart filled invalid prescriptions through the knowing actions of individuals on its compliance team and the knowing actions of its pharmacists. * * *
    • “In addition to the monetary payment announced today, Walmart has entered into a memorandum of agreement with DEA to address its future obligations in dispensing controlled substances. This agreement requires Walmart to establish a hotline for both employees and patients to report suspected illegal dispensing of controlled substances, proactively monitor the dispensing patterns of its pharmacies to identify and address potentially illegal dispensing, and establish a process to evaluate prescribers suspected of illegal prescribing.” * * *
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“
  • STAT News adds,
    • “A U.S. appeals court [panel for the 5th Circuit] ruled the Food and Drug Administration went through the proper process when it declared Novo Nordisk and Eli Lilly’s diabetes and obesity drugs are no longer in shortage, Bloomberg Law notes. The order is a loss for the Outsourcing Facilities Association, which representing large-scale compounders and challenged FDA decisions in the last two years that shortages ended for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound. That declaration restricted compounders from legally mass-producing versions of the drugs.”

From the public health and medical / Rx research front

  • The Center for Disease Control and Prevention announced today,
    • “As of August 28, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “National and regional COVID-19 activity is increasing. 
    • “Rhinovirus/Enterovirus (RV/EV) is increasing nationally.”
  • The American Journal of Managed Care reports,
    • “Children and young adults who were unvaccinated and infected with COVID-19 were at an increased risk of developing myocarditis, pericarditis, and mortality when compared with those who were vaccinated against COVID-19 with the Pfizer-BioNTech vaccine and not infected.1
    • “The recent findings published in Vaccine underscored the BNT162b2 vaccine’s favorable benefit profile, particularly for children and young adults. Prior research, also published in Vaccine, described COVID-19 vaccinations in general as reducing the risk of severe or prolonged disease—such as long COVID—in adolescents.2 These data, in tandem with the more recent study, provide ample evidence supporting preventive action against COVID-19 for children and adults.” 
  • The University of Minnesota CIDRAP adds,
    • “Giving children antiviral drugs within the first two days of the onset of flu symptoms reduces their likelihood of hospitalization by 81%, a study published last week in Pediatrics finds. 
    • “This protective effect remained robust among children aged 5 years or younger,” wrote the authors, led by scientists at Hsinchu Municipal MacKay Children’s Hospital in Taiwan.” * * *
    • “In an accompanying commentary, James Antoon, MD, PhD, MPH, and Kathryn Edwards MD, both of Vanderbilt University, noted that some pediatricians seem reluctant to use antivirals, adding that about 40% of high-risk pediatric flu patients go without them. 
    • “They urged more widespread use of the drugs. “The time has come for antivirals to be used in children with influenza,” they said. “With greater public hesitancy regarding vaccines, declining seasonal influenza vaccination rates, and recent influenza seasons with record pediatric deaths and hospitalizations, providers should strongly consider the use of antivirals in high-risk and hospitalized patients.” 
  • and
    • “Pennsylvania continues to see numbers climb in its ongoing measles outbreak, with 86 new cases added this week, which brings the total number of cases to 460 with 83 hospitalizations, according to an update today of the state’s measles dashboard. None of the cases have occurred in fully vaccinated people.” * * *
    • “For the third week in a row, Utah, which had the largest measles outbreak, reported no new cases. The state’s tally remains at 518. 
    • “The Georgia Department of Health confirmed four cases of measles linked to a daycare in the Atlanta area, with cases occurring in children who were unvaccinated or had not received the full measles, mumps, and rubella (MMR) vaccine series. 
    • “While the Centers for Disease Control and Prevention (CDC) typically update their measles numbers on Friday, a notification said the August 28, 2026, data have been delayed but will be updated as soon as possible. As of August 20, 2026, the CDC said there were 2,777 cases of measles in 47 states. Of those cases, 94% have been in unvaccinated individuals.”
  • Healio relates
    • “Rates of substance use fell among adolescents and young adults across most substances between 2021 and 2025, even as marijuana use increased among adults aged 26 years and older, according to the 2025 National Survey on Drug Use and Health.
    • “Substance use began declining among children aged 12 to 17 years prior to the COVID-19 pandemic, and those trends seem to be continuing among young adults aged 18 to 25 years in the new data, said Chris Jones, PharmD, DrPH, MPH, director of the Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration (SAMHSA).
    • “Coupling that with other surveys that show downward trends, that seems to be a durable effect that we’re seeing in recent years,” Jones told Healio.”
  • Cardiovascular Business tells us,
    • “Patients with peripheral artery disease (PAD) face a significantly higher risk of developing new-onset atrial fibrillation (NOAF), according to a new meta-analysis published in JACC: Advances.[1]
    • “The study’s authors reviewed data from more than 1,500 studies, landing on seven they wanted to focus on for this research. All studies were associated with a low risk of bias. The oldest study was performed in 2013 and the most recent was performed in 2022. All five studies were observational; five were prospective and the other two were retrospective. One study enrolled only women.
    • “In total, this meta-analysis included data from 763,919 patients. Approximately 56,000 of those patients had PAD as determined by ankle-brachial index (ABI) or a clinical diagnosis. In addition, there were approximately 26,000 cases of NOAF during follow-up. 
    • “Overall, researchers noted, PAD was linked to a 34% higher risk of developing NOAF. The hazard ratio was 1.34.” 
  • Genetic Engineering and Biotechnology News informs us,
    • “Researchers at the University of Toronto have developed a next-generation RNA therapeutic strategy that could have the potential to treat a wide range of genetic diseases that share certain types of disease-causing mutations. The team showed that chemically enhanced suppressor transfer RNAs (sup-tRNAs) combined with a lung-targeted delivery system can restore production of a critical protein in models of cystic fibrosis (CF) caused by “nonsense mutations.”
    • ‘These mutations introduce a premature stop signal into the genetic instructions for making a protein. The result is that cells may produce little or no full-length functional protein, disrupting vital functions in ways that are difficult to treat.
    • “The researchers, led by Bowen Li, PhD, an associate professor in U of T’s Leslie Dan Faculty of Pharmacy, engineered sup-tRNAs to help cells read through these premature stop signals introduced by nonsense mutations into the mRNAs, and complete production of full-length proteins that would otherwise be truncated or absent. They tested the approach in bronchial epithelial cells, mouse models, and patient-derived cystic fibrosis organoids and found that the chemical modifications increased the readthrough of premature termination codons and tRNA aminoacylation, prolonged the tRNAs’ functional activity, and reduced innate immune activation. Moreover, the approach restored CFTR protein production and function across cell, animal, and patient-derived organoid models. The researchers also found that the approach can be combined with existing cystic fibrosis drugs, suggesting the potential for combination therapy.”
  • The New York Times points out,
    • “A one-time gene-editing treatment to lower cholesterol had long-lasting effects a year later, scientists reported on Friday. The results highlight the potential to treat even common diseases by altering people’s genes.
    • “In the small study, which followed only 15 patients, participants who got the highest dose saw their cholesterol levels plunge by half — and stay that way for a year. The results were presented at the European Society of Cardiology Congress and published in the New England Journal of Medicine.
    • “Earlier this year, a similar “one-and-done” clinical trial that used a different gene-editing approach also reported significantly reduced “bad” LDL cholesterol in 35 patients.
    • “Both efforts are early safety studies and are years away from becoming an option people will be offered in a doctor’s office. But an approach that once seemed almost outlandishly far out has inched closer to reality as evidence accrues that it works, and that the results stick.”

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

  • Beckers Hospital Review reports,
    • “Health system CEOs are navigating a growing list of financial pressures, including Medicaid coverage and reimbursement changes under HR 1 and ongoing payment and policy challenges surrounding the federal 340B drug discount program. Site-neutral payment adds another consideration as health systems weigh where to invest and deliver care. 
    • “At Winchester, Va.-based Valley Health, concerns about site-neutral payment are already influencing where the system adds outpatient capacity. President and CEO Mark Nantz said Valley Health is keeping new outpatient sites on its hospital campuses in part to preserve hospital outpatient department rates. Peter Slavin, MD, president and CEO of Los Angeles-based Cedars-Sinai, said eliminating the outpatient payment differential entirely could cost Cedars-Sinai Medical Center about $200 million annually. J. Stephen Jones, MD, president and CEO of Fairfax, Va.-based Inova, said the policy has not changed where the system invests, but it has prompted greater focus on site of care when evaluating projects.
    • “It disrupts the financial model that includes things like 340B, hospital outpatient department rates and Medicare disproportionate share,” Mr. Nantz told Becker’s. “All of those things together help us cobble together a pretty fragile financial model. And so if any part of that financial model, somebody starts pulling the string on it, it unravels pretty fast.”
  • Beckers ASC Review lets us know,
    • “Hospital-employed physicians command significantly higher commercial reimbursement rates than independent peers across every specialty, with a $92 average gap in blended evaluation and management rates in the Chicago market, and the cost difference extends well beyond the professional fee, according to 2026 Trilliant Health price transparency data.
    • “Employed urologists averaged $263 per blended E/M visit compared with $141 for independent urologists, a $122 gap. Employed gastroenterologists averaged $240 versus $141 for independents, employed orthopedic surgeons averaged $260 versus $154, and employed cardiologists averaged $234 versus $144. Even the smallest gap, primary care at $196 employed versus $154 independent, represents a 27% premium for identical services.
    • “The stakes are significant given how many physicians have moved into hospital employment. Approximately 253,000 physicians became employees of hospitals or corporate entities between January 2018 and January 2026, and 79.5% of physicians who sold their practices to a hospital or health system cited the ability to negotiate higher payment rates as an important or very important reason for doing so.”
  • Per Beckers Physician Leadership,
    • “More than 60% of physicians are not satisfied with how the medical profession deals with work-life balance, according to a new report from Medscape. 
    • “State of the Medical Profession Index Report 2026,” published Aug. 28, surveyed more than 1,000 physicians across 29 specialties to rate their satisfaction with how the profession is dealing with key issues, and their optimism levels for improvement going forward.” 
  • Healthcare Dive relates,
    • “Virtual healthcare company Sword Health is planning to acquire digital mindfulness company Headspace, according to a regulatory filing.
    • “Headspace’s parent company OrangeDot is seeking to be acquired by Sword in an all-cash deal, the company told regulators in Massachusetts on July 22.
    • “The acquisition is expected to close on Sept. 14. The financial terms of the deal were not disclosed. Neither Headspace nor Sword Health responded to a request for comment by publication time.”
  • Managed Care Executive tells us,
    • “Cancer biosimilars are associated with lower costs for both insurers and patients, according to a new study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center. Patients with cancer who exclusively used biosimilars had average monthly costs that were $3,820 lower for insurers and $39.50 lower out-of-pocket costs compared with patients who exclusively used the branded biologic drugs, according to a study published today in JAMA Oncology.“
    • “Although the savings were substantially greater for insurers than for patients, even modest reductions in out-of-pocket costs may be meaningful for people facing the financial challenges of cancer care,” senior author Tina Shih, Ph.D., director of the Cancer Health Economics Research Program at the UCLA Health Jonsson Comprehensive Cancer Center, said in a news release. Shih is also a professor of Health Economics in the Department of Radiation Oncology.”
  • Fierce Pharma informs us,
    • “Twenty weeks into its launch, Eli Lilly’s Foundayo has finally exceeded 40,000 in weekly prescriptions, according to IQVIA data cited by Citi. The oral GLP-1 drug posted 40,862 scripts last week, bouncing back from a small dip the week prior. Still, the drug’s scripts level is no match for the roughly 57K that Novo Nordisk’s Wegovy pill garnered at week 6 of its own launch.
    • In its 33rd week of launch, the Wegovy pill booked roughly 175K scripts, slightly down from 176K, per IQVIA. The share of the oral version of semaglutide in all Wegovy obesity scripts was flat week over week at 35%. All told, across the pill and the injectable, Wegovy’s weekly scripts were a little over 500K, down 0.8% sequentially.
    • “As Jefferies analysts observed in an Aug. 21 note, Wegovy has been relatively flat since the Medicare GLP-1 Bridge program began July 1.
    • “Overall, the roughly 60%-40% obesity market share split between Lilly and Novo remained stable, as Lilly’s Zepbound held its ground as the most popular drug.”

Monday report

David Ermer–Agentic & Generative AI, CMS, Federal employment benefits, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services news release,
    • “The Trump Administration announced today that a $144 million investment is being delivered to improve health outcomes for Alabamians through the federal Rural Health Transformation Program (RHTP) This investment will support 138 grants to expand access to care, modernize healthcare technology and infrastructure and strengthen the rural healthcare workforce.
    • “This funding will help rural providers modernize their technology and cybersecurity, enhance telehealth and mobile care services, strengthen emergency and maternal care, and improve access to mental health and substance use care. The Trump Administration is also investing in expanding the healthcare workforce through training, scholarships, apprenticeships, and recruitment efforts, while helping local providers strengthen community-based care and better coordinate services. These investments will help make healthcare more accessible, connected, secure and sustainable across Alabama regardless of your zip code.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. and Secretary of Agriculture Brooke L. Rollins today announced sweeping new efforts to strengthen school meals by connecting more American farmers with local schools, investing in school kitchen infrastructure, and giving states and school districts new tools to serve healthier, more nutrient-dense meals to America’s children.
    • “Secretary Kennedy joined Secretary Rollins at the U.S. Department of Agriculture (USDA) alongside farmers, students, school nutrition leaders, athletes, chefs, and parents to announce the next phase of the Trump Administration’s work to Make America Healthy Again.” * * *
    • “If we want to Make America Healthy Again, we have to start with our children, and that means improving what we put on their lunch trays every single day,” said Secretary Brooke L. Rollins. “Harvest to Hallways is about bringing more American agriculture into the school cafeteria. We are connecting schools with the farmers and ranchers in their own communities, investing in the kitchens and equipment school nutrition professionals need to prepare real food, and cutting through barriers that have made it too difficult to serve healthy, American-grown food. When we strengthen the connection between the farm and the lunchroom, everybody wins: our children eat better, our farmers gain new markets, and our communities grow stronger.”
  • STAT News adds,
    • “New restrictions on the use of food benefits to purchase soda and candy have been one of the biggest changes enacted by the Make America Healthy Again movement. But a key question has been how profoundly the bans would affect public health, with some economists arguing that people would just use other funds to buy Coke and other sugary drinks instead.
    • “Now a new study shows that soda purchases did indeed fall by about 12% among people who receive Supplemental Nutritional Assistance Program benefits after the bans went into effect in 10 states. The study, which was published by the National Bureau of Economic Research and has not yet been peer-reviewed, says this translates to a person drinking about 34 fewer 12-ounce cans of soda per year.”
    • “That’s not huge, according to the study’s authors, but it’s far from nothing.”
  • Beckers Hospital Review reports,
    • “More than 200 healthcare organizations urged CMS not to finalize proposed limits on remote monitoring, warning the changes would disrupt care for about 1 million Medicare beneficiaries who manage chronic conditions from home.
    • “In a sign-on letter to CMS Administrator Mehmet Oz, MD, the coalition asked the agency to hold off on remote physiologic monitoring and remote therapeutic monitoring policies included in the 2027 Medicare Physician Fee Schedule proposed rule. More than 30 health systems and hospitals signed the letter. 
    • “The provision at issue, proposed July 14, would allow clinical practices to bill Medicare for the services only if the clinical staff delivering them are directly employed by the billing practice rather than contracted through a third-party vendor. Staff could still work off-site; the billing relationship would have to run in-house.
    • “That distinction carries broad reach. An estimated 60% to 70% of hospitals and health systems using remote monitoring rely on partially or fully outsourced vendor models, according to Becker’sprior reporting. The signers of the letter said small practices, rural providers and safety-net organizations would be hit hardest, and that many would have no option but to cut enrollment or end their programs.”

From the U.S. Office of Personnel Management front

  • FedWeek reports,
    • “President Trump has not yet sent Congress the alternative pay plan letter that will determine the 2027 federal pay raise, and the statutory deadline to do so arrives August 31. The letter is the clearest remaining signal of whether federal employees face a full pay freeze next year or another modest increase similar to the one delivered a year ago.
    • “Under the Federal Employees Pay Comparability Act (FEPCA) of 1990, the president must submit an alternative pay plan to Congress by the end of August, or a statutory formula tied to private-sector wage growth automatically takes effect instead, producing a far larger locality pay increase than any administration has allowed to take hold since the law passed. FedSmith has explained the mechanics of this deadline before, and last year’s letter covering the 2026 raise arrived on August 28, just three days before the cutoff. A similarly late announcement is likely again this year.”
  • and
    • Federal employees under the General Schedule receive a base salary plus a locality payment that varies by geographic area. The 2026 rates range from 17.06% in the Rest of U.S. locality pay area to 46.34% in the San Jose-San Francisco-Oakland, CA, locality pay area.
    • “The federal locality pay system adjusts General Schedule salaries to reflect differences in non-federal pay levels across geographic regions. Authorized by the Federal Employees Pay Comparability Act of 1990, the system took effect in January 1994. Its purpose is to reduce pay disparities between federal and non-federal workers performing similar work in the same labor market.
    • “Locality payments are calculated as a percentage of base pay and applied according to the employee’s official worksite. The Office of Personnel Management publishes annual tables that incorporate both the across-the-board base pay increase and the locality adjustment for each designated area. For 2026, locality pay percentages remain at the prior year’s levels, while base pay received a 1.0% across-the-board increase.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration cleared a blood test for identifying Alzheimer’s disease symptoms, which was developed by Roche and Eli Lilly.
    • “The Elecsys Phospho-Tau Plasma test identifies amyloid pathology associated with Alzheimer’s in people 55 years or older.
    • “It provides positive, intermediate and negative result categories to support doctors assessing the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of an Alzheimer’s diagnosis.
    • “The blood test is meant to address the gap in diagnoses, as an estimated 75% of people living with dementia are undiagnosed, Roche said.
    • “Quest Diagnostics and Labcorp both said they plan to start offering the blood test.”
  • MedTech Dive relates,
    • “The Food and Drug Administration has picked two behavioral health companies to join its Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, growing the total number of participants to four.
    • “Limbic and Sondermind are the next companies to join the pilot program, which allows participants to gather real-world data on devices while being exempted from premarket authorization requirements.
    • “Amid the pilot program, the FDA has also held discussions on digital health technologies for mental health, with patient groups calling for broader oversight in the use of generative artificial intelligence.”
  • Beckers Hospital Review tells us,
    • “The FDA has again paused Regenxbios RGX-121 gene therapy trial for Hunter syndrome after small, asymptomatic masses were found on the spines of five patients. Regenxbio does not expect to resubmit its biologics license application for the therapy in the near term.
    • “The spine findings, either a small nodule or cystic mass, surfaced through an expanded MRI monitoring plan Regenxbio adopted a few months ago, according to an Aug. 24 news release. All five patients received intracisternal or intraventricular RGX-121 three to six years ago, remain asymptomatic and have shown stability to improvement on neurocognitive assessments. Investigators consider the findings nonserious and likely benign, though no pathological evidence confirms their cause.
    • “The pause comes seven months after Regenxbio disclosed that a boy who received its similar MPS I therapy, RGX-111, developed a brain tumor, a case researchers have since linked to AAV gene therapy, the vector platform used in most gene therapies over the past 20 years.”

From the judicial front,

  • Fierce Pharma reports,
    • “On Monday, the U.S. District Court for the District of Columbia ruled against Merck & Co., rejecting its claim that the price negotiations are unconstitutional because they violate the First and Fifth Amendments. The argument is one that has been made by multiple drugmakers pushing back against the program.” 
  • Per a Justice Department news release,
    • “Today, the U.S. Department of Justice announced the launch of the National Fraud Detection Center (NFDC), a prosecutor-led, multi-agency team designed to investigate the most harmful actors defrauding federal government programs, including illicit actors overseas and those operating fraud schemes across federal programs. The NFDC will bring together law enforcement agencies and analytical capabilities to generate criminal leads to drive more impactful prosecutions and enhance fraud-fighting results for the American people.
    • “The creation of the NFDC marks a decisive shift in how the federal government detects and investigates complex fraud,” said Assistant Attorney General Colin McDonald of the Justice Department’s National Fraud Enforcement Division. “By breaking down institutional silos, embedding analysts from across the IG community, and leveraging shared technology, the NFDC is actively closing the window of opportunity for bad actors who seek to exploit taxpayer dollars. Today’s announcement sends a clear message: if you defraud federal programs, we have the tools and the law enforcement partners to find you.”

From the public health and medical / Rx research front,

  • Beckers Hospital Review reports,
    • “A fast-moving wildfire in the Sierra Nevada foothills has forced two Northern Nevada Health System facilities in the Reno, Nev., area to evacuate patients and close, according to CBS News and The New York Times.
    • “Both facilities remain closed with no timeline to reopen. The health system said it is in active communication with emergency response teams and will reopen each facility once crews clear the area and deem it safe, at which point it will activate an opening plan and notify the community.”
  • Better Report tells us.
    • “We spoke with board-certified emergency medicine physician Dr. Joseph Radachy about what he wishes more patients would prioritize. From simple ways to avoid everyday accidents to daily practices that support long-term health, here are six things your doctor wishes you’d do.
      • Stay Active Physically and Medically
      • Make your House Safer.
      • Advocate for Yourself
      • Know your Medical History
      • Remember: Moderation in Everything
      • Stop Smoking
  • The New York Time asked experts whether the bland BRAT diet is the best way to treat a stomach bug.
  • The American Medical Association lets us know “what doctors want patients to know about dry eyes.
    • “Dry eye disease can cause burning, tearing and blurry vision. Learn what triggers symptoms, which treatments help and when to seek care.”
  • Beckers Behavioral Health informs us,
    • “The age-adjusted death rate for alcohol-induced deaths among U.S. adults aged 45 and older increased from 2014 to 2024, according to an Aug. 20 report from the CDC’s National Center for Health Statistics.
    • “Death rates increased from 19.5 per 100,000 population in 2014 to 25.2 in 2024. In 2024, the death rate was 36.8 among men and 14.3 among women. Death rates were higher among men than women throughout the 2014–2024 period.
    • “The findings are based on National Vital Statistics System mortality data.
  • Parkinson’s News Today points out,
    • “Parkinson’s disease involves the progressive loss of dopamine-producing neurons, leading to motor symptoms.
    • “Starting rehabilitation within the first year of a Parkinson’s diagnosis may be linked to longer survival.
    • “Delaying rehabilitation is associated with a progressively higher risk of mortality across all disability levels.”
  • Genetic Engineering and Biotechnology New notes,
    • “Cancer metastasis is responsible for at least two-thirds of cancer deaths. Drugs targeting the metastatic progression have largely failed, in part due to the lack of predictive models that would help identify the underlying mechanisms of metastasis.
    • “Now, new work reports the development of a multi-organ chip that mimics how cancer cells spread from vascular flow to distant organs—the first model of cancer metastasis of its kind. The chip includes compartments with millimeter-sized engineered human bone and lung tissues, and the vascular flow that contains circulating breast cancer cells and allows the dynamic cross-talk of the tissues being colonized.
    • “The key advantages of this advanced model of metastasis are that it is human and can be patient-specific,” said Gordana Vunjak-Novakovic, PhD, university professor and professor of biomedical engineering and professor of medical sciences at Columbia University. “It faithfully mimics some of the key aspects of human metastasis that are otherwise largely inaccessible for direct study.”
    • “This work is published in Science Translational Medicine in the paper, “Organ-specific colonization and niche remodeling in a human tissue model of metastasis.”
  • STAT News takes us “inside Moderna and Merck’s cancer vaccine triumph.
    • “The drugmakers overcame rampant doubts, logistical challenges, and the pandemic.”

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

  • Fierce Healthcare reports,
    • “Highmark Health closed the first half of the year with $17.5 billion in revenue and $2 billion in net income, bolstered by a significant turnaround at its insurance unit.
    • “The $2 billion in net income accounts for $911 million in non-cash gains from the company’s affiliations with Blue Cross and Blue Shield of Kansas City and Heritage Valley Health System.
    • “Highmark Health Plans posted $672 million in operating income through the first two quarters of 2026, an increase of $612 million compared to the first half of 2025. Highmark said in the announcement that it expects elevated utilization and cost trends to persist across the industry, though pressures have eased.”
  • and
    • “Berry Street, a nutrition care company, has merged with India-based Healthify to form what executives call the largest insurance-covered AI metabolic health platform in the U.S. 
    • “The merger combines Healthify’s AI technology, including its nutrition and metabolic health assistant Ria, with Berry Street’s nationwide network of more than 2,000 clinicians and insurance-covered nutrition and GLP-1 care. The companies say the goal is to offer AI-powered, clinician-backed metabolic health support accessible through health insurance.
    • “Financial details of the merger were not disclosed. Berry Street shared the news exclusively with Fierce Healthcare.”
  • Beckers ASC Review relates,
    • “Kaiser Permanente is advancing construction plans for its long-planned Redlands, Calif., medical campus, with the Redlands Planning Commission set to review detailed site plans for the project’s first building Aug. 25, Community Forward Redlands reported  Aug. 24.
    • “The commission will consider a 113,000-square-foot, three-story medical office and ASC at Kaiser’s existing property. The building, known as Medical Office Building/Ambulatory Surgery Center 2, would house urgent care, outpatient surgery, chemotherapy infusion, imaging, laboratory services and medical offices.”
  • and
    • “Becker’s has reported on more than 30 ASC closures in 2026 as outpatient surgery facilities cite consolidation, efficiency and shifting care sites. 
    • “[The article offers] a look inside five more recent ASC closures as the industry battles reimbursement declines, staffing shortages and shifting market power dynamics. 
  • Healthcare IT News tells us,
    • “Telemedicine has made it routine for clinicians and patients to connect by video. But for health systems, establishing that connection is no longer the hardest part of virtual care. The bigger challenge is making sure the right patient gets a virtual visit in the first place – and that everything that should happen afterward actually happens.
    • “For telehealth veteran Dr. Joe Kvedar, professor of dermatology at Harvard Medical School and senior clinical advisor and two-time board chair at the American Telemedicine Association, the operational issues confronting provider organizations now come down largely to two areas: EHR integration and patient triage.
    • “Many health systems have made substantial progress integrating telemedicine into the electronic health record, says Kvedar, but determining which patients and conditions truly belong in a virtual encounter remains more difficult.”
  • and
    • “For decades, hospitals have largely treated discharge as the end of the acute care journey. Once patients left the building with a folder of instructions and follow-up recommendations, responsibility shifted largely to them and their families.
    • “But that approach is becoming increasingly difficult to sustain as hospitals assume greater accountability for patient outcomes long after patients leave inpatient care.
    • “New payment models, continued pressure to reduce avoidable readmissions and growing expectations for coordinated care are forcing provider organizations to rethink what happens after discharge.
    • “For Dimer Health CEO Caroline Hodge, PA-C, the answer is straightforward: Transitional care must become an active, technology-enabled extension of the hospital, rather than a passive handoff.
    • “The first 90 days aren’t an afterthought anymore,” Hodge said. “They’re where the outcome, and the economics, actually get decided.”
  • MedTech Dive informs us,
    • “MiniMed has begun shipping its new insulin pump in the U.S. with the Abbott-made Instinct sensor, the Medtronic spinout said last week. The sensor can be used for up to 15 days before it needs to be changed.
    • “The company said the rollout of its new MiniMed Flex delivery device with Instinct combines the smallest and only app-controlled insulin pump with the world’s smallest sensor.
    • “MiniMed is supporting the launch with its first major marketing campaign for the insulin pump. The campaign focuses on MiniMed Flex’s “discreet” design, app control and automation.”
  • Beckers Hospital Review notes,
    • “Mark Cuban Cost Plus Drug Co. has partnered with RxSaveCard and nonprofit Golden Thread to streamline sourcing and reduce costs of pediatric cancer clinical trial medications. 
    • “Once enrolled in a study, patients will sign up for RxSaveCard and receive trial medications delivered to their homes through Cost Plus Drugs, according to a news release shared with Becker’s.
    • “No study should stall over the price of a generic drug and no family should wait on one,” Alan Bowe, chief commercial officer at Cost Plus Drugs, said in the release. “We’re proud to work with Golden Thread and RxSaveCard to make trial medications affordable and deliver them directly to patients’ doors and we hope every trial that needs this model uses it.”

Monday report

David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Mental health care, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    •  “In the chapel of a homeless shelter, health secretary Robert F. Kennedy Jr. stood behind a lectern with a “Cancel Corruption” sign and lambasted local officials for mishandling the city’s homelessness and substance use crisis.
    • “Just 24 hours earlier, Kennedy was in the Oval Office, standing alongside President Trump, as the president signed an executive order calling for major changes to childhood vaccinations.
    • “The change in tone — from day to day and coast to coast — shows how Kennedy’s sprawling political messages tied to his Make America Healthy Again movement vary depending on the audience he is in front of.”
    • “In Los Angeles, Kennedy kept the message fairly local, speaking before conservative city officials and a mission group of roughly a hundred teenagers and praising the shelter he was visiting. But from Washington, Kennedy has become a spokesman of the administration’s more far-reaching policies: fewer vaccines for kids and more regulation of food additives, both announced on Monday from the nation’s capital, before he headed West.” 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced $96.7 million in grants and cooperative agreements to strengthen behavioral health services and supports across the country. The awards provide funding for a range of behavioral health services and initiatives, including services for people with serious mental illness who are homeless, suicide prevention and early intervention, substance use disorder treatment, training and technical assistance, peer support, and disaster-related emotional support.
    • “Every American deserves the opportunity to recover and live with dignity,” said HHS Secretary Robert F. Kennedy, Jr. “These investments will expand access to treatment, strengthen behavioral health services, and help more people move from crisis to recovery. That is how we restore health, rebuild lives, and strengthen our communities.”
  • Meritalk interviews the U.S. Office of Personnel Management’s Chief Information Officer Adam Starr.
    • “As CIO roles become more strategic, OPM CIO Adam Starr says agencies need to give technologists room to move faster, embed AI and security into the business, and create a culture that rewards measured risk.”
  • Federal News Network relates,
    • “The Defense Logistics Agency’s five-year IT modernization journey reached an important milestone earlier this summer.
    • “DLA moved its catalog system off a 35-year-old COBOL-based system and onto a new modern platform.
    • “Adarryl Roberts, DLA’s chief information officer, said the agency will now have a system that will allow it to process data and requests much faster.”
  • FEHBlog observation — This is another example of IT modernization that causes the FEHBlog to wonder why OPM cannot convert its outdated CLER system to the modern HIPAA 820 electronic transaction that allows carriers to reconcile premiums at the individual enrollee level.
  • Fierce Healthcare tells us,
    • “Amid instability in the Affordable Care Act marketplaces, proponents of ICHRA have suggested that these models could help support risk pools. A new survey from the HRA Council adds to the body of evidence on the matter. 
    • “The council, a nonpartisan organization that pushes for expanded coverage options, released its latest look at trends around individual coverage reimbursement arrangements, or ICHRA, and found that a growing number of larger employers are considering it as an option.
    • “The larger employee base from these firms could bring more younger, healthier individuals into the market, adding greater stability to the risk pools that would be felt on the exchanges, according to the report.”

From the Food and Drug Administration front,

  • The Hill reports,
    • “More cases have been linked to outbreaks of cyclospora that do not have an identified source, according to the Food and Drug Administration. The outbreak linked to iceberg lettuce, meanwhile, has expanded to two additional states. 
    • “There have been nearly 14,000 cases of domestically acquired cyclospora confirmed in the U.S. since May this year, the Centers for Disease Control and Prevention report. That’s well over the roughly 1,180 cases reported from May through August last year.
    • :Of this year’s cases, at least 9,480 were reported in the 17 states connected to the cyclospora outbreak traced back to iceberg lettuce, according to the FDA and the CDC. Two states, Maine and Massachusetts, were added to that tally late last week.
    • At least some of the nation’s cases are also linked to the ongoing cyclospora outbreaks that the FDA has been investigating. 
    • “There are seven active investigations into cyclospora outbreaks, the FDA’s tracking shows. Three – sickening 18, eight and two people, respectively – are listed as ended. Only the outbreak linked to iceberg lettuce has an identified source.
    • “Two outbreaks have grown, according to the FDA. One, which was first reported in early August, has grown to 11 cases. Another, from late July, has grown to 172 cases, up from 115. The FDA continues to conduct traceback in both outbreaks, as well as three other still active outbreaks.
    • “We may never know the cause of the outbreak. Because of how long it can take for people to experience symptoms, and the difficulties of sequencing cyclospora, investigations can “take a significant amount of time,” Gwen Biggerstaff, the deputy director of the CDC’s Division of Foodborne, Waterborne, and Environmental Diseases, previously explained.”
  • MedTech Dive relates,
    • “Johnson & Johnson said Monday its Monarch bronchoscopy robot for lung cancer diagnosis received Food and Drug Administration clearance for a software update that adds several new features to the platform, including artificial intelligence tools designed to make pre-procedure planning more intuitive.
    • “Other improvements broaden compatibility with commonly used imaging systems and support navigation and targeting to help physicians address anatomical changes that can occur during the procedure.
    • “The Quest 3 update is the Monarch system’s fourth major software launch in the past 18 months, according to J&J.”
  • and
    • “The Food and Drug Administration has selected Cadence, a software company that makes an artificial intelligence-assisted tool for hypertension management, as the second company for its digital health pilot. 
    • “The Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, exempts certain digital health devices from FDA premarket authorization requirements while allowing companies to collect real-world data through a related Medicare program. 
    • “Cadence, which announced the FDA’s selection last week, plans to report real-world data related to the safety, performance and patient outcomes associated with its device to help inform how clinical AI systems are built and regulated in the future.”

From the judicial front,

  • On August 3, 2026, a Title VII class action was filed in the U.S. District Court for the District of Columbia against OPM Director Scott Kupor and his agency due to OPM’s exclusion of gender affirming care in the FEHB and PSHB programs.  On August 14, the Chief Judge granted the named plaintiffs’ motion to use pseudonyms and seal certain identifying information. On August 17, the District Court’s Clerk assigned the case to U.S. District Judge Amit T. Mehta.

From the public health and medical / research front,

  • The Washington Post reports,
    • “More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “Novo Nordisk announced Tuesday that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels. 
    • “Starting this week, that grueling regimen can be reduced to just one shot a week.
    • “The appeal of reducing 365 shots a year to 52 is obvious: greater convenience, less pain. Novo Nordisk says removing the daily requirement can create “a routine that feels more manageable.” 
    • “But there are other issues to keep in mind — most importantly, the risk of hypoglycemia, or low blood sugar, which Novo Nordisk said was a common adverse reaction in Awiqli clinical trials. Hypoglycemia can make people feel shaky, irritable, and, if the blood sugar gets very low, confused. It can be dangerous and can even cause death if it gets excessively low.
    • “Novo Nordisk announced Tuesday [August 11, 2026] that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
    • “Another factor is access: It is not yet clear which insurance plans will cover Awiqli and whether they will require patients to jump through hoops to qualify for coverage.”
  • MedPage Today relates,
    • “Using a panel of 11 genes linked to pediatric cancer predisposition syndromes, researchers found pathogenic or likely pathogenic variants in 7% of newborns who later developed a solid or brain tumor.
    • “Targeted sequencing of this panel would identify approximately 1/27,000 infants who will develop cancer by age 8 years in the setting of a genetic cancer predisposition syndrome.
    • “Researchers said it is feasible to conduct genomic newborn screening universally.” * * *
    • “[E]arly identification of these children could alter their survival outcomes, Diller and team noted.
    • “It’s become clear over the past few decades that at least 10% or more of kids who develop cancer have genetic predisposition to cancer, and a good chunk of those kids are diagnosed in the first few years of life,” Diller told MedPage Today. “It predisposes them to very-early-onset cancers. So the clinical problem is, can we do anything other than wait for them to develop their cancers?”
  • Health Day tells us,
    • “Ultra-processed foods might be linked to a higher risk of prostate cancer, a new study says.
    • “Men who ate the most ultra-processed foods had as much as a 34% higher risk of prostate cancer, compared to those who ate less, researchers reported recently in theAmerican Journal of Medicine.
    • “Among adult men in this nationally representative U.S. population, those who consumed higher amounts of UPFs had significantly higher risks of the subsequent development of prostate cancer,” said senior researcher Dr. Charles Hennekens, a professor of medicine and preventive medicine at Florida Atlantic University.
    • “These findings add to emerging evidence that UPFs have major adverse health effects and underscore the need for large-scale observational studies and randomized trials to adequately test the hypothesis,” Hennekens said in a news release.”
  • and
    • “A person’s sleep patterns could be an early sign of Alzheimer’s disease, a new study says.
    • “A greater number of micro-awakenings during sleep is linked to a greater genetic risk for Alzheimer’s, researchers reported recently in the journal Sleep.
    • “In fact, more frequent micro-awakenings go hand in hand with that genetic risk, long before any memory problems arise, according to a team from the University of Liege in Belgium. 
    • “Sleep could become an accessible marker for the early identification of vulnerable individuals,” senior researcher Gilles Vandewalle said in a news release.
    • “It’s well-known that people with Alzheimer’s have sleep problems, but sleep hasn’t been established as an early indicator of the disease, researchers noted.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN  said it is ending the Phase 3 trial of volrustomig plus chemotherapy for metastatic non-small-cell lung cancer.
    • “The Cambridge-based pharmaceutical company said Monday that the decision is based on the recommendation of the Independent Data Monitoring Committee after a planned review of trial data.
    • “The committee concluded that the volrustomig combination was unlikely to reach either of the primary endpoints for the drug in the eVolve-Lung02 trial.” * * *
    • “The other Phase 3 volrustomig trials will continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
    • “Separately, AstraZeneca said Tagrisso plus Orpathys showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival in a Phase 3 trial in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer.” * * *
    • “The company said this was the first global Phase 3 trial to show significant progression-free and overall survival benefits in this setting.
    • “Tagrisso plus Orpathys is being jointly developed with Hutchmed, but is being solely commercialized by AstraZeneca.
    • “AstraZeneca also said a Phase 3 trial of Enhertu showed a significant and clinically meaningful improvement in progression-free survival as a treatment for unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small-cell lung cancer.”
  • BioPharma Dive points out,
    • “Shares for Argenx soared over 13% Monday morning after the company announced positive data from a Phase 3 trial for a rare autoimmune condition that could expand use of its blockbuster drug Vyvgart. 
    • “The Dutch biopharmaceutical company said Monday an under-the-skin injection version of Vyvgart, called Vyvgart Hytrulo, met its primary endpoint in a late-stage combined study of people with myositis, a rare autoimmune disease that attacks the muscles and has limited treatments. The company said that Vyvgart, when compared to placebo, showed improvements in two subsets of the disease, as measured by a scale evaluating muscle strength and physical health known as Total Improvement Score, or TIS.”
  • and
    • “EyePoint, a Boston-area biotechnology company, lost nearly a billion dollars in market value Monday after its main drug failed to hit the central goal of a key clinical trial.
    • “Titled LUGANO, the trial enrolled roughly 400 people with the less common “wet” form of age-related macular degeneration, meaning they have impaired vision because of abnormal, fluid-leaking blood vessels in their eyes. They received inside-the-eye injections of either “aflibercept,” the active ingredient in Regeneron Pharmaceuticals’ blockbuster medicine Eylea, or EyePoint’s drug, which the company has branded as Durayvu.
    • “Researchers then evaluated these participants for a little over a year, with a particular focus on any changes in average “best-corrected visual acuity” — a measure of how clearly a person, when outfitted with optimal prescription lenses, can read the kind of standard eye chart found in an optometrist office. EyePoint has now revealed that, on that measure, across the trial’s full dataset, its drug didn’t prove “non-inferior” to aflibercept.
    • “The company largely blamed the failure on an “asymmetric cohort” of nine patients in the Durayvu-treated group, who had vision loss — or a dropoff of at least 15 letters on the eye exam — that was “unrelated to wet AMD.” According to EyePoint, an after-the-fact analysis found the drug would have achieved non-inferiority had that group been excluded.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente reported nearly $1.7 billion in operating income (4.6% operating margin) during the second quarter of 2026, a more than $600 million improvement over the same period in 2025. 
    • “The country’s largest nonprofit health system, in a quarterly financial update shared Friday that precedes its more granular regulatory filing, outlined $35.6 billion in operating revenues, a 10.9% year-over-year increase, and nearly $34 billion in operating expenses, a 9.3% year-over-year increase.
    • “Kaiser noted that its structure as a membership-based, premiums-collecting integrated health system typically yields stronger operating income in the first half of the calendar year “due to health plan enrollment cycles,” moderating later on “as care utilization, labor costs, and other expenses increase while revenue stays relatively flat.”
    • “The quarter’s performance follows an opening frame in which the organization’s $711 million operating income (2.1% operating margin) reflected a pullback from early 2025’s $932 million operating gain (2.9% operating margin), due in part to a major month-long work strike. Year to date, that still places Kaiser and its subsidiaries about $400 million ahead of 2025. 
    • “In today’s complex health care environment, positive operating performance helps us make care more affordable, invest in our future, and expand access to value-based care,” Kaiser Permanente Chair and CEO Greg A. Adams said in a statement. “Together, Kaiser Permanente and Risant Health are helping more people benefit from evidence-based, coordinated care that improves quality, enhances the patient experience, and makes high-quality care more accessible and affordable. I’m grateful to our employees and physicians for bringing our mission to life every day.”
  • Beckers Payer Issues relates,
    • “Blue Cross Blue Shield of Massachusetts earned $83.4 million in after-tax second-quarter profit. 
    • “This was made up of $35.7 million in operating and other income, as well as $47.7 million in investment income. The insurer’s revenue was $2.7 billion, marking a net margin of 3%. During the same period in 2025, BCBS Massachusetts had a $129.7 million loss on revenue of $2.6 billion.
    • “Since the beginning of the year, after-tax net income has been $142.9 million with revenue at $5.4 billion, a 2.7% net margin. The results include a premium deficiency reserve.
    • “After two consecutive years of record losses, we are also laser focused on restoring our company’s financial health,” Executive Vice President and CFO Ruby Kam said in an Aug. 14 news release. “We are doing this by carefully managing our own administrative costs and making necessary adjustments to our pricing and benefits.”
  • Healthcare Dive tells us,
    • “Universal Health Services has completed its $835 million acquisition of online therapy provider Talkspace, bolstering the for-profit system’s already extensive behavioral health offerings.
    • “The deal closed Monday five months following its announcement, after the companies secured necessary regulatory approvals.
    • “With the buy, UHS will be able to provide a full range of behavioral health services, including inpatient, intensive outpatient, partial hospitalization, therapy sessions and virtual assessments.”
  • Beckers Clinical Leadership adds,
    • “Salt Lake City-based Intermountain Health is approaching behavioral health access challenges by first addressing one quality concern in particular: whether patients are actually getting better.
    • “That’s the premise behind the health system’s push to embed measurement-based care across its behavioral health service line, Tammer Attallah, executive clinical director of Intermountain’s behavioral health clinical program, told Becker’s. The nonprofit system has locations in six primary states and additional operations across the western U.S., operating 34 hospitals and more than 400 clinics.
    • “We want more patients to get better faster. That’s all,” he said. “It’s as simple as that.” 
  • Beckers Physician Leadership informs us,
    • “Three physician leaders shared what they believe healthcare organizations and the system as a whole need to stop asking of physicians, pointing to burdensome technology, systemic dysfunction and workflows that pull clinicians away from patient care. 
    • “James Augustine, MD. Medical Director for Lee County EMS (Fort Myers, Fla.): Mandated use of very unfriendly computer systems, which don’t contribute to good practice.
    • “Peter Bravos, MD. Chief Medical Officer of Sutter Health’s Surgery Center Division (Yuba City, Calif.): Asking physicians to personally absorb systemic dysfunction and calling it resilience. When the schedule is broken, the staffing is thin, and the administrative load keeps climbing, a wellness webinar isn’t a solution. It’s a way of relocating a system’s problem onto the individual and then measuring the individual for how well they cope with it. Resilience was never meant to be a substitute for fixing the conditions that exhaust people. Build systems worthy of the people working in them, and resilience takes care of itself.
    • “Walter Allen Fink, DO. Associate Vice President and Chief Medical Officer UT Health San Antonio: We need to stop putting unnecessary things between physicians and the work they were educated and trained to do.
    • “Too much physician time is spent working around inefficient processes, navigating technology, dealing with fragmented workflows, and doing tasks that do not really require a physician’s expertise.
    • “For me, this is bigger than just reducing administrative burden. We should be designing systems that allow physicians to spend more of their time caring for patients, making complex clinical decisions, talking with patients and families, and improving care.”
  • Fierce Healthcare notes,
    • “Since April, more than 300 enterprise health systems have adopted Abridge’s artificial intelligence-based decision support solution, and the company is now making the tool available to every clinician at its partner health systems.
    • “It’s part of Abridge’s strategy to broadly expand from AI documentation to functioning as an enterprise AI assistant for clinicians.
    • “Adoption of decision support has outpaced anything we’ve shipped before because it feels like a natural extension of Abridge. It understands the context of the patient in front of the clinician, it’s grounded in the evidence they already trust, and it connects to what they want to do next,” Shiv Rao, M.D., CEO and co-founder of Abridge, and a practicing cardiologist, said in a statement.

Midweek update

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

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a $4 million initiative to expand access to rapid, point-of-care syphilis testing, with a focus on reaching women in emergency departments and other nontraditional healthcare settings.
    • “Congenital syphilis is preventable, yet too many mothers and babies are still suffering its devastating consequences,” said HHS Secretary Robert F. Kennedy Jr. “HHS is putting rapid tests where women receive care so we can detect infections earlier, treat them faster, and protect more babies.”
  • Beckers Behavioral Health adds,
    • “HHS Secretary Robert F. Kennedy Jr., White House Office of National Drug Control Policy Director Sara Carter, and Housing and Urban Development Secretary Scott Turner released a toolkit Aug. 12 focused on addressing homelessness and addiction through treatment.
    • “The “Best Practices Toolkit: Addressing Homelessness and Addiction Through Treatment First” outlines strategies for communities to “help Americans transition from homelessness and addiction to recovery and self-sufficiency,” according to an Aug. 12 news release from HHS.
    • “The toolkit centers on a “Treatment First” model, which prioritizes coordinated and accountability-driven engagement in evidence-based treatment and recovery support services. It supports drug treatment and recovery efforts through the Great American Recovery Initiative.”
  • The American Hospital Association relates,
    • “The Centers for Medicare & Medicaid Services today released an advisory for certain clinicians who are qualifying alternative payment model participants and eligible to receive APM incentive payments, notifying them that their current billing information must be updated to receive funds for the 2026 payment year. CMS said that it was unable to identify a taxpayer identification number associated with some participants after processing 2026 APM incentive payments and therefore was unable to disburse payments. The agency said that all information must be received by Oct. 13. Following that date, CMS said any claim to an APM incentive payment for the 2026 payment period based on an eligible clinician’s qualifying APM participant status for the 2024 performance period will be forfeited.” 
  • Beckers Hospital Review adds,
    • “Participation in mandatory value-based payment programs from CMS is associated with significantly higher annual administrative costs for hospitals, according to a study published Aug. 7 in JAMA Health Forum.
    • “Researchers at the Brown University School of Public Health in Providence, R.I., examined 2006 to 2020 Medicare cost report data for 4,332 hospitals, including 2,820 that participated in the Hospital Value-Based Purchasing program, Hospital Readmissions Reduction Program and Hospital-Acquired Condition Reduction Program. They also assessed costs associated with participation in the Comprehensive Care for Joint Replacement model. * * *
    • “Participation in the first three programs was tied to annual administrative cost increases ranging from $650,000 per hospital compared with long-term acute care hospitals to $1.23 million compared with general acute care hospitals in Maryland. Participation in the CJR model was linked to a $1.4 million annual increase in administrative costs per hospital.
    • “Aggregated nationally, the programs accounted for more than $3 billion in additional annual administrative spending.”
  • Beckers Clinical Leadership tells us,
    • “HHS is creating a new pathway to evaluate which conditions should be added to the national newborn screening panel as part of a broader effort to modernize a review process that officials say has lagged behind advances in genetic medicine.
    • “The Health Resources and Services Administration on Aug. 11 launched a framework to streamline evidence reviews for the Recommended Uniform Screening Panel, the federal guideline nearly all state newborn screening programs follow. 
    • :A Federal Register notice published Aug. 12 laid out the mechanism: a National Newborn Screening Stakeholder Workgroup funded through a $700,000 award to the Silver Spring, Md.-based Association of Public Health Laboratories.”

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

  • My Federal Retirement reports,
    • “Based on CPI-W data through July 2026, the trend toward an estimated 2027 COLA holds at 3.1% for Social Security and CSRS retirees, which would translate to a FERS COLA of approximately 2.1% once the FERS reduction formula is applied — unchanged from last month’s estimate. The official 2027 COLA won’t be announced by the Social Security Administration until mid-October 2026. This page is updated monthly as new CPI-W data is released.”

From the Food and Drug Adminstration front,

  • The Hill reports,
    • The Food and Drug Administration (FDA) is assuring Americans that they should feel confident eating fresh produce again, seeking to ease concerns over the nation’s food supply after a cyclospora outbreak linked to iceberg lettuce spread across more than a dozen states.
    • “We have the safest food supply in the world,” acting FDA Commissioner Kyle Diamantas said in a Tuesday interview with CNBC. “Americans should feel confident in eating fresh produce including leafy greens at this point.
    • “Diamantas added that his agency “remains confident that all iceberg lettuce related to the cyclospora outbreak has been effectively removed from the market” since California-based vegetable producer Taylor Farms voluntarily recalled products linked to the outbreak on July 17.” * * *
    • “The FDA and CDC are still investigating the outbreak, and officials have warned that the number of confirmed illnesses could continue to climb long after the recall because it can take as long as six weeks to determine whether an illness is connected to the outbreak.”
  • Medscape relates,
    • “Following unprecedented results from the RASolute 302 trial, cancer centers across the US are making daraxonrasib available to patients ahead of FDA approval.
    • “The RAS inhibitor has been in the news since it was shown to nearly double median overall survival vs standard chemotherapy — from 6.7 to 13.2 months — among patients with previously treated metastatic pancreatic cancer.
    • “The survival gain, in a notoriously difficult-to-treat disease, earned a standing ovation when the data were presented at this year’s American Society of Clinical Oncology annual meeting. And on July 22, daraxonrasib’s maker Revolution Medicines, announced that the FDA had accepted its approval application.”
  • Beckers Hospital Review tells us,
    • “San Francisco-based Hims & Hers plans to start selling compounded peptides by the end of 2026, with six more to follow pending final FDA rulemaking, executives said Aug. 10.
    • “The direct-to-consumer telehealth company laid out a phased rollout on its second-quarter earnings call. Executives said they expect to offer a first group of already-permitted peptides — including sermorelin, glutathione and a product it markets as MEDplus — by year’s end, then expand to six wellness peptides an FDA advisory committee recommended in July.
    • “We are currently developing a best-in-class peptide experience including U.S.-manufactured products, clinical-led guidance and ongoing blood testing,” co-founder and CEO Andrew Dudum said. He said the company is “waiting on full and final rulemaking from the FDA” before launching the recommended peptides.”

From the judicial front,

  • Bloomberg Law reports,
    • “The full Fifth Circuit partly struck down a series of federal rules on surprise medical bills, concerning the qualifying payment amount, or median in-network rate. 
    • “The court overturned a provision allowing insurers to include “ghost rates” in the QPA, and rejected a provision excluding bonuses and case-specific rates from the QPA. 
    • “The court sided with the agencies on a provision excluding one-time, case-specific agreements from the QPA calculation, saying the word rate “connotes a per-unit price for multiple units.”
  • Beckers Hospital Review adds,
    • “The court said the agencies can use their enforcement discretion to let insurers keep using existing QPAs while new calculations are completed, preserving balance billing protections for patients in the interim.”
  • The Wall Street Journal relates,
    • “Eli Lilly filed six lawsuits against U.S. entities it alleges are selling a version of its investigational weight-loss drug on the black market.
    • “The lawsuits claim the entities sell retatrutide, a GLP-1 drug that is still in trials and not yet approved by the FDA.
    • “Eli Lilly is calling on social media platforms and payment processors to help stop the black market sales of the drug.”

From the NCQA front,

  • The Cotiviti Blog tells us,
    • “Many health plans wrapped up Measurement Year (MY) 2025 with a smoother HEDIS® season than ever before. The organizations that performed best weren’t necessarily those with the largest teams or budgets—they were the ones with integrated data, aligned workflows, and the ability to identify and act on quality opportunities earlier.
    • For many health plans, MY 2025 brought an unexpected outcome: fewer fire drills. The most successful organizations relied on repeatable steps focused on:
      • Integrated clinical and quality data
      • Aligned teams around clear priorities
      • Chart review productivity reporting
      • Population-level measures dashboards
    • Established repeatable workflows that reduced operational friction throughout the season
    • High-achieving plans started by identifying the right opportunities by using HEDIS logic and integrated data sources to pinpoint the gaps that matter most. Effective approaches centered on opportunities where both impact and intervention are possible, targeting outreach at the provider, care manager, or member level depending on where change can occur most effectively.
    • Next, operationalizing those insights was key during MY 2025. Analytics may reveal performance gaps, but improvement happens when those findings are embedded directly into workflows. Plans that consistently outperform their peers translate data into outreach campaigns, care management activities, and provider engagement efforts with clearly defined accountability.
    • Standardization is equally important. Quality initiatives only create value when the work performed is accurately reflected in reporting. Aligning documentation and coding practices with NCQA-approved value sets helps ensure that quality improvements appear in measure results.
    • Finally, leading health plans embrace continuous measurement. They evaluate intervention effectiveness, monitor gap closure rates, assess outcomes, and create feedback loops that help refine future strategies. Over time, this transforms quality programs from a series of one-off campaigns into a scalable operating model built around continuous improvement.

From the public health and medical / Rx research front,

  • MedPage Today tells us,
    • “Wait times are increasing between cancer diagnosis and the start of first-course therapy for six cancer types, according to a retrospective cohort study.
    • “Predictors of longer wait times included Medicaid insurance, lowest-quartile income, Black race, increased travel distance, and treatment at academic institutions, among other factors.
    • “These results should be considered in the context of previous research linking treatment delays with worse survival outcomes, researchers said.”
  • Beckers Hospital Review notes,
    • “Ascension Saint Thomas in Nashville has rescheduled some elective surgeries and said it could be forced to cancel or delay additional cases because of shortages of blood products.
    • “Platelets are a particular concern at Saint Thomas, according to an Aug. 6 news release from the hospital, which is part of the St. Louis-based Ascension health system. Chief Clinical Officer Brian Wilcox, MD, told NBC News affiliate WNKY that the shortage is affecting hospitals nationwide as donations of blood products have fallen to a four-year summer low even as demand for transfusions holds steady.
    • :The disruption comes as the American Red Cross declared its second national blood crisis in history July 27, with type O blood critically scarce and distributions to hospitals now limited. The shortage began building in May, when a gap widened between the amount of blood hospitals need and the amount being donated. The Red Cross is currently sending hospitals roughly 3,500 more units of blood per week than expected.
    • “An Illinois Red Cross spokesperson told NBC News affiliate WGEM that without a constant blood supply, hospitals could be forced into situations where doctors have to choose who gets blood and who doesn’t, adding that elective surgeries that need transfusions may have to be postponed.”
  • Cardiovascular Business adds,
    • “Clinicians should pay close attention to any incidental lung findings identified when transcatheter aortic valve replacement (TAVR) patients undergo preprocedural CT scans. That is according to new findings published in Heart Lung, a journal from the American Association of Heart Failure Nurses.[1]
    • “Over the past decade, TAVR has transformed the therapeutic landscape of symptomatic severe aortic stenosis (AS),” wrote first author Mustafa Mousa Basha, MD, a researcher with University Hospital Bonn in Germany, and colleagues. “Pulmonary diseases are frequently co-existent in AS patients, often ranging from mild restriction to a mixed restrictive and obstructive pattern, and represent an important risk factor for postoperative complications following TAVR.”
  • STAT News relates,
    • “Not long after guidelines shifted to considering statin therapy as early as age 30, new research from France suggests there may be no harm in stopping the cholesterol-lowering drugs at age 75 in people with no history of cardiovascular disease. The lessons, however, may not translate elsewhere. 
    • “The “non-inferiority” study, published Tuesday in the Lancet Healthy Longevity, does not advise doctors to tear up statin prescriptions for older people. Nor does it conclude that going off statin therapy is better than staying on. It does say patients should talk to their doctors to see if they’d be no worse off for dropping the daily pills.
    • “Invoking patient choice, the authors highlight the lack of scientific literature on older people, noting what research does exist has found the link between cholesterol and cardiovascular events weakens with age. They believe their own study needs to be repeated for a longer period of time and extended to populations at higher cardiovascular risk or otherwise not as healthy as their participants.
    • “For the majority of American patients over the age of 75, this trial will not change anything,” Romit Bhattacharya, a general and preventive cardiologist from the Mass General Brigham Heart and Vascular Institute, told STAT in an interview. He was not involved in the research. “It does give us a little bit of permission and greater flexibility and choice for our individuals who maybe have a short time horizon to live and who are already quite healthy and engaged in care.”
  • The New York Times reports,
    • “President Trump issued an executive order this week calling for immunizations for measles, mumps and rubella, a mainstay of vaccination programs worldwide, to be offered as three individual jabs given at separate times, instead of in one combination shot.
    • “In an Oval Office signing ceremony, the president made a frightening and unsubstantiated claim about the combination shot. “Together, there could be a possibility they’re quite lethal.” 
    • “Researchers have not linked the combination M.M.R. shot to a risk of death, and there is no evidence that it is dangerous or that splitting it into its three components is any safer or more effective, vaccine experts said. Combination shots for the diseases have been used in the United States since 1971, and were introduced only after careful comparison against individual shots. They have been given to hundreds of millions of children.
    • “What’s more, separate vaccines for measles, mumps or rubella have not been available in the United States for many years. Vaccine manufacturers said it would take a minimum of five to 10 years for them to be tested and made available.”
  • Health Day informs us,
    • “Restarting obesity medications, including glucagon-like peptide-1 (GLP-1) receptor agonists, soon after sleeve gastrectomy (SG) surgery is associated with greater one-year weight loss than surgery alone in adolescents, according to a research letter published online July 22 in JAMA Surgery.”
  • and
    • “The 4C meningococcal B (MenB) vaccine confers modest protection against gonorrhea among adolescents, according to a study published online Aug. 4 in Open Forum Infectious Diseases.”
  • Genetic Engineering and Biotechnology News points out,
    • :A multi-disciplinary, multi-institutional group of researchers said they relied on their expertise in genetics, mechanics, chemistry, and biology to create a chip the size of a postage stamp to model a particular class of heart conditions.
    • “The team, led by Guang Li, PhD, an associate professor in the University of Pittsburgh School of Medicine’s department of cell biology, has grown heart valves on organoids. The study “Human iPSC-derived heart valve-like assembloids model valve development and disease pathology” appears in Cell Stem Cell and is an important step toward better understanding and treating a number of serious heart disorders, according to the scientists.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of baxdrostat (Baxfendy™, AstraZeneca) and lorundrostat (Mineralys Therapeutics, Inc.) for hypertension.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” * * *
    • The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on September 9, 2026.

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

  • The Austin American-Statesman reports,
    • “On Wednesday, the University of Texas System Board of Regents’ Facilities Planning and Construction Committee will adopt a timeline and budget for phase one of the much-awaited artificial intelligence-native hospital, UT Dell Medical Center. 
    • “Construction on the $5 billion hospital is expected to begin this fall, and initial site preparation could begin within a month after board approval of this first phase, which does not include the actual building but includes design and site preparation as well as equipment that takes time to arrive such as MRIs. The committee’s agenda includes information such as a timeline and the cost of the project, which has not yet been disclosed publicly. 
    • “The hospital will include both specialty care and an MD Anderson Cancer Center Central Texas location. UT announced the project in 2023 as a $2.5 billion investment to expand access to high-quality healthcare for Central Texas and bring thousands of jobs to Austin, but when a new site chosen and the hospitals were combined into one, the price tag went up to an estimated $5 billion.” 
  • Modern Healthcare relates,
    • “Intermountain Health and AdventHealth have signed a definitive agreement to merge services at multiple hospitals, clinics and medical practices through a joint venture in the Denver area. 
    • “The deal is slated to close in early 2027, pending regulatory approval, according to a Wednesday notice from AdventHealth. The organizations signed the definitive agreement last week.
    • “Financial terms were not disclosed.”
  • KFF Health News explains how “Hospital Prepayment Requirements Add New Wrinkles to Patients’ Financial Responsibility.”
  • Beckers Health IT tells us,
    • “Bethlehem, Pa.-based St. Luke’s University Health Network and UnitedHealthcare have automated claim status updates for 88% of the claims exchanged between the two organizations, using Epic’s Payer Platform, according to Epic’s newly released 2026-2027 Almanac.
    • “The two organizations turned on Epic’s Claim Status feature to give St. Luke’s staff real-time visibility into where claims stand with UnitedHealthcare, replacing manual status checks that previously required calling the payer or logging into external portals. Brian Burd, IT director at St. Luke’s, said the health system’s main motivation was to improve revenue cycle efficiency by reducing manual claim status inquiries and speeding up follow-ups.
    • “UnitedHealthcare manages most of its claims operations outside Epic, so the insurer routes claim data through its own Epic environment first, then delivers it to St. Luke’s through the Payer Platform connection. That setup avoided the time and transaction fees of building a separate direct link between the two systems.
    • “Since the feature went live, UnitedHealthcare has seen a 25% drop in claim status calls from St. Luke’s, while St. Luke’s staff have shifted their time from chasing payer updates to higher-value revenue cycle work.”
  • Beckers ASC Review informs us,
    • “There comes a point when health system’s ASC moves stop being a side project and start requiring a more involved strategy, and, according to Atlas Healthcare Partners CEO Aric Burke it’s when revenue is above roughly $2 billion to $3 billion, and a portfolio has grown past about five centers.
    • “I think health systems over two to three billion in revenue probably need to have a real, dedicated ASC strategy,” Mr. Burke told Becker’s.”
  • and 
    • “Anesthesia has become one of the most persistent staffing headaches for ASCs and hospitals alike.
    • “It’s not just a bad labor market, but a pipeline problem stacked on top of an aging workforce, a bottlenecked training system and a reimbursement environment that’s making it harder to attract new anesthesiologists and certified registered nurse anesthetists into the specialty.”
  • and
    • “GI procedure demand keeps climbing while Medicare keeps cutting what it pays for the exact setting where those procedures are cheapest to perform.”
  • Beckers Hospital Review notes,
    • “U.S. News & World Report released its debut ratings Aug. 12 for the best GLP-1 telehealth platforms, its first evaluation of the online companies prescribing brand-name weight loss drugs.
    • “The media company rated 20 platforms offering FDA-approved, brand-name GLP-1 medications, including Wegovy, Zepbound, Ozempic and Foundayo, according to an Aug. 12 news release. Companies that offer only compounded GLP-1s were excluded, and for platforms selling both, U.S. News evaluated only the branded portion of the business.”
    • Here are the top five:
      • “Amazon One Medical: 4.8
      • “Found: 4.6
      • “Mochi Health: 4.4
      • “Ro: 4.4
      • “Noom: 4.3”
  • MedTech Dive lets us know,
    • “Abbott and Google plan to pair Abbott’s over-the-counter glucose sensor with Google’s artificial intelligence and consumer technology, the companies said Tuesday.
    • “The multiyear partnership is focused on making metabolic insights from Abbott’s device easier to use, helping people proactively manage their health. 
    • “The two companies plan to launch a large study that could inform Google’s AI health coaching and future features for Abbott’s Lingo sensor. Abbott did not disclose how many people they plan to enroll in the study.”

Midweek report

David Ermer–AHRQ, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, Patient safety, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “A bipartisan group of senators Aug. 5 introduced the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act), a bill aimed at providing statutory clarity for the 340B Drug Pricing Program while establishing new transparency, reporting and program integrity requirements. The bill was introduced by Sens. Jerry Moran, R-Kan.; Tammy Baldwin, D-Wis.; Shelley Moore Capito, R-W.Va.; Tim Kaine, D-Va.; John Boozman, R-Ark.; and John Hickenlooper, D-Colo. 
    • “The AHA appreciates the leadership of the Senate 340B Bipartisan Working Group,” said Aimee Kuhlman, AHA group vice president of advocacy and grassroots. “We look forward to reviewing their legislation in detail, discussing it with our 340B hospitals, and working with them and other policymakers to ensure the 340B program remains strong for patients, communities, and providers across the country.”
  • and
    • “The Senate Aug. 5 voted 51-44 to confirm Erica Schwartz as the new director of the Centers for Disease Control and Prevention. Schwartz was previously deputy surgeon general during the first Trump administration.”
  • Per an Health and Human Service Department news release,
    • “The U.S. Department of Health and Human Services (HHS) today began the decertification of Network for Hope, the federally designated organ procurement organization (OPO) serving Kentucky and parts of Indiana, Ohio, and West Virginia, after multiple federal reviews found persistent patient safety failures despite extensive oversight and despite Network for Hope having been provided repeated opportunities to correct them. Those failures put prospective organ donors and patients awaiting lifesaving transplants at risk.”
  • Roll Call relates,
    • “At King’s College Hospital in the south of London, anyone who has blood drawn in the emergency department is automatically tested for hepatitis B and C.
    • “Posters throughout the facility inform patients that the screening is routine, part of a new approach helping find and treat thousands of people who might otherwise never know they have the viruses, which can be fatal if left untreated.
    • “We pick up a lot of people who would never have actively accessed this kind of testing themselves — women in later life, people who’d never think they’re the sort of person who would have this condition,” said Dr. Oliver Mizzi, a consultant in emergency medicine at the hospital.
    • “Across England, 90 hospitals now have opt-out testing for hepatitis, leading to thousands getting treatment and putting the country on the path to meeting its goal of eliminating the hepatitis C virus as a public health threat by 2030.
    • “As Congress considers legislation to establish a national hepatitis C elimination program, experts say expanding opt-out testing in emergency departments is an indispensable way identify undiagnosed infections.”

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

  • FedSmith reports,
    • “The OPM retirement backlog kept falling in July, marking a fifth consecutive monthly decline. The backlog dropped by 9,067 cases, or 26.8%, last month to 24,784 total retirement claims, even as the average time to process a claim climbed to a record 109 days, the highest figure since OPM began publishing the data in 2018.
    • “The Office of Personnel Management (OPM) received 10,538 new retirement claims in July while processing 17,841 cases, a gap of more than 7,300 cases that continued pushing the backlog down. OPM has now cut the backlog for five straight months since it peaked at 65,237 in February.
    • “So far in 2026, the average number of retirement claims received per month (both digital and paper) is 15,336 and OPM has processed 17,594. For digital, the monthly averages have been 9,429 received and 8,726 processed.”
  • Per LinkedIn, James Muetzel has been promoted to the position of Principal Deputy Associate Director for Healthcare and Insurance at U.S. OPM.

From the Food and Drug Administration front,

  • Food and Wine reports,
    • “The FDA is investigating 10 active foodborne illness outbreaks, a higher-than-usual number that experts attribute to improved detection methods and a more interconnected food supply.
    • “Two Cyclospora outbreaks linked to iceberg lettuce account for the most reported illnesses, with cases in 41 states. Michigan reports the highest number of illnesses, hospitalizations, and deaths.
    • “The remaining FDA investigations involve Salmonella, Listeria monocytogenes, E. coli, and Clostridium botulinum. Some are linked to recalled products such as frozen blueberries, powdered infant formula, eggs, and soft cheeses, while others remain under investigation.”
  • STAT News relates,
    • “The Food and Drug Administration on Wednesday approved a novel type of treatment for narcolepsy made by Takeda, backing a drug class that scientists hope can transform the treatment of sleep disorders and potentially address a broad range of neurologic conditions. 
    • “The twice-a-day pill, which will be marketed as Orzeyful, is an orexin receptor agonist. It’s cleared to treat narcolepsy type 1, a taxing condition in which patients have a deficiency of the orexin neuron and experience bouts of sleepiness and muscle weakness during the day.
    • “The drug is likely to be very appealing to patients. Current therapies, stimulants and sodium oxybates, carry risk of misuse, and patients still feel sleepy while taking them. In two Phase 3 trials, Orzeyful helped patients stay awake during the day for much longer than what’s been seen with current treatments. Throughout the studies, participants also reported less daytime sleepiness, less frequent muscle weakness, and greater attentiveness.”
  • BioSpacc lets us know,
    • From an outright refusal to file to a backpedaled review earlier this year, Moderna has secured the FDA’s greenlight for its mRNA-based flu vaccine mFLUVISA.
    • The decision, revealed late on Wednesday, grants traditional approval for mFLUVISA to prevent seasonal influenza in patients 50 through 64 years of age, and accelerated approval for use in people 65 years and older. MFLUVISA is the first mRNA-based flu shot in the U.S., according to Moderna’s announcement.
    • The company expects to make mFLUVISA available “in the coming weeks,” in time for the 2026-2027 respiratory virus season in the U.S. Moderna didn’t disclose pricing for mFLUVISA.
  • Per a Reckitt news release,
    • “Reckitt announced today a milestone for the cold and flu category and the company: Mucinex® 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter (OTC) innovation in the cold and flu category in 14 years, and the first New Drug Application (NDA) under the Reckitt name to receive FDA approval.¹ Developed to align with the way consumers choose to manage cold and flu symptoms, this achievement reflects more than a decade of Reckitt’s scientific research, development, clinical evaluation and regulatory collaboration.”
  • MedTech adds,
    • “BD is recalling certain lots of intraosseous vascular access system needle sets due to a problem associated with four deaths, according to a Food and Drug Administration early alert posted Tuesday. 
    • “The needles are used to provide access to the bone marrow in emergency care situations when intravenous access is difficult. BD said in a statement last week that certain lots were manufactured with out of tolerance dimensions and may be more difficult to remove after placement. 
    • “BD reported four deaths where inability to remove the stylet occurred during resuscitation efforts for cardiac arrests. The company has received 75 complaints, including 45 serious injury reports.”

From the judicial front,

  • The New York Times reports,
    • “The Justice Department filed charges on Tuesday against Dr. Stephen Dubin, a doctor in Nevada, alleging that he orchestrated a $95 million Medicare fraud scheme that involved applying expensive and unnecessary wound coverings to elderly patients.
    • “Dr. Dubin was included in a 2025 New York Times investigation into skin substitutes, bandages manufactured out of dehydrated placentas that cost thousands of dollars per square inch but have not been found to help most wounds heal any better than regular bandages.
    • Medicare paid nearly $15 billion for skin substitutes in 2025, a spike that analysts have called one of the largest examples of waste in the federal health program’s history.
    • “After the Times investigation, the Trump administration sharply cut reimbursement rates for skin substitutes. Spending on the products has since plummeted to $100 million so far this year.”

From the public health and medical / Rx research front

  • Medscape reports,
    • “The ranks of long-term cancer survivors are growing, thanks to improved therapies, but along with that welcome trend comes a hard truth: Life-saving treatments can also have sometimes lasting adverse effects.
    • “Cardiac damage, a well-known risk of certain chemotherapies and other cancer treatments, may arise during treatment. But it can also surface years later, when it may not be recognized as a cancer therapy side effect.
    • “That’s the tsunami coming to medical systems around the world,” said Alexander Lyon, BM, BCh, PhD, a consulting cardiologist at Royal Brompton Hospital in London, England, and the co-chair of a task force that issued the first European guidelines in cardio-oncology in 2022.
    • Those guidelines, and similar ones from US groups, recommend various measures for preventing, detecting, and managing cardiac toxicity from cancer therapy. 
  • Beckers Clinical Leadership relates,
    • “About half of US hospital patients were on an antibiotic in 2023 — essentially flat from 2015 — even as nearly all hospitals now run stewardship programs, a CDC survey found.
    • “Among 151 hospitals that took part in both the 2015 and 2023 point-prevalence surveys, antibiotic use held steady: 49.2% of patients in 2015 and 49.1% in 2023. The findings were published July 31 in Open Forum Infectious Diseases.”
  • Healio adds,
    • “A Mayo Clinic study showed that more than 80% of patients who did not meet prescribing criteria for acute sinusitis were unnecessarily prescribed antibiotics, revealing a gap in adherence to treatment guidelines.
    • “The researchers found that clinicians often relied solely on a 10-day symptom duration to justify prescriptions, ignoring evidence that viral infections — which cannot be treated by antibiotics — can last that long.” * * *
    • “Guidelines from both the Infectious Diseases Society of America and American Academy of Otolaryngology “suggest a conservative approach” to treating sinusitis, the study noted. Those guidelines recommend antibiotics when symptoms have persisted for more than 10 days while also advising treatment for severe symptoms such as high fever and purulent discharge or facial pain lasting for 3 or more days.”
  • and
    • “Men prescribed testosterone without hypogonadism had 49% higher risk for CV events than men with hypogonadism.
    • “Asian men without hypogonadism had the most pronounced increased CV risk among racial-ethnic groups.”
  • Alzheimer’s’ News Today informs us,
    • “A panel of 19 blood proteins may help estimate when symptoms of amyotrophic lateral sclerosis (ALS) will emerge in people who carry disease-associated genetic variants, a new study suggests. When the model was tested using data from carriers whose symptom-onset dates were known, its estimates differed from the actual timing by an average of 1.6 years.
    • “If someone carrying an ALS-associated genetic variant had asked me in the past when they would become symptomatic, I would have struggled to provide a reasonable estimate,” Michael Benatar, MD, PhD, senior author of the study at the University of Miami, said in a press release. “These biomarkers give us a far better idea of the timing, allowing us to estimate the time to symptom onset with an average error of about 18 months. That’s something we can work with.”
    • “The study, “Longitudinal plasma proteomics predict phenoconversion to clinically manifest ALS,” was published in Nature Medicine. The work was funded by the National Institutes of Health (NIH), the Muscular Dystrophy Association, the ALS Association, and other organizations.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health CVS  said it will revamp its weight management program through a partnership with Eli Lilly LLY  as the company lifted its full-year outlook and reported a nearly threefold increase in its second-quarter profit.
    • “The company on Wednesday said patients will be able to use the CVS Health app to view transparent pricing options for Zepbound and Foundayo, two Lilly GLP-1 treatments, by early in the fourth quarter. Those treatments also may be available for same-day pickup at CVS pharmacies, the company said.
    • “CVS Health also will offer expanded pharmacy support for GLP-1 patients and $29 MinuteClinic online visits for eligible patients to connect with clinicians about GLP-1 treatments.
    • “Weight management is a deeply personal health journey, and too many people face barriers before they start treatment,” said Sid Tenneti, interim president of CVS’ pharmacy and consumer wellness segment. “Our collaboration with Lilly is one more way we’re expanding direct to consumer access to help eligible patients find options that work best for them.”
    • “The company also lifted its full-year outlook, projecting revenue of at least $414 billion and adjusted earnings between $7.90 and $8.10 a share.” * * *
    • “In the health care benefits segment, revenue rose 3.5% to $37.54 billion, driven by an increase in the government business. Health services revenue rose 11.5% to $51.8 billion, and pharmacy and consumer wellness revenue ticked up about 0.7% to $33.82 billion.”
  • and
    • “Eli Lilly reported higher net income and revenue in the recent quarter, driven by surging demand for its GLP-1 weight-loss drugs.
    • “Sales of the weight-loss treatment Mounjaro rose 91% to $9.94 billion, while Zepbound sales increased 46% to $4.93 billion.
    • “Eli Lilly raised its full-year revenue outlook, but lowered the high end of its adjusted earnings guidance.”
  • Fierce Healthcare adds,
    • “AstraZeneca and Bristol Myers Squibb do not have any ongoing discussions about a potential deal, Reuters reported Wednesday, citing a senior source close to the matter.
    • “There is ⁠no deal between AstraZeneca and BMS. There ​never was a deal to be done, and ​there are no discussions between the companies,” the person said, as quoted by Reuters.
    • “The development comes after the Financial Times reported Sunday that AZ was in talks to combine with BMS. A merger would create a new pharmaceutical giant valued at nearly $400 billion.”
  • Modern Healthcare relates,
    • “A decades-old spin on traditional employee health benefits is making a comeback.
    • “Cigna Group subsidiary Cigna Healthcare, UnitedHealth Group subsidiary UnitedHealthcare division and a bevy of insurers and emerging companies are offering “level-funded” products to employers desperate to reduce rising healthcare costs.
    • “A level-funded plan is a hybrid of the two most common forms of employer-sponsored health insurance: self-funded plans (also called self-insured), under which the employer assumes all financial risk for medical costs and pays a third-party administrator to manage the plan; and fully insured plans, under which an employer pays premiums to an insurance company that bears the risk. Level-funded plans feature a cap on what employers pay paired with stop-loss coverage for excess costs.
    • “Level-funded plans are intended for small and midsized businesses that lack the resources to fully cover their workers’ claims in self-funded plans but are subject to significant year-to-year fluctuations in premiums based on medical expenses in fully insured arrangements. Level-funded plans can offer a balanced approach that mitigates both kinds of risk.”
  • Fierce Healthcare tells us,
    • “Hinge Health inked a deal to acquire a digital gastrointestinal care management startup as it moves to broaden its business beyond musculoskeletal and migraine care.
    • “Hinge Health plans to pick up Cylinder Health for $105 million in cash. The acquisition accelerates Hinge Health’s entry into one of healthcare’s largest underserved categories, executives said, and the company plans to launch an integrated gastrointestinal (GI) care program in 2027. The deal is expected to close in the third quarter.
    • “With its expansion into GI care, the company is “following the same playbook” as it used for MSK and migraine care, Daniel Perez, co-founder and CEO of Hinge Health, told investors during the company’s second-quarter earnings call Tuesday. The company’s vision from the outset has been “use technology to automate the delivery of care within MSK and beyond,” Perez said, noting that the company’s tech platform was designed to scale across multiple conditions.”
  • Beckers Payer Issues informs us,
    • “In 2026, Aetna offers the best digital experience among major insurers on both desktop and mobile, according to new research from Corporate Insight shared with Becker’s.
    • “Corporate Insight’s “2026 Commercial Health Plan Experience Benchmark,” published Aug. 5, evaluated 24 commercial payers across more than 240 desktop and mobile functions. The report identifies overall health plan leaders on each platform, as well as top experiences across eight key categories, including claims, coverage and health information, design and navigation, digital care tools, health and wellness resources, prescriptions and pharmacy, profile and settings, and support.
    • “The analysis also consisted of 32 subcategories and 120+ attributes covering functionality, design, navigation and usability. Websites and mobile apps received scores on a scale of 1-100. The 2025 rankings are here.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Punchbowl News reports,
    • “The Senate’s ability to clear its pile-up of legislation and nominations before a five-week summer recess may come down to two GOP decisions: whether to attempt to pass a budget resolution and whether to force a crypto vote that could fail.
    • “A short-term government funding bill cleared its first procedural hurdle Monday night, with 89 votes — a major boost for the bipartisan push to fast-track it. That followed 86 votes for a landmark Russia sanctions bill last week.
    • “Neither bill can pass before the scheduled August recess without consent from all 100 senators. That gives Democrats leverage, and they’re using it against two Republican priorities.”
  • Beckers Behavioral Health relates,
    • “The Centers for Medicare & Medicaid Services released a toolkit to help state Medicaid and Children’s Health Insurance Program agencies strengthen oversight of applied behavior analysis (ABA) services for children with autism, according to an Aug. 4 news release from the federal agency. 
    • :This toolkit comes as Medicaid spending on autism therapy has surged in several states in recent years. In Colorado, Medicaid spent more on autism therapy for children last year than on emergency room care for all patients, according to a recent investigation by The New York Times. The investigation also found some clinics prescribe 25 or even 40 hours of therapy each week for young children. Average daily appointments also have increased over time, according to Medicaid data analyzed by Trilliant Health.” * * *
    • “CMS said the resource is designed to help states ensure ABA services are medically necessary, individualized and evidence-based while identifying fraud, waste and abuse. The agency said it does not establish new federal requirements, reduce Early and Periodic Screening, Diagnostic, and Treatment obligations, endorse a single ABA treatment approach or limit access to medically necessary care.”
  • The ABA toolkit is available at: https://www.medicaid.gov/medicaid/downloads/autism-services-aba-toolkit.pdf 
  • Beckers Clinical Leadership notes,
    • “CMS will require hospitals to report performance on a patient malnutrition measure starting in 2028 under the Hospital Inpatient Quality Reporting Program.
    • The agency finalized the measure as part of its fiscal year 2027 Inpatient Prospective Payment System final rule released July 31.
  • Beckers Payer Issues points out,
    • “ACA insurers are pitching a median rate increase of 15% for 2027, the second year in a row of double-digit premium hikes, according to a July 8 Peterson-KFF Health System Tracker analysis that was updated Aug. 3.
    • “The tracker reviewed 276 insurers in marketplaces across the country with publicly filed rates. The tracker’s analysis considered an insurer’s premium increase as the enrollment-weighted average rate change across its offerings in a state. While rates will be finalized in late summer, these filings provide a glimpse of the year ahead.” * * *
    • “For 2026, the median nationwide proposed rate change was 18%. The median finalized rate change was 20%.”

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

  • Govexec reports,
    • “Most funds offered as part of the federal government’s 401(k)-style retirement savings program finished July in the red, continuing the downward trend that began the prior month.
    • “Only the Thrift Savings Plan’s G Fund, which is made up of government securities, grew last month, increasing by its statutorily mandated rate of 0.39%. So far this year, the G Fund has gained 2.57% in value.
    • “The common stocks of the C Fund were virtually flat in July, falling 0.07% and bringing its 2026 performance down to 10.13%. And the international (I) fund lost 1.01% last month; since January, the I Fund is up 15.35%.
    • “The small- and mid-size businesses of the S Fund finished July 4.12% in the red. So far this year, the S Fund has gained 13.52%. And the fixed income (F) Fund lost 1.29% last month, bringing its 2026 losses to 0.56%.
    • “Each of the TSP’s lifecycle (L) funds, which shift toward more conservative investments as participants approach retirement age, likewise lost ground in July.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the electronic Official Personnel Folder (eOPF) Document Request Service (DRS), a secure online portal that enables eligible former federal employees to request and receive copies of their official personnel records electronically — eliminating a manual process that previously often required paper forms, agency requests, or a request to the National Personnel Records Center.”
    • * * * “Users access the Document Request Service through Login.gov, complete a one-time identity verification, and submit a brief online request. Once processed, they receive a secure email containing a time-limited download link to a password-protected ZIP file with their complete eOPF Employment Folder.
    • “The DRS is available to separated federal employees whose records are maintained in eOPF, as well as current federal employees whose agencies do not provide government-furnished equipment to access their own personnel records. Current employees with access to the eOPF application should continue to retrieve their records directly through that system.
    • “The launch of the Document Request Service is part of OPM’s broader effort to modernize federal human resources systems, improve customer service, and reduce reliance on manual, paper-based processes across the federal government. Additional information, including a user guide, is available at Documents Request Service – eOPF Resource Center.”
  • FEHBlog Observation — OPM continually is improving IT services for which the agency deserves credit. The efforts make it more puzzling why OPM has not yet implemented the HIPAA 820 Standard Enrollment Roster Transaction in the FEHB, PSHB, and FEDVIP programs.
  • Noah Peters, an OPM Senior Adviser has added a post to the Secrets of OPM blog titled (OPM.gov link) “Restoring Merit With the Right Civil Service Exam.”

From the Food and Drug Administration front,

  • QualityAssuranceMag reports,
    • “A multistate outbreak of E. coli O145:H28 infections has been linked to organic frozen blueberries from Frutas y Hortalizas del Sur S.A., of San Carlos, Chile, sold under the GreenWise brand at Publix.
    • “The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), along with state and local partners, are investigating the outbreak, which has sickened 12 and hospitalized four in two states, Florida and Georgia.
    • “Publix recalled all lots of GreenWise Organic Frozen Whole Blueberries and Whole Mixed Berries due to potential E. coli contamination. Recalled product was shipped to Publix retail stores in eight states: Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee and Virginia.” 
  • MedTech Dive relates,
    • “Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging scans, the company said last week.
    • “The Food and Drug Administration authorization covers a device, CaRi-Heart, that uses coronary computed tomography angiography to estimate a patient’s risk of cardiovascular mortality over 10 years.
    • “Research suggests the tool could help physicians stratify risk among patients who present with chest pain but are free from obstructive coronary artery disease.”
  • and
    • “DeepHealth last week received the Food and Drug Administration’s 510(k) clearance for an artificial intelligence tool that reads breast ultrasound images and generates reports.
    • “The feature can help clinicians localize suspicious soft tissue lesions; characterize details about the lesion such as its shape, orientation, and margin; and generate a report with key findings and impressions. Radiologists still have control of the final assessment. 
    • “DeepHealth’s parent company, RadNet, plans to offer the tool across its network of imaging centers by the end of the year.”
  • Targeted Oncology tells us,
    • “FDA authorized a new rituximab biosimilar based on comprehensive comparability data demonstrating high similarity to reference rituximab and no clinically meaningful clinical differences. 
    • “Market expansion of CD20 biosimilars may increase competitive pressure, shaping formulary positioning, contracting, and purchasing decisions that weigh price against continuity of supply. 
    • “Rituximab remains foundational across B-cell malignancies and autoimmune indications, reflecting its CD20-binding mechanism and B-cell depletion via multiple immune effector pathways. 
    • “Class safety considerations persist, including boxed warnings for fatal infusion reactions, severe mucocutaneous reactions, HBV reactivation, and PML, alongside risks of serious infections.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has announced that Ascend Laboratories is recalling specific lots of dabigatran etexilate, a blood thinner taken to reduce the risk of stroke or blood clots in patients with nonvalvular atrial fibrillation. This is a generic version of a popular direct oral anticoagulant (DOAC) most commonly sold by Boehringer Ingelheim under the brand name Pradaxa. 
    • “The recall was put in place due to a failed impurity/degradation test. After 12 months, the drug produced an out-of-specification (OOS) test result.“
    • “The FDA is still investigating this issue. Click here for additional details from the agency.”
  • The American Hospital Association News points out.
    • “The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline Industries have been recalled due to the containment of recalled Huons Bupivacaine Hydrochloride Dextrose Injections. The injections pose a risk of infection, inflammatory response and/or reduced anesthetic effectiveness. Certain convenience kits by Medical Action Industries have also been recalled due to the containment of Medline’s Namic Angiographic Star Off Handle Manifolds, which have been found to contain particulate within the fluid path of the manifolds.
    • “In addition, the FDA issued an early alert for certain Intraosseous Vascular Access System Needle Sets by Becton Dickinson due to some lots being manufactured with out-of-tolerance dimensions. BD said it has resulted in some lots being manufactured with out-of-tolerance dimensions, with some users reporting difficulty removing the obturator following placement of the needle sets.” 

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention is expanding the largest known cyclosporiasis outbreak to 15 states, adding six states where illnesses have been traced to shredded iceberg lettuce sourced from central Mexico, according to three individuals familiar with the investigation.
    • “Missouri, which is reporting 1,095 cases, is one of the states being added, according to a state health department spokesperson. The number of state cases jumped dramatically in the past week. Patients who were interviewed at length by state and local investigators said they consumed Taco Bell before getting sick, spokesperson Lisa Cox said.
    • “The other states are Arkansas, Iowa, Nebraska, New Hampshire and North Carolina, according to a fourth person familiar with the investigation.”
  • The New York Times considers,
    • “Is It OK to Eat the Same Things Every Day?
    • “Some people do it to lose weight, others to avoid the hassle of planning meals. We asked experts how “food monotony” affects your health.”
  • Beckers Hospital Review relates,
    • “In 2025, New Mexico confirmed 100 measles cases across nine of its 33 counties, and each case cost an average $53,522, according to research published Aug. 4 in Annals of Internal Medicine. 
    • “Researchers with the CDC and New Mexico Department of Health analyzed the societal economic burden of these 100 cases through public health response costs, direct medical costs and productivity losses. The public health response costs totaled about $3.2 million, including $2.1 million for vaccination-related activities. About 130 public health responders worked on contact tracing across 205 contacts, which each cost $1,817, according to the study. 
    • “The $53,522 per measles case, equal to $5.35 million in total, ranged from February through September 2025.”
  • MedPage Today tells us,
    • “A peptide vaccine targeting KRAS mutations in patients at high risk for pancreatic cancer induced durable T-cell responses.
    • “In 16 patients with evaluable pancreatic cysts, three had complete resolution of the cysts, three had partial regression, and the rest had stable cyst status.
    • “No patient developed severe vaccine-related adverse events.”
  • and
    • “In a randomized trial, a novel system for autonomous control of supplemental oxygen for inpatients who needed it improved the proportion of time spent with adequate oxygen levels.
    • “The study showed safety of the approach and lower oxygen use overall compared with usual care.
    • “The trial could not assess clinical outcome effects like reduced respiratory decompensation, shorter hospital stays, or improved survival.”
  • Health Day points out,
    • “Women who enter menopause at an earlier age have an increased risk of high blood pressure, a new study says.
    • “Researchers found that nearly 23% of women with premature menopause and 19% of women with early menopause had high blood pressure, compared to under 17% of women with normal menopause, researchers found.
    • “Overall, premature menopause brought a 12% higher risk of high blood pressure compared to women who reached menopause after age 45, researchers reported recently in the journal Menopause.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Recurrent urinary tract infections (rUTIs) are among the most common bacterial infections worldwide. The difficult-to-treat condition, which affects primarily women, is defined as two urinary tract infections (UTIs) within six months or three UTIs within the past year. They are a leading cause of outpatient antibiotic use, accounting for more than 15% of all prescriptions.
    • “While antibiotics remain the standard treatment, frequent recurrences and rising antibiotic resistance highlight the need for alternative therapeutic approaches. Now, researchers have, for the first time, administered a combined phage therapy (PT) with fecal microbiota transplantation (FMT), to decolonize urinary and intestinal reservoirs of rUTI patients.
    • “The novel treatment approach, combining PT and elective FMT, was administered to three female patients, between May and July 2023, with rUTI that did not respond to antibiotics and commonly used non-antibiotic strategies. All had microbiologically confirmed E. coli in multiple infections.
    • “All three women received PT orally and intravesically (locally applied to the bladder via catheter) for eight days outside of acute episodes. Two of these three patients were elected to receive subsequent FMT. Since the bacteria causing the recurring infections often reside in the gut as well as the urinary tract, the FMT treatment targeted the intestinal reservoirs of E. coli that survive antibiotic treatment of acute infections and can become increasingly resistant.
    • “While phage therapy acts to remove the pathogen, FMT aims to restore a healthy microbiome, combining both immediate and long-term effects,” Lena Biehl, MD, PhD, group leader at Fraunhofer ITMP, deputy lead of Cologne Microbiota Bank, University Hospital Cologne.
    • “This work is published in Nature Microbiology in the paper, “Combined Phage therapy and fecal microbiota transplantation to treat recurrent urinary tract infection: a case series.”
  • Per Fierce Pharma,
    • “In a milestone for IgA nephropathy, Otsuka’s Voyxact has shown for the first time in a phase 3 trial that a drug can stabilize patients’ kidney function decline to the normal rate seen in healthy adults. 
    • “Results from the phase 3 Visionary trial showed that Voyxact (sibeprenlimab) achieved an annualized estimated glomerular filtration rate (eGFR) slope of a 0.3 mL/min/1.73m² gain over two years, suggesting an improvement in kidney function. The rate matches the normal age-related decline of less than 1 mL/min/1.73m² per year, as laid out in the KDIGO 2025 Clinical Practice Guideline for IgAN.
    • “To be presented at the GlomCon Hawaii 2026 conference, the latest Voyxact result is better than an annualized eGFR slope of negative 4.2 mL/min/1.73m² for placebo. It’s also better than Voyxact’s own performance over 12 months, when it recorded an annualized loss of 3 mL/min/1.73m² at an interim analysis of the Visionary trial.”
  • and
    • After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer.
    • In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report.
    • The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy performed even worse than other chemotherapy regimens, while a combination of Zepzelca and irinotecan showed a numerical advantage that didn’t meet statistical significance.

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

  • Beckers Payer Issues tells us,
    • “Louisiana workers pay the largest share of their income toward their portion of health insurance premiums, while workers in Hawaii pay the smallest, according to an AHIP analysis of Commonwealth Fund data published in July.”
    • The article lists all of the States’ percentages. 
  • and
    • “UnitedHealthcare is rolling out new reimbursement limits on five categories of lab tests across its commercial, ACA, Medicare Advantage and Medicaid plans.
    • “The five policies cover allergen testing, liver fibrosis testing, in vitro chemotherapy sensitivity assays, testosterone blood tests and vitamin B12 testing. 
    • “The policies generally take effect Sept. 1 for commercial, exchange and MA plans, though several states have an effective date of Oct. 1 in the commercial and exchange markets. The Medicaid rollout is staggered by state, with effective dates ranging from August through November.
    • “Broadly, the policies set frequency caps or exclude specific test types from reimbursement.”
  • Fierce Healthcare informs us
    • “AI health tech company Daffodil Health is rolling out a new platform aimed at supporting payers in managing the No Surprises Act dispute process.
    • “The number of cases reaching the NSA’s independent dispute resolution process continues to grow. For example, when the process was established by regulators, they projected about 17,000 cases would make it to IDR each year—however, 1.2 million were filed in just the first half of 2025.
    • “Daffodil’s tool is built to support insurers and third-party administrators in handling that volume of disputes, starting with intake and through negotiation, arbitration and reporting, the company said in an announcement.”
  • Beckers ACS Review lets us know,
    • “Austin, Texas-based Ouma Health has acquired a multisite maternal-fetal medicine practice led by Tamara Takoudes, MD, expanding the telemedicine company’s footprint across Connecticut, Massachusetts, Maine and New Hampshire, according to an Aug. 4 news release.
    • “The acquisition adds established in-person clinical locations to Ouma’s national teleMFM network and strengthens the company’s relationships with hospitals, imaging centers, birth centers and community obstetric practices across New England. 
    • “Ouma, which describes itself as the nation’s largest independent maternity telemedicine company, said the deal is part of a broader effort to build clinical infrastructure for high-risk pregnancy care as MFM workforce shortages and hospital labor and delivery unit closures continue to limit access in many communities. Financial terms were not disclosed.”
  • Beckers Behavioral Health adds,
    • “San Francisco-based Amae Health, a provider of mental healthcare, is collaborating with Google Health Enterprise to bring wearable-derived data into its precision psychiatry care model.
    • “The collaboration will allow Amae Health’s care teams to incorporate data from wearable devices — including sleep patterns, physical activity, heart rate variability and changes in daily routines — alongside existing clinical information, according to an Aug. 4 news release. The company said the additional data is intended to help clinicians detect changes in patients’ conditions earlier and better identify potential relapses among people with schizophrenia, bipolar disorder and major depressive disorder.”
  • Per a Lown Institute news release,
    • “U.S. hospitals can excel at both clinical care and making critical investments in the people and communities they serve. That is the key takeaway of the 2026 Lown Hospitals Index ‘Honor Roll’, which recognizes 123 institutions that achieved top ratings on health equity, value of care, and patient outcomes.
    • “With financial pressures forcing painful choices on many hospitals, those on the Lown Honor Roll have found ways to put their patients and communities first,” said Vikas Saini, MD, president of the Lown Institute. “These hospitals are staying true to their mission when it matters most, and in healthcare, that’s everything.”
  • Per Beckers Hospital Review,
    • U.S. News & World Report released its 2026-27 Best Hospitals rankings and ratings Aug. 4, which included a list of 505 Best Regional Hospitals across 49 states and the District of Columbia.
    • The latest edition of Best Hospitals, now in its 37th year, evaluated hospitals on measures such as risk-adjusted mortality rates, preventable complications and patient experience. This year’s rankings placed significantly greater weight on risk-adjusted patient outcome measures in determining results. For the first time, Maternity Care recognition was also incorporated into Best Regional Hospitals point calculations. More information about the methodology is available here and here.
  • Healthcare Dive adds,
    • “New Jersey health system Hackensack Meridian Health has become the first organization to earn the Joint Commission’s seal of approval for the responsible use of artificial intelligence in healthcare.
    • “The Joint Commission, an independent accreditation organization, launched the certification in June with the goal of endorsing U.S. healthcare organizations able to demonstrate they have the proper governance, resources, policies and training programs for the safe and effective use of AI.
    • “HMH has been refining its AI systems for years, according to Dr. Lauren Koniaris, the organization’s chief medical informatics officer. “As we expand our clinical AI initiatives, we operate under the utmost governance to ensure patient quality and safety are always the priority,” she said”
  • Per the Wall Street Journal,
    • “Pfizer reported second-quarter revenue of $15.03 billion, up 3% and beating analyst expectations as non-Covid drug sales grew.
    • “Pfizer recorded a second-quarter loss of $248 million, driven by a $3.8 billion write-down on an experimental lung-cancer drug.
    • “Pfizer raised the low end of its full-year sales guidance to a range of $60.5 billion to $62.5 billion.”
  • and
    • “Amgen AMGN  lifted its outlook for the year after strong drug sales bolstered the company’s bottom line in the second quarter, but added that it would end development of an early-stage obesity treatment.
    • “The biotechnology company on Tuesday said it was halting the development of AMG 513, a potential obesity treatment currently in a phase 1 study. That study will be carried to completion to follow enrolled participants, Amgen said. The company didn’t provide a reason for the discontinuation.
    • “With development of AMG 513 ending, Amgen’s only candidate in the space is MariTide, which is currently in phase 3 studies for a range of indications such as obesity, Type 2 diabetes and chronic weight management.
    • “Amgen also lifted its guidance, saying it now expects full-year revenue between $38.2 billion and $39.4 billion, up from a previous view of $37.1 billion to $38.5 billion. Adjusted per-share earnings are expected between $22.30 and $23.50, up from a range of $21.70 to $23.10.”
  • and
    • “Gilead Sciences reported second-quarter revenue rose to $7.8 billion, but swung to a $10.5 billion loss due to acquired research expenses.
    • “Gilead Sciences’ revenue growth was driven by a 12% rise in HIV product sales to $5.69 billion, while sales of Covid-19 drug Veklury fell 81%.
    • “Gilead Sciences narrowed its full-year product-sales guidance to a range of $30.1 billion to $30.4 billion.”
  • and
    • “Novo Nordisk said annual sales and operating profit should fall less than previously expected following a boost in the second quarter.
    • “Novo Nordisk expects adjusted sales and operating profit to decline up to 6% at constant exchange rates this year, compared with its prior forecast of a 4% to 12% decline.
    • “Adjusted sales for Novo Nordisk grew 7% to 78.49 billion Danish kroner in the second quarter, while adjusted operating profit rose 11%.”
  • STAT News adds,
    • “BioNTech on Monday named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.
    • “Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines.
    • “Oelkers, who has worked in biopharma for more than 30 years, will start by Feb. 1, 2027, the company said. He said that he would continue BioNTech’s work to be a global company with multiple approved medicines by 2030.”
  • BioPharma Dive helps us track the patent expiration dates of name brand prescription drugs.

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • The New York Times reports,
    • “The Senate health ​committee on Thursday advanced the nomination of Dr. Erica Schwartz, President Trump’s pick for director of the Centers for Disease Control and Prevention, for a full Senate vote.
    • “The committee’s Republican members and Senator Tim Kaine, Democrat of Virginia, all voted in favor of her candidacy, with the remaining Democrats opposed.” * * *
    • “The committee on Thursday also voted to ​advance ⁠the nomination of Sean Kaufman for assistant secretary for preparedness and response, a role that includes oversight of emergency measures during public health crises.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services [(CMS)] July 30 released the fiscal year 2027 final rule for inpatient rehabilitation facilities. The rule will increase payments by 2.3% overall, which includes a 3.2% market basket update reduced by a 0.9 percentage point productivity adjustment. In addition, CMS updated the outlier threshold, which it says will increase overall payments by 0.4% in FY 2027.
    • “CMS also finalized two changes to the IRF coverage requirements. This includes a requirement that therapies be initiated within 36 hours of admission to the IRF and an initial interdisciplinary team meeting be held within four days of admission to the IRF. CMS did not finalize a third proposal that would have required the patient’s current functional status be documented on the preadmission screening. For the IRF Quality Reporting Program, CMS finalized a shortened timeframe for submitting program data.
    • “Changes are generally effective Oct. 1, 2026.”
  • Per a CMS fact sheet,
    • “On July 30, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-1851-F) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2027 under existing statutory and regulatory requirements.” * * *
    • “For FY 2027, CMS updated the hospice payment rate by 2.3% (an estimated increase of $755 million in payments from FY 2026). This figure results from the finalized 3.2% inpatient hospital market basket percentage increase reduced, as required by law, by a finalized 0.9 percentage point productivity adjustment. The finalized FY 2027 rates for hospices that do not submit required quality data information include the finalized FY 2027 hospice payment update percentage of 2.3% minus four percentage points as required by law, which would result in a 1.7% reduction over the previous year’s payment rate. These finalized payment rates reflect the most accurate, updated data available on the cost of goods, services, and labor.
    • “Hospice payments are subject to a statutory aggregate cap limiting the overall payments made to a hospice annually. The finalized hospice cap amount for FY 2027 is $36,174.75 (FY 2026 cap amount of $35,361.44 increased by the FY 2027 hospice payment update percentage of 2.3%).” 
  • Beckers Hospital Review shares 11 things to know about these new CMS rules.
  • U.S. Office of Personnel Management, writing in Substack, added another post to this Secrets of OPM blog titled “Plans are good, Execution is better.”
    • “Last year, I wrote about how the federal government needed to adopt a more disciplined approach to workforce planning. Every successful organization develops a thoughtful plan for the talent it needs to accomplish its mission. The federal government should be no different.
    • “Today, we’re taking the next step.
    • “The guidance OPM has issued to agencies on Annual Staffing Plans is about much more than compliance with a new planning process. It is about changing how the federal government thinks about hiring. Rather than defaulting to last year’s staffing levels or treating hiring as a series of isolated decisions, agencies will build comprehensive staffing strategies that begin with a simple question: “What workforce do we need to best serve the American people?””
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued an interim final rule removing references to the Uniform Guidelines on Employee Selection Procedures (UGESP) from OPM’s federal personnel regulations, bringing the agency’s regulations into conformity with the Department of Justice Office of Legal Counsel’s June 9, 2026, legal opinion concluding the Uniform Guidelines are unlawful and unconstitutional by encouraging race-conscious decision-making via “disparate impact” liability.
    • “The rule removes UGESP regulatory provisions while preserving longstanding federal requirements that employment practices be job-related, professionally developed, based on sound job analysis, and administered without prohibited discrimination.” * * *
    • “Federal hiring should be based on merit, qualifications, and the ability to perform the job,” OPM Director Scott Kupor said. “This rule ensures OPM’s regulations reflect legal guidance while preserving the rigorous, job-related standards that help agencies recruit and hire the most qualified workforce in service to the American people.”
    • “The interim final rule is effective upon publication in the Federal Register. OPM will accept public comments for 60 days before determining whether to revise, withdraw, or finalize the rule.”
  • NextGov adds,
    • “The General Services Administration on Wednesday celebrated the graduation of 71 U.S. Digital Corps fellows, marking the largest graduating class since the program’s inception. Those graduates updated the FedRAMP website, helped streamline Agriculture Department environmental reviews and supported other technology projects during their stints in the federal government.
    • “This government has starved for talent, for people who understand how to do all the things that we want to do to deliver better,” OPM Director Scott Kupor said during graduation remarks.
    • “Some of the graduates of the two-year fellowship program are continuing civil service while others are headed to the private sector.”
  • Tammy Flanagan, writing in Govexec, explains “Why time, not timing, is the biggest retirement advantage for federal employees.”
    • “A look at decades of market shifts and TSP data shows the biggest driver of retirement wealth isn’t picking the right stock. It’s starting early, contributing consistently and letting compounding do its work.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “A Food and Drug Administration advisory panel voted 10-3 Thursday for Replimune Group’s experimental melanoma therapy, after a contentious meeting in which experts raised doubts about whether the company’s data and trial design could be trusted to show the skin-cancer drug works.
    • “Thursday’s recommendation is the latest turn in a regulatory saga that has stretched nearly two years.” * * * 
    • “Thursday’s meeting came a day after another closely watched advisory session, in which FDA advisers voted against Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy—a rejection that, like Replimune’s, followed a prior FDA denial.” 
  • MedTech Dive relates,
    • “Artificial intelligence is here to stay at the FDA, but its integration and evolution may not be a straight line now that one of its biggest proponents, former commissioner Marty Makary, has stepped down.” * * *
    • “Acting commissioner Kyle Diamantas said AI remains a top priority for the FDA. Still, recent high-level departures, including Makary, Jeremy Walsh, chief artificial intelligence officer, and Sridhar Mantha, acting chief information officer, have raised questions about the future of AI implementation.
    • “It’s unclear now what the leadership and governance structure are around FDA-wide efforts,” said Tala Fakhouri, chief artificial intelligence and regulatory strategy officer at Parexel, and a former FDA AI policy official.”

No Surprises Act news,

  • Beckers Payer Issues reports,
    • “Another health insurance CEO is taking aim at the No Surprises Act’s arbitration system.
    • “We do support the overall strategic intent of consumer protection from surprise billing. However, we’re seeing some clear abuses of the IDR vehicle in practice,” Cigna Group President and CEO Brian Evanko said on the company’s second-quarter earnings call July 30, adding that the system is seeing “unsustainable volume levels, much of which is concentrated amongst a small number of providers.” 
    • “On July 22, a Wall Street Journal analysis of CMS data put 2025 arbitration payouts at nearly $15 billion, up from $4.08 billion in 2024, with arbitration firms collecting about $1.3 billion in fees. On the earnings call, Mr. Evanko referenced last year’s payout figure but said the impact “has been manageable” within Cigna’s insurance business.”

From the judicial front,

  • Fierce Healthcare reports,
    • “A federal judge has rejected a request from 26 states for a preliminary injunction in the Trump administration’s rollout of work requirements in Medicaid.
    • “The Centers for Medicare & Medicaid Services finalized implementation guidelines for states in June, with the eligibility requirements set to take effect on Jan. 1. States have until Aug. 31 to communicate with enrollees about the impacts of the changes.
    • “In an order issued Wednesday, Massachusetts District Judge Richard Stearns wrote that the states did not prove that establishing the systems necessary to make the eligibility determinations would cause them irreparable harm, as CMS said it would reimburse them for 90% of the costs for setting up those mechanisms.
    • :However, he said that the order does not reflect the court’s opinion on the merits of the broader litigation, which challenge provisions of the rule under the Administrative Procedure Act. Making a determination on that, as it questions whether officials hewed closely to Congressional intent in regulating the rollout of the requirements, requires a more complete picture.”
  • Healthcare Dive relates,
    • “The Federal Trade Commission is suing Hims & Hers [in a California federal court], alleging the telehealth company illegally shared sensitive health information with advertisers and misled customers about its billing practices. 
    • “The agency says California-based Hims & Hers made it difficult for users to cancel subscriptions, charged patients for medications before they consulted with a provider and shared their health data with third-party advertising platforms like Meta and Snap. 
    • “Hims & Hers called the FTC’s claims “baseless,” saying in a Wednesday statement that the agency “contorts the law to try to manufacture claims.”
  • Per a Justice Department news release,
    • “Access DX Laboratory, located in Houston, Texas, its former CEO Michael Stewart, and Florida businessman Harold Shatz, have each entered into settlements and will pay a combined total of $36.4 million to the United States to resolve allegations that they violated the False Claims Act (FCA) by paying kickbacks and billing Medicare and Medicaid for medically unnecessary genetic testing.
    • “The United States alleged that, from January 2018 through January 2020, Access DX, Stewart, and Shatz paid kickbacks to marketers in return for referrals of patients for genetic testing, unbundled billing codes for genetic testing, paid telemedicine providers for false and fraudulent doctors’ orders, and submitted and caused the submission of false claims for genetic testing.” * * *
    • “Except to the extent admitted by Stewart and Shatz in their plea agreements, the claims resolved by the settlement are allegations only and there has been no determination of liability.” 

From the public health and medical/Rx research front,

  • The AP reports,
    • “A first-of-its-kind U.S. study suggests invasive mold infections may be an underappreciated — and potentially deadly — threat.
    • “The researchers detected about 450 cases in Atlanta-area hospitals over five years. About a third of the patients died in the hospital.
    • “The findings, published this week by the U.S. Centers for Disease Control and Prevention, come from an attempt to better gauge how common these kinds of illnesses are. The government does not require doctors to report the illnesses.
    • “It’s kind of the first time we’ve had an estimate like this,” said the CDC’s Dr. Jeremy Gold, the study’s senior author.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. today announced the launch of The Real Food Show, a new cooking series designed to help Americans prepare healthy, affordable meals using real, everyday ingredients.
    • “More than a cooking show, The Real Food Show is a national initiative that empowers families to make healthy eating practical, approachable, and affordable. Each episode combines simple recipes with the science behind them, translating the new Dietary Guidelines for Americans into meals that Americans can prepare in their own kitchens.”
    • “Visit The Real Food Show webpage for more details.”
  • Radiology Business tells us,
    • “Adult CT radiation doses have decreased substantially over the last decade in the U.S., according to new research published Tuesday. 
    • “About 10 years have passed since data underlying the most recent national benchmarks for radiation dosing were collected. This underscores the need for updated reference values, as these guidelines may not reflect new advances in scanner technology, reconstruction methods and protocol changes, experts write in RSNA’s Radiology. 
    • “Researchers recently aimed to address this information gap, analyzing adult CT acquisitions performed across U.S. facilities in 2025. They discovered clear progress, with CT diagnostic reference levels declining an average of nearly 22% since 2014.
    • “The magnitude and consistency of these reductions across examination categories suggest that such advances have translated into measurable, population-level dose reductions in routine clinical imaging in the United States,” Kalpana M. Kanal, PhD, with the Department of Radiology at the University of Washington, Seattle, and colleagues wrote July 28.”
  • The July 30 issue of NIH Research Matters covers the following topics:
    • Tracking diets via wastewater
      • “Measuring DNA from food in wastewater could provide snapshots of dietary patterns.
      • “Monitoring these patterns could be a powerful tool for informing nutrition policy.” 
    • Lung tumor signals may tamp down food intake
      • “Researchers found that a high-fat diet in mice amplifies nerve signals between certain lung cancers and the brain, leading to reduced appetite and weight loss.
      • “If confirmed in further studies, the results could inform strategies to improve nutrition and survival in certain patients with cancer.”
    • Bacteria share proteins to survive antibiotics
      • “Researchers found that some bacteria share proteins that help others survive antibiotics.
      • “The study suggests a novel approach that may help treat persistent bacterial infections.”
  • MedPage Today informs us,
    • “Consuming less sugar before birth and during the first 1 to 2 years of life was tied to a lower risk of dementia decades later, U.K. Biobank data showed.
    • “The study used the abrupt end of World War II rationing as a natural experiment to test whether early-life sugar exposure was associated with late-life dementia.
    • “Previous research has linked early-life sugar rationing to less risk of diabetes and hypertension in adults and better cardiovascular outcomes.”
  • Health Day adds,
    • “Want to give your tot a brain boost when it comes to learning language?
    • “Maintain eye contact as much as possible when you’re talking to them, a new study suggests.
    • “Eye contact helps a baby decide what is important, acting as a switch that triggers synchronization of their brain waves with those of the speaker, researchers reported recently in the journal Nature Communications.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “An international team of researchers has identified multiple new genetic risk factors associated with fibromyalgia, a syndrome characterized by widespread pain and tenderness, fatigue, and problems with sleep, memory and mood.
    • :The team analyzed genetic data from more than 2.5 million adults, of which 55,000 were fibromyalgia patients. They identified DNA sequence variants in 26 regions of the genome that affect the risk of developing fibromyalgia. Many of the genes implicated in these regions are involved in brain and nerve function.
    • “The results provide the strongest evidence yet that fibromyalgia is primarily a nervous system disorder rather than an autoimmune disease, as has long been debated. “This work changes how we think about fibromyalgia at a fundamental level,” said Michael Wainberg, PhD, an investigator at the Lunenfeld-Tanenbaum Research Institute, part of Sinai Health, and the University of Toronto. “For decades, patients have been dismissed or told their pain is simply psychological. Our findings confirm the condition has a clear biological basis.”
    • “Weinberg is co-senior author of the researchers’ published paper in Nature Medicine, titled “The genetic architecture of fibromyalgia across 2.5 million individuals,” in which they concluded, “This study provides robust genetic evidence defining fibromyalgia as a central nervous system disorder, thereby establishing a biological framework for its complex pathophysiology and extensive clinical comorbidities.”
  • Fierce Pharma points out,
    • “Investors anxiously waiting for Bristol Myers Squibb’s key Alzheimer’s disease psychosis readout for Cabenfy will have to wait a little longer. The company has once again delayed the expected phase 3 data from its Adept trial program, even as it delivered a group-wide quarterly beat that’s driving a significant forecast raise. 
    • “Rather than readouts in 2026, BMS now expects data from the three Adept trials to arrive beginning in early 2027 and be “spread across the year,” CEO Chris Boerner, Ph.D., said on the company’s earnings call Thursday.
    • “The delay was attributed to slower enrollment in the Adept-2 and Adept-4 studies and slower relapse event accrual in Adept-1, Boerner explained. Adept-1 could undergo an interim analysis as early as later this year, and BMS also plans to share safety and efficacy data this year from the trial’s open-label lead-in portion, he added.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Cigna’s employer-sponsored plans reaped higher profits than expected in the second quarter after hiking premiums, spurring the company to raise its earnings outlook for 2026.
    • “Cigna results released Thursday are a relief for investors worried about broader pressures in the employer-sponsored market, which covers the majority of U.S. adults and has been a buoy for insurers slammed with higher spending in government programs in recent years.” * * *
    • “Cigna’s health services division Evernorth — which includes Express Scripts, one of the largest pharmacy benefit managers in the U.S. — brought in $1.7 billion in operating income in the quarter, down 2% year over year despite revenue growth.”
  • Modern Healthcare adds,
    • “The weight-loss drug boom is beginning to show signs of a slowdown as employers and insurers pull back on coverage, signaling the market could be entering a more restrained phase after years of breakneck expansion.
    • “In the past few months, growth in prescriptions for GLP-1 drugs for weight loss like Novo Nordisk A/S’ Wegovy and Eli Lilly & Co.’s Zepbound have moderated, according to Cigna Group Chief Executive Officer Brian Evanko. The insurer’s unit that manages drug benefits has noted coverage declines and slower utilization growth compared to prior periods, executives said during an earnings call with Wall Street analysts Thursday.”
  • Optum Rx, writing in LinkedIn, discusses “how plan sponsors can stay ahead of the latest drug cost trends.”
  • Fierce Healthcare relates,
    • “Teladoc Health trimmed its 2026 revenue outlook as its virtual behavioral health unit, BetterHelp, faces revenue pressure with consumer demand for insurance-covered services outpacing clinical capacity.
    • “Teladoc shares fell more than 27% on Thursday following the company’s release of its second-quarter financial performance report on Wednesday.
    • “The company is shifting from subscription to visit-based revenue models, while also transitioning its virtual mental health business to accept insurance, moving from a cash-pay model to an in-network, insurance-covered model. The company is making “considerable progress” in building the insurance offering, including establishing a baseline national footprint a year after launching its first state, Teladoc Health CEO Chuck Divita told analysts and investors on a call Wednesday. 
    • “We have contracted for over $150 million in-network lives and credentialed more than 8,000 mental health professionals for the network at this point,” he said.”
  • and
    • “Nearly three-quarters of patients with gambling disorder achieved clinically meaningful symptom improvement through Birches Health, a new study finds.
    • “The peer-reviewed outcomes study was recently published in the Journal of Medical Internet Research. It was a retrospective analysis of 1,305 adults treated by Birches between mid-2024 and mid-2026. 
    • “Birches, a virtual provider for digital addictions, says the study is the largest real-world dataset on virtual gambling disorder treatment in the U.S.” ‘
  • Beckers Hospital Review tells us,
    • “Forbes rated the country’s hospitals state by state for 2026, with 259 earning the top mark of five stars.
    • “The Forbes Top Hospitals by State list, published July 14, draws on the national Forbes Top Hospitals 2026 ratings, which score general acute-care hospitals on measures pulled from the CMS Provider Data Catalog across four areas: patient outcomes (weighted at 55%), hospital best practices (20%), value (15%) and patient experience (10%). Each hospital lands on a single Forbes Overall Hospital Quality Rating of one to five stars.
    • “The article includes] the top of that scale: every hospital awarded five stars for overall quality, grouped by state. The five-star tier spans 42 states, ranging from a single hospital in states such as Alabama, Delaware and Wyoming to 19 in Wisconsin. Eight states — Alaska, Connecticut, Hawaii, Mississippi, Nevada, New Hampshire, Rhode Island and Vermont — along with the District of Columbia had no hospital reach five stars.”
  • Radiolology Business informs us,
    • “A new analysis from Definitive Healthcare pinpoints [and the article lists] the 10 largest imaging center corporations in the U.S., based on location count. 
    • “RadNet tops the list with approximately 383 outposts at the time of the analysis, followed by the US Oncology Network (141), a chain of independent cancer docs backed by McKesson. Definitive Healthcare, a publicly traded commercial-intelligence firm, based the findings off data from its ImagingView product, which includes info from more than 22,000 centers. 
    • “As demand for outpatient imaging continues to rise, larger imaging companies are expanding through acquisitions, new site development, and care models focused on improving access and convenience for patients,” Definitive Healthcare said in an update posted July 23. “Several factors are contributing to this growth, including advances in imaging technology, increased demand for preventive diagnostic screenings, and an aging U.S. population.”
  • Fierce Healthcare notes,
    • “Health tech company Stellarus announced Thursday the launch of an artificial intelligence-driven copilot geared towards helping health plan customer service representatives.
    • ‘The solution—dubbed Customer Service Representative (CSR) Chat—provides representatives with real-time guidance and contextual support during live interactions, surfacing relevant information, policy and recommended responses directly in workflows. 
    • ‘Stellarus president and CEO Vanessa Colella told Fierce Healthcare in an interview that “unsustainable healthcare costs” have been dominating conversations about the American healthcare system.
    • “It’s not about talking about someday it might not be working,” Colella said. “It is not working today. One of the places that it’s not working is cost. And another place it’s not working is member experience.”
    • “The solution hopes to address both core issues through administrative burden reduction and allowing representatives and members “to have the conversation that matters,” according to Colella.”

Midweek report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Per Centers for Medicare and Medicaid Services fact sheets
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update Medicare payment policies and rates for Inpatient Psychiatric Facilities (IPFs) under the IPF Prospective Payment System (PPS) (CMS-1847-F) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with its statutory authority to update Medicare payment policies for IPFs annually. 
    • “This fact sheet discusses the provisions of the final rule, including annual updates to the prospective payment rates, the outlier threshold, the wage index, and associated impact analysis. In addition, the rule finalizes a policy effective for FY 2028 (October 1, 2027) to limit outlier payments at the facility level to no more than 20% of an IPF’s total IPF PPS payments in a year, for IPFs with at least 50 stays per year. For the IPF Quality Reporting Program, CMS is removing two measures from the program, as well as implementing a standardized IPF patient assessment instrument.
    • “For FY 2027, CMS is updating the IPF PPS payment rates by 2.3%, based on the 2021-based IPF market basket increase of 3.2% less a 0.9 percentage point productivity adjustment. Additionally, CMS is updating the outlier threshold so that estimated outlier payments remain at 2% of total IPF PPS payments. Total estimated payments to IPFs would increase by 2.3%, or $60 million, in FY 2027, relative to IPF payments in FY 2026.”
  • and 
    • “On July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a final rule for updates to Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2027. CMS is publishing this final rule consistent with the legal requirements to update Medicare payment policies for SNFs annually. This fact sheet discusses the final rule’s provisions.
    • “For FY 2027, CMS finalized updating SNF PPS rates by 2.4% based on the final SNF market basket of 3.3%, reduced by a 0.9% productivity adjustment, for an estimated increase of $882.74 million in aggregate payments to SNFs.”
  • Beckers Hospital Review points out twelve things to know about these rules.
  • The American Hospital Association News relates,
    • “The Health and Human Services Secretary today announced that dozens of insurers, medical societies, healthcare providers and behavioral health experts have pledged to strengthen the nation’s behavioral health system by advancing best practices aimed at improving mental health and addiction treatment. The pledge commits participants to promoting timely access, improving quality measurement and accountability, supporting patient-centered recovery services and expanding whole-person treatment that addresses behavioral and physical health needs. HHS said the initiative aligns with the administration’s broader efforts to address addiction and mental illness and improve long-term patient outcomes.” 
  • Federal News Network clears up common misconceptions about federal retirement benefits.
    • “Misconception: Federal Employee Health Benefits (FEHB) go away at retirement, or become more expensive.
    • “Fact: Under certain eligibility requirements, federal employees can continue their FEHB coverage into retirement. These requirements include enrollment in FEHB for at least five consecutive years leading up to, and having coverage on, the retirement date. It is important to note that qualified spouses, dependent children, and children with disabilities can be covered without meeting this five-year rule. Employees become classified as annuitants upon retiring, at which point the government will continue to cover about 72% of the FEHB premium.
    • In addition, retirees can also enroll in Medicare parts A and B, offering nearly comprehensive coverage, with Medicare as the primary payer and FEHB as secondary. To reduce costs, some retirees opt for a basic FEHB plan.”
    • “Misconception: Spouses will automatically continue to be covered by FEHB into retirement
    • “Fact: This is the biggest caveat about survivor’s benefits: If survivors were on the federal retiree’s health insurance plan, that health insurance will cease if there is no survivor’s benefit. Any amount of survivor’s benefit will continue the health insurance plan, so prospective retirees and their spouses should speak with a federal retirement consultant, and consider the holistic picture of their assets, the spouse’s income, their needs and budget, life insurance, and whether they have any additional financial obligations, like debt or a child in college.”
    • “Misconception: Survivor’s benefits are automatic and free
    • “Fact: Federal employees will need to make some decisions about survivor’s benefits on their retirement application. The pension is the main place where retirees need to consider their options along with their potential beneficiaries — these will primarily be spouses, except in a few special circumstances. Each of these options comes with a cost, in the form of a monthly percentage deducted from the overall pension. The options and percentages vary between the Federal Employees Retirement System and the Civil Service Retirement System.”
  • Beckers Hospital Review tells us,
    • “Federal policy changes could reshape pharmacy reimbursement, drug pricing and hospital operations in 2027, according to a new Vizient outlook. The report, published July 27, highlights four pharmacy developments health systems should monitor as they plan for the year ahead.
    • “The four policy developments:
      • “340B outpatient drug reimbursement: CMS has proposed reducing reimbursement for 340B-acquired drugs from average sales price plus 6% to ASP-33.4%. 
      • “340B remedy offset: CMS has proposed increasing the offset from -0.5% to -3%, a change the agency estimates would reduce payments by $2.3 billion in 2027.
      • “Section 232 tariffs: New pharmaceutical tariffs and ongoing investigations into medical devices could affect supply chains and costs.
      • “Medicare Drug Price Negotiation Program: CMS has issued draft guidance for implementing negotiated prices in 2028, including drugs covered under Medicare Parts B and D.

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
    • “Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
    • “Ezplaz is a freeze-dried (lyophilized) plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, chosen to mitigate risk of giving to patients in emergencies before their blood type is determined.”
  • Contemporary OB/GYN relates,
    • “On July 29, 2026, the FDA approved norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris Inc.) as a once-weekly combined hormonal contraceptive (CHC) patch with a low dose of estrogen for women of childbearing potential with a body mass index (BMI) below 30 kg/m², the company announced in a news release.1
    • “The approval was granted under the FDA’s 505(b)(2) regulatory pathway and was supported by results from the phase 3 Luminous Study (NCT05139121).2 Norelgestromin and ethinyl estradiol delivers norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day over each 7-day wear interval. The patch, which is reversible and non-invasive, is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week.” * * *
    • “Viatris expects norelgestromin and ethinyl estradiol to be commercially available later in 2026.”
  • and
    • “Natural Cycles has received its sixth FDA clearance, this time for an updated version of the algorithm underlying its FDA-cleared birth control app. The company described the update as combining statistical modeling with machine learning trained on real-world fertility data to generate more individualized fertility predictions for users, according to a news release published July 27, 2026.”
  • Cancer Network tells us,
    • “The FDA has granted fast track designation to ISM6331, an AI-designed pan-TEAD inhibitor, for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed on or after prior anti–PD-1 antibody therapy, with or without anti–CTLA-4 antibody therapy, and platinum-based chemotherapy, according to a news release from the developer, Insilico Medicine.”
  • Cardiovascular Business points out,
    • “The U.S. Food and Drug Administration (FDA) has granted de novo market clearance for the first and only biomarker technology to directly see and quantity coronary inflammation from routine coronary CT angiography (CCTA). 
    • “The CaRi-Heart technology from Caristo Diagnostics has been heralded by numerous cardiac CT experts as a potential paradigm shift in cardiology. It is the first technology that can visualize and clearly quantify coronary inflammation using fat attenuation index (FAI) scores. This helps care teams estimate the residual risk of heart attacks in patients who otherwise appear to be managed well on optimal medical therapy.
    • “We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” Ron Blankstein, MD, director of cardiac CT at Brigham and Women’s and a former Society of Cardiovascular Computed Tomography (SCCT) president, said in a statement. “And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard CCTA, or calcium scoring alone. It is exciting to see Caristo’s long-awaited, pioneering solution available in the U.S.”
  • STAT News informs us.
    • “A group of outside experts convened Wednesday by the Food and Drug Administration concluded clinical data for a treatment for Duchenne muscular dystrophy from Capricor Therapeutics did not provide “substantial evidence” of efficacy.  
    • “The vote was 9-3, sending to the FDA a recommendation that the Capricor treatment, called deramiocel, should not be approved. 
    • “The FDA is not required to adhere to the expert panel’s stance, but it typically does. The agency review is still underway with a decision expected by Aug. 22. 
    • “The negative vote came at the end of an all-day meeting during which disputed results from a Phase 3 clinical trial were discussed and debated. Capricor’s presentation highlighted an analysis showing deramiocel preserved upper-arm function and staved off the heart failure most patients with Duchenne eventually experience.
    • “The FDA countered with a critique of the data that reached opposite conclusions — deramiocel was unable to separate from placebo at all. The agency also spent a good deal of time during Wednesday’s meeting calling out Capricor, saying it made major changes to the study’s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.” 
  • Beckers Hospital Review notes,
    • “The FDA has published 17 revised draft product-specific guidances for peptide products, updating its recommendations for the development and assessment of certain generic peptide drugs.” * * *
    • “The FDA said the updates provide recommendations in five areas: submission of recombinantly, synthetically or semi-synthetically produced peptides as abbreviated new drug applications, innate immune response testing, impurity thresholds, higher order structure assessment and biological activity assessment.
    • “The FDA also said it is withdrawing its May 2021 guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, because it no longer reflects the agency’s current scientific thinking. The Center for Drug Evaluation and Research plans to revise that guidance this year.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 12,000 pounds of smoked bacon imported from Canada were recalled because of lack of proper reinspection before entering the country, the Agriculture Department’s Food Safety and Inspection Service said.
    • “The bacon from Maple Leaf Foods was shipped to grocery distributors and retailers in Idaho, Oregon and Washington state. FSIS inspects imported products for packaging, documentation, condition and contamination.” * * *
    • “There are currently no confirmed cases of illness or injuries due to the products, FSIS said.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention yesterday reported 18,207 confirmed or suspected cases of cyclosporiasis across the U.S. from the current outbreak. The agency said it is investigating multiple case clusters, including an outbreak impacting nine states that is linked to iceberg lettuce. A July 17 Food and Drug Administration notice said that Taylor Farms recalled iceberg lettuce sourced from central Mexico that was distributed to 27 states, due to the potential of being contaminated with cyclospora.” 
  • The New York Times lets us know about “Nine Things Experts Wish You’d Do in Midlife to Increase Longevity.”
    • “How you treat your body and brain in your midlife years, loosely defined as 40 to 60, can hugely influence how you age in the decades to come.
    • “The seeds for many age-related diseases, including cardiovascular disease, diabetes, cancer and dementia, are sown in middle age, so it’s important to start thinking about prevention early. And it takes a lifetime of healthy habits, not just a few weeks, to move the needle on your longevity.
    • “Midlife is the ideal time to make changes, not only to benefit you in the present, but also in the future,” said Margie Lachman, a psychology professor at Brandeis University and the author of “Primetime: A New Vision for Midlife.”
    • “After all, she added, “What happens in midlife doesn’t stay in midlife.”
    • “We spoke with experts about some small habits that can make a big difference.”
  • Health Day tells us,
    • “Childhood obesity can be effectively treated through a family-based program provided through their local pediatrician, a new clinical trial says.
    • “About 42% of kids in the program lost enough weight to improve their heart health and lower their diabetes risk within a year and a half, researchers reported July 27 in JAMA Pediatrics.
    • “The program teaches families how to establish healthy eating and exercise habits, including positive reinforcement and supportive routines, researchers said.
    • “Our results show that an established, effective obesity treatment for children and adolescents can be successfully delivered in their pediatrician’s office,” lead researcher Amanda Staiano said in a news release. She is director of the Pediatric Obesity and Health Behavior Laboratory at Pennington Biomedical Research Center at Louisiana State University.”
  • Drug Topics informs us,
    • “Alcohol use, binge drinking, and heavy drinking have all increased significantly among pregnant women in the US from 2011 to 2024, according to a JAMA study. Likewise, with no end in sight for the trends in their findings, study authors consider them “concerning,” highlighting the need to address the growing trends among expecting mothers and their alcohol consumption.
    • “It is well established that alcohol is a teratogen, and numerous existing guidelines advise women to abstain from alcohol during pregnancy and while breastfeeding,” wrote the authors of a study in Drug and Alcohol Review. “However, many women consume alcohol in pregnancy even after learning they are pregnant. Worldwide, approximately 10% of women in the general population consume alcohol in pregnancy, although the European region has the highest rate of consumption (25%).
    • “The JAMA analysis revealed that from 2011 to 2024, the relative increase in current alcohol use among pregnant individuals reached 59%, and binge drinking rose by 77% and heavy drinking surged by a startling 166%. These absolute increases, 5.4%, 2%, and 1.2%, respectively, represent a significant shift in behavior that researchers indicate has no clear sign of reversal.”
  • Genetic Engineering and BioTechnology New lets us know,
    • “Engineers and neuroscientists at the University of California (UC) San Diego have developed a soft, wearable fingertip patch that continuously tracks a Parkinson’s disease (PD) patient’s levodopa medication levels by measuring chemicals in their sweat, with no batteries required. Tests in healthy volunteers and in Parkinson’s disease patients showed that measurements generated using the device were comparable to those obtained by standard laboratory blood tests.
    • “The wearable device offers a way to continuously track real-time concentrations of levodopa in the body and could enable doctors to precisely customize daily medication schedules for patients at home.
    • “The research was led by Tamoghna Saha, PhD, a postdoctoral researcher in the lab of Joseph Wang, DSc, professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering. Saha is co-first author of the team’s published paper in PNAS titled “A wearable patch for continuous levodopa monitoring in sweat: Towards exertion and power-free pharmacodynamic assessment in Parkinson’s disease.” In their paper the authors wrote in summary, “Overall, our easy-to-use, energy-efficient wearable supports real-time, stimulation-free monitoring, potentially enabling at-home dosage adjustments and paving the way for future autonomous closed-loop L-dopa therapeutic system development.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tavapadon (AbbVie Inc.) for Parkinson’s Disease.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On August 5, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.”
  • Per STAT News,
    • “For decades, efforts to develop non-opioid pain drugs were marked by failure. But what was once a graveyard of drug discovery is quickly turning into a race for a multibillion-dollar market, with Latigo Biotherapeutics publishing positive data on Wednesday for a therapy meant to rival a Vertex medicine already on the market.
    • “The startup’s Phase 2 trial enrolled 343 patients who’d gotten tummy tuck surgery; they were randomized to receive a high or low dose of Latigo’s experimental pill, a placebo, or a combination of acetaminophen and the opioid hydrocodone. Those given either dose of Latigo’s oral drug, LTG-001, showed statistically significant pain relief compared to placebo after 48 hours. And while participants in all groups had the option to use the opioid oxycodone if they needed additional pain management, those on a high dose of Latigo’s therapy were significantly less likely to do so than participants on placebo.” * * *
    • “The biotech plans to start a Phase 3 study later this year of patients who’ve had bunion removal surgery, with results expected in the second half of 2027.”

From the U.S. healthcare business and articifical intelligence fronts,

  • Beckers Payer Issues reports,
    • “Humana reported a $694 million profit for the second quarter, up more than 27% year over year, according to its July 29 earnings report.
    • “Revenue reached $40.8 billion, a 26% increase from the same period in 2025, driven by Medicare membership growth, higher per-member Medicare Advantage and standalone prescription drug plan premiums from increases in benchmark funding and the Part D direct subsidy, and a payer-agnostic CenterWell client base. Star ratings headwinds persisted.
    • “Total Medicare membership reached 11.1 million, up from 8.2 million in the comparable quarter. Total medical membership was 17.9 million, an increase from 14.8 million.
    • “The company’s benefit ratio was 91.1%, up from 89.7% in the second quarter of 2025, spurred by the star ratings revenue issue, new individual MA members with higher benefit ratios and an expectation of lower favorable prior period development. However, MA recontracting, pricing and clinical excellence efforts offset that growth.”
  • Beckers Hospital Review notes,
    • “Jaewon Ryu, MD, the founding CEO of Risant Health, will step down, and Dale Maxwell has been named interim CEO.
    • “According to a July 29 news release, Dr. Ryu made the decision to leave the role to focus on his family. Mr. Maxwell, former president and CEO of Albuquerque, N.M.-based Presbyterian Healthcare Services, will serve as interim CEO while the Risant Health board conducts a national search for a permanent successor.
    • “Washington, D.C.-based Risant Health is a nonprofit created by Oakland, Calif.-based Kaiser Permanente to expand value-based care by partnering with community health systems. As the organization’s inaugural CEO, Dr. Ryu built its leadership team and operating model and oversaw the additions of Danville, Pa.-based Geisinger, which operates 10 hospital campuses, and Greensboro, N.C.-based Cone Health, which has five hospitals and more than 150 locations.
    • “Jaewon has been instrumental in turning the vision for Risant Health into reality,” Greg Adams, chair and CEO of Kaiser Permanente and chair of the Risant Health board, said in the release. Mr. Adams said Dr. Ryu built an exceptional leadership team and positioned the organization to expand value-based care.”
  • Fierce Healthcare relates,
    • “AI doctor startup Doctronic aims to broaden its reach beyond adult primary care by acquiring text-based pediatric care platform Summer Health.
    • “The companies did not disclose the financial terms of the deal.
    • “Fast-growing Doctronic is an AI-native primary care provider that has supported 30 million health encounters in just two years. It offers a proprietary AI doctor and nationwide network of licensed clinicians delivering personalized medical guidance and video visits for $39, according to the company.
    • “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.”
  • and
    • “Hospitals should plan for their supply chain expenses to climb in 2027, with the prices for indirect spending categories like IT, construction and even food projected to grow at an even faster rate than those for drugs, Vizient warned in its most recent forecast report. 
    • “Vizient’s latest twice-yearly report mapped out overall supply chain price inflation of 3.39% for 2027, an increase of 0.61 percentage points compared to the forecast it released in February for the 12-month period beginning in H2 2026. 
    • “The primary culprits, Vizient research and intelligence director Jeff King told Fierce Healthcare, are AI demand and elevated costs of logistics and energy that are being felt across the world.”
  • and
    • “Alongside an update to its 2026 ratings, national nonprofit Leapfrog Group announced Monday the launch of an expanded ambulatory service center (ASC) reporting program. The expanded Leapfrog ASC Public Reporting Program, first unveiled in April, reports safety and quality information for facilities nationwide. More than 3,900 ASCs are now included in the 2026 ratings, along with more than 2,400 hospitals—which the nonprofit says is the highest level of participation in its 26-year history.”
  • Fierce Pharma points out,
    • “With increased sales of its newer drugs compensating for declining revenues from its multiple sclerosis (MS) portfolio, Biogen is once again positioned for a “growth story,” CEO Chris Viehbacher said Wednesday during the company’s second-quarter earnings call.
    • “To that end, Biogen reported revenue of $2.74 billion for the period, marking its highest quarterly haul since Q3 of 2021. With the result, the company flipped its 2026 revenue guidance from an expected mid-single digit decline in 2026 to a mid-single digit increase.  
    • “This quarter is a reflection of the significant progress Biogen has made repositioning the company for long-term growth,” Viehbacher added.
  • Beckers Hospital Review tells us what 17 pharmacy leaders think about “the biggest shifts they’re seeing in patient expectations.”
  • MedCity News informs us,
    • “For many people, managing a disease means chronic therapy. Scribe Therapeutics has a different vision: genetic medicines that offer durable effects for the masses. With its lead program on a path to report its first human data next year, Scribe has joined the public markets, raising $128.7 million. 
    • “While current genetic medicines are largely limited to rare disorders, we are engineering our technologies for use in common diseases affecting millions,” Scribe said in its IPO filing. “By targeting prevalent diseases with significant unmet need and high clinical burden, we aim to usher in a new era of broadly scalable, transformative, and preventative genetic medicines.”
    • * * * “Alameda, California-based Scribe has selected cardiometabolic disorders as its first focus. Lead therapeutic candidate STX-1150 is intended to lower the “bad” form of cholesterol, which is a risk factor for atherosclerotic cardiovascular disease (ASCVD). This therapy is designed to lower LDL-cholesterol by repressing expression of PCSK9, a protein that in high amounts, reduces the ability of the liver to clear cholesterol from the blood. Injectable PCSK9 inhibitors are already available from Amgen, Regeneron Pharmaceuticals, and Novartis. Last week, Merck received FDA approval for Lipfendra, an oral PCSK9 inhibitor. While dosing frequency for these therapies varies, all of them are taken chronically.”
  • STAT News reports,
    • “Hundreds of thousands of U.S. doctors use clinical large language models, pitched by companies like OpenEvidence, Doximity, and UpToDate as an antidote to the dangers of hallucination-prone generalist models from Big Tech. Yet few studies have pitted them against each other — and this summer brought a high-profile head-to-head. 
    • “Researchers from NYU Langone Health had tested general and clinical models, including OpenEvidence and UpToDate Expert AI, on three sets of clinical questions. The findings, published in Nature Medicine in June: The clinical AI performed worse than the general models. 
    • “The results rang out like a gunshot. “I’ve never seen a single paper trigger the kind of reactions this one has in the health AI community,” wrote Kaiser Permanente’s vice president of AI and emerging technologies on LinkedIn. The paper’s findings, like all science, are subject to interpretation and debate — but many online reactions treated them more like a clear victory for general frontier models.” * * *
    • “Scientists acknowledge that no one test will ever tell the whole story about clinical AI performance. And day-to-day, the choice of when and how to use large language models in care — by individual doctors, and increasingly health system leaders — is shaped by more than research.
    • “I don’t see the benchmarks really playing a role among doctors,” said OpenEvidence’s Nadler. “Academics like talking about them.” 
    • “The more important question, companies, doctors, and researchers agree, is how these tools impact patients. 
    • “Anytime a new technology is introduced into medicine, its impact on those outcomes depends on how it’s used by physicians. Are they using the tool safely and correctly, on the right patients, in the right situations?
    • “In the case of AI, that often comes down to trust. An accurate model inspires confidence, but it can still occasionally be wrong — potentially leading a physician astray, if they rely on it outright. Conversely, a good model can leave gains on the table if a physician doesn’t trust its output.” 


Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC

  • Politico reports,
    • “House GOP leaders released text Friday for a bill to fund the vast majority of the federal government from the start of the next fiscal year on Oct. 1 until after the midterm elections — bypassing the bipartisan appropriations process and daring Democrats to pick a shutdown fight months before voters head to the polls.
    • “Speaker Mike Johnson said Thursday he plans to put the legislation on the floor next week.
    • “The measure would fund the government through Dec. 4 and, as Republican leaders promised, would not include additional policy riders or unrelated provisions.”
  • Roll Call offers a wrap up of this week’s activities on Capitol Hill.
  • STAT News relates,
    • “Pretty much everyone who cares about public health agrees that it’s a good idea to help people quit smoking, the No. 1 cause of preventable death in the U.S. Doctors may soon get some extra encouragement to lend a hand, thanks to proposed changes in Medicare’s physician fee schedules.
    • “Physicians who offer counseling on quitting cigarettes or other tobacco products during visits with patients would get a 19% increase in reimbursement, according to a few paragraphs buried in the 1,592-page document released this week. The same adjustment would also apply to assessments of, and interventions for, alcohol and substance misuse during doctors’ visits.
    • “Given the evidence supported role these services play in preventing and managing chronic disease […] we believe that valuation should more accurately reflect the clinical intensity and work associated with these time-based services,” the proposal from the Centers for Medicare and Medicaid Services explains. Comments on the proposal are due Sept. 14. 
    • “The prioritization of cessation as a service is long overdue, and we’re very excited about it,” said Anne DiGiulio, the American Lung Association’s senior director of nationwide tobacco cessation and health policy.”
  • Health Day adds,
    • “For people assigned to smoking very low nicotine-content cigarettes (VLNCs), there is minimal evidence for compensation for reduced nicotine levels, according to a review published online July 15 in JAMA Network Open.
    • “Rachel L. Denlinger-Apte, Ph.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues examined whether people who smoke may increase their smoking to compensate for the reduced nicotine levels when smoking VLNCs for prolonged periods. Data were obtained from 17 randomized controlled trials published between 2010 and 2024, representing 5,500 adolescents and adults who smoked cigarettes daily or nondaily. A subset of 2,454 participants from seven trials were included in the pooled meta-analysis.”
  • Food Dive relates,
    • “The FDA’s acting head of food on Tuesday [July 14] admitted crafting its highly anticipated definition of ultraprocessed foods is proving “quite challenging,” though he added it’s still a “priority” for the agency.
    • “Just because it’s a tough challenge, it doesn’t mean it’s something that we should shy away from,” Donald Prater, FDA’s acting deputy commissioner for food, said during a keynote at the IFT First conference in Chicago.
  • Genetic Engineering and Biotechnology News adds,
    • “Ketogenic diets, originally developed in the 1920s to treat epilepsy, have been adapted in the past few decades as a strategy to lose weight or increase lifespan. This type of diet (a high percentage of fat, low percentage of carbohydrates, and normal or reduced amounts of protein) forces the body to burn fatty acids for energy in place of carbohydrates such as glucose. Burning these lipids produces ketone bodies—primarily β-hydroxybutyrate (BHB) and acetoacetate—as byproducts of fatty acid metabolism. The impact of ketogenic diets on the gastrointestinal tract remains poorly understood.
    • “In recent years, scientists investigated whether this type of diet might affect the development of cancer. While some research has shown that the diet may protect against the development of colon cancer, a new study suggests that in the small intestine, a ketogenic diet may increase the risk of cancer—with a mechanism through fatty acid oxidation rather than ketone metabolism.”
    • “This work appears in Nature in the paper, “Ketogenic diet mediates intestinal tumorigenesis through lipids not ketones.”

From the Food and Drug Administration,

  • Fierce Pharma reports,
    • “With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication.
    • “On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug’s accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression. 
    • “The original, speedy IgAN approval for the first-in-class factor B complement inhibitor came two years ago to reduce proteinuria.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has shared updated recommendations about recalled thoracic stent grafts. Customers were previously told they could still use the devices as long as they were aware of the risk and knew how to respond if an issue occurred. Now, however, the FDA is emphasizing that these devices should be returned to the manufacturer and not be used to treat any other patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has temporarily halted provisions of a rule from the Trump administration meant to reshape the Affordable Care Act exchanges days before they were scheduled to go into effect.
    • “On Thursday, a Maryland district court determined the coalition of cities and provider groups that filed a lawsuit challenging the rule would suffer “irreparable harm” from the policies, including the expansion of bare-bones catastrophic coverage and stricter verification of enrollees’ eligibility for subsidies.
    • “The stay is a victory for insurers, given it staves off further disruption to the already destabilized ACA marketplaces. However, the relief may be short-lived, as some of the policies codified in the GOP’s “Big Beautiful Bill” will be enacted in 2028.”

From the public health and medical / Rx research front,

  • The Centers for Medicare and Medicaid Services announced today,
    • “As of July 17, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “COVID-19 activity is very low and stable nationally but is beginning to show early signs of an increase, mainly in the South.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Rhinovirus/enterovirus (RV/EV) activity is elevated in some regions. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 29 newly confirmed cases, the the US measles total is just 29 cases short of last year’s sobering total, the Centers for Disease Control and Prevention (CDC) said in an update today.
    • “The CDC announced 2,260 confirmed cases so far in 2026, all but 15 of them locally acquired. The total for all of last year was 2,289 infections, which was the most since 1991. The country could lose its measles elimination status this fall, which it gained in 2000.
    • Of the 2,260 cases for the year, 20% of infections are in children age 5 and under, and 70% involve kids and young adults to age 19. Six percent of patients have been hospitalized, compared with 10% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status. 
    • “No measles deaths have been reported this year, compared with three in 2025.”
  • MedPage Today adds,
    • “Declining U.S. vaccination rates have led to a resurgence in large measles outbreaks.
    • “Two papers examining South Carolina and Utah’s outbreak showed that hypoxemia and pneumonia were the most common conditions leading to hospitalization for measles.
    • “In the South Carolina report, two of 13 hospitalized patients developed measles encephalitis, a life-threatening complication that can cause brain damage.”
  • The American Hospital Association points out,
    • “A Centers for Disease Control and Prevention report released July 16 found that wastewater surveillance failed to detect an internationally circulating measles genotype that accounted for about 5% to 10% of U.S. measles cases in 2025, highlighting potential challenges of using wastewater surveillance as a public health tool. The report said that of two unrelated measles cases reported to the Wisconsin Department of Health Services in February 2026, wastewater surveillance detected one case before the case was reported. The second, caused by the international B3 genotype, was undetected. Public health officials later released a modified laboratory procedure that improved the detection of the B3 genotype. The CDC said that wastewater testing should be standardized and revalidated against circulating viruses and supported by publicly available whole-genome sequencing data.”
  • The Washington Post reports,
    • “Taylor Farms announced Friday that it is “voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market,” after federal investigators identified some of the lettuce it provided to Taco Bell restaurants as linked to one of the largest U.S. outbreaks of cyclosporiasis this summer. 
    • “The company said in a statement that it made the decision based on information provided by the Food and Drug Administration, whose investigators had traced the outbreak to “a specific independent farm” representing less than 1 percent of the U.S. iceberg lettuce supply. The company added that it would remove all iceberg lettuce from the region indefinitely “out of an abundance of caution.”
    • “The company said no other Taylor Fresh Foods products across the country are impacted. It said no Taylor Farms branded salad kits contain iceberg lettuce.” * * *
    • “Other companies have begun to respond to a parasite-borne illness that has sickened thousands, and the federal health investigation has widened beyond Taco Bell restaurants. Sysco, one of the world’s largest food suppliers, on Thursday voluntarily stopped distributing certain iceberg lettuce products from Mexico after the agency said it was tracing where the contaminated lettuce may have been distributed throughout the food supply.”
  • The Wall Street Journal explains “What to Know About the Cyclosporiasis Outbreak and How to Stay Safe”
    • “More than 30 states have reported cases of the illness. Taco Bell’s lettuce is linked to cases in at least five states.” * * *
    • “Norovirus is a highly contagious virus that can cause vomiting and diarrhea, but it typically comes on within 12 to 48 hours of exposure and lasts one to three days. 
    • “Cyclospora, on the other hand, can cause weeks of relapsing diarrhea where someone gets sick, feels better, and then gets sick again, said Caitlin Rivers, director of the Center for Outbreak Response Innovation and an associate professor at the Johns Hopkins Bloomberg School of Public Health. “It lasts much longer than a stomach bug where you’re sick for a day and you bounce back.” 
    • “Another big difference: Many foodborne illnesses, like norovirus, are highly infectious and spread between humans through something as simple as touching a doorknob. 
    • “One piece of good news: Cyclosporiasis is rarely contagious between people.” 
  • The Washington Post tells us,
    • “Plumes of thick, toxic wildfire smoke from fires burning in Canada are billowing into the United States. The phenomenon, where smoke blots out the blue sky overhead, making the air appear milky-white or even orange, has become a relatively regular fixture of summers where out-of-control wildfires in the West bring noxious smoke downwind.” * * *
    • “There’s essentially a west-to-east conveyor belt that’s pumping high-altitude smoke eastward. That’s because the smoke is surfing the jet stream, a river of swiftly moving winds in the upper atmosphere. The jet stream is cresting around a ridge of high pressure parked over the central states.
    • “The smoke is also being steered by persistent troughing, or areas of low pressure, east of the Hudson Bay in northern Quebec. That counterclockwise-spinning low induces northwesterly winds, which are winds that blow from the northwest and pump the smoke in a southeast direction.
    • “That brings surface-level smoke into the Lower 48 in copious quantities. Medium-range weather models suggest a similar pattern continues into late July, meaning smoke will continue taking this trajectory.” * * *
    • “As of early Friday morning, Chicago, Detroit, D.C. and New York City were the most polluted major cities in the world — exceeding Delhi and Kolkata, India; Jakarta, Indonesia; and most major cities in China.”
  • Kaufmann Hall notes,
    • “Less than half of adults in rural communities have had a routine medical visit or cancer screening in the past year, according to a recent survey by the Prevent Cancer Foundation. The broader survey of U.S. adults found that half of all respondents expressed concerns and confusion about the cost of medical screenings. Nearly 15% of respondents also expressed concerns about the costs of follow-up appointments and lost wages. The news comes as the American Association for Cancer Research’s latestprogress report finds that declines in cancer death rates have been slower among rural residents than those living in urban areas.”
  • The Wall Street Journal journalist lets us know “I Tested My Blood for Microplastics. I Got a Number, but Few Answers.
    • “Plastics are accumulating in our bodies, but scientists aren’t sure how bad that is for our health.”
    • “Microplastics are ubiquitous. Bottled water and processed food are big culprits. So is clothing, furniture and just about everything else.
    • “It’s hard to find things that are not made of plastic,” says Phoebe Stapleton, an associate professor in the department of pharmacology and toxicology at the Ernest Mario School of Pharmacy at Rutgers University. 
    • “And they get into our bodies through both ingestion and inhalation. There hasn’t been a tissue or organ in the body where microplastics haven’t been found. Lungs, heart, kidneys, liver, brain, testicles, the fluid in our eyes, and ovaries—all have microplastics, says Stapleton.
    • “No wonder there’s more interest in testing. The blood test has been commercially available since 2023. I purchased it for $135 through Bryan Johnson’s longevity health site, Blueprint.” 
  • STAT News informs us,
    • “For the last year, a small California startup has been making extraordinary claims about the ability of its technology to potentially treat Duchenne muscular dystrophy — and maybe a slew of other genetic diseases, too.
    • “The company, Sonothera, does not yet have clinical data. But it’s presented data in animals so stunning that other experts can’t quite wrap their minds around it.” * * *
    • “The technology in question is ultrasound — yes, the same technology used for imaging pregnancies. Sonothera is using it to deliver replacement genes into the muscles of mice and monkeys.
    • “The approach marks a radical departure in the gene-therapy field, which has long relied on viruses to ferry genes into cells. Those viruses, while occasionally powerful, have severe drawbacks. They can only deliver genes of a certain size and can only be administered once, after which patients develop immunity. If the first treatment didn’t get enough of the gene to enough cells — well, you’d better have some other fix.” * * *
    • “Answers may come soon in clinical trials. Sonothera’s backers point to multiple pieces of supporting evidence, including improved muscle function in mice. And the company is still optimizing its therapy. 
    • “For humans, Sonothera’s goals are far more modest than what was achieved in some of its studies: a 15% increase in dystrophin, while creating protein in at least 20% of a patient’s muscle fibers.”
  • Per BioPharma Dive,
    • “GSK is discontinuing trials of an experimental chronic cough medicine it bought in a $2 billion deal three years ago, announcing Friday that camlipixant had failed to meet nearly all of the goals in two Phase 3 trials. The British pharmaceutical giant said the “limited efficacy demonstrated is unlikely to transform patient care.”
    • “The termination closes a blockbuster opportunity for GSK, which hoped to add camlipixant to a portfolio of respiratory drugs that includes asthma and COPD treatments like Trelegy and Anoro. The company said it is continuing Phase 2 trials in people with irritable bowel syndrome.
    • “Camlipixant’s failure follows that of two others in the “P2X3 antagonist” class that were developed by Bayer and Merck & Co, the latter of which spent more than $500 million to gain control of its drug. The setback also clears away a threat to Trevi Therapeutics, which is advancing a different type of treatment in chronic cough.”
  • and
    • “Merck & Co.’s partner Kelun-Biotech said its experimental medicine sac-TMT helped patients with a form of lung cancer stave off disease progression better than a standard regimen including chemotherapy in a new Phase 3 study.
    • “The trial, conducted in China, included patients with locally advanced or metastastic non-squamous non-small cell lung cancer whose tumor cells don’t have enough of a protein called PD-L1. When working properly, PD-L1 helps the immune system focus on killing diseased cells instead of healthy ones. But too much or too little of this protein can throw the system off kilter.
    • “Kelun previously saw success with sac-TMT in PD-L1-positive patients and is now tackling the “negative” patients who represent what it calls a “therapeutic bottleneck.” Sac-TMT is the first so-called antibody drug conjugate to succeed in a Phase 3 study of this patient population in combination with an immunotherapy like Keytruda, Kelun said Tuesday [July 14].”

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

  • Beckers Hospital Review reports,
    • “Vascular surgery is projected to have the highest shortages of physicians, the Health Resources and Services Administration’s National Center for Health Workforce Analysis found.
    • “The HRSA workforce simulation model assesses the adequacy of the nation’s projected workforce supply for 35 physician specialties from 2023 through 2038.
    • “Across all specialties, there is a projected shortage of 141,160 full-time equivalent physicians by 2038. Only five of the 35 physician specialties are expected to see a surplus of workers. The shortages in some specialties can be mitigated by increasing the use of nurse practitioners and physician assistants, according to the center.”
  • and 
    • “Novant Health is the latest health system to launch round-the-clock virtual primary care that uses AI to assess patients before connecting them with a clinician, joining at least seven other systems offering similar 24/7 care models.”
    • The article lists seven other health systems using this model.
  • and
    • The pandemic revealed a demand for telehealth, forcing the healthcare industry to rethink how and where care could be delivered. 
    • Patients and providers alike discovered that high-quality care doesn’t have to mean an in-person visit. Hospitals, health systems and healthcare companies rapidly expanded their telehealth offerings accordingly.
    • The momentum hasn’t slowed, and today’s telehealth landscape is defined by smarter platforms, broader access and solutions designed to bring expert care directly to patients regardless of geography, mobility, or circumstance. 
    • [The article lists] 272 telehealth companies to know. 
  • STAT News relates,
    • “Every day, doctors turn to specialized calculators to make decisions about their patients’ care. Kidney performance? There’s a calculator for that. Chance of a successful vaginal birth after a previous C-section? There’s a calculator for that. 
    • “Medicine has accumulated hundreds of these clinical scores and decision-making tools, and their numbers continue to grow along with the scale of clinical data. But just because a calculator exists doesn’t mean doctors should always trust its output. 
    • “In clinical practice, a lot of the tools that we use, we genuinely have no idea how limited it is in its validation,” said health systems researcher and gastroenterologist Shazia Siddique. That is why MDCalc, the company Siddique joined last year, is launching a quality-rating system to apply to the more than 800 clinical tools and calculators that doctors use through its site.”
  • Per Fierce Pharma,
    • “Following the Independence Day holiday, the overall GLP-1 market was down 5.1% week over week as measured by total prescriptions across obesity and diabetes uses, according to IQVIA data cited by Citi.
    • “In the obesity field specifically, total scripts for Eli Lilly’s Zepbound shrank by 3.1% sequentially to a little below 660K, while Novo Nordisk’s Wegovy dipped 4.4% to about 448.5K.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 
  • Per BioPharma Dive,
    • “Cash-strapped biotechnology company Jasper Therapeutics has gained a financial lifeline through a merger with a privately held immune drug developer.
    • “Jasper said Thursday it has completed an all-stock acquisition of Kira Pharmaceuticals and, alongside that deal, raised $132 million in a private stock offering. The new funding will enable Jasper, which had just $14 million in cash at the end of March, to operate through the second half of 2028. The combined company will retain the Jasper stock ticker, but have a bigger pipeline that now includes two immune disease drugs Kira has been developing.” 

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.”